Ativan 1 mg Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Lorazepam
Available from:
Pfizer Healthcare Ireland
ATC code:
N05BA; N05BA06
INN (International Name):
Lorazepam
Dosage:
1 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Benzodiazepine derivatives; lorazepam
Authorization status:
Marketed
Authorization number:
PA0822/090/001
Authorization date:
1997-01-10

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Package leaflet: Information for the patient

Ativan

®

1mg 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 Ativan Tablets are and what they are used for

2.

What you need to know before you take Ativan Tablets

3.

How to take Ativan Tablets

4.

Possible side effects

5.

How to store Ativan Tablets

6.

Contents of the pack and other information

1. What Ativan Tablets are and what they are used for

The name of your medicine is Ativan Tablets. Ativan Tablets contain the active substance lorazepam.

Ativan Tablets are a member of a group of medicines called benzodiazepines. It can help to relieve

anxiety.

Ativan Tablets 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 Ativan Tablets

Do not take Ativan Tablets:

If you are allergic to lorazepam, other benzodiazepines 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)

If any of the above apply to you, do not take Ativan Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ativan Tablets

If you are pregnant or trying to become pregnant

If you abuse or have in the past abused drugs or alcohol

If you have a personality disorder. If so, you have a greater chance of becoming dependent on

Ativan Tablets

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If you have any kidney or liver problems

If you are elderly or debilitated (weak)

If you have suffered from depression before since it could re-occur during treatment with

Ativan Tablets

If you are suffering from depression, since Ativan Tablets may increase any suicidal feelings

which you may have

If you have a history of psychotic illness

If you have a history of convulsions/seizures

If you suffer from breathing problems

If you suffer from an eye problem called glaucoma

If you are taking any other medicines, including those which have not been prescribed by a

doctor, since they may affect the way Ativan Tablets works. Ativan Tablets may also affect the

way other drugs work

Other medicines and Ativan Tablets

Tell your doctor

or pharmacist

if you are taking, have recently taken or might take any other

medicines, in particular

barbiturates - sedatives, anti-anxiety drugs

antidepressants

strong pain killers (e.g. opioids- keep the dosages and duration of the medicine to a minimum

as recommended by your doctor). Taking Ativan with these pain killers may make you more

sleepy and in rare cases can cause breathing difficulty and death.

drugs for epilepsy (e.g. sodium valproate)

antihistamines

anti-psychotic drugs for mood or mental disorders (e.g. loxapine or clozapine)

anaesthetics – drugs that cause anaesthesia – reversible loss of sensation

drugs for asthma (theophylline, aminophylline)

probenecid (a drug to treat gout)

The dose of these drugs may need to be reduced before you can take Ativan Tablets.

Ativan Tablets with food, drink and alcohol

Alcohol will increase the sedative effects of Ativan Tablets and should therefore be avoided.

Please

refer to section 3.

Things to note before taking Ativan Tablets

Tell your doctor or pharmacist that you are taking Ativan Tablets before taking any other medicine or

if you enter hospital for treatment.

Some elderly patients may feel dizzy after taking Ativan Tablets and may be in danger of falling.

Tolerance and dependence

Tolerance to benzodiazepines may occur. Therefore the beneficial effect of Ativan Tablets may be

less apparent after several weeks of use.

Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol

abuse.

Dependence is unlikely to occur but the risk increases with higher doses and longer-term use and is

further increased in patients with a history of alcoholism, drug abuse or in patients with personality

disorders. Therefore use in individuals with a history of alcoholism or drug abuse should be avoided.

Dependence may lead to withdrawal symptoms, especially if treatment is discontinued abruptly.

Therefore, the drug should always be discontinued gradually.

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If you are given Ativan Tablets for more than 4 weeks, your doctor might want to take blood samples

occasionally to check your blood and liver, since drugs like Ativan Tablets have occasionally

affected liver function.

Dependence on benzodiazepines may occur following prolonged treatment. Therefore Ativan Tablets

are usually prescribed for short courses of treatment, lasting from a few days to 4 weeks including a

dose reduction at the end. This reduces the risk of becoming dependent on Ativan Tablets, or

suffering unpleasant effects when you stop taking it. (See section 3 ‘If you stop taking Ativan

Tablets’, below).

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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask

your doctor or pharmacist for advice before taking this medicine.

Benzodiazepines, including Ativan Tablets may cause damage to the foetus if taken during early

pregnancy. If you take this medicine during late pregnancy or during labour, your baby, when born,

may be less active than other babies, have a low body temperature, be floppy or have breathing or

feeding difficulties for a while. Your baby’s response to the cold might be temporarily impaired also.

If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms

after birth.

Ativan should not be given to breastfeeding mothers unless the expected benefit to the mother

outweighs the potential risk to the infant, as the drug may pass into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ativan Tablets may make you sleepy or affect your concentration. This may affect your performance

at skilled tasks e.g. driving and operating machinery, particularly if you have not had enough sleep.

Ativan Tablets contain lactose monohydrate

Ativan Tablets contain lactose monohydrate. If you have been told by your doctor that you have an

intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to take Ativan Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not

sure.

If you have been given Ativan Tablets for anxiety or sleeping problems, treatment will usually last

from a few days to 4 weeks and will usually include a dose reduction at the end.

You will be prescribed the lowest effective dose for the shortest possible time.

Ativan Tablets should be swallowed with water.

The recommended dose is:

Adults (and children over 13 years of age)

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Anxiety:

1 to 4 mg daily in divided doses. Your doctor will tell you how often

to take your tablets. Ativan is not recommended for the treatment of

anxiety in children under 12 years of age.

Sleeping Problems:

1 to 2 mg before going to sleep. You should make sure that you will

be able to sleep for 7 to 8 hours before taking your tablets.

Before Surgery:

2 to 3 mg the night before your operation and 2 to 4 mg one or two

hours before your operation.

Children (between 5 and 13 years of age)

Before Surgery:

The dose is usually between 0.5 and 2.5 mg (depending on your

child’s weight) at least one hour before your child’s operation.

Ativan Tablets are not recommended for the treatment of anxiety or sleeping problems in children.

Nor is it recommended for children below 5 years of age.

Elderly

Elderly and debilitated (weak) patients may be given lower doses. They may respond to half the usual

adult dose or less. However, this lower dose may be adjusted if needed.

Patients with Renal or Hepatic Impairment

Lower doses may be sufficient in patients with impaired renal function or mild to moderate hepatic

insufficiency. Use in patients with severe hepatic insufficiency is contraindicated.

If you take more Ativan Tablets than you should

If anyone has taken an overdose of Ativan Tablets (that is more than the doctor has prescribed), seek

medical help immediately, either by calling your doctor, or going to the nearest casualty department.

Always take the labelled medicine container with you, even if there are no tablets left.

If you forget to take Ativan Tablets

If you forget to take a tablet for anxiety and if it is less than 3 hours since your usual time, you should

take it as soon as you remember. If more than 3 hours has passed from when you usually take your

tablet, don’t worry; just take your next tablet when it is due. Do not take a double dose to make up for

a forgotten tablet.

If you forget to take a tablet for sleeping problems, only take it if you will be able to sleep for 7 to 8

hours afterwards.

If you stop taking Ativan Tablets

After you have finished your prescribed treatment with Ativan Tablets, your doctor will decide

whether or not you need further treatment.

The number of Ativan Tablets and how often you take them should always be reduced slowly before

you stop taking them altogether. This allows your body to get used to being without your tablets, and

reduces the risk of unpleasant effects when you stop taking them. Your doctor will tell you how to do

this.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Withdrawal Symptoms

On stopping Ativan Tablets, you may experience withdrawal symptoms such as headaches, muscle

pain,

anxiety,

tension,

depression,

restlessness,

dizziness,

nausea,

diarrhoea,

loss

appetite,

confusion, irritability, agitation, shaking, stomach pain, changes in heart rate, short-term memory loss,

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high body temperature and sweating. Your original sleeplessness may also return. If you suffer from

any of these symptoms, ask your doctor for advice.

Do not stop taking your tablets suddenly. This could lead to more serious withdrawal symptoms such

as a loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion.

Some patients have experienced numbness or tingling of the arms or legs, vomiting, tinnitus (ringing

sounds in your ears), twitching, hallucinations, convulsions and hypersensitivity to light, sound and

touch. If you suffer from any of these symptoms, ask your doctor for advice immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Benzodiazepines, including lorazepam, may lead to potentially fatal breathing problems.

Severe allergic reactions can occur with benzodiazepine use, even after the first dose.

Symptoms

include swelling of the tongue or throat, shortness of breath, throat closing, nausea or vomiting.

such cases, immediate medical attention should be sought.

Occasionally, you may have unwanted effects whilst taking Ativan 1mg Tablets. These are usually

not serious and do not last long. However, you should tell your doctor if any of your symptoms are

severe or become troublesome:

Other side effects that may occur are:

Very common: may affect more than 1 in 10 people

Sedation

Fatigue

Drowsiness

Common: may affect up to 1 in 10 people

Muscle weakness

Asthenia (loss of strength)

Ataxia (poor muscle control)

Confusion

Depression

Unmasking of depression (revealing signs of depression that were previously hidden)

Dizziness

Uncommon: may affect up to 1 in 100 people

Nausea

Change in libido

Impotence

Decreased orgasm

Not known: frequency cannot be estimated from the available data

Increased sensitivity to light, sound and touch

Convulsions/fits

Constipation, yellowing of the skin and eyes

Shaking

Problems with vision (double and blurred vision)

Slurred speech

Headache

Memory loss

Heightened emotions

Coma

Impaired attention/concentration

Loss of inhibitions

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Thoughts or attempts of suicide

Increase in specific liver enzymes (bilirubin, liver transaminases and alkaline phosphatase)

Anxiety, excitation, hostility, aggression, sexual arousal

Balance disorder

Difficulty breathing

Difficulty breathing when you are asleep

Worsening of lung disease

Allergic skin reactions (e.g. rash, swelling)

Alopecia (loss of hair from the head or body)

Hypersensitivity reactions

Angioedema (swelling of the face, hands and feet)

SIADH - syndrome of inappropriate antidiuretic hormone hypersecretion (a condition in which

the body produces too much antidiuretic hormone (ADH). Increased ADH may cause too much

water to remain inside your body.)

Hyponatremia (low level of sodium in the blood which can cause tiredness and confusion,

muscle twitching, fits and coma)

Hypothermia

Lowering of blood pressure

Thrombocytopenia (unexplained bruising, nosebleeds and/or bleeding gums), agranulocytosis

(severe infection), pancytopenia (bleeding, bruising easily, fatigue, shortness of breath, and

weakness)

Vertigo

Problems sleeping

The following side effects may be more likely to occur in children and elderly patients:

Restlessness

Agitation

Irritability

Aggressiveness

Violent anger

Nightmares

Hallucinations

Personality changes

Abnormal behaviour

False beliefs

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly (see details below). By reporting

side effects you can help provide more information on the safety of this medicine.

Ireland:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2.

Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;

E-mail:medsafety@hpra.ie

Malta

ADR Reporting: www.medicinesauthority.gov.mt/adrportal

5.

How to store Ativan Tablets

Keep this medicine out of the sight and reach of children.

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Do not use this medicine after the expiry date which is stated on the bottle label, blister and carton

after EXP. The expiry date refers to the last day of that month.

Do not store Ativan Tablets above 25

C. Blisters should be stored in the original package and bottles

should be kept tightly closed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6. Content of the pack and other information

What Ativan Tablets contains

The active ingredient is lorazepam. Each tablet contains 1mg of lorazepam. The other ingredients are

lactose monohydrate (see section 2 “Ativan Tablets contain lactose monohydrate”), microcrystalline

cellulose, polacrilin potassium and magnesium stearate .

What Ativan Tablets looks like and the contents of the pack

Ativan Tablets are round, flat, white, bevelled-edged tablets impressed with “1.0” on one side, and a

breakbar on the other.

Supplied in PVC blister packs of 30 and 100 tablets/ Strips of aluminium foil with PE-film strips of 10,

20 or 100 tablets or amber glass bottles with screw caps of 100 or 500 tablets.

However, your doctor may prescribe a different number of tablets for you.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder:

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Manufacturer:

Pfizer Ireland Pharmaceuticals

Little Connell

Newbridge

Co. Kildare

Republic of Ireland

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

D-79090 Freiburg

Germany

Company Contact Address:

For further information on your medicine contact Medical Information at the following address:

Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.

Telephone 01304 616161.

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This leaflet was last revised in MM/YYYY

Ref: AT 8_0

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Ativan 1 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains lorazepam 1mg.

Excipient(s) with known effect:

Lactose monohydrate 67.65mg per tablet.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet.

Round, flat, white, bevelled-edged tablets, impressed with ‘1.0’ on one side and a breakbar on the other.

The tablet can be divided into equal halves.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Ativan 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. Ativanmay also be 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.

Dosage:

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 operatio

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 warnings and precautions for use)

Paediatric population (aged 5-13 years):

Premedication: 0.5 - 2.5mg at 0.05mg/kg to the nearest 0.5mg according to weight, not less than one hour before operation.

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Ativan is not recommended for the treatment of anxiety or insomnia in children.

Patients with Renal or Hepatic impairment:

Lower doses may be sufficient in patients with impaired renal function or mild to moderate hepatic insufficiency (see section

4.4). Use in patients with severe hepatic insufficiency is contraindicated (see section 4.3).

Method of Administration:

Ativan tablets are for oral administration only.

4.3 Contraindications

Hypersensitivity to lorazepam, other benzodiazepines or to any of the excipients listed in section 6.1

Severe respiratory insufficiency

Sleep apnoea syndrome

Myasthenia gravis

Severe hepatic insufficiency

4.4 Special warnings and precautions for use

Use of benzodiazepines, including lorazepam, may lead to potentially fatal respiratory depression.

Severe anaphylactic/anaphylactoid reactions have been reported with the use of benzodiazepines. Cases of angioedema

involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of

benzodiazepines. Some patients taking benzodiazepines have had additional symptoms such as dyspnoea, throat closing, or

nausea and vomiting. Some patients have required medical therapy in the emergency department. If angioedema involves the

tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with a

benzodiazepine should not be rechallenged with the drug.

Lorazepam should be used with caution in patients with compromised respiratory function (e.g., COPD, sleep apnoea

syndrome).

Patients should be advised that since their tolerance for alcohol and other CNS depressants will be diminished in the presence

of lorazepam, these substances should either be avoided or taken in reduced dosage.

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.

Abuse of benzodiazepines has been reported, especially in patients with a history of drug and/or alcohol abuse.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Limit dosages and durations to the minimum required.

Tolerance

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

There is evidence that tolerance develops to the sedative effects of benzodiazepines.

Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse.

Dependence

The use of benzodiazepines may lead to physical and psychological dependence. The risk of dependence on Ativan is low

when used at the recommended dose and duration, but increases with higher doses and longer term use. The risk of

dependence is further increased in patients with a history of alcoholism or drug abuse, or in patients with significant

personality disorders. Therefore, use in individuals with a history of alcoholism or drug abuse should be avoided.

Dependence may lead to withdrawal symptoms, especially if treatment is discontinued abruptly. Therefore, the drug should

always be discontinued gradually.

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Withdrawal symptoms (e.g. rebound insomnia) can appear following cessation of recommended doses after as little as one

week of therapy. Abrupt termination of treatment may be accompanied by withdrawal symptoms.

Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression,

insomnia, restlessness, dizziness, nausea, diarrhoea, loss of appetite, confusion, hallucinations/delirium, perceptual changes,

irritability, dysphoria, convulsions/seizures, tremor, abdominal cramps, myalgia, agitation, palpitations, tachycardia, panic

attacks, vertigo, hyperreflexia, short-term memory loss, hyperthermia, sweating, and the occurrence of "rebound" phenomena

whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form. These symptoms may be

difficult to distinguish from the original symptoms for which the drug was prescribed.

In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, tinnitus, numbness and

tingling of the extremities, hypersensitivity to light, noise, and physical contact/perceptual changes, involuntary movements,

vomiting, hallucinations, convulsions. Convulsions/seizures may be more common in patients with pre-existing seizure

disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants.

Duration

Treatment should be as short as possible. Generally, the duration of treatment varies from a few days to 4 weeks including the

tapering off process.

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.

There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become

manifest within the dosage interval, especially when the dosage is high.

When benzodiazepines with a long duration of action are being used it is important to warn against changing to a

benzodiazepine with a short duration of action, as withdrawal symptoms may develop.

Amnesia

Transient anterograde amnesia or memory impairment has been reported in association with the use of benzodiazepines. This

effect may be advantageous when Ativan is used as a premedicant. However, if Ativan 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).

Psychiatric and paradoxical reactions

Paradoxical reactions have been occasionally reported during benzodiazepine use (see section 4.8). Such reactions may be

more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued.

Specific patient groups

Ativan is not intended for the primary treatment of psychotic illness or depressive disorders, and should not be used alone to

treat depressed patients. The use of benzodiazepines may have a disinhibiting effect and may release suicidal tendencies in

depressed patients. Therefore, large quantities of Ativan should not be prescribed to these patients. The use of

benzodiazepines in these patients should not be used without adequate antidepressant therapy.

Pre-existing depression may emerge during benzodiazepine use.

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

Patients with impaired renal function or mild to moderate hepatic insufficiency 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.

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Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver

enzymes. Periodic haematologic and liver-function assessments are recommended where repeated courses of treatment are

considered clinically necessary.

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. Elderly patients should be warned of the risk of falls due to the myorelaxant effect of lorazepam.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

should not take this medicine.

Elderly patients

Lorazepam should be used with caution in elderly due to the risk of sedation and/or musculoskeletal weakness that can

increase the risk of falls, with serious consequences in this population. Elderly patients should be given a reduced dose (see

section 4.2 Posology).

4.5 Interaction with other medicinal products and other forms of interactions

Not recommended: Concomitant intake with alcohol

The sedative effects may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or

use machines.

The benzodiazepines, including lorazepam produce additive central nervous system (CNS) depressant effects, including

respiratory depression when co-administered with other medications which themselves produce CNS depression e.g., opioids,

barbiturates, antipsychotics, sedatives/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines,

anticonvulsants, and anaesthetics (see section 4.4).

An enhancement of the euphoria induced by narcotic analgesics may occur with benzodiazepine use, leading to an increase in

psychic dependence.

Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of

benzodiazepines. To a lesser degree this also applies to benzodiazepines which are metabolised only by conjugation.

There have been reports of excessive stupor, significant reduction in respiratory rate and, in one patient, hypotension when

lorazepam and loxapine have been given concomitantly.

There have been reports of marked sedation, excessive salivation, and ataxia when lorazepam and clozapine have been given

concomitantly.

Concurrent administration of lorazepam with sodium valproate may result in increased plasma concentrations and reduced

clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with sodium

valproate.

Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam

due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when

coadministered with probenecid.

Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

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. In particular, an increased risk of congenital malformations

associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested in several studies. In

humans, umbilical cord blood samples indicate placental transfer of benzodiazepines and their glucuronide metabolites.

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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.

If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labour at high

doses, effects on the neonate can be expected due to the pharmacological action of the compound.

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.

Breast-feeding:

There is evidence that lorazepam is excreted, albeit in pharmacologically insignificant amounts, in human breast milk.

Therefore, Ativan should not be given to breastfeeding mothers unless the expected benefit to the mother outweighs the

potential risk to the infant. Sedation and inability to suckle have occurred in neonates of lactating mothers taking

benzodiazepines. Infants of lactating mothers should be observed for pharmacological effects (including sedation and

irritability).

4.7 Effects on ability to drive and use machines

Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use

machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see section 4.5). Patients should

be warned not to operate dangerous machinery or motor vehicles if any of these effects occur.

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.

System Organ

Class

Very Common

≥ 1/10

Common

≥ 1/100 to

< 1/10

Uncommon

≥ 1/1,000

to

< 1/100

Frequency

not known (cannot be estimated from the available

data)

Blood and

lymphatic

system

disorders

Thrombocytopenia, agranulocytosis, pancytopenia

Immune system

disorders

Hypersensitivity reactions, anaphylactic/oid reactions

Endocrine

disorders

SIADH

Metabolism and

nutrition

disorders

Hyponatremia

Psychiatric

disorders

Confusion,

depression,

unmasking

depression

Change in

libido,

decreased

orgasm

Disinhibition, euphoria, suicidal ideation/attempt,

paradoxical reactions, including anxiety, agitation,

excitation, hostility, aggression, rage, sleep

disturbances/insomnia, sexual arousal, hallucinations

Nervous system

disorders

Sedation, drowsiness

Ataxia,

dizziness

Extrapyramidal symptoms, tremor, dysarthria/slurred

speech, headache, convulsions/seizures, amnesia, coma,

impaired attention/concentration, balance disorder

Eye disorders

Visual disturbances (including diplopia and blurred

vision)

Ear and

Vertigo

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System Organ

Class

Very Common

≥ 1/10

Common

≥ 1/100 to

< 1/10

Uncommon

≥ 1/1,000

to

< 1/100

Frequency

not known (cannot be estimated from the available

data)

labyrinth

disorders

Vascular

disorders

Hypotension, lowering in blood pressure

Respiratory,

thoracic and

mediastinal

disorders

Respiratory depression,

apnea, worsening of sleep

apnea, worsening of obstructive pulmonary disease

Gastrointestinal

disorders

Nausea

Constipation

Hepatobiliary

disorders

Jaundice

Skin and

subcutaneous

tissue disorders

Angioedema, allergic skin reactions, alopecia

Musculoskeletal

and connective

tissue disorders

Muscle

weakness

Reproductive

system and

breast disorders

Impotence

General

disorders and

administration

site conditions

Fatigue

Asthenia

Hypothermia

Investigations

Increase in bilirubin, increase in liver transaminases,

increase in alkaline phosphatase

± Benzodiazepine effects on the CNS are dose-dependent, with more severe CNS depression occurring with high doses.

β The extent of respiratory depression with benzodiazepines is dose-dependent, with more severe depression occurring with

high doses.

Pre-existing depression may emerge during benzodiazepine use.

Transient anterograde amnesia or memory impairment may occur using therapeutic doses, the risk increasing at higher doses

(see section 4.4)

Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rage, nightmares, hallucinations,

psychoses, and inappropriate behaviour have been occasionally reported during benzodiazepine use. Such reactions may be

more likely to occur in children and the elderly (see section 4.4 ).

Use (even at therapeutic doses) may lead to physical or psychological dependence and discontinuation of treatment may result

in withdrawal reactions or rebound phenomena (see section 4.4 ).

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. In

postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other

drugs.

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Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from

drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy. In more serious cases, and

especially when other CNS-depressant drugs or alcohol are ingested, symptoms may include dysarthia, ataxia, paradoxical

reactions, CNS depression, hypotension, hypotonia, respiratory depression, cardiovascular depression, coma, and very rarely,

death.

When there is a risk of aspiration, induction of emesis is not recommended. If ingestion was recent, induced vomiting and/or

gastric lavage should be undertaken followed by general supportive care, monitoring of vital signs and close observation of the

patient. If there is no advantage in emptying the stomach, activated charcoal may be effective in reducing absorption.

Hypotension, though unlikely, may be controlled with noradrenaline. Lorazepam is poorly dialysable. Lorazepam glucuronide,

the inactive metabolite, may be highly dialysable.

The benzodiazepine antagonist, flumazenil may be useful in hospitalised patients as an adjunct to, not as a substitute for,

proper management of benzodiazepine overdose. Flumazenil product information should be consulted prior to use. The

physician should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term

benzodiazepine users and in cyclic antidepressant overdose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacological class: Benzodiazepine

Therapeutic class: Anxiolytic

ATC code: NO5BA06

Lorazepam is a benzodiazepine with anxiolytic, sedative, hypnotic and muscle relaxant properties.

5.2 Pharmacokinetic properties

Absorption:

Lorazepam is almost completely absorbed from the gastrointestinal tract and peak serum levels are reached in 2 hours.

Metabolism:

It is metabolised by a simple one-step process to a pharmacologically inert glucuronide. There are no major active

metabolites.

Elimination:

The elimination half-life is about 12 hours and there is minimal risk of excessive accumulation. At clinically relevant

concentrations, lorazepam is approximately 90% bound to plasma proteins.

5.3 Preclinical safety data

Oesophageal dilation occurred in rats treated with lorazepam for more than one year at 6 mg/kg/day.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Microcrystalline cellulose

Polacrilin potassium (Amberlite)

Magnesium stearate

6.2 Incompatibilities

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Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Blisters - Do not store above 25°C. Store in the original package.

Bottles - Do not store above 25°C. Keep the container tightly closed.

6.5 Nature and contents of container

1. PVC blister packs of 30 or 100 tablets.

2. Strips of aluminium foil with PE-film strips of 10, 20, or 100 tablets.

3. Amber glass bottles with screw caps of 100 or 500 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0822/090/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 10 January 1997

Date of last renewal: 10 January 2007

10 DATE OF REVISION OF THE TEXT

March 2019

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