Lorazepam Stada 1 mg tablets EFG: detailed information

Brand name Lorazepam Stada 1 mg tablets EFG

Form tablets

Active substance / Dosage

LORMETAZEPAM · 1 mg

Prescription type Psychotropic Medicine. Prescription Only

ATC code

N05C N05CD N05CD06

Registration number 75732

Manufacturer Laboratorio Stada S.L.

Lorazepam Stada 1 mg tablets EFG tablets

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Lormetazepam Stada is and what it is used for
2. What you need to know before taking Lormetazepam Stada
3. How to take Lormetazepam Stada
4. Possible adverse effects
5. Storage of Lormetazepam Stada
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lormetazepam Stada 1 mg tablets EFG

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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

What Lormetazepam Stada is and what it is used for
What you need to know before taking Lormetazepam Stada
How to take Lormetazepam Stada
Possible side effects
How to store Lormetazepam Stada
Contents of the pack and other information

1. What Lormetazepam Stada is and what it is used for

Lormetazepam is a hypnotic medicine that promotes sleep: it normalizes the time required to fall asleep and the total duration of sleep, while reducing the number of sleep interruptions.

It is indicated for:

Short-term treatment of insomnia.
Sleep induction in pre- and postoperative periods.

Lormetazepam belongs to a group of hypnotic medicines known as benzodiazepines. Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair the patient's functioning or subject them to considerable stress.

2. What you need to know before taking Lormetazepam Stada

Do not take Lormetazepam Stada

If you are allergic (hypersensitive) to lormetazepam, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6).
If you have myasthenia gravis (a disease characterized by abnormal muscle weakness)
If you have severe respiratory insufficiency
If you have sleep apnoea syndrome (interruption of breathing during sleep)
In case of acute intoxication with alcohol, hypnotics, analgesics, or medicines acting on the central nervous system (neuroleptics, antidepressants, lithium).

Warnings and precautions

Consult your doctor or pharmacist before starting to take lormetazepam:

If you have chronic respiratory insufficiency, as you should receive a lower than usual dose
If you have hepatic insufficiency
If you have severe renal insufficiency
Lormetazepam should not be used as first-line treatment for psychotic illness, nor as sole treatment for anxiety or sleep disorders associated with depression.
Lormetazepam should be administered with caution in patients with medullary or cerebellar ataxia.

Tolerance

After continuous use for several weeks, a certain degree of reduced efficacy regarding hypnotic effects may be observed.

Dependence

Lormetazepam may lead to physical and psychological dependence. The risk of dependence increases with dose and duration of treatment, and is also higher in patients with a history of drug or alcohol abuse. Abrupt discontinuation of treatment may be accompanied by withdrawal symptoms such as marked anxiety, tension, restlessness, confusion, irritability, headache, and muscle pain. In more severe cases, derealization, depersonalization, hallucinations, paresthesia in the limbs, sensory intolerance to light, sounds, and physical contact, hyperacusis, and epileptic seizures may occur. Follow exactly the administration instructions for lormetazepam given by your doctor in order to minimize, as much as possible, the occurrence of these symptoms.

Rebound insomnia and anxiety

You may experience a rebound episode (transient reappearance of symptoms that led to starting treatment). The likelihood of withdrawal/rebound phenomena is higher after abrupt discontinuation of treatment; therefore, it is recommended to gradually reduce the dose until complete discontinuation. Follow exactly the usage recommendations and administration instructions for lormetazepam given by your doctor to minimize the risk of these symptoms.

Amnesia

Lormetazepam may cause anterograde amnesia, i.e., difficulty in remembering recent events; this occurs more frequently within the first few hours after taking the medicine. To reduce this risk, you should ensure that you will be able to sleep uninterrupted for 7–8 hours (see section 4).

Psychiatric and paradoxical reactions

Lormetazepam may cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, abnormal and inappropriate behavior, and other adverse behavioral effects. These reactions occur more frequently in children, elderly patients, and patients with organic brain syndrome (physical disorders causing reduced mental function). Your doctor will discontinue treatment with lormetazepam if such reactions occur.

Inform your doctor if you suffer from depression. Lormetazepam should not be used as the sole treatment for sleep disturbances associated with depression.

Lormetazepam should not be used as first-line treatment for psychotic illness (see section 4).

Children and adolescents

Lormetazepam should not be administered to patients under 18 years of age for the treatment of insomnia without careful medical assessment of the necessity. In addition, treatment duration should be kept as short as possible (see section 3).

Use in elderly patients

Elderly patients should receive a lower than usual dose, as they are more susceptible to the effects of the medicine. Your doctor will recommend the most appropriate dosage (see section 3).

Taking Lormetazepam Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

The effect of lormetazepam may be enhanced when taken concomitantly with the following medicines:

Medicines used to treat psychiatric disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
Medicines used to relieve severe pain (narcotic analgesics). With these medicines, an increased feeling of euphoria may also occur, potentially increasing psychological dependence.
Medicines used to treat epilepsy (antiepileptics).
Anaesthetics.
Medicines used to treat allergic symptoms (sedating antihistamines).
Medicines used to treat cardiovascular diseases (calcium antagonists, cardiac glycosides).
Medicines used to treat hypertension (beta-blockers).
Oral contraceptives.
Certain antibiotics (such as rifampicin).

Interactions have also been reported with some medicines used to treat high blood pressure (beta-blockers) and with central nervous system stimulants (methylxanthines).

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

However, if your doctor prescribes lormetazepam 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 closely follow your doctor’s dosing recommendations. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.

If you are taking other medicines, consult your doctor.

Taking Lormetazepam Stada with food, drink, and alcohol

During treatment with lormetazepam, avoid alcoholic drinks.

Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse. The sedative effect may be enhanced when this medicine is taken together with alcohol; therefore, consumption of alcoholic beverages is not recommended. This is particularly important as it affects the ability to drive or operate machinery (see section “Driving and use of machines”).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

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

If lormetazepam is administered during the third trimester of pregnancy or during delivery due to strict medical necessity, effects on the newborn such as hypothermia, hypotonia, moderate respiratory depression, and difficulties with breastfeeding may be expected.

Infants born to mothers who chronically take benzodiazepines during the last trimester of pregnancy may develop physical dependence, potentially leading to a postnatal withdrawal syndrome.

Lactation

As benzodiazepines pass into breast milk, their use is contraindicated in breastfeeding mothers.

Driving and use of machines

Lormetazepam is a medicine that causes drowsiness and therefore significantly affects the ability to drive or operate machinery. Do not drive or operate machinery if you feel sleepy or if your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased.

Lormetazepam Stada contains lactose

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

Lormetazepam Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Lormetazepam Stada

Follow exactly the instructions for use of this medicine as given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

The recommended dose is:

For short-term treatment of insomnia

The duration of treatment should be as short as possible. In general, it ranges from a few days to two weeks, with a maximum period, including gradual dose reduction, of four weeks.

The tablets should be taken with some liquid shortly before going to bed.

Use in adults

The recommended dose is 1 mg of lormetazepam (1 tablet of lormetazepam 1 mg or ½ tablet of the lormetazepam 2 mg formulation), taken as a single dose.

In cases of severe or persistent insomnia, and always according to strict medical judgment, the dose may be increased to 2 mg.

Use in children and adolescents

Lormetazepam must not be used in children and adolescents under 18 years of age without careful assessment of the necessity of treatment. Other formulations of lormetazepam (oral solution) are available if needed for this patient group.

Use in elderly patients

A daily dose of 0.5 mg of lormetazepam (½ tablet of lormetazepam 1 mg) is recommended, taken as a single dose.

In elderly individuals, benzodiazepines may be associated with an increased risk of falls due to possible muscle weakness, dizziness, drowsiness, and fatigue. Therefore, your doctor will determine the dose best suited to your condition.

Use in patients with respiratory problems

If you have mild or moderate difficulty breathing, inform your doctor, who may advise you to use a lower dose of lormetazepam.

Use in patients with liver problems

If your liver is not functioning properly, inform your doctor, who may advise you to use a lower dose of lormetazepam.

If you feel that the effect of lormetazepam is too strong or too weak, consult your doctor or pharmacist.

For sleep induction in pre- and postoperative periods

Doses will depend on the patient's age, weight, and general condition.

Use in adults

A daily dose of 2 mg of lormetazepam is recommended. The dose range is 0.5 to 3 mg of lormetazepam per day. One hour before surgery, half of this dose is recommended.

Use in children and adolescents

A daily dose of 0.5 mg to 1 mg of lormetazepam (½ to 1 tablet of lormetazepam 1 mg) is recommended. One hour before surgery, half of this dose is recommended. Other formulations of lormetazepam (oral solution) are available if needed for this patient group.

Use in elderly patients

A daily dose of 1 mg of lormetazepam is generally recommended. One hour before surgery, half of this dose is recommended.

Use in patients with respiratory problems

If you have mild or moderate difficulty breathing, inform your doctor, who may advise you to use a lower dose of lormetazepam. One hour before surgery, half of the dose is recommended.

Use in patients with liver problems

If your liver is not functioning properly, inform your doctor, who may advise you to use a lower dose of lormetazepam. One hour before surgery, half of the dose is recommended.

The tablet can be divided into equal doses.

If you take more Lormetazepam Stada than you should

Overdose is not usually life-threatening unless the drug is taken together with other central nervous system depressants (including alcohol). In cases of overdose, consider the possibility that the patient may have ingested multiple substances.

Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, ataxia (impaired coordination of movement), visual disturbances, hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression, and rarely coma or, very rarely, death may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Lormetazepam Stada

Do not take a double dose to make up for a missed dose.

If you stop taking Lormetazepam Stada

Your doctor will determine the duration of treatment with lormetazepam. Do not discontinue treatment prematurely, as the desired effect may not be achieved.

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.

If the dosage is not adjusted to the individual conditions of each patient, adverse effects due to excessive sedation and muscle relaxation may occur.

At the beginning of treatment, daytime drowsiness, emotional disturbance, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (impaired coordination of movements), or double vision may occur. All of these effects occur predominantly at the start of treatment and usually disappear with repeated administration.

The most serious adverse reactions observed in patients treated with lormetazepam are angioedema (swelling), completed suicide or suicide attempt, generally associated with the masking of a pre-existing depression.

The most frequently observed adverse reactions in patients treated with lormetazepam are headache, sedation, and anxiety.

Very common adverse effects

(may affect more than 1 in 10 people)

Headache

Common adverse effects

(may affect up to 1 in 10 people)

Angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing).

Anxiety, decreased libido (reduced sexual desire).

Dizziness, sedation, somnolence (drowsiness), attention disturbance, amnesia, visual disturbance, speech disorder, dysgeusia, mental slowing.

Tachycardia (increased heart rate).

Vomiting, nausea, upper abdominal pain, constipation, dry mouth.

Pruritus (itching).

Urinary disturbance.

Asthenia (lack of energy), excessive sweating.

Adverse effects of unknown frequency

(cannot be estimated from available data)

Suicide attempt or completed suicide (masking of a pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false sensory perceptions), dependence, depression (masking of a pre-existing depression), delirium (false beliefs held as true and impossible to disprove), withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, restlessness, rage attacks, nightmares, inappropriate behaviour, emotional disturbances.

Confusion, decreased level of consciousness, ataxia (impaired coordination of movements), muscle weakness.

Urticaria, exanthema (rash).

Fatigue.

Falls.

For further information on the following points, see section “Warnings and precautions”.

Dependence:

Administration of lormetazepam and other benzodiazepines may lead to the development of physical and psychological dependence (see section “Warnings and precautions”).

Psychiatric disorders:

Rebound insomnia may occur upon discontinuation of the medicine (see section “Warnings and precautions”).

Psychiatric and paradoxical reactions: When using lormetazepam, reactions such as restlessness, agitation, irritability, aggressiveness, delirium (false beliefs held as true and impossible to disprove), rage attacks, nightmares, hallucinations (false sensory perceptions), psychosis (a type of mental disorder), inappropriate abnormal behaviour, and other behavioural disturbances may occur.
Depression: The use of benzodiazepines may mask a pre-existing depression. In such patients, suicide may be triggered. Lormetazepam should be used with caution in patients with depression.

Nervous system disorders

Amnesia: Lormetazepam may cause anterograde amnesia (difficulty in remembering recent events). (See section “Warnings and precautions”).

Reporting of adverse effects

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

5. Storage of Lormetazepam Stada

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

This medicine does not require any special storage conditions.

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 packaging at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lormetazepam Stada 1 mg tablets

The active substance is lormetazepam. Each tablet contains 1 mg of lormetazepam.
The other components (excipients) are monohydrate lactose, sodium croscarmellose, magnesium stearate, maize starch, povidone K-25.

Appearance of the medicinal product and contents of the pack

Lormetazepam Stada 1 mg tablets are presented in packs containing blisters with 30 tablets (standard pack) and 500 tablets (clinical pack). The tablets are white, round, and scored on one side.