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SERC

Information leaflet

                                                    Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Serc 8mg Tablets

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains 8 mg betahistine dihydrochloride.

 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Tablet
 A white to almost white, round, flat tablet, imprinted ‘256’ on one face.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.

 4.2 Posology and method of administration

 The usual daily dose is 8 to 16 mg, three times daily taken preferably with meals.

 4.3 Contraindications

      Hypersensitivity to any component of the product.
      Use in phaeochromocytoma.
      Use concurrently with antihistamines.
      Use in children.

 4.4 Special warnings and precautions for use

 Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to Serc in bronchial
 asthma patients has been shown in a relatively few patients and therefore caution should be exercised when
 administering betahistine to patients with bronchial asthma.

 4.5 Interaction with other medicinal products and other forms of interaction

 Although an antagonism between Serc and antihistamines could be expected on a theoretical basis, no such interactions
 have been reported.

 4.6 Fertility, pregnancy and lactation

 Betahistine should only be used in pregnancy if considered essential by the physician.




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Date Printed 25/10/2011                               CRN 2107201                                         page number: 1
                                                    Irish Medicines Board




 4.7 Effects on ability to drive and use machines

 It has been shown that at over 4 times the recommended daily dose, betahistine does not affect driving or psychomotor
 ability.

 4.8 Undesirable effects

 Gastrointestinal disorders
 In some cases mild gastric complaints have been observed. These can normally be dealt with by taking the dose during
 meals or by lowering the dose.

 Nervous system disorders
 In some cases headaches have been reported.

 Skin and subcutaneous tissue disorders
 In very rare cases cutaneous hypersensitivity reactions have been reported, in particular rash, puritus and urticaria.

 4.9 Overdose

 A few overdose cases have been reported. In most cases no overdose symptoms were reported. Some patients
 experienced mild to moderate symptoms at doses above 200 mg. At a dose of 728 mg a convulsion was reported. In all
 cases recovery was complete. Treatment of overdose should include standard supportive measures.

 5 PHARMACOLOGICAL PROPERTIES

 5.1 Pharmacodynamic properties

 The mechanism of action of betahistine is not known. Pharmacological testing in animals has shown that the blood
 circulation in the striae vascularis of the inner ear improves, probably by means of a relaxation of the precapillary
 sphincters of the microcirculation of the inner ear.

 In pharmacological studies, betahistine was found to have weak H1 receptor agonistic and considerable H3 antagonistic
 properties in the CNS and autonomic nervous system. Betahistine was also found to have a dose-dependent inhibiting
 effect on spike generation of neurons in lateral and medial vestibular nuclei. The importance of this observation in the
 action against Ménière's syndrome or vestibular vertigo, however, remains unclear.

 5.2 Pharmacokinetic properties

 Betahistine dihydrochloride is completely absorbed after oral administration. Only one metabolite 2-pyridylacetic acid,
 which is excreted in the urine, is known.

 5.3 Preclinical safety data

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




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Date Printed 25/10/2011                               CRN 2107201                                         page number: 2
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