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Abbott Healthcare Products Limited
Mansbridge Road, West End, Southampton, SO18 3JD
Telephone: +44 (0)2380 467 000
Fax: +44 (0)2380 465 350
Medical Information Direct Line: +44 (0)2380 467 000
Medical Information e-mail: medinfo.shl@abbott.com
Medical Information Fax: +44 (0)2380 474518

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/05/2012
SPC Serc-8mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   22-May-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changed From:

4.5       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 P450 enzymes is expected.

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

 

Changed To:

 

4.5       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 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.

Updated on 21/05/2012 and displayed until 23/05/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-May-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changed From:

4.2       Posology and method of administration

            Adults (including the elderly):  initially two tablets three times daily taken preferably with meals.  Maintenance doses are generally in the range 24-48 mg daily.

           Children:  No dosage recommendations.

Changed To:

4.2       Posology and method of administration

            Adults (including the elderly):  initially two tablets three times daily taken preferably with meals.  Maintenance doses are generally in the range 24-48 mg daily.

            Paediatric population: not recommended for use in children below 18 years due to insufficient data on safety and efficacy.

 
Updated on 12/04/2011 and displayed until 21/05/2012
Reasons for adding or updating:
  • Company name change or merger
  • Change to MA holder contact details
Date of revision of text on the SPC:   28-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 7.  The Marketing Authorisation Holder has changed name from Solvay Healthcare Limited to Abbott Healthcare Products Ltd
Updated on 06/08/2009 and displayed until 12/04/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8:

 

Changed from:

 

Relatively few side effects have been reported.  They include gastro-intestinal upset, (including dyspepsia), headache, skin rash and pruritus.

 

 

To:

 

The following undesirable effects have been experienced with the below indicated frequencies in betahistine-treated patients in placebo-controlled clinical trials [very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000)].

 

Gastrointestinal disorders

Common: nausea and dyspepsia

 

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 have been reported.

 

Gastrointestinal disorders

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

 

Nervous System disorders

Headache

 

Skin and subcutaneous tissue disorders

Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.
Updated on 02/06/2009 and displayed until 06/08/2009
Reasons for adding or updating:
  • 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 4.9 - Overdose
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following sections of the SPC have been updated.

Section 4.3

Changes from:

Phaeochromocytoma.
Hypersensitivity to any component of the product.

To:

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


Section 4.4

Changes from:

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.

To:

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. These patients need to be carefully monitored during the therapy.


Section 4.5

Changes from:

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


To:

No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.
Although an antagonism between Serc and antihistamines could be expected on a theoretical basis, no such interactions have been reported.





Section 4.6

Changes from:

High dosage animal tests have shown no teratogenic properties, but the usual precautions should be observed when administering Serc to patients during pregnancy.


To:

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.



Section 4.7

Change from:

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

To:

Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.


Section 4.9

Changes from:

A few overdose cases have been reported. In most cases no overdose symptoms were reported. Two patients experienced transient mild to moderate symptoms (dry mouth, abdominal pain, somnolence and nausea) at doses of 200 mg or above. At a dose of 728 mg a convulsion was reported. In all cases recovery was complete. Treatment of overdose should include standard supportive measures.



To:

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (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 26/10/2006 and displayed until 02/06/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

New

Serc-16: Tablet 

A round, biconvex, scored, white to almost white tablets imprinted '267' on one face and ‘ ' on the reverse.

 

Old

Serc-16:  A round, flat, white to almost white tablet imprinted ‘267’ on one face and ‘ ’ on the reverse.
Updated on 28/05/2004 and displayed until 26/10/2006
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Updated on 14/09/2001 and displayed until 28/05/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 12/07/2001 and displayed until 14/09/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 20/03/2000 and displayed until 12/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  betahistine dihydrochloride