Serc 16mg Tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company

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
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.
It is not known whether betahistine is excreted in human milk.
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.
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.
Reproduction toxicity
10. DATE OF REVISION OF THE TEXT
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 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
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
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
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
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
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
Tablet
Circular, flat, white to almost white tablets imprinted '267' on one face and ‘
10. DATE OF REVISION OF THE TEXT
June 2004
Amended
3. PHARMACEUTICAL
Tablet:
Round, biconvex, scored , white to almost white tablets imprinted '267' on one face and ‘
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

Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1