ACICLOVIR TABLETS BP 400MG

Active substance: ACICLOVIR

View full screen / Print PDF » Download PDF ⇩

Transcript
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

REG0124438

Version 0.2

Approved

Page 1 of 6




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

REG0124438

Version 0.2

Approved

Page 2 of 6

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

REG0124438

Version 0.2

Approved

Page 3 of 6

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.

REG0124438

Version 0.2

Approved

Page 4 of 6

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

REG0124438

Version 0.2

Approved

Page 5 of 6

Expand view ⇕

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.

Hide
(web2)