HALCION 0.125 mg TABLETS

Introduction

Package Leaflet: Information for the User

Halcion 0.125 mg Tablets

Triazolam

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Halcion is and what it is used for

Halcion (triazolam) is a hypnotic medicine (which helps you sleep), indicated for the treatment of patients with insomnia (difficulty falling asleep or altered 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.

2. What you need to know before you take Halcion

Do not take Halcion:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from hypersensitivity (allergy) to a type of medicines called benzodiazepines.
• if you suffer from myasthenia gravis(a disease characterized by muscle weakness).
• if you have severe respiratory problems.
• if you suffer from sleep apnea (episodes of brief respiratory arrest during sleep)
• if you have severe liver problems.
• if you are taking
• medicines for fungal infections that contain ketoconazole or itraconazole;
• medicines for depression that contain nefazodone;
• medicines for HIV infection that contain efavirenz or HIV protease inhibitors (e.g., ritonavir);
• or other medicines that strongly reduce the activity of certain liver enzymes (see section "Taking Halcion with other medicines").

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, are debilitated, or have mild or moderate liver or lung problems, as 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, it is not recommended that you take this medicine.
• Before taking this medicine, you should tell your doctor if you have a history of alcoholism or drug dependence.
• This medicine may cause amnesic episodes (memory loss). This effect occurs mainly several hours after taking the medicine. To reduce this risk, you should ensure, before taking the medicine, that you have the possibility of sleeping uninterrupted for at least 7-8 hours.
• When treatment with triazolam is interrupted, as with the rest of benzodiazepine medicines, insomnia (difficulty sleeping) may reappear transiently with greater intensity (rebound insomnia). Since the risk of rebound insomnia is greater after sudden withdrawal of treatment, your doctor will recommend that you gradually reduce the dose over a period of time.
• As with other sedative hypnotic medicines, during treatment with triazolam, cases related to complex behavior during sleep have been reported, such as driving while not fully awake after taking the medicine and not remembering having done so. If this happens to you, contact your doctor immediately.
• Taking Halcion with opioid-type medicines (potent pain relievers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Halcion with opioids, the dose and duration of concomitant treatment should be limited by your doctor. Inform your doctor about all opioid medicines you are taking and closely follow your doctor's dose recommendation. It may be helpful to inform friends or family members so they are aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.
• Since triazolam can cause sedation (drowsiness, sleepiness, dizziness, and difficulty controlling movements), patients, especially the elderly, are at greater risk of falls.
• If during treatment, reactions such as restlessness, agitation, irritability, aggression, delirium, rage 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 abuse

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

Treatment with this medicine also increases sensitivity to the effects of alcohol and other medicines that affect brain activity. Therefore, consult your doctor if you drink alcohol or are using this type of medicine.

The use of benzodiazepines, including Halcion, can lead to 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 drugs;
• you regularly drink alcohol or have frequently consumed large amounts of alcohol in the past;
• you have had or currently have a desire to take large amounts of medicines.

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

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

Some withdrawal reactions can be potentially fatal.

Withdrawal reactions can range from mild depressive mood, insomnia, and headaches to a severe syndrome with muscle pain, muscle cramps, and abdominal cramps, vomiting, sweating, tremors, convulsions, anxiety, tension, restlessness, confusion, and irritability. The most severe withdrawal symptoms, including potentially fatal reactions, may include: feeling of detachment or alienation from oneself and the outside world, excessive perception of noise, numbness and tingling in the limbs, increased sensitivity to light, noise, and physical contact, hallucinations, delirium tremens, depression, mania, psychosis, epileptic seizures, and suicidal tendencies.

The symptoms for which you were prescribed this medicine may also reappear during a brief period (rebound phenomena).

Do not give Halcion to family members or friends. Keep this medicine in a safe place to prevent harm to others.

Other medicines and Halcion

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Halcion should not be used with the following medicines:

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

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

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

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

Taking Halcion with food, drinks, and alcohol

Halcion should not be taken with alcohol, as the sedative effect of the medicine may be intensified.

Concomitant administration of grapefruit juice may increase the effect of Halcion.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

Its administration is not recommended during breastfeeding.

Driving and using machines

Halcion is a sleep-inducing medicine. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced. Pay special attention at the start of treatment or if the dose is increased.

Halcion contains lactose, sodium, and sodium benzoate

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially "sodium-free".

This medicine contains 0.15 mg of sodium benzoate (E-211) in each tablet.

3. How to take Halcion

Follow exactly the administration instructions of this medicine 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).
• Elderly: 0.125 mg (1 tablet).

The duration of treatment will be as short as possible, not exceeding a period of two weeks. In certain cases, your doctor may consider it appropriate to extend the treatment period and even increase 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 number of times a day you should take the medicine and the duration of your treatment with Halcion, so that you take the lowest possible dose for the shortest possible time, as there is a risk of dependence. Do not change or exceed the dose that has been prescribed for you. To stop treatment, the dose should be gradually reduced after consulting your doctor. This reduces the risk of withdrawal reactions, which can be potentially fatal in some cases (see section 2).

If you have any liver or lung problems, your doctor may consider reducing your dose.

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

If you take more Halcion than you should

If you have taken more Halcion than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

Overdose of benzodiazepines is generally manifested by different degrees of central nervous system depression, ranging from drowsiness to coma.

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

If you forget to take Halcion

Do not take a double dose to make up for forgotten doses.

If you stop taking Halcion

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

When stopping treatment, restlessness, anxiety, insomnia, lack of concentration, headache, and sweating may appear.

If you have any other questions 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.

Some side effects of this type of medicine (benzodiazepines) are drowsiness during the day, 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 during treatment. 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, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior and physical and psychological dependence (with withdrawal symptoms) have been described.

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

• Drowsiness, dizziness, ataxia (lack of coordination in body movements)

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

• Confusion, insomnia
• Memory impairment
• Visual disturbances

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

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Halcion

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

No special storage conditions are required.

Do not use Halcion after the expiry date stated on the package. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Halcion Composition

• 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%.

Product Appearance and Packaging Content

Halcion is presented in tablet form. Each package contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Pfizer, S.L.

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

28108 Alcobendas (Madrid)

Manufacturer:

Pfizer Italia S.r.l.

Località Marino del Tronto- 63100

Ascoli Piceno (Italy)

Date of the Last Revision of this Leaflet: November 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/