Lorazepam Sandoz GmbH: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lormetazepam Sandoz GmbH 1 mg tablets, 2 mg tablets

Generic medicine
Please 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lormetazepam Sandoz GmbH is and what it is used for

Lormetazepam Sandoz GmbH is a medicinal product belonging to the group of hypnotic drugs that promote sleep: it works by normalizing the time required to fall asleep and the overall duration of sleep, while simultaneously reducing sleep interruptions.
It is indicated for:

short-term treatment of insomnia.

Lormetazepam Sandoz GmbH belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are indicated only when the disorder is severe, disabling, or causes extreme distress to the patient.

2. What you need to know before taking Lormetazepam Sandoz GmbH

Do not take Lormetazepam Sandoz GmbH

if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of Lormetazepam Sandoz GmbH (listed in section 6)
if you suffer from severe myasthenia gravis (a disorder characterized by abnormal muscle weakness)
if you suffer from severe respiratory insufficiency (e.g. severe chronic obstructive pulmonary disease)
if you suffer from sleep apnoea syndrome (a disorder characterized by brief episodes of breathing interruption occurring during sleep)
in case of acute intoxication with alcohol, hypnotics, analgesics, or medicines acting on the central nervous system (neuroleptics, antidepressants, lithium)
if you suffer from severe hepatic insufficiency
if you are pregnant or breastfeeding (see also “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lormetazepam Sandoz GmbH:

if you suffer from chronic respiratory insufficiency, as in this case you should take a lower than usual dose
if you suffer from severe renal insufficiency
if you suffer from hepatic insufficiency.
Lormetazepam Sandoz GmbH should not be used as first-line treatment for psychotic illness or as the sole treatment for anxiety and sleep disorders associated with depression
Lormetazepam Sandoz GmbH should be administered with caution in patients with spinal or cerebellar ataxia.

Tolerance

After repeated use for several weeks, a certain loss of efficacy regarding hypnotic effects may develop.
Tolerance to other central nervous system (CNS) depressants may be reduced in the presence of lormetazepam; therefore, these substances should be avoided or taken at reduced doses.

Dependence

Lormetazepam Sandoz GmbH 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 alcohol or drug abuse. Abrupt discontinuation of treatment may be accompanied by withdrawal symptoms such as headache, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and rebound phenomena (i.e. temporary recurrence of symptoms that led to starting treatment). These symptoms may be difficult to distinguish from the original symptoms for which the medicine was previously prescribed. Take Lormetazepam Sandoz GmbH exactly as directed by your doctor to minimize the occurrence of these symptoms as much as possible. Rebound insomnia and anxiety
You may experience a rebound phenomenon (i.e. temporary recurrence of symptoms that led to starting treatment). This may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. The likelihood of withdrawal/rebound syndrome is greater after abrupt discontinuation of treatment; therefore, it is recommended to gradually reduce the dose until complete discontinuation of the medicine. Follow the recommendations for use and administration instructions of Lormetazepam Sandoz GmbH, strictly adhering to your doctor’s advice, to minimize the occurrence of these symptoms as much as possible.

Amnesia

Lormetazepam Sandoz GmbH may cause anterograde amnesia, i.e. difficulty in remembering recent events. This is most common within the first few hours after taking the medicine. Therefore, to reduce this risk, ensure you are able to sleep uninterrupted for 7–8 hours (see section 4).

Psychiatric and paradoxical reactions

Lormetazepam Sandoz GmbH may cause restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, inappropriate behaviour, and other adverse behavioural effects. These reactions are more common in children, elderly patients, and patients with organic brain syndrome (physical disorders causing reduced mental function). If such reactions occur, your doctor will discontinue treatment with Lormetazepam Sandoz GmbH. Inform your doctor if you suffer from depression. Lormetazepam Sandoz GmbH should not be used as single-dose treatment for sleep disorders associated with depression.
Lormetazepam Sandoz GmbH should not be used as first-line treatment for psychotic disorders (see section 4).

Other warnings

Some patients taking benzodiazepines have developed blood dyscrasias and some have shown increased liver enzymes. When repeated treatment cycles are considered clinically necessary, periodic assessment of blood parameters and liver function is recommended.
Although hypotension has been reported only rarely, benzodiazepines should be administered with caution in patients in whom a marked drop in blood pressure could lead to cardiovascular or cerebrovascular complications. This is particularly important in elderly patients.
Abuse of benzodiazepines has been reported.
Treatment of patients with narrow-angle glaucoma should be carried out with caution.

Children and adolescents
Lormetazepam Sandoz GmbH must not be administered to patients under 18 years of age for the treatment of insomnia without careful medical evaluation of the necessity of such treatment.
Additionally, treatment duration should be as short as possible (see section 3).
Use in elderly patients
Elderly patients should receive a lower dose than the normal dose, as they are more susceptible to the effects of this medicine. Your doctor will recommend the most appropriate dose (see section 3).
Other medicines and Lormetazepam Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When Lormetazepam Sandoz GmbH is administered concomitantly with the following medicines, an increase in its effect may occur:

Medicines used to treat psychiatric disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants)
Medicines used to relieve severe pain (narcotic analgesics). These medicines may also cause increased feelings of euphoria, which in turn may increase psychological dependence
Medicines used to treat epilepsy (antiepileptics)
Anaesthetics
Medicines used to treat allergy symptoms (sedating antihistamines)
Medicines used to treat cardiovascular disorders (calcium antagonists, cardiac glycosides)
Medicines used to treat hypertension (beta-blockers)
Oral contraceptives
Some antibiotics (such as rifampicin)
Theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lormetazepam
Clozapine may cause increased sedative effects, increased salivation, and ataxia.

Interactions have also been reported with certain medicines used to treat hypertension (beta-blockers) and central nervous system stimulants (methylxanthines).
Inform your doctor if you are taking other medicines.
Lormetazepam Sandoz GmbH with food, drinks and alcohol
Avoid drinking alcoholic beverages during treatment with Lormetazepam Sandoz GmbH.
Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. The sedative effect may be enhanced when the product is used in combination with alcohol; therefore, consumption of alcoholic beverages must be avoided. This should be particularly considered, as the medicine impairs the ability to drive vehicles and operate machinery (see section “Driving and use of machines”).
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
As a general precaution, you should not use Lormetazepam Sandoz GmbH during pregnancy, childbirth, or breastfeeding.
If, for strict medical reasons, the medicine is administered during the last trimester of pregnancy or at high doses during delivery, effects on the newborn such as hypothermia, hypotonia, and moderate respiratory depression may occur.
Newborns of mothers who have chronically taken benzodiazepines during the last trimester of pregnancy may develop physical dependence and may exhibit a withdrawal syndrome in the postnatal period.
Breastfeeding
Since benzodiazepines pass into breast milk, their use is contraindicated in women who are breastfeeding.
Driving and use of machines
Lormetazepam Sandoz GmbH is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or notice reduced attention and reaction ability. Pay particular attention at the beginning of treatment or after any possible dose increase.
Lormetazepam Sandoz GmbH contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Lormetazepam Sandoz GmbH

Take Lormetazepam Sandoz GmbH exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. Remember to take the medicine as directed.
Your doctor will determine the duration of treatment with lormetazepam. Do not stop treatment prematurely, as this may prevent the desired effect from being achieved.
Treatment should be as short as possible. Typically, treatment duration ranges from a few days to two weeks, up to a maximum period (including gradual dose reduction) of four weeks.
The tablets should be taken with a small amount of liquid before going to bed.

Lormetazepam Sandoz GmbH 1 mg tablets:
Adults
The recommended dose is 1 mg of lormetazepam (1 tablet of Lormetazepam Sandoz GmbH 1 mg) administered as a single dose.
In cases of severe or persistent insomnia, and always according to the doctor's advice, the dose may be increased to 2 mg.

Elderly patients
The recommended dose is 0.5 mg of lormetazepam per day (½ tablet of Lormetazepam Sandoz GmbH 1 mg) administered as a single dose.

Lormetazepam Sandoz GmbH 2 mg tablets:
Adults
The recommended dose is 1 mg of lormetazepam (½ tablet of Lormetazepam Sandoz GmbH 2 mg) administered as a single dose.
In cases of severe or persistent insomnia, and always according to the doctor's advice, the dose may be increased to 2 mg (one tablet of Lormetazepam Sandoz GmbH 2 mg).

Elderly patients
The recommended dose is 0.5 mg of lormetazepam per day (½ tablet of Lormetazepam Sandoz GmbH 1 mg or 1 tablet of Lormetazepam Sandoz GmbH 0.5 mg) administered as a single dose.
In elderly patients, benzodiazepines may be associated with an increased risk of falls, as they can cause muscle weakness, dizziness, drowsiness, and fatigue. Your doctor will therefore determine the dose most suitable for your condition.
In patients with mild to moderate respiratory impairment or with hepatic impairment, a dose reduction should be considered.
If you feel that the effect of Lormetazepam Sandoz GmbH is too strong or too weak, consult your doctor or pharmacist.
If Lormetazepam Sandoz GmbH is not available in the prescribed dose, other dosage strengths of lormetazepam are available.

If you take more Lormetazepam Sandoz GmbH than you should
Overdose is generally not life-threatening unless combined with other centrally acting depressants (including alcohol). In cases of overdose, consider the possibility that the patient may have taken multiple medications.
Benzodiazepine overdose typically presents 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 overdose or accidental ingestion, contact your doctor or pharmacist immediately, specifying the medicine and the amount taken.
If you go to the emergency room, remember to bring this patient information leaflet with you.

If you forget to take Lormetazepam Sandoz GmbH
Do not take a double dose to make up for the missed dose.

If you stop taking Lormetazepam Sandoz GmbH
Your doctor will determine the duration of treatment with Lormetazepam Sandoz GmbH. Do not stop treatment prematurely, as otherwise the medicine may not have the desired effect.
When stopping treatment, the symptoms that led to the need for taking the medicine may reappear. Symptoms such as restlessness, anxiety, insomnia, headache, and sweating may occur; therefore, your doctor will clearly explain how to gradually reduce the dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lormetazepam Sandoz GmbH can cause side effects, although not everyone experiences them.
If the dose is not adjusted to the individual condition of each patient, side effects due to excessive sedation and muscle relaxation may occur.
At the beginning of treatment, the following may occur: daytime drowsiness, emotional disturbances, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (abnormal coordination of movements), and double vision. All of these effects occur mainly at the start of treatment and usually disappear with repeated administration.
The most serious adverse reactions observed in patients treated with Lormetazepam Sandoz GmbH are angioedema (swelling), suicide and attempted suicide, generally associated with the masking of pre-existing depression.
The most commonly observed adverse reactions in patients treated with Lormetazepam Sandoz GmbH are headache, sedation, and anxiety.

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

Headache

Common side effects (may affect up to 1 in 10 people)

Angioedema (swelling of the face, lips, mouth, tongue, and throat that may cause difficulty swallowing and breathing)
Anxiety, decreased libido (reduced sexual desire)
Dizziness, sedation, somnolence, attention disturbances, amnesia, visual disturbances, speech disorders, altered taste sensation, slowed thinking
Tachycardia (rapid heartbeat)
Vomiting, nausea, upper abdominal pain, constipation, dry mouth
Itching
Urinary disorders
Asthenia (lack of energy), excessive sweating

Side effects with unknown frequency (cannot be estimated from the available data)

Suicide attempt or suicide (due to unmasking of pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false sensory perceptions), dependence, depression (due to unmasking of pre-existing depression), delirium (false beliefs considered true and impossible to disprove), withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, nervousness, anger outbursts, nightmares, inappropriate behaviors, emotional disturbances
Confusion, decreased level of consciousness, ataxia (abnormal coordination of movements), muscle weakness
Urticaria, rash (skin eruption)
Fatigue
Falls

For further information on the following points, see the section "Warnings and precautions".
Dependence
The use of Lormetazepam Sandoz GmbH and other benzodiazepines may lead to the development of physical or psychological dependence (see section "Warnings and precautions").

Psychiatric disorders

Rebound insomnia may occur upon discontinuation of treatment (see section "Warnings and precautions").
Paradoxical psychiatric reactions: use of Lormetazepam Sandoz GmbH may lead to reactions such as restlessness, agitation, irritability, aggressiveness, delirium (unreal ideas believed to be true but impossible to prove), anger, nightmares, hallucinations (illusory sensory perceptions), psychosis (a type of mental disorder), inappropriate behavior, and other behavioral disturbances.
Depression: the use of benzodiazepines may unmask pre-existing depression. In these patients, the risk of suicide may be increased. Lormetazepam Sandoz GmbH should be used with caution in patients with depression.

Nervous system disorders

Amnesia: Lormetazepam Sandoz GmbH may cause anterograde amnesia (difficulty in remembering recent events) (see section "Warnings and precautions").

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lormetazepam Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Lormetazepam Sandoz GmbH does not require any special storage conditions.
Do not use Lormetazepam Sandoz GmbH after the expiry date stated on the packaging after the word EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lormetazepam Sandoz GmbH contains
Lormetazepam Sandoz GmbH 1 mg tablets

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

Lormetazepam Sandoz GmbH 2 mg tablets

The active substance is lormetazepam. Each tablet contains 2 mg of lormetazepam.
The other components are: monohydrate lactose, sodium croscarmellose, magnesium stearate, maize starch and povidone K-25.

Description of the appearance of Lormetazepam Sandoz GmbH and contents of the pack
Lormetazepam Sandoz GmbH 1 mg tablets
Lormetazepam Sandoz GmbH 1 mg tablets are available in packs containing blisters with 14 and 30 tablets (regular packs) and 500 tablets (hospital pack). The tablets are round, white and have a score line on one side. The score line is used to divide the tablet into two equal parts.

Other formulations
Lormetazepam Sandoz GmbH 2 mg tablets, available in packs containing blisters with 14, 20 and 30 tablets (regular packs) and 500 tablets (hospital pack).
Not all pack sizes may be marketed.

Lormetazepam Sandoz GmbH 2 mg tablets
Lormetazepam Sandoz GmbH 2 mg tablets are available in packs containing blisters with 14, 20 and 30 tablets (regular packs) and 500 tablets (hospital pack). The tablets are round, white and have a score line on both sides. The score line is used to divide the tablet into two equal parts.

Other formulations
Lormetazepam Sandoz GmbH 1 mg tablets, available in packs containing blisters with 14 and 30 tablets (regular packs) and 500 tablets (hospital pack).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Representative in Italy: Sandoz SpA, Largo U. Boccioni 1, 21040 Origgio (VA)

Manufacturer
Kern Pharma, S.L., Venus, 72. Polígono Industrial Colon II, 08228 (Terrasa), Spain
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Arrow Génériques, 26 avenue Tony Garnier, 69007 Lyon, France

This medicinal product has been authorized in the Member States of the EEA under the following names:

SPAIN
Lormetazepam Kern Pharma 0.5 mg tablets

UNITED KINGDOM
Lormetazepam 0.5 mg tablets

Lormetazepam Sandoz GmbH 1 mg tablets:
SPAIN
Lormetazepam Kern Pharma 1 mg tablets
FRANCE
Lormetazepam Actavis 1 mg tablets
BELGIUM
Lormetazepam Sandoz 1 mg tablets
LUXEMBOURG
Lormetazepam Sandoz 1 mg tablets
ITALY
Lormetazepam Sandoz GmbH
UNITED KINGDOM
Lormetazepam 1 mg tablets

Lormetazepam Sandoz GmbH 2 mg tablets:
SPAIN
Lormetazepam Kern Pharma 2 mg tablets
FRANCE
Lormetazepam Actavis 2 mg tablets
BELGIUM
Lormetazepam Sandoz 2 mg tablets
LUXEMBOURG
Lormetazepam Sandoz 2 mg tablets
ITALY
Lormetazepam Sandoz GmbH