PATIENT INFORMATION LEAFLET

Aciclovir Powder for Infusion 250mg

This information will provide you with important information about your medicine. Please read it carefully before your treatment commences.

WHAT’S IN YOUR MEDICINE

The active ingredient is Aciclovir. Each vial contains 250mg Aciclovir (as the sodium salt) in the form of a specially prepared sterile powder.

Inactive ingredients: Sodium Hydroxide and Water for Injections

Pack sizes: The product is available in packs of 1x250mg or 5x250mg vials.

Holder of Product Licence:

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. Product Licence Number: PL 02848/0190.

Manufacturer: Dr. Madaus GmbH, Herderstrasse 2, 83512 Wasserburg, Germany ABOUT YOUR MEDICINE

Aciclovir is an anti-viral drug and it is active against the viral infections described under ‘USES’ below. Aciclovir Powder for Infusion 250mg may be used against certain viral infections as follows:

■    Treatment and prevention of Herpes simplex virus (HSV) infections in patient who have a reduced immune response (weakened resistance) to infection.

■    Treatment of infection of the brain caused by Herpes simplex virus (HSV)

■    Treatment of infections due to Varicella zoster virus (shingles and chickenpox)

■    Treatment of Herpes simplex virus infections in the newborn and in the infants up to 3 months of age

BEFORE TAKING YOUR MEDICINE

Before you receive this medicine, tell your doctor if

■    you are allergic to aciclovir or valaciclovir

■    you are pregnant or think you may be pregnant, or if you are breast feeding.

■    you are suffering from a disease of the kidneys

■    you are an elderly patient

■    you are taking any other medicines, including probencid (for gout or for use in combination with an antibiotic), cimeditine (to reduce the amount of acid in your stomach), mycophenolate mofetil, cyclosporin or tacrolimus (drugs used to reduce the body’s immune response).

This medicine contains 26mg of sodium per vial. Discuss this with your doctor if you are on a controlled sodium diet.

Pregnancy and breast feeding

If you are pregnant or planning to become pregnant, or are breast feeding, please tell your doctor before taking Aciclovir Infusion. Caution should be exercised by balancing the potential benefits of treatment against any possible risk.

Driving, using machinery and other similar activities

Aciclovir Infusion can cause problems such confusion, hallucinations, agitation, tremors, drowsiness and a reduced level of consciousness. If affected you should not drive, operate machinery or take part in any activities where these may put you or others at risk until such symptoms go away.

HOW YOUR MEDICINE IS GIVEN

Before use, the powder in the vial must be dissolved in Water for Injections. The resultant solution, which may be further diluted, is administered slowly into a vein over 1 hour. Treatment with this medication is usually over a 5 day period, depending on your condition and how you respond to the treatment. For infection of the brain caused by Herpes simplex virus (HSV), the treatment period is usually 10 days. Treatment for herpes infection in the newborn usually lasts 14 days for skin-eye-mouth infections and 21 days for disease of the brain and spinal cord or disease which has spread over the body. When used to prevent an infection, the length of treatment will depend on the risk period. Dosage recommendations are as follows:

Adults: The recommended dosage for Herpes simplex infections (excluding herpes infection of the brain) or Varicella zoster infections is 5mg per kg bodyweight every 8 hours, provided that the kidneys are functioning normally. In patients who have a reduced immune response against infection, the recommended dosage for herpes infection of the brain or Varicella zoster infections is 10mg per kg bodyweight every 8 hours, provided that kidneys are functioning normally

Children 3 months of age or older: The recommended dosage for Herpes simplex infections (excluding herpes infection of the brain) or Varicella zoster infections is 250mg per square metre of body surface area every 8 hours. In patients who have a reduced immune response against infection, the recommended dosage for herpes infection of the brain or Varicella zoster infections is 500mg per square metre of body surface area every 8 hours, provided that the kidneys are functioning normally.

The recommended dosage for known or suspected Herpes infections in the newborn is 20mg/kg body weight IV every 8 hours for 21 days for disease spread over the body and for disease of the brain and spinal cord; or for 14 days for disease limited to the skin and linings.

Elderly, obese patients and people with kidney problems:

Your doctor may decide to adjust your dose if you are elderly or have kidney problems.

AFTER YOU RECEIVE YOUR MEDICINE

As well as having beneficial effects, a medicine may sometimes cause unwanted effects in some patients. If you notice any one of the following effects, tell your doctor:

All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheezing, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

You should inform your doctor immediately if you suffer from a sore throat, high fever or chills, unusual tiredness, become pale, develop bruises or nose bleeds. These may indicate blood problems developing as a result of using this medicine.

■    Nausea or vomiting

■    Blood tests may show decreased number of blood cells

■    Feeling weak or light-headed, bruising of the skin, fever, chills, or signs of an infection

■    A skin rash causing red patches and itching increased sensitivity of the skin to sunlight, swelling of the tissues

■    Breathlessness, swelling of the face or mouth, feeling very weak and unwell, pain or inflammation around the site of injection.

■    Any problems with your kidneys, for example passing too little or too much urine

■    Laboratory tests with abnormal kidney or liver function tests.

■    Yellowing of the skin or the white of the eyes, enlarged liver.

■    Confusion, seeing or hearing things which do not exist, feeling agitated or shaky, drowsiness, mental disorder (psychosis), mood changes or convulsions (fits),

■    Stomach pain, diarrhea, headache, tiredness, dizziness, lack of co-ordination of muscle movements, difficulty in speaking

■    Coma (unconscious state)

You should tell your doctor is your experience any unwanted effects that are not listed here.

In children who have kidney damage, the doctor may decide to reduce the dosage of Aciclovir.

Newborn babies and infants up to age 3 months: The recommended dosage for treatment of Herpes simplex infections is 10mg per kg bodyweight every 8 hours. For Herpes simplex infections in the newborn, the usual treatment period is 10 days.

Elderly patients: If you are elderly, your doctor may decide to reduce the dosage of Aciclovir depending on your ability to clear the drug through the kidneys.

Patients with kidney damage: If you have a problem with your kidneys, your doctor will reduce the dosage of Aciclovir in maintenance with your particular requirements.

WHAT TO DO IN CASE OF AN OVERDOSE OR A MISSED DOSE

If you think that you may have been given too much of this medicine, or that you may have missed a dose, tell your doctor.

STORING THIS MEDICINE

Do not use this product after the expiry date printed on the vial or carton. Do not store ° above 25° C. Store the vials in original packaging. After reconstitution use immediately. Discard any unused portion.

Marketing authorization holder

Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

Date of revision: March 2012