TRANKIMAZIN 0.25 mg TABLETS

Introduction

Package Leaflet: Information for the User

TRANKIMAZIN0.25mgtablets

Alprazolam

Read the package leaflet carefully before starting to take this 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 symptoms of anxiety 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 gravis, characterized by muscle weakness
• if you have severe liver impairment

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).
• 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:

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients) and will never be recommended to other people.
• Do not increase the prescribed doses by your doctor, nor prolong the treatment for a longer period than recommended.
• Regularly consult your doctor so that he can decide 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 you to start 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 your doctor's instructions (see section "If you stop taking Trankimazin").
• The use of alprazolam along with opioid medications can cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines can cause memory loss and reactions such as restlessness, agitation, irritability, aggression, delirium, outbursts of anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this happens, 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 to treat anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medications for treating allergies).
• The concomitant use of Trankimazin and opioids (potent analgesics, medications for substitution therapy, and some cough medications) increases the risk of somnolence, 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 along 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 may 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.
• Gastric 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 disturbances).

Taking Trankimazin with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol can 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 labor, 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 in children under 18 years have not been established.

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 monitor 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, reduce your attention, or reduce your reaction capacity. 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 you consume alcohol at the same time.

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 0.25 mg tablet.

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

3. How to take Trankimazin

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Dosage:

The tablet or part of it should be swallowed without chewing, with a little liquid. Your doctor will prescribe the most suitable presentation of Trankimazin, 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 impairment, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with the total daily amount of alprazolam being 0.5 mg to 0.75 mg in divided doses, which can 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 otherwise.

Duration and discontinuation of treatment:

The maximum duration of treatment 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 they will closely monitor your situation.

Never stop treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and 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, taking this package leaflet with you.

Overdose with benzodiazepines is usually 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 extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and convulsions. If this happens, 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 gets them.

The side effects that may occur during treatment with Trankimazin occur predominantly at the start of treatment and usually 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, outbursts of anger, agitation, dependence.
• Memory loss (amnesia).
• Muscle weakness.
• Inability to retain urine in the bladder (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, altered liver function, 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.
• Increased 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 usually disappear with continued administration. Occasionally, gastrointestinal disorders, changes in sexual desire, or skin reactions may 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.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, outbursts of anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disorders may appear. These reactions can be severe and occur more frequently in children and the elderly.
• The 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 side effects, consult your doctor or pharmacist, even if they are 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the indicated month.

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

6. Package Contents and Additional Information

Composition of Trankimazin

• The active ingredient is alprazolam, each tablet contains 0.25 mg.
• The other components are: lactose monohydrate, microcrystalline cellulose, cornstarch, dioctyl sodium sulfosuccinate (docusate sodium) (85%) with sodium benzoate (E-211) (15%), colloidal silicon dioxide, and magnesium stearate.

Appearance of the Product and Package Contents

It is presented in white, scored, oval-shaped tablets, with UPJOHN 29 engraved on one face. Each package (blister) contains 30 tablets.

Other Presentations:

• Trankimazin 0.50 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 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 about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/