TRIAZOLAM 0.125 MG Таблетки

Содержание инструкции

1. TRIAZOLAM DOC Generici 0,125 mg tablets, 0,25 mg tablets
   1. What is TRIAZOLAM DOC Generici and what is it used for?
   2. What you need to know before taking TRIAZOLAM DOC Generici
   3. How to take TRIAZOLAM DOC Generici
   4. Possible side effects
   5. How to store TRIAZOLAM DOC Generici
   6. Contents of the pack and other information

TRIAZOLAM DOC Generici 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

This medicine contains the active ingredient triazolam, which belongs to a group of medicines called
benzodiazepines.
Benzodiazepines are indicated in cases where the disorder is severe, debilitating and subjects the individual to
serious discomfort.
This medicine is indicated for the short-term treatment of insomnia.

2. What you need to 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 that causes muscle weakness and fatigue;
• if you have severe breathing problems (severe respiratory failure) and breathing problems during sleep (sleep apnea syndrome);
• if you have 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, itraconazole and fluconazole (antifungal medicines, used to treat infections caused by fungi), 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 liver problems (hepatic insufficiency) of mild or moderate severity;
• you have breathing problems (impaired respiratory function);
• you are also taking other medicines that act on the central nervous system (see section “Pay particular attention and tell your doctor if you are taking the following medicines”);
• you have previously abused alcohol and drugs;
• 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 can 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. This medicine should be taken for a short period of time (7-10 days). The doctor will assess whether treatment for longer periods is necessary;
• tolerance, if you use TRIAZOLAM DOC Generici for a few weeks, a loss of the medicine’s effectiveness may occur. Talk to your doctor if, after a few weeks, it seems to you that the medicine is not working as well as at the beginning of treatment;
• memory loss(anterograde amnesia). This can happen to you even several hours after taking the medicine. To reduce the risk, take the medicine before going to bed and make sure you have 7-8 hours of uninterrupted sleep;
• 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 in children;
• sleep disturbances, such as drowsiness while driving;
• withdrawal, whose symptoms can manifest when you stop taking TRIAZOLAM DOC Generici. These can include: headache, muscle pain, extreme anxiety, tension, agitation, confusion and irritability. In severe cases, 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, sensitivity to light, noise and physical contact, hallucinations (seeing and hearing things that do not exist) or seizures may appear;
• rebound insomnia and anxiety, a temporary worsening of insomnia which may be accompanied by other reactions such as mood changes, anxiety or sleep disturbances and restlessness (see section “If you stop taking TRIAZOLAM DOC Generici”).

Benzodiazepines are not recommended for psychotic illnesses 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 occur especially 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 the age of
18 years.

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

Pay particular attention and tell 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 can cause an increased sense of well-being when taken with TRIAZOLAM DOC Generici. This can increase your desire to continue taking these medicines (dependence);
• antiepileptics(e.g. carbamazepine), medicines used for epilepsy;
• anesthetics, used during surgical operations;
• antihistamines with a sedative effect, used to treat allergies;
• cimetidine, a medicine used to treat ulcers;
• macrolide antibioticssuch 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;
• diltiazemand verapamil, medicines used to treat high blood pressure;
• oral contraceptives, medicines used to prevent pregnancy;
• imatinib, a medicine for treating some cancers;
• HIV protease inhibitors(e.g. ritonavir, efavirenz), medicines used in the treatment of AIDS;
• aprepitant, a medicine used against vomiting;
• antifungal drugs(itraconazole, ketoconazole). The concomitant use of TRIAZOLAM DOC Generici and opioids (strong painkillers, medicines for addiction therapy and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may 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 DOC Generici 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 to be aware of the signs and symptoms mentioned above. See a doctor if you experience these symptoms.

TRIAZOLAM DOC Generici with food, drinks and alcohol
Avoid taking grapefruit juice during treatment with this medicine because grapefruit juice can increase the levels of triazolam in the blood and therefore the effects.
Do not drink alcohol during treatment with TRIAZOLAM DOC Generici, as it can increase the sedative effect of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before using this medicine.
Do not take TRIAZOLAM DOC Generici if you are pregnant or if you become pregnant during
treatment with this medicine as it may cause harm to the newborn.
If your doctor believes that you need to take TRIAZOLAM DOC Generici in the late stages of pregnancy or
during childbirth, your baby may develop floppy baby syndrome at birth, characterized by
low body temperature, loss of muscle tone, difficulty breathing.
In addition, if TRIAZOLAM DOC Generici has been taken regularly during the late 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 can impair your ability to drive and operate machinery because it can
cause drowsiness, confusion, dizziness. These effects are increased if you have not had enough sleep. If this
happens to you, do not drive or operate machinery.

TRIAZOLAM DOC Generici contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue to take this medicine until your doctor tells you to stop.
The duration of treatment should be as short as possible and, generally, ranges from a few days to two
weeks, up to a maximum of four weeks, including a period of gradual discontinuation. In
certain cases, the doctor may decide to prolong the treatment, after evaluating your health
conditions.
Treatment should be started with the lowest recommended dose.
The maximum dose must not be exceeded.
Swallow the TRIAZOLAM DOC Generici tablets without chewing them with some water or other liquid
before going to bed.

Adults
The recommended dose is 0.125 - 0.25 mg per day.

Use in the elderly and patients with liver and/or kidney problems
In the elderly, 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 the age of 18 years.

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 nearest hospital emergency room.
An overdose can cause drowsiness, difficulty speaking, confusion, lethargy, muscle
problems, breathing problems, coma, death.
The most serious symptoms are rare unless you have taken other medicines and/or alcohol together with
TRIAZOLAM DOC Generici as well.

If you forget to take TRIAZOLAM DOC Generici
Do not take a double dose to make up for a missed dose.

If you stop taking TRIAZOLAM DOC Generici
Do not stop treatment with TRIAZOLAM DOC Generici suddenly or without first having
agreed with your doctor, as withdrawal symptoms may occur.
If the doctor has decided to stop the 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.
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)

• Confusion, insomnia;
• Memory disorders;
• Vision problems.

Rare(may affect up to 1 in 1000 people)

• Skin rash;
• Muscle weakness (myasthenia).

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

• Aggression, hallucinations, sleepwalking, restlessness, agitation, irritability, delusion, anger, nightmares, psychosis, behavioral disorders (see section Warnings and precautions);
• Loss of consciousness, sedation, decreased level of consciousness, speech disorders, attention disorders, altered sense of taste (dysgeusia);
• Respiratory depression in patients with respiratory problems;
• Changes in sexual desire;
• Sudden, potentially life-threatening allergic reactions (anaphylactic shock, anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing, due to fluid accumulation potentially fatal (angioedema, allergic edema);
• 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/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 which is stated on the packaging after SCAD. 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 DOC Generici contains
TRIAZOLAM DOC Generici 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 (E 211), corn starch, magnesium stearate, indigotine (E132),
aluminium hydroxide oxide.

TRIAZOLAM DOC Generici 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 (E 211), corn starch, magnesium stearate, indigotine (E132),
aluminium hydroxide oxide.

Description of the appearance of TRIAZOLAM DOC Generici and contents of the pack
0.125 mg tablets: pack of 10 - 20 tablets
0.25 mg tablets: pack of 10 - 20 tablets

Marketing Authorisation Holder
DOC Generici S.r.L. – Via Turati 40 – 20121 Milano

Manufacturer
ABC FARMACEUTICI S.p.A.- Canton Moretti, 29 Località San Bernardo 10090 Ivrea (TO)