Lormetazepam Kern Pharma 1 mg tablets EFG: detailed information

Brand name Lormetazepam Kern Pharma 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 73584

Manufacturer Kern Pharma S.L.

Lormetazepam Kern Pharma 1 mg tablets EFG tablets

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Lormetazepam Kern Pharma is and what it is used for
2. What you need to know before taking Lormetazepam Kern Pharma
**Do not take Lormetazepam Kern Pharma**
**Warnings and precautions**
**Children and adolescents**
Lormetazepam Kern Pharma must not be administered to patients under 18 years of age for the treatment of insomnia without careful medical evaluation of the necessity for such treatment. In addition, the duration of treatment should be as short as possible (see section 3).
**Use in elderly patients**
**Use of Lormetazepam Kern Pharma with other medicines**
3. How to take Lormetazepam Kern Pharma
4. Possible adverse effects
5. Storage of Lormetazepam Kern Pharma
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

LormetazepamKern pharma 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. 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 must not be given to other people, even if they have the same symptoms as you. It could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

1. What Lormetazepam Kern Pharma is and what it is used for

Lormetazepam Kern Pharma is a medicine belonging to the group of hypnotics that promote sleep: it normalizes the time required to fall asleep and total sleep duration, while reducing the number of sleep interruptions.

It is indicated for:

Short-term treatment of insomnia.

Lormetazepam Kern Pharma belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are only indicated for the treatment of severe disorders that limit the patient's activity or subject the patient to significant stress.

2. What you need to know before taking Lormetazepam Kern Pharma

Do not take Lormetazepam Kern Pharma

if you are allergic (hypersensitive) to the active substance or to any of the other components 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 (e.g. severe chronic obstructive pulmonary disease),
if you have sleep apnoea syndrome (a condition characterized by brief episodes of breathing cessation during sleep),
in case of acute intoxication with alcohol, hypnotics, analgesics, or medicines acting on the central nervous system (neuroleptics, antidepressants, lithium),
if you have severe hepatic insufficiency,
if you are pregnant or breastfeeding (see also “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Consult your doctor or pharmacist before taking Lormetazepam Kern Pharma:

if you have chronic respiratory insufficiency, as you may require a lower than usual dose,
if you have severe renal impairment,
if you have hepatic impairment.
Lormetazepam Kern Pharma must not be used as first-line treatment for psychotic illness, nor as monotherapy for anxiety or sleep disorders associated with depression.
Lormetazepam Kern Pharma should be administered with caution in patients with spinal or cerebellar ataxia.

Tolerance

After continuous use for several weeks, a certain degree of reduced efficacy regarding hypnotic effects may be observed.
In the presence of lormetazepam, tolerance to other central nervous system (CNS) depressants may be reduced; these substances should be avoided or taken at reduced doses.

Dependence

Lormetazepam Kern Pharma may lead to physical and psychological dependence. The risk of dependence increases with dose and duration of treatment, and is higher in patients with a history of drug or alcohol abuse. Abrupt discontinuation of treatment may result in withdrawal symptoms such as headache, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and rebound phenomena (temporary re-emergence of symptoms that led to initiating treatment). It may be difficult to distinguish these symptoms from the original symptoms for which the medicine was prescribed. Follow exactly the administration instructions for Lormetazepam Kern Pharma 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 re-emergence of symptoms that prompted initiation of 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 discontinuation of treatment; therefore, it is recommended to gradually reduce the dose until complete withdrawal. Follow exactly the usage recommendations and administration instructions for Lormetazepam Kern Pharma provided by your doctor to minimize the risk of these symptoms.

Amnesia

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

Psychiatric and paradoxical reactions

Lormetazepam Kern Pharma may cause restlessness, agitation, irritability, aggression, delusions, 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 Kern Pharma if such reactions occur.
Inform your doctor if you suffer from depression. Lormetazepam Kern Pharma must not be used as the sole treatment for sleep disturbances associated with depression.
Lormetazepam Kern Pharma must not be used as first-line treatment for psychotic illness (see section 4).

Other warnings

Some patients have developed blood dyscrasias, and some have experienced increased liver enzymes while taking benzodiazepines. Periodic hematological and liver function monitoring is recommended when repeated treatments are clinically necessary.
Although hypotension occurs only rarely, benzodiazepines should be administered with caution in patients for whom a drop in blood pressure could lead to cardiovascular or cerebrovascular complications. This is especially important in elderly individuals.
Cases of benzodiazepine abuse have been reported.
Use with caution in patients with narrow-angle glaucoma.

Children and adolescents

Lormetazepam Kern Pharma must not be administered to patients under 18 years of age for the treatment of insomnia without careful medical evaluation of the necessity for such treatment. In addition, the duration of treatment should be 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 regimen (see section 3).

Use of Lormetazepam Kern Pharma with other medicines

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

The effect of Lormetazepam Kern Pharma may be enhanced when taken concomitantly with the following medicines:

Medicines used in the treatment of 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, which could increase psychological dependence.
Medicines used in the treatment of epilepsy (antiepileptics).
Anaesthetics.
Medicines used to treat allergic symptoms (sedating antihistamines).
Medicines used to treat cardiovascular diseases (calcium channel blockers, cardiac glycosides).
Medicines used to treat hypertension (beta-blockers).
Oral contraceptives.
Certain antibiotics (such as rifampicin).
Theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lormetazepam.
Clozapine may increase sedative effects, increase salivation, and cause ataxia.

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 even be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes this medicine together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.

Please 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 so they can watch for the symptoms mentioned above. Contact your doctor if you experience such symptoms.

If you are taking other medicines, consult your doctor.

Use of Lormetazepam Kern Pharma with food, drink, and alcohol

During treatment with Lormetazepam Kern Pharma, avoid alcoholic beverages.

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 product is taken together with alcohol; therefore, the 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 taking any medicine.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

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

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 syndrome in the postnatal period.

Breastfeeding

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

Driving and use of machines

Lormetazepam Kern Pharma 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 your dose is increased.

Lormetazepam Kern Pharma contains lactose and sodium.

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

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

3. How to take Lormetazepam Kern Pharma

Follow exactly the dosing 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 determine the duration of your treatment with lormetazepam. Do not stop treatment prematurely, as it may not achieve the desired effect.

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 some liquid shortly before going to bed.

Adults

The recommended dose is 1 mg of lormetazepam (1 tablet of Lormetazepam Kern Pharma 1 mg), taken 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 0.5 mg of lormetazepam (½ tablet of Lormetazepam Kern Pharma 1 mg) as a single dose is recommended.

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

A dose reduction should be considered in patients with mild or moderate breathing difficulties or in those with hepatic impairment.

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

Other lormetazepam formulations are available in case Lormetazepam Kern Pharma 1 mg does not allow the prescribed dose to be achieved.

If you take more Lormetazepam Kern Pharma 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.

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 movements), hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death may occur.

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

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

If you forget to take Lormetazepam Kern Pharma

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

If you stop taking Lormetazepam Kern Pharma

Your doctor will determine the duration of treatment with Lormetazepam Kern Pharma. Do not stop treatment prematurely, as it will not have the desired effect.

When stopping treatment, the symptoms that led to taking the medication may reappear. You may experience restlessness, anxiety, insomnia, headache, and sweating. Therefore, your doctor will give you specific 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 Kern Pharma may cause 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.

At the beginning of treatment, daytime drowsiness, emotional disturbance, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (impaired coordination of movement), or double vision may appear. All 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 Kern Pharma are angioedema (swelling), completed suicide or suicide attempt, usually associated with the masking of a pre-existing depression.

The most commonly observed adverse reactions in patients treated with Lormetazepam Kern Pharma are headache, sedation, and anxiety.

Very common adverse effects

(may affect more than 1 in 10 patients)

Headache

Common adverse effects

(may affect up to 1 in 10 patients)

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 disorder.
Asthenia (lack of energy), excessive sweating.

Adverse effects of unknown frequency

(cannot be estimated from available data)

Suicide attempt or completed suicide (due to masking of a pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false sensory perceptions), dependence, depression (due to masking of a pre-existing depression), delirium (false beliefs held as true and impossible to disprove), withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, rage attacks, nightmares, inappropriate behavior, emotional disturbances.
Confusion, decreased level of consciousness, ataxia (impaired coordination of movement), muscle weakness.
Urticaria, exanthema (rash).
Fatigue.
Falls.

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

Dependence:

Administration of Lormetazepam Kern Pharma 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 medication (see section “Warnings and precautions”).

Psychiatric and paradoxical reactions: When using Lormetazepam Kern Pharma, reactions such as restlessness, agitation, irritability, aggression, delirium (false beliefs held 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.
Depression: The use of benzodiazepines may mask pre-existing depression. In such patients, suicide may be triggered. Lormetazepam Kern Pharma should be used with caution in patients with depression.

Nervous system disorders

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are 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 Lormetazepam Kern Pharma

Keep out of sight and reach of children.

Lormetazepam Kern Pharma does not require special storage conditions.

Do not use Lormetazepam Kern Pharma 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 containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Lormetazepam Kern Pharma

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

Appearance of the product and contents of the pack

Lormetazepam Kern Pharma 1 mg tablets are presented in boxes containing blister packs with 14 and 30 tablets (regular packs) and 500 tablets (hospital pack). The tablets are white, round, and scored on one side. The score line is intended to divide the tablet into two equal parts.