Lorazepam Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Lormetazepam Zentiva 2.5 mg/ml oral drops, solution

Generic Medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LORMETAZEPAM ZENTIVA is and what it is used for

Lormetazepam Zentiva contains the active substance lormetazepam, which belongs to a group of
medicines called benzodiazepines.
This medicine is indicated for the short-term treatment of sleep disorders (insomnia).
Benzodiazepines are indicated only in cases where the disorder is severe, disabling and causes the individual severe distress.

2. What you need to know before taking Lormetazepam Zentiva

Do not take Lormetazepam Zentiva

• if you are allergic to lormetazepam or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other similar medicines (benzodiazepines);
• if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
• if you have loss of muscle coordination making it difficult to perform certain movements due to damage to the spinal cord and cerebellum (spinal and cerebellar ataxia);
• if you have severe breathing difficulties (e.g. severe chronic obstructive pulmonary disease);
• if you have breathing problems during sleep (sleep apnea);
• if you have a type of eye disease called narrow-angle glaucoma;
• if you have severe liver problems (severe hepatic insufficiency);
• if you have intoxication from alcohol or other medicines that depress the central nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lormetazepam Zentiva.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly. The use of this medicine may cause falls due to the onset of ataxia (loss of muscle coordination), muscle weakness, dizziness, drowsiness, fatigue, and tiredness. In such cases, your doctor may decide to reduce the dose (see section 3 “How to take Lormetazepam Zentiva – Use in the elderly”);
• if you have long-standing respiratory problems (chronic respiratory insufficiency). In this case, your doctor may decide to reduce the dose;
• if you have liver problems (and other related disorders) or kidney problems;
• if you suffer from loss of muscle coordination making it difficult to perform certain movements due to damage to the spinal cord and cerebellum (other than spinal and cerebellar ataxia, see previous section “Do not take Lormetazepam Zentiva”);
• if you suffer from depression or other mental illnesses such as psychotic disorders. Benzodiazepines, the class of medicines to which this medicine belongs, should not be used alone to treat depression, insomnia, or anxiety associated with depression, as suicidal thoughts may occur in such patients;
• if you have previously abused alcohol or drugs;
• if you have low blood pressure or heart problems (heart failure). In this case, your doctor may decide to carry out regular check-ups.

Tolerance: If after a few weeks you feel that the medicine is less effective, consult your doctor.
Dependence: When taking this medicine, there is a risk of dependence, meaning a need to continue taking the medicine, which may lead to excessive use (abuse). The risk increases with higher doses and longer treatment duration; it is greater if you have previously abused drugs or alcohol. If the medicine is taken at the prescribed dose and for short-term treatment, the risk of dependence is reduced.
Discontinuation and withdrawal: When you stop taking this medicine, you may experience a temporary condition in which the symptoms that led to treatment with benzodiazepines reappear in a worsened form (rebound syndrome). Other symptoms may also occur, such as mood changes, anxiety, restlessness, or sleep disturbances. If dependence has developed during treatment (see previous section), abrupt discontinuation of treatment will be accompanied by withdrawal symptoms, which may include: headache, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following may occur: derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds (hyperacusis), numbness and tingling in hands and feet (paresthesia), sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures (sudden, uncontrolled movements). To minimize the occurrence of such symptoms, it is recommended to gradually reduce the dose (see section “If you stop taking Lormetazepam Zentiva”).
For certain medicines (benzodiazepines with a short duration of action), withdrawal symptoms may also occur between doses, especially with high doses. This is unlikely to happen with this medicine; however, when switching to this medicine after using other benzodiazepines (with longer duration of action) for a prolonged period and/or at high doses, withdrawal symptoms may occur.
Amnesia: This medicine may cause amnesia (memory loss), particularly within the first few hours after taking the medicine. To reduce the risk of amnesia, ensure an uninterrupted sleep of 7–8 hours.
Duration of treatment: The treatment duration should be as short as possible. It generally ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual discontinuation period during which the dose should be progressively reduced.
Behavioural reactions: If you experience behavioural disturbances (such as restlessness, agitation, irritability, aggressiveness, delirium, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly), abnormal behaviour, or other behavioural changes), contact your doctor immediately, who may decide to discontinue the medicine (see section 4. Possible side effects). These reactions are more frequent in children, the elderly, and patients with certain brain disorders (organic brain syndrome).
Children and adolescents
In children and adolescents under 18 years of age, Lormetazepam Zentiva should be used only when absolutely necessary, and the treatment duration should be as short as possible.
Other medicines and Lormetazepam Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• anaesthetics (to induce anaesthesia during surgical procedures);
• antipsychotics (neuroleptics including clozapine), used to treat mental disorders;
• certain antidepressants;
• anticonvulsants (to treat seizures);
• hypnotics, medicines used to promote sleep;
• anxiolytics, tranquillisers, and sedatives, used to treat anxiety;
• certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with Lormetazepam Zentiva. This may increase your desire to continue taking these medicines (dependence);
• antihistamines with sedative effects, used to treat allergies;
• theophylline, aminophylline, and other methylxanthines, used to treat asthma or other respiratory diseases;
• certain medicines used to treat high blood pressure and other heart conditions (beta-blockers and cardiac glycosides);
• cough medicines (antitussives);
• oral contraceptives (the pill);
• certain medicines used for infections (antibiotics).

The concomitant use of Lormetazepam Zentiva and opioids (strong analgesics, medicines for addiction therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Lormetazepam Zentiva 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 carefully follow the doctor’s dosage recommendations. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Lormetazepam Zentiva and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine. This negatively affects your ability to drive vehicles and operate machinery.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not take Lormetazepam Zentiva during pregnancy.
If your doctor considers it necessary for you to take Lormetazepam Zentiva during the late stages of pregnancy or during labour, your baby may experience low body temperature, loss of muscle strength, low blood pressure, and difficulties with sucking and breathing (neonatal hypotonia).
If Lormetazepam Zentiva has been taken regularly during the late stages of pregnancy, your baby may develop dependence and may experience withdrawal symptoms immediately after birth.
Breastfeeding
You must not take this medicine if you are breastfeeding, as lormetazepam passes into breast milk.
Driving and using machines
The use of Lormetazepam Zentiva may affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, have difficulty concentrating, or experience muscle problems. These effects are worsened if you have not had enough sleep. If this happens, avoid driving or operating machinery. Consuming alcohol during treatment with this medicine negatively affects your ability to drive and operate machinery.
LORMETAZEPAM ZENTIVA contains ethanol (alcohol)
This medicine contains small amounts of alcohol, less than 100 mg per the recommended dose of 20 drops.

3. How to take Lormetazepam Zentiva

Take this medicine exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
The duration of treatment should be as short as possible, but you must continue taking
this medicine until your doctor tells you to stop.
Take this medicine before going to bed. The drops must be diluted with a small amount of
water or another drink.
Your doctor will determine the correct dose for you.
The recommended single dose in adults ranges from 1 mg (10 drops) to 2 mg (20 drops).
Take the Lormetazepam Zentiva drops as follows:

• To open the bottle: press on the cap and simultaneously unscrew it (Fig. 1).
• Let the drops fall into a glass, holding the bottle in an upright position with the opening facing downwards (Fig. 2).
• To close the bottle: screw the cap back on until tightly sealed (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
The duration of treatment should be as short as possible and generally ranges from a few days
to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period.
In specific cases, your doctor may decide to extend the treatment after evaluating your
health condition.
Treatment should be started with the lowest recommended dose. The maximum dose must
not be exceeded.
Your doctor will regularly monitor your condition to reduce, if necessary, the dose or frequency of administration.
Use in children and adolescents (under 18 years of age)
This medicine should only be used when absolutely necessary.
The recommended dose depends on the person's age, weight, and condition.
Use in elderly patients
In elderly patients, the recommended dose is 0.5–1 mg (5–10 drops).
Use in patients with kidney, liver, or respiratory problems
In these patients, your doctor may prescribe a reduced dose.
If you take more Lormetazepam Zentiva than you should
If you (or someone else) have taken an excessive dose of Lormetazepam Zentiva, or if you think a
child may have taken this medicine, contact your doctor immediately or go to the nearest
hospital emergency department.
A mild overdose may cause significant depression of the central nervous system, with symptoms
such as drowsiness (even severe), fatigue, ataxia (movement disorders), visual disturbances, and
mental confusion. Oral administration of higher doses may lead to symptoms ranging from
deep sleep to unconsciousness, severe muscle weakness, low blood pressure, breathing difficulties,
rarely coma, and, very rarely, death.
Take this leaflet, the bottle, and its container with you to the hospital or doctor so they know which medicine has been taken.
If you forget to take Lormetazepam Zentiva
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lormetazepam Zentiva
Do not stop treatment with Lormetazepam Zentiva suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur (see section: “Warnings and precautions – Discontinuation of treatment and withdrawal”).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the beginning of treatment, daytime drowsiness, emotional disturbances, reduced level of consciousness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (movement disorder), or double vision may occur; these side effects usually disappear with continued treatment.
The most frequently observed side effects in patients receiving lormetazepam are headache, sedation, and anxiety. The more serious ones are: angioedema (swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing and potentially be life-threatening), suicide or attempted suicide in patients who had undiagnosed depression.

Seek immediate medical advice if you experience:

• depression and mental disturbances such as restlessness, agitation, irritability, aggressiveness, delirium, rage, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), behavioural changes. These reactions are more common in children and elderly patients.

Consult your doctor anyway if you experience any of the following side effects, listed in order of frequency:
Very common (may affect more than 1 in 10 people):

• headache.

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

• swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing which may be potentially life-threatening (angioedema);
• anxiety;
• decreased sexual desire;
• dizziness, sedation, drowsiness, attention disturbances;
• memory loss (amnesia) (see section “Warnings and precautions”);
• visual problems and double vision (diplopia);
• difficulty speaking;
• altered taste (dysgeusia);
• intellectual dysfunction characterized by slowed thinking, inattention, and reduced concentration (bradyphrenia);
• increased heart rate (tachycardia);
• vomiting, nausea, abdominal pain, constipation;
• dry mouth;
• itching;
• urinary problems;
• muscle weakness (asthenia);
• increased sweating (hyperhidrosis).

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

• sudden potentially life-threatening allergic reactions (anaphylactic/anaphylactoid reactions);

Not known (frequency cannot be estimated from the available data):

• depression and tendency to self-harm (suicide and attempted suicide) in patients who had undiagnosed depression;
• psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), hallucinations (seeing or hearing things that do not exist), dependence, delirium, delusions, withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, restlessness, rage, nightmares, abnormal behaviour, emotional disturbances (see sections “Warnings and precautions” and “If you stop taking Lormetazepam Zentiva”);
• confusion, reduced level of consciousness, loss of muscular coordination (ataxia), muscle weakness;
• daytime drowsiness, reduced alertness;
• reduced emotional responsiveness;
• vertigo;
• skin reactions with redness and urticaria;
• fatigue;
• falls.

Rarely, yellowish discoloration of the skin and whites of the eyes (jaundice), increased liver enzyme levels, increased bilirubin levels, decreased platelets or white blood cells (thrombocytopenia, agranulocytosis), decreased levels of all blood cells (pancytopenia), and disturbances in antidiuretic hormone secretion (SIADH) may also occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lormetazepam Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
The product should be used within 30 days of first opening the bottle. Any remaining product must be discarded.
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 Zentiva contains
The active substance is lormetazepam. 1 ml of solution contains 2.5 mg of lormetazepam.
The other components are: sodium saccharin, glycerol 85 percent, ethanol 96 percent, orange flavour, lemon essence, caramel flavour, propylene glycol.
Description of the appearance of Lormetazepam Zentiva and pack contents
Pack containing one 20 ml bottle of solution.
The bottle has a child-resistant closure to protect against tampering by children.
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa, 7, 20121 Milan
Manufacturer
ICE S.p.A., Canton Moretti 29, 10015 S. Bernardo d'Ivrea (TO)