Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - viramune

Document Subject

Generated Narrative: MedicinalProductDefinition mp72e5f5398f762b4570a837b92d9db036

identifier: http://ema.europa.eu/identifier/EU/1/97/055/001 (60 tablets)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Viramune 200 mg tablets

type: Full name

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part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-72e5f5398f762b4570a837b92d9db036

identifier: http://ema.europa.eu/identifier/EU/1/97/055/001 (60 tablets)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - viramune

Attesters

What is in this leaflet

1. What Viramune is and what it is used for
2. What you need to know before you take Viramune
3. How to take Viramune
4. Possible side effects
5. How to store Viramune
6. Contents of the pack and other information

Viramune belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection. The active substance of your medicine is called nevirapine. Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working. By stopping reverse transcriptase from working, Viramune helps control HIV-1 infection. Viramune is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age. You must take Viramune together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. If Viramune has been prescribed for your child, please note that all information in this leaflet is addressed to your child (in this case please read your child instead of you ).

Do not take Viramune

if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6 ).

if you have taken Viramune before and had to stop the treatment because you suffered from:

severe skin rash

skin rash with other symptoms for example:

fever

blistering

mouth sores

inflammation of the eye

swelling of the face

general swelling

shortness of breath

muscle or joint pain

general feelings of illness

abdominal pain

hypersensitivity (allergic) reactions

inflammation of the liver (hepatitis)

if you have severe liver disease

if you have had to stop Viramune treatment in the past because of changes in your liver function

if you are taking a medicine containing the herbal substance St. John s Wort (Hypericum perforatum). This herbal substance may stop Viramune from working properly. Warnings and precautions Talk to your doctor or pharmacist before taking Viramune. During the first 18 weeks of treatment with Viramune it is very important that you and your doctor watch out for signs of liver or skin reactions. These can become severe and even life threatening. You are at greatest risk of such a reaction during the first 6 weeks of treatment. If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other side effects such as

fever,

blistering,

mouth sores,

inflammation of the eye,

swelling of the face,

general swelling,

shortness of breath,

muscle or joint pain,

general feelings of illness,

or abdominal pain YOU SHOULD DISCONTINUE TAKING VIRAMUNE AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death. If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking Viramune. If you experience symptoms suggesting damage of the liver, such as

loss of appetite,

feeling sick (nausea),

vomiting,

yellow skin (jaundice),

abdominal pain you should discontinue taking Viramune and must contact your doctor immediately. If you develop severe liver, skin or hypersensitivity reactions whilst taking Viramune, NEVER TAKE VIRAMUNE again without referring to your doctor. You must take the dose of Viramune as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information in How to take Viramune ). The following patients are at increased risk of developing liver problems:

women

infected with hepatitis B or C

abnormal liver function tests

treatment-na ve patients with higher CD4 cell counts at the start of Viramune therapy (women more than 250 cells/mm , men more than 400 cells/mm )

pre-treated patients with detectable HIV-1 plasma viral load and higher CD4 cell counts at the start of Viramune therapy (women more than 250 cells/mm , men more than 400 cells/mm ) In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. Changes of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat (see section 4 Possible side effects ). Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system and higher body mass index may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor. If you are taking nevirapine and zidovudine concomitantly please inform your doctor since he might need to check your white blood cells. Do not take Viramune after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so by your doctor. Prednisone should not be used to treat a rash related to Viramune. If you are taking oral contraceptives (e.g. pill ) or other hormonal methods of birth control during treatment with Viramune, you should use a barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV transmission. If you are receiving post-menopausal hormone therapy, ask your doctor for advice before taking this medicine. If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Viramune. Children and adolescents Viramune tablets can be taken by:

children 16 years of age or older

children under 16 years of age who:

weigh 50 kg or more

or have a body surface area above 1.25 square metres. For smaller children an oral suspension liquid form is available. Other medicines and Viramune Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Inform your doctor about all other medicines you are taking before you start taking Viramune. Your doctor might need to monitor whether your other medicines are still working and adjust doses. Carefully read the package leaflet of all other HIV medicinal products you are taking in combination with Viramune. It is particularly important that you tell your doctor if you are taking or have recently taken:

St. John s Wort (Hypericum perforatum, medicine to treat depression)

rifampicin (medicine to treat tuberculosis)

rifabutin (medicine to treat tuberculosis)

macrolides e.g. clarithromycin (medicine to treat bacterial infections)

fluconazole (medicine to treat fungal infections)

ketoconazole (medicine to treat fungal infections)

itraconazole (medicine to treat fungal infections)

methadone (medicine used for treatment of opiate addicts)

warfarin (medicine to reduce blood clotting)

hormonal contraceptives (e.g. the pill )

atazanavir (another medicine to treat HIV-infection)

lopinavir/ritonavir (another medicine to treat HIV-infection)

fosamprenavir (another medicine to treat HIV-infection)

efavirenz (another medicine to treat HIV-infection)

etravirine (another medicine to treat HIV-infection)

rilpivirine (another medicine to treat HIV-infection)

zidovudine (another medicine to treat HIV-infection)

elvitegravir/cobicistat (another medicine to treat HIV-infection) Your doctor will carefully monitor the effect of Viramune and any of these medicines if you are taking them together. If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Viramune. This is because Viramune can be partly washed out of your blood by dialysis. Taking Viramune with food and drink There are no restrictions on taking Viramune with food and drink. Pregnancy and breast-feeding If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible Driving and using machines You may experience fatigue when taking Viramune. Use caution when engaging in activities such as driving, using any tools or machines. If you experience fatigue you should avoid potentially hazardous tasks such as driving or using any tools or machines. Viramune contains lactose and sodium Viramune tablets contain lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Viramune tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

You should not use Viramune on its own. You must take it with at least two other antiretroviral medicines. Your doctor will recommend the best medicines for you. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dose: The dose is one 200 mg tablet per day for the first 14 days of treatment ( lead-in period). After days, the usual dose is one 200 mg tablet twice a day. It is very important that you take only one Viramune tablet a day for the first 14 days ( lead-in
period). If you have any rash during this period, do not increase the dose but consult your doctor. The 14-day lead-in period has been shown to lower the risk of skin rash. As Viramune must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully. These are supplied in the package leaflets for those medicines. Viramune is also available in liquid form as an oral suspension. This is particularly suitable if:

you have problems swallowing tablets

or you are a child weighing less than 50 kg

or you are a child having a body surface area less than 1.25 square metres (your doctor will work out your surface area). You should continue to take Viramune for as long as instructed by your doctor. As explained in Warnings and precautions , above, your doctor will monitor you with liver tests or for undesirable effects such as rash. Depending on the outcome your doctor may decide to interrupt or stop your Viramune treatment. Your doctor might then decide to restart you on a lower dose. Only take Viramune tablets by mouth. Do not chew your tablets. You may take Viramune with or without food. If you take more Viramune than you should Do not take more Viramune than prescribed by your doctor and described in this leaflet. There is at present little information on the effects of Viramune overdose. Consult your doctor if you have taken more Viramune than you should. If you forget to take Viramune Try not to miss a dose. If you notice that you have missed a dose within 8 hours of when it was due, take the missed dose as soon as possible. If it has been more than 8 hours since the dose was due only take the next dose at the usual time. If you stop taking Viramune Taking all doses at the appropriate times:

greatly increases the effectiveness of your combination antiretroviral medicines

reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines. It is important that you continue taking Viramune correctly, as described above, unless your doctor instructs you to stop. If you stop taking Viramune for more than 7 days your doctor will instruct you to start the 14 day 'lead-in' period (described above) once again, before returning to the twice daily dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes. Like all medicines, this medicine can cause side effects, although not everybody gets them. As mentioned in Warnings and precautions', above, the most important side effects of Viramune are severe and life threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with Viramune. This is therefore an important period which requires close monitoring by your doctor. If you ever observe any rash symptoms, inform your doctor immediately. When rash occurs it is normally mild to moderate. However, in some patients a rash, which appears as a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded. Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment. If rash occurs and you also feel sick, you must stop treatment and visit your doctor immediately. Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:

rash

swelling of the face

difficulty breathing (bronchial spasm)

anaphylactic shock Hypersensitivity reactions can also occur as rash with other side effects such as:

fever

blistering of your skin

mouth sores

inflammation of the eye

swelling of the face

general swelling

shortness of breath

muscle or joint pain

a reduction in the numbers of your white blood cells (granulocytopenia)

general feelings of illness

severe problems with liver or kidneys (liver or kidney failure). Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction. Such reactions can be life-threatening. Abnormal liver functioning has been reported with the use of Viramune. This includes some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver failure, which can be both fatal. Tell your doctor if you experience any of the following clinical symptoms of liver damage:

loss of appetite

feeling sick (nausea)

vomiting

yellow skin (jaundice)

abdominal pain The side effects described below have been experienced by patients given Viramune: Very common (may affect more than 1 in 10 people):

rash Common (may affect up to 1 in 10 people):

decreased numbers of white blood cells (granulocytopenia)

allergic reactions (hypersensitivity)

headache

feeling sick (nausea)

vomiting

abdominal pain

loose stools (diarrhoea)

inflammation of the liver (hepatitis)

feeling tired (fatigue)

fever

abnormal liver function tests Uncommon (may affect up to 1 in 100 people):

allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock

decreased numbers of red blood cells (anaemia)

yellow skin (jaundice)

severe and life-threatening skin rashes (Stevens-Johnson syndrome/ toxic epidermal necrolysis)

hives (urticaria)

fluid under the skin (angioedema)

joint pain (arthralgia)

muscle pain (myalgia)

decreased blood phosphorus

increased blood pressure Rare (may affect up to 1 in 1000 people):

sudden and intense inflammation of the liver (fulminant hepatitis)

drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms) The following events have also been reported when Viramune has been used in combination with other antiretroviral agents:

decreased numbers of red blood cells or platelets

inflammation of the pancreas

decrease in or abnormal skin sensations These events are commonly associated with other antiretroviral agents and may be expected to occur when Viramune is used in combination with other agents; however, it is unlikely that these events are due to treatment with Viramune. Additional side effects in children and adolescents A reduction in white blood cells (granulocytopenia) can occur, which is more common in children. A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children. As with rash symptoms, please inform your doctor of any side effects. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP . The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Viramune contains

The active substance is nevirapine. Each tablet contains 200 mg nevirapine.

The other ingredients are: microcrystalline cellulose, lactose (as monohydrate), povidone K25, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate. What Viramune looks like and contents of the pack White, oval, biconvex tablets. One side is marked with the code 54 193 , with a single bisect separating the 54 and 193 . The opposite side is marked with the company symbol. The score line is not intended for breaking the tablet. Viramune tablets are supplied in blisters, with 14, 60 or 120 tablets per carton. Not all pack sizes may be marketed. Viramune is also available as an oral suspension. Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 55216 Ingelheim am Rhein Germany or Boehringer Ingelheim Hellas Single Member S.A. 5th km Paiania Markopoulo Koropi Attiki, 19Greece or Boehringer Ingelheim France 100-104 avenue de France 75013 Paris France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Belgi /Belgique/Belgien Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel.: +370 5 2595 -

: +359 2 958 79 Luxembourg/Luxemburg Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 esk republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 Magyarorsz g Boehringer Ingelheim RCV GmbH & Co KG Magyarorsz gi Fi ktelepe Tel.: +36 1 299 8Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 Malta Boehringer Ingelheim Ireland Ltd. Tel: +35 31 295 9Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 Nederland Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13
Boehringer Ingelheim . . T : +30 2 10 89 06 sterreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7Espa a Boehringer Ingelheim Espa a, S.A. Tel: +34 93 404 51 Polska Boehringer Ingelheim Sp. z o.o. Tel.: +48 22 699 0 France Boehringer Ingelheim France S.A.S. T l: +33 3 26 50 45 Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 Rom nia Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti Tel: +40 21 302 2Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podru nica Ljubljana Tel: +386 1 586 40 sland Vistor hf. Tel: +354 535 7Slovensk republika Boehringer Ingelheim RCV GmbH & Co KG organiza n zlo ka Tel: +421 2 5810 1Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102
Boehringer Ingelheim . . T : +30 2 10 89 06 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas fili le Tel: +371 67 240 United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9This leaflet was last revised in {MM/YYYY} Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: