Summary of medicine characteristics - DIBENYLINE 10 MG CAPSULES, PHENOXYBENZAMINE 10 MG CAPSULES
1 NAME OF THE MEDICINAL PRODUCT
Dibenyline 10mg Capsules.
Phenoxybenzamine 10mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg Phenoxybenzamine hydrochloride BP.
Excipient with known effect:
Each 10mg of Phenoxybenzamine contains 179.9 mg of Lactose (see section 4.4).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules
Size no. three hard gelatin capsule with opaque body and a clear red cap, both printed with ‘P10’ in grey. The capsules are filled with a white powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Hypertensive episodes associated with Phaeochromocytoma.
4.2 Posology and method of administration
Posology
Adults: The usual starting dose is 10 mg daily. This may be increased by 10 mg daily until control of hypertensive episodes is achieved, or postural hypotension occurs. Usually the dosage required is 1–2 mg/kg body weight daily in two doses. Concomitant beta-adrenergic blockade may be necessary to control tachycardia and arrythmias notably when tumours are secreting an appreciable amount of adrenaline as well as noradrenaline.
Elderly: Use with caution: 10mg daily dose should be sufficient (see ContraIndications and Cautions below).
Paediatric population: There is little experience in children but, doses of 1 to 2 mg/kg daily have been used successfully.
Method of Administration
Oral
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Do not use in patients who have had a cerebrovascular accident; or in the recovery period (usually 3–4 weeks) after acute myocardial infarction.
4.4 Special warnings and precautions for use
Use with great caution in patients in whom a fall in blood pressure and/or tachycardia may be undesirable, such as the elderly or those with severe heart disease, congestive heart failure, cerebrovascular disease or renal damage. The mode of action should be borne in mind, if used concurrently with a-sympatho-mimetics or myocardial depressants.
Phenoxybenzamine is carcinogenic in the rat and has shown mutagenic activity in the bacterial Ames test and mouse lymphoma assay. It should only be used after very careful consideration of the risks, in patients in which alternative treatment is inappropriate.
Excipients
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
See under Special Precautions and Warnings.
4.6 Fertility, pregnancy and lactation
Pregnancy
There is little evidence of safety of Dibenyline in pregnancy and it should not be used in pregnancy unless essential.
Breast-feeding
No data available
Fertility
No data available
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Side effects are generally mild and transient but may include the following adverse reactions:
Not known (cannot be estimated from the available data)
| System organ class | Frequency | Adverse reactions |
| Nervous system disorders | Not known | dizziness |
| Eye disorders | Not known | miosis |
| Cardiac disorders | Not known | compensatory tachycardia |
| Vascular disorders | Not known | postural hypotension |
| Respiratory, thoracic and mediastinal disorders | Not known | nasal congestion |
| Gastrointestinal disorders | Not known | gastro-intestinal upset |
| Reproductive system and breast disorders | Not known | inhibition of ejaculation |
| General disorders and administration site conditions | Not known | lassitude |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
Symptoms
The main effect of overdosage is profound hypotension, which may last several hours, tachycardia and collapse.
Management
Treatment consists of the induction of vomiting and/or gastric lavage together with appropriate symptomatic and supportive measures.
Treat hypotension with plasma expanders and the ‚head down‘ position.
Noradrenaline is of little value when a-adrenergic receptors are blocked.
Adrenaline should not be used since stimulation of P-adrenergic receptors will further increase blood pressure.
5.1 Pharmacodynamic properties
Phenoxybenzamine is a non-competitive long acting alpha-adrenergic receptor antagonist, ATC code: C04AX02
5.2 Pharmacokinetic properties
Absorption
Phenoxybenzamine is incompletely absorbed from the gastrointestinal tract.
Distribution
The maximum effect is attained in about 1 hour after an intravenous dose. Following oral administration the onset of action is gradual over several hours and persists for 34 days following a single dose. The plasma half-life is about 24 hours.
Biotransformation
Phenoxybenzamine is metabolized in the liver.
Elimination
It is excreted in the urine and bile but small amounts remain in the body for several days. It has prolonged action probably owing to stable covalent bonding.
5.3
No further information of relevance.
6.1 List of excipients
Lactose
Talc
Hard Gelatin Capsules: Titanium Dioxide E171
Indigotin E132
Erythrosine E127 Edible grey ink.
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store in a dry place and protect from light.
6.5 Nature and contents of container
6.5 Nature and contents of containerPolypropylene securitainers, amber glass bottles, polythene containers and blisters. (PVC/PVDC/Aluminium foil). In packs of 30 and 100.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 12762/0224
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
28/02/1994 / 12/09/2006