Lamivudine Accord 300 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Lamivudine Accord 300 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents:
- What Lamivudine Accord is and what it is used for
- What you need to know before taking Lamivudine Accord
- How to take Lamivudine Accord
- Possible side effects
- How to store Lamivudine Accord
- Contents of the pack and other information
1. What Lamivudina Accord is and what it is used for
Lamivudina Accord is used to treat HIV (human immunodeficiency virus) infection in adults and children.
The active substance in Lamivudina Accord is lamivudina. Lamivudina Accord is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
Lamivudina Accord does not completely cure HIV infection; it reduces the amount of virus 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 play an important role in helping the body fight infection.
Not everyone responds to treatment with Lamivudina Accord in the same way. Your doctor will monitor how well your treatment is working.
2. What you need to know before taking Lamivudine Accord
Do not take Lamivudine Accord:
- 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
Talk to your doctor or pharmacist before taking Lamivudine Accord.
Some people who take Lamivudine Accord or other similar medicines have an increased risk of serious side effects. You should be aware that the risk is higher:
-
if you have ever had other types of liver disease, such as hepatitis C
-
if you are significantly overweight (especially if you are female)
-
Talk to your doctor if you have any of these conditions. You may need additional tests, such as blood tests, while taking this medicine. See Section 4 for more information.
Do not stop taking Lamivudine Accord without consulting your doctor, as there is a risk that your hepatitis may worsen. After stopping Lamivudine Accord, your doctor will monitor you for at least four months to check for any problems. This will involve blood tests to check for abnormalities in liver enzymes, which may indicate liver damage. See section 3 for more information on how to take Lamivudine Accord.
Protecting others
Hepatitis B is spread through sexual contact with someone who has the disease or through transfer of infected blood (for example, by sharing needles). Lamivudine Accord does not prevent the risk of transmitting hepatitis B infection to others. To help prevent others from becoming infected with hepatitis B:
- Use a condom during oral or penetrative sex.
- Avoid the risk of blood transfer — for example, do not share needles.
Taking Lamivudine Accord with other medicines
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including herbal medicines or over-the-counter medicines.
Remember to inform your doctor or pharmacist if you start taking any other medicine while taking Lamivudine Accord.
The following medicines must not be taken with Lamivudine Accord:
- 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 (sometimes also called AIDS virus).
- Emtricitabine, used to treat HIV or hepatitis B infection.
- Cladribine, used to treat hairy cell leukemia.
Tell your doctor if you are being treated with any of these medicines.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant:
- Speak to your doctor immediately about the risks and benefits of taking Lamivudine Accord during pregnancy.
Do not stop treatment with Lamivudine Accord without consulting your doctor.
Breastfeeding
Components of Lamivudine Accord may pass into breast milk. If you are breastfeeding or planning to breastfeed:
- Talk to your doctor before taking Lamivudine Accord.
Driving and using machines
Lamivudine Accord may make you feel tired, which could affect your ability to drive or operate machinery.
- Do not drive or operate machinery unless you are sure this does not affect you.
Lamivudine Accord contains isomalt
If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Lamivudine Accord
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Swallow the tablet whole with water. Lamivudine Accord can be taken with or without food. If you cannot swallow the tablets whole, you may split them and mix them with a small amount of food or drink; take the entire dose immediately.
Maintain regular contact with your doctor
Lamivudine Accord helps control your condition. You will need to take it every day to prevent your disease from worsening. You may still develop other infections and illnesses associated with HIV infection.
Stay in contact with your doctor and do not stop taking Lamivudine Accord without first speaking to your doctor.
How much to take
Adults, adolescents, and children weighing at least 25 kg:
The usual dose of Lamivudine Accord is 300 mg daily.
The 150 mg Lamivudine Accord tablet is available for treatment of children from 3 months of age who weigh less than 25 kg.
It is also available as an oral solution for treatment of children over three months of age and for patients who cannot swallow tablets or who require a lower than usual dose.
If you or your child has kidney problems, your dose may need to be adjusted.
Consult your doctor if this applies to you or your child.
If you take more Lamivudine Accord than you should
If you accidentally take too much Lamivudine Accord, inform your doctor or pharmacist, or go to the nearest hospital emergency department for advice. If possible, show them the Lamivudine Accord packaging.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Lamivudine Accord
If you forget to take a dose, take it as soon as you remember, and then continue with your regular treatment schedule. Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to the anti-HIV medications themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
When undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of Lamivudine Accord, of other medications you are taking, or due to the HIV disease itself. Therefore, it is very important that you inform your doctor about any changes in your health.
In addition to the adverse effects listed below for Lamivudine Accord, other disorders may develop during combination therapy for HIV.
It is important that you read the information under the section “Other possible adverse effects of combination therapy for HIV”.
Frequent adverse effects
May affect up to 1 in 10 patients:
- headache
- malaise (nausea)
- vomiting
- diarrhea
- stomach pain
- fatigue, lack of energy
- fever (elevated temperature)
- general feeling of discomfort
- muscle aches and discomfort
- joint pain
- difficulty sleeping (insomnia)
- cough
- irritated nose or excessive nasal discharge
- skin rash
- hair loss (alopecia).
Uncommon adverse effects
May affect up to 1 in 100 patients:
Uncommon adverse effects that may appear in blood tests include:
- a decrease in the number of cells involved in blood clotting (thrombocytopenia)
- low red blood cell count (anemia) or low white blood cell count (neutropenia)
- increased levels of liver-produced enzymes.
Rare adverse effects
May affect up to 1 in 1,000 patients:
- severe allergic reaction causing swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing
- inflammation of the pancreas (pancreatitis)
- muscle tissue rupture
- liver problems, such as jaundice, enlarged liver, fatty liver, inflammation (hepatitis).
A rare adverse effect that may appear in blood tests is:
- increased level of an enzyme called amylase.
Very rare adverse effects
May affect up to 1 in 10,000 patients:
-
lactic acidosis (excess lactic acid in the blood)
-
tingling or numbness in the arms, legs, hands, or feet.
A very rare adverse effect that may appear in blood tests is:
- failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
If you experience adverse effects
Inform your doctor or pharmacist if you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not mentioned in this leaflet.
Other possible adverse effects of combination therapy for HIV
Combination therapies, such as Lamivudine Accord, may cause other disorders to develop during HIV treatment.
Exacerbation of previous infections
People with advanced HIV infection (AIDS) have weakened immune systems and are more likely to suffer from serious infections (opportunistic infections). When these individuals start treatment, previously hidden infections may flare up, causing signs and symptoms of inflammation. These symptoms are likely due to an improved immune response, which enables the body to fight these infections.
In addition to these opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you have started taking medications for your HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness in the hands and feet spreading toward the trunk, palpitations, tremors, or hyperactivity, please inform your doctor immediately to receive appropriate treatment.
If you notice any symptoms of infection while taking Lamivudine Accord:
Inform your doctor immediately. Do not take any other medication for the infection unless advised by your doctor.
You may have bone problems
Some patients receiving combination therapy for HIV may develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone. People are more likely to develop this disease:
- if they have been on combination therapy for a long time
- if they also take anti-inflammatory drugs called corticosteroids
- if they drink alcohol
- if their immune system is severely weakened
- if they are overweight
Signs of osteonecrosis include:
- joint stiffness
- pain and discomfort (especially in the hip, knee, and shoulder)
- difficulty moving
If you notice any of these symptoms: Inform your doctor.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines, www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lamivudine Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Lamivudina Accord
The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
The other components are: isomalt (E953), crospovidone A, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), yellow and red iron oxides (E172).
Appearance of the product and contents of the pack
Lamivudina Accord 100 mg film-coated tablets EFG is available in Alu/PVC-Alu-OPA blisters containing 28 or 84 tablets.
The tablets are pink, film-coated, capsule-shaped, biconvex, with dimensions of 12.00 x 6.00 mm, scored on both sides, with the code ''37'' on one side and ''I'' on the other.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center
Moll de Barcelona, s/n
Edifici Est, 6th floor
08039 Barcelona, Spain
Manufacturer
Pharmadox Healthcare Ltd.
KW 20A - Kordin Industrial Park
PLA 3000 Paola
Malta
This medicinal product is authorized in the European Economic Area member states under the following names:
Italy: Lamivudina Accord
Netherlands: Lamivudine Accord 100 mg, filmomhulde tabletten
Spain: Lamivudina Accord 100 mg, comprimidos recubiertos con película EFG
United Kingdom: Lamivudine 100 mg Film-coated tablets
Date of the most recent review of this leaflet: April 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).