Lorazepam Mylan Generics

Package leaflet: information for the patient

Lormetazepam Mylan Generics 2.5 mg/ml oral drops, solution

lormetazepam
Generic medicinal product
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 adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lormetazepam Mylan Generics is and what it is used for

Lormetazepam Mylan Generics contains the active substance lormetazepam, which belongs to a group of
medicines called benzodiazepines, sedative-hypnotic medicines.
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 person.

2. What you need to know before taking Lormetazepam Mylan Generics

Do not take Lormetazepam Mylan Generics

• 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 severe respiratory insufficiency (the inability of the lungs to effectively absorb oxygen and eliminate carbon dioxide, for example, severe chronic obstructive pulmonary disease);
• if you have breathing problems during sleep (sleep apnoea syndrome);
• if you have a disease causing a rapid increase in pressure within the eye (narrow-angle glaucoma);
• if you have severe liver problems (severe hepatic insufficiency);
• if you have acute intoxication (excessive use) of alcohol or other medicines that depress the central nervous system (hypnotics, analgesics, neuroleptics, 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 Mylan Generics.
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 Mylan Generics” – Use in the elderly), as adverse reactions such as lack of coordination in movement may occur;
• if you have respiratory problems (chronic respiratory insufficiency). In this case, your doctor may decide to reduce the dose due to the risk of respiratory depression (increased level of carbon dioxide in the blood) (see “How to take Lormetazepam Mylan Generics” and “Do not take Lormetazepam Mylan Generics”);
• if you have liver problems (hepatic insufficiency). In this case, your doctor will assess whether to prescribe a lower dose (see “How to take Lormetazepam Mylan Generics”), 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);
• if you have reduced kidney function (severe 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 (cardiac insufficiency). In this case, your doctor may decide to perform regular check-ups.

Benzodiazepines, such as this medicine, and benzodiazepine-like agents are indicated only when
the disorder is severe, disabling, or causes severe distress.
Benzodiazepines are not recommended for the primary treatment of psychotic disorders and should not
be used alone to treat depression or insomnia associated with depression, as suicidal thoughts may occur in such
patients (see “Patients with psychosis”).
Tolerance: if after a few weeks the medicine seems less effective than at the beginning of
treatment, consult your doctor, as after repeated use over several weeks a certain
loss of hypnotic effect (“tolerance”) may develop.
Dependence and abuse: during treatment with this medicine, there is a risk of 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. The possibility of dependence is
reduced when this medicine is used at the appropriate dose and for short-term treatment.
Abuse of benzodiazepines has been reported.
Withdrawal: when you stop taking Lormetazepam Mylan Generics, you may experience withdrawal
or rebound symptoms, even if you have taken the medicine at the recommended doses and for a short period
of time (see section “If you stop treatment with Lormetazepam Mylan Generics”). To
minimize such symptoms, 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.
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 period at the end.
Amnesia: lormetazepam may cause anterograde amnesia (difficulty in memorizing new information).
This occurs most frequently in the first hours after taking the medicine; therefore, to reduce the risk of
amnesia, ensure an uninterrupted sleep of 7–8 hours before taking the medicine.
Behavioural reactions: if you experience behavioural disturbances (restlessness, agitation, irritability,
aggression, delirium, delusion, anger, rage, nightmares, hallucinations, psychosis), stop taking the medicine immediately (see section 4 “Possible side effects”). These reactions are more
frequent in children and the elderly, as well as in patients with organic brain syndrome (reduced mental function). During the use of benzodiazepines, including Lormetazepam Mylan Generics, a pre-existing depressive state may be unmasked. If you suffer from depression, use Lormetazepam
Mylan Generics with caution.
Children and adolescents
In children and adolescents under 18 years of age, Lormetazepam Mylan Generics should be used only
in cases of absolute necessity, and treatment duration 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 coordination in movement), muscle weakness, dizziness, drowsiness, fatigue, and exhaustion. In this case, your doctor will prescribe
a reduced dose (see “Use in the elderly”).
Patients with psychosis (mental disorders)
Lormetazepam Mylan Generics should not be used alone to treat insomnia associated with
depression. Benzodiazepines are not recommended for the primary treatment of psychotic disorders and
should 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 Mylan Generics
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, tranquillisers, and sedatives, used to treat anxiety;
• certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with Lormetazepam Mylan Generics. 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;
• methylxanthines, 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 (containing oestrogens);
• medicines for infections (antibiotics, such as rifampicin).

Concomitant use of Lormetazepam Mylan Generics with opioids (strong analgesics, medicines for opioid substitution therapy, and some cough medicines) and/or medicines that depress the Central
Nervous System 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 other treatment options are not feasible.
However, if your doctor prescribes Lormetazepam Mylan Generics together with opioids/medicines that
depress the Central Nervous System, the dose and duration of concomitant treatment must be
limited by your doctor.
Inform your doctor about all opioid/medicines that depress the Central Nervous System you are taking and follow your doctor’s dose recommendations carefully. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Lormetazepam Mylan Generics and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may enhance the sedative effect of the medicine. This negatively affects your ability to drive or operate machinery.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Lormetazepam Mylan Generics during pregnancy (see “Do not take Lormetazepam
Mylan Generics”).
If your doctor considers it necessary for you to take Lormetazepam Mylan Generics during the late stages of pregnancy or during labour, your baby may experience low body temperature (hypothermia), loss of muscle tone (hypotonia), low blood pressure (hypotension), difficulty sucking (infant hypotonia), and breathing problems.
If Lormetazepam Mylan Generics has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms.
Fertility
If you start treatment with Lormetazepam Mylan Generics and are of childbearing age, consult your doctor, whether 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 (see “Do not take Lormetazepam Mylan Generics”).
Driving and using machines
The use of Lormetazepam Mylan Generics may affect your ability to drive and operate
machinery, as you may feel confused, experience memory problems, feel drowsy, or have muscle tone issues. These effects increase if you have not had sufficient sleep. If this happens, avoid driving or operating machinery.
These reactions may vary depending on the time of ingestion, your individual sensitivity, and the dose taken. This is particularly relevant with high doses combined with alcohol.
Lormetazepam Mylan Generics contains propylene glycol, ethanol, and benzyl alcohol (contained in the orange flavour)
This medicine contains approximately 700 mg of propylene glycol per ml (1 ml corresponds to 25 drops).
This medicine contains 82 mg of alcohol (ethanol) in each ml (25 drops). The amount in each ml of this medicine is equivalent to 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.
This medicine contains 2 mg of benzyl alcohol per ml (contained in the orange flavour). Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Lormetazepam Mylan Generics

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 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 in adults is from 1 mg (10 drops) to 2 mg (20 drops).
Take the Lormetazepam Mylan Generics drops as follows:

• To open the bottle: press on the cap and unscrew at the same time (Fig. 1).
• Let the drops fall into a glass, holding the bottle in an upright position with the opening facing downwards (Fig. 2).
• To close the bottle: screw the cap until tightly sealed (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
The duration of treatment should be as short as possible and generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual withdrawal.
In certain cases, your doctor may decide to prolong the treatment after evaluating your health condition.
Treatment should be started 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
Your doctor will prescribe Lormetazepam Mylan Generics to patients under 18 years of age only in cases of absolute necessity and after careful evaluation (see section 2 “Warnings and precautions”).
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 Mylan Generics than you should
If you (or someone else) have taken an excessive dose of Lormetazepam Mylan Generics, 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 can 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 Mylan Generics
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 Mylan Generics
Do not stop treatment with Lormetazepam Mylan Generics 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 sounds (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 (abnormal sensations), perceptual disturbances, abdominal and muscular cramps, tremor, myalgia (muscle pain), agitation, palpitations, tachycardia (rapid heartbeat), panic attacks, dizziness, hyper-reflexia (exaggerated reflexes), short-term memory loss, hyperthermia (increased body temperature). Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may reappear more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is higher if you stop taking Lormetazepam Mylan Generics suddenly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances. If you have any doubts about using 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.

Seek immediate medical advice 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 you experience any of these side effects, treatment must be stopped. 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, potentially fatal (angioedema)*;
• anxiety;
• decreased sexual desire (decreased libido);
• dizziness, sedation, drowsiness, attention disorders/hyperactivity;
• 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, upper abdominal pain, constipation;
• dry mouth;
• itching;
• urinary disorders;
• muscle weakness (asthenia);
• increased sweating (hyperhidrosis).

Rare (may affect up to 1 in 100 people)

• sudden potentially life-threatening allergic reactions (anaphylactic/anaphylactoid reactions).

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, depression (unmasking of pre-existing depression), delirium, 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 Mylan Generics”);
• confusion, reduced level of consciousness, loss of muscle coordination (ataxia), muscle weakness;
• drowsiness (reduced alertness);
• reduced emotional responsiveness (flattened affect);
• dizziness;
• urticaria, skin rash;
• fatigue;
• increased risk of falls.

* Life-threatening and/or fatal cases have been reported.

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), and disturbances in the secretion of antidiuretic hormone (SIADH).

Following the instructions in this leaflet reduces the risk of side effects.

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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 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 Mylan Generics 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 per cent, ethanol 96 per cent, orange flavour,
lemon essence, caramel flavour, propylene glycol.

Description of the appearance of Lormetazepam Mylan Generics 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 S. Bernardo d’Ivrea (TO)
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)