Trankimazin 0.75 mg/ml oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TRANKIMAZIN 0.75 mg/ml oral drops solution

Alprazolam

Read the entire leaflet carefully before you start taking this medicine, as 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, because 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.

Contents of the leaflet

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 side effects
5. How to store Trankimazin
6. 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 severe, disabling, or distressing anxiety symptoms. This medicine 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, to other 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 apnea (sleep apnea)
• if you have a disease called myasthenia gravis, which is characterized by muscle weakness
• if you have severe liver impairment

Warnings and precautions

Talk to 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.
  • 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, particularly after prolonged uninterrupted use.

To minimize the risk of dependence, the following precautions should be observed:

• Benzodiazepines should only be taken under medical prescription (never because they worked for someone else), and you should never recommend them to others.
• Do not increase the dose prescribed by your doctor or extend the treatment beyond the recommended duration.
• Consult your doctor regularly so they can determine 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 may occur (rebound effect). To avoid this, it is recommended not to stop 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 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 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 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:

• Major tranquilizers (antipsychotics).

• Sleep-inducing agents (hypnotics).

• Medicines used to treat depression.

• Medicines used for epilepsy treatment (antiepileptics).

• Narcotic analgesics and opioids (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence.

• Medicines used for anxiety treatment (anxiolytics/sedatives).

• Anesthetics.

• Sedating antihistamines (medicines for allergies).

• The concomitant use of Trankimazin and opioids (strong analgesics, medications for substitution therapy (opioid addiction treatment), 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 their 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 affect the body (cytochrome P450 inhibitors) may interact with Trankimazin and, in some cases, increase its activity. Some of the medicines that may interact with Trankimazin include:

• Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. Their concomitant 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. Alcohol may enhance sedation, which can affect your 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.

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 due to a medical decision, 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 withdrawal syndrome in the postnatal period.

Trankimazin 0.75 mg/ml oral solution contains ethanol (alcohol). The alcohol content should be considered in pregnant or breastfeeding women (see “Trankimazin 0.75 mg/ml oral solution contains ethanol” below).

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

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

Alprazolam is not recommended for children and adolescents under 18 years of age. Benzodiazepines should not be given 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 have a greater effect on this group of patients than on younger patients. 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”).

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.

Use in athletes

Trankimazin 0.75 mg/ml oral solution contains ethanol, which may result in a positive doping test.

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.

Do not take this medicine if you have hepatic or renal insufficiency unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

If you have 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 attention, or decrease reaction capacity. 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 propylene glycol

This medicine contains 700 mg of propylene glycol per 0.75 mg dose (30 drops, equivalent to 1 ml).

It may cause symptoms similar to those of alcohol, thereby potentially reducing your ability to drive or operate machinery.

For information on the effect of propylene glycol during pregnancy, see the section on pregnancy, fertility, and breastfeeding.

If you have hepatic or renal insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

Trankimazin contains ethanol

This medicine contains 176.75 mg of alcohol (ethanol) per ml (30 drops, equivalent to 17.7% (w/v) ethanol). The amount of ethanol per ml is equivalent to less than 5 ml of beer or 2 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect in adults or adolescents. However, it may have some effects in young children, such as drowsiness.

The amount of alcohol contained in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

If you are alcohol-dependent, consult your doctor or pharmacist before taking this medicine.

Trankimazin contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 10 mg dose (13.33 ml), which is essentially “sodium-free”.

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:

Trankimazin 0.75 mg/ml oral solution drops are administered orally. 10 drops correspond to 0.25 mg of alprazolam.

The usual doses are as follows:

• The initial dose is 0.25 mg (10 drops) to 0.5 mg (20 drops) of alprazolam three times daily.
• The usual dose ranges from 0.5 mg (20 drops) to a maximum of 4 mg per day (160 drops), divided into 2 or 3 doses.

In elderly patients, or those with chronic respiratory insufficiency, or with liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam (10 drops) two or three times daily, with a total daily alprazolam intake of 0.5 mg (20 drops) to 0.75 mg (30 drops) in divided doses. This dose may be gradually increased if necessary and well tolerated.

Each individual dose must not exceed the limits indicated, nor must 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 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 course of your illness and will explain how you should gradually reduce the dose until treatment is completed.

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, contact 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 (state of deep and prolonged sleepiness), 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 was recent, take it immediately; otherwise, wait until the next scheduled dose, without taking a double dose to compensate.

If you stop taking 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, intolerance 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, somnolence, coordination disorder (ataxia), memory impairment, difficulty 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), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), prolonged and profound 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 (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, liver function impairment, yellowing of the skin and whites of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling beneath 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:

• Somnolence, 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 behaviours.
• The use of benzodiazepines may unmask pre-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 the elderly.
• Administration of the product (even at usual doses) may lead to physical dependence. Discontinuation of treatment may lead to 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

Keep this medicine out of 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.

The Trankimazin 0.75 mg/ml oral solution drops bottle must be discarded 90 days after first opening.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Trankimazin

• The active substance is alprazolam. Each milliliter of solution contains 0.75 mg of alprazolam.
• The other components are: propylene glycol (E-1520), ethanol, sodium saccharin grapefruit flavor (contains ethanol), and purified water.

Appearance of the product and contents of the container

It is supplied in amber glass bottles with dropper containing 20 ml of solution.

Other pack sizes:

• Trankimazin 0.25 mg in packages of 30 tablets.
• 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 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 commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Delpharm Orleans
5 Avenue de Concyr
45071 Orleans Cedex 2
France

or

Doppel Farmaceutici S.R.L
Via Martiri Delle Foibe, 1-29016
Cortemaggiore (PC)
Italy

or

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 Madrid
Spain

Date of the most recent review of this leaflet: November 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/