Lorivan таблетки инструкция по применению

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). Therefore, the drug should always be discontinued gradually.

It may be useful to inform the patient that treatment will be of limited duration and that it will be discontinued gradually. The patient should also be made aware of the possibility of «rebound» phenomena to minimise anxiety should they occur.

Abuse of benzodiazepines has been reported.

Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few weeks.

Anxiety or insomnia may be a symptom of several other disorders. The possibility should be considered that the complaint may be related to an underlying physical or psychiatric disorder for which there is more specific treatment.

Caution should be used in the treatment of patients with acute narrow-angle glaucoma.

Patients with impaired renal or hepatic function should be monitored frequently and have their dosage adjusted carefully according to patient response. Lower doses may be sufficient in these patients. The same precautions apply to elderly or debilitated patients and patients with chronic respiratory insufficiency.

As with all CNS-depressants, the use of benzodiazepines may precipitate encephalopathy in patients with severe hepatic insufficiency. Therefore, use in these patients is contraindicated.

Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes. Periodic haematology and liver-function assessments are recommended where repeated courses of treatment are considered clinically necessary.

Transient anterograde amnesia or memory impairment has been reported in association with the use of benzodiazepines. This effect may be advantageous when Lorivan is used as a premedicant. However, if Lorivan is used for insomnia due to anxiety, patients should ensure that they will be able to have a period of uninterrupted sleep which is sufficient to allow dissipation of drug effect (e.g., 7-8 hours).

Paradoxical reactions have been occasionally reported during benzodiazepine use. Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued (see Undesirable effects).

Although hypotension has occurred only rarely, benzodiazepines should be administered with caution to patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications. This is particularly important in elderly patients.

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Not recommended

Alcohol

Lorivan should not be used together with alcohol (enhanced sedative effects; impaired ability to drive/operate machinery)

Sodium oxybate

Avoid concomitant use (enhanced effects of sodium oxybate)

HIV-protease inhibitors

Avoid concomitant use (increased risk of prolonged sedation — see below for zidovudine

Take into account

Centrally acting drugs

Enhancement of the central depressive effect may occur if Lorivan is combined with drugs such as neuroleptics, antipsychotics, tranquillisers, antidepressants, hypnotics, analgesics, anaesthetics, barbiturates and sedative antihistamines. The elderly may require special supervision.

Anti-epileptic drugs

Pharmacokinetic studies on potential interactions between benzodiazepines and antiepileptic drugs have produced conflicting results. Both depression and elevation of drug levels, as well as no change have been reported.

Phenobarbital taken concomitantly may result in an additive CNS effect. Special care should be taken in adjusting the dose in the initial stages of treatment.

Side effects may be more evident with hydantoins or barbiturates

Valproate may inhibit the glucuronidation of Lorivan (increased serum levels: increased risk of drowsiness)

Narcotic analgesics

Enhancement of the euphoria may lead to increased psychological dependence

Clozapine

Reports of marked sedation, excessive salivation, hypotension, ataxia, delirium and respiratory arrest when given concurrently with Lorivan.

Muscle Relaxants

When taken with muscle relaxants, the overall muscle-relaxing effect may be increased (accumulative) therefore caution is advised, especially in elderly patients and at higher doses

Other drugs enhancing the sedative effect of diazepam

Cisapride, lofexidine, nabilone, disulfiram and the muscle relaxants — baclofen and tizanidine

Compounds that affect hepatic enzymes (particularly cyctochrome P450)

— Inhibitors (e.g. cimetidine, isoniazid; erythyromycin; omeprazole; esomeprazole) reduce clearance and may potentiate the action of benzodiazepines. Itraconazole, ketoconazole and to a lesser extent fluconazole and voriconazole are potent inhibitors of the cytochrome P450 isoenzyme CYP3A4 and may increase plasma levels of benzodiazepines. The effects of benzodiazepines may be increased and prolonged by concomitant use. A dose reduction of the benzodiazepine may be required.

— Inducers (e.g. rifampicin) may increase clearance of benzodiazepines

Antihypertensives, vasodilators and diuretics: Enhanced hypotensive effect with ACE-inhibitors, alpha-blockers, angiotensin-II receptor antagonists, calcium channel blockers, adrenergic neurone blockers, beta-blockers, moxonidine, nitrates, hydralazine, minoxidil, sodium nitroprusside and diuretics

Enhanced sedative effect with alpha-blockers or moxonidine.

Dopaminergics

Possible antagonism of the effect of levodopa

Antacids

Concurrent use may delay absorption of Lorivan

Zidovudine

Increased zidovudine clearance by Lorivan

Oestrogen-containing contraceptives

Possible inhibition of hepatic metabolism of Lorivan

Theophylline/aminophylline

Increases metabolism of Lorivan which possibly reduces the effect

Caffeine

Concurrent use may result in reduced sedative and anxiolytic effects of Lorivan.

Grapefruit juice

Inhibition of CYP3A4 may increase the plasma concentration of Lorivan (possible increased sedation and amnesia). This interaction may be of little significance in healthy individuals, but it is not clear if other factors such as old age or liver cirrhosis increase the risk of adverse events with concurrent use.

4.6 Fertility, pregnancy and lactation

Pregnancy: Benzodiazepines should not be used during pregnancy, especially during the first and last trimesters. Benzodiazepines may cause foetal damage when administered to pregnant women.

If the drug is prescribed to a woman of childbearing potential, she should be warned to contact her physician about stopping the drug if she intends to become, or suspects that she is, pregnant.

There is a possibility that infants born to mothers who take benzodiazepines chronically during the later stages of pregnancy may develop physical dependence. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery have been reported to have withdrawal symptoms during the postnatal period. Symptoms such as hypoactivity, hypotonia, hypothermia, respiratory depression, apnoea, feeding problems, and impaired metabolic response to cold stress have been reported in neonates born of mothers who have received benzodiazepines during the late phase of pregnancy or at delivery.

Lactation: Lorivan is excreted in small amounts in breast milk. Mothers who are breast-feeding should not take benzodiazepines. Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines.

4.7 Effects on ability to drive and use machines

Patients should be advised that sedation, amnesia, impaired concentration, dizziness, blurred vision and impaired muscular function may occur and that, if affected, they should not drive or to use machines, or take part in other activities where this would put themselves or others at risk. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Concurrent medication may increase these effects

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

— The medicine is likely to affect your ability to drive

— Do not drive until you know how the medicine affects you

— It is an offence to drive while under the influence of this medicine

— However, you would not be committing an offence (called ‘statutory defence’) if:

— The medicine has been prescribed to treat a medical or dental problem and — You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and — It was not affecting your ability to drive safely”

4.8 Undesirable effects

Adverse reactions, when they occur, are usually observed at the beginning of therapy and generally decrease in severity or disappear with continued use or upon decreasing the dose.

Most frequently reported adverse reactions associated with benzodiazepines include daytime drowsiness, dizziness, muscle weakness, and ataxia.

Adverse reactions are listed by frequency:

Very common (>1/10); Common (>1/100 to <1/10); Uncommon (>1/1,000 to <1/100); Rare (>1/10,000 to <1/1,000); Very rare (<1/10,000); not known (cannot be estimated from the available data)

Blood and lymphatic system disorders

Very rare: Thrombocytopenia, leucopenia, agranulocytosis, pancytopenia

Immune system disorders

Very rare: Hypersensitivity including anaphylaxis/anaphylactoid reactions

Endocrine disorders

Very rare: Inappropriate antidiuretic hormone secretion, hyponatraemia

Psychiatric disorders

Rare: Confusion, depression and unmasking of depression, numbed emotions, disinhibition, euphoria, appetite changes, sleep disturbance, change in libido, decreased orgasm.

Unknown: Dependence, Suicidal ideation/attempt

Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rage, insomnia, nightmares, hallucinations, psychoses, sexual arousal, and inappropriate behaviour have been occasionally reported during use.

Nervous system disorders

Very common: Daytime drowsiness, sedation

Common: Dizziness, ataxia

Rare: headache, reduced alertness, dysarthria/slurred speech, transient anterograde amnesia or memory impairment.

Very rare: Tremor, extrapyramidal reactions, Coma (see

Patient Information leaflet

                                mt-pl-lorivan-2mg-tabs-a3
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LORIVAN 2 MG TABLETS
lorazepam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lorivan is and what it is used for
2.
What you need to know before you take Lorivan
3.
How to take Lorivan
4.
Possible side effects
5.
How to store Lorivan
6.
Contents of the pack and other information
1. WHAT LORIVAN IS AND WHAT IT IS USED FOR
Lorivan contains the active substance lorazepam.
Lorivan is a member of a group of medicines called benzodiazepines. It
can help to relieve
anxiety.
Lorivan may be prescribed as short-term therapy for anxiety or
sleeping difficulties due to
anxiety which is significantly affecting normal daily life.
It may also be used as a sedative before surgery or operative dental
treatment.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORIVAN
DO NOT TAKE LORIVAN
•
if you are allergic to lorazepam or any of the other ingredients of
this medicine (listed in
section 6).
•
if you have severe breathing or chest problems.
•
if you have ‘myasthenia gravis’ (very weak or tired muscles).
•
if you have serious liver problems.
•
if you suffer from ‘sleep apnoea’ (breathing problems when you are
asleep).
mt-pl-lorivan-2mg-tabs-a3
2
If any of the above apply to you, do not take Lorivan.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lorivan.
•
if you are pregnant or trying to become pregnant.
•
if you abuse or have 
                                
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Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICAL PRODUCT
Lorivan
2 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lorazepam 2 mg.
Excipient(s) with known effect
This product contains 60.1 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Yellow, flat, scored tablets.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lorivan is indicated for the short-term treatment of unacceptable
disabling or distressful
anxiety states including anxiety associated with psychosomatic,
organic and psychotic
illness and the short-term treatment of insomnia associated with
anxiety. Lorivan is also
used as premedication before operative dentistry and general surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage and duration of therapy should be individualised. The lowest
effective dose
should be prescribed for the shortest time possible. The risk of
withdrawal and rebound
phenomena is greater after abrupt discontinuation; therefore, the drug
should be
discontinued gradually for all patients (see section 4.4). Generally,
the duration of
treatment
varies
from
a
few
days
to
4
weeks
including
the
tapering
off
process. Extension of the treatment period should not take place
without re-evaluation
of the need for continued therapy.
Increases in the dosage of lorazepam should be made gradually to help
avoid adverse
effects. The evening dose should be increased before the daytime
doses.
mt-spc-lorivan-2mg-tabs-v04-r00-a2 Page 2 of 12
_Adults _
Moderate and severe anxiety:
1-4mg daily in divided doses
Insomnia:
1-2mg before retiring
Premedication before operative dentistry or
general surgery:
2-3mg the night before operation
2-4mg
one
to
two
hours
before
operation
_Elderly and debilitated patients _
_ _
For elderly and debilitated patients reduce the initial dose by
approximately 50% and
adjust the dosage as needed and tolerated (see section 4.4 Special
warni
                                
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