Leaflet: information for the user

Rivotril 2.5 mg/ml oral drops in solution

Clonazepam

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isRivotriland what it is used for

2. What you need to know before starting to takeRivotril

3. How to takeRivotril

4. Possible side effects

5. Storage ofRivotril

6. Contents of the pack and additional information

Rivotril contains clonazepam as the active ingredient, which belongs to a group of medications known as benzodiazepines. Clonazepam has anticonvulsant properties, meaning it prevents seizures (convulsions).

It is used in most forms of infantile and childhood epilepsy, especially petit mal and tonic-clonic seizures. It is also indicated in adult epilepsy, focal seizures, and status epilepticus.

Do not take Rivotril

• if you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication (listed in section 6)
• if you are allergic (hypersensitive) to other medications in the benzodiazepine group
• if you have severe and persistent respiratory difficulties (sensation of choking), severe liver failure (the liver cannot perform its functions) or if you have drug or alcohol dependence problems, unless it has been strictly indicated by your doctor

If you are unsure about these aspects, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivotril.

You may experience a loss of effect during treatment with Rivotril.

Rivotril should be used with special caution in the following situations:

• if you have any liver or kidney disease,
• if you are elderly, suffer from muscle weakness, sleep apnea, or have respiratory difficulties (sensation of choking),
• if you have allergies,
• if you have porphyria (a disease that can affect the nervous system and makes the skin very sensitive to the sun),
• if you have hereditary intolerance to galactose, lactase deficiency of Lapp or malabsorption of glucose or galactose,
• if you have other diseases,
• if you are taking other medications, especially medications for epilepsy, sleep aids (hypnotics), pain medications (analgesics), medications for mental illnesses (neuroléptics), depression medications (antidepressants) or lithium,
• if you have drug or alcohol dependence problems,
• if you have depression and/or have attempted suicide,
• if you have ataxia (discoordination of voluntary movements).

A reduced number of people who were treated with antiepileptic medications like Rivotril have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

Before starting treatment with Rivotril, your doctor will decide whether you can take a lower dose or not take it at all.

Taking Rivotril with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication. This is very important, because taking several medications at the same time can increase or decrease its effect.

For example, tranquilizers, sleep-inducing medications, and other medications that affect the central nervous system can increase the effect of Rivotril.

Therefore, do not take Rivotril with other medications without consulting your doctor. When your doctor authorizes it, you can start taking it.

Your doctor may prescribe Rivotril along with other medications for epilepsy, in which case your doctor will adjust the dose of each medication to achieve the desired effect.

Taking Rivotril with alcohol

You should avoid taking alcohol during treatment with Rivotril, as it can modify its effects, reducing the effectiveness of the treatment or producing unforeseen adverse effects.

Risk of dependence

The use of benzodiazepines can cause dependence, mainly when the medication is taken continuously for a long time. To prevent this risk, please consider the following precautions:

• The use of benzodiazepines should only be under medical prescription (never because they have worked for other patients) and never advise others.
• Do not increase the prescribed doses or prolong the treatment longer than recommended.
• Consult your doctor regularly to decide if the treatment should continue.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Rivotril may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce your reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Rivotril contains propylene glycol

Warnings about excipients:

This medication contains 10.2 g of propylene glycol in each 2.5 mg/ml bottle.It may cause symptoms similar to those of alcohol, reducing your ability to drive or operate machinery.

Caution:Do not administer the drops directly from the bottle. Use a spoon.

After each opening of the bottle, ensure that the dropper is firmly attached to the neck of the bottle before administering the drops.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the correct dose for you, starting with a low initial dose and gradually increasing the dose until the desired effect is achieved, depending on your response to the medication, the nature of your illness, and your weight.

• Adults: the initial dose should not exceed 1.5mg/day (equivalent to 0.6ml/day or 15 drops/day), divided into three doses. This dose can be increased by 0.5mg (0.2 ml or 5 drops) every 3 days until the seizures are well controlled or side effects prevent further dose increases. The maintenance dose should be adjusted for each patient. A maintenance dose of 3-6mg/day (equivalent to 1.2-2.4 ml or 30-60 drops/day) is usually sufficient.

The maximum dose should never exceed 20 mg/day (equivalent to 8 ml or 200 drops) in adults.

To facilitate dose adjustment, the use of 0.5mg ranitidine tablets is recommended for children and adults in the initial phase of treatment.

Use in liver disorders and advanced age

Use the minimum necessary dose in advanced age and mild to moderate liver disorders. Do not administer in severe liver disorders.

Use in children and adolescents

• Infants and children under 10 years (or up to 30 kg in weight): the initial dose is 0.01-0.03mg/kg/day (0.004-0.012 ml/kg/day), divided into two or three doses. This dose can be increased by 0.25-0.50 mg (0.1-0.2 ml or 2.5-5 drops) every 3 days until the seizures are well controlled or side effects prevent further dose increases.

The approximate maintenance dose is 0.1mg/kg/day (0.04ml/kg/day).

The maximum dose should never exceed 0.2mg/kg/day (0.08ml/kg/day) in infants and children under 10 years.

To facilitate dose adjustment, the use of drops (1 drop = 0.1 mg of active substance) is recommended for infants.

If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol. (See section 2 "Warnings about excipients").

• Children and adolescents 10-16 years: the initial dose is 1-1.5 mg/day (0.4-0.6 ml/day or 10-15 drops/day), divided into two or three doses. This dose can be increased by 0.25-0.5 mg (0.1-0.2 ml or 2.5-5 drops) every 3 days until the maintenance dose (usually 3-6mg/day, equivalent to 1.2-1.4 ml or 30-60 drops/day) is reached.

As with all antiepileptic medications, do not discontinue treatment with Rivotril abruptly, but rather taper off the medication gradually.

Guidelines for correct administration

To use the bottle with dropper, it must be kept in an upright position, with the mouth facing downwards. If the solution does not flow immediately, gently shake the bottle, tap it lightly with your finger, or invert it several times in a row.

The drops should be administered using a spoon, and may be mixed with water, tea, or fruit juices.

Never administer the drops directly from the container to the mouth.

Do not change the dose indicated by your doctor.

Consult your doctor if you believe the effect of this medication is too strong or too weak.

Dose duration

Your doctor will indicate when to discontinue treatment with Rivotril.

This treatmentmay last a lifetime, so if you want to stop taking Rivotril, always consult your doctor, as abruptly stopping treatment may cause withdrawal symptoms such as tremors.

If you take more Rivotril than you should

The symptoms of overdose or intoxication vary greatly from person to person, depending on age, weight, and individual response to the medication. Symptoms may range from fatigue and dizziness to ataxia (loss of coordination), somnolence (sleep), respiratory failure, absence of reflexes, hypotension (low blood pressure), and stupor (low response to stimuli), and finally, coma with respiratory depression and circulatory insufficiency. Convulsions may occur, especially in patients with blood concentrations of the medication above the recommended levels.

The treatment of intoxication will consist of close monitoring of respiration, heart rate, and blood pressure; gastric lavage, intravenous hydration, general supportive measures, and emergency measures in case of respiratory tract obstruction. In case of hypotension (low blood pressure), sympathomimetic medications may be administered.

Warning:

The medication flumazenil (benzodiazepine antagonist) is not indicated in patients with epilepsy treated with benzodiazepines. In these patients, flumazenil may cause convulsions.

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If you take more Rivotril than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Teléfono 91 562.04.20. It is recommended to bring the package insert and the medication container to the healthcare professional.

If you forget to take Rivotril

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Rivotril

Stopping administration may cause restlessness, anxiety, insomnia, lack of concentration, headache, and sweating. It is not generally recommended to discontinue treatment abruptly, but rather to taper off the medication gradually, in accordance with the doctor's instructions.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Rivotril may cause side effects, although not everyone will experience them.

The following side effects have been described:

• Uncontrollable and involuntary movement of the eyes (nystagmus).
• Drowsiness (sleep), slowness of reflexes, hypotonia, muscle weakness, dizziness, fatigue, ataxia (discoordination of voluntary movements). These side effects are usually temporary and generally disappear without the need to interrupt treatment.
• Anterograde amnesia.
• Thrombocytopenia (decrease in platelet count).
• Urticaria (allergy), itching, skin rash (redness of the skin), temporary hair loss, skin pigmentation (color) changes.
• Headache.
• Nausea and epigastric discomfort (in the upper abdomen).
• Urinary incontinence (loss of bladder control).
• Impotence, decreased libido (decreased sexual desire).
• Allergic reactions and anaphylactic shock (severe allergic reaction).

• Generalized seizures.
• Decreased concentration ability, restlessness, confusion, disorientation.
• Emotional and mood alterations.
• Depression, which may be due to an underlying disease.
• Paradoxical reactions (appearance of reactions opposite to those expected by the action of the medication): restlessness, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disorders, delirium, anger, nightmares, intense dreams, hallucinations, psychosis, hyperactivity, behavioral alterations.
• Respiratory depression (slow and shallow breathing), especially if clonazepam is administered intravenously. The risk of respiratory depression is higher in patients with respiratory tract obstruction or previous brain damage. Respiratory depression can also occur when other central nervous system depressants are administered at the same time. This effect can usually be avoided with careful individual dose adjustment.
• Increased risk of falls and fractures in elderly patients and patients taking other sedatives (including alcoholic beverages) at the same time.
• Heart failure (heart does not pump blood well) and heart attack.
• Dependence and withdrawal syndrome.

When treatment is prolonged or high doses are used, reversible disorders such as: dysarthria (difficulty articulating words), ataxia (discoordination of voluntary movements), and double vision (diplopia) may appear.

In some forms of epilepsy, an increase in seizure frequency (convulsions) may occur during long-term treatment.

It is known that the use of benzodiazepines can cause anterograde amnesia (difficulty remembering recent events) and the risk of this side effect increases with the dose.

Other side effects in children:

• Increased salivation (excessive saliva production) and bronchial secretions in infants and young children, so it is essential to pay special attention to keeping the airways clear.
• Incomplete premature puberty (rapid body development) in children of both sexes.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in the original packaging.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the bottle.

The expiration date is the last day of the month indicated.

Once the bottle is opened, the contents must be used before 120 days.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rivotril

• The active principle is clonazepam (DCI). It is presented in a solution with 2.5 mg of active substance per ml (1 ml = 25 drops).
• The other components of the solution are sodium saccharin, peach aroma, glacial acetic acid, propylene glycol, and brilliant blue FCF (E 133).

Appearance of the product and contents of the packaging

Rivotril is presented in a packaging containing a 10 ml amber glass bottle (solution containing 2.5 mg per ml (1 drop = 0.1 mg of active substance)).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing:

Delpharm Milano S.r.l.

Via Carnevale, 1

20054, Segrate (MI), Italy

Local representative:

Laboratorios Rubió, S.A.

C/ Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet: November 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/