Betametasona L.D.A. may be available in the countries listed below.
Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Betametasona L.D.A. in the following countries:
International Drug Name Search
Tranxa may be available in the countries listed below.
Tranexamic Acid is reported as an ingredient of Tranxa in the following countries:
International Drug Name Search
Molsidomine Biogaran may be available in the countries listed below.
Molsidomine is reported as an ingredient of Molsidomine Biogaran in the following countries:
International Drug Name Search
Mebezonio ioduro may be available in the countries listed below.
Mebezonio ioduro (DCIT) is also known as Mebezonium Iodide (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Vicoprofen is a brand name of hydrocodone/ibuprofen, approved by the FDA in the following formulation(s):
A generic version of Vicoprofen has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Vicoprofen and have been approved by the FDA:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vicoprofen. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Maxiclear Relief may be available in the countries listed below.
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Maxiclear Relief in the following countries:
International Drug Name Search
Mencord may be available in the countries listed below.
Olmesartan Medoxomil is reported as an ingredient of Mencord in the following countries:
International Drug Name Search
Menaven may be available in the countries listed below.
Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Menaven in the following countries:
International Drug Name Search
T.S.-Sol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfamethoxazole is reported as an ingredient of T.S.-Sol in the following countries:
Trimethoprim is reported as an ingredient of T.S.-Sol in the following countries:
International Drug Name Search
In the US, Mepron (atovaquone systemic) is a member of the drug class miscellaneous antibiotics and is used to treat Babesiosis, Malaria, Pneumocystis Pneumonia, Pneumocystis Pneumonia Prophylaxis and Toxoplasmosis.
US matches:
Atovaquone is reported as an ingredient of Mepron in the following countries:
International Drug Name Search
Treating and preventing ulcers. It is also used to treat conditions that cause increased acid secretion (eg, Zollinger-Ellison syndrome), gastroesophageal reflux disease (GERD), and esophagitis. It may also be used for other conditions as determined by your doctor.
Famotidine Solution is an H2 (histamine) blocker. It works by reducing stomach acid by blocking one of the chemicals (histamine) that stimulates the release of acid into the stomach.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Famotidine Solution. 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 Famotidine Solution. 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 Famotidine Solution 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 Famotidine Solution 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 Famotidine Solution.
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:
Constipation; diarrhea; dizziness; headache.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); irregular heartbeat; seizures.
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: Famotidine 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.
Famotidine Solution is usually handled and stored by a health care provider. If you are using Famotidine Solution at home, store Famotidine Solution as directed by your pharmacist or health care provider. Keep Famotidine Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Famotidine Solution. 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.
Treating herpes eye infection.
Viroptic Drops are an antiviral. It works by killing sensitive viruses.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Viroptic Drops. 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 Viroptic Drops. Because little, if any, of Viroptic Drops are absorbed into the blood, the risk of it interacting with another medicine is low.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Viroptic Drops 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 Viroptic Drops 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 Viroptic Drops.
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:
Temporary burning or stinging.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening eye irritation or pain; red or bloodshot eyes; swelling of the eye or eyelid; 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: Viroptic 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.
Store Viroptic Drops in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Viroptic Drops out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Viroptic Drops. 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.
Minims Lignocaine & Fluorescein may be available in the countries listed below.
Fluorescein sodium (a derivative of Fluorescein) is reported as an ingredient of Minims Lignocaine & Fluorescein in the following countries:
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Minims Lignocaine & Fluorescein in the following countries:
International Drug Name Search
Mixtard 20 may be available in the countries listed below.
Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Mixtard 20 in the following countries:
International Drug Name Search
Generic Name: salicylate (Oral route, Rectal route)
In the U.S.
In Canada
Available Dosage Forms:
Aspirin may also be used to lessen the chance of heart attack, stroke, or other problems that may occur when a blood vessel is blocked by blood clots. Aspirin helps prevent dangerous blood clots from forming. However, this effect of aspirin may increase the chance of serious bleeding in some people. Therefore, aspirin should be used for this purpose only when your doctor decides, after studying your medical condition and history, that the danger of blood clots is greater than the risk of bleeding. Do not take aspirin to prevent blood clots or a heart attack unless it has been ordered by your doctor.
Salicylates may also be used for other conditions as determined by your doctor.
The caffeine present in some of these products may provide additional relief of headache pain or faster pain relief.
Some salicylates are available only with your medical doctor's or dentist's prescription. Others are available without a prescription; however, your medical doctor or dentist may have special instructions on the proper dose of these medicines for your medical condition.
Make certain your health care professional knows if you are on a low-sodium diet. Regular use of large amounts of sodium salicylate (as for arthritis) can add a large amount of sodium to your diet. Sodium salicylate contains 46 mg of sodium in each 325-mg tablet and 92 mg of sodium in each 650-mg tablet.
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.
Do not give aspirin or other salicylates to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in children and teenagers with fever caused by a virus infection, especially flu or chickenpox.
Some children may need to take aspirin or another salicylate regularly (as for arthritis). However, your child's doctor may want to stop the medicine for a while if a fever or other symptoms of a virus infection occur. Discuss this with your child's doctor, so that you will know ahead of time what to do if your child gets sick.
Children who do not have a virus infection may also be more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.
Elderly people are especially sensitive to the effects of salicylates. This may increase the chance of side effects during treatment.
Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin but not with other salicylates. However, salicylates caused birth defects in animal studies.
Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn infant.
Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn infant. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.
Studies in humans have not shown that caffeine (present in some aspirin products) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).
Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly, as for arthritis (rheumatism).
Caffeine passes into the breast milk in small amounts.
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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
Using medicines in this class 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.
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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain salicylate. It may not be specific to Bismuth Extra Strength. Please read with care.
Take this medicine after meals or with food (except for enteric-coated capsules or tablets and aspirin suppositories) to lessen stomach irritation.
Take tablet or capsule forms of this medicine with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after swallowing the medicine. This helps to prevent irritation that may lead to trouble in swallowing.
For patients taking aspirin (including buffered aspirin and/or products containing caffeine):
To use aspirin suppositories:
To take choline and magnesium salicylates (e.g., Trilisate) oral solution:
To take enteric-coated sodium salicylate tablets:
Unless otherwise directed by your medical doctor or dentist:
When used for arthritis (rheumatism), this medicine must be taken regularly as ordered by your doctor in order for it to help you. Up to 2 to 3 weeks or longer may pass before you feel the full effects of this medicine.
The dose medicines in this class 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 these medicines. 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 this medicine, 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.
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain aspirin or other salicylates (including bismuth subsalicylate [e.g., Pepto-Bismol] or any shampoo or skin medicine that contains salicylic acid or any other salicylate), check with your health care professional. Taking or using them together with this medicine may cause an overdose.
If you will be taking salicylates for a long time (more than 5 days in a row for children or 10 days in a row for adults) or in large amounts, your doctor should check your progress at regular visits.
Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.
Check with your medical doctor or dentist:
For patients taking aspirin to lessen the chance of heart attack, stroke, or other problems caused by blood clots:
Taking certain other medicines together with a salicylate may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with a salicylate for more than a few days, unless your doctor has directed you to do so and is following your progress:
For diabetic patients:
Do not take aspirin for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.
For patients taking buffered aspirin, choline and magnesium salicylates (e.g., Trilisate), or magnesium salicylate (e.g., Doan's):
If you are taking a laxative containing cellulose, take the salicylate at least 2 hours before or after you take the laxative. Taking these medicines too close together may lessen the effects of the salicylate.
For patients taking this medicine by mouth:
For patients using aspirin suppositories:
Salicylates may interfere with the results of some medical tests. Before you have any medical tests, tell the doctor in charge if you have taken any of these medicines within the past week. If possible, it is best to check with the doctor first, to find out whether the medicine may be taken during the week before the test.
For patients taking one of the products that contain caffeine:
If you think that you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of these medicines may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.
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.
Get emergency help 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.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Spiriva Respimat may be available in the countries listed below.
Tiotropium Bromide monohydrate (a derivative of Tiotropium Bromide) is reported as an ingredient of Spiriva Respimat in the following countries:
International Drug Name Search
Morantel Tartrate may be available in the countries listed below.
Morantel Tartrate (BANM, USAN) is also known as Morantel (Prop.INN)
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| Prop.INN | Proposed International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Generic Name: cabazitaxel (ka BAZ i TAX el)
Brand Names: Jevtana
Cabazitaxel is a cancer medication that interferes with the growth and spread of cancer cells in the body.
Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body (metastatic).
Cabazitaxel is usually given after other cancer medicines have been tried without successful treatment.
Cabazitaxel may also be used for purposes not listed in this medication guide.
Before you receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.
Cabazitaxel is used together with prednisone, and you may also be given other medications to help prevent certain side effects. Use all medications as directed by your doctor.
liver disease;
low white blood cell counts; or
an allergy to any medicine that contains polysorbate 80.
To make sure you can safely receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.
Cabazitaxel is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Cabazitaxel must be given slowly, and the IV infusion can take about 1 hour to complete.
Cabazitaxel is usually given once every 3 weeks. You will most likely take prednisone by mouth every day throughout your cabazitaxel treatment. Follow your doctor's dosing instructions very carefully.
About 30 minutes before you receive cabazitaxel, you may be given other medications to help prevent certain side effects.
Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.
Your doctor may tell you to check your temperature at home throughout your treatment with cabazitaxel.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while receiving cabazitaxel, which can lead to a serious electrolyte imbalance.
Call your doctor for instructions if you miss an appointment for your cabazitaxel injection.
Overdose symptoms may include some of the serious side effects listed in this medication guide.
fever, cough, chills, muscle aches, flu symptoms, sores in your mouth and throat, rapid and shallow breathing, fainting;
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
severe or ongoing diarrhea;
trouble breathing;
feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
swelling or rapid weight gain; or
blood in your urine, pain or burning when you urinate.
Less serious side effects may include:
nausea, vomiting, stomach pain;
constipation, mild diarrhea;
weakness, tired feeling;
joint pain, back pain;
numbness, burning pain, or tingly feeling en your hands or feet;
changes in your sense of taste; or
hair loss.
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.
Usual Adult Dose for Prostate Cancer:
Initial dose: 25 mg/m2 IV every 3 weeks in combination with prednisone 10 mg orally once daily.
Many drugs can interact with cabazitaxel. Below is just a partial list. Tell your doctor if you are using:
conivaptan (Vaprisol);
imatinib (Gleevec);
isoniazid (for treating tuberculosis);
aprepitant (Emend);
cimetidine (Tagamet);
cyclosporine (Gengraf, Neoral, Sandimmune);
haloperidol (Haldol);
lidocaine (Xylocaine);
an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl), norfloxacin (Noroxin), telithromycin (Ketek), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
antifungal medication such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);
an antidepressant such as nefazodone, desipramine (Norpramin), or sertraline (Zoloft);
heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).
See also: cabazitaxel side effects (in more detail)
Mastrinal may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cloxacillin benzathine (a derivative of Cloxacillin) is reported as an ingredient of Mastrinal in the following countries:
Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Mastrinal in the following countries:
International Drug Name Search
Mannitol Fresenius Kabi may be available in the countries listed below.
Mannitol is reported as an ingredient of Mannitol Fresenius Kabi in the following countries:
International Drug Name Search
Masc borna may be available in the countries listed below.
Boric Acid is reported as an ingredient of Masc borna in the following countries:
International Drug Name Search
Metoprololtartraat A may be available in the countries listed below.
Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Metoprololtartraat A in the following countries:
International Drug Name Search
MicardisPlus
80 mg/12.5 mg tablets
telmisartan/hydrochlorothiazide
MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both substances help to control high blood pressure.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
MicardisPlus is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not controlled enough when either telmisartan or hydrochlorothiazide is used alone.
If any of the above applies to you, tell your doctor or pharmacist before taking MicardisPlus.
Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
You must tell your doctor if you think you are (or might become) pregnant. MicardisPlus is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor.
You should also tell your doctor, if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.
In case of surgery or anaesthetics, you should tell your doctor that you are taking MicardisPlus.
The use of MicardisPlus in children and adolescents up to the age of 18 years is not recommended.
As with all other angiotensin II receptor antagonists, telmisartan may be less effective in lowering the blood pressure in black patients.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with MicardisPlus:
MicardisPlus may increase the blood pressure lowering effect of other medicines and you should consult with your doctor if you need to adjust the dose of your other medicine while taking MicardisPlus.
As with other blood pressure lowering medicines, the effect of MicardisPlus may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).
You can take MicardisPlus tablets with or without food.
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking MicardisPlus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of MicardisPlus. MicardisPlus is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. MicardisPlus is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
No information is available on the effect of MicardisPlus on the ability to drive or operate machinery. Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.
MicardisPlus contains milk sugar (lactose) and sorbitol.
If you are intolerant to some sugars, consult your doctor before taking MicardisPlus.
Always take MicardisPlus exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose of MicardisPlus is one tablet a day. Try to take the tablet at the same time each day. You can take MicardisPlus with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take MicardisPlus every day until your doctor tells you otherwise.
If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.
If you have further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, MicardisPlus can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
Common side effects may include:
Dizziness
Uncommon side effects may include:
Decreased blood potassium levels; anxiety; fainting (syncope); sensation of tingling, pins and needles (paraesthesia); feeling of spinning (vertigo); fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up; shortness of breath (dyspnoea); symptoms of an upset stomach such as diarrhoea; dry mouth, flatulence; back pain, muscle spasm, muscle pain; erectile dysfunction (inability to get or keep an erection); chest pain, increased blood uric acid levels.
Rare side effects may include:
Inflammation of the lung (bronchitis); feeling sad (depression); difficulty falling asleep (insomnia); impaired vision; difficulty breathing; abdominal pain, constipation, bloating (dyspepsia), feeling sick; abnormal liver function; rapid swelling of the skin and mucosa (angioedema), redness of the skin (erythema); allergic reactions such as itching or rash; increased sweating, hives (urticaria); joint pain (arthralgia) and pain in extremities, muscle cramps; flu-like-illness; pain; increased levels of uric acid, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Side effects of unknown frequency may include:
Sore throat, inflamed sinuses; inflammation of the stomach (gastritis)
Telmisartan
In patients taking telmisartan alone the following additional side effects have been reported:
Side effects of unknown frequency may include:
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections; increase in certain white blood cells (eosinophilia), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia); serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash); high potassium levels; slow heart rate (bradycardia); upset stomach; eczema (a skin disorder); inflammation of the tendons; kidney impairment including acute kidney failure; weakness; decreased haemoglobin (a blood protein), sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response which can lead to death).
*In a long-term study involving more than 20,000 patients, more patients treated with telmisartan experienced sepsis compared with patients who received no telmisartan. The event may have happened by chance or could be related to a mechanism currently not known.
Hydrochlorothiazide
In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Side effects of unknown frequency may include:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising), decreased or loss of appetite; restlessness, weakness, light-headedness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin; increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, or fat in the blood.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use MicardisPlus after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. You should store your medicine in the original package in order to protect the tablets from moisture.
Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets. You do not need to take any action if this happens.
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.
The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
MicardisPlus 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the company logo and the code ‘H8’.
MicardisPlus is available in blister packs containing 14, 28, 56, 84, or 98 tablets, or unit dose blister packs containing 28 x 1, 30 x 1 or 90 x 1 tablets.
Not all pack sizes may be available in your country.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in 04/2010.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/
55220-08
