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Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Telephone: +44 (0)1276 692 255
Fax: +44 (0)1276 698 449
Medical Information Direct Line: +44 (0)1276 698 370
Medical Information e-mail: medinfo.uk@novartis.com
Customer Care direct line: +44 (0)845 741 9442

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: 27/10/2011
SPC SANOMIGRAN 0.5mg Tablets

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 27/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5

The following drugs may exhibit drug interactions with pizotifen upon concomitant administration.

 

Anticipated drug interactions to be considered

 

Pizotifen is extensively metabolized in the liver, primarily by N-glucuronidation. Increased plasma concentration of pizotifen upon concomitant administration of drugs which exclusively undergo glucuronidation can not be excluded.

 

Central nervous system agents

           

            The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by SANOMIGRAN.

 

SANOMIGRAN antagonises the hypotensive effect of adrenergic neurone blockers


Section 4.8

            The most common side-effects are appetite stimulating effect, increase in body weight and drowsiness (including somnolence and fatigue).

 

Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon
(≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (< 1/10,000), including isolated reports unknown (frequency cannot be estimated from available data).

           

Immune system disorders

 

Rare:

Hypersensitivity reactions, face oedema, urticaria and rash

Metabolism and nutrition disorders

 

Very common:

Increased Aappetite stimulating effect and increase in body weight increased

Psychiatric disorders

 

Rare:

Depression, CNS stimulation (e.g. aggression, agitation), hallucination, insomnia, anxiety

Nervous system disorders

 

Common:

Sedation (including somnolence), dizziness

 

Rare:

Paraesthesia

 

Very rare:

Seizures

Gastrointestinal disorders

 

Common:

Nausea, dry mouth

 

Uncommon

Constipation

Hepatobiliary disorders

                          Unknown:                              Hepatic enzyme increased, jaundice, hepatitis*1

 

 

 

Skin and subcutaneous tissue disorders

                           Rare:                                     Urticaria, rash                 

Musculoskeletal and connective tissue disorders

 

Rare:

Unknown:

     

Myalgia, arthralgia

Muscle cramps*1

General disorders and administration site conditions

 

Common

 

Fatigue

 

 

 

*1  These adverse events were reported in patients treated with pizotifen based on post-marketing spontaneous reports.

 

Withdrawal symptoms

 

Acute withdrawal reactions have been reported following abrupt cessation of SANOMIGRAN therefore gradual withdrawal is recommended. Withdrawal symptoms include anxiety, tremors, insomnia, nausea and loss of consciousness.

 

Withdrawal reactions have been reported following abrupt cessation of pizotifen, therefore gradual withdrawal is recommended (see section 4.4 Special warnings and precautions for use). Withdrawal symptoms may include: depression, tremor, nausea, anxiety, malaise, dizziness, sleep disorder and weight decrease.
Updated on 06/09/2011 and displayed until 27/10/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to section 4.1 to include the following paragraph:-

The International Classification of Headache Disorders 2nd edition (ICHD-II) are standard classifications of headache used by health professionals and describe the above-mentioned disorders as follows: prophylactic treatment of recurrent migraine headache with or without aura and of cluster headache.

Update to section 4.2:-

Change to heading from Children (aged over 2 years) to Children and adolescents from 2 years of age.

Also addition of the following wording:-

Special populations

 

Renal and hepatic impairment

 

Caution is required in patients with renal or hepatic impairment and dosage adjustment may be necessary (see section 5.2).
Updated on 18/08/2011 and displayed until 06/09/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to Section 4.4 as follows

4.4       Special Warnings and Precautions

 

Hepatic injury has been reported, ranging from transaminase elevations to severe hepatitis.  Pizotifen treatment should be discontinued if there is any clinical evidence of hepatic dysfunction during treatment and until the cause of the liver abnormality is determined.

 

            Although the anticholinergic activity of SANOMIGRAN is relatively weak, caution is required in the presence of closed angle glaucoma and in patients with a predisposition to urinary retention.  Dosage adjustment may be necessary in patients with kidney insufficiency.

 

            Pizotifen should be used with caution in patients with a history of epilepsy.

           

            SANOMIGRAN coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-glactose malabsorption should not take SANOMIGRAN.

 

Withdrawal symptoms like depression, tremor, nausea, anxiety, malaise, dizziness, sleep disorder and weight decrease have been reported following abrupt cessation of pizotifen, therefore gradual withdrawal is recommended.


 Update to Section 4.7 first paragraphas shown

 

4.7       Effects on Ability to Drive and use Machinery

 

            Pizotifen may cause drowsiness, somnolence, and, dizziness and other CNS effects. Therefore, caution should be exercised when driving or using machines.


Update to Section 4.9 as follows

4.9       Overdose

 

Symptoms:  drowsiness, dizziness, pyrexia,  hypotension, dryness of the mouth, confusion, excitatory states (in children), ataxia, nausea, vomiting, dyspnoea, cyanosis, tachycardia, convulsions (particularly in children), coma and respiratory paralysis. 

 

Treatment: Administration of activated charcoal is recommended; in case of very recent uptake, gastric lavage may be considered. Severe hypotension must be corrected (CAVE: adrenaline may produce paradoxical effects).  If necessary, symptomatic treatment should be given including monitoring of the cardiovascular and respiratory systemssymptoms. Excitatory states or convulsions may be treated with short acting benzodiazepines.

 

 
Updated on 19/07/2011 and displayed until 18/08/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The heading for Lactation within the text has been changed to Breast-feeding.
Updated on 27/01/2010 and displayed until 19/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   13-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes as follows:

0.5mg:

Section 2- add the wording on 'For a full list of excipients, see section 6.1.' to ensure all 3 formulations have the same wording.

Section 4.3 - removal of 'Sanomigran should not be given to children under 2 years of age' as this was not on MHRA database. It had been added to our registered and customer SPCs at last BPI update in 1997, but had never been assessed or approved by MHRA

Section 4.8-  comma inserted after brackets and before dizziness in Nervous System Disorders paragraph

Section 5.1 - antimigraine drug correction to spelling of this word

Section 8.0  - add extra zero to PL number
Updated on 10/04/2007 and displayed until 27/01/2010
Reasons for adding or updating:
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SECTION 4.4:
 
"Pizotifen should be used with caution in patients with a history of epilepsy" added
 
Paragraph starting "Sanomigran coated tablets contain lactose...." added
 
SECTION 4.5:
 
"Sanomigran antagonises the hypotensive effect of adrenergic neurone blockers" added
 
SECTION 4.7:
 
Reworded and additional information added
 
SECTION 4.8:
 
Frequencies added
 
Side effects listed according to body area
 
Dizziness, seizures, myalgia, arthralgia and fatigue added
 
Paragraph on acute withdrawal reactions added
 
SECTION 5.1:
 
Pharmacotheapeutic group and ATC code added
 
SECTION 5.2:
 
All paragraphs reworded and additional information added
Updated on 20/02/2004 and displayed until 10/04/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  pizotifen hydrogen malate