Iburodem 600 tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ibuprofen

Available from:

Farmalabor - Produtos Farmaceuticos

ATC code:

M01AE01

INN (International Name):

ibuprofen

Dosage:

600mg

Pharmaceutical form:

tablets film-coated

Units in package:

(20/2x10/) in blister, (30/3x10/) in blister, (60/6x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-06-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBURODEM 600, 600 MG, FILM-COATED TABLETS
Ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT HAS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others, it may harm
them, even if their symptoms are the same as yours.
- If you have any side effects, including possible side effects not
listed in this leaflet, talk
to your doctor, pharmacist or nurse. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Iburodem 600 is and what it is used for
2. What you need to know before taking Iburodem 600
3. How to take Iburodem 600
4. Possible side effects
5. How to store Iburodem 600
6. Contents of the pack and other information
1. WHAT IBURODEM 600 IS AND WHAT IT IS USED FOR
Iburodem 600 is a medicine that contains ibuprofen as active
substance. Iburodem 600
has anti-inflammatory, analgesic and antipyretic action.
Iburodem 600 is a medicinal product used in the symptomatic treatment
of the following
situations:
-
antirheumatic:
osteoarthritis;
rheumatoid
arthritis;
juvenile
rheumatoid
arthritis;
ankylosing spondylitis; extra-articular rheumatism
- analgesic: post-traumatic pain (sprains, contusions, dislocations,
fractures); post-
surgical pain (general surgery, childbirth and dental extraction);
odontalgia (toothache);
dysmenorrhoea (menstrual pain).
- antipyretic: fever (children weighing more than 30 kg and adults).
2. WHAT YOU NEED TO KNOW BEFORE TAKING IBURODEM 600
DO NOT TAKE IBURODEM 600
- if you are allergic (hypersensitive) to ibuprofen or any of the
other ingredients of this
medicine (listed in section 6)
- if you are allergic to other non-steroidal anti-inflammatory drugs
(e.g. acetylsalicylic
acid) generally used for the relief of pain, inflammation or fever.
This allergy usually
manifests itself by asthma, rhinitis, urticaria or difficulty
breathing
- if y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Iburodem 600, 600 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of ibuprofen.
Excipient(s) with known effect:
Sunset yellow FCF (E110)
-
0.45 mg
Ponceau 4R red (E124)
–
1.35 mg
Glucose – 4.20 mg
Sodium – less than 23 mg (as sodium carboxymethylcellulose and
sodium glycolate starch)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Iburodem 600 is indicated in the symptomatic treatment of the
following situations:
AS AN ANTIRHEUMATIC:
osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis,
ankylosing
spondylitis, extra-articular rheumatism.
AS AN ANALGESIC
: post-traumatic pain (sprains, contusions, dislocations, fractures),
post-surgical
pain (general surgery, episiotomy, dental extraction), toothache,
dysmenorrhoea.
AS AN ANTIPYRETIC
: fever (children weighing over 30 kg and adults).
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose varies according to individual patients, age and
clinical condition.
ADULTS
Usual doses in the adult:1200-1800 mg/day (2 to 3 tablets/day),
administered every 12 h or every 8
h.
There are clinical conditions where higher doses may be required.
However, the maximum dose
should not exceed 2400mg/day (4 tablets/day), administered every 6h.
PAEDIATRIC POPULATION
Iburodem 600 should not be used in children younger than 12.
FOR ORAL USE.
Iburodem 600 should be preferably taken after meals.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest period of
time required to control symptoms (see section 4.4.).
4.3. CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
mentioned in section 6.1;
- Patients with a history of asthma, rhinitis, urticaria,
angioneurotic oedema or bronchospasm
associated with the use of acetylsalicylic acid or other non-steroidal
anti-inflammato