Lamivudine Teva

Package leaflet: Information for the patient

Lamivudine Teva 100 mg film-coated tablets

lamivudine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lamivudine Teva is and what it is used for

The active substance in Lamivudine Teva is lamivudine.
Lamivudine Teva is used for the long-term (chronic) treatment of hepatitis B infection in adults.
Lamivudine Teva is an antiviral medicine that suppresses the hepatitis B virus and belongs to a
group of medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).
Hepatitis B is caused by a virus that infects the liver, causes a long-term (chronic) infection, and
can lead to liver damage. Lamivudine Teva can be used in people whose liver is damaged but still
functions normally ( compensated liver disease ) and in combination with other medicines in people
whose liver is damaged and does not function properly (decompensated liver disease).
Treatment with Lamivudine Teva can reduce the amount of hepatitis B virus in the body. This
should lead to a reduction in liver damage and an improvement in liver function. However, not
everyone responds to treatment with Lamivudine Teva in the same way. Your doctor will monitor
the effectiveness of your treatment with regular blood tests.

2. What you need to know before taking Lamivudine Teva

Your doctor should provide counselling and perform an HIV test before starting treatment with
lamivudine for hepatitis B infection, and during treatment. If you have or may have HIV infection, see
section 3.
Do not take Lamivudine Teva

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

Warnings and precautions
Some people who take Lamivudine Teva or similar medicines are at higher risk of serious side effects. You should be aware of these additional risks:

• if you have had other types of liver disease such as hepatitis C
• if you are severely overweight (especially if you are a woman). Inform your doctor if any of these situations apply to you. You may need additional monitoring, including blood tests, while taking this medicine. See section 4 for further information on risks.

Do not stop taking Lamivudine Teva without medical advice, as there is a risk of worsening hepatitis. If you stop taking Lamivudine Teva, your doctor will monitor you for at least four months to check for any problems. This will involve blood tests to monitor for any increases in liver enzyme levels, which may indicate liver damage. See section 3 for further information on how to take Lamivudine Teva.
Protecting other people
Hepatitis B infection spreads through sexual contact with infected individuals or through transfer of infected blood (for example, by sharing injecting needles).
Lamivudine Teva will not prevent transmission of hepatitis B infection to other people. To protect others from hepatitis B infection:

• use a condom during oral or penetrative sex.
• avoid contact with blood – for example, do not share needles.

Other medicines and Lamivudine Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other non-prescription medicines.
Remember to inform your doctor or pharmacist if you start taking a new medicine while being treated with Lamivudine Teva.
The following medicines must not be taken with Lamivudine Teva:

• medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
• other medicines containing lamivudine, used to treat HIV infection (sometimes called the AIDS virus)
• emtricitabine (used to treat HIV infection or hepatitis B)
• cladribine used to treat hairy cell leukaemia
  Inform your doctor if you are being treated with any of these medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant:
Talk to your doctor about the risks and benefits of taking Lamivudine Teva during pregnancy. Do not stop treatment with Lamivudine Teva without consulting your doctor.
Lamivudine Teva may pass into breast milk. If you are breastfeeding or planning to breastfeed:
Talk to your doctor before taking Lamivudine Teva.

Driving and using machines
Lamivudine Teva may make you feel tired, which could affect your ability to drive and use machines.
Do not drive or operate machinery if you feel tired.

Lamivudine Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially “sodium-free”.

3. How to take Lamivudine Teva

Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
Stay in regular contact with your doctor.
Lamivudine Teva helps control hepatitis B infection. You must take it every day
to keep the infection under control and to prevent the disease from worsening.
Stay in contact with your doctor and do not stop taking Lamivudine Teva
without your doctor's advice.

Dosage
The usual dose of Lamivudine Teva is one tablet (100 mg of lamivudine) once daily.
Your doctor may prescribe a lower dose if you have kidney problems. An oral solution of
Lamivudine Teva is available for people who require a lower dose than recommended or who cannot take tablets.
Talk to your doctor if this applies to you.

Patients who have or may contract HIV infection
If you have or acquire HIV infection that is not treated with antiretroviral medicines while taking
lamivudine for the treatment of hepatitis B, the HIV virus may develop resistance to certain HIV medicines,
making the infection harder to treat. Lamivudine can also be used to treat HIV infection. Talk to your doctor if you have HIV infection. Your doctor may treat you with another medicine containing a higher dose of lamivudine, usually 150 mg twice daily, because the lower dose of 100 mg of lamivudine is not sufficient to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor first.
Talk to your doctor if this applies to you.

Swallow the tablet whole with water. Lamivudine Teva can be taken with or without food.

If you take more Lamivudine Teva than you should
If you accidentally take too much Lamivudine Teva, inform your doctor or pharmacist, or contact
the Emergency Department of your nearest hospital for further advice. If possible, show them the
packaging of Lamivudine Teva.

If you forget to take Lamivudine Teva
If you forget to take a dose, take it as soon as you remember. Then continue with your regular dosing schedule.
Do not take a double dose to make up for the missed dose.

If you stop taking Lamivudine Teva
You must not stop taking Lamivudine Teva without consulting your doctor. There is a risk that
hepatitis may worsen (see section 2).
When you stop taking Lamivudine Teva, your doctor will monitor you for at least four months
to check for any problems. This will involve blood tests to monitor for any increases in liver enzyme levels,
which may indicate liver damage.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects commonly reported in clinical studies of lamivudine have been fatigue, respiratory tract infections, sore throat, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, and increases in liver enzymes and in enzymes produced in the muscles (see below).

Allergic reaction
These are rare (may affect up to 1 in 1,000 people). Signs include:

• swelling of the eyelids, face or lips
• difficulty swallowing or breathing. Contact your doctor immediately if you experience these symptoms. Stop taking Lamivudina Teva

Side effects considered to be caused by Lamivudina Teva:
A very common side effect (may affect more than 1 in 10 people), which may be detected by blood tests, is:

• an increase in levels of certain liver enzymes (transaminases), which may be a sign of liver inflammation or damage.

A common side effect (may affect up to 1 in 10 people) is:

• muscle cramps and pain
• rash or hives anywhere on the body

A common side effect that may be detected by blood tests is:

• an increase in the level of an enzyme produced in the muscles (creatine phosphokinase), which may be a sign of tissue damage.

A very rare side effect (may affect up to 1 in 10,000 people) is:

• lactic acidosis (excess lactic acid in the blood).

Other side effects
Other side effects may occur in a small number of people, but their exact frequency is unknown:

• breakdown of muscle tissue
• worsening of liver disease after stopping Lamivudina Teva or during treatment if the hepatitis B virus becomes resistant to Lamivudina Teva. This may be fatal in some people.

A side effect that may be detected by blood tests is:

• a reduction in the number of cells involved in blood clotting (thrombocytopenia).

If you experience side effects
Tell your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamivudina Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container, box, or blister pack, following "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Lamivudina Teva if you notice any changes in the appearance of the tablet.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lamivudina Teva contains

• The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
• The other components are:
  Tablet core: microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Lamivudina Teva and pack contents
Orange, capsule-shaped, biconvex, film-coated tablet, marked with "L 100" on one side and smooth on the other side.
Lamivudina Teva is available in aluminum blisters containing 28, 30, 84, or 100 tablets, or in HDPE containers containing 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The 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
Teva Operations Poland Sp.z o.o.
Mogilska 80 Str.
31-546 Kraków
Poland

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Teл.: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/