MST CONTINUS Prolonged release granules for oral suspension (2019)

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Περιεχόμενα

1. Name of the medicinal product

MST CONTINUS suspension 20, 30, 60, 100, 200 mg.

2. Qualitative and quantitative composition

Each sachet contains Morphine equivalent to Morphine Sulfate 20, 30, 60, 100 and 200 mg. Excipients with known effect: Ponceau 4R (E124) For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Prolonged release granules for oral suspension. Pink granules.

4.1. Therapeutic indications

For the prolonged relief of severe and intractable pain.

4.2. Posology and method of administration

Posology Adults A patient presenting with severe pain, uncontrolled by weaker opioids (e.g. dihydrocodeine) should normally be started on 30 mg 12 hourly. Patients previously on normal release oral morphine ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of excipients listed in section 6.1. Respiratory depression, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, obstructive airways ...

4.4. Special warnings and precautions for use

As with all narcotics, a reduction in dosage may be advisable in the elderly, in hypothyroidism and in patients with significantly impaired renal or hepatic function. Use with caution in patients with ...

4.5. Interaction with other medicinal products and other forms of interaction

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of the additive CNS depressant ...

4.6. Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of morphine in pregnant women. MST CONTINUS suspension is not recommended during pregnancy and labour due to the risk of neonatal respiratory ...

4.7. Effects on ability to drive and use machines

MST CONTINUS suspension may modify the patients reactions to a varying extent depending on the dosage and susceptibility. If affected, patients should not drive or operate machinery. This medicine can ...

4.8. Undesirable effects

In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness. With chronic therapy, nausea and vomiting are unusual with MST CONTINUS suspension but should ...

4.9. Overdose

Signs of morphine toxicity and overdose are drowsiness, pin-point pupils, skeletal muscle flaccidity, bradycardia, hypotension, pneumonia aspiration, respiratory depression, somnolence and central nervous ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: natural opium alkaloid ATC code: N02AA01 Morphine acts as an agonist at opiate receptors in the CNS particularly mu and to a lesser extent kappa receptors. Mu receptors ...

5.2. Pharmacokinetic properties

Morphine is bound to a cationic exchange resin and drug release is effected when morphine is displaced by ions in the gastrointestinal tract. Morphine is well absorbed and adequate plasma morphine levels ...

5.3. Preclinical safety data

In male rats, reduced fertility and chromosomal damage in gametes have been reported. There are no other pre-clinical data of relevance to the prescriber which are additional to that already included in ...

6.1. List of excipients

Dowex 50WX8 100-200 mesh cationic exchange resin Xylitol Xanthan gum Raspberry flavour Ponceau 4R (E124)

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Pack type: surlyn lined, laminated aluminium foil sachets coated with polyethylene and clay coated Kraft paper. Pack size: Boxboard cartons of 10, 20, 30, 60 sachets or medical sample packs ...

6.6. Special precautions for disposal and other handling

The contents of the sachet should be added to water or sprinkled onto soft food, e.g. yoghurt (see 4.2 Posology and Method of Administration).

7. Marketing authorization holder

Napp Pharmaceuticals Ltd, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom

8. Marketing authorization number(s)

PL 16950/0030 -0034

9. Date of first authorization / renewal of the authorization

14 January 1994/19 November 2006

10. Date of revision of the text

18/01/2019

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