Brotizolam EG

Package leaflet: Information for the patient

BROTIZOLAM EG 0.25 mg tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BROTIZOLAM EG is and what it is used for

BROTIZOLAM EG contains the active substance brotizolam, which belongs to a group of medicines called benzodiazepines.
This medicine is indicated for the short-term treatment of sleep disorders (insomnia), in cases where the disorder is severe, disabling and causes severe distress to the patient.

2. What you need to know before taking BROTIZOLAM EG

Do not take BROTIZOLAM EG

• if you are allergic to brotizolam, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
• if you have severe breathing problems (severe respiratory insufficiency);
• if you have severe liver problems (severe hepatic insufficiency);
• if you have breathing difficulties during sleep (sleep apnea);
• if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if the patient is a child or adolescent under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BROTIZOLAM EG:

• if you are elderly and/or suffer from liver problems (reduced liver function). In this case, your doctor may decide to reduce the dose (see section 3 “Use in the elderly”). In particular, if your liver function is impaired, the use of benzodiazepines may worsen mental confusion associated with this condition (encephalopathy);
• if you have respiratory problems (chronic respiratory insufficiency) or excess carbon dioxide in the blood due to lung problems (hypercapnia), as you may experience serious breathing difficulties, especially during the night (respiratory depression);
• if you suffer from mental disorders (psychosis) or depression and anxiety; in this case, consult your doctor, as it may be necessary to take BROTIZOLAM EG in combination with other medicines; in particular, if you suffer from depression and anxiety and take only this medicine, you may exhibit suicidal behaviour. During treatment with this medicine:
• a reduction in effectiveness (tolerance) may occur; if this happens, consult your doctor;
• you may feel the need to continue taking the medicine (physical and psychological dependence). The risk increases with the dose and duration of treatment and is greater if you have previously abused drugs or alcohol (see section 4 “Possible side effects”). If you have previously abused drugs or alcohol, you must not take BROTIZOLAM EG. Pay special attention if you develop dependence and discontinue treatment with this medicine, as withdrawal symptoms (abstinence) may occur (see section 3 “If you stop taking BROTIZOLAM EG”);
• you may experience memory lapses (anterograde amnesia), especially if you take this medicine at high doses. This effect occurs several hours after taking the medicine; to reduce this risk, ensure an uninterrupted sleep of 7–8 hours after taking BROTIZOLAM EG;
• if you are depressed, your symptoms may worsen;
• you may experience behavioural disturbances (paradoxical psychiatric reactions) such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, and other behavioural disorders. If you experience these disturbances, consult your doctor, as treatment must be discontinued (see section 4 “Possible side effects”). These reactions are more common in children and the elderly.

After stopping treatment, you may experience symptoms known as rebound phenomena, meaning you may experience, more intensely, the symptoms that led you to take this medicine (see section “If you stop taking BROTIZOLAM EG”).
You should take this medicine for the shortest possible time and should not exceed 2 weeks. Your doctor will discontinue treatment gradually by reducing the dose to minimize the occurrence of withdrawal symptoms (see section 3 “If you stop taking BROTIZOLAM EG”). However, you may still experience these symptoms, especially between doses and if your dose is high.

Other medicines and BROTIZOLAM EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• antipsychotics (neuroleptics), medicines used to treat mental disorders;
• antidepressants, medicines used to treat depression;
• hypnotics and sedatives, medicines used to treat sleep problems;
• anxiolytics, medicines used to treat anxiety;
• narcotic analgesics, medicines used to treat moderate to severe pain, which may increase feelings of well-being (euphoria) when taken with BROTIZOLAM EG. This may increase your desire to continue taking these medicines (psychological dependence);
• antiepileptics, medicines used to treat epilepsy;
• anaesthetics, medicines used during surgical procedures to induce anaesthesia;
• sedating antihistamines, medicines used to treat allergies and which may cause drowsiness;
• rifampicin, used to treat bacterial infections;
• ketoconazole, used to treat fungal infections.

The concomitant use of BROTIZOLAM EG and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes BROTIZOLAM EG together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or family members about the signs and symptoms listed above.
Contact your doctor if these symptoms occur.

BROTIZOLAM EG and alcohol
Avoid consuming alcohol during treatment with this medicine, as you may experience dizziness (increased sedative effect), fatigue, and difficulty concentrating (see section “Driving and using machines”).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take BROTIZOLAM EG during pregnancy.
If your doctor considers it necessary for you to take BROTIZOLAM EG during the last stages of pregnancy or during childbirth, be aware that your baby may show signs at birth such as low body temperature (hypothermia), muscle weakness (hypotonia), and breathing difficulties (“Floppy Infant Syndrome” or infantile hypotonia).
Moreover, if BROTIZOLAM EG has been taken regularly during the last stages of pregnancy, your baby may develop physical dependence or withdrawal symptoms.

Breastfeeding
Do not take this medicine if you are breastfeeding, as brotizolam passes into breast milk.

Driving and using machines
This medicine may cause side effects such as drowsiness (sedation), memory lapses (amnesia), and reduced motor coordination, especially if you have not rested enough, or if you are simultaneously consuming alcohol or other medicines affecting the central nervous system (CNS depressants). If this occurs, avoid driving vehicles and operating machinery.

BROTIZOLAM EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

BROTIZOLAM EG contains sodium starch glycolate
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take BROTIZOLAM EG

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
Begin treatment with BROTIZOLAM EG at the lowest recommended dose. The maximum recommended dose is 0.25 mg; do not exceed this dose.
Treatment with this medicine should be as short as possible and should not last longer than two weeks. If your doctor considers it necessary, they may extend the duration of treatment.
Your doctor will gradually reduce the dose according to your health condition.
Take this medicine with a glass of water in the evening before going to bed, and make sure you have at least 6–7 hours available to rest or sleep.

Adults
The recommended dose is 0.25 mg (1 tablet), unless otherwise prescribed by your doctor.

Elderly
The recommended dose ranges from 0.125 mg (half a tablet) to 0.25 mg (one whole tablet).
If you have liver problems, your doctor will reduce the dose.

If you take more BROTIZOLAM EG than you should
An overdose of this medicine can be very dangerous or even fatal if taken together with alcohol or medicines that act on the central nervous system (CNS depressants; see section “Other medicines and BROTIZOLAM EG”).
Symptoms of overdose include:

• confusion and reduced awareness or orientation (obnubilation), mental confusion, extreme tiredness (lethargy);
• in more severe cases: serious difficulty with movement (ataxia), reduced muscle strength (hypotonia), low blood pressure (hypotension), breathing difficulties (respiratory depression), rarely coma, and very rarely death.

If you accidentally take too much BROTIZOLAM EG, contact your doctor immediately or go to the nearest hospital.

If you forget to take BROTIZOLAM EG
Do not take a double dose to make up for the forgotten dose.

If you stop taking BROTIZOLAM EG
Do not stop treatment with BROTIZOLAM EG suddenly. Your doctor will decide when to discontinue treatment.
Stopping treatment abruptly increases the risk of withdrawal symptoms. Your doctor will advise you to gradually reduce the dose before completely stopping treatment.
Withdrawal symptoms may include:

• headache (cephalalgia);
• muscle pain;
• anxiety, tension, restlessness, confusion, irritability.

In severe cases of withdrawal, the following may occur:

• feeling that things are not real (derealization);
• feeling of detachment from the surrounding environment (depersonalization);
• intolerance to sound (hyperacusis);
• numbness and tingling in hands and feet;
• sensitivity to light, noise, and physical touch;
• hallucinations (seeing or hearing things that are not real);
• epileptic seizures.

If you have any questions about how to use 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.
You may experience side effects mainly at the beginning of treatment, and they usually gradually disappear.
The risk of withdrawal symptoms (e.g. rebound phenomena, mood changes, anxiety, and restlessness) increases with the duration of treatment, which should not exceed two weeks.

The following side effects may occur:
Common (may affect up to 1 in 10 people):

• drowsiness, headache (cephalalgia);
• stomach and intestinal problems (gastrointestinal disorders).

Uncommon (may affect up to 1 in 100 people):

• nightmares, drug dependence, depression, mood alteration, anxiety, emotional disturbances, abnormal behaviour, agitation, disturbances in sexual desire (libido);
• dizziness, sedation, difficulty in coordinating movements (ataxia), memory gaps (anterograde amnesia), dementia, mental impairment, reduced coordination abilities (reduced psycho-motor performance);
• double vision (diplopia);
• dry mouth;
• liver problems (hepatic disorders, jaundice);
• skin disorders (skin reactions);
• muscle weakness;
• withdrawal syndrome, rebound phenomena, paradoxical reactions, irritability, feeling of fatigue;
• altered results in certain liver function tests.

Rare (may affect up to 1 in 1,000 people):

• confusion, restlessness;
• reduced level of consciousness.

Frequency not known (frequency cannot be estimated from the available data):

• reduced concentration and attention level, which may lead to traffic accidents and falls;
• physical dependence, psychological dependence; after discontinuation of treatment (see sections “Warnings and precautions” and “If you stop taking BROTIZOLAM EG”) withdrawal effects or other effects known as rebound phenomena may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BROTIZOLAM EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BROTIZOLAM EG contains

• The active substance is brotizolam. Each tablet contains 0.25 mg of brotizolam.
• The other components are: monohydrate lactose, microcrystalline cellulose, maize starch, sodium starch glycolate, magnesium stearate, gelatin.

Description of the appearance of BROTIZOLAM EG and contents of the pack
Pack containing 30 divisible tablets.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Manufacturer
Doppel Farmaceutici S.r.l - Via Volturno, 48 - 20089 Quinto de' Stampi - Rozzano (MI)