Lormetazepam Ratiopharm Italia: detailed information

Package leaflet: Information for the patient

Lormetazepam ratiopharm Italia 2.5 mg/ml oral drops, solution

Equivalent medicinal product
Please read all of this leaflet carefully before you start 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 they have the same symptoms 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 ratiopharm Italia is and what it is used for
What you need to know before taking Lormetazepam ratiopharm Italia
How to take Lormetazepam ratiopharm Italia
Possible side effects
How to store Lormetazepam ratiopharm Italia
Contents of the pack and other information

1. What Lormetazepam ratiopharm Italia is and what it is used for

Lormetazepam ratiopharm Italia contains lormetazepam, a substance that belongs to a group of
medicines called benzodiazepines, used for the short-term treatment of insomnia.
This medicine is indicated when insomnia is severe, disabling and causes the patient significant distress.

2. What you should know before taking Lormetazepam ratiopharm Italia

Do not take Lormetazepam ratiopharm Italia

if you are allergic to the active substance, to other similar medicines (other 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 have severe breathing problems (severe respiratory insufficiency);
if you have breathing difficulties during sleep (sleep apnoea);
if you suffer from a condition characterized by a marked increase in pressure within the eye (narrow-angle glaucoma);
if you have severe liver problems (severe hepatic insufficiency or hepatic encephalopathy);
if you have taken excessive doses (intoxication) of medicines with central nervous system depressant activity, such as analgesics, antidepressants, hypnotics, neuroleptics, and lithium;
if you are in a state of drunkenness (acute alcohol intoxication);
during pregnancy or while breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Lormetazepam ratiopharm Italia.
Avoid taking this medicine if you are taking medicines that depress the central nervous system (calming effect on the brain), unless absolutely necessary, because taking these medicines together could cause excessive calming effects (profound sedation).
Be especially careful and consult your doctor before taking Lormetazepam ratiopharm Italia if:

you suffer from depression or anxiety states associated with depression;
you suffer from spinal or cerebellar ataxia (severe movement coordination disorder);
you are elderly;
your respiratory capacity is impaired (chronic respiratory insufficiency); in this case, your doctor will prescribe a lower dose due to the risk of respiratory depression (increased carbon dioxide levels in the blood) (see "How to take Lormetazepam ratiopharm Italia" and "Do not take Lormetazepam ratiopharm Italia");
you suffer from hepatic insufficiency (reduced liver function). In this case, your doctor will assess whether a lower dose should be prescribed (see "How to take Lormetazepam ratiopharm Italia"), as in patients with severe hepatic insufficiency and/or encephalopathy, the use of benzodiazepines may worsen hepatic encephalopathy (altered level of consciousness and coma due to liver failure);
your kidney function is impaired (severe renal insufficiency);
you have previously abused alcohol or drugs;
you have heart problems (heart failure);
to treat a child or adolescent under 18 years of age;
your blood pressure is low.

Additionally, you must stop treatment and contact your doctor immediately if any of the following symptoms occur:
behavioural disturbances such as restlessness, agitation, irritability, aggressiveness, confusion (delirium), anger, nightmares, hallucinations, and psychosis. These reactions are more frequent in children, the elderly, and in individuals with altered mental state, mood, or behaviour (organic brain syndrome). See section "Possible side effects".
Duration of treatment
The duration of treatment should be as short as possible and may vary from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period.
The treatment period may be extended following careful reassessment of your health status by your doctor.
Tolerance
If, after a few weeks of treatment with this medicine, you feel that the medicine is no longer effective, consult your doctor.
Dependence and withdrawal
During treatment with benzodiazepines, such as lormetazepam, there may be a risk of developing dependence, i.e., an uncontrollable need to continue taking the medicine. This risk increases with higher doses and longer treatment duration. It is more likely to occur if you have previously abused drugs or alcohol.
The risk of dependence is reduced when this medicine is used at the appropriate dose and for short-term treatment.
Withdrawal symptoms
If you develop dependence, you must avoid stopping treatment abruptly, as the following withdrawal symptoms may occur (see section "Side effects"):

headache, muscle pain;
extreme anxiety, tension, restlessness, confusion, and irritability.

In severe cases of withdrawal, the following symptoms may also occur: 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, altered limb sensitivity (limb paresthesia), hypersensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that are not real), or seizures (neurological disturbances causing sudden, uncontrollable movements).
Other symptoms may include: depression, insomnia, sweating, ringing in the ears (persistent tinnitus), involuntary movements, vomiting, altered sensitivity (paresthesia), perceptual disturbances, abdominal and muscle cramps, tremor, muscle pain (myalgia), agitation, palpitations, altered heart rhythm (tachycardia), panic attacks, dizziness, increased tendon reflexes (hyperreflexia), short-term memory loss, and heat stroke (hyperthermia).
After stopping treatment, rebound insomnia may also occur, a transient syndrome in which the symptoms that led to benzodiazepine treatment reappear in an aggravated form. This may be accompanied by other reactions including: mood changes, anxiety, restlessness, or sleep disturbances.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one (such as lormetazepam). Therefore, switching from one benzodiazepine to another is not recommended. Your doctor will advise you on the most suitable treatment for your case.
It is important to know that after stopping treatment with this medicine, the same symptoms for which you were being treated may reappear, sometimes even more intensely than before (rebound symptoms).
Since withdrawal or rebound symptoms are more likely when treatment is stopped abruptly, it is recommended to gradually reduce the dose until treatment is discontinued, in order to minimize the occurrence of such symptoms (mood changes and sleep disturbances).
Amnesia
Benzodiazepines may cause anterograde amnesia (memory loss that does not affect past memories but severely impairs the ability to memorize new information).
This phenomenon occurs more frequently a few hours after taking the medicine; therefore, to reduce the risk, ensure you can sleep uninterrupted for 7–8 hours after taking Lormetazepam ratiopharm Italia.
Psychiatric and paradoxical reactions
The use of benzodiazepines, such as this medicine, may lead to reactions such as restlessness, agitation, irritability, aggressiveness, delirium, delusion, anger, nightmares, hallucinations (seeing or hearing things that are not present in reality), psychosis (mental disorder characterized by detachment from reality), inappropriate behaviour, and other behavioural changes. If this occurs, stop using the medicine. These reactions are more likely in children, the elderly, and in patients with organic brain syndrome (reduced mental function). During the use of benzodiazepines, including Lormetazepam ratiopharm Italia, a pre-existing depressive state may be unmasked. If you suffer from depression, use Lormetazepam ratiopharm Italia with caution.
Children
The use of Lormetazepam ratiopharm Italia in children and adolescents under 18 years of age is not recommended. Lormetazepam ratiopharm Italia should only be used in cases of absolute necessity, and the duration of treatment should be as short as possible.
Elderly
The use of benzodiazepines, including this medicine, may be associated with an increased risk of falls due to side effects such as ataxia (lack of movement coordination), muscle weakness, dizziness, drowsiness, fatigue, and tiredness. In this case, your doctor will prescribe a reduced dose (see "Elderly patients").
Patients with psychosis (mental illnesses)
Lormetazepam ratiopharm Italia must not be used alone to treat insomnia associated with depression.
Benzodiazepines are not recommended for the primary treatment of psychotic disorders and must not be used alone to treat depression or anxiety associated with depression (the risk of suicide may be increased in these patients).
Other medicines and Lormetazepam ratiopharm Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Be especially careful and inform your doctor if you are taking any of the following medicines:

medicines causing breathing difficulties, i.e., those that depress respiratory function ( opioids, analgesics, antitussives ), particularly if you are elderly (see also section "Opioids");
medicines with central nervous system sedative effects; your doctor will advise you if any of the medicines you regularly take belong to this category;
medicines capable of inhibiting certain liver enzymes (especially cytochrome P450); your doctor will help you identify any medicines belonging to this category;
beta-blockers (used to treat cardiac dysfunction and to lower high blood pressure);
cardiac glycosides (used in the treatment of heart failure);
methylxanthines, theophyllines, or aminophyllines (used in the treatment of asthma);
oral contraceptives (medicines containing estrogens);
antibiotics such as rifampicin ;
medicines containing alcohol;
clozapine (a medicine used to treat mental illnesses).

Opioids
Concomitant use of Lormetazepam ratiopharm Italia and opioids/central nervous system depressants (strong analgesics, drugs for opioid dependence substitution therapy, and some 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 ratiopharm Italia 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 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 these symptoms.
Lormetazepam ratiopharm Italia and alcohol
DO NOT consume alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy or breastfeeding (see "Do not take Lormetazepam ratiopharm Italia").
If you have been prescribed Lormetazepam ratiopharm Italia and are a woman of childbearing age, contact your doctor regarding discontinuation of treatment if you plan to become pregnant or suspect you are pregnant.
Pregnancy
If, for serious medical reasons, your doctor considers it necessary to prescribe Lormetazepam ratiopharm Italia during the last stages of pregnancy, during labour, or delivery, your baby may experience low body temperature (hypothermia), reduced muscle strength (hypotonia), breathing difficulties at birth, low blood pressure (hypotension), and impaired muscle tone (hypotonia in the newborn).
Additionally, if Lormetazepam ratiopharm Italia has been taken regularly during the last stages of pregnancy, your baby may experience symptoms of physical dependence and withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as lormetazepam passes into breast milk.
Driving and using machines
Lormetazepam ratiopharm Italia may impair your ability to drive vehicles or operate machinery, as during treatment, symptoms such as amnesia, sedation, concentration disturbances, and muscle weakness may occur. Furthermore, if you have not had sufficient rest, the risk of impaired attention is higher.
Finally, remember that consuming alcohol during treatment with this medicine enhances the sedative effect of lormetazepam, leading to pronounced drowsiness and further reduction in your level of attention.
Lormetazepam ratiopharm Italia contains:

ethanol (alcohol) This medicine contains 30.76 mg of alcohol (ethanol) per 0.4 ml dose (10 drops). The amount in 10 drops of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not produce significant effects;
propylene glycol This medicine contains 285 mg of propylene glycol per 0.4 ml dose (10 drops);
sodium This medicine contains less than 1 mmol (23 mg) of sodium per 0.4 ml dose (10 drops), i.e., essentially "sodium-free".

3. How to take Lormetazepam ratiopharm Italia

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.
The duration of treatment should be as short as possible and may range from a few days to two weeks,
up to a maximum of 4 weeks, including a period of gradual withdrawal.
The treatment period may be extended following a careful reassessment of your health status by your doctor.

Adult patients
The recommended single dose is 1–2 mg (10 or 20 drops, since 1 mg corresponds to 10 drops), unless otherwise
prescribed by your doctor. Your doctor will determine the correct dose for you based on your health condition.
Never exceed the dose prescribed by your doctor.

Elderly patients
The recommended single dose is 0.5–1 mg (5 or 10 drops, since 1 mg corresponds to 10 drops).

Use in patients with chronic respiratory insufficiency or impaired liver and/or kidney function
In patients with impaired renal function, your doctor will carefully determine the appropriate dosage for your
condition and may consider reducing the doses listed above.
In patients with mild to moderate respiratory difficulties or impaired liver function, a dose reduction should be
considered.

Use in children and adolescents under 18 years of age
In this patient group, lormetazepam should be used only when absolutely necessary and under strict medical
supervision. The doctor will determine the dose based on the patient’s age, weight, and general condition. The
duration of treatment should be as short as possible.

Method of administration
The drops should be diluted with a small amount of water or another drink (do not take together with
alcoholic beverages), half an hour before going to bed.

If you take more Lormetazepam ratiopharm Italia than you should
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go immediately
to the nearest hospital.
Taking an excessive dose of lormetazepam together with other medicines that depress the central nervous system
or alcohol may result in a fatal outcome.
Symptoms of mild intoxication may include drowsiness, fatigue, muscle problems (ataxia), visual disturbances,
temporary loss of sensory and intellectual functions (mental clouding, confusion), and lethargy; in more severe
cases, symptoms may include deep sleep, unconsciousness, muscle problems (ataxia, hypotonia), low blood
pressure, breathing difficulties, rarely coma, and very rarely death.

Treatment of overdose
In managing overdose, it should be considered that other substances may have been taken simultaneously,
potentially causing respiratory depression (elevated carbon dioxide levels in the blood), rarely coma, and very
rarely death.
Patients with mild symptoms of intoxication should sleep under observation. Following an excessive oral dose
of benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious, or gastric lavage
should be performed with protection of the airways if the patient is unconscious.
If no improvement is observed after stomach emptying, activated charcoal should be administered to reduce
absorption. Special attention must be paid to respiratory and cardiovascular functions during emergency
treatment.
In cases of hypotension (low blood pressure), peripheral circulation drugs of the noradrenergic and volume type
should be used. Assisted ventilation is required in case of respiratory impairment, which may also be caused by
peripheral muscle relaxation.
In cases of mixed intoxication, hemodialysis and peritoneal dialysis (blood dialysis) may be beneficial. However,
they are not efficient in cases of isolated intoxication with Lormetazepam ratiopharm Italia.
Flumazenil may be useful as an antidote (to counteract the harmful effects of the medicine).
Morphine antagonists are contraindicated.

If you forget to take Lormetazepam ratiopharm Italia
If you forget to take a dose, take it as soon as you remember, keeping in mind that to reduce the risk of side
effects, you must ensure you can sleep uninterrupted for 7–8 hours after taking Lormetazepam ratiopharm
Italia. Do not take a double dose to make up for the missed dose.

If you stop taking Lormetazepam ratiopharm Italia
Do not stop treatment with Lormetazepam ratiopharm Italia suddenly or without first discussing it with your
doctor, as withdrawal or rebound symptoms may occur (see section “Warnings and precautions”).

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 everybody gets them.
Stop taking the medicine and contact your doctor immediately if you experience even just one of the
following symptoms:

skin rash, itching, difficulty breathing or swallowing, swelling of the face, eyes, lips and/or tongue (angioedema), skin irritation: these may be symptoms of a severe allergic reaction (anaphylactic shock), which is rare;
depression and mental disorders such as restlessness, agitation, irritability, aggressiveness, confusion, anger, 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. These reactions occur more frequently in children and elderly patients.

To help you recognize some of the side effects, it may be helpful to inform a close relative or friend
that you are taking this medicine and ask them to read this leaflet. You may ask them to alert you if they notice any changes in your behaviour.
Other possible side effects include:
Very common (may affect more than 1 in 10 people)

headache (cephalalgia).

Common (may affect up to 1 in 10 people)

angioedema* (swelling of the skin of the face, lips and tongue);
anxiety;
decreased sexual desire;
dizziness;
sedation;
drowsiness;
attention disorders;
amnesia (memory impairment);
visual disturbances;
speech alteration;
altered sense of taste (dysgeusia);
impairment of mental functions causing slowing of voluntary movements and activities (psychomotor retardation);
double vision (diplopia);
changes in heart rate (tachycardia);
vomiting;
nausea;
upper abdominal pain;
constipation;
dry mouth;
itching;
difficulty urinating;
reduced muscle strength (asthenia);
excessive sweating (hyperhidrosis).

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

liver function abnormalities (increased bilirubin);
yellowing of the skin and whites of the eyes (jaundice);
increased levels of certain liver enzymes (transaminases, alkaline phosphatase);
reduced number of blood cells called platelets (thrombocytopenia);
reduced number of white blood cells in the blood (agranulocytosis);
reduced number of all blood cells (pancytopenia);
condition characterized by excessive secretion of antidiuretic hormone (Syndrome of Inappropriate Antidiuretic Hormone Secretion);
anaphylactic/anaphylactoid reactions (severe allergic or allergy-like reactions).

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

suicide* and attempted suicide* (due to pre-existing depression emerging during treatment);
acute psychosis (mental disorder);
hallucinations (seeing or hearing things that are not present in reality);
development of medicine dependence;
withdrawal syndrome;
agitation;
aggression;
irritability;
restlessness;
anger;
nightmares;
abnormal behaviour;
depression (pre-existing and emerging during treatment);
delirium;
emotional disturbances;
confusion;
reduced attention;
muscle problems (ataxia and muscle weakness);
dizziness;
urticaria and skin rashes;
fatigue;
increased risk of falls;
daytime drowsiness;
progressive reduction in intellectual and sensory responsiveness (emotional blunting).

* life-threatening or fatal cases have been reported
§ see "Warnings and precautions"
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact 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 ratiopharm Italia

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Use the product within 30 days after first opening the bottle; any remaining product must be
discarded.
Do not use this medicine after the expiry date stated on the packaging after “Expiry”. The expiry date refers to the last day of that month.
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 ratiopharm Italia contains

The active substance is lormetazepam. 1 ml 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 ratiopharm Italia and pack contents
Lormetazepam ratiopharm Italia is presented in a box containing a 20 ml bottle of solution
closed with a child-resistant cap and equipped with a dropper.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy