Lorazepam PensA

Package leaflet: Information for the patient

LORMETAZEPAM PENSA 2.5 mg/ml oral drops, solution

lormetazepam
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 side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

LORMETAZEPAM PENSA contains the active substance lormetazepam, which belongs to a group of
medicines called benzodiazepines.
This medicine is indicated for 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 PENSA

Do not take LORMETAZEPAM PENSA

• 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 it difficult to perform certain movements due to damage to the spinal cord and cerebellum (spinal and cerebellar ataxia);
• if you suffer from severe respiratory insufficiency (e.g. severe chronic obstructive pulmonary disease);
• if you have breathing difficulties during sleep (sleep apnea);
• if you have a nerve disorder of the eye called narrow-angle glaucoma (rapid increase in pressure inside the eye);
• if you have severe liver problems (hepatic insufficiency);
• if you have intoxication from alcohol or other medicines that depress the 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 PENSA.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly. The use of benzodiazepines, including LORMETAZEPAM PENSA, may be associated with an increased risk of falls due to side effects such as loss of coordination, muscle weakness, dizziness, drowsiness, fatigue, and tiredness. In this case, your doctor may decide to reduce the dose (see section 3 “How to take LORMETAZEPAM PENSA – 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 it difficult to perform certain movements 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 have low blood pressure or heart problems (heart failure). In this case, your doctor may decide to perform regular check-ups. Depending on any of the above conditions, your doctor may decide to reduce the dose or subject you to regular monitoring during treatment with this medicine.

Duration of treatment: The treatment duration should be as short as possible depending on the indication (see section “How to take LORMETAZEPAM PENSA”). It usually lasts from a few days up to two weeks, and at most four weeks, including gradual dose reduction. Only your doctor can decide whether to extend therapy beyond the periods mentioned above. You should be informed at the start of treatment that it is intended to be of limited duration, and it should be clearly explained that the dose may be progressively reduced.

Tolerance: After repeated use for several weeks, a certain loss of hypnotic efficacy of LORMETAZEPAM PENSA may develop.

Dependence:
Taking this medicine may lead to the development of physical and psychological dependence, characterized by an overwhelming and uncontrollable need to take the medicine. The risk increases with dose and duration of treatment. It is higher if you have previously abused drugs or alcohol.
The risk of dependence is reduced when Lormetazepam Pensa is used at the appropriate dose and for short-term treatment.

Withdrawal symptoms:
When you stop taking LORMETAZEPAM PENSA, you may experience withdrawal or rebound symptoms, even if you have taken the medicine at recommended doses and for a short period of time (see section “If you stop taking LORMETAZEPAM PENSA”). To minimize these symptoms, a gradual dose reduction is recommended.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.

Amnesia:
LORMETAZEPAM PENSA may cause anterograde amnesia, i.e. the inability to memorize new information. This occurs more frequently several hours after taking the medicine. To reduce these risks, take this medicine immediately before going to bed (see section “How to take LORMETAZEPAM PENSA”) and ensure an uninterrupted sleep of 7–8 hours.

Behavioral reactions: If you experience restlessness, agitation, irritability, aggression, delirium, delusion, rage, anger, nightmares, hallucinations, psychosis, inappropriate behavior, or other behavioral changes, stop taking the medicine immediately (see section 4. “Possible side effects”). These reactions are more frequent in children and the elderly.
In patients suffering from mental disorders (psychosis) and severe depressive states, symptoms of the illness may worsen with the use of lormetazepam.
Therefore, patients suffering from depression or anxiety associated with depression should not be treated with benzodiazepines, as suicidal tendencies may be enhanced in such patients.
The use of this medicine in individuals predisposed to dependence, such as alcoholics and drug-dependent individuals, should be avoided entirely, due to their predisposition to habituation and dependence.

For athletes: The use of medicines containing ethanol, including LORMETAZEPAM PENSA, may result in positive anti-doping tests according to the alcohol concentration limits set by certain sports federations.

Children and adolescents
In children and adolescents under 18 years of age, LORMETAZEPAM PENSA should only be used in cases of absolute necessity, and the duration of treatment should be as short as possible (see section “How to take LORMETAZEPAM PENSA”).

Other medicines and LORMETAZEPAM PENSA
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 psychiatric disorders;
• hypnotics, medicines used to promote sleep;
• anxiolytics, tranquillizers, and sedatives, used to treat anxiety;
• certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with LORMETAZEPAM PENSA. This may increase your desire to continue taking these medicines (dependence);
• antiepileptics, used for epilepsy;
• anesthetics, used during surgical procedures;
• antihistamines with sedative effects, used to treat allergies;
• methylxanthines (e.g. 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).

The concomitant use of LORMETAZEPAM PENSA and opioids (strong analgesics, medicines for opioid 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 PENSA 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 dosing recommendations. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above.
Contact your doctor if you experience any of these symptoms.

LORMETAZEPAM PENSA and alcohol
Do not consume 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, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take LORMETAZEPAM PENSA during pregnancy.
If your doctor considers it necessary for you to take LORMETAZEPAM PENSA 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 PENSA has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms.
If you start treatment with LORMETAZEPAM PENSA and are of childbearing age, consult your doctor if you plan to become pregnant or 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 PENSA may affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are increased if you have not had sufficient sleep. If this occurs, avoid driving or operating machinery.

LORMETAZEPAM PENSA contains alcohol (ethanol)
This medicine contains 81.89 mg of alcohol (ethanol) per ml (20 drops), equivalent to 10% (v/v). The amount in 1 ml of this medicine (20 drops) is equivalent to less than 2 ml of beer or 0.8 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

LORMETAZEPAM PENSA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml (20 drops), i.e. essentially 'sodium-free'.

LORMETAZEPAM PENSA contains propylene glycol (E 1520)
This medicine contains 705 mg of propylene glycol (E 1520) per ml (20 drops).

LORMETAZEPAM PENSA contains flavorings which themselves contain allergens (benzyl alcohol)
This medicine contains 0.21 mg of benzyl alcohol per ml (20 drops). Benzyl alcohol may cause allergic reactions. In addition to allergic reactions in sensitized patients, non-sensitized patients may become sensitized. Consult your doctor or pharmacist if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease, as large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).

3. How to take LORMETAZEPAM PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
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 varies from a few days to two weeks, up to a maximum of four 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 should 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 should only be used when absolutely necessary.
The recommended dose depends on age, weight, and individual condition. The duration of treatment should be as short as possible.

Use in elderly patients
The recommended dose in elderly patients 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 dose for your case and may consider reducing the above-mentioned doses.
In patients with mild to moderate respiratory impairment or hepatic impairment, a dose reduction should be considered.

If you take more LORMETAZEPAM PENSA than you should
If you (or someone else) have taken an excessive dose of LORMETAZEPAM PENSA 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 of LORMETAZEPAM PENSA should not be life-threatening unless other medicines that depress the central nervous system (including alcohol) have also been taken.
An overdose may cause severe depression of the central nervous system with symptoms such as drowsiness, fatigue, confusion, visual disturbances, deep sleep progressing to 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 into coma and, very rarely, death.
Bring 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 PENSA
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 PENSA
Do not stop treatment with LORMETAZEPAM PENSA 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 withdrawal cases, derealization (feeling that things are not real), depersonalization (feeling of detachment 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 are not real), or epileptic seizures.

Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may reappear even more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is higher if you stop taking LORMETAZEPAM PENSA abruptly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances (see section “Warnings and precautions”).
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 will experience them.
Contact your doctor immediately if you experience:

• depression and mental disorders such as restlessness, agitation, irritability, aggression, 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. If any of these side effects occur, treatment must be discontinued. These reactions are more frequent in children and elderly patients.

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 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 and motor functions;
• 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 100 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), acute psychosis, hallucinations, dependence, disappointment, withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, rage, nightmares, abnormal behaviour, emotional disorders (see sections “Warnings and precautions” and “If you stop taking LORMETAZEPAM PENSA”);
• confusion, loss of muscular coordination (ataxia), muscle weakness;
• reduced alertness;
• 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, decreased platelets or white blood cells (thrombocytopenia, agranulocytosis), decreased levels of all blood cells (pancytopenia), 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 PENSA

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 30 days of first opening the bottle. Any excess product must 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 PENSA 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 percent, ethanol 96 percent, orange flavour,
lemon essence, caramel flavour, propylene glycol (E 1520).
Description of the appearance of LORMETAZEPAM PENSA and contents of the pack
Pack containing one 20 ml solution bottle.
The bottle has a child-resistant closure to protect against tampering by children.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via E. Tazzoli, 6
20154 Milan - Italy
Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea (TO) – Italy