Package Insert: Information for the Patient

Ketazolam Adamed 45 mg Hard Capsules

Ketazolam

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ketazolam Adamed is an anxiolytic of the benzodiazepine group.

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

Benzodiazepines are only indicated for the treatment of an intense disorder, which limits the patient's activity or subjects them to a situation of significant stress.

Do not take Ketazolam Adamed:

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

Warnings and precautions

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

• you have chronic respiratory insufficiency, as you should receive a lower than usual dose.
• you have severe renal insufficiency.
• you have epilepsy, as you may experience a seizure if you stop taking Ketazolam Adamed abruptly.

Tolerance

• After continuous use for several weeks, a certain degree of efficacy loss may be detected.
• In the presence of ketazolam, tolerance to other central nervous system 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 dose and duration of treatment, and is also higher in patients with a history of substance abuse or alcohol consumption. Abrupt termination of treatment 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 the symptoms that led to initiation of treatment). It may be difficult to distinguish these symptoms from the original symptoms for which the medication was prescribed.

Follow exactly the administration instructions for Ketazolam Adamed indicated by your doctor, in order to avoid, to the extent possible, the appearance of these symptoms.

Insomnia and anxiety rebound

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

Amnesia

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

Psychiatric and paradoxical reactions

• Ketazolam may produce restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. 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 appear.
• Ketazolam should not be used as first-line treatment for psychiatric disease.
• A previous depression may be masked during treatment with ketazolam. 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 medication may cause these alterations in the blood and/or liver.
• Use with caution in patients with narrow-angle glaucoma (eye disorder that may cause damage to the optic nerve due to a rapid and intense increase in intraocular pressure).

Use in children and adolescents

Ketazolam is not recommended for use in children under 18 years old.

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 medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is extremely important because the simultaneous use of multiple medications may increase or decrease their effect.

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

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

Consult your doctor if you are taking other medications.

Taking Ketazolam Adamed with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may 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, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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, for strict medical reasons, the medication is administered during the third trimester of pregnancy, or at high doses during childbirth, it is predictable that the newborn may experience effects such as hypothermia, hypotonia, and moderate respiratory depression.

Due to the fact that benzodiazepines pass into breast milk, their use is contraindicated in lactating mothers.

Driving and operating machinery

Ketazolam may affect your ability to drive or operate machinery, as it may produce drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is 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.

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

Your doctor will indicate the duration of treatment with Ketazolam Adamed, but generally, the total duration of treatment should not exceed 8-12 weeks, including gradual withdrawal, although in certain cases your doctor may prolong treatment beyond what is recommended, according to your needs. Do not discontinue treatment even if you feel better.

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

The recommended dose is:

Anxiety

• Adults: the dose varies 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 most common dose is usually 30-45 mg per day.
• Older adults: initially 15 mg per day, with the dose increased according to the needs and tolerance of each patient.

Muscle spasms

• Adults: doses vary from 30 mg to 60 mg per day.
• Older adults: initially 15 mg per day, with the dose increased according to the needs and tolerance of each patient.

Generally, prescribed doses should not exceed the indicated limits, unless your doctor prescribes a higher dose. Never change the dose that has been prescribed for you.

Use in children

Administration of ketazolam to children is not recommended.

If you take more Ketazolam Adamed than you should

Overdose does not represent a vital threat unless its administration is combined with other central nervous system depressants (including alcohol). In case of overdose, consider the possibility that the patient may have ingested other medications or products.

Overdosing with benzodiazepines generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more serious cases, ataxia (alteration of movement coordination), hypotonia (muscle tone decrease), 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 medication and the amount ingested.

If you forgot to take Ketazolam Adamed

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ketazolam Adamed

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

When stopping administration, the symptoms that led to taking the medication may reappear, including restlessness, anxiety, insomnia, headaches, and sweating, so your doctor will indicate precisely how to gradually decrease the dose.

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

Like all medications, Ketazolam Adamed may produce adverse effects, although not everyone will experience them.

Most patients tolerate ketazolam well, but some, especially at the beginning of treatment, may experience daytime drowsiness, emotional disturbance, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, coordination of movement alteration, or double vision. Occasionally, gastrointestinal alterations, changes in libido, or skin reactions may appear.

You may develop anterograde amnesia, meaning you will not remember what happened while you were awake after taking the medication, so you should ensure you can rest for at least 7 hours without being disturbed.

The use of benzodiazepines like ketazolam may mask an existing depression. If you ever have thoughts of self-harm or suicide, contact your doctor immediately.

When using ketazolam, you may experience restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations. If this happens, consult your doctor immediately.

The administration of ketazolam may induce the development of physical and psychological dependence; treatment withdrawal may induce a withdrawal or rebound phenomenon (see section 2, Warnings and Precautions). Cases of abuse have been reported.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es).

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Ketazolam Adamed

• The active ingredient 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 packaging

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 gelatin capsules are presented in packs of 20 capsules, conditioned in blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Adamed Laboratories, 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]

Responsible for manufacturing

TOLL MANUFACTURING SERVICES, S.A.

C/ Aragoneses, 2

28108 Alcobendas

Madrid

Date of the last review of this leaflet:December 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/