SEDOTIME 45 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Sedotime 45 mg hard capsules

Ketazolam

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sedotime is and what it is used for
2. What you need to know before you take Sedotime
3. How to take Sedotime
4. Possible side effects
5. Storing Sedotime
6. Contents of the pack and other information

1. What Sedotime is and what it is used for

The active substance of Sedotime belongs to a group of medicines called benzodiazepines.

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

It is also indicated for its muscle relaxant action in spasticity (increased muscle tone that makes muscles feel stiffer) associated with cerebrovascular accidents, spinal trauma, cervical syndrome, stiffness in encephalitis, etc.

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

Treatment should be started with the lowest dose. The maximum dose should not be exceeded.

2. What you need to know before you take Sedotime

Do not take Sedotime

• If you are allergic to ketazolam, benzodiazepines, or 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 syndrome characterized by episodes of brief respiratory arrest that occur during sleep).
• If you have severe liver failure.
• In case of pregnancy or breastfeeding.

Warnings and precautions

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

• you have any liver or kidney disorder,
• 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, you should not take this medicine unless your doctor formally indicates it. If you have any doubts, consult your doctor,
• you have epilepsy, as a seizure may occur if treatment with Sedotime is abruptly interrupted,
• 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 duration of treatment and is also greater in patients with a history of drug or alcohol use. 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 symptoms that led to the initiation of treatment).

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

• Benzodiazepines should only be taken under medical prescription (never because they have been effective in other patients) and should never be recommended to other people.
• Do not increase the prescribed doses in any way, nor prolong treatment for longer than recommended.
• Regularly consult your doctor so that they can decide whether to continue treatment.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient reappearance of symptoms that determined the initiation of treatment). This episode may be accompanied by other reactions such as mood changes, anxiety, or sleep disorders and restlessness. The probability of appearance of a withdrawal/rebound syndrome is greater after abruptly stopping treatment, so it is recommended to gradually decrease the dose until its definitive suppression. Follow your doctor's recommendations for use and administration instructions for Sedotime 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. Under normal conditions, you should not take more than 20 minutes to fall asleep after taking ketazolam.

Psychiatric and paradoxical reactions

• Ketazolam may produce restlessness, agitation, irritability, aggression, delirium, rage 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 if these reactions appear.
• Ketazolam should not be used as a first-line treatment for psychotic illness.
• A pre-existing depression may be masked during treatment with ketazolam. In these patients, there is a risk of suicide.

Other warnings

• Your doctor may indicate that you need to have blood tests or liver function tests, as this medicine could produce alterations 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).

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age.

Use in elderly patients

Elderly patients may be more sensitive to the effects of this medicine than the rest of adults. Therefore, it is especially important that elderly patients immediately inform their doctor 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 associated risk of respiratory depression.

Use in patients with severe liver failure

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

Use in patients with severe kidney failure

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

Using Sedotime with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. 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 these medicines:

• Antipsychotics (neuroleptics, medicines used in the treatment of psychiatric disorders).
• Hypnotics (medicines that improve the onset and duration of sleep).
• 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 can produce an increased sensation of euphoria when administered with ketazolam, which can lead to an increased risk of psychological dependence.
• Antiepileptics (medicines used in the treatment of epilepsy and convulsions). Additionally, ketazolam reduces the effect of anticonvulsants, so your doctor may consider it necessary to adjust the dose of both 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.

Taking Sedotime with alcohol

Avoid alcoholic beverages during treatment. The effect of alcohol may potentiate sedation, and this 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.

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 necessity, the medicine is administered during the third trimester of pregnancy, or at high doses during delivery, it is foreseeable that effects such as hypothermia, hypotonia, and moderate respiratory depression may appear in the newborn.

Breastfeeding

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

Driving and using machines

Sedotime may alter your ability to drive or operate machinery, as it can cause drowsiness, reduce your alertness, 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 operate machinery if you experience any of these effects.

3. How to take Sedotime

Follow your doctor's instructions for taking Sedotime exactly. If you are in 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 in general, the total duration of treatment should not exceed 8-12 weeks, including gradual withdrawal, although in certain cases, the doctor may prolong treatment beyond what is recommended based on your needs. Do not stop treatment even if you feel better.

Remember to take your medicine.

The recommended dose is between 15 and 60 mg per day, as a single dose at bedtime or divided throughout the 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 just before bedtime and swallow the capsule without chewing, with water or another non-alcoholic beverage.

Under normal conditions, you should not take more than 20 minutes to fall asleep after taking Sedotime, and it is convenient to ensure that you can rest without being awakened for at least 7 hours. Otherwise, although this happens rarely, it is possible that you will not remember what happened while you were awake.

Use in children and adolescents

The administration of Sedotime is not recommended in children and adolescents under 18 years of age.

Use in elderly patients

Elderly patients may be more affected by Sedotime than younger patients. If you are an elderly patient, your doctor may prescribe a lower dose and check 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 it is convenient for you to take a lower dose of Sedotime or not to take it at all.

If you take more Sedotime than you should

If you or another person has ingested an overdose of Sedotime, call your doctor immediately. Overdose is not life-threatening unless it is combined with other central nervous system depressants (including alcohol). In case of overdose, it should be taken into account that the patient may have ingested other medicines or products.

Overdose with benzodiazepines is generally manifested by different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, or lethargy; in more severe cases, ataxia (alteration in coordination of voluntary muscle movements), hypotonia (decrease in muscle tone), low tension, 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 forget to take Sedotime

Do not take a double dose to make up for forgotten doses, but instead continue with the normal dose.

If you stop taking Sedotime

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

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

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

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

4. Possible side effects

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

The following side effects have been observed, whose frequency has not been established with precision.

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

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

It is known that when benzodiazepines are used, behavioral side effects such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, or inappropriate behavior may occur. These reactions are more frequent in the elderly and children. If you experience these effects, you should discontinue treatment and consult your doctor immediately.

Anterograde amnesia (loss of memory) may appear at normal doses, i.e., you may not remember what happened while you were awake after taking the medicine. The risk increases when the dose is increased. Amnestic effects may be associated with behavioral disorders.

Sedotime can very rarely produce sudden anxiety, hallucinations, excitement, and sleep disorders. If this happens, consult your doctor immediately.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system: https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storing Sedotime

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

Store below 25°C.

Do not use Sedotime after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sedotime 45 mg

• The active ingredient is ketazolam. Each capsule contains 45 mg of ketazolam.
• The other components (excipients) are calcium carboxymethylcellulose, hydrogenated vegetable oil (Sterotex), erythrosine (E127), carmine indigo (E132), titanium dioxide (E171), quinoline yellow (E104), gelatin, and water.

Product Appearance and Package Contents

Sedotime 45 mg are hard gelatin capsules with a red body and a strong pink head, serigraphed on the body and cap with "SEDOTIME 45 MG" in black.

Each package contains 20 capsules.

Other Presentations

Sedotime 15 mg hard capsules. Each package contains 30 capsules.

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

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Bizkaia Science and Technology Park

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the Last Revision of this Leaflet:July 2017

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