Lorazepam Normon 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lorazepam Normon 2 mg tablets EFG

Lorazepam

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Lorazepam Normon is and what it is used for
2. What you need to know before taking Lorazepam Normon
3. How to take Lorazepam Normon
4. Possible side effects
5. How to store Lorazepam Normon
6. Contents of the pack and other information

1. What Lorazepam Normon is and what it is used for

This medicine contains the active substance lorazepam, a sedative and anxiolytic (tranquilizer) medicine belonging to a group of medicines called "benzodiazepines".

What it is used for:

• Short-term symptomatic treatment of anxiety and sleep disorders caused by anxiety, when the anxiety is severe, disabling, or causes the individual unacceptable distress.
• Preoperative sedation before diagnostic procedures, as well as prior to surgical interventions.

2. What you need to know before taking Lorazepam Normon

Do not take Lorazepam Normon

• If you are allergic to the active substance, to other benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have ever had addiction to any medication, alcohol, or drugs.
• If you have severe respiratory problems, e.g. chronic obstructive pulmonary disease (COPD).
• If you have abnormal muscle weakness (myasthenia gravis).
• If you have movement coordination problems (spinal and cerebellar ataxias).
• If you have severe liver problems.
• If you suffer from breathing difficulties while sleeping (sleep apnea syndrome).
• In case of acute intoxication with alcohol or central nervous system (CNS) depressants (e.g. sleeping pills or analgesics, medications for mental disorders such as antipsychotics, antidepressants, and lithium).
• If you are under 6 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking lorazepam if:

• You have difficulty controlling your movements (spinal or cerebellar ataxia).
• You suffer from respiratory problems, e.g. chronic obstructive pulmonary disease.
• Your liver or kidney function is impaired.
• You have a specific eye condition called glaucoma, e.g. high pressure inside the eye.
• You abuse or have previously abused drugs or alcohol.
• You have a personality disorder; this may mean you have a higher risk of becoming dependent on lorazepam.
• You have previously suffered from depression, as it could reappear during treatment with lorazepam.
• You suffer from depression, as lorazepam may increase suicidal thoughts or feelings you may have.
• You are elderly, as you are more likely to experience falls.
• You have low blood pressure.

Some patients have experienced suicidal thoughts while taking medicines containing lorazepam, especially if they are already depressed. If you are depressed, have fears or irrational obsessions, or have started having suicidal thoughts or self-harming impulses, inform your doctor immediately.

At the beginning of therapy, your doctor will monitor your individual response to this medicine so that any possible overdose can be detected as early as possible. If you are a child, elderly, or debilitated patient, you may show a more sensitive response to the effect of lorazepam. Therefore, therapy should be monitored more frequently.

If you have impaired kidney or liver function, heart failure and/or low blood pressure (hypotension), you may be more sensitive to the effects of this medicine; the same applies if you are elderly. You may be at increased risk of falls, especially when getting up at night.

You may develop hepatic encephalopathy (brain disease due to liver damage) with the use of lorazepam. Therefore, lorazepam should not be used in patients with severe liver failure and/or hepatic encephalopathy.

You may experience memory loss during treatment with lorazepam.

When you take the tablet before going to sleep, you should ensure that you will be able to sleep uninterrupted for 7–8 hours after taking the tablet. Following this recommendation will usually help you avoid next-day side effects (e.g. tiredness, impaired reaction ability).

Ask your doctor for more detailed advice on how to manage your daily life, taking into account your particular lifestyle (e.g. your profession).

Rare cases of paradoxical reactions have been reported with the use of benzodiazepines, such as anxiety, agitation, delirium, irritability, aggressive behavior, sleep disturbances, sexual excitement, hallucinations, psychosis (see section 4). These reactions are more likely if you are a child or an elderly patient. Treatment with lorazepam should be discontinued if paradoxical reactions occur.

With the use of benzodiazepines, including lorazepam, potentially life-threatening respiratory depression may occur.

There is a risk of dependence when taking this medicine, which increases with dose and duration of treatment, and also in patients with a history of alcoholism or drug abuse. Therefore, you should take this medicine for the shortest time possible (see section 4).

If after a few weeks you notice that the medicine is not working as well as it did at the beginning of treatment, you should consult your doctor.

Treatment with lorazepam should be discontinued gradually to avoid withdrawal symptoms. See section 3.

Severe allergic reactions have been reported with the use of benzodiazepines. Some patients have developed swelling of the skin and/or mucous membranes affecting the tongue, larynx, or vocal cord area (angioedema) after taking the first or subsequent doses of benzodiazepines. Some patients have experienced other symptoms while taking benzodiazepines, such as difficulty breathing (dyspnea), throat swelling, or nausea and vomiting.

Some patients required urgent treatment. If these symptoms occur, inform your doctor immediately or go to hospital straight away. Airway obstruction may occur, which could be fatal.

Children and adolescents

As with other benzodiazepines, lorazepam should not be administered to children under 18 years of age, unless urgently needed for sedation before surgery or diagnostic procedures. Lorazepam is contraindicated in children under 6 years of age. Further information can be found in the following section.

Other medicines and Lorazepam Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular:

• Medicines for narcolepsy (excessive daytime sleepiness and sleep attacks) with cataplexy (e.g. sodium oxybate).
• Medicines for treating delusions or hallucinations (e.g. chlorpromazine, loxapine, or clozapine).
• Medicines to aid digestion (e.g. antacids or omeprazole).
• A medicine used to control chemotherapy-induced nausea and vomiting called nabilone.
• Medicines for treating addiction (e.g. lofexidine).
• Strong analgesics (e.g. methadone, tramadol, codeine, morphine).
• Medicines used to treat tuberculosis, such as isoniazid.
• Antibiotics, such as erythromycin.
• Medicines for treating high blood pressure (e.g. ACE inhibitors, alpha-blockers, angiotensin II receptor antagonists, calcium channel blockers, adrenergic neuron blockers, beta-blockers, moxonidine, nitrates, hydralazine, minoxidil, sodium nitroprusside, and diuretics).
• Medicines used to treat asthma (e.g. theophylline).
• Muscle relaxants (e.g. baclofen and tizanidine).
• Other sedatives (e.g. barbiturates or sedative antihistamines).
• Other medicines used to treat anxiety.
• Medicines used to treat depression.
• Antihistamines for allergies.
• Medicines for Parkinson's disease, e.g. levodopa.
• Medicines for epilepsy (e.g. phenobarbital or valproate/valproic acid).
• A medicine for gout called probenecid.
• Medicines affecting liver enzymes (e.g. cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If you use this medicine together with other central nervous system (CNS) depressants (e.g. psychotropic agents, sleeping pills, sedatives, anesthetics, beta-blockers, opioid-type analgesics, sedative antihistamines, antiepileptics), an interaction may occur, resulting in additive CNS depressant effects.

Concomitant use of this medicine and opioids (e.g. strong analgesics, some cough medicines, and medicines for substitution therapy) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes lorazepam together with opioids, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all opioid medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

The effect of muscle relaxants and analgesics may be increased.

If lorazepam is used together with clozapine, intense sedation, excessive salivation, and impaired movement coordination may occur.

Concomitant administration of lorazepam and valproic acid/sodium valproate may increase lorazepam blood levels. If valproic acid/sodium valproate is used concomitantly, the dose of this medicine should be reduced by approximately half.

Concomitant administration of lorazepam and probenecid may accelerate the onset of action or prolong the effect of lorazepam. If used together with probenecid, the dose of this medicine should be reduced by half.

The use of theophylline or aminophylline may reduce the sedative effect of lorazepam.

Taking Lorazepam Normon with food, drinks, and alcohol

You should avoid drinking alcohol, as alcohol can unpredictably alter and enhance the effects of lorazepam.

Grapefruit juice and caffeine-containing beverages should also be avoided, as they may affect how lorazepam works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

This medicine should not be taken during pregnancy.

Inform your doctor immediately if you become pregnant while taking lorazepam; your doctor will decide whether treatment should be discontinued.

Prolonged use of lorazepam during pregnancy may cause withdrawal symptoms in the newborn. Administration of lorazepam late in pregnancy or during delivery may result in the baby having reduced activity, reduced muscle tone, lowered body temperature (hypothermia) and/or blood pressure (hypotonia), respiratory insufficiency, apnea, and difficulty feeding (known as "floppy infant syndrome"). In addition, cases of malformation and mental retardation in children with prenatal exposure after lorazepam overdose or intoxication have been reported.

Breastfeeding

Since the active substance of this medicine, lorazepam, passes into breast milk, it should not be taken during breastfeeding. Taking this medicine while breastfeeding may cause sedation and feeding difficulties in the infant.

Driving and using machines

Even if you take this medicine as directed, you should expect your reaction abilities to be impaired, especially during the first days of treatment. In this case, you may not be able to react quickly enough to unexpected or sudden events. Do not drive a car or any other vehicle. Do not use dangerous electrical tools or machinery. Do not work without secure support. In particular, remember that alcohol will further impair your reaction ability.

The decision on how far you can drive or perform other hazardous activities will be made by your doctor, taking into account your individual response and dose.

Lorazepam Normon contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Lorazepam Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again. The dose and duration of treatment must be adjusted according to the individual response to treatment, the indication, and the severity of the illness. As a general rule, the dose should be as low as possible, and the duration of treatment should be as short as possible.

Dosage

Follow the instructions for use exactly, as otherwise this medicine may not work properly.

Unless your doctor has prescribed lorazepam differently, the following information applies:

Treatment of anxiety states and sleep disorders caused by anxiety

The usual daily dose for adults is 0.5 to 2.5 mg of lorazepam, divided into 2 or 3 doses or as a single nightly dose. In isolated cases, especially in hospitalized patients, the daily dose may be increased up to a maximum of 7.5 mg of lorazepam, taking into account all necessary precautions. For administration of higher doses, pharmaceutical forms with higher individual doses are available.

If the main problem involves sleep disorders requiring treatment, the daily dose (0.5 to 2.5 mg of lorazepam) may be administered as a single dose approximately half an hour before bedtime; for this purpose, pharmaceutical forms with higher individual doses are also available.

When used as a sleep aid, it should be taken approximately half an hour before going to bed; otherwise, it will likely take longer to take effect and, depending on the duration of sleep, may cause more severe side effects the following morning.

If the full dose is taken at night, it should not be taken with a full stomach.

Premedication before diagnostic procedures or surgical interventions

For adults: 1 to 2.5 mg of lorazepam the night before and/or 2 to 4 mg approximately 1 to 2 hours before the procedure.

Use in children and adolescents

Lorazepam should not be used for the treatment of anxiety or insomnia in children and adolescents under 18 years of age.

Children under 6 years

Children under six years of age must not be treated with lorazepam.

Children aged 6 to 12 years

Before diagnostic procedures or surgical interventions: the recommended dose is 0.5 to 1 mg, depending on the child's weight (the dose must not exceed 0.05 mg/kg body weight), taken at least one to two hours before surgery.

Adolescents aged 13 to 18 years

Before diagnostic procedures or surgical interventions: the recommended dose is 1 mg to 4 mg, taken one or two hours before surgery.

Use in elderly or debilitated patients

In elderly or debilitated patients, as well as in patients with organic brain changes, the initial dose should be reduced by approximately 50%. The doctor must adjust the dose according to individual needs and tolerability.

Use in patients with renal impairment

Patients with kidney problems may require lower doses. The initial dose is usually half the normal recommended adult dose. Your doctor will monitor your response to the medicine and adjust the dose if necessary.

Use in patients with hepatic impairment

Patients with mild to moderate liver problems may require lower doses. The initial dose is usually half the normal recommended adult dose.

Lorazepam is contraindicated in patients with severe hepatic impairment.

Method of administration

Oral use.

Swallow the tablets whole with a little liquid (e.g., half a glass or a full glass of water). The tablets may be taken with or without food.

When used as a sleep aid, it should be taken approximately half an hour before going to bed; otherwise, it will likely take longer to take effect and, depending on the duration of sleep, may cause more severe side effects the following morning.

Duration of use

The duration of treatment is determined by your doctor. In acute conditions, the use of this medicine should be limited to single doses or for a few days only. In chronic conditions, the duration of treatment depends on the course of the disease. After two weeks of daily use, your doctor should evaluate whether continued treatment with lorazepam is necessary and gradually reduce the dose if treatment is still indicated.

It should be emphasized that after prolonged treatment (more than 1 week) and abrupt discontinuation of the medicine, transient worsening of sleep disorders, anxiety and tension, restlessness, and agitation may occur. Therefore, treatment must not be stopped abruptly, but should be discontinued by gradually reducing the dose.

If you take more Lorazepam Normon than you should

Contact a doctor immediately or call the Toxicology Information Service at telephone: 91 562 04 20 if you suspect poisoning after taking a large amount of this medicine. Follow the first-aid instructions received by phone. Do not induce vomiting unless specifically instructed by a doctor.

Signs of overdose include: drowsiness, confusion, lethargy, shallow breathing, impaired coordination of movement, apathy, and, in severe cases, loss of consciousness.

If you forget to take Lorazepam Normon

If you forget to take a tablet, take the next dose as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Lorazepam Normon

Never stop or discontinue treatment on your own initiative, except if you suspect a serious adverse reaction. In such a case, contact your doctor immediately.

If you abruptly stop treatment after prolonged use, withdrawal symptoms described in section 4 may occur. To avoid these symptoms, treatment should be discontinued by gradually reducing the dose (see section 3).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse reactions may be expected especially at the beginning of treatment, with higher doses, and in the population described in "Warnings and precautions" (see section 2).

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

• Sedation, tiredness, drowsiness.

Common (may affect up to 1 in 10 people):

• Unsteady movements and gait (ataxia).
• Confusion.
• Depression, onset of depression.
• Feeling dizzy.
• Muscle weakness, feeling of fatigue (lassitude).

Uncommon (may affect up to 1 in 100 people):

• Changes in libido, impotence, less intense orgasms.
• Feeling unwell.

Rare (may affect up to 1 in 1,000 people):

• Rash.
• Reduced level of alertness.
• Changes in salivation.

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

• Leukopenia.

Frequency not known (frequency cannot be estimated from available data):

• Changes in blood counts (thrombocytopenia, agranulocytosis, pancytopenia).
• Prolonged reaction times.
• Impaired movement coordination (extrapyramidal symptoms).
• Tremor.
• Dizziness.
• Visual disturbances (double vision and blurred vision).
• Difficulty speaking/slurred speech.
• Headache.
• Seizures/convulsions.
• Memory lapses (amnesia).
• Disinhibition, euphoria.
• Coma.
• Suicidal thoughts/attempts.
• Impaired attention/concentration.
• Balance disorders.
• Vertigo.
• Paradoxical reactions such as anxiety, agitation, delirium, excitability, aggressive behavior (hostility, aggression, rage), sleep disturbances/insomnia, increased sexual arousal, hallucinations, psychosis. If such reactions occur, treatment with lorazepam should be discontinued.
• Low blood pressure (hypotension), mild drop in blood pressure.
• Respiratory depression (severity depends on dose), difficulty breathing (apnea), worsening of sleep apnea (temporary cessation of breathing during sleep).
• Worsening of chronic obstructive pulmonary disease (airway constriction).
• Constipation.
• Increased bilirubin.
• Jaundice, increased liver enzymes (transaminases, alkaline phosphatase).
• Allergic skin reactions.
• Hair loss.
• Hypersensitivity reactions, anaphylactic/anaphylactoid reactions, swelling of the skin and/or mucous membranes (angioedema).
• Inappropriate secretion of antidiuretic hormone (SIADH).
• Low sodium levels in the blood (hyponatremia).
• Decreased body temperature (hypothermia).

Benzodiazepines cause dose-dependent central nervous system depression.

Dependence/abuse

Even after a few days of daily treatment with this medicine, withdrawal syndromes (e.g., sleep disturbances, increased dreaming) may occur when treatment is discontinued, especially if stopped abruptly. Anxiety, tension, as well as agitation and restlessness may reappear in an intensified form. Other symptoms reported after discontinuation of benzodiazepines include headache, depression, confusion, irritability, sweating, dysphoria, dizziness, depersonalization, behavioral disturbances, exaggerated perception of noise, numbness and tingling in the extremities, hypersensitivity to light, sound, and physical touch, distorted perception, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delusions, seizures, tremors, abdominal cramps, muscle pain, agitation, palpitations, rapid pulse, panic attacks, dizziness, increased reflexes, short-term memory loss, and fever. Abrupt discontinuation may lead to increased seizures in epileptic patients on chronic lorazepam treatment or in patients taking other medications that lower the seizure threshold (e.g., antidepressants).

The risk of withdrawal symptoms increases with the duration of use and dosage. These symptoms can generally be avoided by gradually reducing the dose.

There is evidence of tolerance development (increased dose due to habituation) to the sedative effect of benzodiazepines.

There is a risk of abuse with lorazepam. Patients with a history of drug and/or alcohol abuse are at greater risk.

What should be done in case of adverse effects?

Many of the adverse effects listed above will disappear during continued treatment or when the dose is reduced. If adverse effects persist, inform your doctor, who will decide whether to discontinue treatment. Inform your doctor immediately if you develop an unexplained skin rash, skin discoloration, or swelling.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lorazepam Normon

Keep this medicine out of sight and reach of children.

Store below 30°C. Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lorazepam Normon

• The active substance is lorazepam. Each tablet contains 2 mg of lorazepam.
• The other components (excipients) are: yellow iron oxide (E-172), polacrilin potassium, low-substituted hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and contents of the pack

Yellow, round, biconvex tablets, printed with "LZ" on one side and scored on the other, with a diameter of 6.6 mm ± 10%.

Presented in aluminum/PVC-PVDC blisters (120).

Pack sizes of 30 and 60 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the most recent review of this leaflet: July 2023

Detailed information on this medicinal product is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer carton. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/88965/P_88965