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VALACICLOVIR 1 G FILM-COATED TABLETS

Active substance(s): VALACICLOVIR HYDROCHLORIDE

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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.


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;

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)



Nausea*;
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.

Very rare effects (affecting fewer than one person in 10,000)
















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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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