SEVREDOL Film-coated tablet (2020)

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Περιεχόμενα

1. Name of the medicinal product

Sevredol tablets 10mg, 20 mg, 50 mg.

2. Qualitative and quantitative composition

Each tablet contains Morphine Sulfate 10mg, 20 mg, 50 mg. Excipient with known effect: Lactose, anhydrous. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet. 10 mg: Blue, film coated, capsule shaped, biconvex tablet, with a score line on one side. IR is marked on the left side and 10 on the right. 20 mg: Pink film coated capsule ...

4.1. Therapeutic indications

Sevredol tablets are indicated for the relief of severe pain.

4.2. Posology and method of administration

Posology Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with morphine in order to minimise the risk of addiction and ...

4.3. Contraindications

Morphine products are contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe chronic obstructive pulmonary disease Severe bronchial ...

4.4. Special warnings and precautions for use

Sevredol tablets should be administered in caution in patients with: Impaired respiratory function Respiratory depression (see below) Severe cor pulmonale Sleep apnoea CNS depressant co-administration ...

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 depressant ...

4.6. Fertility, pregnancy and lactation

Pregnancy Sevredol 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 opioid use ...

4.7. Effects on ability to drive and use machines

Treatment with Sevredol tablets may cause sedation and it is not recommended that patients drive or use machines if they experience drowsiness. This medicine can impair cognitive function and can affect ...

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 Sevredol tablets but should they occur ...

4.9. Overdose

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur. Signs of morphine ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloid ATC Code: N02A01 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 well absorbed from Sevredol tablets, however first pass metabolism does occur. Apart from the liver, metabolism also occurs in the kidney and intestinal mucosa. The major urinary metabolite ...

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

Table core Lactose (anhydrous) Pregelatinised maize starch Povidone Magnesium stearate Talc Film coat 10 mg tablet: Opadry (blue) 06B20843 containing Macrogol 400, E464, E133, E171 20mg tablet: ...

6.2. Incompatibilities

None known.

6.3. Shelf life

Three years.

6.4. Special precautions for storage

Do not store above 30°C.

6.5. Nature and contents of container

PVdC coated PVC blister packs and polypropylene containers with polyethylene lids containing 56 and 112 tablets. Medical sample packs containing up to 24 tablets are also available.

6.6. Special precautions for disposal and other handling

None.

7. Marketing authorization holder

Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW

8. Marketing authorization number(s)

PL 16950/0063 0065

9. Date of first authorization / renewal of the authorization

01/05/1999

10. Date of revision of the text

04/11/2020

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