TEXT FOR NON-MARKETED PACKS

PIL FOR

ACICLOVIR 250mg AND 500mg FOR I.V. INFUSION

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aciclovir 250mg and 500mg for I.V. Infusion

Aciclovir

Read all of this leaflet carefully before you start taking this medicine

-    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 you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Aciclovir for I.V. is and it is used for

2.    Before you take Aciclovir for I.V.

3.    How to take Aciclovir for I.V.

4.    Possible side-effects

5.    How to store Aciclovir for I.V.

6.    Further information

1.    WHAT ACICLOVIR FOR I.V. IS AND WHAT IT IS USED FOR

Aciclovir for I.V. contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.

Aciclovir for I.V. can be used to:

•    Treat chickenpox

•    Treat severe cases of genital herpes

•    Treat and stop cold sores and genital herpes in people whose immune systems work less well, which means their bodies are less able to fight infections

•    Treat serious virus infections in children up to 3 months of age. This can rarely be caused by the virus responsible for cold sore infection and genital herpes.

•    Treat inflammation of the brain. This can rarely be caused by the virus responsible for cold sore infection and genital herpes.

2.    BEFORE YOU TAKE ACICLOVIR I.V Do not take Aciclovir for I.V:

•    if you are allergic (hypersensitive) to aciclovir or valaciclovir or any other ingredients (listed in section 6). Do not take Aciclovir for I.V. if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir for I.V.

Take special care with Aciclovir for I.V.

Check with your doctor or pharmacist before having Aciclovir for I.V. if:

•    you have kidney problems

•    you are over 65 years of age

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Aciclovir for I.V.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    probenecid, used to treat gout

•    cimitedine, used to treat stomach ulcers

•    tacrolimus, ciclosporin or mycophenolate mofetil, used to stop your body rejecting transplanted organs.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using any medicine.

Important Information about the ingredients of Aciclovir for I.V.

Aciclovir for I.V. contains 26mg (250mg) and 52mg (500mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

3.    HOW TO TAKE ACICLOVIR FOR I.V.

How your medicine is given

You will never be expected to give yourself this medicine. It will always be given to you by a person who is trained to do so.

Before the medicine is given to you it will be diluted.

Aciclovir for I.V. will be given to you as a continuous infusion into your vein. It is important you receive plenty of fluids while you are being treated with Aciclovir for I.V.

The dose you will be given, the frequency and the duration of the dose will depend on:

•    The type of infection you have

•    Your weight

•    Your age

Your doctor may adjust the dose of Aciclovir for I.V.

If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

If you are given too much Aciclovir for I.V. you may:

•    Feel confused or agitated

•    Have hallucinations (seeing or hearing things that aren’t there)

•    Have fits

•    Become unconscious (coma)

4.    POSSIBLE SIDE-EFFECTS

Like all medicines, aciclovir IV can cause side-effects although not everybody gets them. The following side-effects may happen with this medicine:

Allergic reactions (affects less than 1 in 10,000 people)

If you have an allergic reaction, stop taking Aciclovir for I.V. and see a doctor straight away.

The signs may include:

•    Rash, itching or hives on your skin

•    Swelling of your face, lips, tongue or other parts of your body

•    Shortness of breath, wheezing or trouble breathing

•    Unexplained fever (high temperature) and feeling faint, especially when standing up

Other side effects include:

Common (affects less than 1 in 10 people)

•    Feeling or being sick

•    Itchy, hive-like rash

•    Skin reaction after exposure to light (photosensitivity)

•    Itching

•    Swelling, redness and tenderness at the site of the injection

Uncommon (affects less than 1 in 100 people)

•    Nosebleeds and bruising more easily than usual

Very rare (affects less than 1 in 10,000 people)

•    Headache or feeling dizzy

•    Diarrhoea or stomach pains

•    Feeling tired

•    Fever

•    Effects on some blood urine tests

•    Feeling weak

•    Feeling agitated or confused

•    Shaking or tremors

•    Hallucinations

•    Fits

•    Feeling unusually sleepy or drowsy

•    Unsteadiness when walking and lack of coordination

•    Difficulty speaking

•    Inability to think or judge clearly

•    unconscious (coma)

•    paralysis of part or all of your body

•    disturbances of behaviour, speech and eye movements

•    stiff neck and sensitivity to light

•    inflammation of the liver (hepatitis)

•    yellowing of the skin and whites of your eyes (jaundice)

•    kidney problems where you pass little or no urine

•    pain in your lower back, the kidney area of your back of just above your hip (renal pain)

If any of the side-effects gets serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ACICLOVIR FOR I.V.

Keep out of the reach and sight of children.

Do not take Aciclovir for I.V. after the expiry date which is printed on the pack. The expiry date

refers to the last day of the month.

Store below 25°C

Prepare immediately before use

Discard unused solution

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 protect the environment.

6. FURTHER INFORMATION What Aciclovir for I.V contain

The active substance in the Aciclovir for I.V. is aciclovir Other ingredients are: sodium hydroxide, water for injections

What Aciclovir I.V look like and the contents of the pack

Aciclovir I.V 250mg contains 250mg of white to off-white powder in a vial.

Aciclovir I.V 500mg contains 500mg of white to off-white powder in a vial POM

PL 06831/0055 Aciclovir for I.V. 250mg PL 06831/0061 Aciclovir for I.V. 500mg Marketing Authorisation Holder

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.

Manufacturer

Wasserburger Arzneimittelwerk GmbH,Herderstrasse 2, 83512 Wasserburg, Germany.

This leaflet was last approved in June 2014.

4