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Meda Health Sales

Meda Health Sales
Unit 34/35, Block A, Dunboyne Business Park, Dunboyne, Co. Meath, Dublin, Ireland
Telephone: 00 353 18026624
Fax: 00 353 18026629
Medical Information Direct Line: 00 353 1 802 6627
Medical Information e-mail: medinfo@meda.ie
Medical Information Facsimile: 00 353 1 802 6629


Summary of Product Characteristics last updated on medicines.ie: 24/02/2012
SPC Spasmonal 60mg hard capsules

Table of Contents

  • 1. NAME OF THE MEDICINAL PRODUCT
  • 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
  • 3. PHARMACEUTICAL FORM
  • 4. CLINICAL PARTICULARS
  • 4.1 Therapeutic indications
  • 4.2 Posology and method of administration
  • 4.3 Contraindications
  • 4.4 Special warnings and precautions for use
  • 4.5 Interaction with other medicinal products and other forms of interaction
  • 4.6 Pregnancy and lactation
  • 4.7 Effects on ability to drive and use machines
  • 4.8 Undesirable effects
  • 4.9 Overdose
  • 5. PHARMACOLOGICAL PROPERTIES
  • 5.1 Pharmacodynamic properties
  • 5.2 Pharmacokinetic properties
  • 5.3 Preclinical safety data
  • 6. PHARMACEUTICAL PARTICULARS
  • 6.1 List of excipient(s)
  • 6.2 Incompatibilities
  • 6.3 Shelf life
  • 6.4 Special precautions for storage
  • 6.5 Nature and contents of container
  • 6.6 Special precautions for disposal and other handling
  • 7. MARKETING AUTHORISATION HOLDER
  • 8. MARKETING AUTHORISATION NUMBER(S)
  • 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
  • 10. DATE OF REVISION OF THE TEXT


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1. NAME OF THE MEDICINAL PRODUCT

Spasmonal 60mg hard Capsules


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Spasmonal contains the following active ingredient:

Alverine Citrate 60 mg per capsule

For a full list of excipients see section 6.1


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3. PHARMACEUTICAL FORM

Hard capsules.

Hard gelatin size 3 capsules for oral administration. Each blue/grey opaque capsule is marked 'SP60'


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Spasmonal is indicated for use in the relief of smooth muscle spasm, in conditions such as irritable bowel syndrome and painful diverticular disease of the colon.


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4.2 Posology and method of administration

Recommended dose and dosage schedules:

Adults:

1 or 2 capsules one to three times daily

Elderly:

As adult dose

Children:

Below the age of 12 not recommended


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4.3 Contraindications

Cases of Paralytic ileus or known hypersensitivity to any of the ingredients.

Use during pregnancy and lactation.


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4.4 Special warnings and precautions for use

Additional warnings to be included on 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 60mg; 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 of treatment.


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4.5 Interaction with other medicinal products and other forms of interaction

None known


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4.6 Pregnancy and lactation

Use contraindicated during pregnancy and lactation


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4.7 Effects on ability to drive and use machines

None


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4.8 Undesirable effects

Possible side effects may include nausea, headache, dizziness, itching, rash, and allergic reactions, including anaphylaxis.

There have been isolated cases of jaundice due to hepatitis, which may have been immune-mediated; but this adverse reaction resolved on cessation of alverine treatment.


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4.9 Overdose

Can produce hypotension and atropine-like toxic effects. Management is as for atropine poisoning with supportive therapy for hypotension


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Alverine citrate is a spasmolytic effective on smooth muscle of the alimentary tract. It is non-specific in that it is equally effective in reducing muscular contractions induced by acetylcholine, histamine or 5-hydroxytryptamine. It acts selectively on gut and uterine muscle, only affecting the heart, blood vessels and tracheal muscle at considerable higher doses.


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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 1½ hours after oral dosing.


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5.3 Preclinical safety data

Preclinical studies provide evidence that alverine citrate has no significant systemic toxicity potential at the proposed dosage.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Maize Starch

Magnesium Stearate

Capsule shell

Gelatin

Indigo Carmine (El32)

Titanium Dioxide (El71)

Black Iron Oxide (E172)


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6.2 Incompatibilities

Not applicable


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6.3 Shelf life

3 years


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6.4 Special precautions for storage

Do not store above 25°C.

Store in the original container, in order to protect from light.


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6.5 Nature and contents of container

Cartons of Aluminium foil/UPVC/PVDC blister packs containing 3 or 100 capsules.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

No special requirements


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7. MARKETING AUTHORISATION HOLDER

Meda Health Sales Ireland Limited

Unit 34/35, Block A,

Dunboyne Business Park,

Dunboyne

Co. Meath


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8. MARKETING AUTHORISATION NUMBER(S)

PA 1332/41/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18th October 1993

Date of last renewal: 18th October 2008


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10. DATE OF REVISION OF THE TEXT

February 2012



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Active Ingredients

 
   Alverine Citrate

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