Lorazepam Aurobindo Italia: detailed information

Package leaflet: information for the patient

Lormetazepam Aurobindo Italia 2.5 mg/ml oral drops, solution

Generic medicine
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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lormetazepam Aurobindo Italia is and what it is used for
What you need to know before taking Lormetazepam Aurobindo Italia
How to take Lormetazepam Aurobindo Italia
Possible side effects
How to store Lormetazepam Aurobindo Italia
Contents of the pack and other information

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

Lormetazepam Aurobindo Italia 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), characterized by
difficulty falling asleep and maintaining sleep continuity, particularly when caused by a state of fear or
worry (anxious state), and only in cases where the disorder is severe, disabling, and causes the individual
severe distress.

2. What you should know before taking Lormetazepam Aurobindo Italia

Do not take Lormetazepam Aurobindo Italia

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 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 (the lungs’ inability to effectively absorb oxygen and eliminate carbon dioxide – for example, severe chronic obstructive pulmonary disease);
if you have breathing problems during sleep (sleep apnea);
if you have a type of eye disease affecting the optic nerve called narrow-angle glaucoma (rapid increase in pressure inside the eye);
if you suffer from severe hepatic insufficiency (reduced liver function);
if you have acute intoxication (excessive use) from alcohol, hypnotics (sleeping pills), analgesics (painkillers) or psychotropic medicines (medicines acting on mental functions such as 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 Aurobindo Italia.
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 Aurobindo Italia – Use in the elderly), as certain adverse reactions such as lack of coordination may occur;
if you suffer from chronic respiratory insufficiency (the lungs’ inability to effectively absorb oxygen and eliminate carbon dioxide). 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 Aurobindo Italia and Do not take Lormetazepam Aurobindo Italia);
if you suffer from hepatic insufficiency (reduced liver function). In case of liver problems (hepatic impairment), your doctor will assess whether to prescribe a lower dose (see How to take Lormetazepam Aurobindo Italia), since 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 suffer from severe renal insufficiency (reduced kidney function);
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 carry out regular checks during treatment with this medicine.

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 anxiety associated with depression (suicide may be precipitated in such patients) (see Patients with psychosis).
Treatment with Lormetazepam Aurobindo Italia, as with all benzodiazepines, should be as short as possible: maximum 4 weeks, including a gradual withdrawal period at the end.
Tolerance
After repeated use for several weeks, a certain loss of efficacy of the hypnotic effects of the
medicine (“tolerance”) may develop. If after a few weeks it seems to you that the medicine is not working as well as at the beginning of treatment, consult your doctor.
Dependence and abuse
The use of this medicine and other benzodiazepines may lead to the development of physical and
psychological dependence, i.e., the need to continue taking the medicine. The risk in this regard increases with dose and duration of treatment, and is greater in patients who are prone to abusing drugs or alcohol. Therefore, if you have a history of alcohol or drug abuse, use this medicine with extreme caution (see Warnings and precautions).
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 symptoms
Once physical dependence has developed, abrupt discontinuation of treatment with Lormetazepam
Aurobindo Italia may be accompanied by withdrawal or rebound symptoms, even if the medicine has been taken at the recommended doses and for a short period of time (see section If you stop taking Lormetazepam Aurobindo Italia and Undesirable effects). These symptoms may include:

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

In severe cases, the following symptoms may occur:

derealization (feeling of perceiving reality in a distorted way, as unreal or unfamiliar), depersonalization (loss of sense of personal identity), hyperacusis (difficulty tolerating certain sounds), numbness and tingling in the extremities, paresthesia of the limbs (altered sensitivity of the limbs), hypersensitivity to light, noise and physical contact, hallucinations (seeing or hearing things that are not present in reality) and epileptic seizures.

Other symptoms include:

depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (altered sensitivity), perceptual disturbances, abdominal and muscular cramps, tremor, myalgia (muscle pain), agitation, palpitations, tachycardia (accelerated heart rate), panic attacks, dizziness, hyper-reflexia (exaggerated reflexes), short-term memory loss, hyperthermia (increased body temperature).

Upon discontinuation of treatment, the following may also occur:

rebound insomnia, a transient syndrome in which the symptoms that led to treatment with benzodiazepines recur in an aggravated form. This may be accompanied by other reactions including mood changes, anxiety, restlessness or sleep disturbances.

To minimize such symptoms, it is recommended to gradually reduce the dose. Withdrawal symptoms will not
occur between one administration and the next because
Lormetazepam Aurobindo Italia has a slow elimination. However, when switching to treatment with
Lormetazepam Aurobindo Italia after using benzodiazepines with significantly longer duration of action for a prolonged period and/or at high doses, withdrawal symptoms may occur.
Withdrawal symptoms, especially the more severe ones, are more common in patients who have taken excessive doses for a long time; however, they may also occur after abrupt discontinuation of benzodiazepines taken continuously at therapeutic doses, especially if the discontinuation is sudden.
Since the risk of withdrawal symptoms is higher after abrupt discontinuation of treatment,
treatment discontinuation should be carried out by gradually reducing the dosage.
Duration of treatment
The duration of treatment should be as short as possible. Generally, it varies from a few days to two
weeks, up to a maximum of four weeks, including a gradual withdrawal period.
Amnesia
Lormetazepam Aurobindo Italia may cause anterograde amnesia (difficulty in memorizing new
information). This occurs more frequently in the first hours after taking the medicine; therefore, to reduce the risk, ensure you can sleep for 7-8 hours uninterrupted before taking Lormetazepam Aurobindo Italia (see Possible undesirable effects).
Psychiatric and paradoxical reactions
The use of benzodiazepines, such as this medicine, may lead to reactions such as restlessness, agitation,
irritability, aggressiveness, delirium, delusion, rage, anger, nightmares, hallucinations (seeing or hearing things that
are not present in reality), psychosis (mental disorder characterized by detachment from reality),
inappropriate behavior and other behavioral changes. If this occurs, stop taking the medicine immediately (see section 4. Possible undesirable effects). Such 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 Aurobindo Italia, a pre-existing depressive state may be unmasked. If you suffer from depression, you should use Lormetazepam Aurobindo Italia with caution.
For athletes: this medicine contains ethanol (ethyl alcohol). The use of medicines containing ethyl alcohol may result in positive anti-doping tests in relation to the alcohol concentration limits indicated by certain sports federations.
Children and adolescents
In children and adolescents under 18 years of age, Lormetazepam Aurobindo Italia must not be
administered. If it is necessary to administer the medicine to children, the doctor will first assess the actual need for treatment. The duration of treatment must be as short as possible (see Use in children and adolescents).
Elderly
The use of benzodiazepines, including this medicine, may be associated with an increased risk of falls due to adverse effects such as ataxia (lack of coordination in movements), muscle weakness, dizziness, drowsiness, fatigue and tiredness. In this case, your doctor will prescribe a reduced dose (see Use in the elderly).
Patients with psychosis (mental illnesses)
Lormetazepam Aurobindo 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
increase in these patients).
Other medicines and Lormetazepam Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine, including those without a prescription.
Interactions with other medicines

Other psychotropic medicines (medicines acting on the central nervous system); the combination of these medicines with Lormetazepam Aurobindo Italia requires special attention and monitoring by your doctor to avoid unexpected adverse effects due to interaction.
Medicines that depress respiratory function, such as opioids (analgesics [painkillers], antitussives [cough suppressants], substitution treatments), particularly in elderly patients; combination with these medicines requires special attention.

Medicines that depress the Central Nervous System (CNS)
Exercise particular caution and inform your doctor if you are taking the following medicines:

Antipsychotics (medicines for the treatment of mental illnesses), hypnotics (medicines used to promote sleep), anxiolytics/tranquilizers/sedatives (used to treat anxiety), certain antidepressants, narcotic analgesics and opioid anesthetics (medicines for pain), especially if you are an elderly patient, as they may cause an increased sense of well-being when taken with Lormetazepam Aurobindo Italia. This may increase your desire to continue taking these medicines (dependence); antiepileptics (medicines for the treatment of epilepsy), anticonvulsants (medicines against seizures) and sedative antihistamines (some medicines for the treatment of allergies that induce sedation). The concomitant use of these medicines with Lormetazepam Aurobindo Italia may enhance its effect, and narcotic analgesics may cause increased euphoria leading to increased psychological dependence.
Cytochrome P450 inhibitors (medicines that slow down the activity of certain enzymes involved in drug metabolism); may increase the activity of benzodiazepines.
Cardiac glycosides (medicines for heart failure); concomitant use may increase cardiac glycoside levels in the blood.
Beta-blockers (medicines for the treatment of arrhythmias and heart failure); may increase the clinical effects of Lormetazepam Aurobindo Italia.
Methylxanthines, theophylline or aminophylline (anti-asthmatics), rifampicin (antibiotic); may reduce the effect of Lormetazepam Aurobindo Italia.
Medicines containing estrogens (hormones); concomitant use may reduce benzodiazepine levels in the blood.
Clozapine (medicine for the treatment of mental illnesses); concomitant use with Lormetazepam Aurobindo Italia may cause marked sedation, excessive salivation, ataxia (loss of coordination of movements).

The concomitant use of Lormetazepam Aurobindo Italia and opioids (strong analgesics, medicines for addiction 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 other treatment options are not possible.
However, if your doctor prescribes Lormetazepam Aurobindo Italia 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 carefully follow the doctor’s dose recommendations. 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 Aurobindo Italia 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 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 Aurobindo Italia during pregnancy and breastfeeding (see “Do not take
Lormetazepam Aurobindo Italia”).
If you have been prescribed Lormetazepam Aurobindo 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.
If your doctor considers it necessary for you to take Lormetazepam Aurobindo Italia during the late stages of pregnancy, or during labor and delivery, effects on the newborn may occur such as hypothermia (decreased body temperature compared to normal), hypotonia (loss of muscle tone), hypotension (low blood pressure), difficulty in sucking (“infant hypotonia”) and moderate respiratory depression (increased level of carbon dioxide in the blood) due to the pharmacological action of the medicine.
Moreover, newborns born to mothers who have taken Lormetazepam Aurobindo Italia or other benzodiazepines long-term during the late stages of pregnancy may develop physical dependence and may be at risk of developing withdrawal symptoms in the period after birth.
Since small amounts of the medicine may pass into breast milk, do not take Lormetazepam Aurobindo Italia during breastfeeding (see “Do not take Lormetazepam Aurobindo Italia”).
Driving and using machines
The use of Lormetazepam Aurobindo Italia significantly impairs the ability to drive vehicles and
operate machinery because it causes sedation, amnesia (memory loss), altered concentration, and impaired muscle function. These effects increase if you have not slept enough. If this happens to you, avoid driving vehicles or operating machinery. Reactions may vary depending on the time of ingestion, your individual sensitivity, and the dose taken. This is particularly evident with high doses in combination with alcohol (see “Lormetazepam Aurobindo Italia with alcohol”).
Lormetazepam Aurobindo Italia contains ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose. This should be taken into account in patients suffering from alcoholism, as it could be dangerous for them, in pregnant or breastfeeding women, in children and in high-risk groups such as patients with liver disease or epilepsy.
This medicine contains less than 1 mmol (23 mg) of sodium per unit volume, i.e., essentially ‘sodium-free’.

3. How to take Lormetazepam Aurobindo 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 do so.
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.
Unless otherwise prescribed by your doctor, the recommended single dose for adults ranges from 1 mg (10 drops) to 2 mg (20 drops).

Use in children and adolescents (under 18 years of age)
This medicine should be used only when absolutely necessary and only after careful evaluation
(see section 2 – Warnings and precautions).
The recommended dose depends on age, body weight, and individual condition. The duration of treatment
should be as short as possible.

Use in elderly patients
The recommended dose in elderly patients is 0.5–1 mg (5–10 drops).

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

Duration of treatment
Your doctor will explain that treatment is intended to be short-term and that the dose may be gradually reduced before stopping.
Treatment with Lormetazepam Aurobindo Italia should be as brief as possible. Your doctor will regularly reassess your condition and the need for continued treatment with this medicine, particularly if you are symptom-free. The duration of treatment generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period.
In certain cases, extension beyond the maximum treatment period may be necessary; however, this will only occur after your doctor has reassessed your condition.
Treatment should begin with the lowest recommended dose and should be increased carefully, without exceeding the maximum dose, and should be as short as possible.
If treatment lasts longer than 2 weeks, Lormetazepam Aurobindo Italia should not be stopped abruptly, as sleep disturbances may temporarily reappear with increased intensity. For this reason, it is recommended to complete treatment by gradually reducing the doses taken.

If you take more Lormetazepam Aurobindo Italia than you should
If you (or someone else) have taken an excessive dose of Lormetazepam Aurobindo Italia, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
As with other benzodiazepines, an overdose of Lormetazepam Aurobindo Italia should not pose a life-threatening risk unless other medicines that depress the central nervous system (including alcohol) have also been taken. Overdose of benzodiazepines typically results in varying degrees of central nervous system depression, ranging from drowsiness (temporary clouding of the senses or consciousness) to coma.
Symptoms of mild poisoning include drowsiness, fatigue, ataxia (loss of coordination of voluntary movements), visual disturbances, mental confusion, and lethargy (tendency to prolonged sleep and unresponsiveness to normal stimuli).
Oral intake of higher doses may lead to symptoms ranging from deep sleep to unconsciousness, ataxia (progressive loss of motor coordination), hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression (increased level of carbon dioxide in the blood), rarely coma, and very rarely, death.

Treatment of overdose
In treating overdose, it must be considered that other substances may have been taken simultaneously, potentially causing respiratory depression (increased level of carbon dioxide in the blood), rarely coma, and very rarely, death.
Patients with mild symptoms of poisoning 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 emptying the stomach, activated charcoal should be administered to reduce absorption. Special attention must be paid to respiratory and cardiovascular functions during emergency treatment.
In case of hypotension (low blood pressure), peripheral circulation-supporting drugs of the noradrenergic type and volume expanders 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 poisoning, hemodialysis and peritoneal dialysis (blood dialysis) may be useful. However, these methods are not efficient in cases of isolated poisoning with Lormetazepam Aurobindo Italia.
Flumazenil may be used as an antidote (to counteract the harmful effects of the medicine).
Opioid antagonists are contraindicated.
Bring 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 Aurobindo Italia
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 Aurobindo Italia
Do not stop treatment with Lormetazepam Aurobindo Italia suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur (see “Withdrawal symptoms”).
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 touch, hallucinations (seeing or hearing things that do not exist), or epileptic seizures.

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 greater when stopping Lormetazepam Aurobindo Italia abruptly.
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 experiences them.

At the beginning of treatment, the following may occur: daytime drowsiness, emotional disturbances, depressed level of consciousness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (loss of coordination of movements), or diplopia (double vision).
These reactions usually disappear with continued treatment.

The most frequently observed adverse reactions in patients receiving Lormetazepam Aurobindo Italia are headache, sedation, and anxiety.

The most serious adverse reactions in patients receiving Lormetazepam Aurobindo Italia are angioedema (swelling of the skin of the face, lips, and tongue), suicide or attempted suicide associated with unmasking of pre-existing depression.

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 severe mental condition in which a person loses touch with reality and the ability to think and judge clearly), or behavioural changes. If any of these side effects occur, treatment must be discontinued. These reactions are more likely to occur 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)

angioedema* (swelling of the skin of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing and potentially be life-threatening);
anxiety;
decreased libido (reduced sexual desire);
dizziness;
sedation;
drowsiness;
attention disturbances;
amnesia (memory impairment);
vision problems;
speech difficulties;
dysgeusia (altered taste);
slowing of mental and motor functions;
tachycardia (increased heart rate);
vomiting, nausea, upper abdominal pain, constipation;
dry mouth;
pruritus (itching);
urinary disorders (difficulty urinating);
asthenia (reduced muscle strength);
hyperhidrosis (excessive sweating).

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

anaphylactic/anaphylactoid reactions (severe allergic or allergy-like reactions);
increased bilirubin (a pigment present in bile);
jaundice (yellowing of the skin, mucous membranes, and whites of the eyes);
increased liver transaminases (liver enzymes);
increased alkaline phosphatase (an enzyme);
thrombocytopenia (low platelet count in the blood);
agranulocytosis (absence of granulocytes, a type of blood cell);
pancytopenia (deficiency of all types of blood cells);
syndrome of inappropriate antidiuretic hormone secretion (a hormonal disorder).

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

suicide (unmasking of pre-existing depression)*;
attempted suicide (unmasking of pre-existing depression);
acute psychosis (mental disorder);
hallucinations (seeing or hearing things that are not present in reality);
dependence;
depression (unmasking of pre-existing depression);
delirium;
withdrawal syndrome (rebound insomnia);
agitation;
aggression;
irritability;
restlessness;
rage (anger);
nightmares;
abnormal behaviour;
emotional disturbances;
confusion;
reduced alertness, confusion;
ataxia (loss of coordination of movements);
muscle weakness;
fatigue;
daytime drowsiness, reduced alertness;
reduced emotional responsiveness;
vertigo;
urticaria, skin rash;
fatigue;
falls.

* Life-threatening or fatal cases have been reported.
See Warnings and precautions.

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 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 Aurobindo Italia

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 remaining 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 used. This will help protect the environment.

6. Package contents and other information

What Lormetazepam Aurobindo Italia 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 flavour, lemon essence,
caramel flavour, propylene glycol.

Description of the appearance of Lormetazepam Aurobindo Italia and package contents
Pack containing one 20 ml solution bottle.
The bottle has a child-resistant closure to protect against tampering by children.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102, 21047 - Saronno (VA)

Manufacturers
ICE S.p.A.
Cantone Moretti, 29
10015 (TO) – Ivrea – Italy