Gerard Laboratories

4.3 Contraindications

Hypersensitivity to baclofen and pulmonary insufficiency.

Use in patients with pulmonary insufficiency.

4.4 Special warnings and precautions for use

Baclofen should only be used with great caution in patients with porphyria, history of alcoholism, hypertension, epilepsy, history of convulsions, psychotic disorders, schizophrenia depressive or manic disorders or confusional states since exacerbation of such conditions may occur.

Patients with acute cerebrovascular ischaemia, a history of/or existent peptic ulcers, or those on anti-hypertensive therapy or with renal impairment should receive baclofen only under careful supervision.

Baclofen should be used with extreme care in patients already receiving antihypertensive therapy.

Use of the drug, particularly if it has been prolonged, should not be terminated abruptly to avoid precipitation of paranoia, hallucinations, and withdrawal syndrome. Treatment should be gradually discontinued by reducing the dosage over 1-2 weeks. should always, (unless adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of 1-2 weeks. Anxiety and confusional states, hallucinations, psychotic, manic or paranoid sates, convulsions (state epilepticus), dyskinesia, tachycardia, hyperthermia and temporary aggravation of spasticity as rebound phenomenon have been reported with abrupt withdrawal of Baclofen, especially after long-term medication.

For the intrathecal formulation of Lioresal, it has been reported that clinical characteristics of withdrawal may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabodomyolysis.

4.5 Interaction with other medicinal products and other forms of interaction

In concomitant administration with other drugs acting on the CNS or with alcohol, increased sedation may occur.

Concurrent use of baclofen with MAO inhibitors may result in increased CNS-depressant and hypotensive effects; caution is recommended and dosage of one or both agents may require reduction.

Prolongation of fentanyl induced anaesthesia may occur in patients pre-treated with baclofen.

The effect of baclofen may be prolonged if co-administered with tricyclic anti-depressants resulting in marked muscle hypotonia.

The risk of respiratory depression is also increased. Careful monitoring of respiratory and cardiovascular functions is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.

The risk of hypotension occurring is increased in patients receiving both baclofen and anti-hypertensive therapy.  Adjustments to the dosage of anti-hypertensive medication should be made accordingly.

Mental confusion, hallucinations and agitation has been reported in patients concurrently treated with baclofen and levodopa plus carbidopa for Parkinson's Disease.

Drugs which may produce renal insufficiency e.g. ibuprofen may reduce baclofen excretion leading to toxic effects.

Since balcofen may increase blood glucose concentrations, dosage adjustments of insulin and/or oral hypoglycemic agents may be necessary during and after concurrent therapy.

Aggravation of hyperkinetic symptoms may possibly occur in patients taking lithium.

4.8 Undesirable effects

These are most common at the start of baclofen therapy; if the dose is raised too rapidly; at high doses and also in the elderly. They are usually temporary and can be relieved or removed by reducing the dose. It is rare for the side effects to require withdrawal of therapy.

Central nervous system:  At the start of treatment frequent effects have included day time sedation, drowsiness, and nausea.  Occasionally dryness of the mouth, respiratory depression, lightheadedness, lassitude, exhaustion, mental confusion, dizziness, retching, vomiting, headache and insomnia are reported.

If nausea persists despite dosage reduction, it is recommended that baclofen be taken with food or a milk beverage.

It is often difficult to distinguish between neurological and/or psychiatric manifestations and those of the disease under treatment.  Those which have occasionally or rarely been reported include:  euphoria, depressive states, paraesthesiae, myalgia, muscular weakness, ataxia, tremor, nystagmus, accommodation disorders, hallucinations, nightmares.  Lowering of the convulsion threshold and seizures may possibly occur, particularly in epileptic patients.

Gastro-Intestinal Tract:  Occasionally, mild gastro-intestinal disturbances (constipation, diarrhoea).

Cardio-vascular System:  Occasionally, hypotension, diminished cardiovascular function.

Urogenital System:  Occasionally or rarely, dysuria, frequency of micturition, enuresis and impotence and ejaculation problems.  It is often difficult to distinguish between these manifestations and those of the disease under treatment.

Miscellaneous Unwanted Effects:  In rare or isolated cases, alterations in the taste sensation, hyperhidrosis, skin rash, hepatic dysfunction.

Paradoxical increased spasticity has been noted in some patients.

An undesirable degree of muscular hypotonia may occur.  This can usually be relieved by dosage re-adjustments (i.e. by reducing the doses given during the day and possibly increasing the evening dose).

Side-effects: Unwanted effects occur mainly at the start of treatment, if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication.

Should nausea persist following a reduction in dosage, it is recommended that Lioresal be ingested with food or a milk beverage.

Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.

Certain patients have shown increased muscle spasticity as a paradoxical reaction to the medication.

In patients with a case history of psychiatric illness or with cerebrovascular disorders (e.g. stroke) as well as in elderly patients, adverse reactions may assume a more serious form.

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (1/10); common (1/100, < 1/10); uncommon (1/1,000, <1/100); rare (1/10,000, < 1/1,000) very rare (< 1/10,000), including isolated reports.

Nervous System Disorders:
Very common: Sedation, somnolence.
Common: Respiratory depression, light-headedness, lassitude, exhaustion, mental confusion, dizziness, headache, insomnia, euphoria mood, depression, muscular weakness, ataxia, tremor, hallucinations, nightmares, myalgia, nystagmus, dry mouth.
Rare: Paraesthesia, dysarthria, dysgeusia. Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.
Very rare: Hypothermia

Eyes disorders:
Certain patients have shown increased spasticity as a paradoxical reaction to the medication. An undesirable degree of muscular hypotonia - making it more difficult for patients to walk or fend for themselves - may occur and can usually be relieved by re-adjusting the dosage (ie. By reducing the doses given during the day and possibly increasing the evening dose).
Common: Accommodation disorders, visual disturbance.

Gastro-intestinal disorders:
Very common: Nausea.
Common: Mild gastro-intestinal disturbances constipation, diarrhoea, retching and vomiting.
Rare: Abdominal pain

Cardiac Disorders:
Common: Diminished cardiovascular function.

Vascular disorders:
Common: Hypotension

Renal and urinaire disorders:
Common:, Pollakiuria, enuresis, dysuria
Rare: Urinary retention

Reproductive system and brest disorders:
Rare: Erectile dysfunction

Hepatobiliary disorders:
Rare: Hepatic function abnormal.

Skin and subcutaneous tissue disorders:
Common: Hyperhidrosis, skin rash.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21st November 1989
Date of last renewal: 21st November 2004 2009

10. DATE OF REVISION OF THE TEXT

March 2010 June 2011

3.   PHARMACEUTICAL FORM

Tablets.

White flat bevel-edge tablet, marked “BN” breakline “10” on one side and “G” on the reverse.

The tablet can be divided into equal halves.

1. NAME OF THE MEDICINAL PRODUCT

Baclopar Tablets 10 mg tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 10 mg of Baclofen.

Excipients: Each tablets contains 40mg of lactose monohydrate

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablets.

A white tablet White flat bevel-edge tablet, marked “BN” breakline “10” on one side and “G” on the reverse.

10. DATE OF REVISION OF THE TEXT