Dumiva Dispersible 120 mg/60 mg Dispersible Tablets

DUMIVA DISPERSIBLE TABLETS belong to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

What they are used for:

These are used to treat Human Immunodeficiency Virus (HIV) infection. DUMIVA DISPERSIBLE TABLETS are used in combination with other antiretroviral medicines for the treatment of HIV infection. DUMIVA DISPERSIBLE TABLETS are always used with other anti-HIV-1 medicines.

DUMIVA DISPERSIBLE TABLETS may improve your child’s condition, but they are not a cure for the HIV infection. HIV infection is a disease spread by contact with blood or sexual contact with an infected individual. Treatment with DUMIVA DISPERSIBLE TABLETS has not been shown to eliminate the risk of passing HIV infection on to others by sexual contact or by blood transfer. Therefore, you/your child must continue to take appropriate precautions to avoid giving the virus to others. This product is intended for use in children. Safety information on its use in adults is also provided.

Do not take DUMIVA DISPERSIBLE TABLETS:

• If your child previously suffered an allergic reaction to any of the active ingredients, abacavir or lamivudine, or any other ingredient of DUMIVA DISPERSIBLE TABLETS (listed in section 6).
• If your child has liver disease.
• If your child has kidney disease.
• If your child is taking emtricitabine (a medicine to treat HIV infection).
• If he/she has phenylketonuria.
• If she is pregnant or breastfeeding her baby (see ‘Pregnancy, breastfeeding and fertility’.

Warnings and precautions

Before giving DUMIVA DISPERSIBLE TABLETS, tell your child’s doctor about all of your child’s medical conditions, including if:

• your child has been tested and know whether or not he/she has a particular gene variation called HLA-B*5701;
• your child has heart problems, smoke or suffer from diseases that increase his/her risk of heart disease e.g. high blood pressure, high cholesterol or diabetes.

If you are not sure about any of these, please consult your child’s doctor.

Take special care with DUMIVA DISPERSIBLE TABLETS:

Hypersensitivity reaction (serious allergic reaction): The most important symptoms of this reaction are high temperature (fever) and 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, ulcers in the mouth or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with DUMIVA DISPERSIBLE TABLETS. However, they usually occur in the first six weeks of treatment and get worse with continued treatment.

• Do not share medicines prescribed for you with any other person.

• Always give DUMIVA DISPERSIBLE TABLETS exactly as your doctor has told you.

• Check with your doctor or pharmacist if you are not sure.

• Treatment should be prescribed and started by a medical doctor experienced in the management of HIV infection.

Children between 3 months and 12 years of age:

• The recommended dose of DUMIVA DISPERSIBLE TABLETS for children is based on the child’s body weight and will be determined by the doctor.

• The doctor will also explain how and when the tablets must be taken.

Your doctor will tell you how long your child’s treatment with DUMIVA DISPERSIBLE TABLETS will last. Do not stop treatment early.

If you have the impression that the effect of DUMIVA DISPERSIBLE TABLETS is too strong or too weak, talk to the doctor or pharmacist.

If you give more DUMIVA DISPERSIBLE TABLETS than you should:

If you accidentally give the child too many DUMIVA DISPERSIBLE TABLETS contact the nearest hospital emergency department for further advice. In the event of overdosage, speak to a doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre for help.

If you forget to give your child DUMIVA DISPERSIBLE TABLETS:

If you forget to give a dose of DUMIVA DISPERSIBLE TABLETS, give it as soon as you remember and then continue as before. Do not give a double dose to make up for missed individual doses.

DUMIVA DISPERSIBLE TABLETS can have side effects. Not all side effects reported for DUMIVA DISPERSIBLE TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DUMIVA DISPERSIBLE TABLETS, please consult your health care provider for advice.

If any of the following happens, stop taking DUMIVA DISPERSIBLE TABLETS and tell 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,
• fainting,
• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis).

Some patients treated with DUMIVA DISPERSIBLE TABLETS and do not have a gene called HLA-B*5701 developed a serious allergic reaction. The hypersensitivity reaction can be life-threatening or fatal if treatment with DUMIVA DISPERSIBLE TABLETS is continued. You should contact your child’s doctor immediately for advice on whether you should stop giving him/her DUMIVA DISPERSIBLE TABLETS if:

• Your child get(s) a skin rash OR
• Your child gets 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 (stomach) pain
• – severe tiredness or aches and pains or generally feeling ill

These are all very serious side effects. If you or your child have them, you may have had a serious reaction DUMIVA DISPERSIBLE TABLETS. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children.

Store at or below 30 °C.

Protect from light.

Store the tablets in the original container.

Keep the container tightly closed.

Do not use after the expiry date stated on the label.

Do not store in the bathroom.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).