ALMIRAL Gel (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Almiral 1% gel.

2. Qualitative and quantitative composition

Each 1 g of gel contains 10 mg diclofenac sodium as diclofenac diethylamine. Excipient with known effect: propylene glycol. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Gel. Colourless, transparent, smooth, homogeneous gel with a characteristic peppermint odour.

4.1. Therapeutic indications

For local symptomatic relief of pain and inflammation in: Trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises. Localised forms of soft tissue rheumatism. It ...

4.2. Posology and method of administration

Posology Adults and children 14 years and over Almiral gel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm ...

4.3. Contraindications

Hypersensitivity to diclofenac or to any of the excipients listed in section 6.1. Patients in who attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other ...

4.4. Special warnings and precautions for use

The possibility of systemic adverse events from application of Almiral gel cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information ...

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

Since systemic absorption of diclofenac from topical application is very low, such interactions are very unlikely. However, the following interactions occur with oral forms of Almiral: Lithium and digoxin: ...

4.6. Pregnancy and lactation

Pregnancy The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the ...

4.7. Effects on ability to drive and use machines

Patients who experience dizziness or other central nervous system disturbances, including visual disturbances, while taking NSAIDs should refrain from driving or operating machinery.

4.8. Undesirable effects

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10) common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); ...

4.9. Overdose

Signs and symptoms The low systemic absorption of topical diclofenac renders overdose very unlikely. However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antiinflammatory preparations, non-steroids for topical use, Topical products for joint and muscular pain ATC code: M02AA15 Mechanism of action Diclofenac is a ...

5.2. Pharmacokinetic properties

Absorption The quantity of diclofenac absorbed through the skin is proportional to the size of the treated area, and depends on both the total dose applied and the degree of skin hydration. Absorption ...

5.3. Preclinical safety data

Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended ...

6.1. List of excipients

Propylene glycol Isopropanol Carboxypolymethylene (carbopol 940) Dipropylene glycol monomethylether Peppermint oil Purified water

6.2. Incompatibilities

None stated.

6.3. Shelf life

Two (2) years.

6.4. Special precautions for storage

Store below 25°C, in the original package.

6.5. Nature and contents of container

Lacquered aluminium tubes sealed with polypropylene screw cap of 25g, 50g and 100g gel. Polyethylene plastic jars of 250g. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

12468

9. Date of first authorization / renewal of the authorization

28.09.1989 / 08.09.2010

10. Date of revision of the text

02/08/2019

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