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Aciclovir Tablets Bp 200mg

Document: leaflet MAH BRAND_PL 00289-0294 change

Patient Information Leaflet Fyris 200 and 400mg Tablets

Read all of this leaflet carefully 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. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet

1.    What is Fyris Tablets and what it is used for

2.    What you need to know before you take Fyris Tablets

3.    How to take Fyris Tablets

4.    Possible side effect

5.    How to store Fyris Tablets

6.    Contents of the pack and other information

1.    What Fyris tablets is and what it is used for

The name of your medicine is Fyris 200 or 400mg Tablets.

Fyris is an antiviral agent effective against infections caused by viruses.

Fyris Tablets are used to treat and prevent recurrence of infections due to the herpes simplex virus including cold sores and genital herpes. Fyris Tablets may also be used to treat chickenpox and shingles.

2.    What you need to know before you take Fyris Tablets Do not take Fyris tablets and talk to your doctor if you :

•    are allergic (Hyper sensitive) to Aciclovir, valaciclovir (another antiviral drug) or to any of the ingredients in the medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fyris tablets tablets if you:

•    have kidney problems

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.

Other medicines and Fyris

Tell your doctor before you start to take this medicine if you :

•    are taking probenecid

•    are taking cimetidine

•    are taking myocophenolate mofetil, a drug used following an organ transplant

are taking theophylline

are taking any other medicines

Driving and using machines

No studies on the effect on the ability to drive and use machines have been performed.

Important information about some of the ingredients of Fyris

Dispersed red can cause and allergic-type reaction, including asthma. This reaction is more common in those people who are allergic to aspirin. Patients who are intolerant to lactose should note that Fyris tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Fyris tablets

Always take Fyris tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with a drink of water.

The usual dosage instructions are given below. It is helpful to maintain your regular fluid intake. Treatment should begin as early as possible.

Adults -

FOR THE TREATMENT OF HERPES SIMPLEX INFECTIONS

200 mg five times a day every 4 hours omitting the night time dose. This dose should be taken for as long as your doctor has stated.

KIDNEY PROBLEMS

200 mg two times a day every 12 hours.

TREATMENT OF CHICKENPOX OR SHINGLES

800 mg five times a day every 4 hours omitting the night time dose for seven days.

SUPRESSION OR PREVENTION OF HERPES SIMPLEX INFECTIONS

200 mg four times a day every 6 hours. This dose may be adjusted, follow your doctor’s instructions. Children

FOR THE TREATMENT OR PREVENTION OF HERPES SIMPLEX INFECTIONS FOR CHILDREN WITH REDUCED IMMUNITY

2 years and above: the adult dose is appropriate Under 2 years: half the adult dose

TREATMENT OF CHICKENPOX

6 years and above:    800    mg four times    a day

2 to 5 years:    400    mg four times    a day

Under 2 years:    200    mg four times    a day

Treatment should continue for five days.

Elderly

Patients with renal impairment:

If you suffer from kidney problems, discuss this with your doctor and the appropriate dosage will be set for your needs.Your doctor has decided the dose which is suited to you. Always follow your doctor’s instructions and those which are on the pharmacy label. If you do not understand these instructions, or you are in any doubt, ask your doctor or pharmacist.

If you forget to take Fyris tablets

You should continue to take these tablets for as long as your doctor tells you to. If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

If you see another doctor or go into hospital, let him or the staff know what medicines you are taking. Do not take a double dose to make up for a forgotten dose.

If you take more Fyris tablets than you should

If you (or someone else) swallow a lot of tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

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

4. Possible side effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Fyris Tablets are taken by many patients without any problems.

However, like many other medicines they may occasionally cause side effects in some people.

The following side effects have been reported:

Common (may affect up to 1 in 10 people/'

•    Headache

•    Dizziness

•    Nausea

•    Vomiting

•    Diarrhoea

•    Abdominal pains

•    Itching

•    Rashes (including photosensitivity)

•    Tiredness

•    Fever

Uncommon (may affect up to 1 in 100 people):

•    Nettle rash

•    Accelerated diffuse hair loss

Rare (may affect up to 1 in 1,000 people)

•    Shortness of breath

•    Serious allergic reaction which causes swelling of the face or throat

•    Changes in blood chemistry

•    Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness

•    Reduction in the number of white blood cells, which makes infections more likely

•    Reduction in blood platelets, which increases risk of bleeding or bruising

Very Rare (may affect up to 1 in 10,000 people)

•    Agitation

•    Confusion

•    Shaking

•    Difficulty in controlling movements

•    Slurred speech

•    Hallucinations

•    Psychotic symptoms

•    Fits

•    Sleepiness

•    Brain disorder

•    Coma

•    Inflammation of the liver

•    Yellowing of the skin or whites of the eyes caused by liver or blood problems

•    Acute renal failure

•    Kidney problems where you pass little or no urine Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fyris tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the outside of the carton and on the blister foil. Do not store above 25°C. Do not transfer them to another container. Keep them in a secure place where children cannot get at them. This medicine is for you ONLY, do not give it to anyone else. Unless your doctor tells you to, do not keep these tablets for longer than you need. Return all unused medicines to your pharmacist for safe disposal.

6. Contents of the pack and other information What Fyris tablets contain

Each Fyris Tablet contains 200 mg or 400 mg of the active ingredient aciclovir.

The other ingredients are lactose, microcrystalline cellulose, sodium starch glycollate, povidone, magnesium stearate and the dye E132 (dispersed blue) in the 200 mg tablet, and E122 (dispersed red) in the 400 mg tablet.

What Fyris tablets look like and contents of the pack

The product is available in pack sizes of 25, 28, 35, 56 or 100 tablets.

Contents: See outer packaging or the pharmacy label for contents i.e. the number of tablets.

Marketing Authorisation Holder and Manufacturer

The product licence holder and company responsible for manufacture is Teva UK Limited, Brampton Rd, Hampden Park, Eastbourne, E. Sussex BN22 9AG England.

This leaflet only gives a brief outline of some of the more important points about Fyris Tablets. If you want to know more about these tablets or their effects, please ask your doctor or pharmacist.

This leaflet was last revised: March 2014 PL 00289/0294-0295

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