Lamivudine Teva Pharma B.V. - patient leaflet, side effects, dosage

- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Lamivudine Teva Pharma B.V. is and what it is used for

• 2. What you need to know before you take Lamivudine Teva Pharma B.V.

• 3. How to take Lamivudine Teva Pharma B.V.

• 4. Possible side effects

• 5. How to store Lamivudine Teva Pharma B.V.

• 6. Contents of the pack and other information

1. What Lamivudine Teva Pharma B.V. is and what it is used for

Lamivudine Teva Pharma B.V. is used to treat HIV (human immunodeficiency virus) infection in adults and children.

The active ingredient in Lamivudine Teva Pharma B.V. is lamivudine. Lamivudine Teva Pharma B.V. is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Lamivudine Teva Pharma B.V. does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells, that are important in helping your body to fight infection.

Not everyone responds to treatment with Lamivudine Teva Pharma B.V. in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Lamivudine Teva Pharma B.V.

Do not take Lamivudine Teva Pharma B.V.

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

Check with your doctor if you think this applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lamivudine Teva Pharma B.V..

Some people taking Lamivudine Teva Pharma B.V. or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks:

• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection,

do not stop Lamivudine Teva Pharma B.V. without your doctor’s advice, as your hepatitis may come back)

• if you are seriously overweight (especially if you are a woman)
• if you or your child has a kidney problem, your dose may be altered.

Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you are taking your medicine. See section 4 for more information.

Look out for important symptoms

Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you are taking Lamivudine Teva Pharma B.V..

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 by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.

Discuss with your doctor the precautions needed to avoid infecting other people.

Other medicines and Lamivudine Teva Pharma B.V.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Lamivudine Teva Pharma B.V..

These medicines should not be used with Lamivudine Teva Pharma B.V.:

• medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or 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, an antibiotic.
• cladribine (used to treat hairy cell leukaemia).

Tell your doctor if you are being treated with any of these.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Lamivudine Teva Pharma B.V. and similar medicines may cause side effects in unborn babies. If you have taken Lamivudine Teva Pharma B.V. during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

Women who are HIV-positive must not breast-feed , because HIV infection can be passed on to the baby in breast milk.

A small amount of the ingredients in Lamivudine Teva Pharma B.V. can also pass into your breast milk.

If you are breast-feeding, or thinking about breast-feeding: Talk to your doctor immediately.

Driving and using machines

Lamivudine Teva Pharma B.V. is unlikely to affect your ability to drive or use machines.

Lamivudine Teva Pharma B.V. contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.

3. How to take Lamivudine Teva Pharma B.V.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets, with some water. Lamivudine Teva Pharma B.V. can be taken with or without food.

If you cannot swallow the tablets whole, you may crush and combine them with a small amount of food or drink, and take all the dose immediately.

Stay in regular contact with your doctor

Lamivudine Teva Pharma B.V. helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.

Keep in touch with your doctor, and do not stop taking Lamivudine Teva Pharma B.V. without your doctor’s advice.

The recommended dose is

Adults, adolescents and children who weigh at least 25 kg

The usual dose of Lamivudine Teva Pharma B.V. is 300 mg a day. This can be taken as either one 150 mg tablet twice a day (leaving approximately 12 hours between each dose), or two 150 mg tablets once a day as advised by your doctor.

Children weighing at least 20 kg and less than 25 kg

The usual dose of Lamivudine Teva Pharma B.V. is 225 mg a day. This can be given as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening, or 225 mg (one and a half 150 mg tablets) once a day as advised by your doctor.

Children weighing at least 14 kg and less than 20 kg

The usual dose of Lamivudine Teva Pharma B.V. is 150 mg a day. This can be given as 75 mg (half a 150 mg tablet) twice a day (leaving approximately 12 hours between each dose), or 150 mg (one 150 mg tablet) once a day as advised by your doctor.

An oral solution is also available for the treatment of children over 3 months of age, or for people who need a lower dose than usual, or who cannot take tablets.

If you or your child has a kidney problem , your dose may be altered.

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

If you take more Lamivudine Teva Pharma B.V. than you should

If you take too much Lamivudine Teva Pharma B.V., tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice. If possible, show them the Lamivudine Teva Pharma B.V. pack.

If you forget to take Lamivudine Teva Pharma B.V.

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

4. Possible side effects

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

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.

When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine Teva Pharma B.V. or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.

As well as the side effects listed below for Lamivudine Teva Pharma B.V. , 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

These may affect up to 1 in 10 people:

• headache
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• stomach pains
• tiredness, lack of energy
• fever (high temperature)
• general feeling of being unwell
• muscle pain and discomfort
• joint pain
• difficulty in sleeping (insomnia)
• cough
• irritated or runny nose
• rash
• hair loss (alopecia).

Uncommon side effects

These may affect up to 1 in 100 people:

Uncommon side effects that may show up in blood tests are:

• a decrease in the number of cells involved in blood clotting (thrombocytopenia)
• a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
• an increase in the level of liver enzymes.

Rare side effects

These may affect up to 1 in 1000 people:

• serious allergic reaction causing swelling of the face, tongue or throat which may cause

difficulty in swallowing or breathing

• inflammation of the pancreas (pancreatitis)
• breakdown of muscle tissue
• inflammation of the liver (hepatitis).

A rare side effect that may show up in blood tests is:

• an increase in an enzyme called amylase.

Very rare side effects

These may affect up to 1 in 10,000 people:

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

A very rare side effect that may show up in blood tests is:

• a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

If you get side effects

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination therapy including Lamivudine Teva Pharma B.V. may cause other conditions to develop during HIV treatment.

Old infections may flare up

People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.

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.

If you get any symptoms of infection while you are taking Lamivudine Teva Pharma B.V.:

Tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

You may have problems with your bones

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:

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

Signs of osteonecrosis include:

• stiffness in the joints
• aches and pains (especially in the hip, knee or shoulder)
• difficulty moving.

If you notice any of these symptoms: Tell your doctor.

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. Y ou 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.

5. How to store Lamivudine Teva Pharma B.V.

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 container or carton and 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 the medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Lamivudine Teva Pharma B.V. contains

• – The active substance is lamivudine. Each film-coated tablet contains 150 mg.

• – The other ingredients are:

What Lamivudine Teva Pharma B.V. looks like and contents of the pack

Light grey, diamond shaped, biconvex film-coated tablet – engraved with “L 150” and breakline on one side and breakline on the other.

Lamivudine Teva Pharma B.V. is available in aluminium blisters containing 20, 30, 60, 80, 90, 100 and 500 tablets or HDPE containers containing 60 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Hol­der

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg ratiopharm GmbH Allemagne/Deut­schland Tél/Tel: +49 73140202
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarország Teva Gyógyszergyár Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland ratiopharm GmbH Tel: +49 73140202	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXÁáóa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmacêuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	România Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland Teva Pharma Iceland ehf. Sími: +354 5503300	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:.