150 mg film-coated tablets 
lamivudine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you personally. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Epivir is and what it is used for 
2. What you need to know before taking Epivir 
3. How to take Epivir 
4. Possible side effects 
5. How to store Epivir 
6. Contents of the packaging and other information 

1. What Epivir is and what it is used for

Epivir is used to treat HIV infection ( human immunodeficiency virus infection ) in adults and children.

The active substance in Epivir is lamivudine. Epivir belongs to a group of antiretroviral medicines called nucleoside reverse transcriptase inhibitors (NRTIs).

Epivir does not completely cure HIV infection. It reduces the number of viruses in the body and keeps it at a low level. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that is important for the body to fight infections.

Not all patients respond to Epivir treatment in the same way. Your doctor will check the treatment effect you are getting.

What you need to know before you take Epivir

Do not take Epivir:

  • if you are allergic to lamivudine or any of the other ingredients of this medicine (see section 6).

Check with your doctor if you think any of these apply to you.

Take special care with Epivir

Some patients taking Epivir or other combination therapies for HIV are at greater risk of serious side effects. You need to be aware of the extra risks:

  • if you have a history of liver disease, including hepatitis B or hepatitis C (if you have hepatitis B infection, do not stop taking Epivir without talking to your doctor as your hepatitis may return)
  • if you are severely overweight (especially if you are a woman)
  • If you or your child have kidney disease, the dose may need to be changed. Talk to your doctor if any of these apply to you. You may need extra checks, including blood tests, while you are taking medication. See section 4 for more information. 

Pay attention to important symptoms

Some patients taking anti-HIV drugs develop other conditions that can be serious. You need to know important signs and symptoms to notice while taking Epivir.

Read the information “Other possible side effects of combination therapy for HIV” in section 4 of this leaflet.

Protect other people

HIV infection is spread through sexual contact with someone who has an infection or through infected blood (eg by splitting injection needles). You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced.

Discuss with your doctor the necessary measures to avoid infecting others.

Other medicines and Epivir

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines, herbal medicines, or other natural products.

Remember to tell your doctor or pharmacist if you start taking a new medicine while you are taking Epivir.

These medicines should not be taken with Epivir:

  • medicines (usual liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol, and maltitol), if taken regularly
  • other medicines containing lamivudine (used to treat HIV infection or hepatitis B infection )
  • emtricitabine (used to treat HIV infection )
  • high doses of co-trimoxazole (trimethoprim + sulfamethoxazole), an antibiotic
  • cladribine (used to treat hairy cell leukemia ). Tell your doctor if you are being treated with any of these medicines.

Epivir with food, drink, and alcohol

Pregnancy

If you are pregnant, become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits of taking Epivir during your pregnancy.

Epivir and similar medicines can cause side effects in the unborn baby. If you have been taking Epivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to check your baby’s development. For children with a mother who has taken NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.

Breast-feeding

Women who are HIV-positive should not breast-feed because the HIV infection can be transmitted to the baby via breast milk.

A small amount of the ingredients in Epivir may also pass into breast milk.

If you are breast-feeding or considering breastfeeding:

Talk to your doctor immediately.

Driving and using machines

Epivir is unlikely to affect your ability to drive or use machines.

How to take Epivir

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Swallow the tablets whole with a little water. Epivir can be taken with or without food.

If you can not swallow the tablets whole, you can crush and mix them with a small amount of food or drink and take the whole dose immediately.

Keep in regular contact with your doctor

Epivir helps keep your disease under control. You must take it every day to prevent the disease from getting worse. You may still develop other infections or diseases associated with HIV infection.

Keep in touch with your doctor and do not stop taking Epivir without your doctor’s advice.

How much to take

Adults, adolescents, and children weighing at least 25 kg:

The usual dose of one of Epivir is 300 mg daily. This can either be as a 150 mg tablet twice daily (approximately 12 hours between dose engines) or as two 150 mg tablets once daily according to the doctor’s prescription.

Children weighing at least 20 kg and less than 25 kg:

The usual dose of Epivir is 225 mg daily. This can either be taken as 75 mg (half 150 mg tablet) in the morning and 150 mg (one 150 mg tablet lot) hours, or 225 mg (one and a half 150 mg tablet) once daily on the doctor’s prescription.

Children weighing at least 14 kg and less than 20 kg:

The usual dose of Epivir is 150 mg daily. This can either be given as 75 mg (half 150 mg tablets) twice daily (approximately 12 hours between dose engines) or that 150 mg (one 150 mg tablet) once daily on the doctor’s prescription.

An oral solution of Epivir is also available for the treatment of children older than 3 months or for people who need a lower dose than normal or who cannot take tablets.

If you or your child have kidney disease, the dose may be changed.

Talk to your doctor if this applies to you or your child.

If you take more Epivir than you should

Taking too much Epivir by mistake probably does not cause any serious problems. If you have accidentally taken too much Epivir, talk to your doctor or pharmacist, or contact the emergency department at the nearest hospital for further advice.

If you forget to take Epivir

If you forget to take a dose, take it as soon as you remember. Then continue with the treatment as before. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. Your doctor will perform tests to find such changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When treating an HIV infection, it is not always possible to distinguish disease symptoms from side effects of medicines caused by Epivir or other medicines taken at the same time. For this reason, you must talk to your doctor about any changes in your state of health.

Like the side effects mentioned below for Epivir, other conditions can develop during combination therapy for HIV.

It is important to read the information later in this section under “Other possible side effects of combination therapy for HIV”.

Common side effects are

These can occur in up to 1 in 10 users:

  • headache
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • fatigue, weakness
  • fever (high temperature)
  • the general (general) feeling of illness
  • muscle pain and discomfort
  • joint pain
  • difficulty sleeping (insomnia)
  • cough
  • irritated or runny nose
  • rash
  • hair loss ( alopecia ).

Uncommon side effects are

These can occur in up to 1 in 100 users:

Uncommon side effects that can be detected in blood tests are:

  • a decrease in the number of cells involved in blood coagulation ( thrombocytopenia )
  • low red blood cell count ( anemia ) or low white blood cell count ( neutropenia )
  • increase in liver enzyme levels.

Rare side effects are

These can occur in up to 1 in 1000 users:

  • the severe allergic reaction which causes swelling of the face, tongue, or throat and which may cause difficulty in swallowing or breathing
  • inflammation of the pancreas ( pancreatitis )
  • degradation of muscle tissue
  • liver diseases, such as jaundice, enlarged liver or fatty liver, inflammation ( hepatitis ).

A rare side effect that can be detected in blood tests is:

  • increase in an enzyme called amylase.

Very rare side effect s

These can occur in up to 1 in 10,000 users:

  • lactic acidosis (excess lactic acid in the blood)
  • numbness and tingling in the arms, legs, hands, or feet.

A very rare side effect that can be detected in blood tests is:

  • failure of the bone marrow’s ability to form new red blood cells (pure erythrocyte plasma).

If you get side effects ar

Tell your doctor or pharmacist if any of these side effects gets serious or bothersome, or if you notice any side effects not listed in this leaflet.

Other possible side effects are with combination therapy for HIV

Combination therapy such as Epivir may cause other conditions to develop during HIV treatment.

Old infection can flare up

Patients with advanced HIV infection ( AIDS ) have a weakened immune system and are more likely to develop serious infections (opportunistic infections ). When these patients start treatment, it happens that old, hidden infections can flare up and cause signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system getting better and the body starts to fight these infections.

In addition to these opportunistic infections, autoimmune diseases (conditions that occur when the immune system attacks healthy body tissue) can also occur after you start medication for your HIV infection. Autoimmune diseases can develop several months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands and feet and moves towards the torso, palpitations, tremors, or hyperactivity, contacts a doctor immediately for the necessary treatment.

If you notice any symptoms of infection while taking Epivir:

Talk to your doctor immediately. Do not take any other anti-infective medication without consulting your doctor.

You may have a skeletal problem

Some patients treated with combination therapy for HIV develop a condition called osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply. Patients may be at greater risk of getting this condition:

  • if they have been treated with combination therapy for a long time
  • if they are also taking anti-inflammatory medicines called corticosteroids s
  • if they drink alcohol
  • if their immune system is very weak
  • if they are overweight.

Characteristics of osteonecrosis include:

  • stiffness in the joints
  • aches and pains (especially in the hips, knees, or shoulders)
  • mobility impairment.

If you notice any of these symptoms:

Tell your doctor.

5. How to store Epivir

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.

Do not store above 30 ° C.

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.

6. Contents of the packaging and other information

Content declaration

The active substance is lamivudine.

Other ingredients are:


Tablet core: microcrystalline cellulose, sodium starch glycolate (gluten-free), and magnesium stearate.

Film coating: hypromellose, titanium dioxide, macrogol, polysorbate 80.

This medicine contains less than 1 mmol (23 mg) sodium per dose ie essentially ‘sodium-free’.

What the medicine looks like and the contents of the pack

Epivir 150 mg film-coated tablets are supplied in white polyethylene cans or blister packs of 60 tablets. The tablets are white, diamond-shaped, film-coated with a notch, and marked with “GXCJ7” on both sides.

Marketing Authorization Holder and Manufacturer

Manufacturer Marketing Authorisation Holder
Glaxo Operations UK Limited(trading as Glaxo Wellcome Operations)Priory StreetWareHerts SG12 0DJUK
or
GlaxoSmithKline Pharmaceuticals SAul. Grunwaldzka 18960-322 PoznanPoland
ViiV Healthcare BVVan Asch van Wijckstraat 55H3811 LP AmersfoortNetherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

België / Belgique / 
Belgien ViiV Healthcare Srl / bv 
Tél / Tel: + 32 (0) 10 85 65 00
Lithuania 
GlaxoSmithKline Lithuania UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com
България 
ГлаксоСмитКлайн ЕООД 
Tel .: + 359 2 953 10 34
Luxembourg / Luxemburg 
ViiV Healthcare SRL / bv 
Belgique / 
Belgien Tél / Tel: + 32 (0) 10 85 65 00
Czech Republic 
GlaxoSmithKline sro 
Tel: + 420 222 001 111 
cz.info@gsk.com
Hungary 
GlaxoSmithKline Kft. 
Tel .: + 36 1 225 5300
Denmark 
GlaxoSmithKline Pharma A / S 
Tel: + 45 36 35 91 00dk-info@gsk.com

Malta 
GlaxoSmithKline (Malta) Limited 
Tel: + 356 21 238131
Deutschland 
ViiV Healthcare GmbH 
Tel .: + 49 (0) 89 203 0038-10 
viiv.med.info@viivhealthcare.com
Netherlands 
ViiV Healthcare BV 
Tel: + 31 (0) 33 2081199
Eesti 
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
estonia@gsk.com
Norway 
GlaxoSmithKline AS 
Tel: + 47 22 70 20 00

Glaλλάδα 
GlaxoSmithKline .ονοπρόσωπη AEBE 
Τηλ: + 30 210 68 82 100
Austria 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0) 1 97075 0 
at.info@gsk.com
España 
Laboratories ViiV Healthcare, SLTel: +34 900 923 501es-ci@viivhealthcare.com
Polska 
GSK Services Sp. z oo 
Tel .: + 48 (0) 22 576 9000
France 
ViiV Healthcare SAS 
Tel .: + 33 (0) 1 39 17 6969 
Infomed@viivhealthcare.com
Portugal 
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA. 
Tel: + 351 21 094 08 01 
viiv.fi.pt@viivhealthcare.com
CroatiaGlaxoSmithKline dooTel: +385 1 6051 999 Romania 
GlaxoSmithKline (GSK) SRL 
Tel: + 4021 3028 208
Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0) 1 4955000
Slovenia 
GlaxoSmithKline doo 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com
Iceland 
Vistor hf.Phone: +354 535 7000
Slovak Republic 
GlaxoSmithKline Slovakia sro 
Tel: + 421 (0) 2 48 26 11 11 
recepcia.sk@gsk.com
Italy 
ViiV Healthcare SrlTel: + 39 (0) 45 9212611
Finland / Finland 
GlaxoSmithKline Oy 
Puh / Tel: + 358 (0) 10 30 30 30 
Finland.tuoteinfo@gsk.com
Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 7312687 
lv-epasts@gsk.com
United Kingdom 
ViiV Healthcare UK LimitedTel: + 44 (0) 800 221441 
customercontactuk@gsk.com

Muhammad Nadeem

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