NUROFEN TABLETS 200 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IBUPROFEN

Available from:

RECKITT BENCKISER (NEAR EAST) LTD

ATC code:

M01AE01

Pharmaceutical form:

TABLETS

Composition:

IBUPROFEN 200 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD, UK

Therapeutic group:

IBUPROFEN

Therapeutic area:

IBUPROFEN

Therapeutic indications:

Relief of mild to moderate pain such as headache, toothache, menstrual pain, backache, muscular pain, anti-inflammatory for rheumatic diseases, reduction of fever.

Authorization date:

2015-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
(PREPARATIONS), 1986
This medicine is sold without a doctor's prescription.
NUROFEN
 TABLETS 200 MG
ACTIVE INGREDIENT AND ITS QUANTITY:
Ibuprofen 200 mg
For list of inactive ingredients, please see section 6. See also
section “IMPORTANT INFORMATION
ABOUT SOME OF THE INGREDIENTS OF THE MEDICINE”.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, ask your doctor or
pharmacist.
This medicine is intended for adults and children over 12 years of
age. Under this age, refer to the
doctor. Use this medicine in accordance with the dosage instructions
in this leaflet. Consult a
pharmacist if you need additional information. You must refer to a
doctor if the signs of the illness
(symptoms) worsen or do not improve after 3 days in children and
adolescents between 12 and 18
years of age, and after 10 days in adults.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Nurofen Tablets 200 mg contains ibuprofen which belongs to a group of
medicines known as non-
steroidal anti-inflammatories.
These medicines act by
altering the body's response to pain, swelling and high temperature.
Nurofen Tablets 200 mg is intended for relief of
mild to moderate pain such as headache,
toothache, menstrual pain, back and muscular pain, anti-inflammatory
for rheumatic diseases and
for fever reduction.
THERAPEUTIC GROUP: Non-steroidal anti-inflammatories (NSAIDs).
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
- You are sensitive (allergic) to ibuprofen or to any of the
additional ingredients this medicine contains
(see section 6).
- You suffer or have suffered in the past from an
ulcer/gastrointestinal bleeding (two separate confirmed
incidents or more of ulcers or bleeding).
- You have suffered from hemorrhage or perforation in the digestive
system in the past as a result of
previous treatment with non-steroidal anti-inflammatories.
- You have suffered from

Summary of Product characteristics

Page 1 of 9
PHYSICIAN'S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
NUROFEN
®
TABLETS 200mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Ibuprofen
200 mg
Excipient(s) with known effect:
Sucrose
Sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated Tablet.
A white to off-white, biconvex, round, sugar coated tablet printed
'Nurofen' in black on
one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults and children over 12 years:
Relief of mild to moderate pain such as headache, toothache, menstrual
pain, backache,
muscular pain, anti-inflammatory for rheumatic diseases, reduction of
fever.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
During short-term use, if symptoms persist or worsen the patient
should be advised to
consult a doctor.
Adults and children and adolescents between 12 and 18 years:
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4).
If in children and adolescents this medicinal product is required for
more than 3 days, or if
symptoms worsen a doctor should be consulted.
If in adults the product is required for more than 10 days, or if the
symptoms worsen the
patient should consult a doctor.
_ _
CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS:_ _
Take 1 or 2 tablets with water up to three times a day as required.
ADULTS:
Take 1 or 2 tablets with water, up to three times a day as required.
Leave at least four hours between doses.
Do not take more than 6 tablets in any 24 hour period.
Not for use by children under 12 years of age.
Page 2 of 9
4.3. CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma, rhinitis,
angioedema, or urticaria) in response to aspirin or other
non-steroidal anti-inflammatory
drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct