TRIAZOLAM 0.125 MG Таблетки

Содержание инструкции

1. Triazolam Zentiva 0.125 mg tablets, 0.25 mg tablets
   1. What is Triazolam Zentiva and what is it used for?
   2. What you need to know before you take Triazolam Zentiva
   3. How to take Triazolam Zentiva
   4. Possible side effects
   5. How to store Triazolam Zentiva
   6. Contents of the pack and other information

Triazolam Zentiva 0.125 mg tablets, 0.25 mg tablets

Generic medicine

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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Triazolam Zentiva and what is it used for?

This medicine contains the active ingredient triazolam, which belongs to a group of medicines called
benzodiazepines. This medicine is indicated for treating sleep disorders (insomnia) only when they are
severe, disabling or cause significant distress.
Triazolam Zentiva is indicated for the short-term treatment of insomnia.

2. What you need to know before you take Triazolam Zentiva

Do not take Triazolam Zentiva

• if you are allergic to triazolam, 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 serious breathing problems (severe respiratory failure) and breathing problems during sleep (sleep apnea syndrome);
• if you have serious liver problems (severe hepatic insufficiency);
• if the person who is going to take the medicine is a child (see section “Children and adolescents”);
• if you are pregnant or if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if you are taking ketoconazole or itraconazole (antifungal medicines, used for infections caused by fungi), nefazodone (a medicine used to treat depression) or efavirenz (a medicine used in the treatment of AIDS) (see section “Other medicines and Triazolam Zentiva”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Triazolam Zentiva.

Take this medicine with caution if:

• you have liver problems (hepatic insufficiency) of mild or moderate severity;
• you have breathing problems (impaired respiratory function);
• you are also taking other substances that depress the central nervous system (e.g. other medicines and alcohol) at the same time;
• you have a history of alcohol and drug abuse;
• you suffer from depression or other mental illnesses. Benzodiazepines, the class to which this medicine belongs, should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients;
• you are elderly or debilitated. In this case, your doctor will prescribe a lower dose at the beginning of treatment.

Taking this medicine may cause:

Tolerance:if after a few weeks you feel that the medicine is working less, contact your doctor.

Dependence:when you take this medicine, the risk of dependence may arise, i.e. the need
to continue taking the medicine, which can lead to excessive use (abuse). The risk increases with
the dose and duration of treatment; it is greater if you have abused drugs or alcohol in the past. If the
medicine is taken at the prescribed dose and with a short-term treatment, the risk of dependence is
reduced.

Amnesia:this medicine can induce amnesia (memory loss), which does not impair past memories
(anterograde amnesia), especially several hours after ingestion of the medicine. To reduce the
risk of amnesia, ensure uninterrupted sleep of 7-8 hours.

Behavioral reactions:if you experience behavioral disturbances (such as restlessness, agitation,
irritability, aggression, delirium, anger, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis
(a serious condition of the mind in which a person loses contact with reality and the ability to
think and judge clearly), inappropriate behavior and other behavioral alterations), contact your doctor
immediately, who may decide to stop taking the medicine
(see section “Possible side effects”). These effects are more likely if you have consumed alcohol or
other medicines that act on the central nervous system. Such reactions are more frequent in children and
the elderly.

Duration of treatment:the duration of treatment should be as short as possible. It generally ranges
from 7 to 10 days, up to a maximum of four weeks, including a period of gradual withdrawal, during which
the dose must be progressively reduced.

Discontinuation of treatment and withdrawal:when you stop taking this medicine, you may
experience a temporary situation in which the disorder that led to treatment with benzodiazepines
reappears in an aggravated form (rebound insomnia). Other disturbances such as
mood changes, anxiety, restlessness or sleep disturbances may also occur (see section “If you stop taking
Triazolam Zentiva”).
If dependence has developed during treatment, abrupt discontinuation of treatment will be
accompanied by withdrawal symptoms, which may consist of: headache, muscle pain, severe
anxiety, tension, restlessness, confusion and irritability. In severe cases, the following may occur: derealization
(feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment
), intolerance to sounds (hyperacusis), numbness and tingling of hands and feet (paresthesia),
hypersensitivity to light, noise and physical contact, hallucinations (seeing and hearing things that do not exist)
or seizures (sudden and uncontrollable movements).
To minimize the occurrence of these symptoms, it is recommended to gradually reduce the dose (see
section “If you stop taking Triazolam Zentiva”).
For a benzodiazepine with a short duration of action, such as Triazolam Zentiva, withdrawal symptoms
may also occur in the interval between two administrations, especially with high doses
(see section “If you take more Triazolam Zentiva than you should”).

Children and adolescents
The use of Triazolam Zentiva is contraindicated in children and adolescents under the age of 18 years.

Other medicines and Triazolam Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Do not take this medicine if you are taking:

• ketoconazole and itraconazoleand other medicines used in the treatment of fungal infections (antifungals);
• nefazodone(a medicine used to treat depression);
• efavirenz(a medicine used in the treatment of AIDS).

Be particularly careful and tell your doctor if you are taking the following medicines:

• pain medicines(narcotic analgesics), with the use of narcotic analgesics can increase the risk of dependence;
• medicines that, by acting on certain liver enzymes, interfere with the eliminationof triazolam;
• cimetidine, a medicine for ulcers;
• macrolide antibioticssuch as erythromycin, clarithromycin and troleandomycin, used for bacterial infections;
• fluvoxamine, sertraline, paroxetine, used to treat mental health problems;
• isoniazidand rifampicinused for the treatment of tuberculosis;
• diltiazemand verapamilused to treat high blood pressure;
• oral contraceptives, medicines used to prevent pregnancy;
• imatinib, a medicine to treat some cancers;
• medicines for the treatment of seizures(antiepileptics) such as carbamazepine;
• HIV protease inhibitors(such as ritonavir) and efavirenz, used in the treatment of AIDS;
• aprepitant, used against vomiting;
• substances that act on the central nervous system depressingly (antipsychotics/neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants, anesthetics and sedative antihistamines).

The concomitant use of Triazolam Zentiva and opioids (strong painkillers, medicines for addiction therapy and some cough medicines) increases the risk of drowsiness, difficulty 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 Triazolam Zentiva 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 family members to watch out for
the above symptoms.

Triazolam Zentiva with food, drinks and alcohol
Do not drink alcohol during treatment with Triazolam Zentiva, as it may increase the sedative
effect of the medicine.
Avoid drinking grapefruit juice during treatment with this medicine because grapefruit juice can increase the levels of triazolam in the blood and therefore its effects.

Pregnancy and breastfeeding.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not take Triazolam Zentiva if you are pregnant or become pregnant during treatment
with this medicine as it can cause damage to the newborn, even serious malformations (see
section “Do not take Triazolam Zentiva”).
If triazolam is administered in late pregnancy, or during childbirth, at high doses, it
can cause effects on the newborn such as: hypothermia (decrease in temperature), hypotonia
(decreased muscle strength) and moderate respiratory depression.

Breastfeeding
Do not take this medicine if you are breastfeeding (see section “Do not take Triazolam
Zentiva”).

Driving and using machines
Triazolam Zentiva can alter your ability to drive vehicles and operate machinery because it can cause
daytime drowsiness and dizziness, altered alertness. These effects increase if you have not slept
enough or if you have consumed alcohol. If this happens to you, do not drive vehicles and do not use machinery.

Triazolam Zentiva contains lactose
This medicine contains lactose monohydrate. If your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.

3. How to take Triazolam Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take this medicine for the shortest possible time.
Generally, the duration of treatment, which must be adapted to the individual needs of each patient,
ranges from a few days to two weeks, up to a maximum of four weeks, including a period of
gradual discontinuation. After re-evaluating your condition, if deemed appropriate, the doctor may
decide to extend the maximum treatment period.
Treatment should be started with the lowest recommended dose.
The maximum dose must not be exceeded.
The recommended dose in adults is 0.125 - 0.25 mg per day.
Swallow the Triazolam Zentiva tablets without chewing with some water or other liquid before
going to bed.

Use in the elderly and in patients with liver and/or kidney problems
The recommended dose is 0.125 mg per day in the elderly and in patients with liver and/or kidney problems.

If you take more Triazolam Zentiva than you should
If you (or someone else) have taken an overdose of Triazolam Zentiva, contact your
doctor immediately or go to the nearest hospital emergency room.
The symptoms of an overdose may be mild, such as drowsiness, difficulty speaking, or severe
such as movement and motor coordination disorders (hypotonia ataxia), serious
breathing problems (respiratory depression) and coma. Among these effects, the most serious are rare unless you
have also taken other medicines or alcohol together with excessive amounts of Triazolam Zentiva.

If you forget to take Triazolam Zentiva
Do not take a double dose to make up for a missed tablet.

If you stop taking Triazolam Zentiva
Never stop treatment with Triazolam Zentiva abruptly or without having agreed with your
doctor because withdrawal effects may occur, especially if you have
taken triazolam at high doses and for a long time (see paragraph “Warnings and precautions -
Discontinuation of treatment and withdrawal”).
If the doctor has decided to stop the treatment, he will indicate how to reduce the dose gradually.
If you have any doubts 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.
Drowsiness during the day, numbness, reduced alertness, confusion, fatigue, headache, dizziness, muscle
weakness, loss of coordination (ataxia) or double vision may occur mainly at the beginning of therapy and
usually disappear with continued treatment.
Occasionally, other side effects such as gastrointestinal disorders, skin reactions and changes in sexual
desire have been reported.

Common(may affect up to 1 in 10 people)

• Drowsiness, dizziness, loss of coordination (ataxia), headache.

Uncommon(may affect up to 1 in 100 people)

• Confusional state, insomnia;
• Memory disorders;
• Vision problems.

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

• Skin irritation (rash);
• Muscle weakness (myasthenia).

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

• Sudden, potentially life-threatening allergic reactions (anaphylactic shock, anaphylactoid reactions sometimes severe), swelling due to fluid retention (angioedema, allergic edema), hypersensitivity;
• Aggression, hallucinations, sleepwalking, memory loss (anterograde amnesia), restlessness, agitation, irritability, delirium, anger, nightmares, psychosis, abnormal behaviour (see section “Warnings and precautions”);
• Temporary loss of consciousness (syncope), sedation, reduced level of consciousness, speech disorders, attention disorders, distorted sense of taste (dysgeusia);
• Worsening of breathing (respiratory depression) in patients who already have respiratory diseases;
• Changes in libido (alterations in sexual desire);
• Falls.

This medicine can cause dependence (see section “Warnings and precautions”).

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
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 Triazolam Zentiva

This medicine does not require any special storage conditions.
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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Triazolam Zentiva contains
Triazolam Zentiva 0.125 mg tablets
The active ingredient is triazolam. Each tablet contains 0.125 mg of triazolam.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica,
dioctylsulfosuccinate sodium, sodium benzoate, corn starch, magnesium stearate, indigotine (E 132),
erythrosine (E 127), hydrated aluminum oxide.

Triazolam Zentiva 0.25 mg tablets
The active ingredient is triazolam. Each tablet contains 0.25 mg of triazolam.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica,
dioctylsulfosuccinate sodium, sodium benzoate, corn starch, magnesium stearate, indigotine (E 132), aluminum
oxide hydrate.

Description of the appearance of Triazolam Zentiva and contents of the pack
0.125 mg tablets: pack of 10 tablets
0.125 mg tablets: pack of 20 tablets
0.25 mg tablets: pack of 10 tablets
0.25 mg tablets: pack of 20 tablets.

Marketing Authorisation Holder
Zentiva Italia S.r.l. - Viale Bodio 37/B - 20158 Milan

Manufacturer
ABC Farmaceutici S.p.A., Via Cantone Moretti 29, Località San Bernardo, 10015 Ivrea (TO)