MST CONTINUS Prolonged-release tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
MST CONTINUS 5 mg, 10 mg, 15 mg, 30 mg, 60 mg, 100 mg, 200 mg prolonged release tablets.
2. Qualitative and quantitative composition
Each tablet contains Morphine Sulfate 5 mg, 10 mg, 15 mg, 30 mg, 60 mg, 100 mg, 200 mg.
Excipients with known effect:
5 mg tablet also contains lactose anhydrous 95 mg.
10 mg tablet also contains ...
3. Pharmaceutical form
Prolonged-release tablet.
Film coated, biconvex tablet marked with the NAPP logo on one side and the strength of the tablet on the other.
MST CONTINUS tablets 5 mg are white
MST CONTINUS tablets 1...
4.1. Therapeutic indications
For the prolonged relief of severe and intractable pain, and for the relief of post-operative pain.
4.2. Posology and method of administration
Posology
MST CONTINUS tablets should be used at 12-hourly intervals. The dosage is dependent upon the severity of the pain, the patient's age and previous history of analgesic requirements.
Pr...
4.3. Contraindications
MST CONTINUS tablets are contraindicated in patients with:
Hypersensitivity to the active substance or to any of the constituents listed in section 6.1.
severe chronic obstructive pulmonary disease...
4.4. Special warnings and precautions for use
MST CONTINUS tablets should be administered with caution in patients with:
impaired respiratory function
respiratory depression (see below)
severe cor pulmonale
sleep apnoea
CNS depressants co-admi...
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 additive CNS depres...
4.6. Fertility, pregnancy and lactation
Pregnancy
MST CONTINUS tablets are not recommended during pregnancy and labour. Regular use in pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If o...
4.7. Effects on ability to drive and use machines
Morphine may modify the patient's reactions to a varying extent depending on the dosage and susceptibility. If affected, patients should not drive or operate machinery.
This medicine can impai...
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 tablets but should...
4.9. Overdose
Signs of morphine toxicity and overdose are pin-point pupils, skeletal muscle flaccidity, bradycardia, hypotension, respiratory depression, pneumonia aspiration, somnolence and central nervous syst...
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 receptor...
5.2. Pharmacokinetic properties
Morphine is well absorbed from MST CONTINUS tablets and, in general, peak plasma concentrations are achieved 1-5 hours following administration. The availability is complete when compared to an equ...
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 includ...
6.1. List of excipients
Tablet core:
Lactose anhydrous
Hydroxyethylcellulose
Purified water
Cetostearyl alcohol
Magnesium stearate
Purified talc
Film coat:
5 mg - Opadry Y-1-7000 white containing E171, Purified water...
6.2. Incompatibilities
None stated.
6.3. Shelf life
Five years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Aluminium foil-backed PVdC/PVC blister packs. Pack size 60 tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW
8. Marketing authorization number(s)
PL 16950/0035, PL 16950/0036, PL 16950/0037, PL 16950/0038, PL 16950/0039, PL 16950/0040, PL 16950/0041
9. Date of first authorization / renewal of the authorization
25/02/2009
10. Date of revision of the text
30/11/2020
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