Triazolam Pensa: detailed information

Patient Information Leaflet

TRIAZOLAM PENSA 0.125 mg tablets, 0.25 mg tablets

Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

TRIAZOLAM PENSA contains the active substance triazolam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are used to treat sleep disorders (insomnia) only when they are severe, cause significant distress to the individual, and impair normal daily activities.
TRIAZOLAM PENSA is indicated for the short-term treatment of insomnia.

2. What you should know before taking TRIAZOLAM PENSA

Do not take TRIAZOLAM PENSA:

if you are allergic to triazolam, to similar medicines (benzodiazepines), or to any of the other ingredients of this medicine listed in section 6;
if you suffer from a disease causing muscle weakness and fatigue (myasthenia gravis);
if you have severe respiratory problems (severe respiratory insufficiency) or breathing problems during sleep (sleep apnea syndrome);
if you have severe liver problems (severe hepatic insufficiency);
if you are taking antifungal medicines used for fungal infections (ketoconazole and itraconazole), antidepressant medicines (nefazodone), or a medicine used in the treatment of AIDS (efavirenz) (see section “Other medicines and TRIAZOLAM PENSA”).

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIAZOLAM PENSA.
Take this medicine with caution and always under medical supervision if:

you have mild or moderate liver problems (hepatic insufficiency);
you have respiratory problems (impaired respiratory function); in this case, your doctor may prescribe a lower dose;
you are taking other medicines that depress the central nervous system (see section “Other medicines and TRIAZOLAM PENSA”);
you have previously abused alcohol or drugs (see section “TRIAZOLAM PENSA with food, drinks and alcohol”);
you are elderly or debilitated. In this case, your doctor should prescribe a lower dose.

Duration of treatment: Treatment duration should be as short as possible (see section “How to take TRIAZOLAM PENSA”) and must not exceed 4 weeks, including the period of gradual discontinuation. Only your doctor can decide whether to extend therapy beyond the period mentioned above.
Taking this medicine may cause:
Tolerance: After repeated use for several weeks, a certain loss of effectiveness of this medicine may occur.
Dependence: Taking this medicine may lead to the development of physical and psychological dependence, which manifests as an absolute and uncontrollable need to take the medicine. The risk increases with dose and duration of treatment. It is higher if you have previously abused drugs or alcohol. Take this medicine for a short period (usually up to 7–10 days). Your doctor will assess whether longer treatment is necessary.
Withdrawal symptoms: Once dependence has developed, abrupt discontinuation of treatment with TRIAZOLAM PENSA is accompanied by withdrawal or rebound symptoms (see section “If you stop taking TRIAZOLAM PENSA”). Symptoms may include headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. 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), increased sensitivity to sound (acoustic hypersensitivity), numbness and tingling in hands and feet, excessive sensitivity to light, intolerance to physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures. To minimize these symptoms, the dose should be gradually reduced.
Rebound insomnia: When treatment is stopped, a temporary syndrome may occur in which the symptoms that led to treatment with TRIAZOLAM PENSA reappear in a worsened form (see section “If you stop taking TRIAZOLAM PENSA”). In addition to insomnia, mood changes, anxiety, sleep disturbances, and restlessness may occur. Since the risk of rebound/withdrawal phenomena is higher when treatment is abruptly stopped, your doctor will gradually reduce your dose.
Keep in mind that these rebound phenomena may occur when you stop using this medicine.
Depression: Benzodiazepines may be associated with mental depression and, occasionally, suicidal thoughts or actual suicide attempts. This may occur rarely and unpredictably. Your doctor will evaluate whether to prescribe this medicine if you show signs or symptoms of depression or suicidal tendencies. TRIAZOLAM PENSA is not recommended for treating depression or anxiety associated with it.
Amnesia: Medicines belonging to the same class as TRIAZOLAM PENSA may cause anterograde amnesia, i.e., the inability to memorize new information. This occurs more frequently several hours after taking the medicine. To reduce these risks, take this medicine immediately before going to bed (see section “How to take TRIAZOLAM PENSA”) and ensure uninterrupted sleep of 7–8 hours.
Behavioral reactions: If you experience restlessness, agitation, irritability, aggression, delusions, hallucinations, anger, nightmares, inappropriate behavior, or other behavioral changes, stop taking the medicine immediately (see section “Possible side effects”). These reactions may be more frequent in elderly patients and children.
Sleep disorders, such as drowsiness while driving, may occur after taking this medicine, even when taken alone at therapeutic doses; the risk increases if you take doses higher than the maximum recommended or if you take other substances that depress the central nervous system (other hypnotic-sedatives) or alcohol simultaneously. Due to the risk to the patient and the community, discontinuation of treatment with TRIAZOLAM PENSA should be strongly considered in patients reporting such events.
Be cautious when using this medicine, as it may cause severe allergic reactions (anaphylactic/anaphylactoid reactions), including rare fatal cases, and swelling affecting the tongue, larynx, and throat (angioedema) (see section “Possible side effects”).
TRIAZOLAM PENSA is not intended for the treatment of primary depressive disorders or as primary treatment for mental illnesses (psychosis).
Children and adolescents
The use of TRIAZOLAM PENSA is not recommended in children and adolescents under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and TRIAZOLAM PENSA
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
Concomitant use of TRIAZOLAM PENSA and opioids (strong analgesics, 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 PENSA 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 carefully follow the dose recommendations provided. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Pay special attention and inform your doctor if you are taking the following medicines:

azole antifungals used to treat fungal infections;
medicines used to treat depression (fluvoxamine, sertraline, paroxetine);
cimetidine, a medicine used to treat ulcers;
macrolide antibiotics (such as erythromycin, clarithromycin, troleandomycin) and other antibiotics such as rifampicin, used for bacterial infections;
isoniazid, used to treat tuberculosis;
medicines used to treat high blood pressure (diltiazem and verapamil);
medicines used to prevent pregnancy (oral contraceptives);
imatinib, a medicine used to treat certain tumors;
medicine used in epilepsy (carbamazepine);
HIV protease inhibitors (such as ritonavir) used in the treatment of AIDS;
aprepitant, a medicine used to prevent vomiting;
substances that depress the central nervous system (antipsychotics/neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics, and sedative antihistamines), as they increase the effect of TRIAZOLAM PENSA;
strong painkillers (narcotic analgesics), medicines used for pain, as they may increase euphoria when taken with TRIAZOLAM PENSA. This may lead to an increased risk of psychological dependence (absolute and uncontrollable need to take these medicines);
do not take TRIAZOLAM PENSA if you are taking medicinal products containing ketoconazole, itraconazole, efavirenz, or nefazodone.

TRIAZOLAM PENSA with food, drinks and alcohol
Do not consume alcohol during treatment with TRIAZOLAM PENSA, 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.
Pregnancy, breastfeeding and fertility
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.
Pregnancy
Do not take TRIAZOLAM PENSA if you are pregnant or become pregnant during treatment with this medicine, as it may harm your baby.
If, due to absolute medical necessity, triazolam must be administered in the late stages of pregnancy or during labor at high doses, effects on the newborn may include: low body temperature (hypothermia), low muscle tone (hypotonia), and moderate respiratory depression caused by the pharmacological action of the drug.
If TRIAZOLAM PENSA has been taken regularly during the last stages of pregnancy, your baby may develop physical dependence and show withdrawal symptoms.
Infants exposed to benzodiazepines during the third trimester of pregnancy or during labor have shown both floppy infant syndrome and neonatal withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as triazolam passes into breast milk.
Fertility
If you plan to become pregnant, consult your doctor before taking this medicine.
Driving and using machines
TRIAZOLAM PENSA may impair your ability to drive vehicles or operate machinery because it may cause drowsiness, altered alertness, dizziness, memory loss (amnesia), difficulty concentrating, and muscle weakness. These effects increase if you have not slept enough or if you have consumed alcohol. If you experience any of these effects, do not drive or operate machinery.
TRIAZOLAM PENSA contains lactose and sodium
This medicine contains lactose monohydrate. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take TRIAZOLAM PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The duration of treatment should be as short as possible.
Generally, the treatment duration ranges from a few days to two weeks, up to a maximum of
four weeks, including a gradual withdrawal period.
Your doctor will prescribe the lowest possible dose for the shortest possible time and will instruct you on how to gradually reduce the daily dose.
In certain cases, your doctor may decide to extend the treatment after evaluating your condition.
Treatment should be initiated with the lowest recommended dose.
The maximum dose must not be exceeded.
The recommended dose is 0.125–0.25 mg per day.
Swallow the TRIAZOLAM PENSA tablets whole, without chewing, with a little water or other liquid, just before going to bed.

Use in children and adolescents
The use of triazolam is not recommended in children and adolescents under 18 years of age.

Use in elderly patients and patients with respiratory problems
The recommended dose is 0.125 mg per day in elderly patients or in patients with respiratory problems (chronic respiratory insufficiency) to avoid the risk of respiratory depression.

Use in patients with liver problems
Do not take TRIAZOLAM PENSA if you have liver problems (hepatic insufficiency).

If you take more TRIAZOLAM PENSA than you should
Symptoms of overdose include drowsiness, difficulty speaking, confusion, excessive sleepiness (lethargy), impaired muscle coordination (ataxia), low muscle tone (hypotonia), low blood pressure, serious breathing problems (respiratory depression), rarely coma, and very rarely death. Among these effects, the most severe are rare unless you have also taken other medicines and/or alcohol in excessive amounts together with TRIAZOLAM PENSA.
In case of accidental ingestion/overdose of TRIAZOLAM PENSA, contact your doctor immediately or go to the nearest hospital.

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

If you stop taking TRIAZOLAM PENSA
Do not stop treatment with TRIAZOLAM PENSA suddenly or without prior agreement with your doctor, as withdrawal symptoms may occur.
Indeed, once physical dependence has developed, abrupt discontinuation of the medicine may be accompanied by withdrawal symptoms such as: headache (cephalalgia), muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
In severe cases, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), increased sensitivity to sounds (auditory hypersensitivity), numbness and tingling in hands and feet, increased sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that are not real), and epileptic seizures may occur.
If your doctor decides to discontinue treatment, he or she will instruct you on how to gradually reduce the dose.
If you have any doubts about using 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.
Drowsiness during the day, numbness, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, impaired muscle coordination (ataxia), or double vision may occur mainly at the beginning of therapy and usually disappear with continued treatment.
Occasionally, other side effects have been reported such as gastrointestinal disturbances, changes in sexual desire, skin reactions.

Common (may affect up to 1 in 10 people):

Drowsiness, dizziness, impaired muscle coordination (ataxia), headache (cephalalgia).

Uncommon (may affect up to 1 in 100 people):

Confusional state, insomnia;
Memory impairment;
Visual disturbances.

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 accumulation (angioedema, allergic edema), hypersensitivity (see section “Warnings and precautions”);
Aggression, hallucinations, sleepwalking, memory loss (anterograde amnesia), restlessness, agitation, irritability, dysphoria, rage, nightmares, psychosis, inappropriate 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);
Breathing difficulties (respiratory depression) in patients with compromised respiratory function;
Changes in sexual desire (libido);
Falls.

Anterograde amnesia may occur even at therapeutic doses, but the risk increases with higher doses. Memory loss effects may also be associated with behavioural changes.
During the use of benzodiazepines, pre-existing depressive states may emerge (see section “Warnings and precautions”).
The use of benzodiazepines (even at therapeutic doses) may lead to the development of physical and psychological dependence (see section “Warnings and precautions” and “If you stop taking TRIAZOLAM PENSA”). Abuse of benzodiazepines has been reported.

Reporting of side effects
If you experience any side effects, 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 the following address:
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 PENSA

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 "Expiry".
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. Package contents and other information

What TRIAZOLAM PENSA contains
TRIAZOLAM PENSA 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, maize starch, magnesium stearate, indigotine (E 132), erythrosine (E 127), hydrated aluminium oxide.

TRIAZOLAM PENSA 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, maize starch, magnesium stearate, indigotine (E 132), hydrated aluminium oxide.

Description of the appearance of TRIAZOLAM PENSA and contents of the pack
0.125 mg tablets: box containing 10 and 20 tablets
0.25 mg tablets: box containing 10 and 20 tablets

Marketing Authorization Holder
Towa Pharmaceutical S.p.A. – Via Enrico Tazzoli, 6 – 20154 Milan – Italy

Manufacturer
ICE S.p.A. – Cantone Moretti, 29 – 10015 Ivrea (TO) – Italy