SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

SPASMONAL Forte 120 mg, Hard capsules

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 120 mg alverine citrate.

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Hard capsules.

An opaque, size 1 capsule with a grey cap and blue body, marked “SP120”.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The relief of smooth muscle spasm, in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea.

4.2    Posology and method of administration

Posology

Adults and the elderly

1 capsule one to three times daily.

Children below the age of 12 years

Not recommended.

Method of administration For oral use.

4.3    Contraindications

•    Paralytic ileus

•    Intestinal obstruction

•    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Additional warnings to be included in the Patient Information Leaflet:

If this is the first time you have had these symptoms, consult your doctor before using any treatment.

If any of the following apply do not use SPASMONAL Forte 120 mg; it may not be the right treatment for you. See your doctor as soon as possible if:

-    You are aged 40 years or over

-    you have passed blood from the bowel

-    you are feeling sick or vomiting

-    you have lost your appetite or lost weight

-    you are looking pale and feeling tired

-    you are suffering from severe constipation

-    you have a fever

-    you have recently travelled abroad

-    you are or may be pregnant

-    you have abnormal vaginal bleeding or discharge

-    you have difficulty or pain passing urine.

Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies is limited.

4.7    Effects on ability to drive and use machines

May cause dizziness. Do not drive or use machinery if affected

4.8    Undesirable effects

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:

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); Not known (cannot be estimated from the available data)

The following undesirable effects were observed:

Immune system disorders

Not known anaphylaxis, allergic reaction

Nervous system disorders

Not known dizziness, headache

Respiratory, thoracic and mediastinal disorders Not known dyspnoea and/or wheezing

Gastrointestinal disorders Not known nausea

Hepatobiliary disorders

Not known jaundice due to hepatitis (typically resolves on cessation of alverine), liver function test abnormal

Skin and subcutaneous tissue disorders Not known rash, itching

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

4.9    Overdose

Symptoms:

Can produce hypotension and atropine-like toxic effects.

Management is as for atropine poisoning with supportive therapy for hypotension. Fatality has occurred following overdose with very high doses.

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Other drugs for functional gastrointestinal disorders. ATC code: A03 AX08

Alverine citrate is an antispasmodic with a direct action on smooth muscle.

Alverine citrate is a spasmolytic, which has a specific action on the smooth muscle of the alimentary tract and uterus, without affecting the heart, blood vessels and tracheal muscle at therapeutic doses.

5.2 Pharmacokinetic properties

After oral administration, alverine is rapidly converted to its primary active metabolite, which is then further converted to two secondary metabolites. There is a high renal clearance of all metabolites indicating that they are eliminated by active renal secretion. The peak plasma level of the most active metabolite occurs between 1 and 1/ hours after oral dosing. The plasma halflife averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.

5.3 Preclinical safety data

Although preclinical data are limited, those available indicate that alverine citrate has no significant potential for toxicity at the proposed dose level.

Alverine citrate acts selectively on gut and uterine muscle, only affecting the heart, blood vessels and tracheal muscle at considerably higher doses.

6.1    List of excipients

Maize starch Magnesium stearate

Capsule shell: gelatine, E132, E171, E172

Printing ink: Shellac, Black Iron Oxide (E172), Propylene Glycol

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

3 years.

6.4 Special precautions for storage

Store in a dry place. Do not store above 25°C.

6.5    Nature and contents of container

A box of aluminium foil/UPVC blister strip packs containing 2, 10, 20, 30, 60 or 90 capsules, in strips of 10 capsules as appropriate.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley

Bishop’s Stortford CM22 6PU

8    MARKETING AUTHORISATION NUMBER(S)

PL 15142/0241

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

October 1997

10 DATE OF REVISION OF THE TEXT

19/03/2015