Valaciclovir 500 Mg Film-Coated Tablets

Informations for option: Valaciclovir 500 Mg Film-Coated Tablets, show other option

Document: leaflet MANX HEALTHCARE_PL 37222-0025 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valaciclovir 500 mg 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 500 mg Film-Coated Tablets is and what it is used for

2. Before you take Valaciclovir 500 mg Film-Coated Tablets

3. How to take Valaciclovir 500 mg Film-Coated Tablets

4. Possible side effects

5. How to store Valaciclovir 500 mg Film-Coated Tablets

6. Further information

1. WHAT VALACICLOVIR 500 MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR

Valaciclovir 500 mg Film-Coated Tablets belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV).

Valaciclovir 500 mg Film-Coated Tablets can be used to:

• treat shingles (in adults)

• treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old).

It is also used to help prevent these infections from returning.

• treat cold sores (in adults and adolescents over 12 years old)

• prevent infection with CMV after organ transplants (in adults and adolescents over 12 years old)

• treat and prevent HSV infections of the eye.

2. BEFORE YOU TAKE VALACICLOVIR 500 MG FILM-COATED TABLETS

Don’t take Valaciclovir 500 mg Film-Coated Tablets

• if you are allergic (hypersensitive) to valaciclovir or aciclovir or any of the other ingredients (listed in Section 6).

• Don’t take Valaciclovir 500 mg Film-Coated Tablets if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir 500 mg Film-Coated Tablets.

Take special care with Valaciclovir 500 mg Film-Coated Tablets

Check with your doctor or pharmacist before taking Valaciclovir 500 mg Film-Coated Tablets if:

• you have kidney problems

• you have liver problems

• you are over 65 years of age

• your immune system is weak

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Valaciclovir 500 mg Film-Coated Tablets.

Prevent passing genital herpes on to others

If you are taking Valaciclovir 500 mg Film-Coated Tablets to treat or prevent genital herpes, or you have had genital herpes in the past, you should still practice safe sex, including the use of condoms. This is important to prevent you passing the infection on to others. You should not have sex if you have genital sores or blisters.

Taking other medicines

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.

Tell your doctor or pharmacist if you are taking any other medicines that affect the kidneys. These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.

Always tell your doctor or pharmacist about other medicines if you are taking Valaciclovir 500 mg Film-Coated Tablets for treatment of shingles or after having an organ transplant.

Pregnancy and breast-feeding

Valaciclovir 500 mg Film-Coated Tablets is not usually recommended for use during pregnancy. If you are pregnant, or think you could be, or if you are planning to become pregnant, don’t take Valaciclovir 500 mg Film-Coated Tablets without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir 500 mg Film-Coated Tablets while you're pregnant or breastfeeding.

Driving or using machines

Valaciclovir 500 mg Film-Coated Tablets can cause side effects that affect your ability to drive.

Don’t drive or use machines unless you are sure you’re not affected.

3. HOW TO TAKE VALACICLOVIR 500 MG FILM-COATED TABLETS

Always take Valaciclovir 500 mg Film-Coated Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose that you should take will depend on why your doctor has prescribed Valaciclovir 500 mg Film-Coated Tablets for you. Your doctor will discuss this with you.

Treatment of shingles

• The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.

• You should take Valaciclovir 500 mg Film-Coated Tablets for seven days.

Treatment of cold sores

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.

• The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose

• You should take Valaciclovir 500 mg Film-Coated Tablets for one day (two doses) only.

Treatment of HSV infections of the skin and genital herpes

• The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.

• For the first infection you should take Valaciclovir 500 mg Film-Coated Tablets for five days or for up to ten days if your doctor tells you to. For recurrent infection the duration of treatment is normally 3-5 days.

Helping to prevent HSV infections from returning after you have had them

• The usual dose is one 500 mg tablet once a day.

• Some people with frequent recurrences may benefit from taking one 250 mg tablet twice a day.

• You should take Valaciclovir 500 mg Film-Coated Tablets until your doctor tells you to stop.

To stop you being infected with CMV (Cytomegalovirus)

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.

• You should take each dose about 6 hours apart.

• You will usually start taking Valaciclovir 500 mg Film-Coated Tablets as soon as possible after your surgery.

• You should take Valaciclovir 500 mg Film-Coated Tablets for around 90 days after your surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir 500 mg Film-Coated Tablets if:

• you are over 65 years of age

• you have a weak immune system

• you have kidney problems.

Talk to your doctor before taking Valaciclovir 500 mg Film-Coated Tablets if any of the above apply.

Taking this medicine

• Take this medicine by mouth.

• Swallow the tablets whole with a drink of water.

• Take Valaciclovir 500 mg Film-Coated Tablets at the same time each day.

• Take Valaciclovir 500 mg Film-Coated Tablets according to instructions from your doctor or pharmacist.

People over 65 years of age or with kidney problems

It is very important while you are taking Valaciclovir 500 mg Film-Coated Tablets that you drink water regularly during the day. This will help to reduce side effects that can affect the kidney or nervous system. Your doctor will closely monitor you for signs of these. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.

If you take more Valaciclovir 500 mg Film-Coated Tablets than you should

Valaciclovir 500 mg Film-Coated Tablets is not usually harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, or be confused, agitated or unusually sleepy. Talk to your doctor or pharmacist if you take too much Valaciclovir 500 mg Film-Coated Tablets. Take the medicine pack with you.

If you forget to take Valaciclovir 500 mg Film-Coated Tablets

• If you forget to take Valaciclovir 500 mg Film-Coated Tablets, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.

• Don’t take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Valaciclovir 500 mg Film-Coated Tablets can cause side effects in some people. The following side effects may happen with this medicine:

Conditions you need to look out for

• severe allergic reactions (anaphylaxis). These are rare in people taking Valaciclovir 500 mg Film-Coated Tablets. Rapid development of symptoms including:

• flushing, itchy skin rash

• swelling of the lips, face, neck and throat, causing difficulty in breathing (angiodema)

• fall in blood pressure leading to collapse.

If you have an allergic reaction, stop taking Valaciclovir 500 mg Film-Coated Tablets and see a doctor straight away.

Very Common (affects more than 1 in 10 people):

• headache

Common (affects up to 1 in 10 people)

• feeling sick

• dizziness

• vomiting

• diarrhoea

• skin reaction after exposure to sunlight (photosensitivity).

• rash

Uncommon (affects up to 1 in 100 people)

• feeling confused

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

• feeling very drowsy

• tremors

• feeling agitated

These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valaciclovir 500 mg Film-Coated Tablets a day. They usually get better when Valaciclovir 500 mg Film-Coated Tablets is stopped or the dose reduced.

Other uncommon side effects:

• shortness of breath (dyspnoea)

• stomach discomfort

• rash, sometimes itchy, hive-like rash (urticaria)

• low back pain (kidney pain)

• blood in the urine (haematuria)

Uncommon side effects that may show up in blood tests:

• reduction in the number of white blood cells (leucopenia)

• reduction in the number of blood platelets which are cells that help blood to clot

(thrombocytopenia)

• increase in substances produced by the liver.

Rare (affects up to 1 in 1,000 people)

• unsteadiness when walking and lack of coordination (ataxia)

• slow, slurred speech (dysarthria)

• fits (convulsions)

• altered brain function (encephalopathy)

• unconsciousness (coma)

• confused or disturbed thoughts

• acute confusional state (delirium)

Other rare side effects:

• kidney problems where you pass little or no urine.

5. HOW TO STORE VALACICLOVIR 500 MG FILM-COATED TABLETS

Keep out of the reach and sight of children.

Do not use the tablets after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of the month.

This medicinal product does not require any special storage conditions.

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 Valacidovir 500 mg Film-Coated Tablets contain

• The active ingredient is valaciclovir. Each tablet contains 500 mg valaciclovir (as valaciclovir hydrochloride monohydrate).

• The other ingredients are magnesium stearate, povidone, crospovidone, microcrystalline cellulose, titanium dioxide, hypromellose, macrogol 400 and polysorbate 80.

What Valaciclovir 500 mg Film-Coated Tablets look like and contents of the pack

• Valaciclovir 500 mg Film-Coated Tablets are white, capsule-shaped, biconvex, film-coated tablets. The tablets are embossed ‘V’ on one side and ‘500’on the other side.

• Your medicine is available in blisters containing 4, 6, 10, 24, 30, 42, 80, 84, 90, 112 tablets.

• Not all pack sizes may be marketed.

Marketing Authorisation Holder

Hetero Europe, S.L.

Viladecans Business Park - Edificio Brasil, Catalunya 83-85, Viladecans, Barcelona, Spain

Manufacturer

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

Kern Pharma, S.L.

Pol. Ind. Colon II, C/ Venus 72 08228 Terrassa (Barcelona) Espana

Distributed in the United Kingdom by:

Manx Pharma Ltd., Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.

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

The Netherlands Valaciclovir Jenson 500 mg filmomhulde tabletten Spain Valaciclovir Kern Pharma 500 mg comprimidos recubiertos

con pelicula EFG

United Kingdom Valaciclovir 500 mg film-coated Tablets

This leaflet was last approved in April 2014.