LAMIVUDINE 150 mg/300 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Lamivudine + Zidovudine Accord, 150 mg + 300 mg, coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Lamivudine + Zidovudine Accord and what is it used for
   1. Lamivudine + Zidovudine Accord is used to treat human immunodeficiency virus (HIV) infections in adults and children.
4. Important information before taking Lamivudine + Zidovudine Accord
   1. When not to take Lamivudine + Zidovudine Accord
   2. Warnings and precautions
   3. You should inform your doctor if any of the above circumstances apply to you
   4. Paying attention to important symptoms
   5. You should read the information 'Other possible side effects associated with HIV combination therapy' in section 4 of this leaflet.
   6. Protecting others
   7. Lamivudine + Zidovudine Accord and other medicines
   8. You should tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines and medicines available without a prescription.
   9. The following medicines should not be taken with Lamivudine + Zidovudine Accord:
   10. Some medicines interact with Lamivudine + Zidovudine Accord
   11. Pregnancy and breastfeeding
   12. Driving and using machines
   13. Lamivudine + Zidovudine Accord contains sodium
5. How to take Lamivudine + Zidovudine Accord
   1. This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
   2. Regular contact with your doctor
   3. You should stay in regular contact with your doctor and not stop taking Lamivudine + Zidovudine Accord
   4. What dose to take
   5. The usual dose of Lamivudine + Zidovudine Accord is one tablet twice a day.
   6. Taking a higher dose of Lamivudine + Zidovudine Accord than recommended
   7. Missing a dose of Lamivudine + Zidovudine Accord
6. Possible side effects
   1. Rare: may affect up to 1 in 1,000 people:
   2. Very rare: may affect up to 1 in 10,000 people:
   3. If you experience side effects
   4. Other possible side effects associated with HIV combination therapy
   5. Previous infections may develop rapidly
   6. Lactic acidosis is a rare but serious side effect
   7. Symptoms of lactic acidosis include:
   8. Bone disorders may occur
   9. Symptoms of osteonecrosis include:
   10. Other symptoms that may be detected in tests
   11. Reporting side effects
7. How to store Lamivudine + Zidovudine Accord
8. Package contents and other information
   1. What Lamivudine + Zidovudine Accord contains
   2. What Lamivudine + Zidovudine Accord looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: June 2022

Leaflet accompanying the packaging: patient information

Lamivudine + Zidovudine Accord, 150 mg + 300 mg, coated tablets

Lamivudine + Zidovudine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Lamivudine + Zidovudine Accord and what is it used for
• 2. Important information before taking Lamivudine + Zidovudine Accord
• 3. How to take Lamivudine + Zidovudine Accord
• 4. Possible side effects
• 5. How to store Lamivudine + Zidovudine Accord
• 6. Package contents and other information

1. What is Lamivudine + Zidovudine Accord and what is it used for

Lamivudine + Zidovudine Accord is used to treat human immunodeficiency virus (HIV) infections in adults and children.

Lamivudine + Zidovudine Accord contains two active substances used to treat HIV infections: lamivudine and zidovudine. Both of these substances belong to a group of antiretroviral medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Lamivudine + Zidovudine Accord does not cure HIV infection; it reduces the amount of viruses 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 plays an important role in helping the body fight infections. Not all patients respond to treatment with Lamivudine + Zidovudine Accord in the same way. The effectiveness of the treatment will be monitored by the doctor.

2. Important information before taking Lamivudine + Zidovudine Accord

When not to take Lamivudine + Zidovudine Accord

• if the patient is allergic to lamivudine, zidovudine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a very low number of red blood cells (anemia) or a very low number of white blood cells (neutropenia).

You should consult your doctorif you suspect that any of the above circumstances apply to you.

Warnings and precautions

Some patients taking Lamivudine + Zidovudine Accord or other anti-HIV combination therapy are more likely to experience severe side effects. The patient should be aware of this additional risk:

• if the patient has ever had liver disease, including hepatitis B or C (if the patient has hepatitis B, they should not stop taking Lamivudine + Zidovudine Accord without their doctor's advice, as this may cause a relapse of hepatitis),
• if the patient has kidney disease,
• if the patient is overweight (especially in women).

You should inform your doctor if any of the above circumstances apply to you

Your doctormay recommend additional monitoring tests during treatment, including blood tests. For more information, see section 4.

Paying attention to important symptoms

Some patients taking HIV medications may experience other complications that can be severe. The patient should be aware of the important signs and symptoms to watch out for when taking Lamivudine + Zidovudine Accord.

You should read the information 'Other possible side effects associated with HIV combination therapy' in section 4 of this leaflet.

Protecting others

HIV infection can be transmitted through sexual contact with infected people or through infected blood (e.g., by sharing needles for injections). The patient can still transmit HIV while taking this medicine, even if effective antiretroviral therapy reduces this risk. The patient should discuss with their doctor the precautions necessary to avoid infecting others.

Lamivudine + Zidovudine Accord and other medicines

You should tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines and medicines available without a prescription.

If you start taking a new medicine while taking Lamivudine + Zidovudine Accord, you should remember to inform your doctor or pharmacist.

The following medicines should not be taken with Lamivudine + Zidovudine Accord:

• other medicinal products containing lamivudine, used to treat HIV infection or viral hepatitis B,
• emtricitabine, used to treat HIV infection,
• stavudine, used to treat HIV infections,
• ribavirin or ganciclovir injections, used to treat viral infections,
• high doses of co-trimoxazole, used as an antibiotic,
• cladribine, used to treat hairy cell leukemia.

You should inform your doctorif you are being treated with any of these medicines.

Some medicines interact with Lamivudine + Zidovudine Accord

These include:

• clarithromycin, an antibiotic. If you are taking clarithromycin, you should take its dose at least 2 hours before or after taking Lamivudine + Zidovudine Accord.
• phenytoin, used to treat epilepsy.

If you are taking phenytoin, you should inform your doctor. Your doctor may recommend monitoring you while taking Lamivudine + Zidovudine Accord.

• medicines (usually in liquid form) containing sorbitol or other sugar alcohols(such as xylitol, mannitol, lactitol, or maltitol), if taken for a long time.

If you are taking any of these medicines, you should tell your doctoror pharmacist.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, think you may be pregnant, or plan to have a child, you should consult your doctor to discuss the benefits and risks to you and your child of taking Lamivudine + Zidovudine Accord during pregnancy.
Lamivudine + Zidovudine Accord and similar medicines may cause side effects in unborn children. If you took Lamivudine + Zidovudine Accord during pregnancy, your doctor may recommend regular blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of reducing the risk of HIV transmission outweighs the risk of side effects.
Breastfeeding
Women with HIV infection should not breastfeed, as they can transmit HIV to their child through breast milk.
A small amount of Lamivudine + Zidovudine Accord may also pass into breast milk.
If you are breastfeeding or plan to breastfeed, you should consult your doctor immediately.

Driving and using machines

Lamivudine + Zidovudine Accord may cause dizzinessand other side effects that can affect your ability to concentrate.
You should not drive or operate machineryunless you feel well.

Lamivudine + Zidovudine Accord contains sodium

This medicine contains 48.15 mg of sodium (the main component of common salt) per tablet.
This is equivalent to 2.4% of the recommended maximum daily intake of sodium for an adult.

3. How to take Lamivudine + Zidovudine Accord

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.

If you are in doubt, you should consult your doctor or pharmacist.
The coated tablet should be swallowed with water. Lamivudine + Zidovudine Accord can be taken with or without food.
If you are unable to swallow the tablet, you can crush it and add it to a small amount of food or liquid, and then take the whole dose immediately after preparation.

Regular contact with your doctor

Lamivudine + Zidovudine Accord helps control the disease. You should take it every day to stop the disease from progressing. Other infections and diseases related to HIV may appear.

You should stay in regular contact with your doctor and not stop taking Lamivudine + Zidovudine Accord

without your doctor's advice.

What dose to take

Adults and adolescents weighing at least 30 kg

The usual dose of Lamivudine + Zidovudine Accord is one tablet twice a day.

Tablets should be taken at regular intervals, with a gap of approximately 12 hours between each tablet.
Children weighing 21 kg to 30 kg
The usual starting dose of Lamivudine + Zidovudine Accord is half (1/2) a tablet in the morning and one tablet in the evening.
Children weighing 14 kg to 21 kg
The usual starting dose of Lamivudine + Zidovudine Accord is half (1/2) a tablet in the morning and half (1/2) a tablet in the evening.
In children weighing less than 14 kg, lamivudine and zidovudine (the ingredients of Lamivudine + Zidovudine Accord) should be given separately.
The tablet can be divided into two equal doses.

Taking a higher dose of Lamivudine + Zidovudine Accord than recommended

If you accidentally take a higher dose of Lamivudine + Zidovudine Accord than recommended, you should tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missing a dose of Lamivudine + Zidovudine Accord

If you miss a dose, you should take it as soon as possible. Continue with the treatment as before. Do not take a double dose to make up for the missed 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 the improvement in health and lifestyle, and sometimes, in the case of lipid levels in the blood, to the effect of anti-HIV medicines. Your doctor will recommend tests to detect these changes.
Treatment with Lamivudine + Zidovudine Accord often causes loss of fat tissue in the legs, arms, and face (lipoatrophy). Loss of fat tissue is not fully reversible after stopping zidovudine. Your doctor should monitor you for signs of lipoatrophy. If you notice any loss of fat tissue in your legs, arms, or face, you should tell your doctor. If such symptoms occur, Lamivudine + Zidovudine Accord should be discontinued and alternative HIV treatment should be used.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During HIV treatment, it is not always possible to determine whether a particular side effect is caused by Lamivudine + Zidovudine Accord, other medicines taken at the same time, or by the HIV infection itself. Therefore, it is very important to inform your doctor of any changes in your health.
In addition to the side effects listed below for Lamivudine + Zidovudine Accord, combination therapy for HIV infection can also cause other side effects.
It is important to read the information below in the section 'Other possible side effects associated with HIV combination therapy'.
Very common: may affect more than 1 in 10 people:

• headache,
• nausea.

Common: may affect up to 1 in 10 people:

• vomiting,
• diarrhea,
• abdominal pain,
• loss of appetite,
• dizziness,
• fatigue, weakness,
• fever (high temperature),
• general feeling of being unwell,
• difficulty sleeping (insomnia),
• muscle pain and discomfort,
• joint pain,
• cough,
• irritation of the nose or runny nose,
• rash,
• hair loss (alopecia).

Common side effects that may be detected in blood tests:

• low number of red blood cells (anemia) or low number of white blood cells (neutropenia or leukopenia),
• increased activity of liver enzymes,
• increased bilirubin levels in the blood, which can cause yellowing of the skin.

Uncommon: may affect up to 1 in 100 people:

• shortness of breath,
• wind (flatulence),
• itching,
• muscle weakness.

Uncommon side effects that may be detected in blood tests:

• decrease in the number of platelets in the blood, which are involved in the blood clotting process (thrombocytopenia) or decrease in the number of all types of blood cells (pancytopenia).

Rare: may affect up to 1 in 1,000 people:

• severe allergic reactions causing swelling of the face, tongue, or throat, which can lead to difficulty swallowing or breathing,
• liver disorders, such as jaundice, liver enlargement, or fatty liver, hepatitis,
• lactic acidosis (a condition caused by the accumulation of lactic acid in the body; see the next section, 'Other possible side effects associated with HIV combination therapy'),
• pancreatitis,
• chest pain, heart disease (cardiomyopathy),
• seizures (epileptic fits),
• feeling depressed or anxious, difficulty concentrating, feeling sleepy,
• indigestion, taste disturbances,
• discoloration of nails or skin or inside the mouth,
• flu-like symptoms - chills and increased sweating,
• tingling or numbness of the skin,
• weakness of the limbs,
• muscle breakdown,
• numbness,
• frequent urination,
• breast enlargement in men.

Rare side effects that may be detected in blood tests:

• increased activity of the enzyme amylase,
• bone marrow failure to produce new red blood cells (pure red cell aplasia).

Very rare: may affect up to 1 in 10,000 people:

Very rare side effects that may be detected in blood tests:

• bone marrow failure to produce new red or white blood cells (aplastic anemia).

If you experience side effects

You should inform your doctor or pharmacistif any of the side effects get worse or if you experience any side effects not listed in this leaflet.

Other possible side effects associated with HIV combination therapy

Combination therapy, including Lamivudine + Zidovudine Accord, can cause other conditions to develop during HIV treatment.

Previous infections may develop rapidly

Patients with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop severe infections (opportunistic infections). In these patients, previously hidden infections may develop soon after starting treatment, causing the appearance of symptoms of inflammation. The appearance of these symptoms is likely due to the strengthening of the immune system, which allows the body to fight these infections. In addition to opportunistic infections, autoimmune diseases (diseases that occur when the immune system attacks healthy tissues) may also occur after starting HIV treatment. These can occur many months after starting treatment. If you notice symptoms of infection or other symptoms, such as muscle weakness, weakness starting in the hands or feet and progressing towards the torso, palpitations, tremors, or hyperactivity, you should inform your doctor immediately to start the necessary treatment.
If you notice any symptoms of infection while taking Lamivudine + Zidovudine Accord:
You should contact your doctor immediately. Do not take other medicines for infections without your doctor's advice.

Lactic acidosis is a rare but serious side effect

In some patients taking Lamivudine + Zidovudine Accord, a condition called lactic acidosis can develop, along with liver enlargement.
Lactic acidosis is caused by the accumulation of lactic acid in the body.
It occurs rarely; if it occurs, it usually develops after several months of treatment. It can be life-threatening, caused by damage to internal organs.
Lactic acidosis occurs more frequently in people with liver disease or those who are overweight (especially in women).

Symptoms of lactic acidosis include:

• deep, rapid breathing, difficulty breathing,
• drowsiness,
• numbness or weakness of the limbs,
• nausea, vomiting,
• abdominal pain.

During treatment, your doctor will monitor you for symptoms that may indicate the development of lactic acidosis. If you experience any of the above or other worrying symptoms you should contact your doctor immediately.

Bone disorders may occur

In some patients undergoing combination HIV therapy, a bone disorder called osteonecrosis can develop. This occurs when a part of the bone tissue dies due to limited blood supply to the bone.
The risk of these disorders is higher in patients who:

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

Symptoms of osteonecrosis include:

• stiffness of the joints,
• pain (especially in the hips, knees, and shoulders),
• difficulty moving. If you experience any of these symptoms you should inform your doctor.

Other symptoms that may be detected in tests

Combination HIV therapy can also cause:

• increased lactic acid levels in the blood, which can rarely lead to lactic acidosis.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel: +48 22 49 21 301
fax: +48 22 49 21 309
email: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamivudine + Zidovudine Accord

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Lamivudine + Zidovudine Accord contains

The active substances of the medicine are lamivudine and zidovudine.
Each coated tablet contains 150 mg of lamivudine and 300 mg of zidovudine.
The other ingredients are:

• microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate
• coating Opadry White YS-1-7003: titanium dioxide (E 171), hypromellose 3cP, hypromellose 6cP, macrogol 400, polysorbate 80.

What Lamivudine + Zidovudine Accord looks like and contents of the pack

Lamivudine + Zidovudine Accord is available in blisters of PVC/PVDC/Aluminum containing 60, 120, or 200 coated tablets or in HDPE bottles with a PP cap with a child-resistant closure containing 60 or 500 coated tablets.
Lamivudine + Zidovudine Accord is a white or almost white, biconvex, film-coated tablet in the shape of a capsule, with a dividing line and engraved with "H" on one side and "L" and "9" on the other side. The length of the tablet is approximately 17.5 mm, and the width is approximately 8.0 mm.
Not all pack sizes and types may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw

Manufacturer/Importer:

Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow
Middlesex, HA1 4HF
United Kingdom
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: June 2022