Package Insert: Information for the User

Rivotril 0.5 mg Tablets

Clonazepam

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Rivotril and how is it used

2. What you need to know before starting to take Rivotril

3. How to take Rivotril

4. Possible adverse effects

5. Storage of Rivotril

6. Contents of the package 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 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.

It may occur 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 your 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), mental health medications (neuroléptics), depression medications (antidepressants), or lithium,
• if you have drug or alcohol dependence problems,
• if you have had depression and/or 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 if 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 as much as possible, the following precautions should be taken:

• The use of benzodiazepines should be made only under medical prescription (never because they have worked in other patients) and never advise others.
• Do not increase the prescribed doses or prolong the treatment longer than recommended.
• Consult your doctor regularly so that they can 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 can cause symptoms such as drowsiness, dizziness, or visual disturbances, and can 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 lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

• Adults: the initial dose should not exceed 1.5 mg/day, divided into three doses. This dose can be increased by 0.5 mg every 3 days until the seizures are well controlled or the adverse effects prevent further dose increase. The maintenance dose should be adjusted for each patient. A maintenance dose of 3-6 mg per day is usually sufficient.

Never exceed the maximum adult dose of 20 mg per day.

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

Use in children and adolescents

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

The approximate maintenance dose is 0.1 mg/kg/day.

Never exceed the maximum dose of 0.2 mg/kg/day in infants and children under 10 years.

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

• Children and adolescents 10-16 years: the initial dose is 1-1.5 mg/day, divided into two or three doses. This dose can be increased by 0.25-0.5 mg every 3 days until the maintenance dose (usually 3-6 mg/day) is reached.

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

Guidelines for correct administration

Take the tablets with water or another non-alcoholic beverage.

The tablet can be divided into equal doses. The tablets are scored to allow for administration of lower doses. To divide the tablet, hold it with the score facing up and apply pressure downwards.

If you forget to take a dose, never take double the medication when it's time for the next dose. Simply continue with the usual dose at the next medication administration.

Do not change the dose indicated by your doctor.

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

Treatment duration

Your doctor will indicate when to discontinue treatment with Rivotril.

This treatment may last a lifetime, so if you want to stop taking Rivotril, always consult your doctor as stopping treatment abruptly 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 (sleepiness), respiratory depression, absence of reflexes, hypotension (low blood pressure), and stupor (reduced 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.

If you take more Rivotril than you should, contact your doctor immediately or go to the nearest hospital. Bring the medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, Telephone 91 562.04.20.

If you forget to take Rivotril

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

If you discontinue treatment with Rivotril

Stopping treatment may cause anxiety, insomnia, lack of concentration, headache, and sweating. It is generally not recommended to discontinue treatment abruptly, but rather taper off gradually, always following your 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, alterations in skin pigmentation (color).
• 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 disturbances, 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 simultaneously. This effect can usually be avoided by careful individual dose adjustment.
• Increased risk of falls and fractures in elderly patients and patients taking other sedatives (including alcoholic beverages) simultaneously.
• Heart failure (heart does not pump blood well) and myocardial infarction.
• 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 maintaining clear airways.
• 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.

Do not usethis medicationafter the expiration date that appears on the packaging.

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

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

Composition ofRivotril

• The active ingredient is clonazepam (DCI). Scored tablets with 0.5 mg of active ingredient.
• The other components are lactose monohydrate, cornstarch, pregelatinized starch (from potato), talc, magnesium stearate, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the product and contents of the packaging

Rivotril is presented in a box containing blister packs with 60 scored tablets.

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:

Recipharm Leganés S.L.U.

Calle Severo Ochoa 13

Leganés

28914 Madrid

Spain

Local representative:

Laboratorios Rubió, S.A.

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

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet:June 2019

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/