IBUGEL Gel (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Ibugel.

2. Qualitative and quantitative composition

Ibuprofen 5.0% w/w. Excipients with known effect: 1g of cream contains 20 mg of propylene glycol (E1520). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Gel. Non-greasy, fragrance-free, clear aqueous-alcoholic gel.

4.1. Therapeutic indications

For the topical treatment of rheumatic and muscular pain, sprains, strains, backache and neuralgia. Ibugel is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.

4.2. Posology and method of administration

Apply the gel to the affected areas, up to three times daily, or as directed by the physician. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the ...

4.3. Contraindications

Not to be used in cases of sensitivity to any of the ingredients, particularly if asthmatic or suffer from allergic disease, and have previously shown hypersensitivity to aspirin, ibuprofen or related ...

4.4. Special warnings and precautions for use

Seek medical advice if symptoms worsen or persist. Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial ...

4.5. Interaction with other medicinal products and other forms of interaction

Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically ...

4.6. Pregnancy and lactation

Do not use during pregnancy or lactation.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Adverse drug reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 ...

4.9. Overdose

Not applicable. Any overdose with a topical presentation of ibuprofen is extremely unlikely.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use ATC code: M02AA13 Ibugel is a topical preparation which has anti-inflammatory and analgesic properties. ...

5.2. Pharmacokinetic properties

Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively, achieving high, therapeutically relevant local concentrations in underlying soft ...

5.3. Preclinical safety data

Published information on subchronic toxicity studies confirms that topically applied ibuprofen is well tolerated both locally and by the gastro-intestinal tract. Any local erythema is only mild and no ...

6.1. List of excipients

IMS Carbomer Propylene glycol (E1520) Diethylamine Purified Water

6.2. Incompatibilities

None known.

6.3. Shelf life

30 g, 50 g and 100 g containers: 36 months from the date of manufacture. 4 g containers: 18 months from the date of manufacture.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

1) Membrane sealed, epoxy resin coated, collapsible aluminium tube, fitted with a screw cap (containing 4 g, 30 g, 50 g or 100 g of product) 2) Membrane-sealed laminate tube, made of a HDPE/aluminium/Ethylene ...

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire SG4 7QR, UK

8. Marketing authorization number(s)

PL 00173/0050

9. Date of first authorization / renewal of the authorization

14 January 1991/2 September 2008 for 02 September 2007 renewal date, unlimited validity granted.

10. Date of revision of the text

28/04/2021

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