Lorazepam Alter

Italy
Brand name Lorazepam Alter
Form drops, oral solution
Active substance / Dosage
LORMETAZEPAM
Prescription type Prescription only
ATC code
N05CD06
Registration number 036147
Manufacturer LABORATORI ALTER S.R.L.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LORMETAZEPAM ALTER

2.5 mg/ml oral drops, solution
Lormetazepam
Equivalent 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 others, even if their symptoms are the same as yours, because it could 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 Alter is and what it is used for
  2. What you need to know before taking Lormetazepam Alter
  3. How to take Lormetazepam Alter
  4. Possible side effects
  5. How to store Lormetazepam Alter
  6. Contents of the pack and other information

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

Lormetazepam Alter 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 the patient
severe distress.

2. What you need to know before taking Lormetazepam Alter

Do not take Lormetazepam Alter

  • 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 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;
  • 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 Alter.
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 (see section 3 “How to take Lormetazepam Alter – 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.

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: When taking this medicine, there is a risk of dependence, meaning the need to continue taking the medicine. The risk increases with dose and duration of treatment. It is higher if you have previously abused drugs or alcohol.
Withdrawal: When you stop taking Lormetazepam Alter, 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 Alter”). 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.
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.
Amnesia: To reduce the risk of amnesia (memory loss), ensure an 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.
Benzodiazepines should not be used alone to treat depression or insomnia associated with depression, as suicidal thoughts may occur in such patients.
For athletes: The use of medicines containing ethyl alcohol may result in positive anti-doping tests according to the blood alcohol concentration limits indicated by some sports federations.

Children and adolescents
In children and adolescents under 18 years of age, Lormetazepam Alter should be used only when absolutely necessary, and the treatment duration should be as short as possible.

Other medicines and Lormetazepam Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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 Alter. This may increase your desire to continue taking these medicines (dependence);
  • antiepileptics, used for epilepsy;
  • anesthetics, 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).

The concomitant use of Lormetazepam Alter and opioids (strong analgesics, medicines for addiction therapy, 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 Alter 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 follow carefully the doctor’s recommendations regarding dosage. 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 Alter and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase 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 a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Lormetazepam Alter during pregnancy.
If your doctor considers it necessary for you to take Lormetazepam Alter during 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 Lormetazepam Alter has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms.
If you start treatment with Lormetazepam Alter 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 Alter may affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects increase if you have not slept enough. If this happens, avoid driving or operating machinery.

Lormetazepam Alter contains ethanol (alcohol) and propylene glycol
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
This medicine contains 283 mg of propylene glycol per dose (1 mg of Lormetazepam Alter corresponding to 0.4 ml of solution).

3. How to take Lormetazepam Alter

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 varies from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
Treatment should be initiated 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 should only be used 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 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 kidney problems, a reduced dose should be administered.
In patients with mild to moderate respiratory difficulties or with impaired liver function, a dose reduction should be considered.

If you take more Lormetazepam Alter than you should
If you (or someone else) have taken an excessive dose of Lormetazepam Alter, 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 marked depression of the central nervous system, with symptoms such as drowsiness, fatigue, confusion, visual disturbances, deep sleep, and unconsciousness, progressive loss of muscular 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 packaging with you to the hospital or doctor so they know which medicine has been taken.

If you forget to take Lormetazepam Alter
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 Alter
Do not stop treatment with Lormetazepam Alter 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 of detachment from the surrounding environment), intolerance to sound (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 greater if you stop taking Lormetazepam Alter suddenly. You may also experience mood changes, anxiety, restlessness, and 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 or hearing things that are not real), 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.

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, 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 problems;
  • muscle weakness (asthenia);
  • increased sweating (hyperhidrosis).

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, disappointment, withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, rage, nightmares, abnormal behaviour, emotional disturbances (see sections Warnings and precautions and If you stop taking Lormetazepam Alter);
  • confusion, reduced alertness, loss of muscle coordination (ataxia), muscle weakness and falls;
  • urticaria, skin rash;
  • fatigue.

Rarely, sudden potentially fatal allergic reactions (anaphylactic/anaphylactoid reactions), jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme levels, increased alkaline phosphatase, increased bilirubin, decreased platelets or white blood cells (thrombocytopenia, agranulocytosis), decreased levels of all blood cells (pancytopenia), and disturbances in antidiuretic hormone secretion (SIAD) may also occur.
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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lormetazepam Alter

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 after the first opening of the bottle. Any excess product should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lormetazepam Alter 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 and propylene glycol.

Description of the appearance of Lormetazepam Alter and contents of the pack
Pack containing one 20 ml bottle of solution.
The bottle has a child-resistant closure to protect against tampering by children.
Marketing Authorization Holder
Laboratori Alter S.r.l. – Via Egadi, 7 – 20144 Milan
Manufacturers
ICE S.p.A., Canton Moretti 29, 10090 S. Bernardo d'Ivrea (TO)
Consorzio Farmaceutico e Biotecnologico Bioprogress S.C.A.R.L., Strada Paduni, 240 -
03012 Anagni (FR)
January 2026