DHC CONTINUS Prolonged release tablet (2020)

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Περιεχόμενα

1. Name of the medicinal product

DHC CONTINUS 60 mg, 90 mg and 120 mg prolonged release tablets.

2. Qualitative and quantitative composition

Each 60 mg tablet contains dihydrocodeine tartrate 60 mg. Each 90 mg tablet contains dihydrocodeine tartrate 90 mg. Each 120 mg tablet contains dihydrocodeine tartrate 120 mg. Excipient with known effect: ...

3. Pharmaceutical form

Prolonged release tablet. White capsule-shaped tablet. 60 mg tablets are marked DHC 60, 90 mg tablets are marked DHC 90 and 120 mg tablets are marked DHC 120.

4.1. Therapeutic indications

For the relief of severe pain in cancer and other chronic conditions. DHC CONTINUS tablets are indicated for use in adults and children over 12 years of age.

4.2. Posology and method of administration

Posology Adults and children over 12 years 60 mg: One or two tablets 12-hourly. 90 mg and 120 mg: The usual dose is one tablet 12-hourly. Elderly Dosage should be reduced. Prior to starting ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; severe respiratory depression with hypoxia; severe chronic obstructive lung disease; severe cor pulmonale; severe ...

4.4. Special warnings and precautions for use

Dihydrocodeine should be administered with caution to the elderly or patients with: a history of opioid abuse or dependence raised intracranial pressure, intracranial lesions or head injury reduced level ...

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. Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of dihydrocodeine in pregnant women. Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in ...

4.7. Effects on ability to drive and use machines

Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery. This medicine can impair cognitive function and can affect a patients ability to drive safely. This ...

4.8. Undesirable effects

The adverse experiences listed below are classified by body system according to their incidence (common or uncommon). Common adverse drug experiences have an incidence of ≥1% and uncommon adverse drug ...

4.9. Overdose

Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloids ATC code: N02AA08 Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It acts on opioid receptors ...

5.2. Pharmacokinetic properties

Dihydrocodeine is well absorbed from the gastrointestinal tract following administration of DHC CONTINUS tablets and plasma levels are maintained throughout the twelve hour dosing interval. Like other ...

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.

6.1. List of excipients

Lactose (anhydrous) Hydroxyethylcellulose Cetostearyl Alcohol Magnesium Stearate Purified Talc Purified Water

6.2. Incompatibilities

None known.

6.3. Shelf life

Three years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

20μm hard tempered aluminium foil backed PVdC/PVC blister packs (8 or 56 tablets). Polypropylene containers with polyethylene lids (8, 56 or 250 tablets). Polyethylene containers with polypropylene lids ...

6.6. Special precautions for disposal and other handling

None stated.

7. Marketing authorization holder

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

8. Marketing authorization number(s)

PL 16950/0019 PL 16950/0020 PL 16950/0021

9. Date of first authorization / renewal of the authorization

01 September 1999

10. Date of revision of the text

13 October 2020

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