600 mg / 300 mg film-coated tablets
abacavir / lamivudine
What Abacavir / Lamivudine STADA is and what it is used for
Abacavir / Lamivudine STADA used to treat HIV – infection ( infection with human immunodeficiency virus) in adults, adolescents, and children weighing at least 25 kg.
Abacavir / Lamivudine Stada 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 Stada 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 Stada in the same way. Your doctor will check the treatment effect you are getting.
Abacavir and lamivudine contained in Abacavir / Lamivudine Stada 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 use Abacavir / Lamivudine STADA
Do not use Abacavir / Lamivudine STADA
- if you are allergic to abacavir (or to any other medicine containing abacavir), lamivudine, or any of the other ingredients of this medicine (listed in 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 Stada.
Warnings and cautions
Some patients taking Abacavir / Lamivudine Stada 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 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 Stada 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 Stada 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 a 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 Stada 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 note while taking Abacavir / Lamivudine Stada.
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 STADA
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, including (traditional) herbal medicines and herbal medicines.
Remember to tell your doctor or pharmacist if you start taking a new medicine while taking Abacavir / Lamivudine Stada.
These medicines should not be taken with Abacavir / Lamivudine Stada:
- emtricitabine, to treat HIV – infection
- αndra medicines containing lamivudine, for treatment of HIV – infection or hepatitis B infection
- one dose 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 Stada
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 Stada.
- 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.
Pregnancy, breastfeeding, and fertility
Pregnancy
Abacavir / Lamivudine Stada is not recommended for use during pregnancy. Abacavir / Lamivudine Stada and similar medicines can cause side effects in the unborn baby. If you have taken Abacavir / Lamivudine Stada 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 must not breastfeed because HIV – infection can be transferred to the baby through breast milk. A small amount of the ingredients in Abacavir / Lamivudine Stada 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 Stada 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 Stada.
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.
Abacavir / Lamivudine STADA contains para-orange aluminum lacquer (E110) and sodium
Abacavir / Lamivudine Stada contains the dye para-orange aluminum lacquer (E110), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Abacavir / Lamivudine STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Abacavir / Lamivudine Stada 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 Stada can be taken with or without food.
Keep in regular contact with your doctor
Abacavir / Lamivudine Stada 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 Stada without your doctor‘s advice.
If you forget to use Abacavir / Lamivudine STADA
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 Stada regularly, as an irregular intake may increase the risk of hypersensitivity reactions.
If you stop using Abacavir / Lamivudine STADA
If you have stopped taking Abacavir / Lamivudine Stada 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 Stada or other medicines containing abacavir again. It is important that you follow this advice.
If your doctor advises you to start taking Abacavir / Lamivudine Stada again, you may be asked to take the first dose in a place where you have access to medical care if needed.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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 STADA 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 Stada, other conditions may develop during combination therapy for HIV.
It is important to read the information later in this section under “
| Hypersensitivity s Abacavir / Lamivudine Stada contains abacavir ( which is also an active substance in similar medicines). 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 Stada may develop a hypersensitivity reaction to abacavir, which may be life-threatening if they continue to take Abacavir / Lamivudine Stada. 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 Stada. If you know you are carrying this gene, talk to your doctor before taking Abacavir / Lamivudine Stada. 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 Stada but more likely during the first six weeks of treatment. Contact your doctor immediately:if you get a rash, ORif 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 Stada. If you have stopped taking Abacavir / Lamivudine StadaIf you have stopped taking Abacavir / Lamivudine Stada due to a hypersensitivity reaction , you should NEVER take Abacavir / Lamivudine Stada or any other medicine containing abacavir 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 Stada 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 Stada or other medicines containing abacavir 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 Stada 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 Stada, return any unused Abacavir / Lamivudine Stada tablets for destruction. Consult your doctor or pharmacist. Packages with Abacavir / Lamivudine Stada contains a warning cards to remind you and medical staff about hypersensitivity reaction you . Tear off this card and 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 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 1,000 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
- the 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 Stada 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 STADA
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 and label or blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 Stada film-coated tablet are 600 mg abacavir and 300 mg lamivudine.
- The other ingredients are microcrystalline cellulose PH 102 (E460), microcrystalline cellulose PH 200 (E460), sodium starch glycolate (Type A), povidone K 90 (E1201), magnesium stearate (E470b), hypromellose 5 (E464), macrogol 400 (E1521) (E171), para-orange aluminum lacquer (E110).
What the medicine looks like and the contents of the pack
Abacavir / Lamivudine Stada film-coated tablet is an orange, film-coated, capsule-shaped tablet. The dimensions of the tablets are 19.4 mm x 10.4 mm.
Abacavir / Lamivudine Stada is supplied in opaque white Aluminum-PVC / PE / PVDC blister packs of 30 tablets and in opaque white Aluminum-PVC / PE / PVDC multiple blister packs of 90 (3×30) tablets.
Abacavir / Lamivudine Stada is supplied in white, HDPE plastic jars with white plastic (PP) lid. The plastic jars contain 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Remedica Ltd
Sharon Street, Limassol Industrial Estate
3056 Limassol, Cyprus
Centrafarm Sveriges BV
New Donk 9
NL 4879 Etten-Leur, The Netherlands
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna, Austria
Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary, Ireland