Triazolam Ratiopharm Italia

Italy
Brand name Triazolam Ratiopharm Italia
Form tablets
Active substance / Dosage
TRIAZOLAM
Prescription type Prescription only
ATC code
N05CD05
Registration number 036220
Manufacturer TEVA B.V.

Table of Contents

Package leaflet: Information for the patient

Triazolam ratiopharm Italia 0.125 mg tablets, 0.25 mg tablets

Generic 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 their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Triazolam ratiopharm Italia is and what it is used for

Triazolam ratiopharm Italia contains the active substance triazolam.
Triazolam belongs to a group of medicines called benzodiazepines, used to treat sleep disorders (insomnia) only when they are severe, disabling or causing significant distress.
Triazolam ratiopharm Italia is used for the short-term treatment of insomnia, when the condition is severe and interferes with normal daily life.

2. What you should know before taking Triazolam ratiopharm Italia

Do not take Triazolam ratiopharm Italia

  • if you are allergic to the active substance, to 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 breathing problems (severe respiratory insufficiency);
  • if you suffer from sleep apnoea, i.e. breathing pauses during sleep;
  • if you have severe liver problems (severe hepatic insufficiency);
  • if you are simultaneously taking: medicines used to treat fungal infections (ketoconazole and itraconazole), medicines used for depression containing nefazodone, medicines used for HIV infection containing efavirenz or HIV protease inhibitors (see also section “Other medicines and Triazolam ratiopharm Italia”), or medicines that strongly reduce the activity of certain liver enzymes (see section “Other medicines and Triazolam ratiopharm Italia”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Triazolam ratiopharm Italia.
Take this medicine with caution if:

  • you are elderly and/or debilitated. Your doctor will prescribe a reduced dose of this medicine;
  • you have liver problems of mild or moderate severity (mild or moderate hepatic insufficiency);
  • you have breathing problems, as this medicine may worsen your condition;
  • you have or have previously had problems with alcohol or drug abuse and dependence, because the risk of developing dependence on Triazolam ratiopharm Italia is higher (see section “Development of dependence”);
  • you are taking other medicines that cause drowsiness or act on the brain and mind (see section “Other medicines and Triazolam ratiopharm Italia”);
  • you suffer from depression. Triazolam ratiopharm Italia, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression, as it may worsen suicidal tendencies;
  • you suffer from psychosis, a mental illness that alters behaviour and causes difficulties in relating to others. Triazolam ratiopharm Italia is not recommended as the main treatment for this condition.

Since triazolam may cause sedation (drowsiness, dizziness, loss of coordination and/or difficulty in coordinating movements), patients, particularly the elderly, are at increased risk of falls.
Memory disturbances
You may experience difficulty remembering events that occurred after taking Triazolam ratiopharm Italia, especially if you have not slept for a sufficient period (approximately 7–8 hours).
This phenomenon is more frequent several hours after taking the medicine; therefore, to reduce the risk, you must ensure you can sleep uninterrupted for 7–8 hours after taking Triazolam ratiopharm Italia.
Paradoxical reactions
Triazolam ratiopharm Italia may cause effects opposite to those expected ( paradoxical effects ) (see section 4 “Possible side effects”). These effects are more common in children and elderly people.
If you experience these effects, consult your doctor, as treatment with Triazolam ratiopharm Italia should be discontinued.
Development of tolerance and dependence, withdrawal reactions, and drug abuse
The effectiveness of this medicine (tolerance) may decrease after prolonged use.
This medicine is recommended for short-term treatment only. If, after several weeks of treatment, you feel the medicine is no longer effective, consult your doctor.
Treatment with this medicine also increases sensitivity to the effects of alcohol and other medicines affecting brain function. Therefore, discuss with your doctor if you are using alcohol or such medicines.
The use of benzodiazepines, including Triazolam ratiopharm Italia, may lead to dependence (increasing desire to take the medicine or development of physical symptoms that decrease or disappear only after taking the medicine). The risk of dependence increases with higher doses and prolonged use. If dependence develops, you must avoid stopping treatment abruptly (see section 3 “If you stop taking Triazolam ratiopharm Italia”), as withdrawal symptoms, even severe ones, may occur.
The risk of dependence is also higher if you have a history of alcohol or drug abuse.
Consult your doctor if:

  • you have taken or are currently taking illegal substances;
  • you regularly consume alcohol or have previously consumed large amounts of alcohol frequently;
  • you have previously or currently have a desire to take large quantities of medicines.

In principle, benzodiazepines should only be used for short periods and discontinued gradually. Before starting treatment, you and your doctor should agree on how long you will take the medicine.
If you stop taking the medicine abruptly or reduce the dosage rapidly, withdrawal reactions may occur. Do not stop this medicine abruptly. Seek advice from your doctor on how to discontinue treatment.
Some withdrawal reactions may be life-threatening.
Withdrawal reactions may range from mild depression, insomnia, and headache to a more severe syndrome with muscle pain, muscle and abdominal cramps, vomiting, sweating, tremors, seizures, anxiety, tension, restlessness, confusion, and irritability. More severe withdrawal symptoms, including life-threatening reactions, may include: feelings of detachment or alienation from oneself and the external world, heightened perception of noise, numbness and tingling in the extremities, increased sensitivity to light, sound, and physical contact, hallucinations, delirium tremens, depression, mania, psychosis, epileptic seizures, and suicidal ideation.
The symptoms for which this medicine was prescribed may also reappear briefly (rebound phenomena).
Do not give Triazolam ratiopharm Italia to family members or friends.
Store this medicine securely so it cannot cause harm to others.

Children and adolescents
The use of benzodiazepines such as Triazolam ratiopharm Italia is not recommended in children and adolescents under 18 years of age, as their efficacy and safety are unknown. Your doctor will therefore decide whether this medicine can be administered to children and adolescents based on their individual condition.

Other medicines and Triazolam ratiopharm Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Triazolam ratiopharm Italia may alter the effect of other medicines, and other medicines may alter the effect of Triazolam ratiopharm Italia.
The following medicines must not be taken together with Triazolam ratiopharm Italia (see also section “Do not take Triazolam ratiopharm Italia”):

  • ketoconazole, itraconazole (medicines for fungal infections);
  • nefazodone (medicine for depression);
  • efavirenz and other medicines used to treat HIV infection (e.g. ritonavir);
  • other medicines that strongly reduce the activity of certain liver enzymes.

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

  • other antifungal medicines (azoles). Their concomitant use with Triazolam ratiopharm Italia is not recommended;
  • cimetidine, a medicine used to reduce stomach acidity;
  • erythromycin, clarithromycin, troleandomycin, isoniazid, and rifampicin (antibiotics);
  • diltiazem and verapamil, medicines used to treat high blood pressure;
  • oral contraceptives;
  • imatinib, a medicine used to treat certain types of tumours;
  • aprepitant, a medicine for nausea and vomiting;
  • medicines acting on the brain and mind, such as:
    • antipsychotics (neuroleptics), medicines for treating certain mental illnesses;
    • hypnotics, sedatives, tranquilizers, and medicines used to promote sleep;
    • anxiolytics, used to treat anxiety;
    • antidepressants (e.g. fluvoxamine, sertraline, and paroxetine), medicines for treating depression;
    • narcotic analgesics, medicines for treating severe pain, which, when taken together with Triazolam ratiopharm Italia, may cause euphoria, increasing the risk of developing dependence;
    • antiepileptics (e.g. carbamazepine), medicines used to treat epileptic seizures;
    • anaesthetics, medicines that induce anaesthesia, i.e. reversible loss of sensation;
    • sedating antihistamines, medicines used to treat allergies.

Concomitant use of Triazolam ratiopharm Italia and opioids (strong analgesics, medicines for opioid dependence substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Triazolam ratiopharm Italia 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 carefully follow the doctor’s dosage recommendations. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Consult your doctor if you experience such symptoms.

Triazolam ratiopharm Italia with beverages and alcohol
It is not recommended to drink alcohol or grapefruit juice during treatment with Triazolam ratiopharm Italia, as the effects of this medicine may be increased.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Use of Triazolam ratiopharm Italia during pregnancy may cause harm to the foetus.
If you take this medicine during the last three months of pregnancy or during labour, the newborn may have low muscle tone (floppy infant syndrome) and withdrawal symptoms (see section 3 “If you stop taking Triazolam ratiopharm Italia”).
Breastfeeding
Triazolam ratiopharm Italia must not be used by breastfeeding mothers, as this medicine may pass into breast milk.

Driving and using machines
Triazolam ratiopharm Italia may impair your ability to drive vehicles and operate machinery.
Do not drive or operate machinery if, during treatment with Triazolam ratiopharm Italia, you experience drowsiness or dizziness. After taking the medicine, you may not be fully alert while driving and may not remember having driven. These effects may be increased if you have not slept enough or have consumed alcoholic beverages.

Triazolam ratiopharm Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Triazolam ratiopharm Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially sodium-free.

Triazolam ratiopharm Italia contains sodium benzoate
This medicine contains 0.15 mg of sodium benzoate per tablet.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

3. How to take Triazolam ratiopharm Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose and duration of treatment must be adjusted according to your individual condition. Your doctor
will advise you on the appropriate dose, the number of daily administrations, and the duration of treatment with Triazolam
ratiopharm Italia, so that you take the lowest possible dose for the shortest possible time. Do not
change or exceed the prescribed dose. To discontinue treatment, the dose should be gradually reduced
under medical supervision. This reduces the risk of withdrawal reactions, which in
some cases may be life-threatening (see section 2 “What you need to know before taking
Triazolam ratiopharm Italia”).
Adults
The recommended dose is 1 tablet of 0.125 mg or 0.25 mg, as directed by your doctor, to be taken once daily immediately before
going to bed.
Your doctor will recommend the lowest effective dose suitable for your case.
Do not exceed the prescribed dose without first consulting your doctor.
If you are elderly and/or have liver or kidney problems
The recommended dose is 1 tablet of 0.125 mg to be taken once daily immediately before
going to bed.
The tablets should be swallowed whole, without chewing, with a glass of water or another drink (do not take the tablets with alcoholic beverages or grapefruit juice (see section “Other medicines and Triazolam ratiopharm Italia”) immediately before lying down.
Duration of treatment
Triazolam ratiopharm Italia should be taken only for short periods. The maximum recommended duration of
treatment should not exceed 4 weeks. This period includes the time needed to gradually reduce the dose of Triazolam
ratiopharm Italia before complete discontinuation. You must continue taking this medicine until your doctor
tells you otherwise. Your doctor will decide, based on your condition, whether you need to take this medicine
for a longer period.
If you take more Triazolam ratiopharm Italia than you should
If you have taken an excessive dose of this medicine, contact your doctor immediately or go
immediately to the nearest emergency room.
Symptoms may include drowsiness, difficulty speaking, confusion, and lethargy in cases of mild
overdose; in more severe cases, symptoms may include loss of coordination (ataxia), muscle problems (hypotonia), low blood pressure, breathing difficulties, rarely coma, and very rarely death.
These symptoms may be worsened by concomitant use of other medicines or alcohol.
If you forget to take Triazolam ratiopharm Italia
If you forget to take a dose, take it as soon as you remember, but only if you are able to rest
immediately afterwards for a sufficient length of time. Do not take a double dose to make up for a
missed tablet.
If you stop taking Triazolam ratiopharm Italia
Do not stop treatment with Triazolam ratiopharm Italia abruptly unless you experience
severe allergic reactions (see section 4 “Possible side effects”).
Always consult your doctor before stopping Triazolam ratiopharm Italia. You should
gradually reduce the dose to avoid experiencing:

  • withdrawal symptoms such as:
    • severe symptoms: feeling detached from yourself or the external world, numbness and tingling in arms or legs, increased sensitivity to light, sounds, and physical touch, hallucinations, epileptic seizures;
    • other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability;
  • rebound insomnia. You may temporarily develop insomnia that is worse than the one you had before starting treatment with this medicine.

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 gets them.
Stop taking this medicine immediately and contact your doctor immediately
if you experience any of the following side effects, as they are serious and could be dangerous:

  • severe allergic reaction (anaphylactic shock, anaphylactoid reactions);
  • swelling of the face, throat and/or tongue, leading to difficulty swallowing or breathing ( angioedema ).

Contact your doctor immediately if you experience any of the following side effects, as you must stop taking
this medicine:

  • effects opposite to those expected ( paradoxical effects ) (see section 2 “Paradoxical disturbances”), such as aggression, hallucinations, restlessness, agitation, irritability, delusions, anger, nightmares, psychotic disorder, inappropriate behaviour, and other behavioural disturbances.

Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

  • depression or unmasking of pre-existing depression;
  • drug or substance abuse, physical and psychological dependence (see section 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”);
  • withdrawal symptoms (withdrawal syndrome) and rebound symptoms (see section 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”);
  • drowsiness while driving (see section 2 “Driving and use of machines”) and difficulty remembering (retrograde amnesia) events that occurred after taking the medicine (see section 2 “Memory disturbances”), sometimes associated with behavioural changes;
  • reduced breathing.

To help you recognize some side effects, it may be helpful to inform a close relative or friend
that you are taking this medicine and ask them to read this leaflet. You may ask them to alert you if they notice any changes in your behaviour.

Other possible side effects include:
Common (may affect up to 1 in 10 people)

  • drowsiness;
  • dizziness;
  • loss of ability to coordinate movements (ataxia);
  • headache.

Uncommon (may affect up to 1 in 100 people)

  • confusion;
  • insomnia;
  • memory impairment;
  • visual disturbances.

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

  • skin rash;
  • muscle weakness (myasthenia).

Not known (frequency cannot be estimated from the available data)

  • allergic reactions, swelling due to allergy, hypersensitivity;
  • sleep disorders (sleepwalking);
  • delirium;
  • fainting (syncope);
  • sedation;
  • reduced level of consciousness;
  • speech disorders;
  • altered attention level;
  • altered sense of taste (dysgeusia);
  • altered sexual desire;
  • increased risk of falls;
  • gastrointestinal disturbances.

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 https://www.aifa.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 ratiopharm Italia

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 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. Package contents and other information

What Triazolam ratiopharm Italia contains
Triazolam ratiopharm Italia 0.125 mg tablets

  • The active substance is triazolam. Each tablet contains 0.125 mg of triazolam.
  • The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, sodium docusate, sodium benzoate, maize starch, magnesium stearate, indigotine (E132), erythrosine (E127), aluminium oxide hydrate.

Triazolam ratiopharm Italia 0.25 mg tablets

  • The active substance is triazolam. Each tablet contains 0.25 mg of triazolam.
  • The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, sodium docusate, sodium benzoate, maize starch, magnesium stearate, indigotine (E132), aluminium oxide hydrate.

Description of the appearance of Triazolam ratiopharm Italia and contents of the pack
Triazolam ratiopharm Italia 0.125 mg tablets
The tablets are available in blisters in packs of 10 or 20 tablets.
Triazolam ratiopharm Italia 0.25 mg tablets
The tablets are available in blisters in packs of 10 or 20 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy