Prescription only medicine
Each Tablet contains: Baclofen 10 mg
Excipients : Microcrystalline Cellulose, Povidone, Lactose, Maize Starch, Pregelatinised Starch, Magnesium Stearate, Talc and Colloidal Silicon Dioxide.
WHAT IS Bamifen AND WHAT ARE ITS USES
Baclofen, the active substance of Bamifen, is a gamma-aminobutyric acid derivative that belongs to the group of medicines named skeletal muscle relaxants. It acts on the Central Nevrous System (CNS) in order to produce its muscle relaxant action. It relaxes principally the body muscle convulsions especially when provoked by CNS damages or diseases.
Bamifen is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as: multiple sclerosis, other spinal lesions, e.g. tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord.
Bamifen is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury.
Patient selection is important when initiating Bamifen therapy; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/or physiotherapy. Treatment should not be commenced until the spastic state has become stabilised.
3. DOSAGE AND ADMINISTRATION
Please follow your doctor’s instructions.
The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements:
5mg three times daily for 3 days.
10mg three times daily for 3 days.
15mg three times daily for 3 days.
20mg three times daily for 3 days.
Satisfactory control of symptoms is usually obtained of up to 60mg daily, a careful adjustment is often necessary to meet the requirements of each individual patient. The dose may be increased slowly if required, but a maximum dose of 100mg is not advised unless the patient is in hospital under medical supervision.
Small frequent dosage may prove better in some cases than large doses. Also, some patients may benefit from the use of Bamifen at night to counteract painfull flexor spasm. Similarly, a single dose given approximately 1 hour prior to performance of specific tasks (washing, dressing, shaving, physiotherapy) will often improve mobility.
Once the maximum recommended dose has been reached, if the therapeutic effect is not apparent within 6 weeks, a decision whether to continue Bamifen should be taken.
Small doses should be used at the start of the treatment and the dose being titrated gradually against the response, under careful supervision.
A dosage range of 0,75 – 2 mg / kg body weight should be used. In children over 10 years of age, a maximum daily dosage of 2,5mg / kg body weight may be given. Treatment is usually started with 2,5mg four times daily. The dosage should be cautiously raised at about 3 day intervals, until it becomes sufficient for the child’s individual requirements.
The recommended daily maintenance dose is:
Children 12 months – 2 years: 10 – 20 mg.
Children 2 years – 6 years: 20 – 30 mg.
Children 6 years – 10 years: 30 – 60mg.
Patients with impaired renal function:
It is recommended a low dose, e.g. 5mg daily.
Patients with spastic states of cerebral origin:
Unwanted effects are more likely to occur at these patients. It is therefore recommended that a very cautious dosage schedule be adopted and that patients be kept under appropriate surveillance.
If you take a dose larger than normal:
In case you take a dose larger than normal, stop taking the medicine and contact your doctor immediately.
Symptoms of overdosage: Symptoms from the Central Nervous System: Drowsiness, confusion, reduced reflexes, difficulty in breathing, hypotension, speech disturbance, general hypotonia and coma. It is also possible that the following may appear: hallucinations, bradycardia, hypothermia, nausea, vomiting, diarrhoea, high values of LDH, SGOT and AP.
Treatment: there is no special antidote for treating overdoses of baclofen. General supportive measures such as stomach lavage, active charcoal and liquids administration as well as diuretic administration can be used.
If you forget to take Bamifen:
If you have to take this medicine continuously and you missed a dose you should take this dose as soon as possible. If your are close to the time of your next dose, do not take the missed dose but go back to your regular dosing schedule. Do not double doses. Consult your doctor in case you missed more than one dose.
Bamifen is contra-indicated to people with hypersensitivity to Baclofen or have peptic ulceration.
5. WARNINGS & PRECAUTIONS:
Bamifen should be administered with caution to patients with impairment of the cerebral vessels, with epilepsy, psychotic states, peptic ulceration and in the elderly. Initial dose should be increased gradually. Treatment should always, (unless serious adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks.
This product contains lactose therefore if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
6. PREGNACY AND LACTATION:
Bamifen is not recommended during pregnancy. Consult your doctor or pharmacist before taking any medication.
The quantity of Baclofen that passes into breast milk is too little to cause any damage. Consult your doctor or pharmacist before taking any medication.
7. EFFECTS ON ABILITY TO DRIVE OR OPERATE MACHINERY:
Bamifen may cause drowsiness and therefore affect the ability to drive or operate machinery. Avoid alcohol consumption.
8. UNDESIRABLE EFFECTS
As all medicines, Bamifen can cause undesirable effects.
Most usual are: central nervous system disorders (sedation, drowsiness, nausea, respiratory depression, light-headedness, lassitude, exhaustion, mental confusion, dizziness, headache, insomnia, euphoria, depression, muscular weakness, ataxia, tremor, hallucinations, nightmares, myalgia, nystagmus, dry mouth, dysarthria, lowering of the convulsion threshold and convulsions), sense organs disorders (accommodation disorders, visual disturbance, dysgeusia), gastro-intestinal disorders (nausea, mild gastro-intestinal disturbances, constipation, diarrhea, retching, vomiting, abdominal pain),cardiovascular system disorders (hypotension, diminished cardiovascular function), urogenital system disorders (frequency of micturition, enuresis, dysuria, urinary retention, impotence), disorders of hepatic function, skin disorders (hyperhydrosis, skin rash).
Some patients have shown increased spasticity. Also, an undesirable degree of muscular hypotonia may occur, and can usually be relieved by re-adjusting the dosage.
If you notice any adverse reactions that are not mentioned above, please inform your doctor immediately.
9. DRUG INTERACTIONS:
A number of medicines interact with Baclofen and should not be used concomitantly. However, a few of them can be used concomitantly under special precautions. In this case, your doctor can change the posology or take other cautions if needed. It is important to inform your doctor or pharmacist if you are taking other medications and particularly anyone of the following:
Tricyclic antidepressants or MAOI, Central Nervous System depressants, ibuprofen, antihypertensives, diuretics, antidiabetics, carbidopa/levodopa, alcohol.
10. PHARMACODYNAMIC PROPERTIES:
Bamifen is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid (GABA) derivative, Bamifen is chemically unrelated to other antispastic agents.
Bamifen depresses monosynaptic and polysynaptic reflex transmission, probably by stimulating the GABAB-receptors, this stimulation in turn inhibiting the release of the excitatory amino acids glutamate and aspartate. Neuromuscular transmission is unaffected by Bamifen.
The major benefits of Bamifen stem from its ability to reduce painful flexor spasms and spontaneous clonus thereby facilitating the mobility of the patient, increasing his independence and helping rehabilitation.
Bamifen also exerts an antinociceptive effect. General well being is often improved and sedation is less often a problem than with centrally acting drugs.
Baclofen stimulates gastric acid secretion.
11. PHARMACOKINETIC PROPERTIES:
Absorption:Bamifen is rapidly and completely absorbed from the gastro-intestinal tract. Following oral administration of single doses (10-30mg) peak plasma concentrations are recorded after 0.5 to 1.5 hours and areas under the serum concentration curves are proportional to the dose.
Distribution:The volume of distribution of baclofen is 0.7 l/kg and the protein binding rate is approximately 30%. In cerebrospinal fluid active substance concentrations are approximately 8.5 times lower than in the plasma.
Biotransformation: Baclofen is metabolised to only a minor extent. Deamination yields the main metabolite, -(p-chlorophenyl)-4-hydroxybutyric acid, which is pharmacologically inactive.
Elimination/excretion:The plasma elimination half-life of Baclofen averages 3 to 4 hours. The serum protein binding rate is approximately 30%.
Baclofen is eliminated largely in unchanged form. Within 72 hours, about 75% of the dose is excreted via the kidneys with about 5% of this amount as metabolites.
12. SHELF LIFE: 60 months
13. STORAGE: Keep below 25° C, away from light and moisture and out of the reach of children.
14. SPECIFICATION: BP Current Edition
Name and Address of Manufacturer
Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU
Name and Address of Registrationer: Nhat Anh Pharmaceutical Co., Ltd (19-C12B Hoa Lan, ward 2, Phú Nhuận district, HCM city)
Please read carefully before use.
Further more information please ask your doctor or pharmacist