Lorazepam Tablets USP 2.5mg Taj Pharma

Rx Only

Lorazepam Tablets USP 0.5mg/1mg/2mg/2.5mg Taj Pharma
(Lorazepam)

  1. Name of the medicinal product

Lorazepam Tablets USP 0.5mg/1mg/2mg/2.5mg Taj Pharma

  1. Qualitative and quantitative composition
    a) Lorazepam Tablets USP 0.5mg
    Each tablet contains
    Lorazepam USP                    0.5mg
    Excipients                               q.s.
    b) Lorazepam Tablets USP 1mg
    Each tablet contains
    Lorazepam USP                    1mg
    Excipients                               q.s.
    c) Lorazepam Tablets USP 2mg
    Each tablet contains
    Lorazepam USP                   2mg
    Excipients                              q.s.
    d) Lorazepam Tablets USP 2.5mg
    Each tablet contains
    Lorazepam USP                   2.5mg
    Excipients                             q.s.

Lorazepam (INN, BAN) is chemically defined as 7-chloro-5-(0-chlorphenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one.

  1. Pharmaceutical form
    Tablets.
  2. Clinical particulars

4.1 Therapeutic indications

FOR SHORT TERM (2-4 weeks only) USE (adults only)

  • Symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress occurring alone or in association with insomnia or short-term psychometric, organic or psychotic illness.

AS PREMEDICATION (adults and children 5 years and above)

Before operative dentistry and general surgery

NOT FOR USE

  • Long term (i.e. longer than 4 weeks)
  • For mild/moderate anxiety
  • For insomnia or anxiety in children

4.2 Posology and method of administration

Route of administration: oral

Treatment to be given:

  • Under close medical supervision
  • At the lowest effective dose
  • For the shortest possible duration (not exceeding 4 weeks)

Doses should be individualised

Extension of use should not take place without further clinical evaluation

Chronic use not recommended (little is known of the long term safety and efficacy; potential for dependence–see section 4.4

When treatment is started the patient should be informed that

  • treatment will be of limited duration
  • the dosage will be progressively decreased
  • there is a possibility of rebound phenomena

Dosage:

Adults:

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 the procedure

Elderly:

The elderly may respond to lower doses (half normal adult dose or less)

Children (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.

Patients with Renal or Hepatic impairment:

Lower doses may be sufficient in these patients (See section 4.4). Use in patients with severe hepatic insufficiency is contraindicated. (See section 4.6).

4.3 Contraindications

  • Hypersensitivity to benzodiazepines or to any of the other ingredients
  • Acute pulmonary insufficiency: respiratory depression; sleep apnoea (risk of further respiratory depression)
  • Obsessional states (inadequate evidence of safety and efficacy)
  • Severe hepatic insufficiency (may precipitate encephalopathy)
  • Planning a pregnancy (see section 4.6)
  • Pregnancy (unless there are compelling reasons- see section 4.6)
  • Myasthenia gravis;

Benzodiazepines should not be used alone in depression or anxiety with depression (may precipitate suicide)

4.4 Special warnings and precautions for use

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.

Due to the potential adverse reactions including ataxia, muscle weakness, dizziness, drowsiness and fatigue (see Section 4.8), Benzodiazepines may be associated with an increased risk of falling especially in elderly patients. As a result, caution should be exercised particularly when getting up at night. The elderly should receive a reduced dose (see section 4.2).

Lorazepam 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 Lorazepam should not be prescribed to these patients.

Pre-existing depression may emerge during benzodiazepine use.

The use of benzodiazepines may lead to physical and psychological dependence. The risk of dependence on Lorazepam 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. (see 4.8 Undesirable effects). 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 Lorazepam is used as a premedicant. However, if Lorazepam 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.

Risk from concomitant use of opioids:

Concomitant use of lorazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as lorazepam with opioids should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe lorazepam concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of these symptoms (see section 4.5).

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

Lorazepam 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

Opioids

The concomitant use of sedative medicines such as benzodiazepines or related drugs such as lorazepam with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see section 4.4).

Centrally acting drugs

Enhancement of the central depressive effect may occur if lorazepam 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 lorazepam (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 lorazepam.

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 (risk of falling, see Section 4.4)

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 lorazepam

Zidovudine

Increased zidovudine clearance by lorazepam

Oestrogen-containing contraceptives

Possible inhibition of hepatic metabolism of lorazepam

Theophylline/aminophylline

Increases metabolism of lorazepam which possibly reduces the effect

Caffeine

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

Grapefruit juice

Inhibition of CYP3A4 may increase the plasma concentration of lorazepam (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: Lorazepam 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 (see section 4.5)

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 4.9 Overdose)

Eye disorders

Rare: Visual disturbances (diplopia, blurred vision)

Vascular disorders

Rare: Hypotension (see 4.4 Special warnings and precautions)

Respiratory thoracic and mediastinal disorders:

Rare: Apnoea, worsening of sleep apnoea, worsening of obstructive pulmonary disease. Respiratory depression (see 4.9 Overdose).

Gastrointestinal disorders

Rare: Nausea, constipation, salivation changes

Hepatobiliary disorders

Rare: Abnormal liver function test values (increases in bilirubin, transaminases, alkaline phosphatise), jaundice

Skin and subcutaneous tissue disorders

Rare: Rash, allergic dermatitis

Musculoskeletal disorders

Common: Muscle weakness

Reproductive system and breast disorders

Rare: Impotence

General disorders

Common: Asthenia, fatigue

Very rare: Hypothermia

Drug withdrawal symptoms (see 4.4 Special warnings and precautions)

Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, 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; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions. Convulsions 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.

Injury, poisoning and procedural complications

Not known: Fall

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

4.9 Overdose

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

Overdose 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 ataxia, hypotension, hypotonia, respiratory depression, coma, and very rarely, death.

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.

The benzodiazepine antagonist, flumazenil may be useful in hospitalised patients for the management of benzodiazepine overdose. Flumazenil product information should be consulted prior to use.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Lorazepam is almost completely absorbed from the gastrointestinal tract and peak serum levels are reached in 2 hours. It is metabolised by a simple one-step process to a pharmacologically inert glucuronide. There are no major active metabolites. The elimination half-life is about 12 hours and there is minimal risk of excessive accumulation.

5.3 Preclinical safety data

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

  1. Pharmceutical particulars

6.1 List of excipients

Lactose 72 mesh, Lactose powdered anhydrous, microcrystalline cellulose, polacrilin potassium, magnesium stearate, Colouring agents.

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Store in a cool, dry place.

6.5 Nature and contents of container

  1. Blister packs of PVC backed by hard tempered aluminium foil: Pack sizes of 28, 30, 56, 60 or 100 tablets.
  2. Opaque polypropylene Securitainers with opaque polythene caps: Pack sizes of 28, 30, 56, 60, 100, 500 or 1000 tablets.
  3. Amber glass bottles with screw caps: Pack sizes of 28, 30, 56, 60, 100, 500 or 1000 tablets.
    Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

None stated.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

                                                                                                                                   Rx Only

                                                                                      Lorazepam Tablets USP 0.5mg/1mg/2mg/2.5mg Taj Pharma
                                                                                                                                (Lorazepam)

Read all of this leaflet carefully before you start taking this medicine.

– 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. Do not pass it on to others. It may harm

them, even if their symptoms are the same as yours.

– If any of the side-effects get serious, or if you notice any side-effects not listed in

this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  1. What Lorazepam Tablets are and what they are used for
  2. Before you take Lorazepam Tablets
  3. How to take Lorazepam Tablets
  4. Possible side-effects
  5. How to store Lorazepam Tablets
  6. Further information
  7. WHAT LORAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Lorazepam Tablets. Lorazepam is a member of a group of medicines called benzodiazepines. It can help to relieve anxiety. Lorazepam is prescribed as short-term therapy for anxiety (2-4 weeks), or sleeping difficulties due to anxiety. It may also be used as a sedative before surgery or operative dental treatment.

Lorazepam Tablets are not to be used for longer than 4 weeks, to treat mild or moderate anxiety in adults or for anxiety/insomnia in children.

  1. BEFORE YOU TAKE LORAZEPAM TABLETS

Do not take Lorazepam Tablets:

  • if you have severe breathing or chest problems
  • if you are allergic to benzodiazepines or any of the other ingredients in Lorazepam
  • Tablets (see list under ‘What Lorazepam Tablets contain’)
  • 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 you are breast-feeding, since the drug may pass into breast milk.
  • if you are planning a pregnancy or are pregnant.

If you have been only prescribed Lorazepam Tablets for anxiety and no other medications, please consult with your doctor whether other medications should also be prescribed.

Warnings and precautions

Talk to your doctor before using Lorazepam Tablets:

  • 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 lorazepam
  • if you have any kidney or liver problems
  • if you are suffering from depression, since lorazepam may increase any suicidal feelings which you may have
  • if you have suffered from depression before, since it could re-occur during treatment with lorazepam
  • if you suffer from breathing problems
  • if you are suffering from an eye problem called glaucoma e.g. high pressure within the eye.

Lorazepam may cause muscle relaxation and caution is advised as you may be at a greater risk of falling (see section 4).

Taking other medicines

Tell your doctor or pharmacist that you are taking lorazepam before taking any other medicine or if you enter hospital for treatment, or if you are taking any other medicines, including those which have not been prescribed by a doctor, since they may affect the way Lorazepam Tablets work.

Lorazepam Tablets may also affect the way other drugs work. In particular, you should tell your doctor if you are taking any other sedative (e.g. barbiturates or antihistamines), anti-anxiety drugs, anti-depressants, strong pain killers (e.g. methadone), drugs for epilepsy (e.g. phenobarbital or valproate), antihistamines, or drugs for mood or mental disorders (e.g. chlorpromazine, loxapine or clozapine), drugs for cataplexy; treating HIV; to treat delusions or hallucinations; to help with indigestion (e.g. omeprazole); muscle relaxants (e.g. baclofen and tizanidine); drugs for addiction treatment (e.g. lofexidine and disulfiram); TB drugs such as isoniazid; antibiotics such as erythromycin; drugs to treat high blood pressure; Parkinson’s disease drugs e.g. levodopa; oestrogen-containing contraceptives and drugs for asthma (theophylline). The dose of these drugs may need to be reduced before you can take lorazepam.

Concomitant use of this product and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe this product together with opioids the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Using Lorazepam with food or drink

Grapefruit juice and drinks containing caffeine should be avoided as they can affect the way that Lorazepam Tablets work.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, or might become pregnant, without

consulting your doctor. Benzodiazepines, including lorazepam, 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. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms after birth.

Do not take this medicine if you are breast-feeding, since the drug may pass into breast milk, and cause the baby to be less active and unable to suckle.

Driving and using machines

Lorazepam may make you feel dizzy, sleepy or forgetful during the day, or may affect your concentration. This may affect your performance at skilled tasks such as driving machinery or operating machinery by affecting your vision or muscle function. You should not take part in any other activities where this could put yourself or others at risk.

You should avoid alcohol while you are taking lorazepam, since this may make you very drowsy and seriously affect your ability to drive or use machines.

The medicine can affect your ability to drive as it may make you feel sleepy or dizzy.

  • Do not drive while taking this medicine until you know how it affects you.
  • It is an offence to drive if this medicine affects your ability to drive.
  • However, you would not be committing an offence 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 or in the

information provided with the medicine and

○ It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Important information about some of the ingredients of Lorazepam Tablets.

The 2.5mg Lorazepam Tablet contains the colour tartrazine (E102) which can cause allergic reactions, including asthma, especially if you are also allergic to aspirin.

Each tablet also contains the equivalent of 0.25mg of potassium. Too much potassium may be harmful if you are on a low potassium diet.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  1. HOW TO TAKE LORAZEPAM TABLETS

Always take Lorazepam Tablets exactly as your doctor has told you. The label on your medicine should also tell you. You should check with your doctor or pharmacist if you are not sure. Lorazepam Tablets should be swallowed with water.

Adults (and children over 13 years of age)

– Anxiety: 1 to 4mg daily in divided doses. Your doctor will tell you how often to take your tablets.

– Sleeping Problems: 1 to 2mg 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 3mg the night before your operation and 2 to 4mg 1 or 2 hours before your operation.

Children (between 5 and 13 years of age)

– Before Surgery: The dose is usually between 0.5 and 2.5mg (depending on your child’s weight) at least 1 hour before your child’s operation.

– Lorazepam is not recommended for the treatment of anxiety or sleeping problems in children. Nor is it recommended for children below 5 years of age.

Elderly or patients with liver or kidney problems

– Older patients may be given lower doses. They may respond to half the usual adult dose or less.

Lorazepam is 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 Lorazepam Tablets, or suffering unpleasant effects when you stop taking them. (See ‘If you stop taking Lorazepam Tablets’ section).

The beneficial effect of Lorazepam Tablets may be less apparent after several weeks of use. If you are given lorazepam for more than 4 weeks, your doctor might want to take blood samples occasionally to check your blood and liver, since drugs like lorazepam have occasionally affected blood and liver function.

If you take more Lorazepam Tablets than you should

If anyone has taken an overdose of Lorazepam 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 Lorazepam Tablets

Do not take a double dose to make up for a forgotten tablet. If you forget to take a tablet for anxiety, you should take it as soon as you remember if it is less than 3 hours since your usual time. If more than 3 hours has passed from when you usually take your tablet, just take your next tablet when it is due.

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 Lorazepam Tablets

– After you have finished your prescribed treatment with lorazepam, your doctor will decide if you need further treatment.

– The number of Lorazepam Tablets and how often you take them should always be reduced slowly before stopping them. 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.

– On stopping lorazepam, you may experience symptoms such as headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability.

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 symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

– Patients taking anti-depressants and patients with seizure disorders may be more likely to experience convulsions.

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

  1. POSSIBLE SIDE-EFFECTS

Like all medicines, Lorazepam Tablets can cause side-effects, although not everybody gets them.

If you experience any of the following serious unwanted effects, you should tell your doctor immediately (these effects are more likely to occur in children and elderly patients):

Restlessness, agitation, irritability, aggressiveness, violent anger, sleeping difficulties, nightmares, hallucinations, personality changes, sexual arousal, abnormal behaviour or false beliefs.

Unexplained bleeding and/or bruising; increased risk of infections e.g. frequent sore throats, mouth ulcers, weakness and pale skin as these are symptoms of blood dyscrasia.

Impaired consciousness (e.g. reduced alertness, confusion, disorientation, fainting) as this may ultimately lead to coma.

Thoughts of harming or killing yourself, becoming dependent on Lorazepam.

Severe allergic reactions e.g. difficulty in breathing, swelling of the lips, mouth, tongue, throat, hands, feet and /or severe faintness or dizziness.

Jaundice e.g. yellowing of the skin, eyes, nose, mouth, pale coloured stools (faeces) and dark coloured urine.

Other side effects

Very common (may affect more than 1 in 10 people):

Daytime drowsiness.

Common (may affect around 1 in 100 people):

Dizziness, poor muscle control, muscle weakness, fatigue.

Rare (may affect around 1 in 1,000 people):

Depression, numbed emotions, difficulty controlling urges and impulses to speak, act or show emotions, a feeling of well-being for no reason, appetite changes, sleep problems, changes in sex drive, decreased orgasm, headache, slurred speech, memory loss or forgetfulness, problems with vision including double vision or blurred vision, worsening of sleep apnoea (e.g. loud snoring, restlessness and choking/gasping during the night), breathing difficulties, stomach upsets, nausea, constipation, changes in the amount of saliva in the mouth, skin problems such as rashes and inflammation, erectile dysfunction, blood or liver function changes, low blood pressure or low body temperature.

Very rare (may affect around 1 in 10,000 people):

Trembling or shaking.

Not known (frequency cannot be estimated from the available data:

Increased risk of falling.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly.

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

  1. HOW TO STORE LORAZEPAM TABLETS

Keep out of the sight and reach of children.

Do not take Lorazepam Tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.

Lorazepam Tablets should be kept in a cool, dry place. They should be stored safely, where children cannot see or reach them.

Return any unused tablets to your pharmacist. Only keep them if your doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

  1. FURTHER INFORMATION

What Lorazepam Tablets contain

The active substance in both 1mg and 2.5mg tablets is lorazepam. Each tablet contains either 1mg of lorazepam (blue tablets) or 2.5mg lorazepam (yellow tablets).

The other ingredients are lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate and either indigo carmine (blue tablet) or tartrazine (yellow tablet).

What Lorazepam Tablets look like and the contents of the pack

Lorazepam Tablets are blue (1mg) or yellow (2.5mg) capsule-shaped tablets, plain on one face and with a break bar on the other face. Each pack contains 28 tablets.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com