Sandoz AS

600 mg / 300 mg film-coated tablets 
abacavir / lamivudine

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.

IMPORTANT – Hypersensitivity reaction you

Abacavir / Lamivudine Sandoz contains abacavir (which is also an active substance in medicines such as Trizivir, Triumeq, and Ziagen ). Some patients taking abacavir may develop a hypersensitivity reaction (a severe allergic reaction ) which may be life-threatening if they continue to take abacavir-containing medicines.

You must carefully read the information under the heading “Hypersensitivity reactions” in the text box under section 4.

The Abacavir / Lamivudine Sandoz package comes with a warning card to remind you and healthcare professionals of a hypersensitivity reaction to abacavir. Always carry the card with you.

This leaflet contains information about: 
1. What Abacavir / Lamivudine Sandoz is and what it is used for 
2. What you need to know before you take Abacavir / Lamivudine Sandoz 
3. How to take Abacavir / Lamivudine Sandoz 
4. Possible side effects 
5. How Abacavir / Lamivudine Sandoz should be stored 
6. Contents of the packaging and other information 

What Abacavir / Lamivudine Sandoz is and what it is used for

Abacavir / Lamivudine Sandoz used to treat HIV – infection ( infection with human immunodeficiency virus) in adults, adolescents, and children weighing at least 25 kg.

Abacavir / Lamivudine Sandoz contains two active substances that are used to treat HIV infection: abacavir and lamivudine. These substances belong to a group of antiretroviral drugs called nucleoside reverse transcriptase inhibitors (NRTIs).

Abacavir / Lamivudine Sandoz does not cure HIV – infection completely. 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 Abacavir / Lamivudine Sandoz in the same way. Your doctor will check the treatment effect you are getting.

Abacavir and lamivudine contained in Abacavir / Lamivudine Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Abacavir / Lamivudine Sandoz

Do not take Abacavir / Lamivudine Sandoz:

  • if you are allergic (hypersensitive) to abacavir (or to other medicines containing abacavir – eg Trizivir, Triumeq, or Ziagen ), lamivudine, or to any of the other ingredients of this medicine (see section 6). Be sure to read all the information about hypersensitivity reactions in section 4.Check with your doctor if you think this applies to you. Do not take Abacavir / Lamivudine Sandoz.

Take special care with Abacavir / Lamivudine Sandoz

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

  • if you have moderate or severe liver disease
  • if you have a history of liver disease, including hepatitis B or hepatitis C (if you have hepatitis B infection, do not stop taking Abacavir / Lamivudine Sandoz without consulting your doctor as your hepatitis may return)
  • if you are severely overweight (especially if you are a woman)
  • if you have any kidney disease.

Talk to your doctor before taking Abacavir / Lamivudine Sandoz if any of these apply to you. You may need extra checks, including blood tests, while you are taking medication. See section 4 for more information.

Hypersensitivity reaction to abacavir

Even patients who do not have the HLA-B * 5701 gene may develop  hypersensitivity reaction (severe allergic reaction ).

Be sure to read all the information about hypersensitivity reactions in section 4 of this leaflet.

Risk of heart attack

It cannot be ruled out that abacavir may increase the risk of myocardial infarction.

Tell your doctor if you have heart problems, if you smoke or if you have other diseases that may increase the risk of heart diseases such as high blood pressure or diabetes. Do not stop taking Abacavir / Lamivudine Sandoz unless your doctor advises you to do so.

Pay attention to important symptoms

Some patients who use drugs against HIV – infection develop other conditions, which can be serious. You need to know important signs and symptoms to notice while taking Abacavir / Lamivudine Sandoz.

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 by sexual contact with someone with infection one or by infected blood (e.g., by sharing 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 Abacavir / Lamivudine Sandoz

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 you are taking Abacavir / Lamivudine Sandoz.

These medicines should not be taken with Abacavir / Lamivudine Sandoz:

  • emtricitabine, to treat HIV – infection
  • other drugs containing lamivudine, for treatment of HIV – infection or hepatitis B infection
  • high doses of 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 affect or are affected by Abacavir / Lamivudine Sandoz

These include:

  • 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 Abacavir / Lamivudine Sandoz.
  • methadone is used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will be checked for withdrawal symptoms. Your methadone dose may need to be changed. Tell your doctor if you are taking methadone.
  • 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, breastfeeding, and fertility

Pregnancy

Abacavir / Lamivudine Sandoz is not recommended for use during pregnancy. Abacavir/lamivudine and similar medicines can cause side effects in the unborn baby. If you have taken Abacavir / Lamivudine Sandoz during your pregnancy, your doctor may ask you to have 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 HIV – infection can be transmitted to the baby through breast milk. A small amount of the ingredients in Abacavir / Lamivudine Sandoz may also pass into breast milk.

If you are breast-feeding or considering breastfeeding:

Talk to your doctor immediately.

Driving and using machines

Abacavir / Lamivudine Sandoz can cause side effects that may affect your ability to drive or use machines.

Talk to your doctor about your ability to drive or use machines while taking Abacavir / Lamivudine Sandoz.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Important information about some of the ingredients of Abacavir / Lamivudine Sandoz

Abacavir / Lamivudine Sandoz contains the dye para-orange (E110) which may cause allergic reactions in some people.

How to take Abacavir / Lamivudine Sandoz

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

The recommended dose of Abacavir / Lamivudine Sandoz for adults, adolescents, and children weighing at least 25 kilograms is one tablet once a day.

Swallow the tablets whole with a little water. Abacavir / Lamivudine Sandoz can be taken with or without food.

Keep in regular contact with your doctor

Abacavir / Lamivudine Sandoz 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 you or illnesses associated with HIV – infection.

Keep in touch with your doctor and do not stop taking Abacavir / Lamivudine Sandoz without your doctor‘s advice.

If you take more Abacavir / Lamivudine Sandoz than you should

If you forget to take Abacavir / Lamivudine Sandoz

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.

It is important that you take Abacavir / Lamivudine Sandoz regularly, as an irregular intake may increase the risk of hypersensitivity reactions.

If you have stopped taking Abacavir / Lamivudine Sandoz

If you have stopped taking Abacavir / Lamivudine Sandoz for any reason – especially when you think you may have had side effects or due to another illness:

Talk to your doctor before taking the medicine again. Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor thinks there is a connection, you will be asked never to take Abacavir / Lamivudine Sandoz or other medicines containing abacavir (eg Trizivir or Ziagen) again. It is important that you follow this advice.

If your doctor advises you to start taking Abacavir / Lamivudine Sandoz again, you may be asked to take the first dose in a place where you have access to medical care if needed.

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

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 tell whether a symptom of drug side effects caused by Abacavir / Lamivudine Sandoz or other medicines you are taking. For this reason, it is very important that you talk to your doctor about any changes in your state of health.

Even patients who do not have the HLA-B * 5701 gene may develop a hypersensitivity reaction (a severe allergic reaction ), described in this leaflet under the heading ‘Hypersensitivity reactions’.

It is very important that you read and understand the information about this serious reaction.

As well as the side effects mentioned below for Abacavir / Lamivudine Sandoz, other conditions may develop during combination therapy for HIV.

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

Hypersensitivity s
Abacavir / Lamivudine Sandoz contains abacavir ( which is also an active substance in Trizivir, Triumeq and Ziagen) . Abacavir can cause a severe allergic reaction , a so-called hypersensitivity reaction . These hypersensitivity reactions have been seen more frequently in people taking abacavir-containing medicines.
Who can get these reactions?Anyone taking Abacavir / Lamivudine Sandoz may develop a hypersensitivity reactionto abacavir, which may be life-threatening if they continue to take Abacavir / Lamivudine Sandoz.
You are more likely to develop this reaction if you have a gene called HLA-B * 5701 (but you can get a reaction even if you do not have this gene). You should have been tested for this gene before you were prescribed Abacavir / Lamivudine Sandoz. If you know that you carry this gene, talk to your doctor before taking Abacavir / Lamivudine Sandoz.
About 3-4 out of every 100 patients treated with abacavir in a clinical study who did not carry the HLA-B * 5701 gene developed a hypersensitivity reaction .
What are the symptoms?The most common symptoms are:fever (high temperature) and rash.Other common symptoms are:nausea, vomiting, diarrhea, abdominal pain, pronounced fatigue.Other symptoms are:Joint or muscle pain, swollen throat, shortness of breath, sore throat, cough, temporary headache, eye inflammation ( conjunctivitis ), cold sores, low blood pressure , tingling or numbness in the hands or feet.
When do these symptoms occur?Hypersensitivity reactions may occur at any time during treatment with Abacavir / Lamivudine Sandoz but more likely during the first six weeks of treatment.
Contact your doctor immediately:1 if you get a rash, OR2 if you get symptoms from at least 2 of the following groups:fevershortness of breath, sore throat or coughnausea or vomiting, diarrhea or abdominal painpronounced fatigue or diffuse pain or general malaise.Your doctor may advise you to stop taking Abacavir / Lamivudine Sandoz.
If you have stopped taking Abacavir / Lamivudine SandozIf you have stopped taking Abacavir / Lamivudine Sandoz due to a hypersensitivity reaction , you should NEVER take  Abacavir / Lamivudine Sandoz or any other medicine containing abacavir (eg Trizivir, Triumeq or Ziagen) again . If you do, you could get a dangerous drop in blood pressure within a few hours, which could result in death.
If you have stopped taking Abacavir / Lamivudine Sandoz for any reason – especially when you think you may have had side effects or due to another illness:
Talk to your doctor before taking the medicine again. Your doctor will check if your symptoms were related to a hypersensitivity reaction . If your doctor thinks there is a connection, you will be asked never to take Abacavir / Lamivudine Sandoz or other medicines containing abacavir (eg Trizivir, Triumeq or Ziagen) again. It is important that you follow this advice.
Occasionally, hypersensitivity reactions have developed in patients who start taking abacavir again and who had only one of the symptoms listed on the warning card before stopping taking the medicine.
In very rare cases, hypersensitivity reactions have developed in patients who start taking abacavir again but have no symptoms before stopping the medicine.
If your doctor advises you to start taking Abacavir / Lamivudine Sandoz again, you may be asked to take the first dose in a place where you have access to medical care if needed.
If you are hypersensitive to abacavir / lamivudine, return any unused Abacavir / Lamivudine Sandoz tablets for destruction. Consult your doctor or pharmacist.
Packages with Abacavir / Lamivudine Sandoz contains a warning cards to remind you and medical staff about hypersensitivity reaction you . This card contains important safety information. Always carry it with you.

Common side effects are

These can occur in up to 1 in 10 users:

  • hypersensitivity reaction
  • headache
  • vomiting
  • nausea
  • diarrhea
  • abdominal pain
  • loss of appetite
  • 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.

Uncommon side effects are

These can occur in up to 1 in 100 users and they can be detected in blood tests:

  • low red blood cell count ( anemia ) or low white blood cell count ( neutropenia )
  • increase in liver enzyme levels
  • reduction in the number of blood cells involved in blood coagulation ( thrombocytopenia ).

Rare side effects are

These can occur in up to 1 in 1000 users:

  • liver diseases, such as jaundice, enlarged liver or fatty liver, inflammation ( hepatitis )
  • inflammation of the pancreas ( pancreatitis )
  • degradation of muscle tissue.

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

  • increase in an enzyme called amylase.

Very rare side effect s

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

  • numbness and tingling in the skin
  • a feeling of weakness in arms and legs
  • skin rash, which can become blisters and look like small targets (dark spot in the middle surrounded by a lighter field and a dark ring along the edge) (erythema multiforme)
  • scattered skin rash with blisters and flaking skin occurs especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), and a more severe form that causes skin flaking on more than 30% of the body surface ( toxic epidermal necrolysis )
  • lactic acidosis (excess lactic acid in the blood)

If you notice any of these symptoms, contact a doctor immediately.

Very rare side effects that can be detected in blood tests are:

  • failure of the bone marrow’s ability to form new red blood cells ( pure erythrocyte plasma ).

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 abacavir/lamivudine may cause other conditions to develop during HIV treatment.

Symptoms of infection and inflammation

Old infection can flare up

Patients with advanced HIV – infection ( AIDS ) have weak immune systems and are more likely to develop a serious infection ( opportunistic infection s ). Such infections may have been “silent” and not detected by the weak immune system before starting treatment. When treatment is started, the immune system becomes stronger and can fight the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever and any of the following:

  • headache
  • gripe
  • breathing difficulties

In rare cases, when the immune system becomes stronger, it can also attack healthy body tissue ( autoimmune diseases ). The symptoms of autoimmune diseases may develop several months after you start taking medicines for your HIV – infection. Symptoms may include:

  • palpitations (rapid or irregular heartbeat) or tremors
  • hyperactivity (excessive restlessness and excessive movement)
  • weakness that begins in the hands and feet and moves upwards towards the torso.

If you get symptoms of an infection and inflammation or if you notice any of the symptoms mentioned above:

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

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.

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.

5. How to store Abacavir / Lamivudine Sandoz

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 after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° 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 in each Abacavir / Lamivudine Sandoz film-coated tablet are abacavir hydrochloride equivalent to 600 mg abacavir and 300 mg lamivudine.

The other ingredients in the tablet core are microcrystalline cellulose, crospovidone (type A), povidone (K-30), yellow iron oxide (E172), and magnesium stearate. The film coating contains hypromellose HPMC 2910 -3mPase, hypromellose HPMC 2910 -6mPase, titanium dioxide (E171), macrogol 400, polysorbate 80, and para-orange aluminum lacquer (E110).

What the medicine looks like and the contents of the pack

Abacavir / Lamivudine Sandoz are orange, capsule-shaped, biconvex, film-coated tablets marked with “300” on one side and “600” on the other side. The tablet size is 20.6 mm x 9.1 mm.

Abacavir / Lamivudine Sandoz is available in:

  • Blister packs containing 30, 60, or 90 film-coated tablets, or in multiple blister packs containing 60 (2×30) or 90 (3×30) film-coated tablets.
  • Jars containing 30 film-coated tablets. Each can contain a bag of activated carbon or a bag of activated carbon and a substance that absorbs oxygen to keep the moisture in the can under control.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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