CLORAZEPATE NORMON 10 mg HARD CAPSULES

2. What you need to know before taking Clorazepate Normon

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

In case you get up at night, after taking a hypnotic (a medicine that induces sleep), you may experience a slow response to stimuli with the consequent risk of falls and dizziness.

Do not take Clorazepate Normon

• if you are allergic to the active ingredient (clorazepate dipotassium) or to any of the other components of this medicine (listed in section 6),
• if you are allergic to a group of medicines called benzodiazepines,
• if you have myasthenia gravis (a muscular problem characterized by abnormal weakness of the voluntary muscles),
• if you have severe liver failure (severe liver alteration),
• if you have severe respiratory failure (difficulty breathing),
• if you have decompensated respiratory failure (an increase in your usual difficulty breathing),
• if you have sleep apnea syndrome (a disorder characterized by episodes of suspended breathing during sleep),
• administration to children: The 10 mg capsules should not be administered to children.

Warnings and precautions

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

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

In case of developing physical dependence, the abrupt interruption of treatment can produce a withdrawal syndrome that manifests as headache or muscle pain, anxiety, muscle tension, restlessness, agitation, confusion, insomnia, and irritability. In severe cases, the following symptoms have been described: depersonalization, hyperacusis, paresthesia, and cramps in the limbs, intolerance to light, sounds, and physical contact, tremors, hallucinations, or convulsions.

Consult your doctor or pharmacist if such symptoms appear. Your doctor will indicate 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 until you stop treatment.

Some tolerance may develop after prolonged use of this medicine.

This medicine can induce anterograde amnesia, especially if used at bedtime and when sleep duration is short. To reduce this risk, you should ensure that you will be able to sleep uninterrupted for 7-8 hours.

When stopping treatment, the symptoms that made the treatment necessary (rebound insomnia and anxiety) may reappear. This is a transient phenomenon that may be accompanied by mood changes, anxiety, restlessness, or sleep disorders. It is more likely to appear if treatment is interrupted abruptly, so it should be gradually reduced.

Elderly people are more susceptible to adverse reactions such as somnolence, dizziness, muscle weakness, which can cause falls and therefore serious injuries (see section "4. Possible side effects"). In these cases, a dose reduction is recommended.

Psychiatric and paradoxical reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inadequate behavior, and other adverse effects on behavior may appear. In this case, you should consult your doctor about stopping treatment. These reactions are more frequent in children and elderly patients.

You should avoid using this medicine in combination with sodium oxybate, due to the risk of respiratory problems (respiratory depression).

Do not take Clorazepate Normon at the same time as opioids (medicines used to relieve intense pain, such as morphine or codeine) unless your doctor prescribes it, 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 and depression, you should use it with extreme caution. Consult your doctor before using this medicine, as it may unmask existing depression. Some studies have shown an increased risk of suicidal ideation, suicide attempt, 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 additional medical advice.

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

• depression or anxiety associated with depression (it could precipitate suicide in these patients),
• psychotic disorders,
• respiratory problems,
• liver diseases, the use of benzodiazepines can cause encephalopathy,
• history of alcohol or drug abuse, as it is not recommended to consume alcoholic beverages during treatment,
• kidney problems, a dose reduction may be necessary,
• muscle weakness.

Use of Clorazepate Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may use any other medicines.

You should be especially careful with medicines that act on the central nervous system, as these medicines can increase central depression and this could have consequences on your ability to drive or use machines.

You should be especially careful if you are being treated with the following medicines:

• alcohol: you should avoid medicines that contain alcohol, as the sedative effect may be enhanced, which can affect your ability to drive or use machines,
• hypnotics: medicines to induce sleep,
• anxiolytics/sedatives: medicines to treat anxiety,
• non-benzodiazepine tranquilizers,
• antidepressants: medicines to treat depression,
• antipsychotics: medicines for the treatment of psychoses,
• narcotic analgesics: medicines for the treatment of pain,
• antiepileptics: medicines to treat epilepsy,
• anesthetics,
• sedating H1 antihistamines: medicines to treat allergies,
• morphine derivatives: used to treat pain and cough,
• barbiturates: medicines that produce sedation of the central nervous system,
• clonidine: a medicine that lowers blood pressure, and related substances,
• cisapride: a medicine to treat gastroesophageal reflux,
• clozapine: a medicine to treat psychoses,
• medicines that inhibit certain liver enzymes (cytochrome P450),
• opioid medicines: the use of Clorazepate Normon at the same time as opioids (medicines used to relieve intense pain, such as morphine or codeine) can increase the risk of sedation, respiratory depression, coma, and even death. Your doctor will decide whether you can use them or not at the same time (see section "Warnings and precautions"),
• neuromuscular depressants such as muscle relaxants, curariform agents.

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

Use of Clorazepate Normon with food, drinks, and alcohol

You should avoid consuming alcohol 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 are limited data on the use of clorazepate dipotassium in pregnant women. Therefore, it is not recommended to use this medicine during pregnancy and in women of childbearing age who do not use contraceptives.

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

If you take clorazepate dipotassium during the last three months of pregnancy or during childbirth at high doses, the newborn may experience somnolence (sedation), respiratory problems (respiratory depression), muscle weakness (hypotonia), decreased body temperature (hypothermia), and difficulty feeding (problems with lactation causing low weight gain).

If you take it regularly at the end of pregnancy, your baby may experience withdrawal symptoms.

In this case, the newborn should be closely monitored during the postnatal period.

Breastfeeding

You should not take this medicine during breastfeeding, as it passes into breast milk.

Driving and using machines

Clorazepate dipotassium can alter your ability to drive or operate machinery, as it can cause somnolence, reduce your attention, or reduce your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

You should pay special attention to driving and using machines due to the risk of somnolence, amnesia, altered concentration, and muscle function associated with the use of this medicine. The combination with other medicines can enhance its sedative effect.

Additionally, insufficient sleep periods can increase the deterioration of the state of alertness (see section "Use of Clorazepate Normon with other medicines").

3. How to take Clorazepate Normon

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

The duration of this treatment is limited. Your doctor will indicate the duration of your treatment with Clorazepate Normon. Do not stop treatment before, nor interrupt it abruptly, in order to avoid the possibility of a withdrawal syndrome or rebound insomnia (see "Warnings and precautions").

The route of administration of Clorazepate Normon is oral.

• Adults: The usual dose ranges from 5 to 30 mg of clorazepate dipotassium per day, which means a maximum daily dose of 3 capsules (30 mg of clorazepate dipotassium) of Clorazepate Normon.

It can be administered in divided doses or in a single dose, preferably before bedtime.

The presentation that best suits the prescribed dose can be used (see "Other presentations").

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

If you take more Clorazepate Normon than you should

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

Deep sleep is the main sign of an overdose, which can even become a coma, depending on the dose ingested.

In moderate cases, the symptoms include somnolence, confusion, and lethargy; in more severe cases, ataxia (loss of coordination), hypotonia, hypotension (decreased blood pressure), respiratory depression, rarely coma, and very rarely death.

The prognosis is positive, and overdose does not represent a vital threat, at least in the absence of combination with other central depressants (psychotropic agents, alcohol) and as long as the subject is treated.

In case of overdose, the patient should be taken to a specialized center and the usual precautions should be taken: inducing vomiting, gastric lavage, and monitoring of respiratory and cardiovascular parameters. If there is no improvement with stomach emptying, activated charcoal will be administered to reduce absorption.

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

If you have taken more Clorazepate Normon than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Clorazepate Normon

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

If you stop treatment with Clorazepate Normon

Abrupt interruption of treatment can produce a withdrawal syndrome that manifests as headache or muscle pain, anxiety, muscle tension, restlessness, confusion, insomnia, and irritability (see section "Warnings and precautions").

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

4. Possible Adverse Effects

Like all medicines, Clorazepato Normon can cause adverse effects, although not all people suffer from them.

Adverse effects are presented grouped by organ and system classification and by frequency:

Very frequent: may affect more than 1 in 10 patients

Frequent: 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 the dose and individual patient sensitivity.

Immune System Disorders:

• Uncommon: hypersensitivity reactions.

Psychiatric Disorders:

• Frequency not known: slow thinking, reduction of mental reflexes (bradypnea).
• In some patients (particularly children and elderly patients), paradoxical reactions may be observed (see also the "Warnings and Precautions" section):

Uncommon: irritability, agitation, confusion.

Frequency not known: aggression, hallucination.

• Frequency not known: rebound syndrome with worsening of the anxiety that motivated this treatment may appear.
• Frequency not known: prolonged use (especially at high doses) may lead to the development of physical dependence, and withdrawal of treatment leads to withdrawal syndrome (see "Warnings and Precautions" section). This occurs more rapidly with short-half-life benzodiazepines than with long-half-life benzodiazepines (several days).

Nervous System Disorders:

• Very frequent: somnolence (particularly in elderly patients and especially during the day if used as a hypnotic).
• Frequent: 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 a higher risk when increasing the dose. Amnestic effects may be associated with inappropriate behavior (see "Warnings and Precautions" section), attention impairment, and speech disorders.

Ocular Disorders:

• Frequency not known: double vision (diplopia).

Skin and Subcutaneous Tissue Disorders:

• Uncommon: skin rash with itching, spots, and papules (pruritic and maculopapular skin rash).

General Disorders and Administration Site Conditions:

• Frequent: asthenia.
• Frequency not known: falls (see "Warnings and Precautions" section).

Additionally, the following adverse effects have been reported with benzodiazepines: emotional bluntness, reduced alertness, headache, loss of movement coordination (ataxia), gastrointestinal disorders, changes in sexual appetite (changes in libido), and amnestic effects that may be associated with inappropriate behavior.

Psychiatric or paradoxical reactions with restlessness, delirium, rage, nightmares, psychosis, and inappropriate behavior and other behavioral adverse effects.

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

Dependence: administration of the product (even at therapeutic doses) may lead to the development of physical dependence: suppression of treatment may lead to the development of withdrawal or rebound phenomena (see "Warnings and Precautions" section). This occurs more rapidly with short-half-life benzodiazepines than with long-half-life benzodiazepines (several days).

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Clorazepato Normon

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

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

Do not use Clorazepato Normon after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Clorazepato Normon

The active ingredient is clorazepate dipotassium. Each capsule contains 10 mg of clorazepate dipotassium.

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

Appearance of the Product and Package Contents

Clorazepato Normon 10 mg hard capsules are presented in the form of pink/pink capsules.

Each package contains 30 capsules or 500 capsules (clinical package).

Other Presentations

Clorazepato Normon NORMON 5 mg hard capsules EFG

Clorazepato 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 Last Revision of this Prospectus:June 2024

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