Lorazepam Sandoz: detailed information

Package leaflet: information for the patient

Lormetazepam Hexal 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 they have the same symptoms as yours, because it could be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Lormetazepam Hexal 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), in cases where the disorder is severe, disabling, and causes severe distress to the person.

2. What you should know before taking Lormetazepam Hexal

Do not take Lormetazepam Hexal

if you are allergic to the active substance, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
if you have severe respiratory insufficiency (e.g. severe chronic obstructive pulmonary disease);
if you have breathing problems during sleep (sleep apnea);
if you have high eye pressure (narrow-angle glaucoma);
if you have severe liver problems (hepatic insufficiency);
if you have alcohol intoxication or intoxication from other medicines that depress the central nervous system (antipsychotics, hypnotics, analgesics, 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 Hexal.
Take this medicine with caution and always under medical supervision in the following cases:

if you are elderly, as there is an increased risk of falls due to certain side effects of this medicine. In this case, your doctor may decide to reduce the dose (see section 3 “How to take Lormetazepam Hexal” – Use in the elderly);
if you have respiratory problems (respiratory insufficiency). In this case, your doctor may decide to reduce the dose;
if you have severe liver or kidney problems (severe hepatic or renal insufficiency);
if you suffer from loss of muscle coordination making certain movements difficult due to damage to the spinal cord or cerebellum (spinal and cerebellar ataxia);
if you suffer from depression or have previously abused alcohol or drugs;
if you have low blood pressure or heart problems (cardiac insufficiency). In this case, your doctor may decide to perform regular check-ups.

Tolerance: If after several weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence and abuse: When taking this medicine, there is a risk of physical and psychological dependence, i.e. the need to continue taking the medicine regardless of actual medical necessity. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously abused drugs or alcohol.
The likelihood of dependence is reduced when Lormetazepam Hexal is used at the appropriate dose for short-term treatment. Withdrawal symptoms: Once physical dependence has developed, stopping treatment may lead to withdrawal symptoms (see section “Possible side effects”).
These may include:

severe anxiety, tension, restlessness, confusion, irritability, headache, muscle pain.

In severe cases, the following symptoms may occur:

derealization (feeling that reality is distorted, unreal, or unfamiliar), depersonalization (loss of sense of personal identity), hyperacusis (difficulty tolerating certain sounds), numbness and tingling in the extremities, paresthesia of the limbs (altered sensation in limbs), hypersensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that are not present in reality), and epileptic seizures.

Other symptoms include:

depression, insomnia, sweating, tinnitus (ringing in the ears), persistent, involuntary movements, vomiting, paresthesia (altered sensation), perceptual disturbances, abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations, tachycardia (rapid heartbeat), panic attacks, dizziness, hyperreflexia (exaggerated reflexes), short-term memory loss, hyperthermia (increased body temperature).

Upon discontinuation of treatment, the following may also occur:

rebound insomnia, a transient syndrome in which symptoms that led to benzodiazepine treatment reappear in a worsened form. This may be accompanied by other reactions including: mood changes, anxiety, restlessness, or sleep disturbances.

When short-acting benzodiazepines are administered, withdrawal symptoms may occur during the dosing interval, particularly at high doses.
However, when switching to Lormetazepam Hexal after prolonged use and/or high doses of benzodiazepines with significantly longer duration of action, withdrawal symptoms may occur.
Withdrawal symptoms, especially the more severe ones, are more common in patients who have taken excessive doses over a long period; however, they may also occur after abrupt discontinuation of benzodiazepines taken continuously at therapeutic doses, especially if stopped suddenly.
Since the risk of withdrawal or rebound symptoms is higher after abrupt discontinuation of treatment, it is recommended to gradually reduce the dose.
Duration of treatment: The treatment duration should be as short as possible.
Generally, it ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period. Any longer treatment requires a reassessment of the clinical situation by the doctor.
Amnesia: This medicine may cause difficulty in memorizing new information (anterograde amnesia). This most commonly occurs within the first few hours after taking the medicine; therefore, to reduce the risk of amnesia, ensure an uninterrupted sleep of 7–8 hours.
Paradoxical and behavioral reactions: If you experience restlessness, agitation, irritability, aggression, dysphoria, delirium, rage, nightmares, hallucinations (seeing or hearing things that are not present in reality), psychosis (mental disorder characterized by detachment from reality), inappropriate behavior, or other behavioral changes, stop taking the medicine immediately (see section 4 “Possible side effects”).
Such reactions are more frequent in children and the elderly, as well as in patients with impaired mental function (organic brain syndrome).
Patients with psychosis (mental illnesses)
Lormetazepam Hexal should not be used alone to treat psychosis, especially depression or insomnia associated with depression, as in such patients the symptoms of depression may be masked but the underlying risks associated with this condition, such as suicidal tendencies, remain.
For athletes: The use of medicines containing ethanol may lead to positive results in doping tests, depending on the blood alcohol concentration limits set by certain sports federations.
Children and adolescents
Lormetazepam Hexal must not be administered to children and adolescents under 18 years of age, except in cases of absolute necessity and after careful evaluation by the doctor. The duration of treatment should be as short as possible (see section 3 “Use in children and adolescents (under 18 years of age)”).
Elderly
The use of benzodiazepines, including this medicine, may be associated with an increased risk of falls due to side effects such as ataxia (lack of coordination in movements), muscle weakness, dizziness, drowsiness, fatigue, and tiredness. In such cases, your doctor will prescribe a reduced dose (see section 3 “Use in elderly patients”).
Other medicines and Lormetazepam Hexal
Inform 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:

antipsychotics (e.g. clozapine) used to treat psychiatric disorders;
antidepressants;
hypnotics, medicines used to promote sleep;
anxiolytics, tranquillizers, and sedatives, used to treat anxiety;
certain strong painkillers (narcotic analgesics), as they may increase your desire to continue taking these medicines (dependence);
medicines belonging to the opioid class that may cause breathing problems (analgesics, antitussives, or substitution treatments);
antiepileptics, used for epilepsy;
anesthetics, used during surgical procedures;
antihistamines with sedative effect, used to treat allergies;
methylxanthines, theophylline and aminophylline, used to treat asthma or other respiratory diseases;
certain medicines used to treat high blood pressure (beta-blockers);
medicines used for irregular heartbeat (cardiac glycosides);
medicines containing estrogens (including oral contraceptives);
rifampicin, a medicine used to treat infections;
medicines that may inhibit certain liver enzymes (CYP450 inhibitors).

Concomitant use of Lormetazepam Hexal and opioids (strong analgesics, medicines for addiction treatment, and certain 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 Hexal together with opioids, the dose and duration of concomitant treatment must be limited by the 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 Hexal and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may enhance the sedative effect of the medicine. This negatively affects your ability to drive vehicles and operate machinery.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Lormetazepam Hexal during pregnancy.
If, for serious reasons, your doctor considers it necessary for you to take Lormetazepam Hexal in the late stages of pregnancy or during labor, your baby may experience low body temperature, loss of muscle tone, low blood pressure, difficulty sucking, and breathing problems.
If Lormetazepam Hexal has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms in the period after birth.
If you start treatment with Lormetazepam Hexal and are of childbearing age, consult your doctor both if you plan to become pregnant and if you suspect you are pregnant, as it will be necessary to discontinue the medicine.
Breastfeeding
Do not take Lormetazepam Hexal if you are breastfeeding, as Lormetazepam passes into breast milk.
Driving and using machines
Taking Lormetazepam Hexal may affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle weakness. These effects are more pronounced if you have not had enough sleep. If this occurs, avoid driving or operating machinery.
Your reactions may vary depending on the time of intake, your individual sensitivity, and the dose taken. This is particularly relevant with high doses combined with alcohol.
Lormetazepam Hexal contains ethanol (alcohol), sodium, and propylene glycol
This medicine contains 80 mg of alcohol (ethanol) per ml (1 ml corresponds to 25 drops), equivalent to 80 mg/ml.
The amount in a maximum dose of 10 drops (0.4 ml) of this medicine is equivalent to 0.768 ml of beer or 0.307 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per 10-drop dose, i.e. essentially “sodium-free”.
This medicine contains 1 mg of propylene glycol per dose, equivalent to 1 mg/ml.
If the child is less than 4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Lormetazepam Hexal

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor tells you to.
Take this medicine just 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 for adults ranges from 1 mg (10 drops) to 2 mg (20 drops).
The duration of treatment should be as short as possible and generally lasts from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
Treatment should start with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment to reduce, if necessary, the dose or frequency of administration.

Use in children and adolescents (under 18 years of age)
This medicine must not be used in children and adolescents under 18 years of age unless your doctor determines it is absolutely necessary.
In such cases, the recommended dose depends on the person's age, weight, and condition. The duration of treatment should be as short as possible. Dosing will be determined solely by the doctor.

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 patients with impaired renal function, your doctor will carefully determine the appropriate dosage for your case and may consider reducing the doses indicated above.
In patients with mild to moderate respiratory impairment or with hepatic impairment, a dose reduction should be considered.

Duration of treatment
Your doctor will explain that treatment is intended to be short-term and that the dose may be gradually reduced before stopping. Treatment with Lormetazepam Hexal should be as short as possible. Your doctor will regularly reassess your condition and the need for continued treatment, especially if you are symptom-free.
The duration of treatment generally ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period.
In certain cases, extension beyond the maximum treatment period may be necessary, but only after your doctor has reassessed your condition.
Treatment should begin with the lowest recommended dose and be increased carefully without exceeding the maximum dose, and should be as brief as possible.
If treatment lasts longer than two weeks, discontinuation of Lormetazepam Hexal must not be abrupt, as sleep disturbances may temporarily return with increased intensity. Therefore, it is recommended to complete treatment by gradually reducing the dose.

If you take more Lormetazepam Hexal than you should
If you (or someone else) have taken an excessive dose of Lormetazepam Hexal, or if you suspect a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department. In hospital, you will be treated according to appropriate protocols, such as induction of vomiting or gastric lavage.
An overdose may cause severe depression of the central nervous system, with symptoms such as drowsiness, fatigue, confusion, visual disturbances, deep sleep, unconsciousness, progressive loss of muscle coordination (ataxia), reduced muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, temporary loss of sensory and intellectual functions (obnubilation), which may worsen to coma and, very rarely, death.
Take this leaflet, the bottle, and its packaging with you to the hospital or doctor so they know which medicine has been taken.

If you forget to take Lormetazepam Hexal
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 the missed dose.

If you stop taking Lormetazepam Hexal
Do not stop treatment with Lormetazepam Hexal suddenly or without consulting your doctor first, as withdrawal symptoms may occur.
Discontinuation, especially if abrupt, may be accompanied by withdrawal symptoms (see section “Withdrawal symptoms (Dependence)”).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
At the beginning of treatment, daytime drowsiness, emotional disturbances, depressed level of consciousness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (loss of coordination of movements), or diplopia (double vision) may occur. These reactions usually disappear with continued treatment.
The most frequently observed adverse reactions in patients receiving Lormetazepam Hexal are headache, sedation, and anxiety. The most serious adverse reactions in patients receiving Lormetazepam Hexal are angioedema (swelling of the skin of the face, lips, and tongue), suicide or attempted suicide in association with unmasking of pre-existing depression.
Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people)

headache (cephalalgia).

Common (may affect up to 1 in 10 people)

swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing, potentially fatal (angioedema)*;
anxiety;
decreased sexual desire;
dizziness, sedation, somnolence, attention disturbances;
memory loss (amnesia);
vision problems and double vision (diplopia);
difficulty speaking;
altered taste (dysgeusia);
slowing of mental functions (bradyphrenia);
increased heart rate (tachycardia);
vomiting, nausea, abdominal pain, constipation;
dry mouth;
itching;
urinary disorders;
muscle weakness (asthenia);
increased sweating (hyperhidrosis).

Rare (may affect up to 1 in 100 people)

sudden potentially fatal allergic reactions (anaphylactic/anaphylactoid reactions).

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

unmasking of pre-existing depression*;
tendency to self-harm (suicide and attempted suicide);
acute psychosis (mental disorder);
hallucinations, dependence, depression (unmasking of pre-existing depression), delirium, delusion, withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, restlessness, rage (anger), nightmares, abnormal behaviour, emotional disturbances;
confusion, loss of muscular coordination (ataxia), muscle weakness, reduced alertness;
urticaria, skin rash;
fatigue;
falls;
vertigo.

Jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme levels (hepatic transaminases), increased alkaline phosphatase, increased bilirubin, decreased platelets or white blood cells (thrombocytopenia, agranulocytosis), decreased levels of all blood cells (pancytopenia), and disturbances in the secretion of antidiuretic hormone (SIADH) have been rarely reported.
*Life-threatening or fatal cases have been reported;
§see section “Warnings and Precautions”.
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 the website https://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 Hexal

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 medicine should be used within 45 days of first opening the bottle. Any remaining product must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lormetazepam Hexal contains
The active substance is: lormetazepam. 1 ml (25 drops) of solution contains 2.5 mg of lormetazepam.
The other components are: sodium saccharin, glycerol 85 per cent, ethanol 96 per cent, orange/lemon/caramel flavour and propylene glycol.
Description of the appearance of Lormetazepam Hexal and contents of the pack
Pack containing one 20 ml bottle of solution.
The bottle has a child-resistant closure which protects against tampering by children.
Marketing Authorisation Holder
Sandoz S.p.A. - Largo U. Boccioni 1 - 21040 Origgio (VA) Italy
Manufacturers
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
Mipharm S.p.A. - Via B. Quaranta, 12 – 20141 – Milan
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10015 Ivrea (TO)