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Serc 16mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Betahistine Dihydrochloride

    *Additional information is available within the SPC or upon request to the company

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Updated on 27 November 2023

File name

ie-pl-Serc 8mg 16mg-pr3083479-maht-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 27 November 2023

File name

ie-spc-Serc 16mg-pr3083479-maht-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 December 2022

File name

IE-SmPC-Serc 16mg-11Oct2017-CRN2190789-clean.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 November 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 16 mg betahistine dihydrochloride, equivalent to 10.42 mg betahistine.

4.6 Fertility, Pregnancy and lactation

Pregnancy:
There are no adequate data from the use of betahistine in pregnant women.
Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposure. As a precautionary measure, it is preferable to avoid the use of betahistine during pregnancy. Betahistine should not be used during pregnancy unless clearly necessary.

Lactation:
It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. Betahistine is excreted in rat milk. Effects seen post-partum in animal studies were limited to very high doses. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.

Fertility
Animal studies did not show effects on fertility in rats.

5.3 Preclinical safety data

Chronic toxicity
Adverse effects in the nervous system were seen in dogs and baboons after intravenous doses at and above 120 mg/kg.
Chronic oral toxicity testing for 18 months in rats at a dose of 500 mg/kg and 6 months in dogs at a dose of 25 mg/kg showed betahistine to be well tolerated with no definitive toxicities.
Studies on the chronic oral toxicity of betahistine dihydrochloride were performed in rats over a period of 18 months and in dogs over 6 months. Doses of 500 mg/kg in rats and 25 mg/kg in dogs were tolerated without changes in the clinical chemical and hematological parameters. There were no histological findings related to treatment at these dosages. After increasing the dose to 300 mg/kg, the dogs showed vomiting. In an investigational study with betahistine in rats over 6 months at 39 mg/kg and above hyperemia in some tissues was reported in the literature. Data presented in the publication are limited. Therefore, the impact of this finding in this study is not clear.

Mutagenic and carcinogenic potential
Betahistine does not have mutagenic potential.
In an 18 months chronic toxicity study in rats betahistine up to a dose of 500 mg/kg did not show any evidence for carcinogenic potential.
Special carcinogenicity studies were not performed with betahistine dihydrochloride. However, in the 18 months chronic toxicity studies in rats there was no indication of any tumors, neoplasms or hyperplasia in the histopathological examination. Therefore, betahistine dihydrochloride up to a dose of 500 mg/kg did not show any evidence for carcinogenic potential in this limited 18 months study.

Reproduction toxicity
Limited data are available for betahistine on reproduction. In a one-generation study in rats, an oral dose of 250 mg/kg/day betahistine had no adverse effect on male and female fertility, implantation of foetuses, parturition and viability of pups during lactation. No abnormalities were noted in weaned rats. In pregnant rabbits treated orally with 10 or 100 mg/kg betahistine, no adverse effects were noted on implantations, vitality or weight of foetuses, and no foetal skeletal or soft tissue abnormalities were noted. From these studies it can be concluded that betahistine has no detectable effects on relevant reproduction parameters in rat and rabbits in the described studies. Betahistine is not teratogenic. However, due to the investigational character of the studies a risk could not fully be excluded.
Effects in reproductive toxicity studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

10. DATE OF REVISION OF THE TEXT

June 2017October 2017


Updated on 05 July 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

7.  MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

BGP Products Ireland Limited

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER

 

PA 2010/16/2 2007/13/2

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 30 June 2017

File name

PIL_8655_379.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 June 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 29 September 2016

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change of distributor details

Updated on 06 September 2016

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 3: Updated to state tablet can be divided into equal doses

Section 4.2: Updated posology for adults: 8 - 16mg three times daily

Section 4.8: Update reporting of suspected adverse reactions details

Date of revision updated

Updated on 05 September 2016

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 August 2015

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 10 April 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Due to transfer of MAH (from Abbott to BGP) there was a change in section 7, 8 and 10 of the SPC

Updated on 10 April 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 24 September 2014

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Reduction in shelf life and change to storage conds

Updated on 19 September 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 10 September 2014

Reasons for updating

  • Change to MA holder contact details

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7: AHPL address change from S'hampton to Maidenhead

Updated on 04 September 2014

Reasons for updating

  • Change to further information section
  • Change to MA holder contact details

Updated on 31 March 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

 

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

 

Paediatric population:

Serc is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.

 

Geriatric population:

Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests that no dose adjustment is necessary in this patient population.

 

Renal impairment:

There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary.

 

Hepatic impairment:

There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary.

 

 

4.3       Contraindications

 

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

Use in phaeochromocytoma

 

 

4.4       Special warnings and precautions for use

 

Patients with bronchial asthma and history of peptic ulcer need to be carefully monitored during the therapy.

 

4.5              Interaction with other medicinal products and other forms of interactions

 

No in vivo interaction studies have been performed. Based on in vitro data no in vivo inhibition on Cytochrome P450 enzymes is expected.

 

In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoamino-oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly.

 

As betahistine is an analogue of histamine, interaction of betahistine with antihistamines may in theory affect the efficacy of one of these drugs.

 

 

4.6       Fertility, Pregnancy and lactation

 

Pregnancy:

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

Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Betahistine should not be used during pregnancy unless clearly necessary.

 

Lactation:

It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.

 

4.7       Effects on ability to drive and use machines

Betahistine is indicated for vertigo, tinnitus and hearing loss associated with Ménière's syndrome which can negatively affect the ability to drive and use machines.  In clinical studies specifically designed to investigate the ability to drive and use machines betahistine had no or negligible effects.

 

4.8       Undesirable effects

 

Gastrointestinal disorders

Common: nausea and dyspepsia

 

Nervous system disorders

Common: headache

 

In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.

 

Immune System disorders

Hypersensitivity reactions, e.g. anaphylaxis

 

Gastrointestinal disorders

Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating). These can normally be dealt with by taking the dose during meals or by lowering the dose.

 

Skin and subcutaneous tissue disorders

Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, rash, pruritus and urticaria.

 

 

 

4.9       Overdose

 

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to  640mg (e.g. nausea, somnolence, abdominal pain). More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs.  Treatment of overdose should include standard supportive measures.

 

Updated on 26 March 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 24 October 2011

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 3 has been amended to remove the Solvay logo from the tablet embossing.

Updated on 21 October 2011

Reasons for updating

  • Change to appearance of the medicine

Updated on 27 June 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 31 May 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 09 May 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7.  Marketing Authoristion Holder

Change from Solvay Healthcare Ltd to Abbott Healthcare Products Ltd

Updated on 21 April 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



In section 1: the product name has been updated.

 

From:

SercÒ-16 tablets

To:

Serc 16mg  Tablets

 

In section 2: has been update to QRD template.

 

From:

Each tablet contains 16 mg betahistine dihydrochloride.

For excipients, see 6.1.

 

To:

Each tablet contains 16 mg betahistine dihydrochloride.

For a full list of excipients, see section 6.1.

 

In section 6.1: E number is now included.

 

From:

Microcrystalline cellulose

Mannitol

Citric acid monohydrate

Colloidal anhydrous silica

Talc.

 

To:

 

Microcrystalline cellulose

Mannitol (E421)

Citric acid monohydrate

Colloidal anhydrous silica

Talc.

 

In section 6.5: a new sample pack size is included.

 

From:

Blister strips of 21 tablets. The blister strips are made of PVC/PVDC film with a covering aluminium foil. Each carton contains 84 tablets.

 

Sample pack: 10 or 20 tablets per carton.

 

Not all pack sizes may be marketed

 

To:

Blister strips of 21 tablets. The blister strips are made of PVC/PVDC film with a covering aluminium foil. Each carton contains 84 tablets.

 

Sample pack: 10, 20 or 84 tablets per carton.

 

Not all pack sizes may be marketed

 

Updated on 20 April 2010

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions

Updated on 16 May 2007

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Previous

 

3.         PHARMACEUTICAL FORM

 

            Tablet

            Circular, flat, white to almost white tablets imprinted '267' on one face and ‘ ' on the           reverse.

 

10.        DATE OF REVISION OF THE TEXT

 

            June 2004

 

Amended

 

3.         PHARMACEUTICAL FORM

 

            Tablet:

            Round, biconvex, scored , white to almost white tablets imprinted '267' on one face and ‘ ' on         the reverse. The score line is only to facilitate breaking for ease of swallowing and not to      divide into          equal doses.

 

10.        DATE OF REVISION OF THE TEXT

 

            May 2006

Updated on 16 May 2007

Reasons for updating

  • Change to appearance of the medicine

Updated on 26 May 2006

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 March 2006

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 September 2004

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 September 2004

Reasons for updating

  • New PIL for new product

Updated on 07 September 2004

Reasons for updating

  • Change to storage instructions

Updated on 27 June 2003

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Mylan IRE Healthcare Ltd

Mylan IRE Healthcare Ltd