Package Insert: Information for the User

Sedotime 15 mg Hard Capsules

Ketazolam

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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.

The active ingredient of Sedotime belongs to the group of medications called benzodiazepines.

Doctors prescribe Sedotime for the treatment of anxiety states, nervousness, and irritability.

It is also indicated for muscle spasticity (an increase in muscle tone that makes muscles feel stiffer or more rigid)associated with stroke, spinal trauma, cervical syndrome, rigidity in encephalitis, etc.

In most cases, only a short-term treatment with Sedotime 15 mg (in general, it should not exceed two weeks) is needed.You should consult a doctor if it worsens or does not improve.

Treatment should start with the lowest dose. Do not exceed the maximum dose.

Do not take Sedotime

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sedotime, especially if:

• You have any liver or kidney disorders,
• You suffer from muscle weakness,
• You have allergies,
• You have chronic respiratory failure, as you should receive a lower dose than usual,
• You suffer from drug or alcohol dependence, do not take this medication unless your doctor tells you to formally. If you have any doubts, consult your doctor,
• You have epilepsy, as a seizure may occur if the treatment with Sedotime is stopped abruptly,
• Sedotime should not be administered to children.

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 central nervous system depressants may decrease, these substances should be avoided or taken in reduced doses.

Risk of dependence

The use of benzodiazepines can lead to physical and psychological dependence. The risk increases with the dose and the duration of treatment and is also higher in patients with a history of drug 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 the initiation of treatment).

To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines should be taken only under medical prescription (never because they have been effective in other patients) and should not be recommended to others.
• Do not increase the prescribed doses at all, or prolong the treatment longer than recommended.
• Consult your doctor regularly to decide whether to continue treatment.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient reappearance of the symptoms that led to the initiation of treatment). This episode may be accompanied by other reactions such as mood changes, anxiety, or sleep and restlessness disorders. 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 its definitive suppression. Follow exactly the usage and administration instructions of Sedotime indicated by your doctor to avoid these symptoms as much as possible.

Amnesia

• Ketazolam may induce anterograde amnesia, that is, difficulty remembering recent events. To reduce this risk, ensure that you will be able to sleep without interruption for 7-8 hours. Normally, it will not take more than 20 minutes to fall asleep after taking ketazolam.

Psychiatric and paradoxical reactions

• Ketazolam may produce restlessness, agitation, irritability, aggression, delusions, outbursts of anger, 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 suspend treatment if these reactions appear.
• Ketazolam should not be used as a 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.

Other warnings

• Your doctor may indicate the performance of blood tests or liver function controls if necessary, as this medication may cause these alterations at the blood level and/or liver.
• It should be used 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).

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years old.

Use in elderly patients

Elderly patients may be more sensitive to the effects of this medication than the rest of adults. Therefore, it is especially important for elderly patients to inform their doctor immediately of any adverse effects.

Use in patients with chronic respiratory failure

It is recommended to use lower doses in patients with chronic respiratory failure, due to the risk of respiratory depression.

Use in patients with severe liver failure

Benzodiazepines are not indicated in patients with severe liver failure, due to the risk of encephalopathy.

Use in patients with severe renal failure

Ketazolam should be administered with caution to patients with severe renal failure.

Use of Sedotime with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, even those acquired without a prescription. This is extremely important because the simultaneous use of more than one medication may increase or decrease its 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 increase the feeling of euphoria when administered with ketazolam, which may lead to an increase in psychological dependence.
• Antiepileptics (medications used in the treatment of epilepsy and seizures). Additionally, ketazolam reduces the effect of anticonvulsants, so your doctor may consider adjusting the dose of both 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.

Taking Sedotime with alcohol

Avoid drinking alcoholic beverages during treatment. 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, consult your doctor or pharmacist before using this medication.

Pregnancy

Sedotime is contraindicated during pregnancy.

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 delivery, it is expected that the newborn may experience effects such as hypothermia, hypotonia, and moderate respiratory depression.

Breastfeeding

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

Driving and operating machinery

Sedotime 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 for Sedotime indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Depending on the nature of your illness, your age and weight, your doctor will prescribe the appropriate dose, 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 based on your needs. Do not discontinue treatment even if you feel better.

Remember to take your medication.

The recommended dose is between 15 and 60 mg per day, as a single dose at bedtime or divided over 24 hours. Most patients respond to a dose of 15 mg at bedtime.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Take Sedotime justbefore going to bedand swallow the capsule without crushing it, with water or another non-alcoholic beverage.

Under normal conditions, you will not take more than 20 minutes to fall asleep after taking Sedotime, and it is advisable to ensure that you can rest without being woken up for at least 7 hours. Otherwise, although this occurs in rare cases, it is possible that you will not remember what happened while you were awake.

Use in children and adolescents

It is not recommended to administer Sedotime to children and adolescents under 18 years old.

Use in elderly people

Elderly people may be affected by Sedotime more than young patients. If you are an elderly person, your doctor may prescribe a lower dose and monitor your response to treatment. Please carefully follow your doctor's instructions.

If you have any liver or kidney disorder, or suffer from muscle weakness, your doctor will decide whether you should take a lower dose of Sedotime or not take it at all.

If you take more Sedotime than you should

If you or someone else has ingested an overdose of Sedotime, call your doctor immediately. An overdose is not a life-threatening situation unless its administration is combined with other central nervous system depressants (including alcohol). In case of an overdose, it is essential to consider the possibility that the patient may have ingested other medications or products.

Sedative overdose with benzodiazepines generally manifests with different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, or lethargy; in more serious cases, ataxia (alteration in 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 91 562 04 20.

If you forgot to take Sedotime

Do not take a double dose to compensate for the missed doses, but rather continue with the normal dose.

If you interrupt treatment with Sedotime

Your doctor will indicate the duration of treatment with Sedotime. Do not discontinue treatment even if you feel better.

When stopping treatment, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear, especially if you have been taking it for a long time. In general, do not stop taking Sedotime abruptly, but rather reduce the dose gradually, according to your doctor's instructions.

Never change the dose prescribed by your doctor yourself. If you think the medication's effect is too strong or too weak, consult your doctor.

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

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

The following adverse effects have been observed, although their frequency is not precisely established.

Most patients tolerate Sedotime well, but some people may feel somewhat tired or drowsy during the day, especially at the beginning of treatment.

Headache, dizziness, reduced alertness, gastrointestinal disturbances, skin reactions, visual disturbances (double vision), ataxia (inability to coordinate voluntary muscle movements), muscle weakness may occur. Occasionally, gastrointestinal disturbances, changes in libido, or skin reactions may appear.

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

It is known that when benzodiazepines are used, adverse effects on behavior may occur, such as restlessness, agitation, irritability, aggression, delirium (incoherent ideas), anger attacks, nightmares, hallucinations, psychosis, or inappropriate behavior. These reactions are more common in the elderly and children. If you experience these effects, you should discontinue treatment and consult your doctor immediately.

Anterograde amnesia (memory loss) may occur at normal doses, meaning you may not remember what happened while you were awake after taking the medication. The risk increases when the dose is increased. Amnestic effects may be associated with behavioral disturbances.

Sedotime may rarely cause sudden anxiety, hallucinations, excitement, and sleep disturbances. If this happens, consult your doctor immediately.

The administration of ketazolam may induce physical and psychological dependence; withdrawal or rebound phenomenon may occur upon treatment discontinuation (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 national notification system:https://www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below 25°C.

Do not use Sedotime 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 disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Sedotime 15 mg

Appearance of the product and content of the packaging

Sedotime 15 mg are hard gelatin capsules with a pale pink body and a strong pink head, printed in body and cap with "SEDOTIME 15 MG" in black.

Each package contains 30 capsules.

Other presentations

Sedotime 30 mg hard capsules. Each package contains 20 capsules.

Sedotime 45 mg hard capsules. Each package contains 20 capsules.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

O

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet: July 2017

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