PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LORMETAZEPAM DOC Generici 2.5 mg/ml oral drops, solution

Generic Medicine
Please read this leaflet carefully before taking this medicine as 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, because it could 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:

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

1. What LORMETAZEPAM DOC Generici is and what it is used for

LORMETAZEPAM DOC Generici 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 patient.

2. What you need to know before taking LORMETAZEPAM DOC Generics

Do not take LORMETAZEPAM DOC Generics

if you are allergic to lormetazepam, 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 suffer from loss of muscle coordination making movements difficult due to damage to the spinal cord and cerebellum (spinal and cerebellar ataxia);
if you have severe respiratory insufficiency (e.g. severe chronic obstructive pulmonary disease);
if you have breathing difficulties during sleep (sleep apnea);
if you have a narrow-angle glaucoma, an eye condition;
if you have severe liver problems (severe hepatic insufficiency);
if you are intoxicated with alcohol or other medicines that depress the central nervous system (hypnotics, analgesics, antipsychotics, 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 DOC Generics.
LORMETAZEPAM DOC Generics must not be used as first-line treatment for psychotic illness.
LORMETAZEPAM DOC Generics must not be used as the sole treatment for depression or anxiety disorders associated with depression, as suicidal thoughts may occur in such patients.
Take this medicine with caution and always under medical supervision in the following cases:

if you are elderly. In this case, use of the medicine may increase the risk of falls (see section 4 Possible side effects), and therefore the dose should be reduced (see section 3 How to take LORMETAZEPAM DOC Generics – Use in the elderly);
if you have respiratory problems (chronic respiratory insufficiency). In this case, your doctor may decide to reduce the dose;
if you have mild or moderate liver problems (hepatic insufficiency);
if you have severe kidney problems (severe renal insufficiency);
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 perform regular check-ups.

Tolerance: consult your doctor if, after a few weeks, you feel the medicine is no longer working as well as it did at the beginning of treatment.
Dependence: physical and psychological dependence (the need to continue taking the medicine) may develop during treatment with this medicine. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously abused drugs or alcohol.
Withdrawal: When you stop taking LORMETAZEPAM DOC Generics, you may experience withdrawal or rebound symptoms (the symptoms that led you to take LORMETAZEPAM DOC Generics reappear in a worsened form), even if you have taken the medicine at the recommended dose and for a short period of time (see section If you stop taking LORMETAZEPAM DOC Generics and section 4. Possible side effects). To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to LORMETAZEPAM DOC Generics.
Amnesia: To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience behavioural disturbances, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more frequent in children, the elderly, and patients with diseases causing reduced mental function (organic brain syndrome).
For athletes: 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
In children and adolescents under 18 years of age, LORMETAZEPAM DOC Generics should be used only when absolutely necessary, and the duration of treatment should be as short as possible.
Other medicines and LORMETAZEPAM DOC Generics
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 and antidepressants (e.g. clozapine), used to treat mental disorders;
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 DOC Generics. 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;
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);
oral contraceptives;
medicines for infections (antibiotics);
medicines that inhibit certain liver enzymes (particularly cytochrome P450).

The concomitant use of LORMETAZEPAM DOC Generics and opioids (strong painkillers, 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 possible.
However, if your doctor prescribes LORMETAZEPAM DOC Generics 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 your doctor’s recommendations regarding dosage. It may be helpful to inform friends or relatives so they can watch for the signs and symptoms mentioned above.
Contact your doctor if you experience such symptoms.
LORMETAZEPAM DOC Generics and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine. This may negatively affect your ability to drive or operate machinery.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take LORMETAZEPAM DOC Generics during pregnancy.
If your doctor considers it necessary for you to take LORMETAZEPAM DOC Generics during the late stages of pregnancy or during childbirth, your baby may show signs at birth such as low body temperature, loss of muscle tone, low blood pressure, and difficulties with sucking and breathing.
If LORMETAZEPAM DOC Generics has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms.
If you start treatment with LORMETAZEPAM DOC Generics 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.
Do not take this medicine if you are breastfeeding, as lormetazepam passes into breast milk.
Driving and using machines
The use of LORMETAZEPAM DOC Generics may affect your ability to drive or use machinery, as you may feel confused, forgetful, drowsy, or experience muscle weakness. These effects are increased if you have not slept enough or if you have taken a high dose of LORMETAZEPAM DOC Generics together with alcohol. If this happens, avoid driving or using machinery.
LORMETAZEPAM DOC Generics contains ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per 20-drop dose (corresponding to 2 mg of lormetazepam).
LORMETAZEPAM DOC Generics drops contain sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose (20 drops), i.e. essentially 'sodium-free'.
LORMETAZEPAM DOC Generics drops contain propylene glycol
This medicine contains 571 mg of propylene glycol per 20-drop dose (corresponding to 2 mg of lormetazepam).

If the child is under 5 years of age, consult 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 DOC Generici

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 until your doctor tells you to stop.
Take this medicine half an hour 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 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.
Your doctor will regularly monitor your condition at the beginning of treatment in order to reduce, if necessary, the dose or frequency of administration.

Use in children and adolescents
This medicine should be used in patients under 18 years of age only when absolutely necessary.
The recommended dose depends on age, weight, and the individual's condition. The duration of treatment
should be as short as possible.

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 kidney problems, the dose must be carefully determined by the doctor and may need to be reduced compared to the recommended dose.
In patients with mild to moderate respiratory difficulties or with hepatic impairment, a dose reduction should be considered.

If you take more LORMETAZEPAM DOC Generici than you should
If you (or someone else) have taken an excessive dose of LORMETAZEPAM DOC Generici or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause severe depression of the central nervous system, especially if LORMETAZEPAM DOC Generici has been taken together with other medicines that depress the central nervous system (including alcohol), leading to 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 and lead to 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 DOC Generici
Do not take a double dose to make up for the forgotten dose.

If you stop taking LORMETAZEPAM DOC Generici
Do not stop treatment with LORMETAZEPAM DOC Generici suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue 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 things are not real), depersonalization (feeling detached from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that do not exist), or epileptic seizures.

After stopping treatment, rebound phenomena may occur; that is, the symptoms that led you to take this medicine may return more intensely, and you may experience additional symptoms such as mood changes, anxiety and restlessness, or sleep disturbances.
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 everyone gets them.
Contact your doctor immediately if you experience:

depression and mental disorders such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations (seeing and 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. Treatment must be discontinued if any of these side effects occur. These reactions are more frequent in children and elderly patients.

Other side effects that may occur are:
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, which may cause difficulty in swallowing or breathing and can be potentially fatal (angioedema);
anxiety;
decreased sexual desire;
dizziness, sedation, drowsiness, attention disturbances;
memory loss (amnesia) (see section Warnings and precautions);
vision problems and double vision (diplopia);
speech difficulties;
altered taste (dysgeusia);
slowing of mental functions (bradyphrenia);
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 potentially fatal allergic reactions (anaphylactic/anaphylactoid reactions).

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

unmasking of pre-existing depression with tendency to self-harm (suicide and suicide attempts), psychosis, hallucinations, dependence, depression (unmasking of pre-existing depression), delirium, delusion, withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, rage, nightmares, abnormal behaviour, emotional disturbances, loss of muscle coordination (ataxia), fatigue (see sections Warnings and precautions and If you stop taking LORMETAZEPAM DOC Generici);
confusion, reduced level of consciousness;
muscle weakness;
daytime drowsiness, reduced alertness;
reduced emotional responsiveness;
dizziness;
urticaria, skin rash;
loss of balance and falls.

Some of the side effects listed above mainly occur at the beginning of treatment and usually disappear as treatment continues: drowsiness, emotional disturbances, confusion, fatigue, headache, dizziness, muscle weakness, double vision, loss of motor coordination.
Rarely, as with other medicines belonging to the benzodiazepine class, cases of 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 counts of all blood cells (pancytopenia), and disturbances in antidiuretic hormone secretion (SIADH) may also occur.
Reporting of side effects
If you experience any side effects, 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 DOC Generici

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 product should be used within 45 days of first opening the bottle. Any remaining product should be discarded.
Do not dispose of any medicine 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 DOC Generici 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 (E 422), ethanol, orange/lemon/caramel flavour,
propylene glycol (E 1520).

Description of the appearance of LORMETAZEPAM DOC Generici and the contents of the pack
Pack containing one 20 ml bottle.
The bottle has a child-resistant safety cap.

Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milan.

Manufacturer
DOPPEL Farmaceutici – Via Martiri delle Foibe 1 – 29016 Cortemaggiore - Piacenza
ABC Farmaceutici S.p.A. – Cantone Moretti 29 – Loc. San Bernardo – 10090 Ivrea (TO)