Package leaflet: Information for the patient

Lormetazepam Sandoz 2.5 mg/ml oral drops, solution

Equivalent medicine
Please read all of 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 reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Lormetazepam Sandoz contains the active substance lormetazepam, which belongs to a group of
medicines called benzodiazepines.
This medicine is indicated for the treatment of sleep disorders, only in cases where the disorder is
severe, disabling, and causes the person severe distress.

2. What you need to know before taking Lormetazepam Sandoz

Do not take Lormetazepam Sandoz

if you are allergic to the active substance 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 difficulties during sleep (sleep apnoea syndrome);
if you have a specific eye condition called narrow-angle glaucoma;
if you have severe liver problems (severe hepatic insufficiency);
if you have acute intoxication (excessive use) from alcohol, hypnotics (sleeping pills), analgesics (painkillers), or psychotropic medicines (medicines acting on mental functions such as neuroleptics, antidepressants, lithium);
if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

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

if you are elderly. In this case, your doctor may decide to reduce the dose;
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 and cerebellum (spinal and cerebellar ataxia);
if you suffer from depression or have previously abused alcohol or drugs;
if you suffer from heart failure.

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence and abuse: The use of this medicine and other benzodiazepines may lead to physical and psychological dependence. The risk increases with higher doses and longer duration of treatment, and is greater in patients with a history of drug or alcohol abuse. Therefore, if you have a history of alcohol or drug abuse, use this medicine with extreme caution (see “Warnings and precautions”).
The risk of dependence is reduced when this medicine is used at the appropriate dose and for a short-term treatment.
Abuse of benzodiazepines has been reported.
Withdrawal: When you stop taking Lormetazepam Sandoz, you may experience withdrawal or rebound symptoms, even if you have taken the medicine at recommended doses and for a short period (see section “If you stop taking Lormetazepam Sandoz”). To minimize such symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
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.
Amnesia: Lormetazepam Sandoz may cause anterograde amnesia (difficulty in memorizing new information). This is more likely to occur in the first hours after taking the medicine; therefore, to reduce the risk, ensure you can sleep uninterrupted for 7–8 hours after taking Lormetazepam Sandoz (see section 4 “Possible side effects”).
Behavioural reactions: If you experience behavioural disturbances, stop taking the medicine immediately (see section 4 “Possible side effects”). Such reactions are more frequent in children and elderly patients.
Benzodiazepines must not be used alone to treat depression or insomnia associated with depression, as suicidal thoughts may occur in such patients.
For individuals engaged in sports, the use of medicines containing ethanol may result in a positive doping test, depending on the alcohol concentration limits set by certain sports federations.
Children and adolescents
Lormetazepam Sandoz must not be administered to patients under 18 years of age. If administration to children is necessary, the doctor will first assess the actual need for treatment. The treatment duration should be as short as possible (see “Use in children and adolescents”).
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 “Use in the elderly”).
Patients with psychosis (mental disorders):
Lormetazepam Sandoz must not be used alone to treat insomnia associated with depression.
Benzodiazepines are not recommended for the primary treatment of psychotic disorders and must not be used alone to treat depression or anxiety associated with depression (the risk of suicide may be increased in these patients).
Other medicines and Lormetazepam Sandoz
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:

antipsychotics and antidepressants, used to treat psychiatric disorders;
hypnotics, medicines used to promote sleep;
anxiolytics and sedatives, used to treat anxiety;
certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with Lormetazepam Sandoz. This may increase your desire to continue taking these medicines (dependence);
antiepileptics, used for epilepsy;
anaesthetics, used during surgical procedures;
sedating antihistamines, used to treat allergies;
methylxanthines, 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);
oral contraceptives;
medicines for infections (antibiotics);
Cytochrome P450 inhibitors (medicines that slow down the activity of certain enzymes involved in drug metabolism); these may increase the activity of benzodiazepines;
cardiac glycosides (medicines for heart failure); concomitant use may increase cardiac glycoside levels in the blood;
beta-blocking agents (medicines for treating arrhythmias and heart failure); may increase the clinical effects of Lormetazepam Sandoz;
methylxanthines, theophylline or aminophylline (anti-asthmatics), rifampicin (antibiotic); may reduce the effect of Lormetazepam Sandoz;
medicines containing oestrogens (hormones); concomitant use may reduce benzodiazepine blood levels. Clozapine (a medicine for treating mental disorders); concomitant use with Lormetazepam Sandoz may cause marked sedation, excessive salivation, and ataxia (loss of coordination of movements).

The concomitant use of Lormetazepam Sandoz 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. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Lormetazepam Sandoz 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 follow the doctor’s dosage recommendations carefully. 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 any of these symptoms.
Lormetazepam Sandoz and alcohol
Do not consume alcohol during treatment with this medicine. Benzodiazepines cause an additive effect when taken with alcohol. This negatively affects your ability to drive vehicles and operate machinery.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Lormetazepam Sandoz is contraindicated during pregnancy.
If your doctor considers that you should take Lormetazepam Sandoz during the late stages of pregnancy or during labour, your baby may experience low body temperature, loss of muscle tone, low blood pressure (hypotension), feeding difficulties (“neonatal hypotonia”), and moderate respiratory depression.
If Lormetazepam Sandoz has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as lormetazepam is excreted in breast milk.
Fertility
If you are of childbearing age and start treatment with Lormetazepam Sandoz, consult your doctor, whether you are planning a pregnancy or suspect you are pregnant, as it will be necessary to discontinue the medicine.
Driving and using machines
Lormetazepam Sandoz significantly impairs your ability to drive or operate machinery, as it causes sedation, amnesia (memory loss), concentration disturbances, and impaired muscle function. If your sleep duration has been insufficient, there may be a higher likelihood of altered alertness.
Reactions may vary depending on the time of intake, individual sensitivity, and dose taken. This is particularly relevant with high doses in combination with alcohol (see “Lormetazepam Sandoz and alcohol”).
Lormetazepam Sandoz 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 less than 5 years old, 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 Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, 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.
The recommended single dose in adults ranges from 1 mg (10 drops) to 2 mg (20 drops).
The duration of treatment should be as short as possible and generally varies 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 be started with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment in order to reduce, if necessary, the dose or frequency of administration.
The maximum dose must not be exceeded.

Use in children and adolescents (under 18 years of age)
Your doctor will prescribe Lormetazepam Sandoz to patients under 18 years of age only if absolutely necessary and only after careful evaluation (see section 2 “Warnings and precautions”). The duration of treatment should be as short as possible. Your doctor will determine the most appropriate dose for you.

Use in the elderly
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 mild to moderate respiratory impairment, kidney problems or hepatic impairment, a dose reduction should be considered.

If you take more Lormetazepam Sandoz than you should
If you (or someone else) have taken an excessive dose of Lormetazepam Sandoz, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital.
Symptoms of mild intoxication include drowsiness, fatigue, ataxia (loss of coordination of movements), visual disturbances, mental clouding (temporary dulling of the senses or consciousness), confusion and lethargy (tendency to prolonged sleep and unresponsiveness to normal stimuli).
Oral administration of higher doses may lead to symptoms ranging from deep sleep to unconsciousness, ataxia (loss of coordination of movements), hypotonia (decreased muscle tone), hypotension (low blood pressure), respiratory depression (increased level of carbon dioxide in the blood), 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 Sandoz
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 forgotten dose.

If you stop taking Lormetazepam Sandoz
Do not stop treatment with Lormetazepam Sandoz suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to stop treatment, they will gradually reduce your dose to minimize withdrawal symptoms such as:

headache, muscle pain, tension
severe anxiety, confusion, restlessness, irritability
in severe cases of withdrawal, derealization (feeling that reality is distorted, unreal or unfamiliar), depersonalization (feeling of detachment from the surrounding environment), intolerance to sound (hyperacusis), hypersensitivity to light, noise and physical contact, hallucinations (seeing or hearing things that are not real), and seizures. Other symptoms include:
depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (abnormal sensations), perceptual disturbances, abdominal and muscular cramps, tremor, myalgia (muscle pain), agitation, palpitations, tachycardia (rapid heartbeat), panic attacks, dizziness, hyperreflexia (exaggerated reflexes), short-term memory loss, hyperthermia (increased body temperature).

Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may return even more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is greater if you stop taking Lormetazepam Sandoz suddenly. You may also experience mood changes, anxiety, restlessness or sleep disturbances.
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 everyone experiences 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 Sandoz are
headache, sedation, and anxiety. The more serious adverse reactions in patients receiving Lormetazepam Sandoz are angioedema (swelling of the skin of the face, lips, and tongue), suicide or attempted suicide in association with the emergence 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.

Common (may affect up to 1 in 10 people)

swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing, potentially fatal (angioedema);
anxiety;
decreased sexual desire;
dizziness, sedation, somnolence, attention disturbances;
memory loss (amnesia) (see section “Warnings and precautions”);
vision problems and double vision (diplopia);
speech difficulties;
altered taste (dysgeusia);
slowing of mental and motor functions;
increased heart rate (tachycardia);
vomiting, nausea, abdominal pain, constipation;
dry mouth;
itching;
urinary disturbances;
muscle weakness (asthenia);
increased sweating (hyperhidrosis).

Rare (may affect up to 1 in 100 people)

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

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

emergence of pre-existing depression with tendency to self-harm (suicide and attempted suicide), psychosis, hallucinations, dependence, depression (unmasking of pre-existing depression), delirium, delusion, withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, rage (anger), nightmares, abnormal behaviour, emotional disturbances (see sections “Warnings and precautions” and “If you stop taking Lormetazepam Sandoz”);
confusion, loss of muscular coordination (ataxia), muscle weakness;
reduced alertness;
urticaria, skin rash;
fatigue;
falls.

Jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme levels, 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 (SIAD) have also been reported rarely.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Lormetazepam Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 20 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 Sandoz contains
The active substance is: lormetazepam. 1 ml (25 drops) of solution contains 2.5 mg of lormetazepam.
The other components are: sodium saccharin, orange flavour, lemon flavour, crème caramel flavour,
96% ethanol, glycerol, propylene glycol.
Description of the appearance of Lormetazepam Sandoz and package contents
Pack containing one 20 ml solution bottle.
The bottle has a child-resistant safety closure.
Marketing Authorization Holder
Sandoz S.p.A. - Largo U. Boccioni, 1 - 21040 Origgio (VA) Italy
Manufacturers
MPF b.v. - Appelhoff 13 – 8465 RX Oudehaske - The Netherlands
Mipharm S.p.A. - Via B. Quaranta, 12 – 20141 – Milan, Italy
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10015 Ivrea (TO)