BUCCASTEM M Buccal tablet (2019)

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Περιεχόμενα

1. Name of the medicinal product

Buccastem M Buccal Tablets.

2. Qualitative and quantitative composition

Each buccal tablet contains 3.0 mg prochlorperazine maleate. Excipients with known effect: Compressible sugar (contains sucrose) 49.493 mg.

3. Pharmaceutical form

Buccal tablet.

4.1. Therapeutic indications

For nausea and vomiting in previously diagnosed migraine, in adults aged 18 years and over.

4.2. Posology and method of administration

To be placed in the buccal cavity, high up along the top gum under the upper lip, until dissolved. Do not chew or swallow the tablet. Duration of treatment: Two days maximum. Adults aged 18 years ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Impaired liver function. Existing blood dyscrasias. Epilepsy. Parkinsons disease. Prostatic hypertrophy. Narrow ...

4.4. Special warnings and precautions for use

Only use when migraine has previously been diagnosed by a doctor. Buccastem M tablets should be avoided in patients with stroke risk factors and myasthenia gravis. Agranulocytosis has been reported with ...

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

Alcohol and CNS depressants should be used with caution due to the possible additive CNS depressant effect. The mild anticholinergic effect of neuroleptics may be enhanced by other anticholinergic drugs. ...

4.6. Pregnancy and lactation

Contraindicated in pregnancy. Neonates exposed to antipsychotics (including prochlorperazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal ...

4.7. Effects on ability to drive and use machines

Patients who drive or operate machinery should be warned of the possibility of drowsiness.

4.8. Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes. Assessment of undesirable effects is based on the following frequency groupings: Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1,000 ...

4.9. Overdose

The signs and symptoms will be predominantly extrapyramidal and may be accompanied either by restlessness and agitation or central nervous depression. Hypotension may also occur. Treatment is essentially ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Phenothiazines with piperazine structure ATC code: N05AB Prochlorperazine is a member of the phenothiazine group of neuroleptics which, in doses lower than those ...

5.2. Pharmacokinetic properties

Buccastem M tablets are placed in the buccal cavity where they form a gel from which the prochlorperazine is released and absorbed. The plasma levels achieved at steady-state on a dosage regimen of one ...

5.3. Preclinical safety data

No preclinical findings of relevance have been reported.

6.1. List of excipients

Compressible sugar Povidone K30 Xanthan gum Locust bean gum Talc Magnesium stearate Riboflavin sodium phosphate

6.2. Incompatibilities

None.

6.3. Shelf life

Three years.

6.4. Special precautions for storage

Protect from light.

6.5. Nature and contents of container

250 micron PVC/PVdC aluminium foil blister packs. Pack size: Blister packs of eight tablets.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

8. Marketing authorization number(s)

PL 16853/0102

9. Date of first authorization / renewal of the authorization

16th February 2010

10. Date of revision of the text

5th December 2019

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