Package Insert: Information for the User

Halcion 0.125 mg Tablets

Triazolam

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Halcion (triazolam) is a hypnotic medication (that promotes sleep), indicated for the treatment of patients with insomnia (difficulty falling asleep or alteration of sleep duration), particularly in those with transient insomnia. Halcion is only indicated when the sleep disorder is acute, limits the patient's activity, or causes extreme exhaustion.

Do not take Halcion:

Warnings and precautions

Consult your doctor or pharmacist before starting to take Halcion.Be especially careful with Halcion in the following circumstances:

• If you have a severe psychiatric disorder.
• If you are over 65 years old, weakened, or have mild or moderate liver impairment or lung problems, your doctor should consider reducing your dose.
• If you feel depressed or have thoughts of suicide, contact your doctor as soon as possible.
• If you are a child or adolescent under 18 years old, do not take this medication.
• Before taking this medication, inform your doctor if you have a history of alcoholism or drug dependence.
• This medication may induce amnestic episodes (memory loss). This effect occurs mainly several hours after administration of the medication. To reduce this risk, ensure that you have the opportunity to sleep uninterrupted for at least 7-8 hours before taking the medication.
• When treatment with triazolam is discontinued, as with other benzodiazepines, rebound insomnia (difficulty sleeping) may occur. Since the risk of rebound insomnia is higher after abrupt discontinuation of treatment, your doctor will recommend that you gradually reduce the dose over a period of time.
• As with other sedative-hypnotic medications, complex behavior during sleep, such as driving while not fully awake after taking the medication and not remembering having done so, has been reported. If this occurs, contact your doctor immediately.
• The use of Halcion with opioid medications (potent analgesics, medication for opioid substitution therapy, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.However, if your doctor prescribesHalcionalong with opioids, the dose and duration of concomitant treatment should be limited by your doctor.Inform your doctor about all opioid medications you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.
• Since triazolam can cause sedation (drowsiness, dizziness, and difficulty controlling movements), patients, especially the elderly, have a higher risk of falls.
• If during treatment, reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior occur, contact your doctor, as treatment should be discontinued.

Development of tolerance and dependence, withdrawal reactions, and drug/medication abuse

You may experience a reduction in the effectiveness of this medication (tolerance) after continuous use. This medication is recommended for short-term treatments.

Treatment with this medication also increases sensitivity to the effects of alcohol and other medications that affect brain activity. Therefore, consult your doctor if you take alcohol or use this type of medication.

The use of benzodiazepines, including Halcion, can cause dependence. The risk of dependence increases with higher doses and continuous use. It also increases if you have a history of alcohol or drug abuse.

You should inform your doctor if:

-you have taken or are currently taking any drug;

-you regularly consume alcohol, or in the past, you have frequently consumed large amounts of alcohol;

-you have had in the past or currently have a desire to take large amounts of medication.

In principle, benzodiazepines should only be used for short periods of time and discontinued gradually. You and your doctor should agree on how long you will take the medication before starting treatment.

If you stop taking the medication abruptly or reduce the dose quickly, withdrawal reactions may occur. Do not stop taking this medication suddenly. Ask your doctor for advice on how to discontinue treatment.

Some withdrawal reactions can be potentially fatal.

Withdrawal reactions can vary from mild depression, insomnia, and headaches to a severe syndrome with muscle pain, muscle cramps, vomiting, sweating, tremors, convulsions, anxiety, tension, restlessness, confusion, and irritability. The most severe signs and symptoms of withdrawal, including potentially fatal reactions, may include: feeling detached or alienated from oneself and the world, excessive sensitivity to noise, numbness and tingling in the extremities, increased sensitivity to light, sound, and physical contact, hallucinations, delirium tremens, depression, mania, psychosis, seizures, and suicidal tendencies.

The symptoms for which you were prescribed this medication may also reappear for a short period (rebound phenomena).

You should not give Halcion to family members or friends. Keep this medication in a safe place to prevent harm to others.

Other medications and Halcion

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Halcion may alter the effect of other medications, and other medications may alter the effect of Halcion.

Halcion should not be used with the following medications:

• Ketoconazole, itraconazole (medications for fungal infections).
• Nefazodone (medication for depression).
• Efavirenz and other medications used to combat HIV infections (e.g., ritonavir).

Other medications that strongly reduce the activity of certain liver enzymes.

Inform your doctor if you are taking the following medications, as they may interact with Halcion and modify its activity:

• Medications used to treat fungal infections.
• Cimetidine (to treat stomach ulcers).
• Erythromycin, clarithromycin, troleandomycin, rifampicin, and isoniazid (to treat bacterial infections).
• Fluvoxamine, sertraline, paroxetine (to treat depression).
• Diltiazem and verapamil (to treat heart problems or high blood pressure).
• Oral contraceptives.
• Imatinib (to treat leukemia and other types of cancer).
• Carbamazepine (to treat epilepsy).
• Aprepitant (to prevent nausea and vomiting after surgery).
• Some medications that act by depressing the central nervous system, such as those used to treat psychosis (antipsychotics), depression (antidepressants), insomnia (hypnotics), anxiety (anxiolytics/sedatives), intense pain (narcotic analgesics, anesthetics, and opioids), epilepsy (antiepileptics), and allergic reactions (antihistamines).

Taking Halcion with food, drinks, and alcohol

Halcion should not be taken with alcohol, as the sedative effect of the medication may intensify.

The concurrent administration of grapefruit juice may increase the effect of Halcion.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Halcion will only be used during pregnancy when it is strictly necessary and the potential risks to the fetus have been weighed against the benefits for the patient.

It is not recommended to administer this medication during breastfeeding.

Driving and operating machinery

Halcion is a sleep medication. Do not drive or operate machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Be especially careful at the start of treatment or if the dose is increased.

Halcion contains lactose, sodium, and sodium benzoate

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

This medication contains0.15mg ofsodium benzoate (E-211)in each tablet.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the most suitable dose for you. The recommended dose is:

• Adults: 0.125 mg – 0.250 mg (1 or 2 tablets).
• Seniors: 0.125 mg (1 tablet).

The treatment duration will be as short as possible, not exceeding a period of two weeks. In certain cases, your doctor may consider prolonging your treatment for a period superior to this and even increasing the dose up to 0.5 mg (4 tablets).

The dose and duration of administration should be adjusted to your individual situation. Your doctor will advise you on the dose and the number of times a day you should take the medication and the duration of your treatment with Halcion, so that you take the lowest possible dose for the shortest time possible, since there is a risk of becoming dependent. Do not change or exceed the dose prescribed to you. To discontinue treatment, the dose should be gradually reduced after consulting with your doctor. This reduces the risk of withdrawal reactions, which can be potentially fatal in some cases (see section 2).

If you have any type of alteration in your liver or lungs, your doctor may consider reducing your dose.

Halcion is exclusively for oral use. You should take it in a single dose immediately before going to bed.

If you take more Halcion than you should

If you have taken more Halcion than you should, consult your doctor, pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Benzodiazepine overdose typically manifests by different degrees of central nervous system depression, ranging from drowsiness to coma.

The treatment of overdose includes measures such as inducing vomiting within 1 hour after the overdose or performing gastric lavage, as well as maintaining respiratory and cardiovascular functions.

If you forgot to take Halcion

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Halcion

Do not discontinue treatment abruptly. It is recommended to gradually reduce the dose according to your doctor's instructions.

When discontinuing administration, anxiety, insomnia, lack of concentration, headache, and sweating may appear.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects of this type of medicine (benzodiazepines) are daytime drowsiness, emotional numbing, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (abnormal coordination), double vision.These reactions occur mainly during the start of treatment, and usually disappear over the course of it. Occasionally, gastrointestinal problems, changes in libido (sexual desire), and skin problems have been described.

During treatment with benzodiazepines, reactions such as anterograde amnesia (difficulty remembering events prior to taking the medicine), restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other side effects on behavior and physical and psychological dependence (with symptoms of withdrawal) have been described.

Frequent side effects (may affect up to one in 10 patients):

• Drowsiness, dizziness, ataxia (discoordination in the movement of body parts)

Less frequent side effects (may affect up to one in 100 patients):

• Confusion, insomnia
• Memory alteration
• Vision alterations

Rare side effects (may affect up to one in 1,000 patients):

• Skin eruptions
• Myasthenia (disease characterized by muscle weakness)

Side effects of unknown frequency (cannot be estimated from available data):

• Allergic reactions that can be very serious and even fatal: anaphylactic shock, anaphylactoid reaction, allergic edema, or angioedema (swelling of the tongue, glottis, or larynx that can cause respiratory tract obstruction that can be fatal)
• Aggression, hallucinations, somnambulism, anterograde amnesia (lack of memory for events prior to taking the medicine), restlessness, agitation, irritability, delirium, anger attacks, nightmares, psychosis, and inappropriate behavior
• Drug/medicine abuse, drug/medicine dependence
• Syncope (fainting), sedation, decreased level of consciousness, speech disorders, attention alteration, and taste alteration
• Respiratory depression in patients with lung problems
• Changes in libido (sexual desire)
• Gastrointestinal discomfort
• Falls
• Withdrawal syndrome

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use Halcion after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Halcion

• The active ingredient is triazolam.
• The other components are: lactose, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, and sodium docusate 85% with sodium benzoate (E-211) 15%.

Appearance of the product and contents of the packaging

Halcion is presented in the form of tablets. Each package contains 30 tablets.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

Pfizer, S.L.

Avda. de Europa 20-B, Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer responsible:

Pfizer Italia S.r.l.

Località Marino del Tronto- 63100

Ascoli Piceno (Italy)

Last review date of this leaflet: November 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/