LORAZEPAM DOC GENERICI

Package leaflet: Information for the user

LORMETAZEPAM DOC - 1 mg tablets, 2 mg tablets, 2.5 mg/ml oral drops, solution

Lormetazepam
Generic medicine
Read this leaflet carefully before using 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

LORMETAZEPAM DOC 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 individual.

2. What you need to know before taking LORMETAZEPAM DOC

Do not use LORMETAZEPAM DOC

• 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 a disease causing muscle weakness and fatigue (myasthenia gravis);
• if you suffer from a disorder leading to lack 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 respiratory insufficiency (e.g., severe chronic obstructive pulmonary disease);
• if you have breathing problems during sleep (sleep apnea syndrome);
• if you have a disease of the optic nerve called "narrow-angle glaucoma";
• if you have serious liver problems (hepatic insufficiency);
• if you have alcohol intoxication or intoxication from other medicines that depress the central nervous system (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 DOC.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly. The use of LORMETAZEPAM DOC may be associated with an increased risk of falls due to side effects such as progressive loss of muscle coordination (ataxia), muscle weakness, dizziness, drowsiness/fatigue, and tiredness. Therefore, in such cases, your doctor may decide to reduce the dose;
• if you suffer from 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 respiratory problems (chronic respiratory insufficiency). In this case, your doctor may decide to reduce the dose;
• if you have serious liver or kidney problems (severe hepatic or renal insufficiency);
• 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 carry out regular check-ups.

Tolerance:
If after a few weeks you feel that the medicine is not working as well as it did at the beginning of treatment,
contact your doctor.
Dependence:
During treatment with this medicine, there may be a risk of dependence, i.e., the need to continue taking the 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, you may experience withdrawal or rebound symptoms, even if you have taken the medicine at the recommended doses and for a short period of time (see section “If you stop taking LORMETAZEPAM DOC”). 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 a short-acting one. Therefore, such substitution is not recommended.
Amnesia:
To reduce the risk of amnesia (memory loss), ensure uninterrupted sleep of 7–8 hours.
Behavioral reactions:
If you experience behavioral disturbances, stop taking the medicine immediately (see section 4. “Possible side effects”). These reactions are more common in children and elderly patients, as well as in patients with organic brain syndrome.
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
For athletes
The oral drop formulation contains ethyl alcohol, which may result in a positive anti-doping test depending on the blood alcohol concentration limits set by certain sports federations.
Children and adolescents
In children and adolescents under 18 years of age, LORMETAZEPAM DOC should be used only when absolutely necessary, and the duration of treatment should be as short as possible.
Other medicines and LORMETAZEPAM DOC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of clozapine (a medicine used for psychiatric disorders) and LORMETAZEPAM DOC may cause sedation, excessive salivation, and ataxia (a disorder causing lack of muscle coordination making it difficult to perform certain movements).
Administration of medicines used to treat asthma or other respiratory diseases such as "theophylline" and "aminophyllines" may reduce the effects of LORMETAZEPAM DOC.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• antipsychotics and antidepressants;
• hypnotics, medicines that promote sleep;
• anxiolytics/tranquilizers/sedatives, medicines used to treat anxiety;
• antiepileptics, used for epilepsy;
• anesthetics, used during surgical procedures;
• opioids, anticonvulsants;
• sedating antihistamines used to treat allergies;
• narcotic analgesics, strong painkillers that may increase euphoria leading to increased psychological dependence;
• cytochrome P450 inhibitors, a group of specialized proteins called "enzymes" that may increase the activity of LORMETAZEPAM DOC;
• beta-blockers, medicines used to treat high blood pressure;
• cardiac glycosides, medicines used for irregular heartbeat;
• methylxanthines, medicines used to treat asthma;
• oral contraceptives;
• medicines for various infections (antibiotics).

Concomitant use of LORMETAZEPAM DOC and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes LORMETAZEPAM DOC together with opioids, the dose and duration of concomitant therapy 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 so they can recognize the signs and symptoms listed above. Contact your doctor if these symptoms occur.
LORMETAZEPAM DOC and alcohol
Avoid consuming alcohol during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take LORMETAZEPAM DOC during pregnancy.
If your doctor considers it necessary for you to take LORMETAZEPAM DOC in the late stages of pregnancy or during labor, your baby may experience low body temperature, loss of muscle tone, low blood pressure, and difficulties with sucking and breathing.
If you have regularly taken LORMETAZEPAM DOC during the late stages of pregnancy, your baby may experience withdrawal symptoms.
If you start treatment with LORMETAZEPAM DOC 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 this medicine if you are breastfeeding, as lormetazepam passes into breast milk.
Driving and using machines
The use of LORMETAZEPAM DOC may affect your ability to drive vehicles or operate machinery because you may feel confused, experience memory problems, feel drowsy, or have muscle tone problems. These effects increase if you have not slept enough. If this happens, avoid driving or operating machinery.
LORMETAZEPAM DOC tablets contain lactose
This medicine contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
LORMETAZEPAM DOC oral drops contain ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to take LORMETAZEPAM DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
LORMETAZEPAM DOC tablets:
The recommended dose for adults is 1 mg to 2 mg, according to your doctor's advice.
The tablets should be taken with some water, without chewing, half an hour before going to bed.
LORMETAZEPAM DOC oral drops:
The recommended single dose for adults is 1 mg (10 drops) to 2 mg (20 drops).
The drops should be taken diluted in a small amount of water, half an hour before going to bed.
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 certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
Use in children and adolescents
The need to administer this product to children must be assessed solely by the doctor, who will carefully determine the dosage.
Use in elderly patients
LORMETAZEPAM DOC tablets:
The recommended dose is 0.5–1 mg.
LORMETAZEPAM DOC oral drops:
The recommended dose is 0.5–1 mg (5–10 drops).
Use in patients with kidney, liver problems or respiratory disorders
In patients with impaired renal function, a possible reduction of the above-mentioned doses should be considered.
In patients with mild to moderate respiratory impairment or with hepatic impairment,
a dose reduction should be considered.
If you take more LORMETAZEPAM DOC than you should
If you (or someone else) have taken an excessive dose of LORMETAZEPAM DOC, contact your doctor immediately or go to the nearest hospital.
An overdose may cause marked depression of the central nervous system, with symptoms such as drowsiness,
fatigue, confusion, visual disturbances, deep sleep progressing to unconsciousness, progressive loss of
muscular coordination (ataxia), reduced muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, temporary loss of sensory and intellectual functions
(mental clouding), which may worsen leading to coma and, very rarely, death.
If you forget to take LORMETAZEPAM DOC
If you forget to take a dose of the medicine, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.
If you stop taking LORMETAZEPAM DOC
Do not stop treatment with LORMETAZEPAM DOC 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 unreal), depersonalization (feeling of detachment from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise and physical contact, hallucinations (seeing or hearing things that are not real), or epileptic seizures may occur. Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may reappear even more intensely than before (rebound insomnia and rebound anxiety). The risk of developing these symptoms is higher if you stop taking LORMETAZEPAM DOC abruptly. You may also experience mood changes, anxiety, restlessness, and 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 everybody gets them.

At the beginning of treatment, the following may occur: daytime drowsiness, emotional disturbances, depressed level of consciousness, confusion, fatigue, headache (cephalalgia), dizziness, muscle weakness, progressive loss of muscle coordination (ataxia), or double vision (diplopia). These reactions usually disappear with continued treatment.

The most frequently observed side effects in patients receiving LORMETAZEPAM DOC are headache (cephalalgia), sedation, and anxiety.

The most serious side effects reported in patients receiving LORMETAZEPAM DOC are swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or life-threatening breathing difficulties (angioedema), and suicide or attempted suicide associated with unmasking of pre-existing depression.

The known side effects associated with the use of LORMETAZEPAM DOC are:

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 life-threatening breathing difficulties (angioedema);
• anxiety;
• decreased sexual desire;
• dizziness, sedation, somnolence, attention disturbances;
• memory loss (amnesia);
• visual 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 (pruritus);
• urinary disorders;
• muscle weakness (asthenia);
• increased sweating (hyperhidrosis).

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

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

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

• unmasking of pre-existing depression with tendency to self-harm (suicide and attempted suicide), psychosis, hallucinations, dependence, depression (unmasking of pre-existing depression), delirium, withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, rage, nightmares, abnormal behaviour, emotional disturbances;
• confusion, depressed level of consciousness, loss of muscle coordination (ataxia), muscle weakness;
• dizziness;
• urticaria, skin rash;
• fatigue;
• falls.

Rarely, the following may also occur: jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme levels, increased bilirubin levels, decreased platelet count, or disturbances in antidiuretic hormone secretion (SIADH).

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 can help provide more information on the safety of this medicine.

5. How to store LORMETAZEPAM DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, stored correctly.
LORMETAZEPAM oral drops, solution:
Do not store above 25°C.
The shelf life after first opening of the bottle is 20 days.
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 contains
1 mg tablet

• The active substance is: Lormetazepam 1 mg.
• The other components are: Lactose monohydrate, maize starch, povidone K 30, magnesium stearate, hypromellose.

2 mg tablet

• The active substance is: Lormetazepam 2 mg.
• The other components are: Lactose monohydrate, maize starch, povidone K 30, magnesium stearate, hypromellose.

Oral drops, solution:
1 ml of solution:

• The active substance is: Lormetazepam 2.5 mg.
• The other components are: Sodium saccharin, orange flavour, lemon flavour, cream caramel flavour, ethanol 96 percent, glycerol, propylene glycol.

Description of the appearance of LORMETAZEPAM DOC and contents of the pack
30 tablets of 1 mg.
30 tablets of 2 mg.
20 ml bottle of solution.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan - Italy
Manufacturer
Genetic S.p.A. Contrada Canfora, 84084 Fisciano (SA)
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