Package Insert: Information for the User

Sintonal 0.25 mg Tablets

Brotizolam

Sintonal belongs to a group of medications known as benzodiazepines.

Sintonal is used for insomnia that requires medication.

Do not take Sintonal

• if you are allergic to brotizolam or any of the other components of this medication (listed in section 6)
• if you have muscle weakness (myasthenia gravis)
• if you have a severe respiratory disorder (difficulty breathing)
• if you have a sleep disorder characterized by pauses in breathing during sleep (sleep apnea syndrome)
• if you have a severe liver function disorder
• in children
• if you have a rare genetic disorder that may be incompatible with a medication excipient.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sintonal:

• physical dependence may occur even at therapeutic doses. Stopping treatment may cause the appearance of withdrawal or rebound phenomenon. Also, a psychological dependence may develop
• if you use it in combination with alcohol, as it may increase sedation, fatigue, and concentration alteration
• if you take opioid analgesics, as it may increase the risk of sedation, difficulty breathing (respiratory depression), coma, and death
• after using this medication for several weeks, as its effectiveness may decrease
• you must ensure that you can sleep for a sufficient amount of time and without interruption after taking this medication, as this reduces the risk of memory loss (amnesia), which may occur at recommended doses, but the risk increases with increased doses
• if you experience reactions such as restlessness, agitation, irritability, aggression, delirium, violent outbursts, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavior-related adverse effects, as your doctor will interrupt your treatment
• in children, as this medication is contraindicated for use
• in elderly patients and those with liver function disorders, as your doctor may prescribe a lower dose
• if you have a chronic respiratory disorder with high carbon dioxide levels in the blood (respiratory insufficiency 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 another 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 problems with glucose or galactose absorption, as you should not take this medication since it contains lactose
• during treatment with Sintonal, a previously existing depression may be unmasked.

Use of Sintonal with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The simultaneous use of Sintonal with other central nervous system depressants, such as major tranquilizers (antipsychotics), sedatives, sleep-inducing medications (hypnotics), anxiety-relieving medications (anxiolytics), depression-relieving medications (antidepressants), opioid-derived pain relievers, and opioid analgesics, may potentiate the central nervous system effects of Sintonal. Therefore, your doctor may adjust your dose.

In the case of opioid-derived pain relievers, the increased feeling of euphoria may facilitate the development of psychological dependence (irrepressible need to use certain substances).

The effects of Sintonal may increase if used with CYP 3A4 enzyme inhibitors, such as antifungal medications (ketoconazole). Conversely, the effects of Sintonal may decrease if used with CYP 3A4 enzyme inducers, such as the antibiotic rifampicin.

Use of Sintonal with alcohol

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

Consult your doctor even if any of the previously mentioned circumstances have occurred at any time.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

No data are available on the use of brotizolam in pregnant women or breastfeeding women. Therefore, the use of Sintonal during pregnancy and lactation is not recommended. If necessary, your doctor will evaluate the convenience of using it.

Women of childbearing age who are trying to become pregnant or think they may be pregnant and are prescribed the medication should contact their doctor to interrupt 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 operating machinery

Sintonal is a sleep-inducing medication. Do not drive or operate machinery if you feel drowsy or notice that your attention and reaction time are reduced. Pay special attention at the beginning of treatment or if the dose is increased.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 vigilance may be altered.

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

Sintonal contains

Lactose monohydrate (lactose)

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Sodium

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

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

Remember to take your medication.

If you estimate that the action of Sintonal is too strong or weak, inform your doctor or pharmacist.

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

Senior Citizens

The recommended dose is half 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 recommended lowest 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 adverse effects related to the central nervous system.

Patients with Liver Insufficiency

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

Patients with Renal Insufficiency

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

Patients with Chronic Respiratory Insufficiency with Hypercapnia

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

Sintonal should be administered orally.

Sintonal tablets can be swallowed with a little liquid or left to dissolve under the tongue, but they must 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 discontinue treatment before, as there is a risk of withdrawal syndrome. The withdrawal syndrome may appear in the usual usage interval, especially at high doses.

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

Since the risk of withdrawal syndrome or rebound is higher if treatment with Sintonal is discontinued 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 Toxicological Information Service 91 562 04 20 indicating the medication and the amount ingested. Bring the packaging and the leaflet to the healthcare professional.

High doses of brotizolam may cause deep sleep that can lead to coma depending on the amount ingested. However, this does not pose a risk to your life if you are treated properly and have not taken other central nervous system depressants, including alcohol. 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 in rare cases, and death very rarely.

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 medication capable of correcting the sedative effect of benzodiazepines).

If you forget to take Sintonal

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

If you discontinue treatment with Sintonal

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

One of the first symptoms of dependence development is the presentation of the rebound phenomenon, in which the symptoms that prompted treatment with Sintonal reappear in a potentiated form when the medication is suppressed. This phenomenon may be accompanied by other reactions such as emotional situation alteration, anxiety, and agitation.

Since the risk of withdrawal syndrome or rebound is higher if treatment with Sintonal is discontinued abruptly, your doctor may prescribe a gradual dose reduction to end treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The classification of side effects is based on the following frequencies:

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

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

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

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 Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sintonal

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

Appearance of the product and contents of the packaging

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

It is presented in packaging containing 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Responsible for manufacturing:

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

51000 Reims

France

Last review date of this leaflet:June 2020

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/.