Aspen Abacavir Film-Coated Tablets

ASPEN ABACAVIR 300 belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection. ASPEN ABACAVIR 300 is used in combination with other antiretroviral medicines for the treatment of HIV infection.

Do not take ASPEN ABACAVIR 300:

• If you have previously suffered an allergic reaction to ASPEN ABACAVIR 300 or to the active ingredient abacavir.
• If you are hypersensitive (allergic) to abacavir or any of the other ingredients in ASPEN ABACAVIR 300.
• If you have liver disease.
• If you are pregnant or breast feeding your baby.

Take special care with ASPEN ABACAVIR 300

Hypersensitivity reaction (serious allergic reaction): The most important symptoms of this reaction are high temperature (fever) and a skin rash. Other frequently seen signs or symptoms are nausea, vomiting, diarrhoea, abdominal pain, shortness of breath, cough, headache, and severe tiredness. Other symptoms may be joint or muscle pain, swelling of the neck and sore throat. Occasionally swelling of the eye (conjunctivitis), ulcers in the mouth or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with ASPEN ABACAVIR 300. However they usually occur in the first six weeks of treatment and get worse with continued treatment. The hypersensitivity reaction can be life-threatening or fatal if treatment with ASPEN ABACAVIR 300 is continued. You should contact your doctor immediately for advice on whether you should stop taking ASPEN ABACAVIR 300 if:

• you get a skin rash OR
• you get one or more symptoms from at least TWO of the following groups:
• fever
• shortness of breath, sore throat or cough
• nausea or vomiting or diarrhoea or abdominal pain
• severe tiredness or achiness or general ill feeling.

If you have discontinued ASPEN ABACAVIR 300 because of a hypersensitivity reaction YOU MUST NEVER TAKE ASPEN ABACAVIR 300 or any other medicine containing abacavir again as within hours you may experience a life-threatening lowering of your blood pressure or death.

Do not share medicines prescribed for you with any other person. Always take ASPEN ABACAVIR 300 exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose in adults and adolescents over 12 years of age is 300 mg (one tablet) twice daily or 2 x 300 mg (two tablets) once daily. Take the doses 12 hours apart. Swallow the tablet whole with water or another drink. ASPEN ABACAVIR 300 tablets should not be broken. Your doctor will tell you how long the treatment with ASPEN ABACAVIR 300 will last.

If you have the impression that the effect of ASPEN ABACAVIR 300 is too strong or too weak, talk to your doctor or pharmacist.

If you take more ASPEN ABACAVIR 300 than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ASPEN ABACAVIR 300

Take your missed dose as soon as you remember, if within a few hours after missing a dose. Do not take a double dose to make up for forgotten individual doses. If you have stopped taking ASPEN ABACAVIR 300 for any reason, especially if you think you are having side effects, or for other illness, it is important that you contact your doctor before restarting. In some cases your doctor will ask you to restart ASPEN ABACAVIR 300 under direct medical supervision or where medical care can be easily accessed by yourself or others. If your doctor thinks that there is a possibility your symptoms were related to hypersensitivity reaction, you may be told never to take ASPEN ABACAVIR 300 or any other medicine containing abacavir, again.

ASPEN ABACAVIR 300 can have side effects. Not all side effects reported for ASPEN ABACAVIR 300 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ASPEN ABACAVIR 300, please consult your doctor, pharmacist or other healthcare professional for advice. It is very important that you inform your doctor about any changes in your health.

A hypersensitivity reaction (serious allergic reaction) has been reported with ASPEN ABACAVIR 300. This is described in the section “SPECIAL WARNINGS” of this leaflet. It is important that you read and understand the information about this serious reaction.

If any of the following occur, stop taking ASPEN ABACAVIR 300 and speak to your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• the side effects described under the ‘Take special care with ASPEN ABACAVIR 300 section;
• blistering of the skin, mouth, eyes and genitals and/or abnormal redness of the skin.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ASPEN ABACAVIR 300. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department of your nearest hospital if you notice the following:

• Inflammation of the pancreas, which causes severe pain in the abdomen and back;
• Graves’ disease, an autoimmune disease, which causes overproduction of the thyroid hormone, and you feel very anxious and irritable;
• osteonecrosis, when you experience joint aches and pain, joint stiffness or difficulty in movement.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been frequently reported:

• Feeling depressed;
• sleep disturbances;
• abnormal dreams;
• headache;
• migraine (severe headache felt as a throbbing pain at the front or on one side of the head);
• fever;
• chills;
• feeling unwell;
• lack of energy;
• sleepiness;
• anorexia (lack or loss of appetite);
• skin rash (without any signs of illness);
• diarrhoea;
• vomiting;
• nausea.

The following side effects have been reported less frequently:

• Ear, nose and chest infections;
• stomach pain and swelling;
• rhabdomyolysis which is muscle breakdown with symptoms such as muscle weakness, low urine output, fatigue, soreness, bruising, dark, tea-coloured urine, infrequent urination, a fever;
• inflammation of the lining of the stomach, characterised by nausea, vomiting and stomach pain (gastritis);
• feeling anxious;
• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness;
• reduction in white blood cells which can increase the risk of getting infections;
• changes/irregularities in the liver tests that show how well your liver is working;
• lactic acidosis (build up of lactic acid in your blood);
• severe inflammation of the liver with fat accumulation (steatosis);
• increase in blood sugar level;
• increase in blood fats;
• irregular deposits of fat on the body.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C. Protect from light. Keep in original packaging until required for use. Do not store in bathroom. Do not use after the expiry date stated on the label. Return all unused medicines to your pharmacist. Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.