ADVIL LIQUI-GELS 200

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IBUPROFEN

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

M01AE01

Pharmaceutical form:

CAPSULES LIQUID FILLED

Composition:

IBUPROFEN 200 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

FAREVA RICHMOND INC, USA

Therapeutic group:

IBUPROFEN

Therapeutic area:

IBUPROFEN

Therapeutic indications:

For the relief of pain associated with headache, toothache, backache, muscular and menstrual pains. Antipyretic. Antiinflammatory for rheumatic diseases.For the treatment of pain assosiated with migraine.

Authorization date:

2014-07-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) –
1986
This medicine is dispensed without a doctor's prescription
ADVIL LIQUI-GELS 200
Liquid Filled Capsules
ACTIVE INGREDIENT – each capsule contains: Ibuprofen 200 mg
Inactive ingredients and allergens: see section 6 “Additional
information” and section 2 “Before using the
medicine" under subsection "Important information about some of the
ingredients of the medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise information about
the medicine. If you have any other questions, refer to the doctor or
the pharmacist.
Take the preparation according to the instructions in the dosage
section of this leaflet. Consult the pharmacist if
you need more information. Refer to the doctor if signs of the ailment
(symptoms) worsen or do not improve
within 10 days in adults and within 3 days in adolescents (12-18
years).
1. WHAT IS THE MEDICINE INTENDED FOR?
For the relief of pain associated with headache, toothache, back pain,
muscle pain and menstrual pain.
For the reduction of fever.
Anti-inflammatory in rheumatic diseases.
For the treatment of migraine-related pain.
THERAPEUTIC CLASS: Ibuprofen belongs to a class of medicines called
non-steroidal anti-inflammatory drugs
(NSAID), that work by relieving pain and reducing inflammation,
swelling and fever.
2. BEFORE USING THE MEDICINE
X DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to ibuprofen, or to any of the other
ingredients this medicine contains (see
section 6).
•
You are sensitive (allergic) to aspirin, or have narrowing of the
airways, asthma, rhinitis, angioedema or
urticaria associated with the use of medicines from the class of
non-steroidal anti-inflammatory drugs
(NSAIDs).
•
You have a stomach ulcer or stomach bleeding or you have had two or
more incidents of stomach ulcers
or bleeding in the past. You have suffered in the past from intestinal
bleeding or perforation because of
treatment with this medicine

Summary of Product characteristics

1
1. NAME OF THE MEDICINAL PRODUCT
ADVIL LIQUI-GELS 200_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg Ibuprofen.
Excipients: sorbitol, lecithin blend
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Liquid filled (Liqui-gels) green and soft capsules with the word
'Advil' printed on one side of each capsule
in white ink.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of pain associated with headache, toothache, backache,
muscular and menstrual pains.
Antipyretic. Anti-inflammatory for rheumatic diseases. For the
treatment of pain associated with
migraine.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
For all indications:
Adults, older people and children and adolescents between 12-18 years
of age:
If in children or adolescents between 12 -18 years of age, this
medicinal product is required for more
than 3 days, or if symptoms worsen, a doctor should be consulted.
For adults aged 18 years or older, the lowest effective dose should be
used for the shortest duration
necessary to relieve symptoms and minimise undesirable effects (see
section 4.4). The patient should
consult a doctor if symptoms persist or worsen, or if the product is
required for more than 10 days.
1 or 2 capsules up to three times per day as required. The respective
dosing interval should be chosen
in line with the observed symptoms and the maximum recommended daily
dose. Doses should be given
approximately every 6-8 hours, with a minimum interval of 4 hours
between each dose. A total dose of
1200 mg of ibuprofen (6 capsules) should not be exceeded in any 24
hour period. The capsules should
be taken with water.
Not to be used for children under 12 years of age.
4.3.
CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the excipients listed in
section 6.1.
Use in patients hypersensitive to aspirin or with bronchospasm,
asthma, rhinitis, angioedema or urticaria
associated with non-steroidal anti-inflammatory drugs (NSAIDs).
Ibupro