Triazolam Zentiva: detailed information

Package leaflet: information for the patient

Triazolam Zentiva 0.125 mg tablets, 0.25 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you take 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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you should know before taking 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 causing muscle weakness and fatigue;
if you have severe respiratory problems (severe respiratory insufficiency) or breathing problems during sleep (sleep apnoea syndrome);
if you have severe liver problems (severe hepatic insufficiency);
if the person taking the medicine is a child (see section “Children and adolescents”);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
if you are taking ketoconazole or itraconazole (antifungal medicines used for fungal infections), 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 mild or moderate liver problems (hepatic insufficiency);
you have respiratory problems (impaired respiratory function);
you are simultaneously taking other substances that depress the central nervous system (e.g. other medicines and alcohol);
you have a history of alcohol or drug abuse;
you suffer from depression or other mental illnesses. Benzodiazepines, the class of medicines 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 initially prescribe a lower dose.

Taking this medicine may cause:
Tolerance: if after a few weeks it seems to you that the medicine is less effective, consult your doctor.
Dependence: when taking this medicine, there is a risk of dependence, i.e. the need to continue taking the medicine, which may lead to excessive use (abuse). The risk increases with dose and duration of treatment; it is higher if you have previously abused drugs or alcohol. If the medicine is taken at the prescribed dose and for a short-term treatment, the risk of dependence is reduced.
Amnesia: this medicine may cause amnesia (memory loss), which does not affect past memories (anterograde amnesia), particularly several hours after taking the medicine. To reduce the risk of amnesia, ensure an uninterrupted sleep of 7–8 hours.
Behavioural reactions: if you experience behavioural disturbances (such as restlessness, agitation, irritability, aggressiveness, delirium, anger, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis (a serious mental condition in which a person loses contact with reality and the ability to think and judge clearly), inappropriate behaviour, and other behavioural changes), contact your doctor immediately, who may decide to discontinue the medicine (see section “Possible side effects”). These effects are more likely if you have consumed alcohol or other medicines acting on the central nervous system. Such reactions are more frequent in children and elderly patients.
Duration of treatment: the duration of treatment should be as short as possible. It usually ranges from 7 to 10 days, up to a maximum of four weeks, including a gradual withdrawal period during which the dose should be progressively reduced.
Discontinuation of treatment and withdrawal: when stopping this medicine, you may experience a temporary condition in which the disorder that led to benzodiazepine treatment reappears in a worsened form (rebound insomnia). Other disturbances may also occur, such as mood changes, anxiety, restlessness, or sleep disturbances (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 include: headache, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following may occur: derealisation (feeling that things are unreal), depersonalisation (feeling of detachment from the surrounding environment), intolerance to sound (hyperacusis), numbness and tingling in hands and feet (paraesthesiae), hypersensitivity to light, noise, and physical contact, hallucinations (seeing and hearing things that do not exist), or epileptic seizures (sudden, uncontrollable movements).
To minimise the occurrence of such 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 between doses, especially at high dosages (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 18 years of age.
Other medicines and Triazolam Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take this medicine if you are taking:

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

Pay special attention and inform your doctor if you are taking the following medicines:

painkillers (narcotic analgesics); the use of narcotic analgesics may increase the risk of dependence;
medicines that, by acting on certain liver enzymes, interfere with the elimination of triazolam;
cimetidine, a medicine for ulcers;
macrolide antibiotics such as erythromycin, clarithromycin, and troleandomycin, used for bacterial infections;
fluvoxamine, sertraline, paroxetine, used to treat mental disorders;
isoniazid and rifampicin, used to treat tuberculosis;
diltiazem and verapamil, used to treat high blood pressure;
oral contraceptives, medicines used to prevent pregnancy;
imatinib, a medicine used to treat certain tumours;
medicines for treating epileptic seizures (antiepileptics) such as carbamazepine;
HIV protease inhibitors (such as ritonavir) and efavirenz, used in the treatment of AIDS;
aprepitant, used to prevent vomiting;
substances that depress the central nervous system (antipsychotics/neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants, anaesthetics, and sedative antihistamines).

Concomitant use of Triazolam Zentiva 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 Triazolam Zentiva together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and follow the doctor’s dose recommendations carefully. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Triazolam Zentiva with food, drinks, and alcohol
Do not consume 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, as grapefruit juice may increase triazolam levels in the blood and thus its effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Triazolam Zentiva if you are pregnant or become pregnant during treatment with this medicine, as it may cause serious harm to the newborn, including birth defects (see section “Do not take Triazolam Zentiva”).
If triazolam is administered in late pregnancy or during labour at high doses, effects on the newborn may include: hypothermia (lowered body temperature), hypotonia (reduced 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 may impair your ability to drive or operate machinery, as it may cause drowsiness (even during the day) and dizziness, and altered alertness. These effects are increased if you have not slept enough or if you have consumed alcohol. If this occurs, do not drive or operate machinery.
Triazolam Zentiva contains lactose
This medicine contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Triazolam Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take this medicine for the shortest possible time.
Generally, the duration of treatment, which should be adjusted according to the individual needs of each patient,
ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period. After reassessing your condition, your doctor may decide, if appropriate, to extend the maximum treatment period.
Treatment should be initiated 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 whole with a little 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 excessive dose of Triazolam Zentiva, contact your doctor immediately or go to the nearest hospital emergency department.
Symptoms of overdose may be mild, such as drowsiness, slurred speech, or more severe, such as disturbances in movement and motor coordination (ataxia, hypotonia), serious breathing problems (respiratory depression), and coma. Among these effects, the most severe ones are rare unless other medicines or alcohol have been taken together with excessive amounts of Triazolam Zentiva.

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

If you stop taking Triazolam Zentiva
Never stop treatment with Triazolam Zentiva abruptly or without consulting your doctor, as withdrawal effects may occur, especially if you have taken triazolam at high doses and for a long time (see section “Warnings and precautions – Discontinuation of treatment and withdrawal”).
If your doctor decides to stop treatment, they will advise you on how to gradually reduce the dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 treatment and usually disappear with continued therapy.
Other side effects have occasionally been reported, such as gastrointestinal disorders, skin reactions, and changes in sexual desire.

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 (frequency cannot be estimated from the available data)

Sudden allergic reactions, potentially fatal (anaphylactic shock, anaphylactoid reactions sometimes severe), swelling due to fluid accumulation (angioedema, allergic edema), hypersensitivity;
Aggression, hallucinations, sleepwalking, memory loss (anterograde amnesia), restlessness, agitation, irritability, delirium, rage, nightmares, psychosis, abnormal behaviour (see section “Warnings and precautions”);
Temporary loss of consciousness (syncope), sedation, reduced level of consciousness, speech disorders, attention disturbances, distortion of taste sensation (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 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 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 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Triazolam Zentiva contains
Triazolam Zentiva 0.125 mg tablets
The active substance is triazolam. Each tablet contains 0.125 mg of triazolam.
The other components are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica,
sodium dioctyl sulfosuccinate, sodium benzoate, maize starch, magnesium stearate, indigotine (E 132),
erythrosine (E 127), aluminium oxide hydrate.

Triazolam Zentiva 0.25 mg tablets
The active substance is triazolam. Each tablet contains 0.25 mg of triazolam.
The other components are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica,
sodium dioctyl sulfosuccinate, sodium benzoate, maize starch, magnesium stearate, indigotine (E 132),
aluminium oxide hydrate.

Description of the appearance of Triazolam Zentiva and pack contents
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 Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa 7, 20121 Milano, Italy

Manufacturer
ICE S.p.A., Canton Moretti 29, 10015 San Bernardo d'Ivrea (TO), Italy