KETAZOLAM ADAMED 45 mg HARD CAPSULES

2. What you need to know before you take Ketazolam Adamed

Do not take Ketazolam Adamed:

• if you are allergic to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe myasthenia (a disease characterized by an abnormal degree of muscle weakness).
• if you have severe respiratory failure (e.g., severe chronic obstructive pulmonary disease).
• if you have sleep apnea (a condition characterized by episodes of brief respiratory arrest that occur during sleep).
• if you have severe liver failure.
• In case of pregnancy or breastfeeding (see section 2, pregnancy and breastfeeding).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

• you have chronic respiratory failure, as you should receive a lower dose than usual.
• you have severe kidney failure.
• if you have epilepsy, as a seizure may occur if treatment with Ketazolam Adamed is suddenly interrupted.

Tolerance

• After continuous use for several weeks, a certain degree of loss of efficacy may be detected.
• In the presence of ketazolam, tolerance to other CNS depressants may decrease; these substances should be avoided or taken in reduced doses.

Dependence

• Ketazolam may induce physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is also higher in patients with a history of drug or alcohol abuse. Stopping treatment abruptly may be accompanied by withdrawal symptoms, such as headache, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and rebound phenomena (temporary reappearance of symptoms that led to treatment initiation). It may be difficult to distinguish between these symptoms and the original symptoms for which the medicine was prescribed.

Follow your doctor's instructions for taking Ketazolam Adamed exactly to avoid these symptoms as much as possible.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient reappearance of symptoms that led to treatment initiation). This episode may be accompanied by other reactions, such as mood changes, anxiety, or sleep disturbances and restlessness. The likelihood of a withdrawal/rebound syndrome is higher after abrupt treatment discontinuation, so it is recommended to gradually decrease the dose until definitive suppression. Follow your doctor's recommendations for use and administration instructions for Ketazolam Adamed 15 mg exactly to avoid these symptoms as much as possible.

Amnesia

• Ketazolam may induce anterograde amnesia, i.e., difficulty remembering recent events. To minimize this risk, you should ensure that you can sleep uninterrupted for 7-8 hours (see section 4). Under normal conditions, you should not take more than 20 minutes to fall asleep after taking Ketazolam Adamed.

Psychiatric and paradoxical reactions

• Ketazolam may cause restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral changes. These reactions occur more frequently in children, elderly patients, and patients with organic brain syndrome (physical disorders that produce a decrease in mental functions). Your doctor will discontinue treatment with Ketazolam Adamed if these reactions occur.
• Ketazolam should not be used as a first-line treatment for psychotic illness.
• A pre-existing depression may be masked during treatment with Ketazolam Adamed. In these patients, there is a risk of suicide (see section 4).

Other warnings

• Your doctor may perform blood tests or liver function tests if necessary, as this medicine may cause changes in blood and/or liver function.
• It should be used with caution in patients with narrow-angle glaucoma (an eye disorder that can cause damage to the optic nerve due to a rapid and intense increase in pressure inside the eye).

Use in children and adolescents

The use of ketazolam is not recommended in children under 18 years of age.

Use in elderly patients

Elderly patients should receive a lower dose than usual. Your doctor will recommend the most suitable dose (see section 3).

Use of Ketazolam Adamed with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

The effect of ketazolam may be potentiated when administered with the following medicines:

• Antipsychotics (neuroleptics, medicines used in the treatment of psychiatric disorders).
• Hypnotics (medicines that improve sleep initiation and duration).
• Anxiolytics/sedatives (medicines used for the treatment of anxiety).
• Antidepressants (medicines used for the treatment of depression).
• Opioid analgesics (certain medicines that reduce pain). These analgesics may produce an increased feeling of euphoria when administered with ketazolam, which can increase psychological dependence.
• Antiepileptics (medicines used in the treatment of epilepsy and convulsions). On the other hand, ketazolam reduces the effect of anticonvulsants, so your doctor may consider it necessary to adjust the dose of these medicines.
• Anesthetics (medicines used generally in surgical interventions to reduce pain and/or consciousness).
• Sedating antihistamines (medicines used primarily for the treatment of allergic symptoms).
• Medicines that inhibit certain liver enzymes (particularly cytochrome P450) may potentiate the activity of ketazolam.

If you are taking other medicines, consult your doctor.

Taking Ketazolam Adamed with food, drinks, and alcohol

Avoid alcoholic beverages during treatment. The effect of alcohol may potentiate sedation, which can affect your ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Pregnancy and breastfeeding

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.

As a general precaution, you should not use ketazolam during pregnancy, childbirth, or breastfeeding.

Children born to mothers who take benzodiazepines chronically during the last trimester of pregnancy may develop physical dependence and trigger withdrawal syndrome in the postnatal period. If, due to strict medical necessity, the medicine is administered during the third trimester of pregnancy or at high doses during childbirth, it is likely that effects on the newborn, such as hypothermia, hypotonia, and moderate respiratory depression, may occur.

Because benzodiazepines pass into breast milk, their use is contraindicated in breastfeeding mothers.

Driving and using machines

Ketazolam may alter your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce your reaction capacity. The occurrence of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

3. How to take Ketazolam Adamed

Follow your doctor's or pharmacist's instructions for taking this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with Ketazolam Adamed, but in general, the total treatment duration should not exceed 8-12 weeks, including gradual withdrawal, although in certain cases your doctor may extend treatment beyond the recommended period, depending on your needs. Do not stop treatment even if you feel better.

Take Ketazolam Adamed just before bedtime and swallow the capsule without chewing it with a glass of water.

The recommended dose is:

Anxiety

• Adults: the dose ranges from 15 mg to 75 mg per day, usually administered in a single dose at night, although it can also be divided into several doses throughout the day. The usual dose is 30-45 mg per day.
• Elderly patients: initially 15 mg per day, which can be increased according to the patient's needs and tolerance.

Muscle spasms

• Adults: doses range from 30 mg to 60 mg per day.
• Elderly patients: initially 15 mg per day, which can be increased according to the patient's needs and tolerance.

Generally, the prescribed doses should not exceed the indicated limits unless your doctor prescribes a higher dose. Never change the dose yourself.

Use in children

The administration of ketazolam is not recommended in children.

If you take more Ketazolam Adamed than you should

Overdose is not life-threatening unless it is combined with other central nervous system depressants (including alcohol). In case of overdose, consider the possibility that the patient may have taken other medicines or products.

Overdose with benzodiazepines usually manifests as different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, ataxia (alteration of movement coordination), hypotonia (decrease in muscle tone), low blood pressure, respiratory depression, rarely coma, and very rarely death.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ketazolam Adamed

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

If you stop taking Ketazolam Adamed

To avoid withdrawal symptoms, do not stop taking Ketazolam Adamed abruptly, especially if you have been taking it for a long time.

When stopping treatment, the symptoms that led you to take the medicine may reappear, and you may experience anxiety, insomnia, headache, and sweating. Your doctor will indicate exactly how to gradually decrease the dose.

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

4. Possible side effects

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

Most patients tolerate ketazolam well, but some, especially at the start of treatment, may experience drowsiness during the day, emotional disturbances, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, altered movement coordination, or double vision. Occasionally, gastrointestinal disorders, changes in libido, or skin reactions may occur.

You may develop anterograde amnesia, i.e., you may not remember what happened while you were awake after taking the medicine. Therefore, you should ensure that you can rest for at least 7 hours without being disturbed.

The use of benzodiazepines like ketazolam may mask a pre-existing depression. If you have thoughts of self-harm or suicide at any time, contact your doctor immediately.

When using ketazolam, restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral changes may occur. If this happens, consult your doctor immediately.

The administration of ketazolam may induce physical and psychological dependence; treatment discontinuation may induce withdrawal or rebound phenomena (see section 2, Warnings and precautions). Cases of abuse have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es).

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketazolam Adamed

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and further information

Composition of Ketazolam Adamed

• The active substance is ketazolam. Each capsule contains 45 mg of ketazolam.
• The other ingredients are hydrogenated vegetable oil and calcium carboxymethylcellulose.

Appearance of the product and pack contents

Ketazolam Adamed 45 mg are hard gelatin capsules with a dark green opaque cap and a dark green opaque body. The contents of the capsules are a white or off-white powder.

Ketazolam Adamed 45 mg hard capsules are presented in packs of 20 capsules in blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Aravaca (Madrid)

Phone: 91 357 11 25

Fax: 91 307 09 70

e-mail: [email protected]

Manufacturer

TOLL MANUFACTURING SERVICES, S.A.

C/ Aragoneses, 2

28108 Alcobendas

Madrid

Date of the last revision of this leaflet:December 2014

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.gob.es/