TRANKIMAZIN 0.50 mg TABLETS

Introduction

Package Leaflet: Information for the User

TRANKIMAZIN0.50mgtablets

Alprazolam

Read the entire package leaflet carefully before starting to take the medication, as it contains important information for you.

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

Contents of the Package Leaflet

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

1. What is Trankimazin and what is it used for

Trankimazin contains the active substance alprazolam. It belongs to a group of medications called benzodiazepines (anxiolytic medications).

Trankimazin is used in adults for the treatment of anxiety symptoms that are severe, disabling, or cause significant distress to the patient. This medication is for short-term use only.

2. What you need to know before taking Trankimazin

Do not take Trankimazin

• • if you are allergic to alprazolam, benzodiazepines, or any of the other components of this medication (listed in section 6)
• if you have breathing difficulties related to or not related to sleep (sleep apnea)
• • if you have a disease called myasthenia gravischaracterized by muscle weakness
• if you have severe liver disorders

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trankimazin

• If you have any lung, kidney, or liver problems.
• If you have felt or feel so depressed that you have had thoughts or ideas of suicide.
  • After continuous use of alprazolam, some loss of efficacy (tolerance) may be detected.
  • There is a risk of developing addiction/dependence when using Trankimazin.
  • If during treatment you notice symptoms of mania (state of overexcitement, feeling of euphoria, or hyperirritability) or hypomania (state of excitement and excessive activity).

• The treatment with benzodiazepines, including alprazolam, may cause dependence,

mainly after uninterrupted use of the medication for a long time. To minimize the risk of dependence, the following precautions should be taken into account:

• Benzodiazepine use will only be done under medical prescription (never because it has worked for other patients) and will never be advised to other people.
• Do not increase the prescribed doses by the doctor, nor prolong the treatment for a longer period than recommended.
• Regularly consult your doctor so that he decides if you should continue with the treatment.
• Do not combine several benzodiazepines regardless of their indication.

• When stopping treatment with alprazolam, symptoms similar to those that led to starting treatment with Trankimazin (rebound effect) may appear. To avoid this, it is recommended not to interrupt treatment abruptly, but to gradually reduce the dose, according to the doctor's instructions (see section "If you stop taking Trankimazin").
• • Taking alprazolam with opioid-type medications may cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines may cause memory loss and reactions such as:

restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, you should stop treatment and consult your doctor.

• It is very important that you inform your doctor if you have a history of drug and alcohol use.

Taking Trankimazin with other medications

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

Alprazolam may interact with other medications. Inform your doctor or pharmacist if you are taking any of the following medications:

• Central nervous system depressants, as they may enhance the sedative effect of Trankimazin:

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medications used to treat depression.
• Medications for the treatment of epilepsy (antiepileptics).
• Narcotic analgesics and opioids (morphine derivatives), as they may increase the feeling of euphoria, which can lead to increased psychological dependence.
• Medications used for the treatment of anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medications for treating allergies).
• The concomitant use of Trankimazin and opioids (potent analgesics, medications for substitution therapy (treatment of opioid addiction), and some medications for cough) increases the risk of drowsiness, difficulty breathing (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 Trankimazin with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Tell your doctor about all opioid medications 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.

• There are groups of medications that, due to their action in the body (cytochrome P450 inhibitors), may interact with Trankimazin and, in some cases, increase its activity. Some of the medications that interact with Trankimazin are:

• Medications used to treat fungal infections, such as ketoconazole, itraconazole, posaconazole, or voriconazole. It is not recommended to take them at the same time as Trankimazin.
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Stomach protectors such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (antihypertensive).
• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medications used to treat AIDS, such as ritonavir, etc.
• Digoxin (medication used to suppress or prevent heart rhythm disorders).

Taking Trankimazin with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may enhance sedation, and this can affect your alertness (see section "Driving and using machines").

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 using this medication.

Trankimazin is not recommended during pregnancy or breastfeeding, unless, in the doctor's opinion, the benefit outweighs the risk to the child.

If Trankimazin is administered during late pregnancy or during childbirth, effects on the newborn, such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression, may occur. Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, and a withdrawal syndrome may be triggered in the postnatal period.

Use in children and adolescents (under 18 years)

Alprazolam is not recommended in children and adolescents under 18 years. Benzodiazepines should not be administered to children unless it is strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam have not been established in children under 18 years.

Use in elderly patients (over 65 years)

Trankimazin may affect this group of patients more than younger patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow their instructions carefully (see the section "How to take Trankimazin").

Benzodiazepines and related products should be used with caution in elderly patients due to the risk of sedation and/or musculoskeletal weakness, which can cause falls, often with serious consequences in this population.

Special patient groups

If your liver or kidneys do not function properly, consult your doctor, who may advise you to use a lower dose of Trankimazin.

If you have respiratory disorders, inform your doctor.

Driving and using machines

Trankimazin may alter your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction ability. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

These effects can be enhanced if alcohol is consumed simultaneously.

Trankimazin contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Trankimazin contains sodium benzoate

This medication contains 0.11 mg of sodium benzoate (E-211) per 0.50 mg tablet.

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

Trankimazin contains orange yellow S

This medication may cause allergic reactions because it contains the orange yellow S (E-110) colorant.

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Trankimazin

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

Dosage:

The tablet or its part should be swallowed without chewing, with the help of a little liquid. Your doctor will prescribe the most suitable Trankimazin presentation for you, according to the dose you need.

The usual doses are as follows:

• The initial dose is 0.25 mg to 0.5 mg of alprazolam three times a day.
• The usual dose ranges from 0.5 mg to a maximum of 4 mg per day, divided into 2 or 3 doses.

In elderly patients, with chronic respiratory insufficiency, liver or kidney disorders, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with the amount of alprazolam ingested per day being 0.5 mg to 0.75 mg in divided doses, and may be gradually increased if necessary and well tolerated.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor explicitly indicates so.

Treatment duration and discontinuation:

The maximum treatment duration should not exceed 2-4 weeks. Long-term treatment is not recommended. If your doctor considers it necessary to prolong treatment in your case, it will be for limited periods, and you will be closely monitored.

Never stop treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and will explain how to gradually reduce the dose until the end of treatment.

If you think the effect of Trankimazin is too strong or too weak, inform your doctor or pharmacist.

If you take more Trankimazin than you should

If you have taken more Trankimazin than you should, consult your doctor or pharmacist immediately or go to the nearest hospital, bringing this package leaflet.

Overdose with benzodiazepines is generally characterized by different degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, lethargy (state of deep and prolonged sleep), decreased muscle tone (hypotonia), decreased blood pressure, respiratory depression, rarely coma, and very rarely death. Serious sequelae are rare, unless alprazolam is taken with other medications or alcohol.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Trankimazin

Do not take a double dose to make up for forgotten doses. If the forgotten dose is recent, take your dose immediately, and if not, wait for the next dose, without taking a double dose to make up for it.

If you stop taking Trankimazin

Treatment with alprazolam may produce dependence, so when stopping Trankimazin abruptly, withdrawal symptoms may appear.

The withdrawal symptoms that may occur are: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discomfort (dysphoria), insomnia, intolerance to light, sounds, and physical contact, tingling and cramps in the limbs and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and convulsions. If this occurs, you should consult your doctor immediately.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The side effects that may occur during treatment with Trankimazin occur predominantly at the start of treatment and generally disappear with continued administration or after a dose reduction.

Very common side effects (may affect more than 1 in 10 people):

• Depression.
• Sedation, drowsiness, coordination disorder (ataxia), memory impairment, difficulty articulating words (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

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

• Feeling of confusion, disorientation, altered sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance disorder, difficulty concentrating, excessive sleepiness (hypersomnia), state of deep and prolonged sleep (lethargy), tremors.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

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

• Mental and behavioral disorders (mania), hallucinations, fits of rage, agitation, dependence.
• Memory loss (amnesia).
• Muscle weakness.
• Urinary incontinence.
• Irregular menstruation.
• Withdrawal symptoms.

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

• Increased prolactin levels in the blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioral disorders (hypomania), aggression, hostility, abnormal thinking, psychomotor hyperactivity, drug abuse.
• Autonomic nervous system imbalance, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, liver function alteration, yellowing of the skin and whites of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin surface).
• Photosensitivity (exaggerated response to light).
• Urinary retention.
• Elevated intraocular pressure.

With the use of benzodiazepines, the following may appear:

• Drowsiness, lack of reaction to emotional stimuli (emotional blunting), reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena occur predominantly at the start of treatment and generally disappear with continued administration. Gastrointestinal disorders, changes in sexual desire, or skin reactions may occasionally occur.
• A loss of memory (amnesia) may develop, which may be associated with inappropriate behavior.
• The use of benzodiazepines may unmask a pre-existing depression.
• The use of benzodiazepines or similar compounds may cause reactions such as restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disorders. These reactions can be severe and occur more frequently in children and the elderly.
• Administration of the product (even at usual doses) may lead to the development of physical dependence. Stopping treatment may lead to the development of withdrawal or rebound phenomena. Psychological dependence may occur. Cases of abuse have been reported.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Trankimazin

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

Do not store above 30 ºC.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Trankimazin

• The active ingredient is alprazolam, each tablet contains 0.5 mg.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, corn starch, dioctyl sodium sulfosuccinate (sodium docusate) (85%) with sodium benzoate (E-211) (15%), colloidal silicon dioxide, magnesium stearate, and orange-yellow S colorant (E-110).

Appearance of the Product and Package Contents

It is presented in scored, oval-shaped, peach-colored tablets with UPJOHN 55 engraved on one face. Each package (blister) contains 30 tablets.

Other Presentations:

• Trankimazin 0.25 mg in packages of 30 tablets.
• Trankimazin 1 mg in packages of 30 tablets.
• Trankimazin 2 mg in packages of 30 and 50 tablets.
• Trankimazin 0.75 mg/ml oral drops in solution in packages of 20 ml.

• Trankimazin Retard 0.5 mg in packages of 30 tablets.
• Trankimazin Retard 1 mg in packages of 30 tablets.
• Trankimazin Retard 2 mg in packages of 30 tablets.

• Trankimazin Retard 3 mg in packages of 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Pfizer Italia S.r.l.

63100

Marino del Tronto, Ascoli Piceno (AP)

Italy

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

or

Fine Foods & Pharmaceuticals N.T.M. S.p.A.

Via Grignano, 43

24041 Brembate (BG)

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the Last Revision of this Leaflet:November 2021

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