BONJELA Gel (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Bonjela.

2. Qualitative and quantitative composition

Active ingredient % w/w Choline salicylate* 8.714 Cetalkonium chloride 0.010 *Added as choline salicylate solution prepared from: Choline bicarbonate solution, ...

3. Pharmaceutical form

Gel.

4.1. Therapeutic indications

For the relief of pain, discomfort and inflammation caused by common mouth ulcers, cold sores, denture and sore spots, as well as mouth ulcers, and sore spots due to orthodontic devices. To help to fight ...

4.2. Posology and method of administration

By topical application to the oral mucosa. Adults and children over the age of 16: Using a clean finger massage approximately half an inch of the gel onto the sore area, not more than once every ...

4.3. Contraindications

Not to be used in children and adolescents under the age of 16. This is because there is a possible association between salicylates and Reyes syndrome when given to children. Reyes syndrome is a very rare ...

4.4. Special warnings and precautions for use

Label warnings: Do not exceed the stated dose. Consult your doctor or dentist before use if you are in the first or second trimester of pregnancy or when symptoms persist for more than seven days. Keep ...

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

Salicylates may enhance the effect of anticoagulants and inhibit the action of uricosurics.

4.6. Fertility, pregnancy and lactation

Pregnancy Salicylates and Acetylsalicylic acid: low doses (up to 100 mg/day): Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, ...

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

The list of the following adverse effects relates to those experienced with topical oral salicylates at OTC doses, in short-term use. In the treatment of chronic conditions, under long-term treatment, ...

4.9. Overdose

Salicylate toxicity can result if the stated dose is exceeded. Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations ...

5.1. Pharmacodynamic properties

Choline salicylate is the choline salt of salicylic acid and its pharmacology is essentially that of salicylic acid. It has exhibited anti-inflammatory analgesic and antipyretic actions in animal models, ...

5.2. Pharmacokinetic properties

Choline salicylate is absorbed from the gut and is likely to be absorbed across mucous membranes such as all buccal mucosa. Metabolism of salicylic acid is by glycine and phenolic or acyl glucuronate conjugation ...

5.3. Preclinical safety data

No preclinical findings of relevance to the prescriber have been reported.

6.1. List of excipients

Alcohol (96% v/v) Glycerol Levomenthol Hypromellose 4500 Star anise oil EP Sodium saccharin Purified water

6.2. Incompatibilities

None known.

6.3. Shelf life

Two years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Gel is contained in an extruded aluminium membrane tube with an internal lacquer, plastic neck insert and plastic tamper-evident closure Or In a multi-layered plastic and aluminium tube with silver plastic ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

8. Marketing authorization number(s)

PL 00063/0121

9. Date of first authorization / renewal of the authorization

21/05/2008

10. Date of revision of the text

20/11/2020

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