150 mg / 300 mg film-coated tablets 
lamivudine / zidovudine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Combivir is and what it is used for 
2. What you need to know before taking Combivir 
3. How to take Combivir 
4. Possible side effects 
5. How to store Combivir 
6. Contents of the packaging and other information 

1. What Combivir is and what it is used for

Combivir is used to treat HIV infection ( human immunodeficiency virus infection ) in adults and children.

Combivir contains two active substances, lamivudine and zidovudine, which are used to treat HIV infection. Both of these belong to a group of antiretroviral drugs called nucleoside reverse transcriptase inhibitors (NRTIs).

Combivir does not completely cure HIV infection. It reduces the number of viruses 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 is important for the body to fight infections.

Not all patients respond to Combivir in the same way. Your doctor will check the treatment effect you are getting.

What you need to know before you take Combivir

Do not take Combivir:

  • if you are allergic to lamivudine or zidovudine or to any of the other ingredients of this medicine (see section 6)
  • if you have a very low number of red blood cells ( anemia ) or a very low number of white blood cells ( neutropenia )Check with your doctor if you think any of these apply to you. 

Take special care with Combivir

Some patients taking Combivir or other combination therapies for HIV are at greater risk of serious side effects. You need to be aware of the extra risks:

  • if you have a history of liver disease, including hepatitis B or hepatitis C (if you have hepatitis B infection, do not stop taking Combivir without talking to your doctor as your hepatitis may return)
  • if you have any kidney disease
  • if you are severely overweight (especially if you are a woman).
    Talk to your doctor if any of these apply to you. Your doctor will determine if the active substances are suitable for you. You may need extra checks, including blood tests, while you are taking medication. See section 4 for more information.

Pay attention to important symptoms

Some patients taking anti-HIV drugs develop other conditions that can be serious. You need to know important signs and symptoms to notice while taking Combivir

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 through sexual contact with someone who has an infection or through infected blood (eg by splitting injection needles). You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced.

Discuss with your doctor the necessary steps to avoid infecting others.

Other medicines and Combivir

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines, herbal medicines, or other natural products.

Remember to tell your doctor or pharmacist if you start taking a new medicine while taking Combivir.

These medicines should not be taken with Combivir:

  • other medicines containing lamivudine, for the treatment of HIV infection or hepatitis B infection
  • emtricitabine, for the treatment of HIV infection
  • stavudine for the treatment of HIV infection
  • ribavirin or injection of ganciclovir to treat viral infections
  • high doses of co-trimoxazole (trimethoprim + sulfamethoxazole), an antibiotic.
  • cladribine, which is used to treat hairy cell leukemia.

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

Some medicines make you more likely to have side effects or make the side effects worse. These include:

  • sodium valproate, for the treatment of epilepsy
  • interferon, for the treatment of viral infections
  • pyrimethamine, for the treatment of malaria and other parasitic infections
  • dapsone, to prevent pneumonia and treat skin infections
  • fluconazole or flucytosine, for the treatment of fungal infections such as candida
  • pentamidine or atovaquone, for the treatment of parasitic infections such as Pneumocystis jirovecii – pneumonia (often called PCP ) 
  • amphotericin or co-trimoxazole (trimethoprim + sulfamethoxazole), for the treatment of fungal and bacterial infections
  • probenecid, for the treatment of gout and similar conditions, and given together with antibiotics to increase its effectiveness
  • methadone, used as a heroin substitute
  • vincristine, vinblastine or doxorubicin, for the treatment of cancer. 
    Tell your doctor if you are taking any of these medicines.

Some medicines affect and are affected by Combivir

These include:

  • clarithromycin, an antibiotic 
    If you are taking clarithromycin, take your dose at least 2 hours before or after taking Combivir.
  • phenytoin, for the treatment of epilepsy. Tell your doctor if you are taking phenytoin. Your doctor may need to check you while you are taking Combivir.
  • medicines (usual liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol, and maltitol), if taken regularly. Tell your doctor or pharmacist if you are being treated with any of these medicines.

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 during your pregnancy.

Combivir and similar medicines can cause side effects in the unborn baby. If you have taken Combivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to check your baby’s development. For children with a mother who has taken NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.

Breast-feeding

Women who are HIV-positive should not breast-feed because the HIV infection can be transmitted to the baby via breast milk.

A small amount of the ingredients in Combivir may also pass into breast milk.

If you are breast-feeding or considering breastfeeding:

Talk to your doctor immediately.

Driving and using machines

Combivir may make you dizzy and have other side effects that make you less alert.

Do not drive or use machines unless you are feeling well.

Combivir contains sodium

  • This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Combivir

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

Swallow the tablets with a little water. Combivir can be taken with or without food.

If you can not swallow the tablets whole, you can crush and mix them with a small amount of food or drink and take the whole dose immediately.

Keep in regular contact with your doctor

Combivir helps keep your disease under control. You must take it every day to prevent the disease from getting worse. You may still develop other infections or diseases associated with HIV infection.

Keep in touch with your doctor and do not stop taking Combivir without your doctor’s advice.

How much to take

Adults and children weighing 30 kg or more:

The usual dose of Combivir is one tablet twice a day.

Take the tablets at regular intervals of about 12 hours.

Children weighing between 21 kg and 30 kg:

The usual starting dose for Combivir is one half (½) tablet in the morning and one whole tablet in the evening.

Children weighing between 14 kg and 21 kg:

The usual starting dose for Combivir is half a tablet (½) in the morning and a half (½) a tablet in the evening.

Children weighing less than 14 kg should take lamivudine and zidovudine (the active substances of Combivir) as separate medicines.

If you take more Combivir than you should

If you accidentally take too much Combivir, talk to your doctor or pharmacist, or contact the emergency department of your nearest hospital for further advice.

If you forget to take Combivir

If you forget to take a dose, take it as soon as you remember. Then continue with the treatment as before. Do not take a double dose to make up for a forgotten 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 restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. Your doctor will perform tests to find such changes.

Combivir treatment often causes loss of fat on the legs, arms, and face (lipoatrophy). It has been shown that such loss of body fat may not go away completely once treatment with zidovudine has been stopped. Your doctor will look for signs of lipoatrophy. Tell your doctor if you notice that the amount of fat decreases on your legs, arms, and face. When such signs occur, stop taking Combivir and receive other HIV treatment.

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

In the treatment of an HIV infection, it is not always possible to distinguish disease symptoms from adverse drug reactions caused by Combivir or by other concomitant drugs. For this reason, you must talk to your doctor about any changes in your state of health.

Like the side effects mentioned below for Combivir, other conditions can develop during combination therapy for HIV.

It is important to read the information in the following sections under “Other possible side effects of combination therapy for HIV”.

Very common side effects are

These can occur in more than 1 in 10 users:

  • headache
  • nausea.

Common side effects are

These can occur in up to 1 in 10 users:

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

Common side effects that can be detected in blood samples are:

  • low red blood cell count ( anemia ) or low white blood cell count ( neutropenia or leukopenia )
  • increase in liver enzyme levels
  • increase in the level of bilirubin (a substance produced by the liver) in the blood, which can yellow your skin.

Uncommon side effects are

These can occur in up to 1 in 100 users:

  • shortness of breath
  • gas in the stomach ( flatulence )
  • itching
  • muscle weakness.

A less common side effect that can be detected in blood tests is:

  • a decrease in the number of blood cells involved in blood coagulation ( thrombocytopenia ) or all types of blood cells (pancytopenia).

Rare side effects are

These can occur in up to 1 in 1000 users:

  • the severe allergic reaction which causes swelling of the face, tongue, or throat and which may cause difficulty in swallowing or breathing
  • liver diseases, such as jaundice, enlarged liver or fatty liver, inflammation ( hepatitis )
  • lactic acidosis (excess lactic acid in the blood, see next section “Other possible side effects of combination therapy for HIV”)
  • inflammation of the pancreas ( pancreatitis )
  • chest pain; heart muscle disease ( cardiomyopathy )
  • seizures
  • depression or anxiety, difficulty concentrating, drowsiness
  • poor digestion, taste changes
  • discoloration of the nails, skin, or mucous membranes on the inside of the mouth
  • flu-like symptoms – chills and sweating
  • numbness and tingling in the skin
  • the feeling of weakness in arms and legs
  • degradation of muscle tissue
  • numbness
  • increased urination frequency
  • breast augmentation in men.

Rare side effects that can be detected by blood tests are:

  • increase in an enzyme called amylase
  • failure of the bone marrow’s ability to form new red blood cells(erythroblastopenia).

Very rare side effect s

These can occur in up to 1 in 10,000 users:

A very rare side effect that can be detected in blood tests is:

  • failure of the bone marrow’s ability to form new red or white blood cells ( aplastic anemia ).

If you get side effects ar

Tell your doctor or pharmacist if any of these side effects gets serious or bothersome, or if you notice any side effects not listed in this leaflet.

Other possible side effects are with combination therapy for HIV

Combination therapy such as Combivir may cause other conditions to develop during HIV treatment.

Old infection can flare up

Patients with advanced HIV infection ( AIDS ) have a weakened immune system and are more likely to develop serious infections (opportunistic infections ). When these patients start treatment, it happens that old, hidden infections can flare up and cause signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system getting better and the body starts to fight these infections.

In addition to these opportunistic infections, autoimmune diseases (conditions that occur when the immune system attacks healthy body tissue) can also occur after you start medication for your HIV infection. Autoimmune diseases can develop several months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands and feet and moves towards the torso, palpitations, tremors, or hyperactivity, contact a doctor immediately for the necessary treatment.

If you notice any symptoms of infection while taking Combivir:

Talk to your doctor immediately. Do not take any other anti-infective medication without consulting your doctor.

Lactic acidosis is a rare but serious side effect

Some patients taking Combivir to develop a condition called lactic acidosis, in combination with an enlarged liver.

Lactic acidosis is caused by an accumulation of lactic acid in the body. This condition is rare and if it does occur, it usually develops after a few months of treatment. It can be life-threatening and cause the failure of internal organs. The risk of developing lactic acidosis is greater in patients who have liver disease, or in severe obesity, especially in women.

Characteristics of lactic acidosis include:

  • deep, fast, strained breathing
  • drowsiness
  • numbness or feeling of weakness in arms and legs
  • nausea, vomiting
  • abdominal pain.

During your treatment, your doctor will closely monitor for signs of lactic acidosis. If you have any of the symptoms mentioned above, or any other symptoms that concern you:

See your doctor as soon as possible.

You may have a skeletal problem

Some patients treated with combination therapy for HIV develop a condition called osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply. Patients may be at greater risk of getting this condition:

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

Characteristics of osteonecrosis include:

  • stiffness in the joints
  • aches and pains (especially in the hips, knees, or shoulders)
  • mobility impairment.

If you notice any of these symptoms:

Tell your doctor.

Other effects that can be detected in blood samples

Combination therapy for HIV can also cause:

  • elevated levels of lactic acid in the blood, which in rare cases can lead to lactic acidosis.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Combivir

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 carton.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are lamivudine and zidovudine. Other ingredients are:

  • tablet core: microcrystalline cellulose, sodium starch glycolate (gluten-free), magnesium stearate, colloidal silica
  • film coating: hypromellose, titanium dioxide, macrogol 400, and polysorbate 80.

What it looks like and the contents of the pack:

Combivir film-coated tablets are supplied in cartons containing blister packs or cans with child-resistant lids. Each pack type contains 60 film-coated tablets. They are white to “off-white”, capsule-shaped with a break notch, and are marked with the code GXFC3 on both sides.

Marketing Authorization Holder and Manufacturer

Show larger

Manufacturer Marketing Authorisation Holder
Glaxo Operations UK Limited(trading as Glaxo Wellcome Operations)Priory StreetWareHerts SG12 0DJUK
or
GlaxoSmithKline Pharmaceuticals SAul. Grunwaldzka 18960-322 Poznan Poland
ViiV Healthcare BVVan Asch van Wijckstraat 55H3811 LP Amersfoort Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine: Show larger

België / Belgique / 
Belgien ViiV Healthcare SRL / bvTel: + 32 (0) 10 85 65 00
LithuaniaGlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.com
BulgariaThe GlaxoSmithKlein ЕООДTel .: + 359 2 953 10 34
Luxembourg / Luxemburg 
ViiV Healthcare Srl / bv 
Belgique / 
Belgien Tél / Tel: + 32 (0) 10 85 65 00
Czech RepublicGlaxoSmithKline sroTel: + 420 222 001 111cz.info@gsk.com
HungaryGlaxoSmithKline Kft.Tel .: + 36 1 225 5300
DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com
MaltaGlaxoSmithKline (Malta) LimitedTel: + 356 21 238131
GermanyViiV Healthcare GmbHTel .: + 49 (0) 89 203 0038–10viiv.med.info@viivhealthcare.com
Netherlands 
ViiV Healthcare BV 
Tel: + 31 (0) 33 2081199
EestiGlaxoSmithKline Eesti OÜTel: + 372 6676 900estonia@gsk.com
Norway 
GlaxoSmithKline AS 
Tel: + 47 22 70 20 00
GreeceGlaxoSmithKline Aονοπρόσωπη AEBE:Ηλ: + 30 210 68 82 100
Austria 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0) 1 97075 0at.info@gsk.com
SpainLaboratories ViiV Healthcare, SLTel: + 34 900 923 501es-ci@viivhealthcare.com
PolandGSK Services Sp. z ooTel .: + 48 (0) 22 576 9000
FranceViiV Healthcare SASTel: + 33 (0) 1 39 17 6969Infomed@viivhealthcare.co
Portugal 
VIIV HEALTHCARE, UNIPESSOAL, LDA 
Tel: + 351 21 094 08 01viiv.fi.pt@viivhealthcare.com
CroatiaGlaxoSmithKline dooTel: + 385 1 6051 999
RomaniaGlaxoSmithKline (GSK) SRLTel: + 4021 3028 208
Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0) 1 4955000
SloveniaGlaxoSmithKline dooTel: + 386 (0) 1 280 25 00gqq41253@glaxowellcome.co.uk
IcelandVistor hf.Phone: + 354 535 7000 Slovak RepublicGlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com
Italy 
ViiV Healthcare SrlTel: + 39 (0) 45 9212611
Finland / Finland 
GlaxoSmithKline Oy 
Puh / Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com
LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com United KingdomViiV Healthcare UK LimitedTel: + 44 (0) 800 221441customercontactuk@gsk.com

Muhammad Nadeem

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