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Active substance(s): TINIDAZOLE

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Version: 3
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Préparé par : Fanny BOUVIER
Date: 11/08/2014
Text only is subject to market approval.

Patient Information Leaflet


500mg Tablets

Read all of this leaflet carefully before you
start taking this medicine.

In this leaflet:
1 What Fasigyn is and what it is used for
2 Before you take Fasigyn
3 How to take Fasigyn
4 Possible side effects
5 How to store Fasigyn
6 Further information

Fasigyn 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
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 Fasigyn.

2. Before you take Fasigyn
Do not take Fasigyn 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 are in the first 13 weeks of pregnancy or
trying to become pregnant.
• you are breast feeding.
• you have a blood disorder or a history of blood
• you have central nervous system (CNS) disease,
including epilepsy.

Taking other medicines with Fasigyn

You should always 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.

Check with your doctor or pharmacist if you are
not sure.
Take Fasigyn 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.

Taking Fasigyn with food or drink

For bacterial infections, Fasigyn 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 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:

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


You should not take Fasigyn 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 or any other medicine.


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

Driving and using machines.

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

3. How to take Fasigyn
Always take your tablets exactly as your doctor has
told you and as written on the label on the pack.

Children under 12 years

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.
Treatment with the three medicines together will
usually be for 1 week.

• 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 tell your doctor or pharmacist.

1. What Fasigyn is and what it is used for

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.


You will find more about FASIGYN on the back of this leaflet

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
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 than you should

If you take too much Fasigyn tell your doctor or
contact your nearest hospital casualty department
immediately. Take any remaining tablets with you.

If you forget to take Fasigyn

If you forget to take Fasigyn 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

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

4. Possible side effects
Like all medicines Fasigyn may cause 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, rash or
itching (especially affecting the whole body).
The following side effects are rare with Fasigyn and
you should contact your doctor as soon as possible
if any of the following occurs:
• dizziness or vertigo
• numbness, tingling, pain or weakness in hands or feet
• clumsiness or unsteadiness
• fits or seizures
fever or chills and painful ulcers in the mouth or

bottom (rectum)

• sore or swollen mouth
• redness of the face or neck.
The most common side effects that occur in people
taking Fasigyn 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 or tiredness
• furry tongue or unpleasant metallic taste
• dark urine
Fasigyn can sometimes cause a temporary reduction
in white blood cells which does not usually give you
any symptoms.

If any of the side effects gets serious or
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

6. Further information
What Fasigyn contains

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

What Fasigyn looks like and contents of the pack
Fasigyn tablets are round and white with FAS 500
printed on one side. The tablets come in blister
packs of 16.

Marketing Authorisation Holder

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


Fareva Amboise, Zone Industrielle, 29 route des
Industries, 37530 Pocé-sur-Cisse, France
This leaflet was last approved in 10/2014
© Pfizer Limited
Ref: FA6_0

5. How to store Fasigyn
Keep all medicines out of the reach and sight of
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.
Do not store above 25°C. Store in the original
package to protect from light.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help to protect the environment.


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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.