PACKAGE LEAFLET: INFORMATION FOR THE USER

Valaciclovir 250 mg film-coated tablets Valaciclovir 500 mg film-coated tablets Valaciclovir 1 g film-coated tablets

Valaciclovir

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

In this leaflet:

1.    What Valaciclovir is and what it is used for?

2.    Before you take Valaciclovir .

3.    How to take Valaciclovir ?

4.    Possible side effects.

5.    How to store Valaciclovir ?

6.    Further information.

1.    WHAT Valaciclovir IS AND WHAT IT IS USED FOR?

Valaciclovir is an antiviral medicine.

It is used in the following situations:

•    in patients over 50 years of age, to treat shingles,

•    to treat genital Herpes simplex virus (HSV) infections,

•    to prevent (suppress) recurrent genital Herpes simplex virus (HSV) infections in patients who have at least 6 recurrences per year,

•    to prevent cytomegalovirus (CMV) infections and disease after organ transplant.

2.    BEFORE YOU TAKE Valaciclovir Do NOT take valaciclovir

•    if you are allergic (hypersensitive) to valaciclovir, aciclovir or any of the other ingredients of Valaciclovir .

Take special care with valaciclovir

•    If you have kidney disease or are elderly, your doctor may need to adjust the usual dosage. Let your doctor know if you have kidney disease.

•    Let your doctor know if you have liver disease.

•    Valaciclovir does not cure genital herpes. It does not completely eliminate the risk of your sexual partner becoming contaminated. You must practice safe sex, in particular condom use, even whilst on treatment with valaciclovir.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, especially medicines for acid-related stomach problems (e.g. cimetidine), gout (e.g. probenecid) or immunosuppressants (e.g. mycophenolate mofetil, ciclosporin, tacrolimus), and including medicines obtained without a prescription.

Taking Valaciclovir with food and drink

Make sure you drink enough water during your treatment with valaciclovir, in order to avoid becoming dehydrated, especially if you are elderly.

Pregnancy and breast-feeding

You must not take this medicine if you are pregnant without the advice of your doctor.

If you discover that you are pregnant during treatment, consult your doctor, as only your doctor can judge whether you need to continue taking the treatment.

You should not breast-feed during treatment with valaciclovir.

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

Driving and using machines

Valaciclovir has no or negligible influence on the ability to drive and use machines.

3. HOW TO USE Valaciclovir

Always take Valaciclovir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be taken by mouth with an ample amount of water.

Adults

•    For the treatment of shingles, the usual dose is 2 tablets, 3 times a day for 7 days. You should start taking valaciclovir no more than 3 days after your symptoms first appeared.

•    To treat a first genital Herpes simplex virus (HSV) infection, the usual dose is 1 tablet twice daily for 10 days. You should start taking valaciclovir as soon as possible at the beginning of the attack, preferably when the first signs of infection develop or at the outbreak of the rash.

•    To treat recurrent genital Herpes simplex virus (HSV) infections, the usual dose is 2 tablets a day for 5 days. The tablets can be taken together or separately, for instance, in the morning and evening. You should start taking valaciclovir as soon as possible at the beginning of the attack, preferably when the first signs of infection develop or at the outbreak of the rash.

•    To prevent recurrent genital Herpes simplex virus (HSV) infections, the usual dose is 1 tablet a day. The tablet can be taken whole or divided into halves, for instance, half in the morning and half in the evening. The value of the treatment is to be re-assessed after 6 to 12 months.

•    To prevent cytomegalovirus (CMV) infections and disease, the usual dose is 4 tablets 4 times a day, usually for 90 days. The treatment should be started as early as possible after the organ transplant.

Adolescents over 12 years of age

•    To prevent cytomegalovirus (CMV) infections and disease, the usual dose is 4 tablets 4 times a day, usually for 90 days. The treatment should be started as early as possible after the organ transplant.

Children under 12 years of age

Valaciclovir is not recommended for use in children below the age of 12 years due to insufficient data on safety and efficacy.

If you have impaired kidney function

The dose will be adapted by your doctor if you have impaired kidney function.

If you feel that the effect of Valaciclovir is too strong or too weak, contact your doctor or pharmacist.

If you take more Valaciclovir than you should

Inform your doctor. You may experience nausea and/or vomiting (feeling and/or being sick), headache, or confusion.

If you forget to take Valaciclovir

Do not take a double dose to make up for a forgotten dose.

If you stop takingValaciclovir

You should take Valaciclovir for as long as your doctor tells you to.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines,Valaciclovir can cause side effects, although not everybody gets them. ¹

extreme dizziness or collapse; itchy, raised skin rash. This can be a severe allergic reaction which has been reported very rarely (in less than one person in 10,000).

•    If you experience any of the following, contact your doctor immediately:

Frequent and/or severe infections (especially sore throats);

Unexplained fever;

Mouth and/or throat ulcers;

Unusual or unexplained bruising or bleeding;

Small (pin-point) red spots on the skin and/or in the mouth.

These can be blood disorders (reduction of white blood cells that protect against infections; reduced platelets that help blood to clot), which have been reported very rarely (in less than one person in 10,000).

•    If you experience any of the following side effects, contact your doctor as soon as possible:

Stomach upsets such as feeling sick, vomiting, diarrhoea and stomach pain;

Headaches;

Skin rash (which may also occur after exposure to UV light e.g. sunbathing or using a sun bed).

The following side effects have also been reported:

Common (affecting fewer than one person in 10 but more than one person in 100)

•    Nausea¹;

•    Headache.

Uncommon (affecting fewer than one person in 100 but more than one person in 1,000)

•    Difficulty in breathing (dyspnoea);

•    Skin rashes sometimes caused by sensitivity to sunlight.

Rare (affecting fewer than one person in 1,000 but more than one person in 10,000)

•    Dizziness;

•    Confusion;

•    Hallucinations;

•    Altered mental state;

•    Reduced consciousness;

•    Drowsiness;

•    Abdominal discomfort;

•    Vomiting;

•    Diarrhoea;

•    Itching;

•    Impaired kidney function.

•    Abnormal decreases in the number of white blood cells (leucopenia)*;

•    Increased bleeding and decreased ability for clotting (thrombocytopenia)*;

•    Severe allergic reaction (anaphylaxis)*;

•    Agitation;

•    Distortion of contact with reality (psychotic symptoms);

•    Involuntary trembling or quivering in any part of the body (tremor);

•    Lack of co-ordination (ataxia);

•    Speech problems, unclear pronunciation (dysarthria);

•    Seizures, convulsions;

•    Disorder of the brain (encephalopathy);

•    Coma;

•    Reversible increases in liver function tests;

•    Hives;

•    Swelling of the lips, eyes or tongue (angioedema)*;

•    Sudden/severe kidney failure.

•    Please refer to the beginning of 4. Possible side effects for important information.

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 Valaciclovir

Keep out of the reach and sight of children.

No special storage condition required.

Expiry date

Do not use Valaciclovir after the expiry date which is stated on the carton and the blister or the bottle after “exp”. The expiry date refers to the last day of that month.

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 to protect the environment.

6.    FURTHER INFORMATION What Valaciclovir contains

The active substance is valaciclovir (as valaciclovir hydrochloride monohydrate).

•    Valaciclovir 250mg, each film-coated tablet contains 250mg valaciclovir (as

valaciclovir hydrochloride monohydrate).

•    Valaciclovir 500mg, each film-coated tablet contains 500mg valaciclovir (as

valaciclovir hydrochloride monohydrate).

•    Valaciclovir 1g, each film-coated tablet contains 1g valaciclovir (as valaciclovir

hydrochloride monohydrate).

The other ingredients in the tablet core are: microcrystalline cellulose (E460) and magnesium stearate (E572). The tablet coating contains hypromellose (E464), titanium dioxide (E171) and macrogol - 400.

What Valaciclovir looks like and contents of the pack

250mg: white coloured, oval shaped, biconvex film-coated tablet.

500mg: white coloured, oval shaped, biconvex film-coated tablet with a break line on one side and plain on the other side. The tablet can be divided into equal halves.

1g: white coloured, oval shaped, biconvex film-coated tablet with a break line on one side and plain on the other side. The tablet can be divided into equal halves.

250 mg: Blister packs Aluminium/Aluminium: 60 tablets.

500 mg: Blister packs Aluminium/Aluminium: 10, 30, 42, 90 tablets. Bottles (HDPE) with polypropylene screw cap: 100 tablets 1 g: Blister packs Aluminium/Aluminium: 7 and 21 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

DOCPHARMA NV

AMBACHTENLAAN 13H

HEVERLEE

B-3001

BELGIUM

This medicinal product is authorized in the Member States of the EEA under the following names:

[To be completed]

This leaflet was last approved in March 2011

1

If you experience any of the following, contact your doctor or local hospital casualty department immediately:

Sudden difficulty in breathing, speaking and swallowing; swelling of the lips, face and neck;