Label: Information for the User

Abacavir/Lamivudina Glenmark 600 mg/300 mg Film-Coated Tablets

Read this label carefully before starting to take this medicine, as it containsimportant information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even ifthey have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do notappear in this label. See section 4.

IMPORTANT — Hypersensitivity Reactions

Abacavir/Lamivudina Glenmark contains abacavir(which is also the active ingredient in medicines such asTrizivir,TriumeqandZiagen). Some people who take abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening ifmedicines containing abacavir are continued.

You must carefully read the information about “Hypersensitivity Reactions” in section 4of this label.

The packaging of Abacavir/Lamivudina Glenmark includes aWarning Cardto remind you and healthcare professionals of your hypersensitivity to abacavir.You must remove this card and carry it with you at all times.

Contents of the package and additional information

Abacavir/lamivudina is used in the treatment of the infection caused by the HIV (human immunodeficiency virus) in adults, adolescents, and in children who weigh at least 25 kg.

Abacavir/lamivudina contains two active ingredients that are used for the treatment of the infection caused by the HIV: abacavir and lamivudina. Both belong to a group of antiretroviral medications known as nucleoside reverse transcriptase inhibitors (NRTIs).

Abacavir/lamivudina does not completely cure the 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 plays an important role in helping the body fight infection.

Not everyone responds to treatment with abacavir/lamivudina in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take Abacavir/Lamivudina Glenmark

• if you areallergic(hypersensitive)to abacavir (or to any other medicine that contains abacavir (p.eg.Trizivir,TriumeqorZiagen).lamivudina or to any of the other components of this medicine(listed in section 6).Read carefully all the information about hypersensitivity reactions in section 4 ofthis leaflet.
• Consult your doctorif you think you are affected by any of these circumstances.Do not take Abacavir/Lamivudina Glenmark

Be particularly careful with Abacavir/Lamivudina Glenmark

Some people taking Abacavir/Lamivudina or other combination treatments for HIV have a higherrisk of severe side effects. You need to know that there is a higher risk:

• if you havemoderate or severe liver disease.
• if you have ever hadliver disease, including hepatitis B or C (if you have hepatitis Bdo not stop taking Abacavir/Lamivudina Glenmark without consulting your doctor, as it may worsen)
• if you havesignificant obesity(especially if you are a woman)
• if you have anykidney problems.

Consult your doctor before starting to take Abacavir/Lamivudina Glenmark if you have any of thesecircumstances. You may need additional tests, including blood tests, while takingthis medicine.For more information see section 4.

Hypersensitivity reactions to Abacavir

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

Read carefully the information about hypersensitivity reactions in section 4 of thisleaflet.

Risk of cardiovascular events

It cannot be ruled out that abacavir may increase the risk of cardiovascular events.

Inform your doctorif you have cardiovascular problems, smoke or have diseases that mayincrease your risk of cardiovascular diseases such as high blood pressure and diabetes. Do not stoptaking this medicine unless your doctor advises you to.

Be aware of important symptoms

Some people taking HIV medicines develop other disorders, whichcan be serious. You need to know what signs and symptoms to be aware of while taking Abacavir/Lamivudina Glenmark.

Read the information about “Other possible side effects of combination HIV treatment” in section 4 of this leaflet.

Other medicines and Abacavir/Lamivudina Glenmark

Inform your doctor or pharmacist if you are taking or have recently taken any othermedicine,including medicines based on plants and those acquired without a prescription.

Remember to inform your doctor or pharmacist if you start taking a new medicine whiletaking Abacavir/Lamivudina Glenmark.

The following medicines should not be used with Abacavir/Lamivudina Glenmark:

• Emtricitabine, to treatHIV infection
• Other medicines that contain lamivudine, used to treatHIV infection or hepatitis B
• High doses of trimetoprim/sulfamethoxazole, an antibiotic
• Cladribine, used to treatacute myeloid leukemia.

Inform your doctorif you are being treated with any of these medicines.

Some medicines interact with Abacavir/Lamivudina Glenmark

These include:

• phenytoin, to treatepilepsy. Inform your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking Abacavir/Lamivudina Glenmark.
• methadone, used as aheroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will need to be monitored for any symptoms of withdrawal. You may need your methadone dose to be adjusted.Inform your doctorif you are taking methadone.
• medicines (usually liquids) that containsorbitol and other polyols(such as xylitol, mannitol, lactitol or maltitol), if taken regularly.

Inform your doctor or pharmacistif you are being treated with any of these.

• riociguat, to treat high blood pressure in the blood vessels (pulmonary arteries) that carry blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase your riociguat blood levels.

Pregnancy

Abacavir/Lamivudina Glenmark is not recommended for use during pregnancy. Abacavir/Lamivudina and similar medicines maycause adverse effects in the fetus during pregnancy.

If you have been taking Abacavir/Lamivudina during your pregnancy, your doctor may request that you have regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took INTIs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

It is recommended not to breastfeed in women with HIV,as the HIV infectioncan be passed to the baby through breast milk. A small amount of the components of Abacavir/LamivudinaGlenmark may also pass into breast milk.

If you are breastfeeding, or have any doubts about breastfeedingcontact your doctor as soon as possible.

Driving and operating machinery

Abacavir/Lamivudina Glenmark may cause side effects that can affect your ability to drive or operatemachines.Consult your doctorabout your ability to drive or operate machines while taking this medicine.

Important information about some of the components of Abacavir/Lamivudina Glenmark.

This medicine contains a colouring called Sunset Yellow FCF (E110), which may cause allergic reactions in some people.

Follow exactly the administration instructions of this medication indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose of abacavir/lamivudine for adults, adolescents, and children weighing at least 25 kg or more, is one tablet once a day.

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

Maintain regular contact with your doctor.

Abacavir/lamivudine helps control your condition. You will need to take it every day to prevent your disease from worsening. You may continue to develop other infections and diseases associated with HIV infection.

Remain in contact with your doctor and do not stop taking abacavir/lamivudine without first speaking with your doctor.

If you take more Abacavir/Lamivudina Glenmark than you should

If you accidentally take more abacavir/lamivudine than you should, inform your doctor or pharmacist, or contact the nearest hospital emergency service for further information.

If you forget to take Abacavir/Lamivudina Glenmark

If you forget to take a dose, take it as soon as you remember and then continue with your regular treatment.

Do not take a double dose to compensate for the missed doses.

It is essential to take abacavir/lamivudine regularly, as irregular intake of abacavir/lamivudine may increase the risk of experiencing a hypersensitivity reaction.

If you have interrupted treatment with Abacavir/Lamivudina Glenmark

If for any reason, you have stopped taking abacavir/lamivudine, especially because you think you have side effects or another illness:

Consult your doctor before resuming treatment.Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers it could have been related,he will instruct you never to take abacavir/lamivudine again or any other medication that contains abacavir(e.g., Trizivir, Triumeq, or Ziagen). It is essential that you follow this warning.

If your doctor advises you to resume treatment with abacavir/lamivudine, you can ask him to take the first doses in a place where you have easy access to medical assistance if necessary.

During treatment for HIV, there may be an increase in weight and blood glucose and lipid levels.This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication may produce side effects, although not all people will experience them.

When you are on treatment for HIV, it may be difficult to distinguish whether a symptom is a side effect of Abacavir/Lamivudina Glenmark or of other medications you are taking, or is due to an effect of the disease caused by HIV.Therefore, it is very important that you inform your doctor about any changes in your health.

Even patients who do not have the HLA-B*5701 gene can develop a hypersensitivity reaction (a severe allergic reaction), described in this prospectus in the box called "Hypersensitivity Reactions".

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

In addition to the side effects listed below for this medication, other disorders may develop during combined HIV treatment.

It is important that you read the information under the heading "Other possible side effects of combined HIV treatment".

Frequent side effects

May affectup to 1 in 10patients:

• hypersensitivity reaction
• headache
• vomiting
• discomfort (nausea)
• diarrhea
• abdominal pain
• loss of appetite
• fatigue, lack of energy
• fever (elevated temperature)
• general feeling of discomfort
• difficulty falling asleep (insomnia)
• muscle pain and discomfort
• joint pain
• cough
• irritated or runny nose
• skin rash
• hair loss.

Rare side effects

May affectup to 1 in 100patients and may be reflected in blood tests:

• low red blood cell count(anemia)or low white blood cell count(neutropenia)
• an increase in liver enzymes
• a decrease in the number of cells involved in blood clotting(thrombocytopenia).

Rare side effectss

May affectup to 1 in 1,000patients:

• liver damage, such as jaundice, enlarged liver or fatty liver, inflammation(hepatitis).
• pancreatitis (inflammation of the pancreas)
• muscle rupture

Rare side effects that may appear in blood tests are:

• an increase in an enzyme calledamylase.

Very rare side effects

May affectup to 1 in 10,000patients:

• tingling, numbness in the skin (pins and needles)
• weakness in the limbs
• skin rash, which may form blisters that look like small darts (central dark spot surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).
• widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).

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

A very rare side effect that may appear in blood tests is:

• failure of the bone marrow to produce new red blood cells(aplastic anemia).

If you experience side effects

Inform your doctor or pharmacistif you consider that any of the side effects you experience areserious or if you notice any side effect not mentioned in this prospectus.

Other possible side effects of combined HIV treatment

Combined treatments, such as Abacavir/Lamivudina, may cause other disorders to develop during HIV treatment.

Symptoms of infection and inflammation

Exacerbation of old infections

People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). These infections may have been "latent" and not detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger, and it begins to fight these infections, which can cause symptoms of infection or inflammation. The symptoms usually includefever, as well as some of the following:

• headache
• abdominal pain
• difficulty breathing

In rare cases, as the immune system becomes stronger, it may also attack healthy tissues (autoimmune disorders). The symptoms of autoimmune disorders may appearmany months after starting to take medications to treat HIV infection. Thesymptoms may include:

• palpitations (rapid or irregular heartbeats) or tremors
• hyperactivity (excessive restlessness and movement)
• weakness that starts in the hands and feet and ascends to the body trunk.

If you notice any symptoms of infectione inflammation or if you notice any of the above symptoms:

?Inform your doctor immediately. Do not take any other medication for the infection without your doctor's advice.

You may have problems with your bones

Some patients receiving combined HIV treatment develop a bone disease called osteonecrosis. With this disease, part of the bone tissue dies due to a reduction in blood supply to the bone. People are more likely to develop this disease:

• if they have been taking a combined treatment for a long time
• if they also take anti-inflammatory medications called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight

The signs of osteonecrosis include:

• stiffness in the joints
• pain and discomfort (especially in the hip, knee, or shoulder)
• difficulty moving

If you notice any of these symptoms:

Inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medications for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25 ° C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Abacavir/Lamivudina Glenmark

• The active ingredients of this medication are 600 mg of abacavir and 300 mg of lamivudina.
• The other components are: microcrystalline cellulose, crospovidone, povidone, yellow iron oxide (E172) and magnesium stearate in the core of the tablet. The tablet coating contains: hypromellose, titanium dioxide (E171), macrogol, polisorbate 80 and yellow-orange lake FCF (E110).

Appearance of the product and contents of the package

Abacavir/Lamivudina Glenmark film-coated tablets are modified capsule-shaped, orange-colored, biconvex tablets with dimensions of 20.6 mm x 9.1 mm, with a “300” engraved on one face and a “600” on the other face.

This medication is available in packages containing 30, 60 or 90 tablets, in unit dose blisters in packages containing 30 x 1 or 90 x 1 film-coated tablets, or in multiple packages containing 60 or 90 film-coated tablets.

The 30-tablet bottles contain an activated carbon and oxygen-absorbing sachet for humidity control in the bottle.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell,

Germany

Responsible manufacturer:

Glenmark Pharmaceuticals sro.

Fibíchova 143

566 17 Vysoké Mýto

Czech Republic

Or

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate

Paola, PLA 3000, Malta

Further information about this medication can be obtained by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta,

28045 Madrid,

Spain

This medication is authorized in the EEA member states with the following names:

Last review date of this leaflet:April 2023.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)