Combivir 150 mg/300 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Combivir 150 mg/300 mg film-coated tablets
lamivudine/zidovudine
Read the entire leaflet carefully before you start taking this medicine, because 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 you should not give it to other people, even if they have the same symptoms as you, because 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.
Contents of the leaflet
- What Combivir is and what it is used for
- What you need to know before taking Combivir
- How to take Combivir
- Possible side effects
- How to store Combivir
- Contents of the pack and other information
1. What Combivir is and what it is used for
Combivir is used in the treatment of HIV (human immunodeficiency virus) infection in adults and children.
Combivir contains two active substances used to treat HIV infection: lamivudine and zidovudine. Both belong to a class of antiretroviral medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).
Combivir does not completely cure HIV infection; it reduces the amount of virus in the body and maintains 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 infection.
Not everyone responds to treatment with Combivir in the same way. Your doctor will monitor how well your treatment is working.
2. What you need to know before taking Combivir
Do not take Combivir
- if you are allergic to lamivudine, zidovudine, or any of the other ingredients of this medicine (listed in section 6)
- if you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia).
Consult your doctor if you think you have any of these conditions.
Be especially careful with Combivir
Some people who take Combivir or other combination treatments for HIV infection are at higher risk of serious side effects. You should be aware that the risk is greater:
- if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B, do not stop taking Combivir without consulting your doctor, as your condition may worsen)
- if you have kidney disease
- if you are significantly overweight (particularly if you are a woman).
Consult your doctor if you have any of these conditions. Your doctor will decide whether the active substances are suitable for you. You may need additional tests, including blood tests, while taking this medicine. For more information, see section 4.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other disorders, which may be serious. You need to know which important signs and symptoms to watch for while taking Combivir.
Read the information on “Other possible side effects of combination HIV treatment” in section 4 of this leaflet.
Other medicines and Combivir
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines and those obtained without a prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine while on Combivir.
The following medicines must not be used with Combivir:
- other medicines containing lamivudine, used to treat HIV infection or hepatitis B
- emtricitabine, used to treat HIV infection
- stavudine, used to treat HIV infection
- ribavirin or ganciclovir injections, used to treat viral infections
- high doses of cotrimoxazole (a combination of trimethoprim and sulfamethoxazole), an antibiotic
- cladribine, used to treat hairy cell leukaemia.
Tell your doctor if you are being treated with any of these medicines.
Some medicines may increase the likelihood of side effects or make them worse.
These include:
- sodium valproate, used to treat epilepsy
- interferon, used to treat viral infections
- pyrimethamine, used to treat malaria and other parasitic infections
- dapsone, used to prevent pneumonia and treat skin infections
- fluconazole or flucytosine, used to treat fungal infections such as Candida
- pentamidine or atovaquone, used to treat parasitic infections such as Pneumocystis jirovecii pneumonia (often referred to as PCP)
- amphotericin or cotrimoxazole (a combination of trimethoprim and sulfamethoxazole), used to treat fungal and bacterial infections
- probenecid, used to treat gout and similar conditions, and given with certain antibiotics to increase their effectiveness
- methadone, used as a heroin substitute
- vincristine, vinblastine or doxorubicin, used to treat cancer.
Tell your doctor if you are taking any of the above medicines.
Some medicines interact with Combivir
These include:
- clarithromycin, an antibiotic
If you are taking clarithromycin, take your dose at least two hours before or after taking Combivir.
- phenytoin, used to treat epilepsy
Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking Combivir.
- medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol or maltitol) if taken regularly.
Tell your doctor or pharmacist if you are being treated with any of these.
Pregnancy
If you are pregnant, become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits of taking Combivir for both you and your baby.
Combivir and similar medicines may cause side effects in babies during pregnancy.
If you have taken Combivir 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 protection against HIV was greater than the risk of adverse effects.
Breastfeeding
Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.
A small amount of the components of Combivir may also pass into breast milk.
If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.
Driving and using machines
Combivir may cause dizziness and other side effects that may reduce your alertness.
Do not drive or operate machinery unless you feel well.
Combivir contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take Combivir
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Swallow the Combivir tablets with a little water. Combivir may be taken with or without food.
If you cannot swallow the tablets whole, you may break them and mix with a small amount of food or drink; take the entire dose immediately.
Keep in regular contact with your doctor
Combivir 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 Combivir without first talking to your doctor.
How much to take
Adults and adolescents weighing at least 30 kg
The usual dose of Combivir is one tablet twice daily.
Take the tablets at regular intervals, approximately 12 hours apart.
Children weighing between 21 and 30 kg
The usual starting dose is half a tablet (½) in the morning and one whole tablet at night.
Children weighing between 14 and 21 kg
The usual starting dose is half a tablet (½) in the morning and half a tablet (½) at night.
For children weighing less than 14 kg, lamivudine and zidovudine (the active substances in Combivir) should be taken separately.
If you take more Combivir than you should
If you accidentally take more Combivir than you should, inform your doctor or pharmacist, or contact the nearest hospital emergency department for advice.
If you forget to take Combivir
If you forget to take a dose, take it as soon as you remember, then continue with your usual treatment schedule. Do not take a double dose to make up for missed doses.
4. Possible adverse effects
During HIV treatment, there may be an increase in body weight and in blood glucose and lipid levels. This may be partly related to improved health, lifestyle factors, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.
Treatment with Combivir often causes loss of fat from the legs, arms, and face (lipoatrophy). This loss of body fat has been shown not to be completely reversible after stopping zidovudine. Your doctor should monitor for signs of lipoatrofia. If you notice any loss of fat in your legs, arms, or face, inform your doctor. When these symptoms occur, Combivir should be discontinued and your HIV treatment changed. Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
While undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of Combivir or of other medicines you are taking, or is due to the HIV disease itself. Therefore, it is very important that you inform your doctor of any changes in your health.
In addition to the adverse effects listed below for Combivir, other disorders may develop during combination HIV treatment.
It is important that you read the information under the section “Other possible adverse effects of combination HIV treatment”.
Very common adverse effects
May affect more than 1 in 10 people:
- headache
- discomfort (nausea).
Common adverse effects
May affect up to 1 in 10 people:
- vomiting
- diarrhoea
- stomach pain
- loss of appetite
- dizziness
- fatigue, lack of energy
- fever (high temperature)
- general feeling of malaise
- difficulty falling asleep (insomnia)
- muscle aches and discomfort
- joint pain
- cough
- irritated or runny nose
- skin rash
- hair loss (alopecia).
Common adverse effects that may appear in blood tests are:
- low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)
- increased levels of liver-produced enzymes
- increased blood bilirubin levels (a substance produced in the liver), which may cause yellowing of the skin.
Uncommon adverse effects
May affect up to 1 in 100 people:
- difficulty breathing
- gas (flatulence)
- itching
- muscle weakness.
Uncommon adverse effects that may appear in blood tests are:
- decreased number of cells involved in blood clotting (thrombocytopenia) or a decrease in all types of blood cells (pancytopenia).
Rare adverse effects
May affect up to 1 in 1,000 people:
-
severe allergic reaction causing swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing
-
liver problems, such as jaundice, enlarged liver, fatty liver, inflammation (hepatitis)
-
lactic acidosis (excess lactic acid in the blood; see the next section “Other possible adverse effects of combination HIV treatment”)
-
inflammation of the pancreas (pancreatitis)
-
chest pain, heart muscle disease (cardiomyopathy)
-
seizures (convulsions)
-
feeling depressed or anxious, difficulty concentrating, drowsiness
-
indigestion, taste disturbances
-
changes in the colour of nails, skin, or mouth mucosa
-
flu-like feeling — chills and sweating
-
tingling sensation in the skin (pins and needles)
-
feeling of weakness in the limbs
-
muscle tissue breakdown
-
numbness
-
frequent urination
-
breast enlargement in men.
Rare adverse effects that may appear in blood tests are:
- increased levels of an enzyme called amylase
- failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Very rare adverse effects
May affect up to 1 in 10,000 people:
A very rare adverse effect that may appear in blood tests is:
- failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).
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 listed in this leaflet.
Other possible adverse effects of combination HIV treatment
Combination treatments, such as Combivir, 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 serious infections (opportunistic infections). When these people start treatment, previously hidden infections may flare up again, causing signs and symptoms of inflammation. These symptoms are likely due to improved immune response, enabling the body to fight these infections.
In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines for your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.
If you notice any signs of infection while taking Combivir:
Inform your doctor immediately. Do not take any other medicine for the infection unless advised by your doctor.
Lactic acidosis is a rare but serious adverse effect
Some people taking Combivir develop a condition called lactic acidosis, along with an enlarged liver.
Lactic acidosis is due to increased levels of lactic acid in the body. It is rare and, if it occurs, usually develops after a few months of treatment. It can be potentially life-threatening, causing failure of internal organs. Lactic acidosis is more likely to occur in patients with liver disease or in obese individuals (with significant overweight), especially women.
Signs of lactic acidosis include:
- difficulty breathing, rapid and deep breathing
- drowsiness
- numbness or weakness in the limbs
- discomfort (nausea), vomiting
- stomach pain.
During your treatment, your doctor will monitor for any signs that you may be developing lactic acidosis. If you experience any of the symptoms listed above or are concerned about any other symptom:
See your doctor as soon as possible.
You may have bone problems
Some people receiving combination HIV treatment 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 treatment for a long time
- they also take anti-inflammatory medicines called corticosteroids
- they drink alcohol
- their immune system is severely weakened
- they are overweight.
Signs of osteonecrosis include:
- stiffness in the joints
- pain and discomfort (especially in the hip, knee, and shoulder)
- difficulty moving.
If you notice any of these symptoms:
Inform your doctor.
Other effects that may appear in blood tests
Combination HIV treatment may also cause:
- increased levels of lactic acid in the blood, which in rare cases may lead to lactic acidosis.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Combivir
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Do not store above 30 ºC.
Medicines should not be disposed of via wastewater or household waste. 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 Combivir
The active substances are lamivudine and zidovudine. The other components are:
- tablet core: microcrystalline cellulose, sodium carboxymethyl starch (gluten-free), magnesium stearate, colloidal silicon dioxide
- coating: hypromellose, titanium dioxide, macrogol 400, polysorbate 80.
Appearance of Combivir and contents of the pack
Film-coated Combivir tablets are supplied in cardboard cartons containing blister packs or a bottle with a child-resistant closure. Each type of packaging contains 60 film-coated tablets. These tablets are white to off-white, capsule-shaped, biconvex, and engraved with the code GXFC3 on both sides.
Marketing Authorization Holder and Manufacturer
Manufacturer | Marketing Authorization Holder |
Delpharm Poznan Spólka Akcyjna ul. Grunwaldzka 189 60-322 Poznan Poland | ViiV Healthcare BV Van Asch van Wijckstraat 55H 3811 LP Amersfoort Netherlands |
You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:
Belgium/Belgium/Belgium ViiV Healthcare srl/bv Tel/Tel: + 32 (0)10 85 65 00 | Lithuania ViiV Healthcare BV Tel: + 370 80000334 |
Bulgaria ViiV Healthcare BV Tel: + 359 80018205 | Luxembourg/Luxembourg ViiV Healthcare srl/bv Belgium/Belgium Tél/Tel: + 32 (0)10 85 65 00 |
Czech Republic GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 | Hungary ViiV Healthcare BV Tel.: + 36 80088309 |
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta ViiV Healthcare BV Tel: + 356 80065004 |
Germany ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 | Netherlands ViiV Healthcare BV Tel: + 31 (0) 33 2081199 |
Estonia ViiV Healthcare BV Tel: + 372 8002640 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece GlaxoSmithKline Monoprosopi EPE Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969 | Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA. Tel: + 351 21 094 08 01 |
Croatia ViiV Healthcare BV Tel: + 385 800787089 | Romania ViiV Healthcare BV Tel: + 40 800672524 |
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenia ViiV Healthcare BV Tel: + 386 80688869 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia ViiV Healthcare BV Tel: + 421 800500589 |
Italy ViiV Healthcare S.r.l. Tel: + 39 (0)45 7741600 | Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 |
Cyprus ViiV Healthcare BV Tel: + 357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvia ViiV Healthcare BV Tel: + 371 80205045 | United Kingdom (Northern Ireland) ViiV Healthcare BV Limited Tel: + 44 (0)800 221441 |
Date of the most recent review of this leaflet:
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu