EDURANT 25 mg. 30 tablets
EDURANT is a drug that is used for the treatment of infection with human immunodeficiency virus (HIV). It belongs to the group of anti-HIV drugs called nucleoside reverse transcriptase inhibitors (NNRTI). EDURANT works by reducing the amount of HIV in your body.
This medicine does not cure HIV-infection. Even while taking EDURANT, are likely to develop infections or other illnesses associated with HIV infection. You can also pass on the virus, so it is important to take appropriate measures to prevent infecting others.
EDURANT is used in combination with other anti-HIV medicines to treat adults above 18 years who are infected with HIV and who have never been treated with anti-HIV medicines.
Your doctor will discuss with you which combination of medicines is best for you.
2. What you need to know before taking EDURANT?
Do not take EDURANT, if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the action of other drugs:
- Carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for the treatment of epilepsy and prevention of seizures)
- Rifabutin, rifampicin and rifapentine (medicines against some bacterial infections such as tuberculosis)
- Omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors, which are drugs for the prevention and treatment of gastric ulcers, heartburn or acid reflux)
- Dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when administered orally or by injection, with the exception of treatment with a single dose of
- Products containing St. John's wort (Hypericum perforatum) (a herbal product used for depression).
If you are taking any of these medicines, ask your doctor about other options.
Warnings and Precautions
Talk to your doctor or pharmacist before taking EDURANT.
EDURANT does not cure HIV infection. It is part of a treatment reducing the amount of virus in the blood. While taking EDURANT is still a risk of HIV transmission by sexual or blood. Must take appropriate measures to prevent transmission of the disease through sexual contact (eg. The use of a condom) or blood contamination.
Persons taking EDURANT, can also develop infections or other illnesses associated with HIV infection. Must keep in regular contact with your doctor.
EDURANT has only been used in limited numbers of patients aged 65 years or more. If you are in this age group, please discuss the use of EDURANT with your doctor.
Tell your doctor about your condition.
Meet the points below and tell your doctor if any of these apply to you.
- Tell your doctor if you have or have had liver problems, including hepatitis B and / or C, and / or kidney problems. Your doctor can assess the severity of your liver or kidney disease before deciding if you can take EDURANT.
- Tell your doctor if you notice changes in your body shape or body fat. If you are taking EDURANT, may occur accumulation, loss or redistribution of body fat.
- Tell your doctor immediately if you notice any symptoms of infection. In some patients with advanced HIV infection and a history of opportunistic infection may be signs and symptoms of inflammation from previous infections soon after starting HIV treatment. It is believed that these symptoms are due to an improvement in the immune response, enabling the body to fight infections that may be present with no obvious symptoms.
Children and adolescents
EDURANT is not for use in children or adolescents, because it has not been adequately studied in patients under 18 years.
Other medicines and EDURANT
You must take EDURANT together with other anti-HIV medicines. Your doctor will advise you on which anti-HIV drugs can be combined with EDURANT and together you will decide which combination is best suited for your needs. Carefully follow your doctor's instructions.
Some medicines can affect the levels of EDURANT in the blood when taken concomitantly.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is not recommended to combine EDURANT with other non-nucleoside reverse transcriptase inhibitors (NNRTI) such as delavirdine, efavirenz, etravirine, and nevirapine.
The effects of EDURANT or other medicines might be influenced if you take EDURANT together with any of the following medicines. Tell your doctor if you take:
- Clarithromycin, erythromycin (antibiotic)
- Cimetidine, famotidine, mizatidin, ranitidine (H2 receptor antagonist used for the treatment of ulcers of the stomach or intestine, or relieve heartburn due to reflux). If you are taking these drugs, carefully read section 3 "Instructions for proper use in adults (over 18 years)" on how to apply them.
- Antacids (used to treat diseases associated with heartburn, for example, aluminum / magnesium hydroxide, calcium carbonate). If you are taking these drugs, carefully read section 3 "Instructions for proper use in adults (over 18 years)" on how to apply them.
- Methadone (used to treat withdrawal symptoms of drug or drug addiction)
- Dabigatran etexilate (anticoagulant)
- Metformin (antidiabetic drug).
EDURANT with food and drink
EDURANT should be taken with food. Food is important in order to achieve appropriate levels of the active substance in the body. Only nutritional drink (eg. A protein-rich) can not substitute for the food. See section 3 "How to take EDURANT".
Pregnancy and lactation
Tell your doctor immediately if you are pregnant. Pregnant women should not take EDURANT, unless it is specifically prescribed by a doctor.
HIV-infected mothers should not breastfeed, as there is a possibility of infecting the baby with HIV through breast milk.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Some patients may experience fatigue, dizziness or drowsiness during treatment with EDURANT. Do not drive or operate machinery if you feel tired, dizzy or drowsy while taking EDURANT.
EDURANT contains lactose
EDURANT tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.
3. How to take EDURANT?
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Instructions for proper use in adults (over 18 years)
The recommended dose of EDURANT is one tablet once daily.
EDURANT should be taken with food. Food is important in order to achieve appropriate levels of the active substance in the body. Only nutritional drink (eg. A protein-rich) can not substitute for the food.
There are two situations that require special attention:
1. If taking an antacid (for the treatment of diseases associated with heartburn, such as aluminum / magnesium hydroxide, calcium carbonate). Take the antacid at least 2 hours before or at least 4 hours after EDURANT (see section 2 "Taking other medicines").
2. If the host-receptor antagonists (drugs used for the treatment of ulcers of the stomach or intestine, or relieve heartburn due to reflux (such as cimetidine, famotidine, mizatidin, ranitidine). Take H2-receptor antagonist at least 12 hours before or at least 4 hours after EDURANT (see section 2 "Taking other medicines"). H2-receptor antagonists should not be adopted in Scheme 2 times daily. Discuss other possible scheme with your doctor.
Removing the cap, a child
The plastic bottle is equipped with a stopper, a child. It can be opened by pressing down and simultaneously rotate counter clockwise.
If you take more dose of EDURANT
Immediately contact your doctor or pharmacist. In case of overdose may experience headaches, nausea, dizziness and / or vivid dreams.
If you forget to take EDURANT
If you notice within 12 hours of the time that usually take EDURANT, must take the tablet as soon as possible. Tablet EDURANT should be taken with food. Then take the next dose at the usual time. If you notice missing after 12 hours, skip the missed dose and continue with the next dose as usual.
Do not take a double dose to make up the missed dose.
If you vomit less than 4 hours after taking EDURANT, take another tablet with a meal. If you vomit more than 4 hours after taking EDURANT, you should not take another tablet until your next dose as usual.
Contact your doctor if you are unsure what to do if you miss a dose or vomit.
Do not stop taking EDURANT
Do not stop taking EDURANT you without consulting your doctor. Even if you feel better, do not stop taking EDURANT or your other anti-HIV medicines because it may increase the risk of the virus developing resistance. First, talk with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (affects more than 1 in 10 people)
- Increased cholesterol and / or pancreatic amylase in the blood
- Changes in one of the standard liver function tests (transaminase)
- Difficulty sleeping (insomnia)
- Headache, dizziness
Common side effects (affects less than 1 in 10 people)
- Decreased number of white blood cells and / or platelets, decreased hemoglobin in the blood, increased triglycerides, lipase and / or bilirubin
- Decreased appetite
- Depression, depressed mood
- Vivid dreams, sleep disorders
- Stomach pain, vomiting, stomach discomfort, dry mouth
Uncommon side effects (affects less than 1 in 100 people)
- Signs or symptoms of inflammation or infection (immune reconstitution syndrome).
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store EDURANT?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of that month.
Store in the original bottle in order to protect from light.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
- The active substance is in the form of rilpivirine rilpivirine hydrochloride. Each tablet of EDURANT contains rilpivirine hydrochloride corresponding to 25 mg rilpivirine.
- The other ingredients in the core of the film-coated tablet are: lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silisitsirana microcrystalline cellulose and magnesium stearate. The film coating contains lactose monohydrate, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000 and triacetin.
EDURANT looks like and contents of the pack?
White to off-white, film-coated, round, biconvex tablet with "TMC" on one side and "25" on the other.
Plastic bottle containing 30 tablets.