Patient information leaflet

TRIAZOLAM DOC Generici 0.125 mg tablets, 0.25 mg tablets

Equivalent 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TRIAZOLAM DOC Generici is and what it is used for

This medicinal product contains the active substance triazolam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are indicated in cases where the disorder is severe, disabling and causes severe distress to the patient.
This medicinal product is indicated for the short-term treatment of insomnia.

2. What you should know before taking TRIAZOLAM DOC Generici

Do not take TRIAZOLAM DOC Generici

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 you are pregnant or breastfeeding (see section Pregnancy and breastfeeding);
if you are taking ketoconazole, itraconazole, or fluconazole (antifungal medicines used to treat fungal infections), nefazodone (a medicine used to treat depression), or efavirenz (a medicine used in the treatment of AIDS).

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIAZOLAM DOC Generici.
Take this medicine with caution if:

you have mild or moderate liver problems (hepatic insufficiency);
you have respiratory problems (impaired respiratory function);
you are also taking other medicines acting on the central nervous system (see section "Take special care and inform your doctor if you are taking the following medicines");
you have previously abused alcohol or drugs;
you are elderly or debilitated. In this case, your doctor should prescribe a lower starting dose.

Taking this medicine may cause:

dependence, meaning the need to continue taking the medicine. The risk increases with dose and duration of treatment. It is higher if you have previously abused drugs or alcohol. This medicine should be taken only for a short period (7-10 days). Your doctor will assess whether longer treatment is necessary;
tolerance, meaning that after using TRIAZOLAM DOC Generici for a few weeks, the medicine may lose its effectiveness. Contact your doctor if after a few weeks the medicine seems less effective than at the beginning of treatment;
memory loss (anterograde amnesia). This may occur several hours after taking the medicine. To reduce the risk, take the medicine just before going to bed and ensure uninterrupted sleep of 7-8 hours;
behavioural disturbances such as restlessness, agitation, irritability, aggressiveness, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behaviour, or other changes. In such cases, stop using the medicine. This is especially likely if you are elderly or in children;
sleep disturbances, such as drowsiness while driving;
withdrawal symptoms, which may occur when you stop taking TRIAZOLAM DOC Generici. These may include: headache, muscle pain, extreme anxiety, tension, agitation, confusion, and irritability. In severe cases, derealisation (feeling that things are not real), depersonalisation (feeling detached from the surroundings), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures;
rebound insomnia and anxiety, a temporary worsening of insomnia which may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness (see section "If you stop taking TRIAZOLAM DOC Generici").

Benzodiazepines are not recommended for psychotic disorders and should not be used alone to treat depression, anxiety, or insomnia associated with depression, as suicidal thoughts may occur in such patients.
These effects are especially likely if you have taken high doses of this medicine (see section "If you take more TRIAZOLAM DOC Generici than you should").

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

Other medicines and TRIAZOLAM DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Take special care and inform your doctor if you are taking the following medicines:

antipsychotics and antidepressants (e.g. nefazodone, fluvoxamine, sertraline, paroxetine), medicines used to treat mental disorders;
hypnotics, medicines used to promote sleep;
anxiolytics and sedatives, used to treat anxiety;
narcotic analgesics, medicines used to treat severe pain, which may cause increased feelings of well-being when taken with TRIAZOLAM DOC Generici. This may increase your desire to continue taking these medicines (dependence);
antiepileptics (e.g. carbamazepine), medicines used for epilepsy;
anaesthetics, used during surgical procedures;
sedative antihistamines, used to treat allergies;
cimetidine, a medicine used to treat ulcers;
macrolide antibiotics such as erythromycin, clarithromycin, and troleandomycin, medicines used for bacterial infections;
rifampicin, a medicine used to treat bacterial infections;
isoniazid, a medicine used to treat tuberculosis;
diltiazem and verapamil, medicines used to treat high blood pressure;
oral contraceptives, medicines used to prevent pregnancy;
imatinib, a medicine used to treat certain tumours;
HIV protease inhibitors (e.g. ritonavir, efavirenz), medicines used in the treatment of AIDS;
aprepitant, a medicine used to prevent vomiting;
antifungal medicines (itraconazole, ketoconazole).
The concomitant use of TRIAZOLAM DOC Generici and opioids (strong painkillers, medicines for addiction 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 no other treatment options are available. However, if your doctor prescribes TRIAZOLAM DOC Generici 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 follow your 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 DOC Generici with food, drinks, and alcohol
Avoid drinking grapefruit juice during treatment with this medicine, as grapefruit juice may increase triazolam blood levels and thus its effects.
Do not drink alcohol while taking TRIAZOLAM DOC Generici, as it may enhance the sedative effect of the medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not take TRIAZOLAM DOC Generici if you are pregnant or become pregnant during treatment, as it may harm the newborn.
If your doctor considers it necessary for you to take TRIAZOLAM DOC Generici during the last stages of pregnancy or during delivery, the baby may show at birth the floppy infant syndrome, characterised by low body temperature, loss of muscle tone, and breathing difficulties.
Moreover, if TRIAZOLAM DOC Generici has been taken regularly during the last stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
Do not take this medicine if you are breastfeeding, as triazolam passes into breast milk.

Driving and using machines
TRIAZOLAM DOC Generici may impair your ability to drive or operate machinery, as it may cause drowsiness, confusion, or dizziness. These effects are increased if you have not slept enough. If this occurs, do not drive or operate machinery.

TRIAZOLAM DOC Generici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

TRIAZOLAM DOC Generici contains sodium benzoate (E 211)
This medicine contains 0.15 mg of sodium benzoate (E 211) per tablet.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

TRIAZOLAM DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take TRIAZOLAM DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor tells you to.
The duration of treatment should be as short as possible and usually ranges from a few days to two
weeks, up to a maximum of four weeks, including a period of gradual withdrawal. In
certain cases, your doctor may decide to extend the treatment after evaluating your
health status.
Treatment should begin with the lowest recommended dose.
The maximum dose must not be exceeded.
Swallow the TRIAZOLAM DOC Generici tablets whole with a little water or other liquid
before going to bed.
Adults
The recommended dose is 0.125 - 0.25 mg per day.
Use in elderly patients and patients with liver and/or kidney problems
In elderly patients, debilitated patients, or patients with liver and/or kidney problems, the recommended dose is
0.125 mg per day.
Use in children and adolescents
The use of triazolam is not recommended in children and adolescents under 18 years of age.
If you take more TRIAZOLAM DOC Generici than you should
If you (or someone else) have taken an excessive dose of TRIAZOLAM DOC Generici, contact
your doctor immediately or go to the Emergency Department of the nearest hospital.
An overdose may cause drowsiness, slurred speech, confusion, lethargy, muscle problems,
breathing difficulties, coma, or even death.
More severe symptoms are rare unless other medicines and/or alcohol have also been taken together with
TRIAZOLAM DOC Generici.
If you forget to take TRIAZOLAM DOC Generici
Do not take a double dose to make up for the missed dose.
If you stop taking TRIAZOLAM DOC Generici
Do not stop treatment with TRIAZOLAM DOC Generici suddenly or without first discussing it with your
doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will advise you on how to gradually reduce the dose.
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 will experience them.
The following side effects may occur:
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 disturbances;
Vision problems.

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

Skin rash;
Muscle weakness (myasthenia).

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

Aggression, hallucinations, sleepwalking, restlessness, agitation, irritability, disappointment, anger, nightmares, psychosis, behavioural disturbances (see section Warnings and precautions);
Loss of consciousness, sedation, reduced level of consciousness, speech disorders, attention disturbances, altered sense of taste (dysgeusia);
Respiratory depression in patients with respiratory disorders;
Changes in sexual desire;
Sudden allergic reactions potentially fatal (anaphylactic shock, anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, due to fluid accumulation potentially fatal (angioedema, allergic edema);
Falls.

This medicine may 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/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRIAZOLAM DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the
last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 DOC Generici contains
TRIAZOLAM DOC Generici 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 silicon dioxide,
sodium dioctyl sulfosuccinate, sodium benzoate (E 211), maize starch, magnesium stearate, indigotine (E132),
erythrosine (E127), aluminium oxide hydrate.
TRIAZOLAM DOC Generici 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 silicon dioxide,
sodium dioctyl sulfosuccinate, sodium benzoate (E 211), maize starch, magnesium stearate, indigotine (E132),
aluminium oxide hydrate.
Description of the appearance of TRIAZOLAM DOC Generici and contents of the pack
0.125 mg tablets: carton pack containing 10 - 20 tablets
0.25 mg tablets: carton pack containing 10 - 20 tablets
Marketing Authorization Holder
DOC Generici S.r.L. – Via Turati 40 – 20121 Milan
Manufacturer
ABC FARMACEUTICI S.p.A. - Canton Moretti, 29, Località San Bernardo, 10090 Ivrea (TO)