Package leaflet: Information for the patient

Clonazepam EG 2.5 mg/ml oral drops solution

Equivalent medicine
Please read all of this leaflet carefully before you start taking/giving the child 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/your child only. Do not pass it on to other people, even if their symptoms are the same as yours, as it could be harmful.
If you/the child experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Clonazepam EG is and what it is used for
What you need to know before taking/giving the child Clonazepam EG
How to take/give the child Clonazepam EG
Possible side effects
How to store Clonazepam EG
Contents of the pack and other information

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

Clonazepam EG contains the active substance clonazepam, which belongs to a class of medicines called
"benzodiazepines".

Clonazepam EG is indicated in newborns and children for the treatment of certain forms of epilepsy (a nervous system disorder characterized by seizures and uncontrollable body movements), such as:
- typical or atypical absence seizures;
- generalized tonic-clonic seizures, primary or secondary;
- status epilepticus in all its forms.

What are typical or atypical absence seizures, generalized tonic-clonic seizures (primary or secondary), and status epilepticus?
Typical or atypical absence seizures are a type of epilepsy in which the person suddenly stops, stares blankly into space, sometimes performs automatic movements or gestures, and utters meaningless words or phrases. After a few seconds (2–15), the person resumes the previous activity as if nothing had happened.
Generalized tonic-clonic seizures, whether primary or secondary, are epileptic seizures characterized by an initial phase lasting only a few seconds during which the person loses consciousness and the muscles suddenly stiffen, followed by a second phase in which the muscles begin to contract and relax rapidly, causing convulsions.
Status epilepticus in all its forms is a serious complication of epilepsy characterized by prolonged seizures and/or lack of recovery of consciousness between seizures.

Contact your doctor if you/your child do not feel better or feel worse.

2. What you should know before taking/giving Clonazepam EG to the child

Do not take/give Clonazepam EG to the child

if you and/or the child are allergic to clonazepam or to any of the other ingredients of this medicine (listed in section 6);
if you and/or the child are allergic to benzodiazepines (medicines similar to clonazepam);
if you and/or the child suffer from severe liver disease;
if you and/or the child suffer from untreated open-angle glaucoma (an eye disease caused by increased pressure of the fluid inside the eye);
if you and/or the child suffer from acute closed-angle glaucoma;
if you and/or the child suffer from severe renal failure (severe reduction in kidney function);
if you and/or the child suffer from severe respiratory insufficiency (severe reduction in respiratory system activity);
if you and/or the child abuse medicines, drugs or alcohol.

Do not take Clonazepam EG during the first 3 months of pregnancy.
Do not give Clonazepam EG to someone who is in a coma (a deep state of unconsciousness).
Do not take Clonazepam EG together with alcohol or other medicines that may have a calming effect
on the central nervous system (see sections “Other medicines and Clonazepam EG” and “Clonazepam EG and
alcohol”), as together they could cause extremely serious adverse effects.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Clonazepam EG to the child.
In particular, inform your doctor if you and/or the child:

have previously suffered from depression or psychotic disorders;
have previously attempted suicide (trying to kill oneself);
suffer from various forms of seizures (uncontrolled body movements). Clonazepam EG may increase the frequency or trigger the onset of seizures; therefore, your doctor may, if necessary, add anticonvulsant medicines (medicines that block and reduce seizures) to the treatment with Clonazepam EG, or increase their dose if already being taken;
suffer from difficulty swallowing, as Clonazepam EG may increase salivation;
suffer from chronic respiratory diseases, as Clonazepam EG may increase mucus production in the bronchi, causing respiratory blockage;
suffer from obstruction of the airways, as adverse effects on the respiratory system may worsen;
have brain damage, as adverse effects on the respiratory system may worsen;
suffer from sleep apnea (temporary cessation of breathing during sleep);
suffer from kidney disorders, as Clonazepam EG is eliminated through urine and may accumulate in the kidneys;
suffer from liver disorders, as incorrect use of this medicine could worsen your health condition;
suffer from a rare inherited blood disorder called "porphyria";
suffer from ataxia (a disease causing difficulty in coordinating movements);
suffer from severe myasthenia gravis (a disease affecting muscles, manifesting as weakness and fatigue);
have previously abused medicines, drugs or alcohol, as you are more likely to develop habituation and dependence on this medicine.

Suicidal thoughts and/or behaviours
Some studies have shown that the use of antiepileptic medicines, such as clonazepam, slightly increases the
risk of suicidal thoughts and/or behaviours.
If during treatment with clonazepam you experience these thoughts/behaviours or notice them in the child, inform your doctor immediately, who will provide appropriate supportive therapy. In such cases, caregivers of you/the child must also inform the doctor immediately if they notice these signs.
Additionally, if you experience restlessness, irritability, aggression, agitation, nightmares, hallucinations, anxiety,
delirium, anger, psychosis, inappropriate behaviours or other negative behaviours, inform your doctor immediately, who will advise whether and how to discontinue treatment with Clonazepam EG.
Benzodiazepines may cause the onset of anterograde amnesia (inability to memorize recent experiences); this is particularly likely after taking high doses.

Blood tests
If treatment with Clonazepam EG is prolonged, your doctor may request appropriate blood tests.

Adverse effects
During treatment with Clonazepam EG, you may experience adverse effects due to prolonged use and/or high doses of this medicine (see section 4 “Possible side effects”).

Dependence
The use of high doses and/or prolonged use of clonazepam may lead to physical and psychological dependence, as occurs with other medicines similar to clonazepam.
This risk is higher if you/the child have previously abused medicines, drugs or alcohol, as you are more likely to develop habituation and dependence on this medicine.
The use of high doses and/or prolonged use may cause reversible adverse effects such as: dysarthria (speech disorders), reduced coordination of movements, gait disturbances (ataxia), nystagmus (involuntary oscillating eye movements), and double vision (diplopia). If dependence develops and you stop taking the medicine abruptly, withdrawal symptoms may occur.
Therefore, abrupt discontinuation of treatment must be avoided, and if necessary, therapy should be stopped by gradually reducing the daily dose according to your doctor’s instructions (see section “If you stop taking Clonazepam EG”).

If you are elderly and/or debilitated
If you are elderly and/or debilitated, take Clonazepam EG with caution and under medical supervision.

Children and adolescents
In newborns and children, Clonazepam EG may increase saliva production and bronchial secretions (mucus). Therefore, inform your doctor if the newborn/child has difficulty controlling secretions and/or suffers from chronic respiratory diseases and/or airway obstruction, as adverse effects on the respiratory system may worsen. It is important to keep the airways clear (see section “Additional adverse effects in children”).

Other medicines and Clonazepam EG
Inform your doctor or pharmacist if you and/or the child are using, have recently used, or might use any other medicine.
In particular, inform your doctor if you and/or the child are taking the following medicines:

other medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine, lamotrigine, valproate and primidone). Your doctor will adjust the dose of each medicine to reduce possible adverse effects that may occur when these medicines are used together with Clonazepam EG (e.g., sedation, apathy, absence states);
fluconazole (a medicine used to treat fungal infections);
medicines that reduce or block the activity of the central nervous system, as they may increase the risk of developing adverse effects, even very serious ones (e.g., reduced respiratory function, severe cardiovascular disturbances, and deep sedation that may lead to coma and death). Generally, concomitant use of these medicines with Clonazepam EG should be avoided (see also section “Warnings and precautions”);
psychotropic medicines (medicines for treating mental disorders), as unexpected adverse effects may occur;
medicines used to treat depression (e.g., tricyclic antidepressants).

The concomitant use of Clonazepam EG and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be potentially life-threatening. For this reason, concomitant use should only be considered when no other therapeutic options are available. However, if your doctor prescribes Clonazepam EG together with opioids, they will limit the dose and duration of concomitant treatment. Inform your doctor about all opioid-containing medicines you are taking and carefully follow their dosage recommendations. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms listed above. If you experience these symptoms, contact your doctor.

The following medicines:

sertraline, fluoxetine (used to treat depression),
felbamate (used for epilepsy), can be used together with clonazepam without the need to adjust the dose.

Clonazepam EG and alcohol
Do not drink alcohol while taking Clonazepam EG, due to the risk of serious adverse effects.
Alcohol in any form may independently trigger epileptic seizures regardless of treatment; therefore, it is essential not to consume alcoholic beverages during treatment with Clonazepam EG.
The combination of Clonazepam EG with alcohol may alter the effects of this medicine, compromise treatment outcomes, or cause unpredictable adverse effects.
If you have previously abused alcohol or have a tendency to abuse alcohol, your doctor will closely monitor you during treatment with Clonazepam EG, as you are more likely to develop habituation and dependence on this medicine. Therefore, do not use Clonazepam EG if you abuse alcohol (see section “Do not use Clonazepam EG”).
Clonazepam EG, when taken with alcohol, may increase the risk of falls and fractures, and may cause adverse effects such as reduced respiratory function, severe cardiovascular disturbances, and deep sedation (physical and mental relaxation similar to that caused by anaesthetics), which may lead to coma and death.

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 Clonazepam EG during the first 3 months of pregnancy.
If you are more than 3 months pregnant, take Clonazepam EG only if strictly necessary and under direct medical supervision.
If you are planning a pregnancy or are of childbearing age, consult a specialist before taking this medicine.
The use of antiepileptic medicines (to treat epilepsy) during pregnancy increases the risk of congenital malformations in children, such as cleft lip, heart/blood vessel malformations, and brain damage.
If you take high doses of Clonazepam EG in the late stages of pregnancy or during labour, your baby may experience irregular heartbeat, hypothermia (low body temperature), hypotonia (loss of muscle strength), breathing problems (moderate respiratory depression), and poor feeding. In addition, your baby may show withdrawal symptoms.
If you are pregnant or discover you are pregnant, do not abruptly stop treatment with antiepileptic medicines, as this may increase the risk of epileptic seizures, with serious consequences for both you and the fetus. Always consult your doctor on how to proceed.

Breastfeeding
Clonazepam EG passes into breast milk, and therefore breastfeeding should be avoided. If you need to take this medicine, consult your doctor.

Driving and using machines
Do not drive during treatment with Clonazepam EG.
This medicine may impair your ability to drive vehicles and operate machinery, as it reduces central nervous system activity.
Depending on the dose and individual sensitivity, Clonazepam EG may affect driving ability or behaviour in traffic. Alterations in reflexes may occur, especially with any dose increase or change in timing of administration.

Clonazepam EG contains sodium (as sodium saccharin) and propylene glycol (E1520)
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.
This medicine contains approximately 41 mg of propylene glycol per drop.
If the child is under 5 years of age (particularly under 4 weeks old), speak to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
Propylene glycol in this medicine may produce effects similar to those of alcohol and may increase the likelihood of side effects.
Use this medicine only as recommended by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take/give Clonazepam EG to the child

Take/give this medicine to the child exactly as directed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.

DOSE

The doctor will start treatment with low doses of Clonazepam EG and gradually increase the daily dose over a period of 3–4 weeks, adjusting it until reaching the most appropriate maintenance dose for you/your child.
The doctor will instruct you to divide the prescribed dose into 3–4 administrations throughout the day.
Once the most suitable maintenance dose has been established by the doctor, he/she will advise you on how to continue the treatment. If necessary, the doctor may increase the maintenance dose without problems.
At the beginning and during treatment, the doctor will advise you on how to divide the doses throughout the day.

Weakened patients
If you are weakened, the doctor will monitor you during treatment with Clonazepam EG.
The doctor may consider reducing the dose if necessary.

Use in children and adolescents
Newborns

The recommended initial dose will be determined by the doctor.
The recommended maintenance dose, reached by gradually increasing the initial dose, generally ranges from 0.5 mg to 1 mg per day:

Drops: 5–10 drops (1 ml corresponds to 25 drops) per day.

Infants

The recommended initial dose will be determined by the doctor. The recommended maintenance dose, reached by gradually increasing the initial dose, generally ranges from 1.5 mg to 3 mg per day: 15–30 drops (1 ml corresponds to 25 drops) per day.

School-age children

The recommended initial dose will be determined by the doctor.
The recommended maintenance dose, reached by gradually increasing the initial dose, generally ranges from 3 mg to 6 mg per day: 30–60 drops (1 ml corresponds to 25 drops) per day.

If you/your child have impaired kidney function
If you/your child have impaired kidney function, the doctor will monitor you/your child during treatment with Clonazepam EG to prevent accumulation of the medicine in the kidneys.
In cases of severe renal insufficiency, the use of Clonazepam EG is contraindicated (see section “Do not use Clonazepam EG”).

If you/your child have impaired liver function
If you/your child have impaired liver function, the doctor will monitor you/your child during treatment with Clonazepam EG. The doctor will evaluate whether to adjust the dose. In cases of severe hepatic impairment, the use of Clonazepam EG is contraindicated (see section “Do not use Clonazepam EG”).

If you/your child have respiratory disorders
If you/your child have respiratory disorders (e.g. chronic lung diseases), the doctor will adjust the dose of Clonazepam EG to reduce the risk of respiratory side effects.
In cases of severe respiratory insufficiency, the use of Clonazepam EG is contraindicated (see section “Do not use Clonazepam EG”).

HOW

Caution: Do not pour Clonazepam EG drops directly into the mouth from the bottle.
After each opening, ensure that the dropper is securely attached to the neck of the bottle.
The drops should be administered with a spoon or may be mixed with water, tea, or fruit juice.
Hold the bottle vertically with the opening facing downwards. If the liquid does not flow, turn the bottle upside down several times or gently shake it.

If you/your child take/give more Clonazepam EG than you should

In case of accidental ingestion/overdose of Clonazepam EG, contact your doctor immediately or go to the nearest hospital.

Symptoms
In case of accidental ingestion/overdose of Clonazepam EG, you may experience:

drowsiness;
ataxia (reduced motor and gait coordination);
dysarthria (speech disorder);
nystagmus (involuntary oscillating eye movements);
areflexia (complete absence of reflexes);
apnea (temporary cessation of breathing during sleep);
hypotension (low blood pressure);
cardiorespiratory depression (reduced respiratory and heart activity);
coma. Coma, if it occurs, usually lasts a few hours but may last longer and may be cyclical, especially in the elderly;
increased frequency of seizures;
increased effects of medicines and substances that reduce central nervous system activity, including alcohol.

If you/your child suffer from respiratory diseases, the effects on the respiratory system are more severe.
Rarely, accidental overdose of Clonazepam EG, when taken alone, is life-threatening or may lead to coma, even cyclical coma.

Treatment
The doctor will provide appropriate supportive therapy based on clinical condition and symptoms after evaluating them.
Measures to reduce absorption of Clonazepam EG may be necessary (e.g. activated charcoal and/or gastric lavage).
In case of severe depression of the central nervous system, the doctor may consider using flumazenil (a medicine that acts by blocking the effects of benzodiazepines). If you/your child are taking medicines for depression (e.g. tricyclic antidepressants), inform the doctor, as flumazenil must be used with extreme caution in such cases.

For further information on the correct use of this medicine, consult your doctor.

Caution: Flumazenil is not indicated in patients with epilepsy who are being treated with benzodiazepines.
Antagonism of the benzodiazepine effect may trigger seizures in these patients.

If you/your child forget to take/give Clonazepam EG

Do not take/give a double dose to make up for a missed dose.

If you/your child stop treatment with Clonazepam EG

Do not stop treatment with Clonazepam EG abruptly.
Discontinuation of the medicine must be gradual and under medical supervision.
Sudden withdrawal of Clonazepam EG, especially after long-term treatment with high doses, may trigger a status epilepticus and worsen the epileptic condition.

Additionally, withdrawal symptoms may occur, such as tremor, sweating, agitation, sleep disturbances, anxiety, headache, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, mood changes, confusion, irritability, and seizures. In more severe 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, hypersensitivity to light, noise and physical contact, and hallucinations (seeing and hearing things that do not exist) may also occur.

Withdrawal symptoms increase when benzodiazepines (such as clonazepam) are used simultaneously with sedatives (medicines that cause physical and mental dullness).

During the discontinuation phase, the doctor may prescribe an alternative treatment with another anticonvulsant (a medicine for treating epilepsy).

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 will experience them.
The most common side effects of Clonazepam EG are related to the reduction of central nervous system activity.
Experience has shown that approximately 50% of patients experience drowsiness and about 30% experience ataxia (reduced motor coordination and gait); in some cases, these disturbances may decrease over time. Behavioural disturbances have been observed in approximately 25% of patients.
The possible side effects are listed below.

Immune system disorders

allergic reactions and hypersensitivity;
anaphylactic reactions (severe allergic reactions).

Psychiatric disorders

disturbances in emotional state and mood;
memory disturbances;
hallucinations (perception of things that do not exist in reality);
agitation;
confusion;
disorientation;
depression (which may also be associated with pre-existing depression);
paradoxical reactions (more likely in children and elderly patients):
- restlessness,
- irritability,
- aggressiveness,
- agitation,
- nervousness,
- hostility,
- anxiety,
- sleep disturbances,
- delirium,
- anger,
- nightmares,
- abnormal dreams;
- psychosis,
- hyperactivity,
- inappropriate behaviours and other negative behaviours;
change in libido (variation in sexual desire).

Nervous system disorders

altered attention;
drowsiness;
slowed reactions;
muscle hypotonia (reduced muscle tone);
tremor;
dizziness;
ataxia (reduced motor coordination and gait);
headache;
generalized seizures;
reversible dysarthria (speech disorder);
reversible reduced motor coordination and gait (ataxia);
reversible nystagmus (involuntary oscillating eye movements). The following side effects increase with high-dose and/or long-term treatment:
anterograde amnesia and amnesic effects, which may be associated with behavioural changes;
increased frequency of seizures (in certain forms of epilepsy).

Eye disorders

reversible visual disturbances (diplopia);
nystagmus (involuntary oscillating eye movements).

Cardiac disorders

palpitations (sensation of increased heart rate);
heart failure (reduced heart function);
cardiac arrest (cessation of heartbeat).

Respiratory disorders

respiratory depression (reduced respiratory activity);
chest congestion (oppression and/or chest pain);
rhinorrhea (runny nose);
breathing difficulties;
increased secretions (mucus) in the upper respiratory tract (nose, throat).

Gastrointestinal disorders

nausea;
epigastric symptoms (stomach disturbances);
appetite disturbances;
sialorrhea (excessive saliva production);
bowel disturbances (defecation problems that may manifest as diarrhoea and/or constipation);
dry mouth;
gastritis (inflammation of the stomach).

Hepatobiliary disorders

hepatomegaly (enlarged liver);
transient increase in serum transaminases and alkaline phosphatase (substances produced by the liver; their increased blood levels may indicate liver damage).

Blood disorders

anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen);
leucopenia (reduction in white blood cells);
thrombocytopenia (reduction in platelets);
eosinophilia (reduction in eosinophils in the blood, a type of white blood cell).

Skin and subcutaneous tissue disorders

urticaria (skin redness accompanied by itching);
pruritus;
rash (skin eruptions);
transient hair loss;
pigmentary changes (alteration in skin colouration).

Musculoskeletal and connective tissue disorders

muscle weakness.

Renal and urinary disorders

urinary incontinence (involuntary loss of urine).

Reproductive system and breast disorders

erectile dysfunction (erection problems).

General disorders and administration site conditions

deterioration in general physical health;
hyperthermia (increased body temperature);
fatigue (tiredness, weakness).

Metabolism and nutrition disorders

dehydration (excessive loss of water from the body);
weight changes.

Injury

falls and fractures. The risk of falls and fractures increases if the patient is elderly and/or is simultaneously taking other medicines with sedative effects (including alcoholic beverages).

Investigations

decreased platelet count in the blood.

Additional side effects in children
The following side effects may occur in children:
Endocrine disorders

reversible incomplete precocious puberty.

Respiratory disorders

increased saliva or mucus secretion. Therefore, particular attention must be paid to maintaining clear airways.

Reporting of side effects
If you/your child 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 the following website: 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 Clonazepam EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine if you notice clear signs of damage or tampering with the bottle.
Do not use this medicine after the expiry date which is stated on the packaging after Exp.
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 required. This will help protect the environment.

6. Package contents and other information

What Clonazepam EG contains

The active substance is: clonazepam (1 ml contains 2.5 mg of clonazepam);
The other components are: sodium saccharin, propylene glycol (E1520), glacial acetic acid, orange-lemon-caramel flavour.

Description of the appearance of Clonazepam EG and package contents
Clonazepam EG is presented as:
a clear and transparent solution for oral administration in drops, packed in a 10 ml amber glass bottle
at a concentration of 2.5 mg/ml (1 drop corresponds to 0.1 mg of clonazepam).
Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano
Manufacturer
ICE S.p.A., Via Cantone Moretti, 29 Località San Bernardo - 10015 Ivrea (TO) - Italy