Nevirapina teva 400 mg comprimidos de liberacion prolongada efg
Introduction
Prospecto:Information for the User
Nevirapina Teva 400 mg prolonged-release tablets EFG
Read this prospectus carefully before starting to take this medicine,because it contains important information for you.
- Keep this prospectus, as you may need to read it again.
- If you have any doubts, consult yourdoctor, pharmacist, or nurse.
- This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you, as it may harm them.
- If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenif they are not listed in this prospectus. See section 4.
1.What isNevirapina Teva 400 mg prolonged-release tablets EFGand for what it is used
2.What you need to knowbeforestarting totakeNevirapina Teva 400 mg
3.How to takeNevirapina Teva 400 mg
4.Possible adverse effects
5.Storage ofNevirapina Teva 400 mg
6.Contents of the package and additional information
1. What is Nevirapina Teva 400mg prolonged-release tablets EFG and what is it used for
Nevirapina belongs to a group of medicines called antiretrovirals, which are used in the treatment of Human Immunodeficiency Virus (HIV) infection.
The active ingredient of this medicine is called nevirapina. Nevirapina belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs to multiply. Nevirapina prevents the functioning of reverse transcriptase. By blocking the action of reverse transcriptase, Nevirapina helps to control HIV-1 infection.
Nevirapina is indicated for the treatment of adults, adolescents, and children three years of age or older who are capable of swallowing tablets and are infected with HIV-1. Nevirapina should be taken in combination with other antiretroviral medicines. Your doctor will advise on the appropriate medicines for you.
Nevirapina prolonged-release tablets should only be used after a two-week treatment with another type of medicine containing nevirapina (suspension or immediate-release tablets) unless you are currently being treated with Nevirapina and are switching to the prolonged-release form.
2. What you need to know before starting Nevirapina Teva 400 mg
Do not takeNevirapina Teva 400 mg
- if you are allergic to nevirapina or any of the other components of this medication (listed in section 6 “Composition of Nevirapina Teva”).
- if you have taken nevirapina in the past and had to stop treatment because you experienced:
- severe skin rash
- skin rash with other symptoms such as:
- fever
- blistering
- mouth sores
- inflammation of the eye
- swelling of the face
- general swelling
- difficulty breathing
- muscle or joint pain
- general feeling of illness
- abdominal pain
- hypersensitivity reactions (allergies)
- inflammation of the liver (hepatitis)
- if you have a severe liver disease
- if you have had to stop nevirapina treatment in the past due to changes in your liver function
- if you are taking any medication that contains hypericum or St. John's Wort (Hypericum perforatum). This product may cause nevirapina to stop working properly.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Nevirapina Teva 400 mg.
During the first 18 weeks of treatment with nevirapina, it is very important that you and your doctor monitor for the appearance of liver or skin reactions. These reactions can be severe and even life-threatening. The risk of developing these reactions is higher during the first 6 weeks of treatment.
If you experience severe rash or hypersensitivity (allergic reactions that can appear as a rash) along with other adverse effects such as: - fever, - blistering, - mouth sores, - inflammation of the eye, - swelling of the face, - general swelling, - difficulty breathing, - muscle or joint pain, - general feeling of illness, - or abdominal pain YOU MUST STOP TAKING NEVIRAPINA AND CONTACT YOUR DOCTOR IMMEDIATELY, as these reactions can be life-threatening or fatal. If you ever experience only mild rash symptoms without any other reaction, inform your doctor immediately, who will tell you if you should stop taking nevirapina. If you experience symptoms that suggest liver damage, such as: - loss of appetite, - nausea, - vomiting, - yellowing of the skin (jaundice), - abdominal pain you must stop taking nevirapina and contact your doctor immediately. If you experience severe liver, skin, or hypersensitivity reactions while taking nevirapina, DO NOT TAKE NEVIRAPINA AGAIN without first consulting your doctor. You must take your dose of nevirapina as directed by your doctor. This is especially important during the first 14 days of treatment (see “How to take Nevirapina Teva 400 mg”). |
The following patients are at higher risk of developing liver problems:
- women
- patients infected with hepatitis B or C
- abnormalities in liver function tests
- patients naïve with higher CD4 cell counts at the start of treatment with nevirapina (women with more than 250 cells/mm³, men with more than 400 cells/mm³)
- patients pre-treated with detectable HIV-1 viral load in plasma and higher CD4 cell counts at the start of treatment with nevirapina (women with more than 250 cells/mm³, men with more than 400 cells/mm³)
In some patients with advanced HIV (AIDS) infection and a history of opportunistic infections (AIDS-defining illness), signs and symptoms of previous infections may appear shortly after starting antiretroviral treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight off infections that were present without apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you start taking medications for HIV treatment. Autoimmune disorders can appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.
Changes in body fat may occur in patients receiving combined antiretroviral therapy. Consult your doctor if you notice changes in body fat (see section 4. “Possible side effects”).
In some patients receiving combined antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone) may develop. The duration of antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune system weakness, and high body mass index may be some of the many risk factors for developing this disease. Symptoms of osteonecrosis are: joint stiffness, pain, and discomfort, especially in the hip, knee, and shoulder, and difficulty moving. If you notice any of these symptoms, inform your doctor.
If you are taking nevirapina and zidovudine together, inform your doctor because you may need to check your white blood cells.
Do not take Nevirapina after exposure to HIV unless you have been diagnosed with HIV and your doctor has instructed you to do so.
Do not use prednisone to treat rashes associated with Nevirapina.
If you are taking oral contraceptives (e.g. “the pill”) or other hormonal birth control methods while taking Nevirapina, you should use an additional barrier method (e.g. condoms) to prevent pregnancy and HIV transmission.
If you are receiving hormone replacement therapy, consult your doctor before taking this medication.
If you are taking rifampicin for tuberculosis treatment, inform your doctor before taking this medication with nevirapina.
The prolonged-release tablets of nevirapina or parts of the tablets may be eliminated and appear occasionally in the feces. These may appear as intact tablets, but it has not been seen to affect the efficacy of nevirapina.
Children and adolescents
Nevirapina Teva 400 mg prolonged-release tablets may be used in children if:
- they are ≥ 8 years old and weigh 43.8 kg or more
- they are more than 3 years old and less than 8 years old and weigh 25 kg or more
- they have a body surface area of 1.17 square meters or more
For smaller children, a liquid oral suspension is available.
Use of Nevirapina Teva 400 mg prolonged-release tablets EFG with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Before starting treatment with nevirapina, inform your doctor of all other medications you are taking. Your doctor may need to check if your other medications are still working and make dose adjustments. Read the leaflet of all other antiretroviral medications you take in combination with nevirapina.
It is especially important to inform your doctor if you are taking or have taken recently:
- hypericum or St. John's Wort (Hypericum perforatum, medicinal plant for the treatment of depression)
- rifampicin (medication for tuberculosis treatment)
- rifabutin (medication for tuberculosis treatment)
- macrolides, e.g. clarithromycin (medication for bacterial infections)
- fluconazole (medication for fungal infections)
- ketoconazole (medication for fungal infections)
- itraconazole (medication for fungal infections)
- methadone (medication used for opioid addiction treatment)
- warfarin (medication to reduce blood clot formation)
- hormonal contraceptives (e.g. “the pill”)
- atazanavir (other medication for HIV treatment)
- lopinavir/ritonavir (other medication for HIV treatment)
- fosamprenavir (other medication for HIV treatment)
- efavirenz (other medication for HIV treatment)
- etravirine (other medication for HIV treatment)
- rilpivirine (other medication for HIV treatment)
- zidovudine (other medication for HIV treatment)
- elvitegravir/cobicistat (other medication for HIV treatment)
Your doctor will carefully monitor the effect of nevirapina and any of these medications if you are taking them together.
Taking Nevirapina Teva 400 mg with food and drinks
There are no restrictions for taking nevirapina with food and drinks.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
Do not recommendthat women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or plan to breastfeed, you should consult your doctoras soon as possible.
Driving and operating machines
When taking nevirapina, you may experience fatigue. Be cautious when participating in activities such as driving or using tools or machines. If you experience fatigue, you should avoid potentially hazardous activities such as driving and using tools or machines.
3. How to Take Nevirapina Teva 400 mg
Do not take nevirapina on your own. You must take it withat least two otherantiretroviral medications. Your doctor will recommend the appropriate medications for you.
Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Dosage:
Adults:
The dosage is one 200 mg nevirapina tablet per day for the first 14 days of treatment (initial period). There are other formulations available for this initial period. After 14 days, the usual dosage is one prolonged-release 400 mg nevirapina tablet once a day.
It is very important that you only take one 200 mg nevirapina tablet per day for the first 14 days (initial period). If you have any rash during this period, do not start taking Nevirapina Teva 400 mg prolonged-release tablets and consult your doctor. |
It has been demonstrated that the initial 14-day period reduces the risk of skin rash.
Patients already on treatment with immediate-release tablets or oral suspension may switch to prolonged-release tablets without an initial period.
Since Nevirapina must always be taken in combination with other antiretroviral medications, you must carefully follow the instructions for your other medications. These are provided in the packaging inserts for these medications.
Your doctor will check, if necessary, the availability of other nevirapina formulations, for example, an oral suspension (for all age groups, weight, and body surface).
You must continue taking nevirapina for as long as your doctor tells you to.
As explained earlier in the ‘Warnings and precautions’ section, your doctor will monitor your liver function and watch for the appearance of adverse effects such as rash. Depending on the results, your doctor may decide to interrupt or reduce the nevirapina treatment. Your doctor may also decide to restart treatment at lower doses.
If you have any degree ofrenalorhepaticinsufficiency, only take nevirapina 200 mg tablets or nevirapina 50 mg/ 5 ml oral suspension. If necessary, your doctor will evaluate these additional formulations.
Only take nevirapina prolonged-release tablets orally. Do not chew the prolonged-release tablets. You can take nevirapina with or without food.
If you take moreNevirapina Teva 400 mgthan you should
Do not take more nevirapina than your doctor has prescribed and what is described in this leaflet. There is currently little information on the effects of a nevirapina overdose. Consult your doctor if you have taken more nevirapina than you should.In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone: 91 562 04 20 and indicate the amount ingested.
If you forget to takeNevirapina Teva 400 mg
Make sure not to forget any dose. If you realize you have forgotten a dose within 12 hours of the scheduled time, take the missed dose as soon as possible. If more than 12 hours have passed since the scheduled time, only take the next dose at your usual time.
If you interrupt treatment withNevirapina Teva 400 mg
Take the doses at the indicated times:
- This greatly increases the effectiveness of your antiretroviral medication combination
- It reduces the likelihood that the HIV infection will become resistant to antiretroviral medications
It is essential that you continue taking nevirapina correctly, as described above, unless your doctor tells you to stop treatment.
If you interrupt nevirapina administration for more than 7 days, your doctor will instruct you to start again with the initial 14-day period with nevirapina tablets (as described above), before returning to once-daily dosing with nevirapina prolonged-release tablets.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
During HIV treatment, there may be an increase in body weight and levels of
glucose and lipids in the blood. This may be partly related to recovery of health and lifestyle, and in the case of increased lipids in the blood, it may sometimes be due to HIV medications themselves. Your doctor will monitor these changes.
Like all medications, this medication may produce side effects, although not all people will experience them.
As mentioned in ‘Warnings and precautions’, the most important side effects of nevirapine are severe skin reactions and life-threatening damage to the liver. These reactions occur mainly during the first 18 weeks of nevirapine treatment. This is, therefore, an important period that requires close monitoring by your doctor.
If you observe any symptoms of rash, inform your doctorimmediately.
When the rash occurs, it is usually mild to moderate. However, in some patients, a rash in the form of a vesicular skin reaction may appear, which can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and fatal cases have been reported. Most cases of rash, both severe and mild/moderate, occur during the first six weeks of treatment.
If the rash appears and you also feel unwell,you should interrupt treatment and visit your doctor immediately.
Severe hypersensitivity reactions (allergies) may occur. These reactions may appear in the form of anaphylaxis (a severe type of allergic reaction) with symptoms such as:
- rash
- facial swelling
- difficulty breathing (bronchospasm)
- anaphylactic shock
Hypersensitivity reactions may also present as a rash with other side effects such as:
- fever
- skin blistering
- mouth sores
- eye inflammation
- facial swelling
- general swelling
- difficulty breathing
- muscle or joint pain
- decrease in white blood cell count (granulocytopenia)
- general feeling of illness
- severe liver or kidney problems (liver or kidney failure)
If you experience a rash and any of the other side effects of a hypersensitivity reaction (allergy), inform your doctor immediately. These reactions can be fatal.
Abnormal liver function has been described with the use of Nevirapine. This includes some cases of liver inflammation (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver failure, which can be fatal.
Inform your doctor if you experience any of the following clinical symptoms of liver damage:
- loss of appetite
- general feeling of illness (nausea)
- vomiting
- yellowing of the skin (jaundice)
- abdominal pain
The following side effects have been described in patients who received nevirapine 200 mg tablets during theinitial phase of 14 days:
Frequent (may affect up to 1 in 10 people):
- rash
- fever
- headache
- abdominal pain
- general feeling of illness (nausea)
- diarrhea
- fatigue
Rare (may affect up to 1 in 100 people):
- allergic reactions (hypersensitivity)
- allergic reactions characterized by rash, facial inflammation, difficulty breathing (bronchospasm), or anaphylactic shock
- drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
- intense and sudden liver inflammation (fulminant hepatitis)
- severe and potentially fatal skin rash (Stevens-Johnson syndrome/toxic epidermal necrolysis)
- yellowing of the skin (jaundice)
- urticaria
- fluid under the skin (angioedema)
- vomiting
- muscle pain (myalgia)
- joint pain (arthralgia)
- decrease in white blood cell count (granulocytopenia)
- abnormalities in liver function tests
- decrease in phosphate in the blood
- increased blood pressure
Rare (may affect up to 1 in 1,000 people):
- liver inflammation (hepatitis)
- decrease in red blood cell count (anemia)
The following side effects have been described in patients who received nevirapine tablets for prolonged release once a day during themaintenance phase:
Frequent (may affect up to 1 in 10 people):
- rash
- headache
- abdominal pain
- general feeling of illness (nausea)
- liver inflammation (hepatitis)
- fatigue
- abnormalities in liver function tests
- decrease in phosphate in the blood
- increased blood pressure
- vomiting
- soft stools (diarrhea)
Rare (may affect up to 1 in 100 people):
- allergic reactions (hypersensitivity)
- allergic reactions characterized by rash, facial inflammation, difficulty breathing (bronchospasm), or anaphylactic shock
- drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
- intense and sudden liver inflammation (fulminant hepatitis)
- severe and potentially fatal skin rash (Stevens-Johnson syndrome/toxic epidermal necrolysis)
- decrease in red blood cell count (anemia)
- decrease in white blood cell count (granulocytopenia)
- yellowing of the skin (jaundice)
- urticaria
- fluid under the skin (angioedema)
- muscle pain (myalgia)
- joint pain (arthralgia)
- fever
When nevirapine has been used in combination with other antiretroviral medications, the following events have also been reported:
- decrease in red or white blood cell count
- pancreatitis
- decrease or abnormalities in skin sensation
These effects are generally associated with other antiretroviral agents and may occur when nevirapine is used in combination with other agents; however, it is unlikely that these effects are due to nevirapine treatment.
Other side effects in children and adolescents
A decrease in white blood cell count (granulocytopenia) may occur, more frequently in children. The decrease in red blood cell count (anemia), which may be related to nevirapine treatment, is also more frequent in children. As with rash symptoms, inform your doctor of any side effects.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national system for the vigilance of medicinal products for human usewww.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Nevirapina Teva 400 mg
Keepthis medicationout of the sight and reach of children.
Do not usethis medicationafter the expiration date that appears onthe box and blister pack or the label on the bottleafter “EXP”. The expiration date is the last day of the month indicated.
This medication does not require special storage conditions
Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition ofNevirapina Teva 400 mg
- The active ingredient is nevirapina.
Each prolonged-release tablet contains 400 mg of nevirapina
- The other components are microcrystalline cellulose, povidone, polyethylene oxide, anhydrous colloidal silica, and magnesium stearate.
Appearance of the product and contents of the pack
Nevirapina Teva 400 mg prolonged-release tablets EFG are white to off-white, oval, biconvex tablets, approximately 20.5 mm in length and 10 mm in width, engraved with “400” on one face and flat on the other.
Aluminium blisters containing 10, 10x1, 30, 30x1, 60, 60x1, 90, 90x1, 100, and 100x1 prolonged-release tablets and a high-density polyethylene (HDPE) bottle containing 30 prolonged-release tablets.
Only some pack sizes may be marketed.
Marketing authorisation holder
TEVA PHARMA, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas, Madrid
28108 Spain
Manufacturers responsible
TEVA Gyógyszergyár Zrt.
Pallagi út 13, Debrecen,
4042 Hungary
or
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, Kraków
31-546 Poland
This medicinal product is authorised in the member states of the European Economic Area with the following names:
DENevirapin-ratiopharm 400 mg Retardtabletten
DKNevirapine Teva B.V.
ESNevirapina Teva 400mg prolonged-release tablets EFG
FRNevirapine Teva LP 400mg, prolonged-release tablet
ITNevirapina Teva Italia
NLNevirapine retard Teva 400 mg, prolonged-release tablets
PTNevirapina Teva
Last review date of thisleaflet:April 2023
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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