Brotizolam Mylan: detailed information

Package leaflet: Information for the patient

BROTIZOLAM MYLAN 0.25 mg tablets

Generic 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What BROTIZOLAM MYLAN is and what it is used for
What you need to know before taking BROTIZOLAM MYLAN
How to take BROTIZOLAM MYLAN
Possible side effects
How to store BROTIZOLAM MYLAN
Contents of the pack and other information

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

BROTIZOLAM MYLAN contains the active substance 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 and over, in cases where the condition is severe, disabling and causes the person severe distress.

2. What you should know before taking BROTIZOLAM MYLAN

Do not take BROTIZOLAM 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 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 apnoea);
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 MYLAN:

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”);
if you have respiratory problems (chronic respiratory insufficiency) or excess carbon dioxide in the blood due to lung problems (hypercapnia), as you may experience severe breathing difficulties, especially at night (respiratory depression);
if you suffer from mental disorders (psychosis) or depression and anxiety; in this case, consult your doctor, as BROTIZOLAM MYLAN may need to be taken in combination with other medicines; particularly, if you suffer from depression and anxiety and take only this medicine, you may develop suicidal behaviour.
if you have previously abused alcohol or drugs.

During treatment with this medicine:

you may experience a decrease in effectiveness (tolerance); if this occurs, consult your doctor;
you may feel the need to continue taking the medicine (physical and psychological dependence). The risk increases with higher doses and longer 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 special attention if dependence develops. In this case, do not stop treatment abruptly, as withdrawal symptoms may occur (withdrawal symptoms, see section 3 “If you stop taking BROTIZOLAM MYLAN”);
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 MYLAN;
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 may need to be discontinued (see section 4 “Possible side effects”). These reactions are more frequent in children and the elderly.

After stopping treatment, rebound symptoms may occur, meaning you may experience, more intensely, the symptoms that led you to take this medicine (see 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 doses and if your dose is high.

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

Other medicines and BROTIZOLAM MYLAN
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 cause an increased sense of well-being (euphoria) when taken with BROTIZOLAM MYLAN. This may increase your desire to continue taking these medicines (psychological dependence);
antiepileptics, medicines used to treat epilepsy;
anaesthetics, medicines used during surgical procedures, causing temporary loss of sensation, pain, and in some cases loss of consciousness, associated with muscle relaxation;
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 activity of BROTIZOLAM MYLAN may be enhanced if taken together with other medicines that reduce central nervous system activity, increasing their effects.
Concomitant use of BROTIZOLAM MYLAN and opioids (strong painkillers, medicines for addiction 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 possible.
However, if your doctor prescribes BROTIZOLAM MYLAN together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Consult your doctor if you experience such symptoms.

BROTIZOLAM MYLAN and alcohol
Avoid 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take BROTIZOLAM MYLAN during pregnancy.
Although not recommended, if your doctor considers it necessary for you to take BROTIZOLAM MYLAN in the late stages of pregnancy or during labour, be aware that your baby may be born with low body temperature (hypothermia), muscle weakness (hypotonia), and breathing difficulties (“Floppy Infant Syndrome” or infantile hypotonia).
In addition, if BROTIZOLAM MYLAN has been taken regularly during the late 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.

Fertility
There are no fertility data available for this medicine. Studies conducted with brotizolam have not shown negative effects on fertility.

Driving and using machines
This medicine may cause side effects such as drowsiness (sedation), memory lapses (amnesia), and reduced coordination. These effects may impair your ability to drive or operate machinery. Furthermore, these side effects may be intensified if you have not had sufficient rest, or if you consume alcohol or take other medicines used to treat mental disorders (CNS depressants). If this occurs, avoid driving and using machinery.

BROTIZOLAM MYLAN contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor 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 exactly as directed by your doctor or pharmacist. If you have
any doubts, consult 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 (one whole tablet) in the evening before
going to bed.
Begin treatment with BROTIZOLAM MYLAN at the lowest recommended dose. The maximum
recommended dose is 0.25 mg. Do not exceed this dose due to the increased risk of central nervous system
side effects (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 show that dose adjustment is not necessary in patients with impaired
renal function.
Use in chronic respiratory disorders (chronic respiratory insufficiency)
If you suffer from chronic respiratory insufficiency (a long-term respiratory disease causing inadequate
levels of oxygen and/or carbon dioxide in the blood), associated with increased levels of 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 ensure that you have at least
6–7 hours available for rest or sleep.
Duration of treatment
Treatment with this medicine should be as short as possible. The duration of treatment varies from a few days
to a maximum of 2 weeks. Your doctor will individually adjust the gradual reduction of the dose. In certain
cases, your doctor may decide to extend the treatment after evaluating your health status.
If you take more BROTIZOLAM MYLAN than you should
In case of accidental ingestion/overdose of BROTIZOLAM MYLAN, contact your doctor immediately or go to
the nearest hospital.
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 MYLAN”).
Symptoms of overdose include:

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

If you forget to take BROTIZOLAM MYLAN
Do not take a double dose to make up for the missed dose.
If you stop taking BROTIZOLAM MYLAN
Do not stop treatment with BROTIZOLAM MYLAN abruptly. Your doctor will decide when to discontinue
treatment.
Since the risk of withdrawal symptoms is higher if treatment is stopped suddenly, 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 unreal (derealization);
feeling detached from the surrounding environment (depersonalization);
sensitivity to sounds (hyperacusis);
numbness and tingling in hands and feet;
sensitivity to light, noise, and physical contact;
hallucinations (seeing or hearing things that are not real);
epileptic seizures.

After stopping treatment, rebound phenomena may occur, meaning the symptoms that led you to take this
medicine may return more intensely. You may also experience other symptoms such as mood changes,
anxiety, and restlessness.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects occur mainly at the beginning of treatment and usually disappear gradually. The risk of withdrawal symptoms (e.g. rebound phenomena, mood changes, anxiety and restlessness) increases with the duration of treatment, which must 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 disorders, abnormal behaviour, agitation, disturbances in sexual desire (libido disorder);
dizziness, sedation, difficulty in coordinating movements (ataxia), memory gaps (anterograde amnesia), dementia, mental alteration, reduced coordination abilities (reduced psychomotor 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;
alteration of test results for certain liver function tests.

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

confusion, restlessness;
reduced levels of consciousness.

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

reduced concentration and attention levels, 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 MYLAN), 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, please inform your doctor or pharmacist. You may also report side effects directly via 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 stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BROTIZOLAM MYLAN 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 MYLAN and the contents of the pack
White to almost white, round tablets with a score line, packed in PVC/PVDC/AL blisters containing 30 tablets.
The tablet can be divided into equal doses.

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

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