Abacavir + lamivudine sandoz: detailed information

Package leaflet: Information for the patient

Abacavir + Lamivudine Sandoz, 600 mg + 300 mg, film-coated tablets
Abacavirum + Lamivudinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

IMPORTANT – Hypersensitivity reactions
Abacavir + Lamivudine Sandoz contains abacavir (which is also the active substance in
medicines such as Trizivir, Triumeq and Ziagen). In some patients receiving abacavir,
a hypersensitivity reaction (a severe allergic reaction) may develop, which may be life-threatening
if treatment with abacavir is continued.
It is essential to read carefully all the information in the box titled 'Hypersensitivity reactions'
in section 4.
A Warning Card is included in the Abacavir + Lamivudine Sandoz package to remind the patient
and healthcare professionals of the risk of abacavir hypersensitivity.
Remove the card from the package and carry it with you at all times.

Contents of the leaflet

What Abacavir + Lamivudine Sandoz is and what it is used for
What you need to know before you take Abacavir + Lamivudine Sandoz
How to take Abacavir + Lamivudine Sandoz
Possible side effects
How to store Abacavir + Lamivudine Sandoz
Contents of the pack and other information

1. What Abacavir + Lamivudine Sandoz is and what it is used for

Abacavir + Lamivudine Sandoz is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents, and children weighing at least 25 kg.
Abacavir + Lamivudine Sandoz contains two active substances used to treat HIV infection: abacavir and lamivudine. They belong to a group of antiretroviral medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
Abacavir + Lamivudine Sandoz does not cure HIV infection completely, but it reduces the amount of virus in the patient's 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 infections.
Not all patients respond in the same way to treatment with Abacavir + Lamivudine Sandoz. Your doctor will monitor how well the treatment is working.

2. Important information before using Abacavir + Lamivudine Sandoz

When not to use Abacavir + Lamivudine Sandoz
Do not use Abacavir + Lamivudine Sandoz if the patient is allergic ( hypersensitive ) to abacavir (or to any other medicine containing
abacavir, e.g. Trizivir, Triumeq or Ziagen ), lamivudine, or to any of the other
components of this medicine (listed in section 6).
Please read carefully all information about hypersensitivity reactions contained
in section 4 of this leaflet.
If the patient suspects that the above information applies to them, they should consult their doctor
and must not use Abacavir + Lamivudine Sandoz.

Warnings and precautions
Some people receiving abacavir with lamivudine or other combination medicines used to treat HIV infection are at higher risk of serious adverse effects. Consider additional risks if the patient:
has moderate or severe liver disease;
has ever had liver disease in the past, including viral hepatitis B or
C (patients with hepatitis B must not stop taking Abacavir +
Lamivudine Sandoz without medical advice, as this may lead to a recurrence of hepatitis symptoms);
has significant overweight (particularly women);
has kidney disease.
If any of the above conditions apply to the patient, discuss this with the doctor
before starting Abacavir + Lamivudine Sandoz. Additional monitoring tests during treatment, including blood tests, may be required. More information is provided in section 4.

Hypersensitivity reactions to abacavir
A hypersensitivity reaction (serious allergic reaction) may occur even in patients who do not carry the HLA-B*5701 gene.
Please read carefully all information about hypersensitivity reactions contained in section
4 of this leaflet.

Risk of cardiovascular events
It cannot be ruled out that abacavir may increase the risk of cardiovascular events.
Inform the doctor if the patient has cardiovascular problems, smokes tobacco, or has other conditions that increase the risk of cardiovascular disease, such as high blood pressure or diabetes. Do not stop taking Abacavir + Lamivudine Sandoz unless advised by the treating doctor.

Important symptoms to watch for
Some people taking medicines for HIV infection may develop other conditions, which can be serious. Please become familiar with the information on important symptoms to watch for while taking Abacavir + Lamivudine Sandoz.
Please read the section “Other possible adverse effects associated with HIV treatment” in section 4 of this leaflet.

Abacavir + Lamivudine Sandoz and other medicines
Tell the doctor or pharmacist about all medicines currently being taken or recently taken, including herbal remedies or other medicines available without prescription. Always inform the doctor or pharmacist when starting a new medicine while taking Abacavir + Lamivudine Sandoz.

The following medicines must not be used together with Abacavir + Lamivudine Sandoz:

didanosine – a medicine used to treat HIV infection
other medicines containing lamivudine, used to treat HIV infection or hepatitis B
high doses of the antibiotic trimethoprim with sulfamethoxazole
cladribine – a medicine used to treat hairy cell leukaemia

If the patient is being treated with any of these medicines, inform the treating doctor.

Some medicines interact with Abacavir + Lamivudine Sandoz.
These include:

phenytoin – a medicine used to treat epilepsy
If the patient is taking phenytoin, inform the treating doctor. Monitoring of the patient’s condition may be required during treatment with Abacavir + Lamivudine Sandoz.
methadone – used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If the patient is taking methadone, the doctor will monitor for withdrawal symptoms. A dose adjustment of methadone may be necessary.
If the patient is taking methadone, inform the treating doctor.
medicines (usually in liquid form) containing sorbitol and other sugar alcohols (such as
xylitol, mannitol, lactitol or maltitol), if taken regularly.
If the patient is taking any of these medicines, inform the treating doctor or pharmacist.
riociguat, used to treat high blood pressure in the blood vessels (in the pulmonary arteries) that carry blood from the heart to the lungs. The treating doctor may need to reduce the dose of riociguat, as abacavir may increase riociguat blood levels.

Pregnancy
Abacavir + Lamivudine Sandoz is not recommended during pregnancy.
Abacavir + Lamivudine Sandoz and similar medicines may cause adverse effects in the unborn child. If the patient has taken Abacavir + Lamivudine Sandoz, the doctor may recommend regular blood tests and other diagnostic tests to monitor the child’s development. In children whose mothers took NRTI medicines during pregnancy, the benefits of protection against HIV outweighed the risk of adverse effects.

Breast-feeding
Breast-feeding is not recommended for women living with HIV, as the infection can be transmitted to the child through breast milk. A small amount of the components of Abacavir + Lamivudine Sandoz may also pass into breast milk.
If the patient is breast-feeding or planning to breast-feed, she should discuss this with her treating doctor as soon as possible.

Driving and operating machinery
Abacavir + Lamivudine Sandoz may cause adverse effects that could affect the ability to drive or operate machinery.
Talk to the doctor about whether it is safe to drive or operate machinery while taking Abacavir + Lamivudine Sandoz.

Abacavir + Lamivudine Sandoz contains an azo dye
This medicine contains a colouring agent called sunset yellow (E110), which may cause allergic reactions.

3. How to use Abacavir + Lamivudine Sandoz
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.

The recommended dose of Abacavir + Lamivudine Sandoz for adults, adolescents and children weighing 25 kg or more is one tablet once daily.
Tablets should be swallowed whole with water. The medicine can be taken with or without food.

Regular contact with the treating doctor
Abacavir + Lamivudine Sandoz helps control the disease. To prevent disease progression, it must be taken every day. However, other infections and HIV-related conditions may still develop.
Remain in regular contact with the treating doctor and do not stop taking Abacavir + Lamivudine Sandoz without medical advice.

Taking more Abacavir + Lamivudine Sandoz than prescribed
If too much Abacavir + Lamivudine Sandoz is taken by mistake, seek advice from the treating doctor or pharmacist, or go to the nearest hospital emergency department immediately.

Missing a dose of Abacavir + Lamivudine Sandoz
If the patient misses a dose, they should take it as soon as they remember, then continue with their regular dosing schedule. Do not take a double dose to make up for a missed dose.
It is important to take Abacavir + Lamivudine Sandoz regularly, as irregular dosing increases the risk of hypersensitivity reactions.

Stopping Abacavir + Lamivudine Sandoz
If the patient stops taking Abacavir + Lamivudine Sandoz for any reason, especially if they suspect adverse effects or have developed another illness:
inform the treating doctor before restarting the medicine. The doctor will assess whether the symptoms experienced could be related to a hypersensitivity reaction. If such a link is considered possible,
the doctor will advise the patient never to take Abacavir + Lamivudine Sandoz again, or any other medicine containing abacavir (i.e. Trizivir, Triumeq or Ziagen). It is essential to follow this advice.
If the doctor considers that the patient may restart Abacavir + Lamivudine Sandoz, they may recommend taking the first dose in a setting where immediate medical assistance is available if needed.

4. Possible side effects

During treatment for HIV infection, patients may experience an increase in body weight and in blood levels of lipids and glucose. This is partly related to improved health and lifestyle, and in the case of lipids, sometimes to the use of anti-HIV drugs themselves. Your doctor will monitor these changes.

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

During treatment of HIV infection, it is not always possible to determine whether a side effect is caused by Abacavir + Lamivudine Sandoz, by other medicines the patient is taking, or by a disease associated with HIV infection. Therefore, it is very important to inform your doctor about any changes in your health status.

Hypersensitivity reaction (a severe allergic reaction), described in this leaflet in the table "Hypersensitivity reactions", may occur even in patients who do not carry the HLA-B*5701 gene. It is very important to read and understand the information about this serious reaction.

In addition to the side effects listed below for Abacavir + Lamivudine Sandoz, other symptoms may also occur during combination treatment for HIV infection. It is important to read the information below titled "Other possible side effects associated with combination treatment for HIV infection".

Hypersensitivity reactions

Abacavir + Lamivudine Sandoz contains abacavir (which is also the active substance in the medicines Trizivir, Triumeq and Ziagen). Abacavir may cause a serious allergic reaction, known as a hypersensitivity reaction. Such hypersensitivity reactions have been observed more frequently in patients taking medicines containing abacavir.

Who may experience these reactions?

Any patient taking Abacavir + Lamivudine Sandoz may develop a hypersensitivity reaction to abacavir, which could be life-threatening if the medicine is continued. The likelihood of such a reaction is higher in individuals who carry the HLA-B*5701 gene (although it may also occur in patients without this gene). Before prescribing Abacavir + Lamivudine Sandoz, your doctor should test whether you carry this gene. If the patient knows they carry this gene, they must inform their doctor before starting treatment with Abacavir + Lamivudine Sandoz.

Hypersensitivity reactions occurred in approximately 3 to 4 out of every 100 patients without the HLA-B*5701 gene who received abacavir in a clinical trial.

What are the symptoms?

The most common symptoms are:
fever (high temperature) and skin rash.

Other commonly observed symptoms include:
nausea, vomiting, diarrhoea, abdominal (stomach) pain, and severe fatigue.

Other symptoms may include:
joint or muscle pain, neck swelling, shortness of breath, sore throat, cough, occasional headaches, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness in the hands or feet.

When do these reactions occur?

Hypersensitivity reactions may occur at any time during treatment with Abacavir + Lamivudine Sandoz, but most commonly occur within the first 6 weeks of treatment.

Seek immediate medical advice if:

1 a skin rash develops
OR
2 symptoms from at least 2 of the following groups occur:

fever,
shortness of breath, sore throat, or cough,
nausea or vomiting, diarrhoea or abdominal pain,
severe fatigue or malaise, or general feeling of being unwell.

Your doctor may advise stopping Abacavir + Lamivudine Sandoz.

Stopping Abacavir + Lamivudine Sandoz

If the patient has stopped taking Abacavir + Lamivudine Sandoz due to a hypersensitivity reaction, they MUST NEVER RESTART Abacavir + Lamivudine Sandoz or any other medicine containing abacavir (i.e. Trizivir, Triumeq or Ziagen), otherwise blood pressure may drop dangerously within a few hours, which could lead to death.

If the patient has stopped taking Abacavir + Lamivudine Sandoz for any reason, especially if they suspect side effects or another illness:

they must consult their doctor before restarting the medicine. The doctor will assess whether the symptoms could have been related to a hypersensitivity reaction. If such a link is considered possible, the doctor will advise the patient never to take Abacavir + Lamivudine Sandoz or any other medicine containing abacavir (i.e. Trizivir, Triumeq or Ziagen) again.

It is important to follow this advice.

Hypersensitivity reactions have occasionally occurred in individuals who restarted abacavir and who previously had only one symptom listed on the Warning Card.

Very rarely, hypersensitivity reactions have occurred in patients restarting abacavir who had no prior symptoms of hypersensitivity before stopping the medicine.

If the doctor approves restarting Abacavir + Lamivudine Sandoz, they may advise taking the first dose in a setting where immediate medical help is available if needed.

If the patient is allergic to abacavir with lamivudine, all unused medicine should be returned for safe disposal. Consult your doctor or pharmacist.

A Warning Card is included with the Abacavir + Lamivudine Sandoz packaging to remind patients and healthcare professionals about hypersensitivity reactions. This card should be detached and carried at all times.

Common side effects

May occur in less than 1 in 10 people:

hypersensitivity reaction
headache
nausea
vomiting
diarrhoea
abdominal pain
loss of appetite
fatigue, lack of energy
fever (high temperature)
general feeling of being unwell
difficulty sleeping (insomnia)
muscle pain and discomfort
joint pain
cough
nasal irritation or runny nose
skin rash
hair loss

Uncommon side effects

May occur in less than 1 in 100 people and may be visible in blood tests:

low number of red blood cells (anaemia) or white blood cells (neutropenia)
increased liver enzyme activity
reduced number of platelets involved in blood clotting (thrombocytopenia)

Rare side effects

May occur in less than 1 in 1000 people:

liver disorders, such as jaundice, enlarged or fatty liver, hepatitis
pancreatitis
muscle tissue breakdown

Rare side effects that may be visible in blood tests:

increased activity of an enzyme called amylase

Very rare side effects

May occur in less than 1 in 10,000 people:

numbness, tingling of the skin
sensation of limb weakness
skin rash which may form blisters resembling small targets (darker in the centre with a surrounding lighter area and a dark ring at the edge) (erythema multiforme)
widespread rash with blisters and peeling of the outer layer of skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form with skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
lactic acidosis (excess lactic acid in the blood)

If any of these symptoms occur, contact your doctor urgently.

Very rare side effects that may be visible in blood tests:

bone marrow failure (inability to produce new red blood cells – red cell aplasia)

If you experience any side effects

If any of the side effects worsen or if any unlisted side effects occur, consult your doctor or pharmacist.

Other possible side effects associated with combination treatment for HIV infection

Combination therapy including Abacavir + Lamivudine Sandoz may lead to the development of other conditions during HIV treatment.

Symptoms of infection and inflammation

Old infections may flare up suddenly

People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop severe infections (opportunistic infections). Starting treatment may cause previously hidden infections to become active, leading to inflammatory symptoms. These symptoms are likely due to the strengthening of the immune system, enabling the body to fight these infections.

Symptoms usually include fever and one or more of the following:

headache
abdominal pain
breathing difficulties

In rare cases, as the immune system becomes stronger, it may also attack healthy body tissues (autoimmune disorders). Symptoms of autoimmune disorders may develop many months after starting treatment for HIV infection. Symptoms may include:

palpitations (rapid or irregular heartbeat) or tremors
hyperactivity (excessive psychomotor agitation)
weakness beginning in the hands and feet and progressing towards the trunk

If any symptoms of infection or inflammation occur, or any of the symptoms listed above, contact your doctor immediately. Do not take other medicines for infections without your doctor's advice.

Bone problems may occur

Some patients receiving combination HIV treatment may develop a disorder called osteonecrosis. This involves the death of bone tissue due to reduced blood supply to the bone. The risk of this disorder is higher if the patient:

has been on long-term combination treatment
is also taking anti-inflammatory medicines called corticosteroids
drinks alcohol
has a severely weakened immune system
is overweight

Symptoms of osteonecrosis include:

joint stiffness
pain (especially in the hip, knee, or shoulder)
difficulty moving

If any of these symptoms occur, inform your doctor.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301 / Fax: +48 22 49 21 309 / Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorisation holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Abacavir + Lamivudine Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
The batch number on the packaging is indicated after the abbreviation "Lot".
Store the medicine below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Abacavir + Lamivudine Sandoz contains

The active substances are abacavir and lamivudine. Each film-coated tablet contains 600 mg of abacavir as abacavir hydrochloride and 300 mg of lamivudine.
Other ingredients are: microcrystalline cellulose (Ceolus KG 802), microcrystalline cellulose (PH 102), crospovidone (Type A), povidone K-30, yellow iron oxide (E172), magnesium stearate.
Coating: hypromellose 3 mPa·s, hypromellose 6 mPa·s, titanium dioxide (E171), macrogol 400, polysorbate 80, orange-yellow lake (E110), lacquer (15–18%), orange-yellow lake (E110), lacquer (38–42%).

What Abacavir + Lamivudine Sandoz looks like and contents of the pack
Abacavir + Lamivudine Sandoz film-coated tablets are orange, biconvex, capsule-shaped, measuring 20.6 mm x 9.1 mm, with the imprint "300" on one side and "600" on the other.
The medicine is packed in blisters (PVC/Aclar/PVDC/Aluminium or PVC/PVDC/Aluminium) containing 30, 60 or 90 film-coated tablets in a cardboard box, or in HDPE bottles (containing a desiccant sachet), with a child-resistant closure made of polypropylene (PP), containing 30 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer
Hormosan Pharma GmbH
Wilhelmshöher Str. 106
D-60389 Frankfurt/Main
Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals, d.d.
Verovskova Ulica 57
Ljubljana, 1526
Slovenia

For more detailed information about the medicine and its names in the Member States of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00