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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
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Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Serc-8mg (2012)

Εκδότης

Εκδότης Abbott Healthcare Products Limited
Διεύθυνση Mansbridge Road, West End, Southampton, SO18 3JD
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Περιεχόμενα

Name of the medicinal product

Serc®-8 or Betahistine Tablets 8 mg.

Qualitative and quantitative composition

Each tablet contains 8 mg betahistine dihydrochloride.

Pharmaceutical form

A round, flat, white to almost white tablet. Serc-8 is imprinted 256 on one face of the tablet. Betahistine ...

Therapeutic indications

Vertigo, tinnitus and hearing loss associated with Ménières syndrome.

Posology and method of administration

Adults (including the elderly): initially two tablets three times daily taken preferably with meals. ...

Contraindications

Phaeochromocytoma. Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance ...

Interaction with other medicinal products and other forms of interaction

No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of betahistine in pregnant women. Animal studies are ...

Effects on ability to drive and use machines

Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as ...

Undesirable effects

The following undesirable effects have been experienced with the below indicated frequencies in betahistine-treated ...

Overdose

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses ...

Pharmacodynamic properties

The active ingredient is a specific histamine agonist with virtually no H2-activity. It appears to act ...

Pharmacokinetic properties

Betahistine is rapidly and completely absorbed after oral administration of the drug in tablets. It is ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included ...

List of excipients

Microcrystalline cellulose Mannitol Citric acid monohydrate Colloidal anhydrous silica Talc

Incompatibilities

None.

Shelf life

5 years.

Special precautions for storage

Do not store above 25°C. Store in the original package.

Nature and contents of container

Blister strips of 15 tablets. The blister strips are made of PVC/PVdC film and aluminium foil. Each carton ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Abbott Healthcare Products Limited Mansbridge Road West End Southampton SO18 3JD

Marketing authorization number(s)

PL 00512/0076

Date of first authorization / renewal of the authorization

7 October 98

Date of revision of the text

August 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.