Document: Valaciclovir Pharmathen film-coated tablet ENG PL change

• Valaciclovir Pharmathen film-coated tablet PL
• Valaciclovir Pharmathen film-coated tablet ENG PL

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Package leaflet: Information for the user

Valaciclovir Pharmathen 500 mg film-coated tablets

Valaciclovir

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 or pharmacist.

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

2. What you need to know before you take Valaciclovir Pharmathen

3. How to take Valaciclovir Pharmathen

4. Possible side effects

6. Contents of the pack and other information

Valaciclovir Pharmathen 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 Pharmathen can be used to:

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

• treat and prevent HSV infections of the eye

Do not take Valaciclovir Pharmathen

- if you are allergic to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in section 6).

- Don’t take Valaciclovir Pharmathen if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir Pharmathen.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valaciclovir Pharmathen 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 Pharmathen.

Prevent passing genital herpes on to others

If you are taking Valaciclovir Pharmathen 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.

Other medicines and Valaciclovir Pharmathen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 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 Pharmathen for treatment of shingles or after having an organ transplant.

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 or pharmacist for advice before taking this medicine. Valaciclovir Pharmathen is not usually recommended for use during pregnancy. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir Pharmathen while you are pregnant or breast-feeding.

Driving and using machines

Valaciclovir Pharmathen can cause side effects that affect your ability to drive.

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

Valaciclovir Pharmathen contains lactose

This medicine contains a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor has told you. 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 Pharmathen for you. Your doctor will discuss this with you.

Treatment of shingles

• The recommended dose is 1000 mg (two 500 mg tablets) three times a day.

• You should take Valaciclovir Pharmathen for seven days.

Treatment of cold sores

Treatment of HSV infections of the skin and genital herpes

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

• For the first infection you should take Valaciclovir Pharmathen 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

To stop you being infected with CMV (Cytomegalovirus)

Your doctor may adjust the dose of Valaciclovir Pharmathen if:

→ Talk to your doctor before taking Valaciclovir Pharmathen if any of the above apply.

Taking this medicine

People over 65 years of age or with kidney problems

It is very important while you are taking Valaciclovir Pharmathen 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 Pharmathen than you should

Valaciclovir Pharmathen 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 Pharmathen. Take the medicine pack with you.

If you forget to take Valaciclovir Pharmathen

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Conditions you need to look out for

• 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 Pharmathen and see a doctor straight away.

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

• feeling sick

• dizziness

• vomiting

• diarrhoea

• skin reaction after exposure to sunlight (photosensitivity)

• rash

Uncommon (may affect 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 Pharmathen a day. They usually get better when Valaciclovir Pharmathen is stopped or the dose reduced.

Other uncommon side effects:

• low back pain (kidney pain)

• haematuria (often associated with other renal events).

Uncommon side effects that may show up in blood tests:

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

• slow, slurred speech (dysarthria)

• fits (convulsions)

• altered brain function (encephalopathy)

• confused or disturbed thoughts

• delirium.

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

Other rare side effects:

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valaciclovir Pharmathen

• 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. The expiry date (Exp.) refers to the last day of that month.

• Store below 30°C.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Valaciclovir Pharmathen contains

The active substance is valaciclovir.

Each film-coated tablet contains 500 mg of valaciclovir (as valaciclovir hydrochloride)

The other ingredients are: Calcium hydrogen phosphate, sodium starch glycolate, hydroxypropylcellulose, talc, magnesium stearate, hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.

What Valaciclovir Pharmathen looks like and contents of the pack

Valaciclovir Pharmathen are white, oblong,biconvex film coated tablets

The film-coated tablets are packed in blister packs (PVC/PE/PVDC/aluminium).

Pack sizes: 10, 30, 42, 90tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[to be completed nationally]

Manufacturer

Pharmathen S.A.

Dervenakion 6

Pallini 15350

Greece

Pharmathen International S.A.

Industrial Park Sapes

Rodopi Prefecture, Block No 5

Rodopi 69300

Greece

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

Sweden: Valaciclovir Pharmathen

Cyprus: Valavir

Greece: Valaciclovir/Pharmathen International

Slovak Republic: Valaciclovir Pharmathen

This leaflet was last revised in2016-03-11