Brand name Trankimazin Retard 0.5 mg tablets

Form tablets, prolonged-release

Active substance / Dosage

ALPRAZOLAM · 0,5 mg

Prescription type Psychotropic Medicine. Prescription Only

ATC code

N05B N05BA N05BA12

Registration number 61152

Manufacturer Viatris Healthcare Limited

Trankimazin Retard 0.5 mg tablets tablets, prolonged-release

Table of Contents

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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TRANKIMAZIN RETARD 0.5 mg tablets

Alprazolam

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

Contents of the leaflet

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

1. What Trankimazin Retard is and what it is used for

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

Trankimazin Retard 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 Retard

Do not take Trankimazin Retard

if you are allergic to alprazolam, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6)
if you have breathing difficulties, with or without sleep-related breathing disorders (sleep apnea)
if you have a disease called myasthenia gravis, characterized by muscle weakness
if you have severe liver problems

Warnings and precautions

Talk to your doctor or pharmacist before starting Trankimazin Retard

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 about suicide.
With 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, especially after long-term, uninterrupted use. To minimize the risk of dependence, the following precautions should be observed:
- Benzodiazepines should only be taken on a doctor's prescription (never because they worked for someone else), and you should never recommend them 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 Trankimazin Retard may reappear (rebound effect). To avoid this, abrupt discontinuation of treatment should be avoided; instead, the dose should be gradually reduced according to your doctor's instructions (see section “If you stop taking Trankimazin Retard”).
The use of alprazolam together with opioid-type medications may cause profound 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 any of these occur, you must 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 Retard with other medicines

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

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

Central nervous system depressants, as they may enhance the sedative effect of Trankimazin Retard:
Major tranquilizers (antipsychotics).
Sleep-inducing agents (hypnotics).
Medicines used to treat depression.
Medicines used for the treatment of epilepsy (antiepileptics).
Narcotic analgesics and opioids (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence.
Medicines used for the treatment of anxiety (anxiolytics/sedatives).
Anesthetics.
Sedating antihistamines (medicines used to treat allergies).
The concomitant use of Trankimazin Retard and opioids (strong analgesics, medications 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. Because of this, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Trankimazin Retard 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 described above. Contact your doctor if you experience any of these symptoms.
There are groups of medicines that, due to their action in the body (cytochrome P450 inhibitors), may interact with Trankimazin Retard and in some cases increase its activity. Some of the medicines that may interact with Trankimazin Retard include:
Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. Concurrent use with Trankimazin Retard is not recommended.
The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
Gastric protectants such as cimetidine.
Dextropropoxyphene (a narcotic analgesic).
Oral contraceptives.
Diltiazem (an 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 Retard with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which can affect your level of alertness (see section “Driving and using machines”).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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

If Trankimazin Retard is administered during late pregnancy or during childbirth, effects in 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, which could trigger a withdrawal syndrome in the postnatal period.

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 Retard may have a stronger effect in this group of patients than in younger individuals. If you belong to this group, your doctor may reduce your dose and monitor your response to treatment. Please follow their instructions carefully (see section “How to take Trankimazin Retard”).

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 Retard.

If you have respiratory disorders, inform your doctor.

Driving and using machines

Trankimazin Retard may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce your attention, or impair your reaction time. These effects are more likely to occur 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 enhanced if alcohol is consumed at the same time.

Trankimazin Retard contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Trankimazin Retard

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

Dosing:

Trankimazin Retard tablets should be taken whole, with a little liquid. They must not be chewed, crushed, or split. If a single daily dose is prescribed, it is preferable to take it in the morning.

Your doctor will prescribe the most suitable Trankimazin Retard formulation according to the dose you require.

The usual doses are as follows:

The initial dose is 1 mg of alprazolam per day, divided into one or two doses.
The usual dose ranges between 0.5 mg and 4 mg of alprazolam per day, divided into one or two doses.

In elderly patients, or those with chronic respiratory insufficiency, or liver or kidney impairment, the initially recommended dose is 0.5 mg to 1 mg of alprazolam per day, divided into one or two doses. This dose may be increased by your doctor if necessary and well tolerated.

No individual dose should exceed the limits indicated, nor should the total daily dose, unless your doctor specifically instructs 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 extend treatment in your case, it will be done only for limited periods, with frequent monitoring of your condition.

You must never stop treatment abruptly. Your doctor will determine the treatment duration based on your condition's progression and will explain how you should gradually reduce the dose before stopping treatment completely.

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

If you take more Trankimazin Retard than you should

If you have taken more Trankimazin Retard than prescribed, consult your doctor or pharmacist immediately, or go to the nearest hospital, taking this leaflet with you.

Overdose with benzodiazepines generally causes varying degrees of central nervous system depression, ranging from drowsiness to coma.

Symptoms include drowsiness (sedation), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (state of deep and prolonged drowsiness), decreased muscle tone, low blood pressure, respiratory depression, rarely coma, and very rarely death. Serious consequences are uncommon 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 Retard

Do not take a double dose to make up for a missed dose. If you remember the missed dose shortly after the scheduled time, take it immediately. Otherwise, wait until the next scheduled dose and do not take a double dose to compensate.

If you stop taking Trankimazin Retard

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

Withdrawal symptoms may include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discomfort (dysphoria), insomnia, sensitivity to light, sound, and physical touch, tingling sensations 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 using 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 Retard occur predominantly 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 speaking (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), anxiety, difficulty sleeping (insomnia), nervousness.
Abnormal coordination, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), prolonged state of drowsiness (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, anger 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 (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 surface).
Photosensitivity (exaggerated response to light).
Urinary retention in the bladder.
Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

Drowsiness, reduced response to emotional stimuli (emotional blunting), reduced 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 can be severe and occur more frequently in children and elderly patients.
Administration of the product (even at usual doses) may lead to physical dependence. Discontinuation of treatment may result in withdrawal or rebound phenomena. Psychological dependence may also 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 Retard

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 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 Point located at the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Trankimazin Retard

The active substance is alprazolam; each tablet contains 0.5 mg.
The other components are: monohydrate lactose, methylhydroxypropylcellulose, colloidal silicon dioxide, magnesium stearate and aluminum lake blue (E-132).

Appearance of the product and contents of the container

It is presented as blue, round, convex tablets, with the imprint VLE 57 on one side. Each pack (blister) contains 30 tablets.

Trankimazin Retard 0.5 mg tablets