Brand name Trankimazin 0.50 mg tablets

Form tablets

Active substance / Dosage

ALPRAZOLAM · 0,5 mg

Prescription type Psychotropic Medicine. Prescription Only

ATC code

N05B N05BA N05BA12

Registration number 56026

Manufacturer Viatris Healthcare Limited

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Trankimazin is and what it is used for
2. What you need to know before taking Trankimazin
3. How to take Trankimazin
4. Possible adverse effects
5. Storage of Trankimazin
6. Contents of the container and additional information
Other presentations:

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TRANKIMAZIN 0.50 mg tablets

Alprazolam

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Trankimazin is and what it is used for

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

Trankimazin is used in adults for the treatment of anxiety symptoms that are severe, disabling, or causing significant distress to the patient. This medicine is intended 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 medicine (listed in section 6)
if you suffer from breathing difficulties, with or without sleep-related apnea (sleep apnea)
if you have a disease called myasthenia gravis, characterized by muscle weakness
if you have severe liver problems

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 currently feel so depressed that you have had thoughts or ideas of suicide.
- After prolonged use of alprazolam, a certain loss of effectiveness (tolerance) may occur.
- There is a risk of developing addiction/dependence when using Trankimazin.
- If during treatment you experience symptoms of mania (a state of overexcitement, feelings of euphoria or hyperirritability) or hypomania (a state of exaggerated excitement and activity).
Treatment with benzodiazepines, including alprazolam, may lead to dependence,

mainly after long-term, uninterrupted use of the medicine. To minimize the risk of dependence, the following precautions should be observed:

Benzodiazepines should only be taken on medical prescription (never because they worked for someone else), and should never be recommended to others.
Do not increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.
Consult your doctor regularly so they can decide whether you should continue treatment.
Do not combine multiple benzodiazepines regardless of their indication.
When stopping treatment with alprazolam, symptoms similar to those that led you to start treatment with Trankimazin may occur (rebound effect). To avoid this, it is recommended not to abruptly stop treatment, but to gradually reduce the dose according to your doctor's instructions (see section "If you stop taking Trankimazin").
- The use of alprazolam together 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, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. 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 or alcohol use.

Taking Trankimazin with other medicines

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

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

Central nervous system depressants, as they may enhance the sedative effect of Trankimazin:
Major tranquilizers (antipsychotics).
Sleep-inducing agents (hypnotics).
Medicines used to treat depression.
Medicines used for the treatment of epilepsy (antiepileptics).
Narcotic and opioid analgesics (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence.
Medicines used for the treatment of anxiety (anxiolytics/sedatives).
Anesthetics.
Sedative antihistamines (medicines used to treat allergies).
The concomitant use of Trankimazin and opioids (strong analgesics, medicines for substitution therapy (treatment of opioid addiction), and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Trankimazin 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 closely follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.
Certain groups of medicines that act on the body (cytochrome P450 inhibitors) may interact with Trankimazin and, in some cases, increase its activity. Some of the medicines that interact with Trankimazin include:
Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. Concurrent use with Trankimazin is not recommended.
The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
Gastric protectants such as cimetidine.
Dextropropoxyphene (narcotic analgesic).
Oral contraceptives.
Diltiazem (antihypertensive).
Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
Medicines used to treat HIV/AIDS such as ritonavir, etc.
Digoxin (a medicine used to suppress or prevent heart rhythm disturbances).

Taking Trankimazin with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may enhance sedation, which can affect your level of alertness (see section "Driving and use of 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 medicine.

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

If Trankimazin is administered during late pregnancy or during childbirth at the doctor's discretion, effects on the newborn may occur, such as decreased body temperature (hypothermia), reduced muscle tone (hypotonia), and moderate respiratory depression. Infants born to mothers who chronically take benzodiazepines during the last stage of pregnancy may develop physical dependence, potentially leading to a postnatal withdrawal syndrome.

Use in children and adolescents (under 18 years of age)

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

Use in elderly patients (over 65 years of age)

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 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 may lead to falls, often with serious consequences in this population.

Special patient groups

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

If you suffer from respiratory disorders, inform your doctor.

Driving and use of machines

Trankimazin may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce your attention, or impair your reaction ability. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

These effects may be intensified if alcohol is consumed simultaneously.

Trankimazin contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

Trankimazin contains sodium benzoate

This medicine contains 0.11 mg of sodium benzoate (E-211) in each 0.50 mg tablet.

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

Trankimazin contains orange-yellow dye

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

It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Trankimazin

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosing:

The tablet or part thereof should be swallowed whole, without chewing, with a little liquid. Your doctor will prescribe the most appropriate Trankimazin formulation according to the dose you require.

The usual doses are as follows:

The initial dose is 0.25 mg to 0.5 mg of alprazolam three times daily.
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, or those with chronic respiratory insufficiency, or with liver or kidney impairment, the initially recommended dose is 0.25 mg of alprazolam, 2 or 3 times daily, resulting in a total daily alprazolam intake of 0.5 mg to 0.75 mg in divided doses. This dose may be gradually increased if necessary and well tolerated.

No individual dose should exceed the stated limits, nor should the total daily dose, unless expressly instructed otherwise by your doctor.

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 extend treatment in your case, it will be done for limited periods, and your condition will be monitored frequently.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment depending on the progression of your condition and will explain how you should gradually reduce the dose until treatment is discontinued.

If you feel that 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 leaflet with you.

Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (sedation), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (a state of prolonged deep drowsiness), decreased muscle tone (hypotonia), low blood pressure, respiratory depression, rarely coma, and very rarely death. Serious consequences are rare unless alprazolam is taken together with other drugs or alcohol.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Trankimazin

Do not take a double dose to make up for a missed dose. If the missed dose is noticed soon, take it immediately; otherwise, wait until the next scheduled dose, without taking a double dose to compensate.

If you stop treatment with Trankimazin

Treatment with alprazolam may lead to dependence; therefore, abruptly stopping Trankimazin may cause withdrawal symptoms.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects that may occur during treatment with Trankimazin predominantly appear at the beginning of treatment and usually disappear with continued administration or after a dose reduction.

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

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

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

Confusion, disorientation, altered sexual desire (libido), difficulty sleeping (insomnia), nervousness.
Abnormal coordination, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), prolonged drowsy state (lethargy), tremor.
Nausea, decreased appetite.
Blurred vision.
Dermatitis.
Sexual dysfunction.
Weight changes.

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

Mental and behavioural disorders (mania), hallucinations, angry reactions, agitation, dependence.
Memory loss (amnesia).
Loss of muscle strength.
Inability to retain urine in the bladder (urinary incontinence).
Irregular menstruation.
Withdrawal symptoms.

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

Increased levels of prolactin in the blood (a hormone responsible for stimulating and maintaining lactation after childbirth).
Mental and behavioural 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).
Photosensitivity (exaggerated response to light).
Urinary retention in the bladder.
Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

Drowsiness, reduced responsiveness to emotional stimuli (emotional blunting), decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena occur predominantly at the beginning of treatment and usually disappear with continued administration. Gastrointestinal disturbances, changes in sexual desire, or skin reactions may occasionally occur.
Memory loss (amnesia) may develop, which may be associated with inappropriate behaviour.
The use of benzodiazepines may unmask an existing depression.
When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behaviour, and other behavioural disturbances may occur. These reactions may be severe and occur more frequently in children and elderly patients.
Administration of the product (even at usual doses) may lead to the development of physical dependence. Discontinuation of treatment may lead to withdrawal or rebound phenomena. Psychic dependence may occur. Cases of abuse have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Trankimazin

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

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Trankimazin

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

Appearance of the product and contents of the pack

It is presented as peach-colored, oval, scored tablets, with "UPJOHN 55" engraved on one side. Each pack (blister) contains 30 tablets.

Trankimazin 0.50 mg tablets