Patient Information Leaflet

Lormetazepam EG 2.5 mg/ml oral drops, solution

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 they have the same symptoms as you, 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 EG is and what it is used for
What you need to know before taking Lormetazepam EG
How to take Lormetazepam EG
Possible side effects
How to store Lormetazepam EG
Contents of the pack and other information

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

Lormetazepam EG 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 EG

Do not take Lormetazepam EG

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 certain movements difficult 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);
if you have a disease of the optic nerve called narrow-angle glaucoma;
if you have severe liver problems (hepatic insufficiency);
if you have alcohol intoxication or intoxication from 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 EG.
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 EG – 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 certain movements difficult 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 suffer from mental disorders (psychosis);
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: taking this medicine may lead to dependence, i.e. 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 stopping Lormetazepam EG, you may experience withdrawal or rebound symptoms, even if you have taken the medicine at the recommended doses and for a short period (see section If you stop taking Lormetazepam EG). 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: 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 discontinuation period.
Amnesia: to reduce the risk of amnesia (memory loss), ensure 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 frequent in children and the elderly.
Benzodiazepines should not be used alone to treat depression or insomnia associated with depression, as suicidal thoughts may occur in such patients.
Children and adolescents
In children and adolescents under 18 years of age, Lormetazepam EG should only be used when absolutely necessary, and treatment duration should be as short as possible.
Other medicines and Lormetazepam EG
Tell 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 mental disorders;
hypnotics, medicines used to promote sleep;
anxiolytics, tranquillisers and sedatives, used to treat anxiety;
certain strong painkillers and antitussives (opioids), which may cause increased feelings of well-being when taken with Lormetazepam EG. This may increase your desire to continue taking these medicines (dependence);
antiepileptics, used for epilepsy;
anaesthetics, used during surgical procedures;
sedating antihistamines, used to treat allergies;
theophylline, aminophylline and methylxanthines, 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);
medicines that inhibit certain liver enzymes such as cytochrome P450.

Concomitant use of Lormetazepam EG and opioids (strong painkillers, medicines for 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 therapeutic options are possible.
However, if your doctor prescribes Lormetazepam EG together with opioids, the dose and duration of concomitant therapy must be limited by your 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 relatives about the signs and symptoms listed above.
Contact your doctor if these symptoms occur.
Lormetazepam EG 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.
Pregnancy
Do not take Lormetazepam EG during pregnancy.
If your doctor considers it necessary for you to take Lormetazepam EG during the last stages of pregnancy or during labour, your baby may experience low body temperature, loss of muscle tone, low blood pressure, and difficulties with sucking and breathing.
If Lormetazepam EG has been taken regularly during the last stages of pregnancy, your baby may experience withdrawal symptoms.
If you start treatment with Lormetazepam EG 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 administration of the medicine.
Breastfeeding
Do not take this medicine if you are breastfeeding, as lormetazepam passes into breast milk.
Driving and using machines
Taking Lormetazepam EG may affect your ability to drive vehicles or operate machinery, as you may feel confused, experience memory problems, feel drowsy, or have muscle tone problems. These effects worsen if you have not slept enough. If this happens, avoid driving or operating machinery.
Lormetazepam EG contains ethanol (alcohol)
This medicine contains 32 mg of alcohol (ethanol) per 1 mg dose. The amount in 1 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
Lormetazepam EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.
Lormetazepam EG contains propylene glycol
This medicine contains 691.50 mg of propylene glycol per ml.
If the child is less than 4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Lormetazepam EG

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 do so.
Take this medicine half an hour 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 gradual withdrawal period.
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 the person's age, weight, and 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).

Special populations
In patients with kidney problems, your doctor may consider reducing the dose.
In patients with mild to moderate respiratory impairment or patients with hepatic impairment, a dose reduction should be considered.

If you take more Lormetazepam EG than you should
If you (or someone else) have taken an excessive dose of Lormetazepam EG or if you think a child may have
taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
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 to coma and, very rarely, death.
Take 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 EG
If you forget to take a dose of the medicine, 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 EG
Do not stop treatment with Lormetazepam EG 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), intolerance to sound (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.

Other symptoms include: depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (altered sensation in limbs or other body parts), perceptual disturbances, abdominal and muscular cramps, tremor, myalgia (localized pain in one or more muscles), agitation, palpitations (irregular heartbeat), tachycardia (increased heart rate), panic attacks, dizziness, hyperreflexia (increased reflexes), short-term memory loss, hyperthermia (elevated body temperature).
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 EG 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 everybody gets them.

At the beginning of treatment, the following may occur: daytime sleepiness, emotional disturbances, awareness of being depressed, confusion, fatigue, headache, dizziness, muscle weakness or double vision; these reactions usually diminish with repeated administration.

Seek immediate medical advice if you experience:

depression and mental disturbances 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;
swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing and could be potentially fatal (angioedema).

Other possible side effects are listed below:
Very common (may affect more than 1 in 10 people):

headache.

Common (may affect up to 1 in 10 people):

anxiety;
decreased sexual desire;
dizziness, sedation, somnolence, attention disturbances;
memory loss (amnesia) (see section Warnings and precautions);
vision problems and double vision (diplopia);
difficulty speaking;
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 suicidal tendencies (suicide and attempted suicide), dependence, disappointment, withdrawal syndrome (rebound insomnia), aggression, restlessness, abnormal behaviour, emotional disturbances (see sections Warnings and precautions and If you stop taking Lormetazepam EG);
confusion, reduced level of consciousness, loss of muscle coordination (ataxia), muscle weakness;
skin irritations (urticaria, skin rash);
fatigue;
falls.

Rarely, sudden potentially fatal allergic reactions (anaphylactic/anaphylactoid reactions), jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme levels (transaminases), increased alkaline phosphatase, increased bilirubin, decreased platelets or white blood cells (thrombocytopenia, agranulocytosis), reduction in 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 EG

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 of first opening the bottle. Any remaining product should be discarded.
Do not dispose of medicines 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 EG 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 EG and contents of the pack
Pack containing one 20 ml bottle of solution.
Marketing Authorisation Holder
EG S.p.A. – Via Pavia, 6 – 20136 Milan – Italy.
Manufacturers
DOPPEL Farmaceutici – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (Piacenza) – Italy.
MIPHARM S.p.A. – Via Quaranta, 12 – 20141 Milan – Italy.
ICE S.p.A., Via Cantone Moretti, 29, Località San Bernardo – 10015 Ivrea (TO) – Italy.