SINTONAL 0.25 mg tablets

Introduction

Package Leaflet: Information for the User

Sintonal 0.25 mg tablets

Brotizolam

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

• Keep this package 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What Sintonal is and what it is used for

Sintonal belongs to a group of medicines called benzodiazepines.

Sintonal is used for insomnia that requires medication.

2. What you need to know before you take Sintonal

Do not take Sintonal

• if you are allergic to brotizolam or any of the other ingredients of this medicine (listed in section 6)
• if you have severe muscle weakness (myasthenia gravis)
• if you have a severe respiratory disorder (difficulty breathing)
• if you stop breathing for short periods during sleep (sleep apnea syndrome)
• if you have a severe liver disorder
• in children
• if you have a rare hereditary disorder that may be incompatible with an excipient of the medicine

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Sintonal:

• you may become physically dependent on it even at therapeutic doses. Stopping treatment may cause withdrawal symptoms or rebound effects. Psychological dependence may also develop
• if you use it in combination with alcohol, as it may increase sedation, fatigue, and impaired concentration
• if you take opioid analgesics, as it may increase the risk of sedation, respiratory depression, coma, and death
• after using this medicine for several weeks, as its efficacy may decrease
• you must ensure that you can sleep for a sufficient amount of time and uninterruptedly after taking this medicine, as this reduces the risk of memory loss (amnesia), which may occur at recommended doses, but the risk increases with increasing dose
• if you experience reactions such as restlessness, agitation, irritability, aggression, delirium, violent outbursts, nightmares, hallucinations, psychosis, and other behavioral effects, as your doctor will stop treatment
• in children, as the use of this medicine is contraindicated
• in elderly patients and those with liver function disorders, as your doctor may prescribe a lower dose
• if you have chronic respiratory failure with high carbon dioxide levels in the blood (respiratory failure with hypercapnia), as your doctor may prescribe a lower dose
• if you have a mental disorder (psychosis), depression, or anxiety accompanied by depression, as your doctor will prescribe other medication in addition to Sintonal
• if you have severe liver problems, as your doctor will not prescribe Sintonal
• if you have hereditary intolerance to galactose, total lactase deficiency, or glucose-galactose malabsorption, as you should not take this medicine since it contains lactose
• during treatment with Sintonal, a pre-existing depression may be unmasked

Using Sintonal with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Concomitant use of Sintonal with other central nervous system depressants, such as major tranquilizers (antipsychotics), sedatives, sleep-inducing medicines (hypnotics), anxiolytics, antidepressants, opioid analgesics, antiepileptics, anesthetics, or sedating antihistamines, may potentiate the central nervous system effects of Sintonal. For this reason, your doctor may adjust the dose.

In the case of opioid analgesics, the increased feeling of euphoria may facilitate the development of psychological dependence.

The effects of Sintonal may increase if used with medicines that inhibit the liver enzyme CYP 3A4, such as antifungal medicines (e.g., ketoconazole). On the other hand, the effects of Sintonal may decrease if used with medicines that induce this liver enzyme (CYP 3A4), such as the antibiotic rifampicin.

Using Sintonal with alcohol

When Sintonal is used in combination with alcohol, sedation, fatigue, and impaired concentration may increase.

Talk to your doctor even if any of the above circumstances have occurred to you at any time.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no data available on the use of brotizolam in pregnant or breastfeeding women. Consequently, the use of Sintonal is not recommended during pregnancy and breastfeeding. If necessary, your doctor will assess the convenience of using it.

Women of childbearing age who are trying to become pregnant or think they may be pregnant and are prescribed this medicine should contact their doctor to stop treatment.

If you take Sintonal regularly during the last stages of pregnancy, your child may experience withdrawal symptoms (see the "Warnings and precautions" section).

Driving and using machines

Sintonal is a sleep-inducing medicine. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction are reduced. Pay special attention when starting treatment or increasing the dose. Note that Sintonal may cause sedation, memory loss (amnesia), and alteration of psychomotor skills during treatment. This alteration may increase the risk of falls and traffic accidents. Additionally, if you take Sintonal simultaneously with alcohol and/or central nervous system depressants, this alteration may be potentiated. If you do not sleep sufficiently, your state of alertness may be altered.

Therefore, it is not recommended to drive vehicles or operate machinery that requires special attention or concentration until it is verified that the ability to perform these activities is not affected.

Sintonal contains

Lactose monohydrate (lactose)

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Sintonal

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

Remember to take your medicine.

If you think the action of Sintonal is too strong or too weak, tell your doctor or pharmacist.

The recommended dose is 1 tablet (0.25 mg of brotizolam) per day in adult patients.

Elderly patients

The recommended dose is 0.5 or 1 tablet (0.125-0.25 mg of brotizolam) per day in patients over 65 years old. Your doctor will indicate that you start treatment with the lowest recommended dose. Your doctor will not exceed the recommended dose of 1 tablet (0.25 mg of brotizolam) per day, as there is a higher risk of central nervous system-related side effects.

Patients with liver impairment

In patients with liver function disorders, the dose should be reduced. Benzodiazepines are not indicated in the treatment of patients with severe liver impairment, as they may cause encephalopathy.

Patients with renal impairment

In cases of renal function disorders, available data indicate that no dose adjustment is necessary.

Patients with chronic respiratory failure with hypercapnia

In patients with chronic respiratory failure with hypercapnia, the dose should be reduced due to the risk of respiratory depression, especially at night.

Sintonal should be taken orally.

Sintonal tablets can be swallowed with a little liquid or left to dissolve under the tongue, but they should always be taken on an empty stomach.

Sintonal should be taken immediately before bedtime, and you should have a period of rest or sleep of 6-7 hours.

Your doctor will indicate the duration of your treatment with Sintonal. Do not stop treatment before, as there is a risk of withdrawal symptoms. Withdrawal symptoms may occur in the usual interval, especially at high doses.

Treatment should be as short as possible, from a few days to a maximum of 2 weeks.

Because the risk of withdrawal symptoms or rebound effects is higher if Sintonal treatment is stopped abruptly, your doctor may prescribe a gradual dose reduction to end treatment.

If you take more Sintonal than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. Bring the package and package leaflet to the healthcare professional.

Taking high doses of brotizolam may cause deep sleep that can lead to coma, depending on the amount taken. However, this does not pose a risk to life if treated properly and if no central nervous system depressants, including alcohol, have been taken. In mild cases, symptoms of benzodiazepine overdose include drowsiness, mental confusion, and lethargy, and in more severe cases, symptoms may include uncoordinated movements, decreased muscle tone, hypotension, weak breathing, coma, and very rarely death.

Your doctor will treat you in intensive care, paying special attention to lung and heart function. As an antidote, your doctor may administer flumazenil (a medicine that can counteract the sedative effect of benzodiazepines).

If you forget to take Sintonal

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

If you stop taking Sintonal

During treatment with Sintonal, you may develop physical and psychological dependence. The risk of dependence increases with dose and duration of treatment and is also higher in patients who have previously abused alcohol, medicines, or drugs. If you develop physical dependence and stop treatment abruptly, withdrawal symptoms may occur, which can be headache, muscle pain, anxiety, and extreme tension, restlessness, confusion, or irritability. In severe cases, it may include a feeling of strangeness to the environment (derealization) or to oneself (depersonalization), increased auditory acuity (hyperacusis), numbness and tingling of the limbs, increased sensitivity to light, noise, or physical contact, hallucinations, or convulsions/epileptic seizures.

One of the first symptoms of dependence development is the presentation of rebound effects, in which the symptoms that led to treatment with Sintonal reappear in a potentiated form when the medicine is stopped. This phenomenon may be accompanied by other reactions such as altered emotional state, anxiety, and agitation.

Because the risk of withdrawal symptoms or rebound effects is higher if Sintonal treatment is stopped abruptly, your doctor may prescribe a gradual dose reduction to end treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The classification of side effects is based on the following frequencies:

Common side effects (may affect between 1 and 10 in 100 patients) are drowsiness, headache, and stomach and intestinal discomfort.

Uncommon side effects (may affect between 1 and 10 in 1,000 patients) are intense nightmares, worsening of pre-existing depression, mood changes, anxiety, dependence on the medicine, feeling of emotional numbness (lack of energy), inappropriate behavior, agitation, altered sexual desire (libido), dizziness, sedation, lack of coordination of voluntary movements (ataxia), memory loss (anterograde amnesia), dementia, mental disorders, alteration of psychomotor skills, visual disturbances (double vision), dry mouth, liver disorders including changes in liver function tests, yellowing of the skin (jaundice), skin reactions, muscle weakness, fatigue, irritability, paradoxical reactions (more likely in elderly patients), withdrawal syndrome, rebound effects, traffic accidents, and falls.

Other rare side effects (may affect between 1 and 10 in 10,000 patients) are restlessness, confusion, and impaired alertness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sintonal

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

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

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you have any further questions, ask your pharmacist.

6. Contents of the pack and other information

Composition of Sintonal

• The active substance is brotizolam. Each tablet contains 0.25 milligrams of brotizolam.
• The other ingredients are lactose monohydrate, cornstarch, sodium carboxymethylcellulose, microcrystalline cellulose, and magnesium stearate.

Appearance and packaging of the product

Sintonal tablets are round, slightly biconvex, with beveled edges and white or almost white in color. One side is marked with the codes 13A and 13A separated by a score line, and the other side is marked with the company logo. The tablet can be divided into equal doses.

It is available in packs containing 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer:

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

5100 Reims

France

Date of last revision of this package leaflet:June 2020

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