SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Baratol Tablets 25 mg

Indoramin Hydrochloride 25 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Indoramin Hydrochloride 27.63mg HSE equivalent to 25mg of indoramin base.

3 PHARMACEUTICAL FORM

Blue film coated tablets with shallow convex faces. “MPL 020” imprinted on one face, “25” on the other face.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Treatment of all grades of essential hypertension and conditions for which alpha blockade is indicated.

4.2 Posology and method of administration

Route of administration

The tablet is taken orally.

Adults

50 mg - 200 mg daily.

Range:

Initial    25mg twice daily for all patients.

Dose:

Dose    The dose of Baratol should be titrated as necessary to

Titration:    control blood pressure to a maximum of 200mg daily in

two or three divided doses. The daily dose may be increased by the progressive addition of 25mg or 50mg. This may be done at intervals of two weeks. Many patients may be stabilised with doses up to 100mg daily, especially those already being treated with diuretics. When unequal doses are used, the largest dose should be given at night in order to avoid day time sedation.

Elderly

Initial    25mg twice daily.

Dose:

Clearance of indoramin may be affected in the elderly. A reduced dose and/or frequency of dosing may be sufficient for effective control of blood pressure in some elderly patients.

Children

Baratol is not recommended for children.

Combination with other anti-hypertensive agents:

The anti-hypertensive effect of Baratol is enhanced by concomitant administration of a thiazide diuretic or a P-adrenoceptor blocking drug.

When Baratol is used in combination with other anti-hypertensive agents, the dose of Baratol should be titrated in the same way as when it is used alone.

4.3 Contraindications

Baratol is contraindicated in patients: - Who are currently receiving monoamine oxidase inhibitors.

- With established heart failure.

4.4 Special warnings and precautions for use

Drowsiness is sometimes seen in the initial stages of treatment with Baratol or when dosage is increased too rapidly. Patients should be warned not to drive or operate machinery until it is established that they do not become drowsy while taking Baratol.

Incipent cardiac failure should be controlled with diuretics and digitalis before treatment with Baratol.

Caution should be observed in prescribing Baratol for patients with hepatic or renal insufficiency.

A few cases of extrapyramidal disorders have been reported in patients treated with Baratol. Caution should be observed in prescribing Baratol in patients with Parkinson’s Disease.

In animals and in the one reported overdose in humans, convulsions have occurred. Due consideration should be given and great caution exercised in the use of Baratol in patients with Epilepsy.

Caution should be observed in prescribing Baratol for patients with a history of depression.

Clearance of indoramin may be affected in the elderly. A reduced dose and/or frequency of dosing may be sufficient for effective control of blood pressure.

4.5 Interaction with other medicinal products and other forms of interaction

The following, when administered at the same time as Baratol, result in an enhanced hypotensive effect:

•    Anaesthetics

•    Antidepressants, especially MAOIs

•    Antihypertensives

Beta-blockers Calcium-channel blockers Diuretics, especially thiazide diuretics

Moxisylyte, when administered at the same time as Baratol, may cause possible severe postural hypotension.

The ingestion of ethanol has been shown to increase both the rate and the extent of absorption of Baratol, and patients should be cautioned to avoid the ingestion of alcohol.

4.6 Pregnancy and lactation

Animal experiments indicate no teratogenic effects but Baratol Tablets should not be prescribed for pregnant women unless considered essential by the physician.

There are no data available on the excretion of Baratol in human milk but the drug should not be administered during lactation unless in the judgement of the physician such administration is clinically justifiable.

4.7 Effects on ability to drive and use machines

Baratol may cause drowsiness. See " Special warnings and precautions for use".

4.8 Undesirable effects

The most commonly reported adverse drug reactions are drowsiness, sedation or somnolence occurring in >10% of patients. This effect is often seen in the initial stages of treatment or when the dose is increased too rapidly.

The suggested therapy is along the following lines:

Recent ingestion of large numbers of tablets would require gastric lavage or a dose of Ipecacuanha to remove any of the product still in the stomach of the conscious patient.

Ventilation should be monitored and assisted if necessary.

Circulatory support and control of hypotension should be maintained.

If convulsions occur, diazepam may be tried.

Temperature should be closely monitored. If hypothermia occurs, rewarming should be carried out very slowly to avoid possible convulsions.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Baratol is an a-adrenoceptor blocking agent, which acts selectively and competitively on post-synaptic oq-adrenoceptors, causing a decrease in peripheral resistance.

5.2 Pharmacokinetic properties

Baratol tablets are rapidly absorbed and have a half-life of about 5 hours. There is little accumulation during long-term treatment. When three volunteers and four hypertensive patients were treated with radiolabelled indoramin at doses of 40 - 60mg daily for up to 3 days, plasma concentrations reached a peak 1-2 hours after administration of single doses. Over 90% of plasma indoramin was protein bound. After 2 or 3 days, 35% of the radioactivity was excreted in the urine and 46% in the faeces. Extensive first pass metabolism was suggested.

Preclinical safety data

None applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Amberlite IRP 88 Avicel PH 101 Lactose

Magnesium Stearate Coating:

Hydroxypropylmethyl Cellulose 2010 Polyethylene Glycol 400 Opaspray M-I-20972

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months.

Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5 Nature and contents of container

Pack sizes of 10, 28, 56, 84 100 and 112 in amber glass bottles with suitable closures, aluminium/polyethylene foil strip and securitainers.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Amdipharm UK Limited

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

United Kingdom.

8    MARKETING AUTHORISATION NUMBER(S)

PL 20072/0044

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23 April 1993

10 DATE OF REVISION OF THE TEXT

10/09/2013