Sintonal 0.25 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sintonal 0.25 mg tablets

Brotizolam

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Sintonal is and what it is used for
2. What you need to know before taking Sintonal
3. How to take Sintonal
4. Possible side effects
5. How to store 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 requiring medical treatment.

2. What you need to know before taking 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 suffer from muscle weakness (myasthenia gravis)
• if you have severe respiratory disorder (difficulty breathing)
• if during sleep breathing stops for short periods of time (sleep apnea syndrome)
• if you have severe liver function impairment
• in children
• if you have a rare hereditary disease that may be incompatible with an excipient in the medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sintonal:

• physical dependence may occur even at therapeutic doses. Stopping treatment may lead to withdrawal or rebound phenomena. Psychological dependence may also develop
• if you use it in combination with alcohol, as sedation, fatigue, and concentration disturbances may increase
• if you take opioid analgesics, as this may increase the risk of sedation, difficulty breathing (respiratory depression), coma, and death
• after using this medicine for several weeks, as its effectiveness may decrease
• you must ensure you can sleep long enough and uninterrupted after taking this medicine, as this reduces the risk of memory loss (amnesia), which may occur at recommended doses, but the risk increases with higher doses
• if you experience reactions such as restlessness, agitation, irritability, aggressiveness, delirium, violent anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects, as your doctor will discontinue treatment
• in children, as use of this medicine is contraindicated
• in elderly patients and patients with impaired liver function, as your doctor may prescribe a lower dose
• if you have chronic respiratory disorder with high blood carbon dioxide levels (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 additional medication besides Sintonal
• if you have severe liver problems, as your doctor will not prescribe Sintonal
• if you have hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption, as you should not take this medicine because it contains lactose
• during treatment with Sintonal, a pre-existing depression may become unmasked.

Using Sintonal with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant use of Sintonal with other central nervous system depressants, such as major tranquilizers (antipsychotics), calming agents (sedatives), sleep-inducing medicines (hypnotics), anti-anxiety agents (anxiolytics), antidepressants, opiate-derived painkillers (opioid analgesics), antiepileptics, anesthetics, or medicines used to treat allergies that cause drowsiness (sedating antihistamines), may enhance the central nervous system effects of Sintonal. Therefore, your doctor may adjust your dose.

In the case of opiate-derived painkillers (opioid analgesics), increased feelings of euphoria may facilitate the development of psychological dependence (irresistible urge to use certain substances).

The effects of Sintonal may increase when used with medicines that inhibit the liver enzyme CYP3A4, such as antifungal medicines used to treat fungal infections (antifungals: ketoconazole). Conversely, the effects of Sintonal may decrease when used with medicines that induce this liver enzyme (CYP3A4), such as the antibiotic rifampicin.

Using Sintonal with alcohol

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

Consult your doctor even if any of the above circumstances have occurred to you in the past.

Pregnancy, breastfeeding, and fertility

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.

There are no available data on the use of brotizolam in pregnant or breastfeeding women. Therefore, the use of Sintonal during pregnancy and breastfeeding is not recommended. If necessary, your doctor will assess whether its use is appropriate.

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

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

Driving and using machines

Sintonal is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or if you notice that your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased. Be aware that Sintonal may cause sedation, memory loss (amnesia), and impairment of psychomotor skills during treatment. This impairment may increase the risk of falls and traffic accidents. In addition, if you take Sintonal simultaneously with alcohol and/or central nervous system depressant medicines, this impairment may be enhanced. If you do not sleep sufficiently, your level of alertness may be impaired.

Therefore, driving vehicles or operating machinery requiring special attention or concentration is not advised until you are certain that your ability to perform these activities is not affected.

Sintonal contains

Lactose monohydrate (lactose)

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Sintonal

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

If you feel that the effect 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 half or 1 tablet (0.125 – 0.25 mg of brotizolam) per day in patients over 65 years of age. Your doctor will instruct you to 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 an increased risk of adverse effects related to the central nervous system.

Patients with hepatic impairment

In patients with impaired liver function, the dose should be reduced. Benzodiazepines are not indicated for the treatment of patients with severe hepatic insufficiency, as they may cause encephalopathy.

Patients with renal impairment

In cases of impaired renal function, available data indicate that dose adjustment is not 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 during the night.

Sintonal should be administered orally.

Sintonal tablets may be swallowed with a little liquid or may be allowed to dissolve under the tongue, but must always be taken on an empty stomach.

Sintonal should be taken immediately before going to bed, and you must ensure a rest or sleep period of 6–7 hours afterwards.

Your doctor will tell you how long your treatment with Sintonal should last. Do not stop treatment prematurely, as there is a risk of withdrawal symptoms. Withdrawal symptoms may occur during usual use, especially at high doses.

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

Because the risk of withdrawal symptoms or rebound phenomena is greater if treatment with Sintonal is stopped abruptly, your doctor may prescribe a gradual reduction of the dose to discontinue treatment.

If you take more Sintonal than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Take the packaging and the leaflet with you to the healthcare professional.

Taking high doses of brotizolam may cause deep sleep that could lead to coma, depending on the amount ingested. However, this does not pose a life-threatening risk if properly treated and if you have not also taken central nervous system depressants, including alcohol. In mild cases, symptoms of benzodiazepine overdose include drowsiness, mental confusion, and lethargy; in more severe cases, symptoms may include uncoordinated movements, decreased muscle tone, hypotension, weak breathing, coma (rarely), 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 medicine capable of reversing the sedative effects of benzodiazepines).

If you forget to take Sintonal

Do not take a double dose to make up for a missed dose.

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, such as headache, muscle pain, extreme anxiety and tension, restlessness, confusion, or irritability. In severe cases, symptoms may include feelings of strangeness toward the environment (derealization) or toward the self (depersonalization), increased auditory acuity (hyperacusis), numbness and tingling in the extremities, increased sensitivity to light, noise, or physical contact, hallucinations, or seizures/epileptic attacks.

One of the first signs of developing dependence is the occurrence of a rebound phenomenon, in which the symptoms that led to treatment with Sintonal reappear in an intensified form after discontinuation of the medicine. This phenomenon may be accompanied by other reactions such as emotional disturbances, anxiety, and agitation.

Because the risk of withdrawal or rebound phenomena is greater if treatment with Sintonal is stopped abruptly, your doctor may prescribe a gradual reduction of the dose to discontinue treatment.

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

4. Possible adverse effects

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

Frequent adverse effects (may affect between 1 and 10 out of 100 patients) are somnolence, headache, and stomach and intestinal discomfort.

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

Other rare adverse effects (may affect between 1 and 10 out of 10,000 patients) are restlessness, confusion, and deterioration in level of consciousness.

Reporting of 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 leaflet. You may also report them directly via the Spanish System of Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 packaging. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

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 components are monohydrate lactose, corn starch, sodium carboxymethyl starch, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and contents of the pack

Sintonal tablets are round, slightly biconvex, with bevelled edges and white or almost white in colour. One side is marked with the codes 13A and 13A separated by a division line, and the other side bears the company's symbol. The tablet can be divided into equal doses.

It is available in packs containing 20 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.