Lorazepam Almus

Italy
Brand name Lorazepam Almus
Form drops, oral solution
Active substance / Dosage
LORMETAZEPAM
Prescription type Prescription only
ATC code
N05CD06
Registration number 036842
Manufacturer ALMUS S.R.L.

Table of Contents

Patient Information Leaflet

LORMETAZEPAM ALMUS 2.5 mg/ml oral drops, solution

Generic 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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

LORMETAZEPAM ALMUS contains the active substance lormetazepam, which belongs to a group of
medicines called benzodiazepines.
This medicine is a sedative with temporary effect (short-term treatment) used in sleep disorders and
inability to sleep (insomnia), and is particularly indicated in cases where the disorder is severe,
disabling, and causes significant distress.

2. What you should know before taking LORMETAZEPAM ALMUS

Do not take LORMETAZEPAM ALMUS

  • if you are allergic to lormetazepam or any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from a disease causing muscle weakness and fatigue (severe myasthenia gravis);
  • 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 apnoea syndrome);
  • if you have a nerve disorder of the eye called "narrow-angle glaucoma";
  • if you have severe liver problems (severe hepatic insufficiency);
  • if you are experiencing symptoms of intoxication from alcohol or other medicines that depress the central nervous system (such as 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 ALMUS.
Always take this medicine as directed by your doctor.
Take LORMETAZEPAM ALMUS with caution 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 ALMUS – "Use in the elderly");
  • if you have respiratory problems (chronic respiratory insufficiency) or liver problems (severe hepatic insufficiency). In this case, your doctor may decide to reduce the dose (see section 3. How to take LORMETAZEPAM ALMUS);
  • if you have severe kidney problems (severe renal insufficiency) (see section 3. How to take LORMETAZEPAM ALMUS);
  • if you suffer from a disorder characterized by lack of muscle coordination making voluntary movements difficult, due to damage to the spinal cord and cerebellum (spinal and cerebellar ataxia);
  • if you suffer from depression;
  • 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
If after several weeks of treatment the medicine seems less effective than at the beginning of therapy, consult your doctor.
Dependence
While taking this medicine, there is a risk of dependence, i.e. the need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment, and decreases with recommended doses and short-term use. The risk is higher if you have previously abused drugs or alcohol.
Withdrawal
When you stop taking LORMETAZEPAM ALMUS, 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 ALMUS").
Withdrawal symptoms may include:

  • 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 contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures may occur. Other symptoms include: depression, insomnia, sweating, persistent and unpleasant ringing in the ears perceived as whistling or buzzing (persistent tinnitus), involuntary movements, vomiting, abdominal and muscle cramps, tremor, palpitations, tachycardia, panic attacks, dizziness, short-term memory loss, increased body temperature (hyperthermia).

To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching to LORMETAZEPAM ALMUS after prolonged use and high doses of long-acting benzodiazepines. Therefore, such substitution is not recommended.
Duration of treatment
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 tapering-off period. Longer treatment requires a reassessment of the clinical situation by the doctor.
Amnesia
To reduce the risk of anterograde amnesia (memory loss, difficulty in memorizing new information from the time the problem occurred) in the first hours after taking the medicine, 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 common in children and the elderly.
LORMETAZEPAM ALMUS is not recommended for the treatment of psychotic disorders.
It should not be used alone to treat insomnia associated with depression, as in such patients, underlying depressive symptoms may be masked and suicidal tendencies (suicidal ideation) may still occur.
Rebound insomnia and anxiety
After stopping LORMETAZEPAM ALMUS, you may experience rebound insomnia, a transient condition in which the symptoms that led you to take the medicine may recur in a more severe form. This may be accompanied by other symptoms such as mood changes, anxiety, restlessness, and insomnia. These symptoms, common to withdrawal, are more pronounced after abrupt discontinuation of treatment. Gradual dose reduction is always recommended.
Specific patient groups
Athletes
For those engaged in sports activities, the use of medicines containing ethanol may result in a positive anti-doping test, depending on the alcohol concentration limits set by certain sports federations.
Elderly
Greater caution is required when using LORMETAZEPAM ALMUS in the elderly, as it is associated with an increased risk of falls due to muscle weakness, dizziness, drowsiness, fatigue, and tiredness. If you are elderly, your doctor may decide to reduce your dose (see section 3. How to take LORMETAZEPAM ALMUS – "Use in the elderly").
Children and adolescents
In children and adolescents under 18 years of age, LORMETAZEPAM ALMUS should only be used when absolutely necessary, and treatment duration should be as short as possible (see section 3. How to take LORMETAZEPAM ALMUS – "Use in children and adolescents (under 18 years of age)").
Alcohol
LORMETAZEPAM ALMUS contains small amounts of ethanol (alcohol). It may be dangerous to take this medicine if you suffer from alcoholism, are pregnant, are breastfeeding, are a child, or suffer from liver problems or epilepsy (see section "LORMETAZEPAM ALMUS with alcohol").
Other medicines and LORMETAZEPAM ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay special attention and inform your doctor if you are taking the following medicines:

  • antipsychotics and antidepressants (e.g. clozapine), used to treat psychiatric disorders;
  • hypnotics, tranquillizers and sedatives, medicines used to promote sleep;
  • anxiolytics, used to treat anxiety;
  • antidepressants, used to treat depression;
  • certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with LORMETAZEPAM ALMUS. This may increase your desire to continue taking these medicines (dependence);
  • antiepileptics, used for epilepsy;
  • anaesthetics, used during surgical procedures;
  • antihistamines with sedative effects, 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);
  • certain medicines used to regulate heart rhythm (cardiac glycosides);
  • oral contraceptives;
  • certain medicines used for infections (antibiotics).

Concomitant use of LORMETAZEPAM ALMUS and opioids (strong analgesics, medicines for addiction treatment, 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 ALMUS 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 your 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 ALMUS with 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, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take LORMETAZEPAM ALMUS during pregnancy.
If your doctor considers it necessary for you to take LORMETAZEPAM ALMUS during the last stages of pregnancy or during labour, your baby may experience low body temperature, loss of muscle tone, low blood pressure, sucking difficulties (infant hypotonia), and breathing problems.
If LORMETAZEPAM ALMUS has been taken regularly during the last stages of pregnancy, your baby may develop physical dependence and may experience withdrawal symptoms after birth.
Breastfeeding
Do not take this medicine if you are breastfeeding, as LORMETAZEPAM ALMUS passes into breast milk.
Fertility
If you start treatment with LORMETAZEPAM ALMUS and are of childbearing age, consult your doctor, whether you intend to become pregnant or suspect you are pregnant, as it will be necessary to discontinue the medicine.
Driving and using machines
The use of LORMETAZEPAM ALMUS may negatively affect your ability to drive vehicles and operate machinery, as you may feel confused, experience memory problems, feel drowsy, or have muscle tone problems. These effects are increased if you have not slept enough and if you have taken an excessive dose in combination with alcohol. If this happens, avoid driving vehicles or operating machinery.
LORMETAZEPAM ALMUS contains ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to take LORMETAZEPAM ALMUS

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended single dose for adults ranges from 1 mg (10 drops) to 2 mg (20 drops).
Your doctor will determine the correct dose for you.
Take this medicine half an hour before going to bed. The drops must be diluted with a small amount of water or another drink.
The duration of treatment should be as short as possible and generally lasts from a few days up to 2 weeks, and in any case not exceeding 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 as brief as possible and should start with the lowest recommended dose, which may be increased without exceeding the maximum dose.
If treatment lasts longer than two weeks, discontinuation of LORMETAZEPAM ALMUS must not be abrupt but gradual, as sleep disorders may reappear with increased intensity.
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 (under 18 years of age)
This medicine should only be used when absolutely necessary and strictly under medical supervision, who will carefully determine the dosage.
The recommended dose depends on age, body weight, and the individual's general 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 problems
In patients with kidney problems, a reduced dose should be administered.

Use in patients with liver problems or respiratory disorders
In patients with mild to moderate respiratory impairment or liver problems, a dose reduction should be considered.

If you take more LORMETAZEPAM ALMUS than you should
If you (or someone else) have taken an excessive dose of LORMETAZEPAM ALMUS, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department. Generally, an overdose of LORMETAZEPAM ALMUS should not pose a life-threatening risk unless it is taken together with other substances that depress the central nervous system (including alcohol).
Symptoms of mild intoxication with LORMETAZEPAM ALMUS include drowsiness, fatigue, progressive loss of muscle coordination (ataxia), visual disturbances, temporary loss of sensory and intellectual functions (obnubilation), mental confusion, and deep sleep (lethargy).
Administration of higher doses may lead to symptoms ranging from deep sleep to unconsciousness, ataxia, reduced muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, rarely coma, and very rarely death.
In case of overdose, bring this leaflet, the bottle, and its container with you to the hospital or doctor so they know which medicine you have taken.

If you forget to take LORMETAZEPAM ALMUS
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 ALMUS
Do not stop treatment with LORMETAZEPAM ALMUS 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 such symptoms (see section “Warnings and precautions” – “Withdrawal”). Treatment should be discontinued gradually also because the symptoms you suffer from may reappear even more intensely than before (rebound insomnia and rebound anxiety). The risk of developing these symptoms is greater when stopping LORMETAZEPAM ALMUS abruptly. 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.
At the beginning of treatment, daytime drowsiness, emotional disturbances, depressed level of consciousness, confusion, fatigue, headache, dizziness, muscle weakness, progressive loss of muscle coordination (ataxia), or double vision (diplopia) may occur. These reactions usually disappear with continued treatment.

Seek immediate medical advice if you experience:

  • depression and mental disturbances such as restlessness, agitation, irritability, aggressiveness, delusions, 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.

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 may 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);
  • difficulty speaking;
  • altered taste (dysgeusia);
  • slowing of mental and intellectual functions (bradyphrenia);
  • increased heart rate (tachycardia);
  • vomiting, nausea, upper abdominal pain, constipation;
  • dry mouth;
  • itching;
  • difficulty urinating;
  • muscle weakness (asthenia);
  • increased sweating (hyperhidrosis).

Rare (may affect up to 1 in 100 people)

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

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

  • suicide and suicide attempts (unmasking of pre-existing depression), psychosis, hallucinations, dependence, depression (unmasking of pre-existing depression), delusions, withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, restlessness, rage (anger), nightmares, abnormal behaviour, emotional disturbances (see sections “Warnings and precautions” and “If you stop taking LORMETAZEPAM ALMUS”);
  • confusion, depressed level of consciousness, loss of muscle coordination (ataxia), muscle weakness;
  • daytime drowsiness, reduced alertness;
  • reduced emotional capacity;
  • vertigo;
  • urticaria, skin rash;
  • falls.

Rarely, increased bilirubin levels and jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme levels (elevated hepatic transaminases), increased blood alkaline phosphatase enzyme, decreased platelets or white blood cells (thrombocytopenia, agranulocytosis), decreased levels of all blood cells (pancytopenia), and disturbances in antidiuretic hormone secretion (SIADH) 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LORMETAZEPAM ALMUS

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 after first opening of the bottle.
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 ALMUS 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%, ethanol 96%, orange/lemon/caramel flavour,
propylene glycol.
Description of the appearance of LORMETAZEPAM ALMUS and contents of the pack
Pack containing a bottle with dropper of 20 ml of solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)