Remov

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NIMESULIDE

Available from:

PIAM Farmaceutici S.p.A. Via Fieschi, 8/7 1-16124, Genoa, Italy

ATC code:

M01AX17

INN (International Name):

NIMESULIDE 100 mg

Pharmaceutical form:

GRANULES FOR ORAL SUSPENSION

Composition:

NIMESULIDE 100 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-08-04

Patient Information leaflet

Page 1 of 4
REMOV 100 MG TABLETS
REMOV 100 MG GRANULATE FOR ORAL SUSPENSION
READ THIS LEAFLET CAREFULLY BEFORE TAKING THE MEDICINE:
- Keep this leaflet. You may need to read it again.
- If you have any doubts, ask your doctor or pharmacist.
- This medicine was prescribed to you. You should not give it to
others: the medicine may be harmful to
them even if they have the same symptoms.
- If You notice the worsen of side effects or a side effect not
mentioned in this leaflet, inform the doctor or
the pharmacist
In this leaflet:
1- What Remov is and what it is used for
2- Before you take Remov
3- How to take Remov
4- Possible side effects
5- How to store Remov
6- Other information
1- WHAT REMOV IS AND WHAT IT IS USED FOR
Remov is a non-steroidal anti-inflammatory drug (NSAID), with
pain-killing properties. It is used for
treatment of acute pain, for the treatment of symptoms of painful
osteoarthritis, and for the treatment of
period pains.
Before prescribing Remov your doctor will assess the benefits this
medicine may give you against your
risks of developing side effects.
2- BEFORE YOU TAKE REMOV
DO NOT TAKE REMOV IF:
-
are hypersensitive (allergic) to nimesulide or any of the other
ingredients of Remov (see. Par. 6)
-
have had allergic reactions (e.g. wheezing, runny or blocked nose,
hives or nettle rash) after
aspirin or other non-steroidal anti-inflammatory drugs;
-
had a reaction to nimesulide affecting the liver in the past;
-
are taking other medicines that are known to affect the liver, e.g.
paracetamol or any other pain-
killers or NSAID treatment
-
are taking drugs of addiction, or have developed a habit that makes
you dependent on drugs or other
substances
-
are a regular heavy drinker (alcohol),
-
if you have liver disease or increased liver enzymes
-
have a peptic ulcer (stomach or duodenal ulcer) now or had one in the
past;
-
have had bleeding from the stomach or bowel;
-
have had bleeding into the brain (a stroke);
-
have any other problem with bleeding or any problems due to your blood
not clotting;
-

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
REMOV
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg nimesulide
Each sachet contains 100mg nimesulide
For excipients, see section 6.1
3. PHARMACEUTICAL FORM
100mg Tablets - 30 tablets
100mg Granules for oral suspension - 30 sachets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acute pain (see section 4.2.).
Symptomatic treatment of painful osteoarthritis (see section 4.2.).
Primary dysmenorrhoea.
Nimesulide should only be prescribed as second line treatment.
The decision to prescribe nimesulide should be based on an assessment
of the individual patient's overall risks (see
sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The minimum effective dose should be used for the shortest duration to
reduce the undesirable effects.
The maximum duration of a treatment course with nimesulide is 15 days.
Nimesulide-containing medicinal products should be used for the
shortest possible duration, as required by the clinical
situation.
Adults:
100mg nimesulide tablets
100mg granules bid after meal
Elderly: in elderly patients there is no need to reduce the daily
dosage (see section 5.2).
Children (< 12 years): Nimesulide containing medicinal products are
contraindicated in these patients (see also section 4.3).
Adolescents (from 12 to 18 years): on the basis of the kinetic profile
in adults and on the pharmacodynamic characteristics
of nimesulide, no dosage adjustment in these patients is necessary.
Impaired renal function: on the basis of pharmacokinetics, no dosage
adjustment is necessary in patients with mild to
moderate renal impairment (creatinine clearance of 30-80 ml/min),
while REMOV are contraindicated in case of severe
renal impairement (creatinine clearance < 30ml/min) (see sections 4.3
and 5.2).
Hepatic impairment: the use of REMOV is contraindicated in patients
with hepatic impairment (see section 5.2).
4.3 CONTRAINDICATIONS
Known hypersensitivity to nimesulide or to any of the e