Clorazepate Normon 10 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clorazepate Normon 10 mg hard capsules EFG

Potassium clorazepate

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

Leaflet contents:

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 benzodiazepine derivatives.

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

• States of anxiety, isolated or associated with an illness (organic condition), with or without insomnia.
• Depressive states伴有 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 locations and moderate intensity.
• Anxiety in elderly (senile) persons 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 taking 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 a delayed response to stimuli, 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 (severe breathing difficulties),
• if you have decompensated respiratory insufficiency (worsening of your usual breathing difficulties),
• if you have sleep apnoea syndrome (a disorder characterized by episodes of breathing cessation during sleep),
• administration to children: The 10 mg capsules must not be given 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 physical and psychological dependence. The risk of dependence increases with dose, duration of treatment, concomitant use of alcohol or certain medicines (anxiolytics, hypnotics, psychotropic agents), or if you have a history of substance 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, tension, muscle stiffness, 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, or physical contact, tremor, hallucinations, or seizures.

If you experience any of these symptoms, consult your doctor or pharmacist. Your doctor will advise you on the duration of your treatment (which should not exceed 4 to 12 weeks) and on how to gradually reduce the dose before stopping treatment.

Tolerance may develop with 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 you can sleep uninterrupted for 7–8 hours.

When stopping treatment, 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.

Elderly patients are more susceptible to adverse reactions such as drowsiness, dizziness, and muscle weakness, which may lead to falls and 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, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behaviour, and other adverse behavioural effects. If any of these occur, consult your doctor about stopping treatment. These reactions are more common in children and elderly patients.

Avoid concomitant use of this medicine 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, use this medicine with extreme caution. Consult your doctor before using it, 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 is not established whether this is caused by the medicine or if other factors may be involved. 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 benzodiazepines may cause encephalopathy,
• history of alcohol or drug abuse, since consumption of alcoholic beverages is not advised during treatment,
• kidney problems, which may require dose reduction,
• muscle weakness.

Use of Clorazepate Normon with other medicines

Tell your doctor or pharmacist if you are currently using, have recently used, or might need to use 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 to induce sleep,
• anxiolytics/sedatives: medicines for treating anxiety,
• non-benzodiazepine tranquillizers,
• antidepressants: medicines for treating depression,
• antipsychotics: medicines for treating psychosis,
• narcotic analgesics: medicines for pain relief,
• antiepileptics: medicines for treating epilepsy,
• anaesthetics,
• sedating H1 antihistamines: medicines for treating allergies,
• morphine derivatives: used for treating pain and cough,
• barbiturates: medicines causing central nervous system sedation,
• clonidine: a medicine that lowers blood pressure, and related substances,
• cisapride: a medicine for treating gastro-oesophageal reflux,
• clozapine: a medicine for treating 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 and curare-like agents.

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

Avoid drinking alcohol while taking this medicine. See section “Use of Clorazepate Normon with other medicines: alcohol”.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 potential 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), low body temperature (hypothermia), and feeding difficulties (feeding 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 time. 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 using machines due to the risk of drowsiness, amnesia, impaired concentration, and impaired muscle function associated with this medicine. The combination with other medicines may enhance its sedative effect.

Additionally, insufficient sleep periods may worsen alertness (see section “Use of Clorazepate Normon with other medicines”).

3. How to take Clorazepato Normon

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

The duration of this treatment is limited. Your doctor will indicate how long you should take Clorazepato Normon. Do not stop the treatment early, nor interrupt it abruptly, to avoid the possibility 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 potassium clorazepate per day, corresponding to a maximum daily dose of 3 capsules (30 mg of potassium clorazepate) of Clorazepato Normon.

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

The presentation best suited to the prescribed dose may be used (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 an overdose, which may even progress to coma, depending on the dose ingested.

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

The prognosis is favorable; overdose does not represent a life-threatening condition, at least when not combined with other central depressants (psychotropic agents, alcohol), and provided appropriate treatment is given.

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 number: 91 562 04 20, indicating the medication and 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

Abruptly stopping 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 produce 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 the 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 (muscular 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 skin 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”).

Additionally, the following adverse effects have 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 which may be associated with inappropriate behaviors.

Paradoxical or psychiatric 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 a 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 the 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 drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Clorazepate Normon

The active substance is potassium clorazepate. Each capsule contains 10 mg of potassium clorazepate.

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

Appearance of the product and contents of the package

Clorazepate Normon 10 mg hard capsules are supplied as pink/pink capsules.

Each package contains 30 capsules or 500 capsules (hospital pack).

Other presentations

Clorazepate Normon Normon 5 mg hard capsules EFG

Clorazepate Normon Normon 15 mg hard capsules EFG

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review 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/