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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

Mundipharma Pharmaceuticals Limited  - Formerly Napp Laboratories
Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Fax: +353 1 294 5104
Medical Information e-mail: info@mundipharma.ie


Summary of Product Characteristics last updated on medicines.ie: 18/01/2011
SPC Codalax Suspension and Codalax Forte Suspension

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
  • Administrative Data
  • 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

CODALAX® 200 mg/25 mg per 5 ml suspension

CODALAX® forte 1000 mg/75 mg per 5 ml suspension


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

5 ml of CODALAX suspension contains 200 mg Poloxamer 188 and 25 mg Dantron.

5 ml of CODALAX forte suspension contains 1000 mg Poloxamer 188 and 75 mg Dantron.

Excipients: Each 5 ml also contains 1000 mg sorbitol liquid (non-crystallising), 0.2 ml 96% ethanol and 10 mg Nipasept sodium containing sodium ethyl, methyl and propyl parahydroxybenzoates (E215, E219 and E217)

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Oral suspension

Orange-yellow coloured oral suspension, with an odour of peach and a sweet taste.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Use only in the treatment of analgesic induced constipation in the terminally ill patient.


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4.2 Posology and method of administration

Codalax Suspension

Oral

Adults

One or two 5 ml spoonfuls daily

Children

Half to one 5 ml spoonfuls daily

Codalax Forte Suspension

Oral

Adults and Elderly

One 5 ml spoonful at bedtime

Children

Not recommended for children under twelve years of age.


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4.3 Contraindications

1. In common with other gastro-intestinal evacuants, CODALAX and CODALAX forte suspensions should not be given when acute or painful conditions of the abdomen are present or when the cause of constipation is suspected to be intestinal obstruction.

2. Pregnancy.

3. Hypersensitivity to any of the constituents of the product.


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4.4 Special warnings and precautions for use

1. Oral administration of dantron has been reported to cause intestinal tumours in rats and mice. It has also been reported to be hepatocarcinogenic in rats as well as in mice. There is no sound evidence to conclude a no effect dose and therefore there may be a risk of such effects in humans.

2. In babies, children and patients wearing nappies, there may be staining of the buttocks. This may lead to superficial sloughing of the skin. Therefore, CODALAX and CODALAX forte suspensions should not be given to infants in nappies, and used with caution in all incontinent patients.

3. Patients with rare hereditary problems of fructose intolerance should not take this medicine.


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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

CODALAX and CODALAX forte suspensions should not be administered during pregnancy and lactation.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

Dantron may cause temporary harmless pink or red colouring of the urine and peri-anal skin. In prolonged high dosage, the mucosa of the large intestine may become coloured.


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4.9 Overdose

In case of overdosage patients should be given plenty of fluids. An anticholinergic agent such as atropine sulphate may be given to offset excessive intestinal motility.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Dantron, combinations

ATC code: A06 AB53

CODALAX suspensions owe their laxative action to the mild purgative dantron. This is an anthraquinone, derivative chemically related to emodin, the active principle of cascara and other naturally occurring products such as senna, aloes and rhubarb. It acts on the nerve endings of the myenteric plexus and stimulates the muscles of the large intestine.

Poloxamer 188 is a wetting agent which increases the penetration of water into faecal material. The surface activity of the poloxamer has a lubricant effect on the gut contents.


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5.2 Pharmacokinetic properties

Like other anthraquinone compounds, dantron is partially absorbed from the small intestine, where it has no action, and is carried via the circulation to the large intestine where it acts on the nerve endings of the myenteric plexus to stimulate the muscles of the large intestine. Because it does not affect the small intestine, griping and cramping do not occur. Dantron begins to act between 6 and 12 hours after administration.

Poloxamer 188, a non-ionic surfactant is not absorbed and is fully recovered in the faeces.


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5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Butyl hydroxytoluene (E321)

Sorbitol liquid (non-crystallising)

Ethanol 96%

Propylene glycol

Magnesium aluminium silicate

Peach flavour

Capsicum oleoresin (CODALAX forte suspension only)

Glyceryl mono/di-oleate

Disodium phosphate dodecahydrate

Nipasept sodium containing:

- Sodium methylparahydroxybenzoate (E219)

- Sodium ethylparahydroxybenzoate (E215)

- Sodium propylparahydroxybenzoate (E217)

Hydroxyethylcellulose (CODALAX suspension only)

Citric acid monohydrate

Potassium sorbate

Saccharin sodium

Potable water


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

Three years.


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6.4 Special precautions for storage

Do not store above 25°C. Store in the original container.


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6.5 Nature and contents of container

Amber PET bottles with child-resistant, tamper-evident closures containing 100 ml or 300 ml suspension.


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6.6 Special precautions for disposal and other handling

No special requirements.


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Administrative Data

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7. MARKETING AUTHORISATION HOLDER

Mundipharma Pharmaceuticals Limited

Millbank House

Arkle Road

Sandyford

Dublin

Ireland.


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8. MARKETING AUTHORISATION NUMBER(S)

PA 1688/3/3,4


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26 March 1993/26 March 2008


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10. DATE OF REVISION OF THE TEXT

January 2011

® The Napp device and CODALAX are Registered Trade Marks.

© Napp Pharmaceuticals Ltd, 2009



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Active Ingredients

 
   Poloxamer 188
   Dantron

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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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