Nistaken may be available in the countries listed below.
Propafenone hydrochloride (a derivative of Propafenone) is reported as an ingredient of Nistaken in the following countries:
International Drug Name Search
Rifabutina may be available in the countries listed below.
Rifabutina (DCIT) is known as Rifabutin in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Ribocine may be available in the countries listed below.
Chloramphenicol is reported as an ingredient of Ribocine in the following countries:
International Drug Name Search
Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa
Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.
Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;
a history of a stroke, blood clot, or circulation problems;
a hormone-related cancer such as breast or uterine cancer;
unusual vaginal bleeding that has not been checked by a doctor;
liver disease or liver cancer;
severe migraine headaches; or
a history of jaundice caused by pregnancy or birth control pills.
To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:
high blood pressure or a history of heart disease;
high cholesterol, gallbladder disease, or diabetes;
migraine headaches or a history of depression; or
a history of breast cancer or an abnormal mammogram.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.
Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.
The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.
Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.
Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.
If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.
If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.
If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.
Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
sudden numbness or weakness, especially on one side of the body;
sudden severe headache, confusion, problems with vision, speech, or balance;
sudden cough, wheezing, rapid breathing, coughing up blood;
pain, swelling, warmth, or redness in one or both legs;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
a change in the pattern or severity of migraine headaches;
pain in your upper stomach, jaundice (yellowing of the skin or eyes);
a lump in your breast;
swelling in your hands, ankles, or feet; or
symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
mild nausea or vomiting, appetite or weight changes;
breast swelling or tenderness;
headache, nervousness, dizziness;
problems with contact lenses;
freckles or darkening of facial skin, loss of scalp hair; or
vaginal itching or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:
acetaminophen (Tylenol) or ascorbic acid (vitamin C);
bosentan (Tracleer);
prednisolone (Orapred);
St. John's wort;
theophylline (Elixophyllin, Theo-24, Uniphyl);
an antibiotic;
HIV or AIDS medications;
phenobarbital (Solfoton) and other barbiturates; or
seizure medication.
This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Junel/20 side effects (in more detail)
Ribofluor may be available in the countries listed below.
Fluorouracil is reported as an ingredient of Ribofluor in the following countries:
International Drug Name Search
Medical Encyclopedia:
Alfuzosin-Mepha may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosin-Mepha in the following countries:
International Drug Name Search
Zolpidemtartraat Stada may be available in the countries listed below.
Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Zolpidemtartraat Stada in the following countries:
International Drug Name Search
Riachol may be available in the countries listed below.
Chloramphenicol is reported as an ingredient of Riachol in the following countries:
International Drug Name Search
Ticarcillina may be available in the countries listed below.
Ticarcillina (DCIT) is known as Ticarcillin in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Riacetamid may be available in the countries listed below.
Sulfacetamide is reported as an ingredient of Riacetamid in the following countries:
International Drug Name Search
Treating ear infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.
Pediazole is a macrolide and sulfonamide antibiotic combination. It works by slowing the growth of and killing sensitive bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Pediazole. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Pediazole. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Pediazole may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Pediazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Pediazole.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; headache; loss of appetite; mild diarrhea; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or dark urine; bloody stools; change in the amount of urine; decreased hearing or hearing loss; fainting; fast or irregular heartbeat; fever, chills, or sore throat; mood or mental changes; numbness or tingling of the hands or feet; pale skin; red, swollen, blistered, or peeling skin; ringing in the ear; seizures; severe or persistent diarrhea, dizziness, or headache; severe stomach pain; stomach cramps; shortness of breath; sore mouth or tongue; symptoms of liver problems (eg, yellowing of skin or eyes; pale stools; severe or persistent nausea, vomiting, or loss of appetite; dark urine); unusual bruising or bleeding; unusual weakness or fatigue; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Pediazole side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blood in the urine; high fever; loss of consciousness; severe or persistent loss of appetite; severe nausea, dizziness, drowsiness, headache, or vomiting.
Store Pediazole in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away any unused medicine after 14 days. Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep Pediazole out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Pediazole. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Roxithromycine Zydus may be available in the countries listed below.
Roxithromycin is reported as an ingredient of Roxithromycine Zydus in the following countries:
International Drug Name Search
Generic Name: scopolamine transdermal (skoe PAL a meen)
Brand Names: Transderm-Scop
Scopolamine reduces the secretions of certain organs in the body, such as the stomach.
Scopolamine transdermal is used to prevent nausea and vomiting caused by motion sickness or from anesthesia given during surgery.
Scopolamine transdermal may also be used for other purposes not listed in this medication guide.
Before using scopolamine transdermal, tell your doctor if you have glaucoma, kidney or liver disease, epilepsy or other seizure disorder, a blockage in your intestines, or if you have a bladder obstruction or are unable to urinate.
Before using scopolamine transdermal, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by scopolamine.
Scopolamine slows the digestive tract, which can make it harder for your body to absorb any medicines you take by mouth. Tell your doctor if any of your oral medications do not seem to work as well while you are using scopolamine transdermal.
Call your doctor at once if you have a serious side effect such as eye pain or redness, seeing halos around lights, blurred vision and increased sensitivity to light, hallucinations, unusual thoughts or behavior; or urinating less than usual.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
glaucoma;
epilepsy or other seizure disorder;
a blockage in your intestines; or
if you have a bladder obstruction or are unable to urinate.
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
The scopolamine transdermal skin patch is applied to a hairless area of skin just behind your ear.
For preventing motion sickness, the skin patch should be applied at least 4 hours before you will be exposed to a situation that may cause motion sickness.
For preventing nausea and vomiting after surgery, the skin patch is usually applied the evening before surgery. Keep wearing the patch for 24 hours after your surgery, then remove it and throw it away.
If the skin patch falls off, replace it with a new one.
One patch may be worn for up to 3 days. If you need to use the medication for longer than 3 days, remove the patch and place a new one behind your other ear.
After removing a patch, fold it closed with the sticky side in, and throw it away in a place where pets and children cannot reach it.
You may have withdrawal symptoms such as nausea, vomiting, headache, muscle weakness, and severe dizziness when you stop using scopolamine transdermal. Talk to your doctor about how to avoid withdrawal symptoms when you stop using this medication.
This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using scopolamine transdermal.
Since this medication is used only when needed, you will not be on a dosing schedule. For best results, the patch should be applied at least 4 hours before motion sickness may occur.
If you forget to apply the patch as directed before surgery, contact your doctor for instructions. Do not use extra patches to make up for applying the medication later than directed.
Overdose can cause vision problems, hallucinations, dry mouth, hot or dry skin, fast heartbeat, and seizure, or urinating less than usual.
eye pain or redness, seeing halos around lights;
blurred vision and increased sensitivity to light;
confusion, agitation, extreme fear, hallucinations, unusual thoughts or behavior; or
urinating less than usual or not at all.
Less serious side effects may include:
drowsiness, dizziness;
dry mouth;
dry or itchy eyes;
feeling restless;
memory problems; or
mild itching or skin rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Scopolamine slows the digestive tract, which can make it harder for your body to absorb any medicines you take by mouth. Tell your doctor if any of your oral medications do not seem to work as well while you are using scopolamine transdermal.
There may be other drugs that can interact with scopolamine transdermal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Roximycin may be available in the countries listed below.
Roxithromycin is reported as an ingredient of Roximycin in the following countries:
International Drug Name Search
Roxifen may be available in the countries listed below.
Piroxicam is reported as an ingredient of Roxifen in the following countries:
International Drug Name Search
Rifampicina L.CH. may be available in the countries listed below.
Rifampicin is reported as an ingredient of Rifampicina L.CH. in the following countries:
International Drug Name Search
Klaroxin may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Klaroxin in the following countries:
International Drug Name Search
Orgacef may be available in the countries listed below.
Cefradine is reported as an ingredient of Orgacef in the following countries:
International Drug Name Search
Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat certain children who are not growing normally due to Turner syndrome or other conditions (eg, chronic kidney problems, idiopathic short stature). It may also be used for other conditions as determined by your doctor.
Somatropin (rDNA origin - Refrigerated) is a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Somatropin (rDNA origin - Refrigerated). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Somatropin (rDNA origin - Refrigerated). Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Somatropin (rDNA origin - Refrigerated) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Somatropin (rDNA origin - Refrigerated) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Somatropin (rDNA origin - Refrigerated).
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.
Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Somatropin (rDNA origin - Refrigerated) side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.
Before mixing, store Somatropin (rDNA origin - Refrigerated) in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from heat, moisture, and light. Do not use Somatropin (rDNA origin - Refrigerated) past the expiration date on the product label. After mixing, store Somatropin (rDNA origin - Refrigerated) according to the product label. Contact your pharmacist if you have any questions about the proper storage of Somatropin (rDNA origin - Refrigerated). Keep Somatropin (rDNA origin - Refrigerated), as well as needles and syringes, out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Somatropin (rDNA origin - Refrigerated). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
sul-fin-PIR-a-zone
Available Dosage Forms:
Therapeutic Class: Antigout
Sulfinpyrazone is used in the treatment of chronic gout (gouty arthritis), which is caused by too much uric acid in the blood. The medicine works by removing the extra uric acid from the body. Sulfinpyrazone does not cure gout, but after you have been taking it for a few months it may help prevent gout attacks. sulfinpyrazone will help prevent gout attacks only as long as you continue to take it.
Sulfinpyrazone is sometimes used to prevent or treat other medical problems that may occur if too much uric acid is present in the body.
Sulfinpyrazone may also be used for other conditions as determined by your doctor.
Sulfinpyrazone is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sulfinpyrazone, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to sulfinpyrazone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on sulfinpyrazone have been done only in adult patients, and there is no specific information comparing use of sulfinpyrazone in children with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of sulfinpyrazone in the elderly with use in other age groups.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sulfinpyrazone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using sulfinpyrazone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using sulfinpyrazone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of sulfinpyrazone. Make sure you tell your doctor if you have any other medical problems, especially:
If sulfinpyrazone upsets your stomach, it may be taken with food. If this does not work, an antacid may be taken. If stomach upset (nausea, vomiting, or stomach pain) continues, check with your doctor.
In order for sulfinpyrazone to help you, it must be taken regularly as ordered by your doctor.
When you first begin taking sulfinpyrazone, the amount of uric acid in the kidneys is greatly increased. This may cause kidney stones in some people. To help prevent this, your doctor may want you to drink at least 10 to 12 full glasses (8 ounces each) of fluids each day, or to take another medicine to make your urine less acid. It is important that you follow your doctor's instructions very carefully.
For patients taking sulfinpyrazone for gout:
The dose of sulfinpyrazone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sulfinpyrazone. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of sulfinpyrazone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Your doctor should check your progress at regular visits to make sure that sulfinpyrazone does not cause unwanted effects.
Before you have any medical tests, tell the person in charge that you are taking sulfinpyrazone. The results of some tests may be affected by sulfinpyrazone.
For patients taking sulfinpyrazone for gout or to help remove uric acid from the body:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: sulfinpyrazone side effects (in more detail)
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Esextin may be available in the countries listed below.
Haloperidol is reported as an ingredient of Esextin in the following countries:
International Drug Name Search
Robitussin DM Extra may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Robitussin DM Extra in the following countries:
Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Robitussin DM Extra in the following countries:
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Targinact
5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged-release tablets
Oxycodone hydrochloride and Naloxone hydrochloride
These tablets contain the active ingredients oxycodone hydrochloride and naloxone hydrochloride. Oxycodone is for the pain-killing effect of the tablets. It is a strong analgesic ('painkiller') that belongs to a group of medicines called opioids. Naloxone is intended to bring relief from constipation. Constipation is a typical side effect of treatment with strong painkillers.
You have been prescribed these tablets for the treatment of severe pain, which requires the use of a strong painkiller (opioid analgesic).
These are prolonged-release tablets. This means that the active ingredients are slowly released from the tablets over a period of 12 hours.
Do not take Targinact tablets
If any of these warnings apply to you, talk to your doctor before starting to take these tablets.
These tablets are not recommended for use in patients with advanced digestive or pelvic cancers where bowel obstruction may be a problem.
If you experience severe diarrhoea at the start of treatment (within the first 3-5 days) this may be due to the effect of naloxone. It may be a sign that your bowel movements are returning to normal. If diarrhoea persists after 3-5 days, or it gives you cause for concern, please contact your doctor.
If you have been using high doses of another opioid, withdrawal symptoms (such as restlessness, bouts of sweating or muscle pain) may occur when you initially switch to taking these tablets. If you experience withdrawal symptoms, you may need to be specially monitored by your doctor.
If you need to undergo surgery, please tell your doctor that you are taking these tablets.
If you have been taking these tablets for a long time, you may become tolerant. This means you may need a higher dose to achieve the desired pain relief. Long-term use of these tablets may also lead to addiction. Withdrawal symptoms may occur if treatment is stopped too suddenly. If you no longer need treatment, you should reduce your daily dose gradually, in consultation with your doctor.
As with other strong opioid painkillers, there is a risk that you may develop a psychological dependence to oxycodone.
You may notice remains of the tablet in your stools. Do not be alarmed, as the active ingredients will have already been released in the stomach and gut, and absorbed into your body.
You must swallow these tablets whole so as not to affect the slow release of oxyecodone. Do not break, chew or crush these tablets. Taking broken, chewed or crushed tablets may result in your body absorbing a potentially fatal dose of oxycodone (see under 'If you take more Targinact tablets than you should').
These tablets are not suitable for withdrawal treatment.
These tablets should never be abused, particularly if you have a drug addiction. If you are addicted to drugs such as heroin, morphine or methadone, severe withdrawal symptoms are likely if you abuse these tablets because they contain the ingredient naloxone. Pre-existing withdrawal symptoms may be made worse.
You should never misuse the tablets by dissolving and injecting them (e.g. into a blood vessel). They contain talc, which can cause destruction of local tissue (necrosis) and changes in lung tissue (lung granuloma). Misuse can also have other serious consequences which may be fatal.
The use of these tablets may produce positive results in drugs tests.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The risk of side effects is increased if you take these tablets at the same time as medicines which affect the way the brain works. For example, you may feel very sleepy, or breathing problems may get worse.
Examples of medicines that affect the way the brain works include:
If you are taking these tablets at the same time as medicines that decrease the blood's clotting ability (coumarin derivatives), this clotting time may be speeded up or slowed down.
These tablets should not be taken with alcohol. Alcohol use could increase the risk of experiencing serious side effects, such as sleepiness, drowsiness and slow and shallow breathing.
Ask your doctor or pharmacist for advice before taking any medicine.
Use of these tablets during pregnancy should be avoided unless your doctor thinks treatment with this medicine is essential. If used over prolonged periods during pregnancy, oxycodone may lead to withdrawal symptoms in the newborn baby. If oxycodone is given during childbirth, the baby may have breathing problems (respiratory depression).
Breastfeeding should be stopped during treatment with these tablets as oxycodone (one of the active ingredients of your medicine) passes into breast milk.
These tablets may affect your ability to drive or operate machines. This is most likely at the start of your treatment, after a dose increase or after switching from a different medication. These side effects should disappear once you are on a stable dose.
Ask your doctor whether you may drive or operate machines.
These tablets contain lactose (milk sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking these tablets.
Always take these tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride every 12 hours.
Your doctor will decide how much you should take every day and how to divide your total daily dose into morning and evening doses. They will also decide on any necessary dose adjustments during treatment depending on your level of pain and individual sensitivity. You should be given the lowest dose needed for pain relief. If you have already been treated with opioids, your treatment with these tablets may be started at a higher dose.
The maximum daily dose is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. If you need a higher dose, your doctor may give you additional oxycodone without naloxone. However, the maximum daily dose of oxycodone should not exceed 400 mg. The beneficial effect of naloxone on bowel movements may be affected if additional oxycodone is given without additional naloxone.
If you experience pain between doses, you may need to take an additional fast-acting painkiller. These tablets are not suitable for this. Please talk to your doctor.
If you feel that these tablets are too strong or too weak, please talk to your doctor or pharmacist.
If you have kidney or mild liver problem your doctor may prescribe a lower dose. You must not take these tablets if you have moderate or severe liver problems, (see also section 2 'Do not take Targinact tablets' and 'Take special care with Targinact tablets').
No studies have been carried out to show that these tablets work properly in children and adolescents, or are safe for them to take. They are therefore not recommended for use in patients under 18 years of age.
In general, no dose adjustment is necessary for elderly patients with normal kidney and/or liver function.
Swallow your tablets whole with a glass of water. You can take these tablets with or without food. Take them every 12 hours. For instance, if you take a tablet at 8 o' clock in the morning, you should take your next tablet at 8 o'clock in the evening. Do not break, chew or crush the tablets.
You should not take these tables for any longer than you need to. If you have been taking them for a long time your doctor should regularly check that you still need them.
If you have taken more than the prescribed dose, you must inform your doctor immediately.
An overdose may result in:
In severe cases, loss of consciousness (coma), fluid on the lungs and circulatory collapse may occur, which may be fatal.
You should avoid situations which require you to be alert, e.g. driving.
or if you take a lower dose than the one prescribed, you may not feel any pain-killing effect.
Do not take more than one dose within any 8 hour period.
Do not take a double dose to make up for a forgoten tablet.
Do not stop taking these tablets without first speaking with your doctor. If you do not require any further treatment, your doctor will advise you how to reduce the daily dose gradually. In this way, you will avoid withdrawal symptoms, such as restlessness, bouts of sweating and muscle pain.
If you have any futher questions on the use of these tablets, ask your doctor or pharmacist.
Like all medicines, these tablets can cause side effects, although not everybody gets them.
The following terms are used to explain how frequently patients experience side effects:
Very common: affecting more than 1 in 10 people taking these tablets
Common: affecting between 1 and 10 in 100 people taking these tablets
Uncommon: affecting between 1 and 10 in 1,000 people taking these tablets
Rare: affecting between 1 and 10 in 10,000 people taking these tablets
Very rare: affecting fewer than 1 in 10,000 people taking these tablets
Not known:frequency not known
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). It mostly occurs in elderly and weak patients. Opioids can also cause a severe drop in blood pressure in susceptible patient. If you are affected by these important side effects, consult a doctor immediately.
Common
Uncommon
Rare
Very rare
Breathing problems, such as breathing more slowly or weakly than expected (respiratory depression), reduction in size of the pupils in the eye, muscle cramps and decreased cough reflex.
Common
Uncommon
Rare
Very rare
Unknown
If any of the side effects become serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use any tablets after the expiry date which is stated on the carton and blister, after 'EXP...' The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Targinact tablets contain
The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.
Each 5 mg/2.5 mg tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg oxycodone), and 2.73 mg naloxone hydrochloride dihydrate (equivalent to 2.5 mg naloxone hydrochloride and 2.25 mg naloxone).
Each 10 mg/5 mg tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg oxycodone), and 5.45 mg naloxone hydrochloride dihydrate (equivalent to 5 mg naloxone hydrochloride and 4.5 mg naloxone).
Each 20 mg/10 mg tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg oxycodone) and 10.9 mg naloxone hydrochloride dihydrate (equivalent to 10 mg naloxone hydrochloride and 9 mg naloxone).
Each 40 mg/20 mg tablet contains 40 mg of oxycodone hydrochloride (equivalent to 36 mg oxycodone and 21.8 mg naloxone hydrochloride dihydrate (equivalent to 20 mg of naloxone hydrochloride and 18 mg naloxone).
The other ingredients are:
Tablet core:
hydropropylcellulose (5 mg/2.5 mg strength tablet only), povidone K30 (10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg strength tablets only), ethyl cellulose, strearyl alcohol, lactose monohydrate, talc, magnesium stearate
Tablet coat:
polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc
The 5 mg/2.5 mg tablets also contain brilliant blue (E133), the 20 mg/10 mg tablets also contain iron (III) oxide red (E172) and the 40 mg/20 mg tablets contain iron oxide yellow (E172).
Targinact
5 mg/2.5 mg tablets are blue, oblong, film coated tablets, marked 'OXN' on one side and '5' on the other.
Targinact
10 mg/5 mg tablets are white, oblong, film coated tablets, marked "OXN" on one side and "10" on the other.
Targinact
20 mg/10 mg tablets are pink, oblong, film coated tablets, marked "OXN" on one side and "20" on the other.
Targinact
40 mg/20 mg tablets are yellow, oblong, film coated tablets, marked 'OXN' on one side and '40' on the other.
In each box there are 28 or 56 tablets.
Marketing Authorization Holder:
Manufacturers:
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:
0800 198 5000
You will need to give details of the product name and reference number.
These are as follows:
Product name: Targinact
Reference number: 16950/0161
This leaflet was last revised in 03/2010
Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks.
© 2010 Napp Pharmaceuticals Limited
7625-3
