KetaZOLAM Adamed 45 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ketazolam Adamed 45 mg hard capsules

Ketazolam

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may 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 Ketazolam Adamed is and what it is used for
2. What you need to know before taking Ketazolam Adamed
3. How to take Ketazolam Adamed
4. Possible side effects
5. How to store Ketazolam Adamed
6. Contents of the pack and other information

1. What Ketazolam Adamed is and what it is used for

Ketazolam Adamed is an anxiolytic belonging to the benzodiazepine group.

Ketazolam Adamed is indicated for the treatment of anxiety and for the symptomatic treatment of skeletal muscle spasticity. The term spasticity means an increase in "muscle tone," resulting in muscles feeling stiffer or more rigid.

Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair the patient's functioning or subject the patient to considerable stress.

2. What you need to know before taking Ketazolam Adamed

Do not take Ketazolam Adamed:

• if you are allergic to benzodiazepines or to any of the other components of this medicine (listed in section 6).
• if you have myasthenia gravis (a disease characterized by abnormally increased muscle weakness).
• if you have severe respiratory insufficiency (e.g., severe chronic obstructive pulmonary disease).
• if you have sleep apnea (a condition characterized by brief episodes of breathing cessation during sleep).
• if you have severe hepatic insufficiency.
• During pregnancy or breastfeeding (see section 2, Pregnancy and breastfeeding).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• you have chronic respiratory insufficiency, as you may require a lower than usual dose.
• you have severe renal insufficiency.
• you have epilepsy, as epileptic seizures may occur if treatment with Ketazolam Adamed is abruptly discontinued.

Tolerance

• After continuous use for several weeks, a certain degree of reduced effectiveness may be observed.
• In the presence of ketazolam, tolerance to other central nervous system (CNS) depressants may be reduced; these substances should be avoided or taken at reduced doses.

Dependence

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

Follow exactly the administration instructions for Ketazolam Adamed provided by your doctor in order to minimize the possibility of these symptoms occurring.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient return of symptoms that led to starting treatment). This may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. The likelihood of withdrawal/rebound syndrome is greater after abrupt discontinuation of treatment; therefore, it is recommended to gradually reduce the dose until complete discontinuation. Follow exactly the recommended use and administration instructions for Ketazolam Adamed 15 mg provided by your doctor to minimize the possibility of these symptoms.

Amnesia

• Ketazolam may cause anterograde amnesia, i.e., difficulty in remembering recent events. To reduce this risk, ensure you can sleep uninterrupted for 7–8 hours after taking Ketazolam Adamed (see section 4). Under normal conditions, you should fall asleep within 20 minutes after taking Ketazolam Adamed.

Psychiatric and paradoxical reactions

• Ketazolam may cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. These reactions occur more frequently in children, elderly patients, and patients with organic brain syndrome (physical disorders causing reduced mental function). Your doctor will discontinue treatment with Ketazolam Adamed if such reactions occur.
• Ketazolam should not be used as first-line treatment for psychotic disorders.
• Pre-existing depression may be masked during treatment with ketazolam. In such patients, there is a risk of suicide (see section 4).

Other warnings

• Your doctor may perform blood tests or liver function monitoring if necessary, as this medicine may cause blood and/or liver abnormalities.
• Use with caution in patients with narrow-angle glaucoma (an eye disorder that can damage the optic nerve due to a rapid and severe increase in intraocular pressure).

Use in children and adolescents

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

Use in elderly patients

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

Use of Ketazolam Adamed with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is extremely important because taking multiple medicines simultaneously may increase or decrease their effects.

The effect of ketazolam may be enhanced when taken with the following medicines:

• Antipsychotics (neuroleptics, medicines used to treat psychiatric disorders).
• Hypnotics (medicines that improve sleep onset and duration).
• Anxiolytics/sedatives (medicines used to treat anxiety).
• Antidepressants (medicines used to treat depression).
• Opioid analgesics (certain medicines that reduce pain). These analgesics may increase feelings of euphoria when taken with ketazolam, potentially increasing psychological dependence.
• Antiepileptics (medicines used to treat epilepsy and seizures). 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 generally used during surgical procedures to reduce pain and/or consciousness).
• Sedating antihistamines (medicines mainly used to treat allergic symptoms).
• Medicines that inhibit certain liver enzymes (particularly cytochrome P450) may enhance the activity of ketazolam.

If you are taking other medicines, consult your doctor.

Taking Ketazolam Adamed with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which could affect your ability to drive or operate machinery. If you need further 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.

Infants born to mothers who take benzodiazepines chronically during the third trimester of pregnancy may develop physical dependence and experience withdrawal symptoms in the postnatal period. If, for strict medical reasons, the medicine is administered during the third trimester of pregnancy or at high doses during delivery, effects in the newborn such as hypothermia, hypotonia, and moderate respiratory depression may be expected.

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

Driving and using machines

Ketazolam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or decrease 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.

3. How to take Ketazolam Adamed

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Take Ketazolam Adamed just before going to bed, swallowing the capsule whole with a glass of water.

The recommended dose is:

Anxiety

• Adults: The dose ranges from 15 mg to 75 mg per day, usually administered as a single nightly dose, although it may also be divided into several doses throughout the day. The most common dose is 30–45 mg per day.
• Elderly patients: Initially 15 mg per day, which may be increased according to individual needs and tolerance.

Muscle spasms

• Adults: Doses range from 30 mg to 60 mg per day.
• Elderly patients: Initially 15 mg per day, which may be increased according to individual needs and tolerance.

In general, prescribed doses should not exceed the limits indicated unless your doctor specifically prescribes a higher dose. Never change your prescribed dose on your own.

Use in children

Ketazolam is not recommended for use in children.

If you take more Ketazolam Adamed than you should

Overdose is not usually life-threatening unless the drug is taken together with other central nervous system depressants (including alcohol). In case of overdose, consider the possibility that the patient may have ingested other medications or substances.

Overdose with benzodiazepines generally manifests as varying 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 (impaired coordination of movement), hypotonia (reduced muscle tone), low blood pressure, respiratory depression, rarely coma, and very rarely death may occur.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone 91562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Ketazolam Adamed

Do not take a double dose to make up for a missed dose.

If you stop taking Ketazolam Adamed

To avoid withdrawal symptoms, you should not stop taking Ketazolam Adamed abruptly, especially if you have been taking it for a prolonged period.

When stopping treatment, the symptoms that led to starting the medicine may reappear, and you may experience restlessness, anxiety, insomnia, headache, and sweating. Therefore, your doctor will give you clear instructions on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, Ketazolam Adamed may produce adverse effects, although not everyone experiences them.

Most patients tolerate ketazolam well, but some, especially at the beginning of treatment, may experience daytime drowsiness, emotional disturbances, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, impaired coordination of movements, or double vision. Occasionally, gastrointestinal disturbances, changes in libido, or skin reactions may occur.

You may develop anterograde amnesia, meaning you will not remember events that occurred while you were awake after taking the medicine. Therefore, you must ensure you can rest for at least 7 hours without interruption.

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

When taking ketazolam, you may experience restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disturbances. If this occurs, consult your doctor immediately.

Administration of ketazolam may lead to the development of physical and psychological dependence; discontinuation of treatment may lead to withdrawal or rebound phenomena (see section 2, Warnings and precautions). Cases of 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 Medicinal Products (www.notificaRAM.es).

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

5. Storage of Ketazolam Adamed

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ketazolam Adamed

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

Appearance of the product and contents of the pack

Ketazolam Adamed 45 mg are hard gelatin capsules, with an opaque dark green cap and an opaque dark green body. The capsule contents consist of a white or almost white powder.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Aravaca (Madrid)

Tel.: 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 most recent revision of this leaflet: December 2014

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/