Clorazepate Normon 15 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clorazepate Normon 15 mg hard capsules EFG

Potassium clorazepate

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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• 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Clorazepate Normon is and what it is used for
2. What you need to know before taking Clorazepate Normon
3. How to take Clorazepate Normon
4. Possible adverse effects
5. How to store Clorazepate Normon
6. Contents of the pack and other information

1. What Clorazepato Normon is and what it is used for

Clorazepato Normon is a medicine that belongs to the group of tranquilizers, anxiolytics, and derivatives of benzodiazepines.

It is indicated for all manifestations of anxiety that may occur in everyday psychological disorders, when the intensity does not reach a psychiatric level:

• Anxiety states, isolated or associated with an illness (organic condition), with or without insomnia.
• Depressive states伴有 an anxiety component, ranging from restlessness to anguish.
• Behavioral disorders due to anxiety: irritability and personality disturbances, hyperemotionality (exaggerated emotional response), and affective conflicts.
• Sleep disorders: insomnia, nocturnal anxiety, anxiety upon waking.
• Neurovegetative dystonias (dysfunction of autonomic nervous centers) of various localizations and moderate intensity.
• Anxiety in elderly (senile) individuals and in severely ill patients.
• Anxiety in menopausal women.
• Anxiety related to the prescription of a surgical procedure.
• Post-traumatic stress syndrome (anxiety problems due to a past trauma).

In general, isolated anxiety or anguish, or associated with depressive states.

2. What you need to know before starting to take Clorazepate Normon

Before taking this medicine, you must ensure that you will be able to sleep uninterrupted for 7–8 hours.

If you get up during the night after taking a hypnotic (a medicine that induces sleep), you may experience slowed responses, increasing the risk of falls and dizziness.

Do not take Clorazepate Normon

• if you are allergic to the active substance (potassium clorazepate) or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to a group of medicines called benzodiazepines,
• if you have myasthenia gravis (a muscle disorder characterized by abnormal weakness of voluntary muscles),
• if you have severe hepatic insufficiency (serious liver impairment),
• if you have severe respiratory insufficiency (difficulty breathing),
• if you have decompensated respiratory insufficiency (worsening of your usual breathing difficulty),
• if you have sleep apnea syndrome (a disorder characterized by episodes of breathing cessation during sleep),
• pediatric administration: The 15 mg capsules must not be administered to children.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Clorazepate Normon.

The use of this type of medicine may lead to the development of physical and psychological dependence. The risk of dependence increases with dose, duration of treatment, combination with alcohol or certain medicines (anxiolytics, hypnotics, psychotropic drugs), or if you have a history of dependence (to medicines or other substances).

If physical dependence develops, abruptly stopping treatment may cause a withdrawal syndrome characterized by headache or muscle pain, marked anxiety, muscle tension, restlessness, agitation, confusion, insomnia, and irritability. In severe cases, the following symptoms have been reported: depersonalization, hyperacusis, tingling and cramps in the limbs, intolerance to light, sound, and physical contact, tremor, hallucinations, or seizures.

Consult your doctor or pharmacist if you experience any of these symptoms. Your doctor will advise you on the duration of your treatment (which should not exceed 4 to 12 weeks) and the precise way in which you should gradually reduce the dose before stopping treatment.

Tolerance may develop after prolonged use of this medicine.

This medicine may cause anterograde amnesia, especially if taken at bedtime and when sleep duration is short. To reduce this risk, ensure that you will be able to sleep uninterrupted for 7–8 hours.

When treatment is discontinued, the symptoms that led to treatment (rebound insomnia and anxiety) may reappear. This is a temporary phenomenon that may be accompanied by mood changes, anxiety, restlessness, or sleep disturbances. This is more likely to occur if treatment is stopped abruptly; therefore, treatment should be gradually tapered off.

Elderly patients are more susceptible to adverse reactions such as drowsiness, dizziness, and muscle weakness, which may lead to falls and thus serious injuries (see section “4. Possible side effects”). In such cases, dose reduction is recommended.

Psychiatric and paradoxical reactions may occur, such as restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. In such cases, consult your doctor about discontinuing treatment. These reactions are more frequent in children and elderly patients.

You must avoid using this medicine together with sodium oxybate due to the risk of respiratory problems (respiratory depression).

Do not take Clorazepate Normon together with opioids (medicines used to relieve severe pain, such as morphine or codeine) unless prescribed by your doctor, due to the possible risk of sedation, respiratory depression, coma, or even death (see “Use of Clorazepate Normon with other medicines”).

If you have suicidal tendencies or depression, this medicine must be used with extreme caution. Consult your doctor before using this medicine, as it may unmask an existing depression. Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.

Also consult your doctor if you have any of the following conditions:

• depression or anxiety associated with depression (may precipitate suicide in these patients),
• psychotic disorders,
• respiratory problems,
• liver disease, as the use of benzodiazepines may cause encephalopathy,
• history of alcohol or drug abuse, as consumption of alcoholic beverages is not recommended during treatment,
• kidney problems, which may require dose reduction,
• muscle weakness.

Use of Clorazepate Normon with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

Exercise particular caution with medicines that act on the central nervous system, as they may increase central depression, which could affect your ability to drive or operate machinery.

Be especially careful if you are taking any of the following medicines:

• alcohol: avoid medicines containing alcohol, as the sedative effect may be enhanced, affecting your ability to drive or operate machinery,
• hypnotics: medicines used to induce sleep,
• anxiolytics/sedatives: medicines used to treat anxiety,
• non-benzodiazepine tranquilizers,
• antidepressants: medicines used to treat depression,
• antipsychotics: medicines used to treat psychosis,
• narcotic analgesics: medicines used to treat pain,
• antiepileptics: medicines used to treat epilepsy,
• anesthetics,
• sedating H1 antihistamines: medicines used to treat allergies,
• morphine derivatives: used to treat pain and cough,
• barbiturates: medicines that cause central nervous system sedation,
• clonidine: a medicine that lowers blood pressure, and related substances,
• cisapride: a medicine used to treat gastroesophageal reflux,
• clozapine: a medicine used to treat psychosis,
• medicines that inhibit certain liver enzymes (cytochrome P450),
• opioid medicines: using Clorazepate Normon together with opioids (medicines used to relieve severe pain, such as morphine or codeine) may increase the risk of sedation, respiratory depression, coma, and even death. Your doctor will decide whether you can use them together (see section “Warnings and precautions”),
• neuromuscular blockers such as muscle relaxants, curare derivatives.

The risk of developing a withdrawal syndrome increases when Clorazepate Normon is combined with benzodiazepines prescribed as anxiolytics or hypnotics.

Use of Clorazepate Normon with food, drinks, and alcohol

Alcohol intake must be avoided while taking this medicine. See section “Use of Clorazepate Normon with other medicines: alcohol”.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

There is limited data on the use of potassium clorazepate in pregnant women. Therefore, the use of this medicine during pregnancy and in women of childbearing age who are not using contraception is not recommended.

If you discover you are pregnant or are planning to have a baby, consult your doctor immediately to reassess the need for treatment.

If you take potassium clorazepate during the last three months of pregnancy or during delivery at high doses, the newborn may experience drowsiness (sedation), breathing problems (respiratory depression), muscle weakness (hypotonia), decreased body temperature (hypothermia), and feeding difficulties (lactation problems leading to poor weight gain).

If taken regularly towards the end of pregnancy, your baby may experience withdrawal symptoms.

In such cases, the newborn should be closely monitored during the postnatal period.

Breastfeeding

This medicine should not be taken during breastfeeding, as it passes into breast milk.

Driving and use of machines

Potassium clorazepate may impair your ability to drive or operate machinery, as it may cause drowsiness, reduced attention, or decreased reaction capacity. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Exercise particular caution when driving or operating machinery due to the risk of drowsiness, amnesia, concentration impairment, and muscle function disturbances associated with this medicine. The combination with other medicines may enhance its sedative effect.

In addition, insufficient sleep periods may increase impairment of alertness (see section “Use of Clorazepate Normon with other medicines”).

3. How to take Clorazepato Normon

Follow exactly the instructions for the administration of Clorazepato Normon as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The duration of this treatment is limited. Your doctor will inform you about the duration of your treatment with Clorazepato Normon. Do not stop the treatment prematurely or interrupt it abruptly, in order to avoid the possible occurrence of withdrawal syndrome or rebound insomnia (see "Warnings and precautions").

The route of administration of Clorazepato Normon is oral.

Adults: The usual dose ranges between 5 and 30 mg of clorazepate dipotassium per day, which means

• a maximum daily dose of 2 capsules (30 mg of dipotassium clorazepate) of Clorazepato Normon.

It may be administered in divided doses or as a single dose, preferably before going to bed.

You may use the presentation that best matches the prescribed dose (see "Other presentations").

• In elderly patients and in patients with liver (hepatic insufficiency) and/or kidney (renal insufficiency) problems, a reduced dose is recommended: for example, half the average dose may be sufficient.

If you take more Clorazepato Normon than you should

Overdose is usually manifested by varying degrees of central nervous system depression, ranging from drowsiness (sleepiness) to coma.

Deep sleep is the main sign of overdose, which may even progress to coma, depending on the ingested dose.

In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, ataxia (loss of coordination of movements), hypotonia, hypotension (decrease in blood pressure), respiratory depression, and rarely coma, and very rarely death may occur.

The prognosis is favorable; overdose does not represent a life-threatening risk, at least in the absence of combination with other central depressants (psychotropic agents, alcohol), provided the patient receives appropriate treatment.

In case of overdose, the patient should be transferred to a specialized center and standard precautionary measures taken: induction of vomiting, gastric lavage, and monitoring of respiratory and cardiovascular parameters. If no improvement occurs after gastric emptying, activated charcoal should be administered to reduce absorption.

Flumazenil may be used for diagnosis and/or treatment of overdose as an antidote.

If you have taken more Clorazepato Normon than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Clorazepato Normon

Do not take a double dose to make up for forgotten doses.

If you stop taking Clorazepato Normon

Abrupt discontinuation of treatment may cause withdrawal syndrome, manifested by headache or muscle pain, anxiety, muscle tension, restlessness, confusion, insomnia, and irritability (see section "Warnings and precautions").

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

4. Possible adverse effects

Like all medicines, Clorazepate Normon may cause adverse effects, although not everyone experiences them.

Adverse effects are grouped according to organ systems and their frequency:

Very common: may affect more than 1 in 10 patients
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
Rare: may affect up to 1 in 1,000 patients
Very rare: may affect up to 1 in 10,000 patients
Frequency not known: cannot be estimated from available data.

Adverse effects are related to dose and individual patient sensitivity.

Immune system disorders:

• Uncommon: hypersensitivity reactions.

Psychiatric disorders:

• Frequency not known: slowed thinking, reduced mental reflexes (bradypsychia).
• In some patients (particularly children and elderly patients), paradoxical reactions may occur (see also section “Warnings and precautions”):

Uncommon: irritability, agitation, confusion.
Frequency not known: aggression, hallucination.

• Frequency not known: rebound syndrome may occur, with worsening of the anxiety that prompted this treatment.
• Frequency not known: prolonged use (especially at high doses) may lead to physical dependence, and discontinuation of treatment may result in withdrawal syndrome (see section “Warnings and precautions”). This occurs more rapidly with short-acting benzodiazepines than with long-acting benzodiazepines (several days).

Nervous system disorders:

• Very common: drowsiness (particularly in elderly patients and especially during the day if used as a hypnotic).
• Common: dizziness.
• Uncommon: decreased muscle tone (muscle hypotonia).
• Frequency not known: cognitive disorders such as memory impairment (anterograde amnesia). Anterograde amnesia may develop when using therapeutic doses, with increased risk at higher doses. Amnesic effects may be associated with inappropriate behaviors (see section “Warnings and precautions”), attention disturbances, and speech disorders.

Eye disorders:

• Frequency not known: double vision (diplopia).

Skin and subcutaneous tissue disorders:

• Uncommon: itchy rash with spots and papules (pruritic maculopapular rash).

General disorders and administration site conditions:

• Common: asthenia.
• Frequency not known: falls (see section “Warnings and precautions”).

The following adverse effects have also been reported with benzodiazepines: emotional blunting, reduced alertness, headache, loss of motor coordination (ataxia), gastrointestinal disturbances, changes in sexual desire (changes in libido), and amnesic effects that may be associated with inappropriate behaviors.

Psychiatric or paradoxical reactions such as restlessness, delusions, rage attacks, nightmares, psychosis, and inappropriate behaviors, as well as other adverse behavioral effects.

Depression: the use of benzodiazepines may unmask pre-existing depression.

Dependence: administration of the product (even at therapeutic doses) may lead to physical dependence; discontinuation of treatment may result in withdrawal or rebound phenomena (see section “Warnings and precautions”).

Psychological dependence may occur. Cases of benzodiazepine abuse have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clorazepate Normon

Keep this medicine out of sight and reach of children.

Store below 25°C. Keep in the original packaging to protect from light and moisture.

Do not use Clorazepate Normon after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clorazepate Normon

The active substance is potassium clorazepate. Each capsule contains 15 mg of potassium clorazepate.

The other components (excipients) are: potassium carbonate, talc, and dibasic calcium phosphate. The gelatin capsule consists of: gelatin, titanium dioxide (E-171), erythrosine (E-127), and indigo carmine (E-132).

Appearance of the product and contents of the pack

Clorazepate Normon 15 mg hard capsules are presented as pink/blue capsules.

Each pack contains 20 capsules or 500 capsules (hospital pack).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Clorazepate Normon 5 mg hard capsules EFG

Clorazepate Normon 10 mg hard capsules EFG

Date of the most recent revision of this leaflet: June 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es//