TRIAZOLAM 0.25 MG Tablets

Зміст інструкції

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

TRIAZOLAM EG 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 their symptoms are the same as yours, 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 EG is and what it is used for
• 2. What you need to know before you take TRIAZOLAM EG
• 3. How to take TRIAZOLAM EG
• 4. Possible side effects
• 5. How to store TRIAZOLAM EG
• 6. Contents of the pack and other information

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

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

2. What you need to know before you take TRIAZOLAM EG

Do not take TRIAZOLAM EG:

• if you are allergic to triazolam, similar medicines (benzodiazepines) or 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 suffer from severe breathing problems (severe respiratory failure) and breathing problems during sleep (sleep apnea syndrome);
• if you suffer from severe liver problems (severe hepatic failure);
• if you are pregnant or if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if you are taking ketoconazole and itraconazole (antifungal medicines, used for infections caused by fungi), nefazodone (antidepressant medicine) and efavirenz (medicine used in the treatment of AIDS).

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIAZOLAM EG.

Take this medicine with caution if:

• you suffer from liver problems (hepatic insufficiency) of mild or moderate severity;
• you suffer from breathing problems (compromised respiratory function);
• used in combination with other medicines that act on the central nervous system;
• you have a history of alcohol and drug abuse;
• you are elderly or debilitated. In this case, your doctor will need to prescribe a lower dose at the beginning of treatment.

Taking this medicine may cause:

• dependence, i.e. the need to continue taking the medicine. The risk increases with the dose and duration of treatment. It is greater if you have previously abused drugs or alcohol. Take this medicine for a short period of time (usually up to 7-10 days). The doctor will assess whether treatment for longer periods is necessary. If you use TRIAZOLAM EG for a few weeks, a loss of the medicine's effectiveness (tolerance) may occur. Take this medicine for as short a period as possible, and do not exceed four weeks of treatment;
• depressionwhich may also be accompanied by suicidal thoughts or actual suicide attempts. This can happen rarely and unpredictably. The doctor will assess whether to prescribe this medicine if you show signs and symptoms of depression or suicidal tendencies. TRIAZOLAM EG is not recommended for treating depression or anxiety associated with it;
• memory lossthat does not affect past memories (anterograde amnesia). This can happen even several hours after taking the medicine. To reduce the risk, you should try to have an uninterrupted sleep of 7-8 hours;
• behavioral changessuch as restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, inappropriate behavior or other changes. In this case, stop using the medicine. This can happen especially if you are elderly or children;
• sleep disturbancessuch as drowsiness while driving.

These effects occur especially if you have taken high doses of this medicine (see section “If
you take more TRIAZOLAM EG than you should”).
If you suddenly stop taking TRIAZOLAM EG, symptoms such as headache,
muscle pain, extreme anxiety, tension, restlessness, confusion and irritability may appear. In severe cases, the
following symptoms may occur: perceptual disturbances (derealization: feeling that things are not
real, depersonalization: feeling of detachment from the surrounding environment), numbness and
tingling of hands and feet, excessive sensitivity to light, intolerance to sounds (hyperacusis) and to contact
physical, hallucinations (seeing and hearing things that do not exist) or seizures.
A temporary worsening of insomnia, called rebound insomnia, may also occur
which may be accompanied by other reactions such as mood changes, anxiety or sleep disturbances and restlessness
(see section “If you stop treatment with TRIAZOLAM EG”).
Since the risk of withdrawal and rebound effects is greater following a sudden interruption of
treatment, gradually reduce the dosage.

Children and adolescents
The use of TRIAZOLAM EG is not recommended in children and adolescents under the age of 18 years.

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

Pay particular attention and tell your doctor if you are taking the following medicines:

• ketoconazole, itraconazole, nefazodoneand other azole medicines used in the treatment of fungal infections;
• cimetidine, a medicine for ulcers;
• macrolide antibioticssuch as erythromycin, clarithromycin, troleandomycin and rifampicin, used for bacterial infections;
• oral contraceptives, medicines used to prevent pregnancy;
• imatinib, a medicine to treat some cancers;
• fluvoxamine, sertraline, paroxetine, used to treat mental health problems;
• diltiazemand verapamilused to treat high blood pressure;
• isoniazidused for the treatment of tuberculosis;
• medicines for epilepsy(antiepileptics) such as carbamazepine;
• HIV protease inhibitors (ritonavir) and efavirenzused in the treatment of AIDS;
• aprepitant, used against vomiting;
• substances that act on the central nervous system depressing it (antipsychotics/neuroleptics, hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines);
• pain medicines(narcotic analgesics).

The concomitant use of TRIAZOLAM EG and opioids (strong painkillers, medicines for substitute therapy and
some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression),
coma and can be life-threatening. For this reason, concomitant use should only be considered when other
therapeutic options are not possible.
However, if your doctor prescribes TRIAZOLAM EG together with opioids, the dose and duration of therapy
concomitant must be limited by your 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 of the signs and symptoms described above.
Contact your doctor when these symptoms occur.

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

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

Pregnancy
Do not take TRIAZOLAM EG if you are pregnant or become pregnant during treatment with
this medicine because it can cause damage to the newborn, even serious, such as malformations.
If, for absolute medical necessity, triazolam must be administered to you in late pregnancy,
or during childbirth, at high doses, effects on the newborn such as hypothermia, hypotonia and
moderate respiratory depression, caused by the pharmacological action of the drug, may occur.
Babies exposed to benzodiazepines during the last trimester of pregnancy or during labor have
presented both floppy baby syndrome and neonatal withdrawal symptoms.

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

Driving and operating machinery
TRIAZOLAM EG can alter your ability to drive and operate machinery because it can cause
drowsiness, altered alertness, dizziness, sedation, memory loss (amnesia), difficulty
concentrating, muscle weakness. These effects are increased if you have not slept enough or if you have taken
alcohol. If this happens to you, do not drive and do not use machines.

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

TRIAZOLAM EG contains sodium benzoate
This medicine contains 0.15 mg of sodium benzoate per tablet.

TRIAZOLAM EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take TRIAZOLAM EG

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have
any 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. Sometimes it may be necessary to extend the maximum treatment period, in which
case, the doctor must reassess your condition more generally.
Treatment should be started with the lowest recommended dose.
The maximum dose must not be exceeded.
The doserecommended is0.125 - 0.25 mg per day.
Swallow the TRIAZOLAM EG 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 is0.125 mg per day in the elderly or in patients with liver and/or kidney problems.

If you take more TRIAZOLAM EG than you should
The symptoms of an overdose may be mild such as drowsiness, difficulty speaking, confusion
mental, lethargy or severe such as muscle problems and disorders of movement and coordination
motor (ataxia, hypotonia), lowering of blood pressure, serious breathing problems
(respiratory depression), rarely coma and very rarely death. Among these effects, the most serious are rare to
unless you have taken together with excessive amounts of TRIAZOLAM EG also other medicines or
alcohol.
If you have accidentally taken an excessive dose of TRIAZOLAM EG, contact your doctor immediately or
go to the Emergency Room of the nearest hospital.

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

If you stop taking TRIAZOLAM EG
Do not stop treatment with TRIAZOLAM EG abruptly or without first agreeing with your
doctor because effects due to discontinuation of treatment may occur, especially if you have taken
high doses of triazolam during treatment (see section “Warnings and precautions”).
If the doctor has decided to stop treatment, he will tell you 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 attention, confusion, fatigue, headache, dizziness, muscle weakness, loss of coordination 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 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 impairment;
• impaired vision.

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

• skin irritation (rash);
• muscle weakness (myasthenia). Frequency not known(cannot be estimated from the available data):
• allergic reactions (anaphylactic shock, anaphylactoid reactions), swelling due to fluid retention (angioedema and allergic edema), hypersensitivity;
• aggression, hallucinations, sleepwalking, loss of memory (anterograde amnesia), restlessness, agitation, irritability, delusion, anger, nightmares, psychosis, inappropriate behaviour (see section “Warnings and precautions”);
• temporary loss of consciousness (syncope), sedation, reduced level of consciousness, speech disorders, attention disorders, altered sense of taste (dysgeusia);
• respiratory depression in patients with impaired respiratory function;
• changes in libido;
• falls.

This medicine can cause dependence (see section “Warnings and precautions”).
Pre-existing depressive states may manifest during the use of benzodiazepines.

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 the address: 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 TRIAZOLAM 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.
This medicine does not require any particular storage conditions.
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 TRIAZOLAM EG contains
TRIAZOLAM EG 0.125 mg tablets
The active ingredient is triazolam.
Each tablet contains 0.125 mg of triazolam.
The other ingredients are: corn starch, lactose monohydrate, microcrystalline cellulose, colloidal silica
anhydrous, sodium docusate, sodium benzoate, magnesium stearate, sodium croscarmellose, indigo carmine lac
(E132), erythrosine lac (E127).

TRIAZOLAM EG 0.25 mg tablets
The active ingredient is triazolam.
Each tablet contains 0.25 mg of triazolam.
The other ingredients are: corn starch, lactose monohydrate, microcrystalline cellulose, colloidal silica
anhydrous, sodium docusate, sodium benzoate, magnesium stearate, sodium croscarmellose, indigo carmine lac
(E132).

Description of the appearance of TRIAZOLAM EG and contents of the pack
0.125 mg tablets: pack of 20 tablets.
0.25 mg tablets: pack of 20 tablets.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan

Manufacturers
DOPPEL FARMACEUTICI S.r.l., Via Volturno, 48, Quinto de Stampi - Rozzano (MI)
MIPHARM S.p.A., Via B. Quaranta, 12 – 20141 Milan