BROTIZOLAM 0.25 MG Coated tablet

Зміст інструкції

1. BROTIZOLAM MYLAN 0,25 mg tablets
   1. What is BROTIZOLAM MYLAN and what it is used for
   2. What you need to know before you take BROTIZOLAM MYLAN
   3. How to take BROTIZOLAM MYLAN
   4. Possible side effects
   5. How to store BROTIZOLAM MYLAN
   6. Contents of the pack and other information

BROTIZOLAM MYLAN 0,25 mg tablets

Equivalent Medicinal Product
Read this leaflet carefully before taking this medicine as 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any undesirable effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

BROTIZOLAM MYLAN contains the active ingredient brotizolam which belongs to a group of
medicines called benzodiazepines.
This medicine is indicated for the short-term treatment of insomnia in adults aged 18 years or
over, in cases where the disorder is severe, disabling and subjects the person to severe discomfort.

2. What you need to know before you take BROTIZOLAM MYLAN

Do not takeBROTIZOLAM MYLAN

• 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 that causes muscle weakness and fatigue;
• if you have severe breathing problems (severe respiratory failure);
• if you have severe liver problems (severe hepatic failure);
• if you have problems breathing during sleep (sleep apnea);
• if the patient is a child or adolescent under the age of 18 years.

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

• if you are elderly and/or suffer from liver problems (reduced liver function). In this case, the doctor may decide to reduce the dose (see section 3 “Use in the elderly”);
• if you have breathing problems (chronic respiratory failure) or an excess of carbon dioxide in the blood due to lung problems (hypercapnia), as you may have severe breathing problems, especially at night (respiratory depression);
• if you suffer from mental disorders (psychoses) or depression and anxiety; in this case, consult your doctor because it is necessary to take BROTIZOLAM MYLAN in association with other medicines; in particular if you suffer from depression and anxiety and only take this medicine, you may experience behaviors with a tendency to suicide.
• if you have previously abused alcohol or drugs

During treatment with this medicine:

• a decrease 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 based on 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, do not take BROTIZOLAM MYLAN. Pay particular attention if you experience dependence. In this case, do not abruptly stop treatment with this medicine, as withdrawal symptoms (abstinence, see section 3 “If you stop taking BROTIZOLAM MYLAN”) may occur;
• 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, make sure you get 7-8 hours of uninterrupted sleep after taking BROTIZOLAM MYLAN.
• if you are depressed, you may experience worsening of its symptoms;
• you may experience behavioral disorders (psychiatric and paradoxical reactions) such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis and other behavioral disorders. If you experience these disorders, consult your doctor as treatment needs to be stopped (see section 4 “Possible side effects”). Such reactions are more common in children and the elderly.

After stopping treatment, some symptoms known as rebound phenomena may occur, that is to say
you may experience, more intensely, the symptoms that led you to take this medicine (see the
section “If you stop taking BROTIZOLAM MYLAN”).
The duration of treatment should be as short as possible and should not exceed 2 weeks. Treatment
with this medicine will be discontinued by gradually reducing the dose to minimize the occurrence of
withdrawal symptoms (see section 3 “If you stop taking BROTIZOLAM MYLAN”). However, you may still experience these symptoms, especially between taking one dose and
the next and if the dose you are taking is high.

Children and adolescents
BROTIZOLAM MYLAN should not be used in children and adolescents under 18 years of age.

Other medicines andBROTIZOLAM MYLAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Pay particular attention and tell 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 and that can cause an increase in the feeling of well-being (euphoria) when taken with BROTIZOLAM MYLAN. This can increase your desire to continue taking these medicines (psychological dependence);
• antiepileptics, medicines used to treat epilepsy;
• anesthetics, medicines used during surgical operations, which cause a temporary loss of sensitivity, pain, and in some cases also consciousness, associated with muscle relaxation;
• antihistamines with a sedative effect, medicines used to treat allergies and that can induce drowsiness;
• rifampicin, used to treat infections caused by bacteria;
• ketoconazole, used to treat fungal infections.

The activity of BROTIZOLAM MYLAN may be increased if it is prescribed together with other medicines that
act by reducing the activity of the central nervous system, increasing their effects.
The concomitant use of BROTIZOLAM MYLAN and opioids (strong painkillers, medicines for
addiction therapy and some medicines for cough) increases the risk of drowsiness, difficulty in
breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes BROTIZOLAM MYLAN together with opioids, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow your doctor's
recommendations on dosage. It may be helpful to inform friends or relatives to watch out for
the signs and symptoms listed above. See a doctor if you experience such symptoms.

BROTIZOLAM MYLANwith alcohol
Avoid drinking alcohol during treatment with this medicine because you may experience a feeling of
dizziness (increased sedative effect), fatigue and difficulty concentrating (see the section “Driving
and using machines”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take BROTIZOLAM MYLAN during pregnancy.
Although not recommended, if your doctor believes that you must necessarily take
BROTIZOLAM MYLAN in the late stages of pregnancy or during labor, you should be aware that
your baby may experience a low body temperature (hypothermia), muscle weakness (hypotonia) and difficulty breathing (“Floppy Infant Syndrome” or infant hypotonia) at birth.
In addition, if BROTIZOLAM MYLAN has been taken regularly during the late stages of pregnancy, your
baby may experience physical dependence or withdrawal symptoms.

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

Fertility
There is no data available for this medicine on fertility. Studies conducted with brotizolam have not
shown any adverse effects on fertility.

Driving and using machines
This medicine can cause side effects such as drowsiness (sedation), memory lapses
(amnesia), reduced ability to coordinate movements. These effects can impair your ability to drive
vehicles and use machines. Furthermore, these side effects are enhanced if you have not had
enough rest, if you drink alcohol at the same time or if you take other medicines used to treat
mental disorders (depressants of the central nervous system). If this happens, avoid driving
vehicles and using machines.

BROTIZOLAM MYLANcontains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact
them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.

3. How to take BROTIZOLAM MYLAN

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Adults aged 18 years and over
The recommended dose is 0.25 mg (1 tablet) in the evening before going to bed.

Use in the elderly
The recommended dose ranges from 0.125 mg (half a tablet) to 0.25 mg (whole tablet) in the evening before
going to bed.
Start treatment with BROTIZOLAM MYLAN with the lowest recommended dose. The maximum
recommended dose is 0.25 mg, do not exceed this dose due to the increased risk of adverse effects
on the central nervous system (see section 4 “Possible side effects”).

Use in hepatic impairment
If you have liver problems, your doctor will reduce the dose.

Use in renal impairment
Available data demonstrate that dose adjustment is not necessary in case of renal
impairment.

Use in chronic respiratory disorders (chronic respiratory failure)
If you suffer from chronic respiratory failure (a long-lasting respiratory disease, which involves an
inadequate supply of oxygen and/or carbon dioxide in the blood) accompanied by increased carbon dioxide
in the blood (hypercapnia), your doctor may reduce the dose of this medicine, as it may
increase the risk of reduced respiratory activity (respiratory depression), especially during the
night.

Use in children and adolescents
BROTIZOLAM MYLAN is contraindicated in children and adolescents under 18 years of age (see
section 2 “Do not take BROTIZOLAM MYLAN”).

Method of administration
Take this medicine with a little water in the evening before going to bed and make sure you have
at least 6-7 hours available to rest or sleep.

Duration of treatment
Treatment with this medicine should be as short as possible. The duration of treatment ranges from
a few days to a maximum of 2 weeks. Your doctor will adjust the gradual dose reduction on an
individual basis. In certain cases, your doctor may decide to prolong the treatment, after assessing your
health conditions.

If you take moreBROTIZOLAM MYLANthan you should
In case of accidental ingestion/intake of an excessive dose of BROTIZOLAM MYLAN, immediately
inform your doctor or go to the nearest hospital.
An excessive dose of this medicine can be very dangerous or fatal if you take
alcohol or medicines that act on the central nervous system (central nervous system depressants, see the
section “Other medicines and BROTIZOLAM MYLAN”).
Symptoms of overdose are:

• confusion and decreased awareness or reason (obnubilation), mental confusion, severe fatigue (lethargy);
• in more severe cases, symptoms may include: severe difficulty in movements (ataxia), reduced muscle strength (hypotonia), low blood pressure (hypotension), difficulty breathing (respiratory depression), rarely coma and very rarely death.

If you forget to takeBROTIZOLAM MYLAN
Do not take a double dose to make up for a missed dose.

If you stop takingBROTIZOLAM MYLAN
Do not suddenly stop treatment with BROTIZOLAM MYLAN. Your doctor will decide
when to stop treatment.
Because the risk of withdrawal symptoms is greater if treatment is stopped
abruptly, your doctor will advise you to gradually reduce the dose before stopping treatment completely.
Withdrawal symptoms may include:

• headache;
• 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 sounds (hyperacusis);
• numbness and tingling of hands and feet;
• sensitivity to light, noise and physical contact;
• hallucinations (seeing and hearing things that do not exist);
• seizures.

After stopping treatment, rebound symptoms may occur, i.e. you may experience, more intensely, the symptoms that led you to take this medicine and you may
experience other symptoms such as mood changes, anxiety and restlessness.
If you have any 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.
Possible side effects occur mainly at the beginning of treatment and generally
disappear gradually. The risk of withdrawal symptoms (for example, 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;
• stomach and intestinal problems (gastrointestinal disorders).

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

• nightmares, drug dependence, depression, mood alteration, anxiety, emotional disorders, abnormal behaviour, agitation, decreased sexual desire (libido disorder);
• dizziness, sedation, difficulty coordinating movements (ataxia), memory loss (anterograde amnesia), dementia, mental alteration, reduction of coordination skills (reduction of psychomotor skills);
• 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;
• alteration of the results of some liver function tests.

Rare(may affect up to 1 in 1000 people):

• confusional state, restlessness;
• decreased level of consciousness.

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

• decreased concentration and degree of attention which can cause road traffic accidents and falls;
• physical dependence, psychological dependence; withdrawal effects or other effects known as rebound phenomena may occur after discontinuation of treatment (see sections Warnings and precautions and If you stop taking BROTIZOLAM MYLAN).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BROTIZOLAM MYLAN

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 any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What containsBROTIZOLAM MYLAN

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

Description of the appearance ofBROTIZOLAM MYLANand contents of the pack
Round tablets, white to almost white in color, with a score line, in packs of 30 tablets in
PVC/PVDC/AL blisters.
The tablet can be divided into equal doses.

Marketing Authorisation Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto dè Stampi - Rozzano (MI)