Valaciclovir 500 Mg Film-Coated Tablets

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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 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 effect

5. How to store Valaciclovir

6. Further information

1. WHAT VALACICLOVIR IS AND WHAT IT IS USED FOR

Valaciclovir 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 can be used to:

• treatshingles (in adults)

• treatHSV 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.

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

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

• treatand prevent HSV infections of the eye

2. BEFORE YOU TAKE VALACICLOVIR

Do not take Valaciclovir

• ifyouare allergic (hypersensitive) to valaciclovir or aciclovir or any of the other ingredients Valaciclovir (listed in Section 6).

• Don'ttake Valaciclovir if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir.

Take special care with Valaciclovir

Check with your doctor or pharmacist before taking Valaciclovir if:

• youhave kidney problems

• youhave liver problems

• youareover 65 years of age

• yourimmune system is weak

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Valaciclovir.

Prevent passing genital herpes on to others If you are taking Valaciclovir 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 for treatment of shingles or after having an organ transplant.

Pregnancy and breast-feeding

Valaciclovir 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 without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir while you're pregnant or breastfeeding.

Driving and using machines

Valaciclovir can cause side effects that affect your ability to drive. ^Don'tdrive or use machines unless you are sure you're not affected.

3. HOW TO TAKE 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 dose that you should take will depend on why your doctor has prescribed Valaciclovir for you. Your doctor will discuss this with you.

Treatment of shingles

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

• Youshould take Valaciclovir for seven days.

Treatment of cold sores

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

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

• Youshould take Valaciclovir for one day (two doses) only. Treatment of HSV infections of the skin and genital herpes

• Theusual dose is 500 mg (one 500 mg tablet) twice a day.

• Forthefirst infection you should take Valaciclovir 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

• Theusual dose is one 500 mg tablet once a day.

• Somepeople with frequent recurrences may benefit from taking one 250 mg twice a day.

• Youshould take Valaciclovir until your doctor tells you to stop. To stop you being infected with CMV (Cytomegalovirus)

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

• Youshould take each dose about 6 hours apart.

• Youwillusually start taking Valaciclovir as soon as possible after your surgery.

• Youshould take Valaciclovir for around 90 days after your surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir if:

• youareover 65 years of age

• youhave a weak immune system

• youhave kidney problems.

® Talkto your doctor before taking Valaciclovir if any of the above apply.

Children under 12 years of age

Valaciclovir should not be used in children under 12 years of age. Taking this medicine

• Takethis medicine by mouth.

• Swallowthe tablets whole with a drink of water.

• TakeValaciclovir at the same time each day.

• TakeValaciclovir 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 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

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unusually sleepy or drowsy.

If you take more Valaciclovir than you should

Valaciclovir 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. Take the medicine pack with you.

If you forget to take Valaciclovir

• Ifyouforget to take Valaciclovir, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.

• Donottake a double dose to make up for a forgotten dose.

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.

Conditions you need to look out for

• severeallergic reactions (anaphylaxis). These are rare in people taking Valaciclovir. Rapid development of symptoms including:

• flushing,itchy skin rash

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

• fallinblood pressure leading to collapse.

® Ifyouhave an allergic reaction, stop taking Valaciclovir and see a doctor straight away.

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

• headache

Common (affects up to 1 in 10 people)

• feelingsick

• dizziness

• vomiting

• diarrhoea

• skinreaction after exposure to sunlight (photosensitivity).

• rash

Uncommon (affects up to 1 in 100 people)

• feelingconfused

• seeingor hearing things that aren't there (hallucinations)

• feelingvery drowsy

• tremors

• feelingagitated

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 a day. They usually get better when Valaciclovir is stopped or the dose reduced.

Other uncommon side effects:

• shortness of breath (dyspnoea)

• stomachdiscomfort

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

• lowback pain (kidney pain)

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)

• increasein 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)

• alteredbrain function (encephalopathy)

• unconsciousness (coma)

• confused or disturbed thoughts

• kidneyproblems where you pass little or no urine.

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.

Do not use Valaciclovir after the expiry date which is stated on the carton after 'EXP:'. 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 Valaciclovir contains

• Theactive substance is valaciclovir.

Each film-coated tablet contains valaciclovir hydrochloride (hydrated) equivalent to 500 mg valaciclovir.

• Theother ingredients are:

Tablet core: Cellulose, microcrystalline, crospovidone (Type A), povidone (K-90), magnesium stearate Film coat: Hypromellose 6cP, indigo carmine aluminium lake

(E132), titanium dioxide (E171), macrogol 400, polysorbate 80

What Valaciclovir look like and contents of the pack

Film-coated tablet.

Blue, film-coated, capsule shaped tablets with a partial score bar on both sides containing 'F' on one side and '9' and '3' on the other side.

The tablet can be divided into equal halves.

Valaciclovir film-coated tablets are available in clear PVC/PVdC Aluminium foil blister.

Pack sizes;

Blister: 7, 10, 21, 30, 42, 50, 90 & 112 tablets

Bottle: 30 & 500 tablets

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

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

France Valaciclovir Arrow 500 mg, comprime pellicule

secable

Germany Valaciclovir Aurobindo 500 mg Filmtabletten

Italy Valaciclovir Aurobindo 500 mg/ 1000 mg

compresse rivestite con film

Netherlands Valaciclovir Aurobindo 500 mg, filmomhulde

tabletten

Portugal Valaciclovir Aurobindo

Spain Valaciclovir Aurobindo 500 mg/1000 mg

comprimidos recubiertos con pelfcula EFG United Kingdom Valaciclovir 500 mg film-coated tablets

Medine.co.uk