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FASIGYN 500MG FILM-COATED TABLETS

Active substance(s): TINIDAZOLE

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NOIR
PMS 277 U
PMS 541 U



Package leaflet:
Information for the user

Fasigyn® 500mg
film-coated
tablets
Tinidazole
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. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
• If you get any side effects, talk
to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See
section 4.

What is in this leaflet:

1 What Fasigyn 500mg film-coated
tablets is and what it is used for
2 What you need to know before you
take Fasigyn 500mg film-coated
tablets
3 How to take Fasigyn 500mg filmcoated tablets
4 Possible side effects
5 How to store Fasigyn 500mg filmcoated tablets
6 Contents of the pack and other
information

1. What Fasigyn 500mg filmcoated tablets is and what
it is used for
Fasigyn 500mg film-coated tablets contain
500mg of the active substance tinidazole.
This medicine is an anti-infective agent.
It is used to treat a variety of bacterial
infections including:
• infections of the skin, blood, chest, lung,
genitals or womb lining.
• an infection associated with stomach
ulcers in combination with other drugs.
• infections caused by organisms called
protozoa, such as amoebiasis and
giardiasis (stomach infections) and
trichomoniasis (a genital infection).
• vaginal infections (vaginitis) and gum
infections (gingivitis).
It is also used before certain surgical
operations to prevent bacterial infections
developing.
You should ask your doctor if you are
unsure why you have been given this
medicine.

2. What you need to know
before you take Fasigyn
500mg film-coated tablets
Do not take Fasigyn 500mg filmcoated tablets if:
• you are allergic (hypersensitive) to
tinidazole or any similar drugs or to any
of the other ingredients listed in section
6. An allergic reaction could cause
itching, a skin rash or wheezing.
• you have a blood disorder or a history of
blood disorders
• you have central nervous system (CNS)
disease, including epilepsy
• you are in the first 13 weeks of
pregnancy or trying to become pregnant
or you are breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse,
if during therapy with Fasigyn 500mg
film-coated tablets abnormal neurological
signs develop (such as, dizziness, vertigo,
difficulty in controlling movements) as you
may be told to stop your treatment.

Other medicines and Fasigyn
500mg film-coated tablets

Tell your doctor if you are taking or have
recently taken any other medicines
including those obtained without a
prescription.
You should tell your doctor if you are
currently taking blood thinners such as
warfarin to prevent blood clots as your
doctor may wish to monitor you more
closely.

Fasigyn 500mg film-coated
tablets with food and drink

You should not drink wine, beer or spirits
during treatment and for 3 days after
stopping treatment with this medicine.
The combination may cause flushing,
stomach cramps, vomiting (being sick)
and palpitations (pounding heart).

Pregnancy

You should not take this medicine if you
are in the first 13 weeks of pregnancy or
are trying to become pregnant. Always
ask your doctor or pharmacist for advice
before taking Fasigyn 500mg film-coated
tablets or any other medicine.

Breast-feeding

You should not take this medicine if you
are breast feeding as small amounts can
pass into your milk. If you stop breastfeeding during treatment you should
not start again until at least 3 days after
stopping Fasigyn 500mg film-coated
tablets.

Driving and using machines

Do not drive or use machinery if this
medicine makes you feel drowsy or
gives you problems with co-ordination or
sensation (e.g. numbness or weakness).

3. How to take Fasigyn 500mg
film-coated tablets
Always take this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Take Fasigyn 500mg film-coated tablets
with a glass of water during or after a meal.
Swallow the tablets whole. It is best to
take the medicine at the same time each
day.

Use in children under 12 years

For bacterial infections, this medicine is
not recommended for use in children less
than 12 years as it has not been tested in
this age group.
For protozoal infections, Fasigyn 500mg
film-coated tablets can be used in children
and has not been shown to cause any
different side effects or more problems
than it does in adults.
The dose and length of treatment depends
upon the infection being treated. If you are
on dialysis, your doctor may prescribe a
different dose.
The doses most commonly used for the
different infections are shown in the table
below:

For treating the infection
associated with stomach ulcers

The usual dose is 1 tablet (500mg) taken
twice a day. Your doctor will probably
prescribe two other medicines to be taken
with Fasigyn 500mg film-coated tablets.
Treatment with the three medicines
together will usually be for 1 week.

For treating most bacterial
infections

The usual dose is 4 tablets (2g) on the first
day then 2 tablets (1g) once a day or 1 tablet
(500mg) twice a day.
The usual length of treatment is 5 to 6 days.

For treating bacterial vaginitis
(a vaginal infection) and acute
ulcerative gingivitis
(a gum infection)

The usual dose is 4 tablets (2g) given as a
single dose.
For vaginitis you may be given 4 tablets (2g)
on two consecutive days.

For preventing bacterial infections
after surgery
Usually 4 tablets (2g) are given as a single
dose about 12 hours before surgery.

For treating protozoal infections

For treating intestinal amoebiasis (a stomach
infection)
Adult The usual dose is 4 tablets (2g) once a
day for 2 to 3 days.
Child The usual dose is 50 to 60mg/kg of
body weight once a day for 3 days.

For treating amoebic involvement
of the liver (a liver infection)

Adult The usual dose is 3 to 4 tablets (1.5 to
2g) once a day for 3 to 6 days.
Child The usual dose is 50 to 60mg/kg of
body weight once a day for 5 days.

For treating giardiasis (an
abdominal infection) and
trichomoniasis (an infection of the
sex organs in males and females)

Adult The usual dose is 4 tablets (2g) given
as a single dose.
Child The usual dose is 50 to-75mg/kg of
body weight given as a single dose.
Your doctor will calculate the dose required
for a child and may repeat the dose once if the
infection has not cleared up completely.

If you take more Fasigyn 500mg
film-coated tablets than you should
If you take too much of this medicine tell
your doctor or contact your nearest hospital
casualty department immediately. Take any
remaining tablets with you.

If you forget to take Fasigyn 500mg
film-coated tablets
If you forget to take this medicine take it as
soon as you can. Take your next dose at the
right time. Do not take a double dose to make
up for a forgotten dose.

If you stop taking Fasigyn 500mg
film-coated tablets

If you stop taking this medicine too soon,
the infection may return. Take this medicine
for the full time of treatment, even when you
begin to feel better.
If you have any further questions about the
use of this medicine, ask your doctor or
pharmacist for advice.

4. Possible side effects
Like all medicines, this medicine causes side
effects, although not everybody gets them.
Tell your doctor immediately if you
experience any of the following symptoms
after taking this medicine.
Although they are very rare, the symptoms
can be severe.
• sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips or tongue
• fits or seizures
The common side effects (that may affect
up to 1 in 10 people) are listed below. These
may go away during treatment as your body
adjusts to the medicine. Tell your doctor if any
of these side effects continue to bother you.
• nausea (feeling sick) or vomiting, loss
of appetite, diarrhoea, stomach pain or
cramps
• headache

• vertigo (See section 2 ‘Warnings and
precautions’)
• skin rash or itching (especially affecting the
whole body).
The frequency of the following side effects
is not known (cannot be estimated from the
available data). You should contact your
doctor if you notice any of the following:
• numbness, tingling, pain or weakness in
hands or feet
• clumsiness or unsteadiness
• fever or chills and painful ulcers in the
mouth
• sore or swollen mouth/tongue
• redness of the face or neck
• dizziness
• tiredness
• dark urine
• tongue discolouration or unpleasant
metallic taste.
Fasigyn 500mg film-coated tablets can
sometimes cause a temporary reduction in
white blood cells which does not usually give
you any symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor
or pharmacist. 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 Fasigyn 500mg
film-coated tablets
Keep all medicines out of the sight and reach
of children.
Do not take this medicine after the expiry date
stamped on the pack after EXP. The expiry
date refers to the last day of that month.
Store below 25ºC in a dry place. Store in the
original package to protect from light and
moisture.
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 Fasigyn 500mg film-coated
tablets contains

The active substance is tinidazole. Each
tablet contains 500mg of tinidazole.
The other ingredients are: alginic acid,
hydroxypropyl methylcellulose, magnesium
stearate, maize starch, microcrystalline
cellulose, propylene glycol, sodium lauryl
sulfate and titanium dioxide (E171).

What Fasigyn 500mg film-coated
tablets look like and contents of
the pack

Fasigyn 500mg film-coated tablets are white,
round and biconvex with FAS 500 embossed
on one side. The tablets come in blister packs
of 16.

Marketing Authorisation Holder

Pfizer Ltd, Ramsgate Rd, Sandwich, Kent,
CT13 9NJ, UK

Manufacturer

Fareva Amboise, Zone Industrielle, 29 route
des Industries, 37530 Pocé-sur-Cisse, France
This leaflet was last revised in: 04/2016
Ref: UK FA 8_1

mock-up from
8814503

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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.

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