HALOXEN Tablet

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Haloxen 5 mg tablets. Haloxen 10 mg tablets.

2. Qualitative and quantitative composition

Each tablet contains haloperidol 5 mg and 10 mg respectively. Excipient(s) with known effect: These products contain 113,7 mg and 112,8 mg lactose respectively. For the full list of excipients, ...

3. Pharmaceutical form

Tablet. Haloxen 5 mg tablets: Pink, round, normal convex tablets, scored with Remedicas logo on one side and HL 5 on the other side. The tablet can be divided into equal doses. Haloxen 10 mg ...

4.1. Therapeutic indications

Adult patients aged 18 years and above Treatment of schizophrenia and schizoaffective disorder. Acute treatment of delirium when non-pharmacological treatments have failed. Treatment of moderate to severe ...

4.2. Posology and method of administration

Posology Adults A low initial dose is recommended, which subsequently may be adjusted according to the patients response. Patients must always be maintained on the minimal effective dose (see section 5.2). ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Comatose state. Central nervous system (CNS) depression. Parkinsons disease. Dementia with Lewy bodies. Progressive ...

4.4. Special warnings and precautions for use

Increased mortality in elderly people with dementia Rare cases of sudden death have been reported in psychiatric patients receiving antipsychotics, including haloperidol (see section 4.8). Elderly patients ...

4.5. Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Cardiovascular effects Haloxen is contraindicated in combination with medicinal products known to prolong the QTc interval (see section 4.3). Examples ...

4.6. Fertility, pregnancy and lactation

Pregnancy A moderate amount of data on pregnant women (more than 400 pregnancy outcomes) indicate no malformative or foeto/neonatal toxicity of haloperidol. However, there have been isolated case reports ...

4.7. Effects on ability to drive and use machines

Haloxen has a moderate influence on the ability to drive and use machines. Some degree of sedation or impairment of alertness may occur, particularly with higher doses and at the start of treatment and ...

4.8. Undesirable effects

The safety of haloperidol was evaluated in 284 haloperidol-treated patients who participated in 3 placebo-controlled clinical studies and in 1295 haloperidol-treated patients who participated in 16 double-blind ...

4.9. Overdose

Symptoms and signs The manifestations of haloperidol overdose are an exaggeration of the known pharmacological effects and adverse reactions. The most prominent symptoms are severe extrapyramidal reactions, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics; Antipsychotics ATC code: N05AD01 Mechanism of action Haloperidol is an antipsychotic belonging to the butyrophenones group. It is a potent central ...

5.2. Pharmacokinetic properties

Absorption The average bioavailability of haloperidol after administration of the tablet or oral solution is 60 to 70%. Peak plasma levels of haloperidol are generally attained within 2 to 6 hours of oral ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazards for humans based on conventional studies of repeat dose toxicity and genotoxicity. In rodents, haloperidol administration showed a decrease in fertility, limited ...

6.1. List of excipients

Haloxen 5 mg tablets: Microcrystalline cellulose Lactose monohydrate Pregelatinized starch Colloidal silicon dioxide Magnesium stearate Talc Erythrosine E127 Povidone Maize starch Haloxen 10 ...

6.2. Incompatibilities

None.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Haloxen Tablets should be stored below 25°C, protected from light and moisture.

6.5. Nature and contents of container

Haloxen 5 mg tablets: 30, 100 and 1000 tablets in blister packs. Haloxen 10 mg tablets: 30 and 100 tablets in blister packs. Not all pack-sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, CYPRUS

8. Marketing authorization number(s)

Haloxen 5 mg tablets: 8589 Haloxen 10 mg tablets: 16307

9. Date of first authorization / renewal of the authorization

Haloxen 5 mg tablets: Date of first authorization: 11 January 1983 Date of latest renewal: 20 November 2009 Haloxen 10 mg tablets: Date of first authorization: 19 October 1995 Date of latest ...

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