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Aciclovir Sodium For Intravenous Infusion B.P.

Document: leaflet MAH GENERIC_PL 11311-0519 change

PATIENT INFORMATION LEAFLET

Aciclovir 250mg / 500mg for Intravenous Infusion

(Aciclovir)_

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor.

•    This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. (See Section 4).

What is in this leaflet:

1.    What Aciclovir Sodium is and what it is used for

2.    What you need to know before you take Aciclovir Sodium

3.    How to take Aciclovir Sodium

4.    Possible side effects

5.    How to store Aciclovir Sodium

6.    Contents of the pack and other information

1.    What Aciclovir Sodium is and what it is used for

Aciclovir Sodium for Intravenous Infusion is an antiviral medicine which acts on infected cells by stopping the virus growing.

Aciclovir Sodium is used to treat and prevent viral infections:

•    Herpes simplex infections (may appear as cold sores around the lips or as blisters on any part of the skin including the genitals) in patients who have a low immune system

•    First and repeat infections with Varicella Zoster (e.g. Shingles or Chickenpox) in patients who have a low immune system

•    Genital herpes

•    Herpes encephalitis (inflammation of the brain following infection with the Herpes simplex virus)

2.    What you need to know before you take Aciclovir Sodium

Do not use Aciclovir Sodium:

If you are allergic to aciclovir, valaciclovir, other antiviral medicines or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information").

Warnings and precautions

Talk to your doctor before taking Aciclovir Sodium:

•    If you are taking other nephrotoxic medicines (medicines that may cause kidney failure) such as cyclosporin and tacrolimus (See "Medicines which may interact with Aciclovir Sodium section")

•    If you are elderly

•    If you suffer from kidney problems (including if you have dialysis therapy)

•    If you have a severely low immune system and need to have this medicine over a long period of time or in repeated doses

Other medicines and Aciclovir Sodium

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those not prescribed for you. This includes herbal medicines.

Medicines which may interact with Aciclovir Sodium:

•    Probenecid (used to treat gout)

•    Cimetidine (used to reduce stomach acid)

•    Mycophenolate mofetil (used to prevent transplant rejection)

•    Lithium (used to treat mood disorders)

•    Medicines which may affect the kidneys e.g. cyclosporin, tacrolimus (nephrotoxic medicines)

•    Theophylline (used to treat breathing problems, such as asthma)

Aciclovir Sodium with food and drink

It is important that you drink/receive plenty of fluids whilst you are being treated with Aciclovir Sodium to prevent you becoming dehydrated, especially if you suffer from kidney problems.

Before you are given this medicine your doctor will check to make sure you are not dehydrated and are passing urine sufficiently.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Aciclovir Sodium should be used with caution during breast-feeding.

Driving and using machines

Aciclovir Sodium may impair your ability to drive. If this is experienced, it is necessary to avoid driving or operating machinery.

3. How to take Aciclovir Sodium 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.

•    For single, intravenous use only. This medicine should not be taken orally.

•    This medicine will be diluted with a solution before it is given to you. Once diluted, Aciclovir Sodium must be used immediately.

•    It will be given to you by a slow injection via a drip into a vein over a period of 1 hour.

•    The course of treatment you are given may vary between 5 and 21 days depending on:

o the type of infection you have o your body weight o your age

o your response to treatment

•    Your doctor may adjust the dose of Aciclovir Sodium if you suffer from kidney problems.

•    Avoid contact with eyes and unprotected skin.

If you are given too much Aciclovir Sodium:

If you think you have been given too much Aciclovir Sodium speak to your doctor immediately.

Symptoms of overdose include: confusion, seeing or hearing things that are not real (hallucinations), feeling agitated, fits, loss of consciousness/coma.    continued...

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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

•    Allergic reactions (anaphylaxis): skin rashes, itching, swelling of the face, tongue or throat, breathlessness, difficulty in breathing, dizziness

•    Severe localised redness and swelling around the injection site

Common side effects: (may affect up to 1 in 10 people)

•    Headache

•    Dizziness

•    Inflammation of the veins (phlebitis)

•    Feeling sick (nausea) or being sick (vomiting)

•    Diarrhoea

•    Stomach pains

•    Severe itching (pruritus), red, raised, itchy skin rash (urticaria), skin rashes

•    Abnormal sensitivity of the skin to sunlight (photosensitivity)

•    Increases in blood urea & creatinine (waste products usually passed out in urine). High blood levels of urea & creatinine (detected in blood tests) indicate that the kidneys may not be working properly

Uncommon side effects (may affect up to 1 in 100 people)

•    Looking pale and feeling tired (anaemia)

•    A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytophenia)

•    A reduction in white blood cells (leukopenia) Symptoms of leukopenia may include: feelings of tiredness or weakness, dizziness or lightheadedness, loss of appetite, headaches, increased risk of infections.

Rare Side Effects (may affect up to 1 in 1,000 people)

•    Shortness of breath (dyspnoea)

•    Increases in bilirubin and liver-related enzymes (reversible)

Very rare side effects (may affect up to 1 in 10,000 people)

•    Agitation

•    Confusion

•    Shakiness (tremors)

•    Lack of voluntary co-ordination of muscle movements (ataxia)

•    Difficulty with speech (dysarthria)

•    Hallucinations

•    Symptoms of an abnormal state of mind (psychosis) such as delusions, confused/disturbed thoughts, lack of insight and self-awareness (unable to recognise own mental illness, need for treatment or consequences of behaviour)

•    Fits (convulsions)

•    Sleepiness (somnolence)

•    Disorder of the brain (encephalopathy)

•    Coma

•    Yellowing of the skin or whites of the eyes (jaundice)

•    Inflammation of the liver (hepatitis)

•    Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)

•    Kidney problems, kidney failure or pain in the kidneys

•    Tiredness (fatigue)

•    Fever

•    Mild localised redness and swelling around the injection site

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Aciclovir Sodium

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 after "EXP". The expiry date refers to the last day of that month.

Store in original container in order to protect from light. Do not store above 25°C. Do not refrigerate.

Discard any unused contents. Do not throw away any medicines via wastewater or household waste. These measures will help to protect the environment.

6.    Contents of the pack and other information What Aciclovir Sodium contain:

•    Each vial of Aciclovir Sodium for Intravenous Infusion contains 250mg or 500mg of active ingredient aciclovir sodium.

•    The other ingredients are water for injection or sodium chloride injection 9 mg/ml diluted with an infusion fluid from a specified list.

What Aciclovir Sodium looks like and contents of the pack:

A white powder dispensed in a clear, glass vial for infusion (a concentrated powder, which is dissolved and diluted to be given as a slow injection via a drip).

Aciclovir Sodium is available in:

Aciclovir Sodium is available in packs of:

•    250mg: 3, 5 vials.

•    500mg: 5 vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer:

Tillomed Laboratories Ltd.

3 Howard Road Eaton Socon St. Neots Cambridgeshire PE19 8ET UK

Product Licence Numbers:

Aciclovir Sodium for Infusion - PL 11311/0519 (250mg) Aciclovir Sodium for Infusion - PL 11311/0520 (500mg)

Date of last revision: February 2015

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