RIVOTRIL 2 mg Tablets

2. What you need to know before you take Rivotril

Do not take Rivotril

• if you are allergic (hypersensitive) to the active ingredient or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to other medicines of the benzodiazepine group
• if you have severe and persistent breathing difficulties (feeling of suffocation), 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 not sure about these aspects, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivotril.

A loss of effect may occur during treatment with Rivotril.

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

• if you suffer from any liver or kidney disease,
• if you are elderly, suffer from muscle weakness, sleep apnea, or have breathing difficulties (feeling of suffocation),
• if you have allergies,
• if you have porphyria (a disease that can affect the nervous system and make the skin very sensitive to the sun),
• if you have hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption,
• if you have other diseases,
• if you are taking other medicines, especially epilepsy medicines, sleep aids (hypnotics), pain relievers (analgesics), mental illness medicines (neuroleptics), depression medicines (antidepressants), or lithium,
• if you have drug or alcohol dependence problems,
• if you have had depression and/or have attempted suicide,
• if you have ataxia (lack of coordination of voluntary movements).

A small number of people who were being treated with antiepileptics such as Rivotril have had thoughts of self-harm or suicide. If at any time you 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 medicines

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

For example, tranquilizers, sleep aids, and other medicines that affect the central nervous system can increase the effect of Rivotril.

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

Your doctor may prescribe Rivotril along with other epilepsy medicines. In this case, your doctor will adjust the dose of each medicine to achieve the desired effect.

Taking Rivotril with alcohol

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

Risk of dependence

The use of benzodiazepines can lead to dependence, mainly when the medicine is taken continuously for a long time. To minimize this risk, the following precautions should be taken into account:

• The use of benzodiazepines will only be done under medical prescription (never because they have worked for other patients) and never advise them to other people.
• Do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.
• Consult your doctor regularly so that he can decide if the treatment should be continued.

Pregnancy and breastfeeding

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

Driving and using machines

Rivotril can produce symptoms such as drowsiness, dizziness, or changes in vision, and reduce your reaction ability. These effects, as well as the disease itself, can make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Rivotril contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Rivotril

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

Depending on your response to the medicine, the nature of your disease, and your weight, 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.

• 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 side effects prevent further dose increases. The maintenance dose should be adjusted for each patient. It is usually sufficient with a maintenance dose of 3-6 mg per day.

The maximum dose of 20 mg per day in adults should never be exceeded.

To facilitate dose adjustment, the use of 0.5 mg scored tablets is recommended 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 of 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 side effects prevent further dose increases.

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

The maximum dose of 0.2 mg/kg/day should never be exceeded 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.

• Children and adolescents from 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 is reached (usually 3-6 mg/day).

As with all epilepsy medicines, treatment with Rivotril should not be stopped abruptly, but rather gradually reduced.

Rules for correct administration

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

The tablet can be divided into equal doses. The tablets are scored to allow for the 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 a double dose to make up for the missed doses. Simply continue with the usual dose at the next administration.

DO NOTchange the dose indicated by your doctor.

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

Duration of treatment

Your doctor will indicate when you should finish treatment with Rivotril.

This treatment can last a lifetime, so if you want to stop taking Rivotril, you should always consult your doctor, as sudden cessation of treatment can cause withdrawal symptoms such as tremors.

If you take more Rivotril than you should

The symptoms of overdose or poisoning vary significantly from person to person, depending on age, weight, and individual response to the medicine. Symptoms can range from fatigue and dizziness to ataxia (lack of coordination of voluntary movements), somnolence (sleep), lack of reflexes, hypotension (low blood pressure), and stupor (low response to stimuli), and finally, coma with respiratory depression and circulatory failure. Seizures can occur, especially in patients with blood levels of the medicine above the recommended levels.

Treatment of poisoning will consist of monitoring (close surveillance) of breathing, heart rate, and blood pressure; gastric lavage, intravenous hydration, general support measures, and emergency measures in case of airway obstruction. In case of hypotension (low blood pressure), sympathomimetic medicines can be administered.

Warning:

The medicine flumazenil (benzodiazepine antagonist) is not indicated in epileptic patients treated with benzodiazepines. In these patients, flumazenil can cause seizures.

If you take more Rivotril than you should, contact your doctor immediately or go to the nearest hospital. Bring the medicine 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 make up for the missed doses.

If you stop taking Rivotril

When stopping the administration, restlessness, anxiety, insomnia, lack of concentration, headache, and sweating may appear. It is not recommended to stop the medication abruptly, but rather to gradually reduce the dose, always following the doctor's instructions.

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

4. Possible side effects

Like all medicines, Rivotril can cause side effects, although not everybody gets them.

The following side effects have been described:

• Involuntary and uncontrolled eye movement (nystagmus).
• Somnolence (sleep), slowness in reflexes, hypotonia, muscle weakness, dizziness, fatigue, ataxia (lack of coordination of voluntary movements). These side effects are usually transient and generally disappear without the need to interrupt treatment.
• Anterograde amnesia.
• Thrombocytopenia (decrease in the number of platelets).
• Urticaria (allergy), itching, skin rash (redness of the skin), temporary hair loss, changes in skin pigmentation (color).
• Headache.
• Nausea and epigastric discomfort (in the upper part of the stomach).
• Urinary incontinence (lack of control of urine).
• Impotence, decreased libido (decreased sexual desire).
• Allergic reactions and anaphylactic shock (severe allergic reaction).

• Generalized epileptic seizures.
• Decreased concentration, restlessness, confusion, disorientation.
• Emotional and mood changes.
• Depression, which may be due to an underlying disease.
• Paradoxical reactions (appearance of reactions contrary to those expected by the action of the medicine): restlessness, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disorders, delirium, anger, nightmares, intense dreams, hallucinations, psychosis, hyperactivity, behavioral changes.
• Respiratory depression (slow and shallow breathing), especially if clonazepam is administered intravenously. The risk of respiratory depression is higher in patients with airway obstruction or previous brain damage. Respiratory depression can also occur when other medicines that depress the respiratory center are administered at the same time. 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) at the same time.

• Heart failure (the 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 (lack of coordination of voluntary movements), and double vision (diplopia) may appear.

In some forms of epilepsy, an increase in the frequency of seizures (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 and bronchial secretions in infants and young children, so it is necessary to pay special attention to keeping the airways clear.
• Precocious puberty (rapid body development) in children of both sexes.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Rivotril

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

Do not use this medicine after the expiration date stated on the packaging.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivotril

• The active ingredient is clonazepam (DCI). Scored tablets with 2 mg of active ingredient.
• The other ingredients are anhydrous lactose, magnesium stearate, pregelatinized starch (from corn), and microcrystalline cellulose.

Appearance of the product and packaging contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer:

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

Date of the last revision of this leaflet:June 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/