Brand name Lormetazepam Pensa 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 73790

Manufacturer Towa Pharmaceutical S.A.

Lormetazepam Pensa 1 mg tablets EFG tablets

Table of Contents

Patient Information Leaflet
Introduction
1. What Lormetazepam Pensa is and what it is used for
2. What you need to know before starting to take Lormetazepam Pensa
**Do not take Lormetazepam Pensa**
**Special precautions with Lormetazepam Pensa**
**Use of other medicines**
3. How to take Lormetazepam Pensa
4. Possible adverse effects
5. Storage of Lormetazepam Pensa
6. Contents of the pack and other information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lormetazepam Pensa 1 mg tablets EFG

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, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Lormetazepam Pensa is a medicine belonging to the group of hypnotics that promote 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 post-operative periods.

Lormetazepam Pensa belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair the patient's daily activities or cause considerable stress.

2. What you need to know before starting to take Lormetazepam Pensa

Do not take Lormetazepam Pensa

if you have myasthenia gravis (a disease characterized by abnormal muscle weakness),
if you have severe respiratory insufficiency (for example, severe chronic obstructive pulmonary disease),
if you have sleep apnea syndrome (a condition characterized by brief episodes of breathing cessation during sleep),
in case of acute intoxication with alcohol, hypnotics, analgesics, or medications acting on the central nervous system (neuroleptics, antidepressants, lithium),
if you have severe hepatic insufficiency,
if you are allergic (hypersensitive) to the active substance or to any of the other components of Lormetazepam Pensa.

Special precautions with Lormetazepam Pensa

if you have chronic respiratory insufficiency, as you should receive a lower than usual dose;
if you have severe renal impairment;
Lormetazepam Pensa must not be used as first-line treatment for psychotic illness, nor as sole therapy for anxiety or sleep disorders associated with depression.

Tolerance

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

Dependence

Lormetazepam Pensa 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 headache, muscle pain, marked anxiety, tension, restlessness, confusion, and irritability. Follow exactly the administration instructions for Lormetazepam Pensa provided 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 recurrence of symptoms that led to starting treatment). This episode may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. The likelihood of developing a withdrawal/rebound syndrome is greater after abrupt termination of treatment; therefore, it is recommended to gradually reduce the dose until treatment is completely discontinued. Follow exactly the usage recommendations and administration instructions for Lormetazepam Pensa provided by your doctor in order to minimize, as much as possible, the occurrence of these symptoms.

Amnesia

Lormetazepam Pensa may cause anterograde amnesia, that is, difficulty in remembering recent events. To reduce this risk, ensure that you will be able to sleep uninterrupted for 7–8 hours (see section “4. POSSIBLE ADVERSE EFFECTS”).

Psychiatric and paradoxical reactions

Lormetazepam Pensa may cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, 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 Pensa if such reactions occur.
Pre-existing depression may be masked during treatment with Lormetazepam Pensa. In these patients, there is a risk of suicide (see section “4. POSSIBLE ADVERSE EFFECTS”).

Use of other medicines

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

The effect of Lormetazepam Pensa may be enhanced when administered concomitantly with the following medicines:

Antipsychotics (neuroleptics, medicines used in the treatment of psychiatric disorders)
Hypnotics (medicines that improve sleep onset and duration)
Anxiolytics/sedatives (medicines used for the treatment of anxiety)
Antidepressants (medicines used for the treatment of depression)
Opioid analgesics (certain medicines that reduce pain). With these medicines, an increased feeling of euphoria may also occur, which could increase psychological dependence
Antiepileptics (medicines used in the treatment of epilepsy)
Anaesthetics (medicines generally used during surgical procedures to reduce pain and/or consciousness)
Sedating antihistamines (medicines mainly used for the treatment of allergic symptoms)
Calcium channel blockers (medicines used for the treatment of cardiovascular diseases)
Oral contraceptives (medicines used to prevent pregnancy)
Certain antibiotics (medicines used for the treatment of certain infections)
Levo-dopa and its combinations (a medicine for the treatment of Parkinson's disease)

If you are taking other medicines, consult your doctor.

Use of Lormetazepam Pensa with food and drinks

Benzodiazepines must be used with extreme caution in patients with a history of drug or alcohol abuse. The sedative effect may be enhanced when the product is taken together with alcohol; therefore, consumption of alcoholic beverages should be avoided. 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.

As a general precaution, you should not use Lormetazepam during pregnancy, childbirth, or breastfeeding.

If you are being treated with Lormetazepam and wish to become pregnant or suspect you are pregnant, consult your doctor, who will advise you on how to discontinue treatment.

If, due to strict medical necessity, the medicine is administered during the third trimester of pregnancy or at high doses during childbirth, effects on the newborn such as hypothermia, hypotonia, and moderate respiratory depression may be expected.

Infants born to mothers who chronically take benzodiazepines during the last trimester of pregnancy may develop physical dependence and experience withdrawal symptoms in the postnatal period.

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

Use in 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. Additionally, the duration of treatment should be as short as possible. For further information on use in patients under 18 years of age, see section “3. HOW TO TAKE LORMETAZEPAM PENSA”.

Use in elderly patients

Elderly patients should receive a lower than the usual dose. Your doctor will recommend the most appropriate dosage. (See section “3. HOW TO TAKE LORMETAZEPAM PENSA”).

Important information about some of the ingredients of Lormetazepam Pensa

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Driving and use of machines

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

3. How to take Lormetazepam Pensa

Follow exactly the dosage instructions for lormetazepam as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will indicate the duration of your treatment with lormetazepam. Do not stop treatment prematurely, as it may not achieve the desired effect.

Short-term treatment of insomnia

The treatment duration should be as short as possible. Generally, 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 a drink, shortly before going to bed.

Adults

It is recommended to take 1 tablet of Lormetazepam Pensa 1 mg or ½ tablet of the alternative Lormetazepam Pensa 2 mg formulation, as a single dose.

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

Elderly patients

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

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.

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

Induction of sleep in pre- and post-operative periods

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

Adults

A recommended average daily dose of 2 mg of lormetazepam (range: 0.5 to 3 mg) is advised.

Children

A recommended daily dose of 0.5 to 1 mg of lormetazepam (½ to 1 tablet of Lormetazepam Pensa 1 mg) is advised.

Elderly patients and patients at risk

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

Dosage reduction should be considered for patients with mild or moderate breathing difficulties or in patients with hepatic insufficiency.

If you take more Lormetazepam Pensa than you should

Overdose is not usually life-threatening unless lormetazepam 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.

Benzodiazepine overdose 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), hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death.

In case of accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medication and amount taken.

If you go to a medical facility, do not forget to bring this leaflet with you.

If you forget to take Lormetazepam Pensa

Do not take a double dose to make up for forgotten doses.

If you stop taking Lormetazepam Pensa

When stopping treatment, the symptoms that led to starting the medication may reappear. Restlessness, anxiety, insomnia, headache, and sweating may occur. Therefore, your doctor will give you precise instructions on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, Lormetazepam Pensa may produce adverse effects, although not everyone will experience them.

If the dosage is not adjusted to the individual patient's condition, adverse effects due to excessive sedation and muscle relaxation may occur.

The meaning of the frequencies of the adverse effects listed below is as follows:

Very common: means that 1 or more out of every 10 people are likely to experience them.

Common: means that between 1 and 10 out of every 100 people are likely to experience them.

Immune system disorders

Common: Quincke's edema (an inflammatory disease affecting the skin and subcutaneous and submucosal tissues).

Psychiatric disorders

Common: Anxiety, decreased libido (sexual desire).

Nervous system disorders

Very common: Headache.

Common: Dizziness, sedation, somnolence (drowsiness), attention disturbance, amnesia, visual disturbance, speech disorder, dysgeusia, slowed thinking.

Cardiac disorders

Common: Tachycardia (increased heart rate).

Gastrointestinal disorders

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

Skin and subcutaneous tissue disorders

Common: Pruritus (itching).

Renal and urinary disorders

Common: Urinary disorders.

General disorders and administration site conditions

Common: Asthenia (lack of strength), sweating.

For further information on the following points, see section "Take special care with Lormetazepam Pensa".

Dependence:

Administration of Lormetazepam (even at therapeutic doses) may lead to the development of physical dependence; discontinuation of treatment may lead to withdrawal or rebound phenomena (see section "Take special care with Lormetazepam Pensa"). Psychological dependence may also occur. Cases of abuse have been reported.

Psychiatric disorders

Rebound insomnia (after stopping treatment, the same symptoms for which treatment was initiated reappear) (see section "Take special care with Lormetazepam Pensa").
Psychiatric and paradoxical reactions: When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggressiveness, delirium (false beliefs accepted as true and impossible to disprove), rage attacks, nightmares, hallucinations (false sensory perceptions), psychosis (a type of mental disorder), inappropriate behavior, and other behavioral disturbances may occur. These reactions may be severe and occur more frequently in children and elderly patients (see section "Take special care with Lormetazepam Pensa").
Depression: The use of benzodiazepines may mask a pre-existing depression. In such patients, suicidal behavior may be triggered.

Nervous system disorders

Amnesia: Anterograde amnesia (difficulty in remembering recent events) may occur with therapeutic doses, with risk increasing at higher doses. Amnesic effects may be associated with inappropriate behaviors (see section "Take special care with Lormetazepam Pensa").

Adverse reactions in other organs and systems

The following adverse reactions have been reported with the administration of Lormetazepam Pensa: daytime drowsiness, emotional blunting, emotional disturbance, decreased level of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (impaired coordination of movement), or double vision. All these effects occur predominantly at the beginning of treatment and usually disappear with repeated administration. Occasionally, jaundice (yellowish discoloration of mucous membranes and skin) and cutaneous adverse reactions such as urticaria, pruritus, or skin rash have been reported.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of 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 System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lormetazepam Pensa

Keep out of the reach and sight of children.

Lormetazepam Pensa does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their packaging should be handed over at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lormetazepam Pensa

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

Appearance of the product and contents of the pack

Lormetazepam Pensa 1 mg tablets are presented in boxes containing blister packs with 30 tablets (standard pack) and 500 tablets (hospital pack). The tablets are white, round and scored on one side. The score mark is intended to facilitate division into two equal parts.