Prospecto: information for the user

TRANKIMAZIN0,75mg/mloral drops in solution

Alprazolam

Read this prospect carefully before starting to take the medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Trankimazin and for what it is used

2.What you need to know before starting to take Trankimazin

3.How to take Trankimazin

4.Possible adverse effects

5.Storage of Trankimazin

6. Contents of the package and additional information

Trankimazincontains the active ingredient alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

Trankimazinis used in adults for the treatment of severe, incapacitating, or extremely distressing anxiety symptoms. This medicine is only for short-term use.

Do not take Trankimazin

• if you have severe liver damage

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

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

Trankimazin with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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:

• Major tranquilizers (antipsychotics)
• Sleep inducers (hypnotics)
• Medications used to treat depression
• Medications used to treat epilepsy (antiepileptics)
• Narcotic analgesics and opioids (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence
• Medications used to treat anxiety (anxiolytics/sedatives)
• Anesthetics
• Sedating antihistamines (allergy medications)
• The concomitant use of Trankimazin and opioids (powerful analgesics, medication for opioid addiction treatment, and some cough medications) increases the risk of somnolence, respiratory depression, coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible
• However, if your doctor prescribes Trankimazin together with opioids, the dose and duration of concomitant treatment should be limited by your doctor
• Inform your doctor about all the opioid medications you are taking and follow your doctor's dose recommendation closely. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms

• 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 (anti-hypertensive)
• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin
• Medications used to treat HIV/AIDS such as ritonavir, etc.
• Digoxin (medication used to suppress or prevent heart rhythm disturbances)

Trankimazin with food, drinks, and alcohol

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication

Trankimazin is not recommended during pregnancy or lactation, unless, in the doctor's opinion, the benefits outweigh the risks for the baby

If, at the doctor's discretion, Trankimazin is administered during a late stage of pregnancy or during delivery, the following effects may occur in the newborn: decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression

Newborns of mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which may trigger a withdrawal syndrome in the postnatal period

Trankimazin 0.75 mg/ml oral solution contains ethanol (alcohol). The alcohol content should be taken into account in the case of pregnant women or breastfeeding women (see "Trankimazin 0.75 mg/ml oral solution contains ethanol" later)

If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication

Use in children and adolescents (under 18 years)

Alprazolam is not recommended for 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 young patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow your doctor's 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 muscle weakness that may cause falls, often with serious consequences in this population

Use in athletes

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

Special groups of patients

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

If you have liver or kidney insufficiency, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication

If you have respiratory problems, inform your doctor

Driving and operating machines

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

These effects may be potentiated if you consume alcohol at the same time

Trankimazin contains propylene glycol

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

It may produce symptoms similar to those of alcohol, which may decrease your ability to drive or operate machines

For the effect of propylene glycol on pregnancy, see the pregnancy section

If you have liver or kidney insufficiency, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication

Trankimazin contains ethanol

This medication contains 176.75 mg of alcohol (ethanol) per ml (30 drops, equivalent to 17.7% (p/v) of 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 contained in this medication will have any perceptible effect in adults or adolescents. It may have some effects in young children, such as drowsiness

The amount of alcohol contained in this medication may affect the effect of other medications. Consult your doctor or pharmacist if you are taking other medications

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

If you have a history of alcohol addiction, consult your doctor or pharmacist before taking this medication

Trankimazin contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose of 10 mg (13.33 ml); it is essentially "sodium-free"

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage:

Trankimazin 0.75 mg/ml oral drops solution is 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 a day.

- 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, with chronic respiratory insufficiency, liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam (10 drops) two or three times a day, with a daily dose of 0.5 mg (20 drops) to 0.75 mg (30 drops) divided into doses, which can be gradually increased as needed and well tolerated.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor instructs you 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, they will do so for limited periods and will closely monitor your situation.

You should never discontinue treatment abruptly. Your doctor will inform you of the duration of treatment based on the evolution of your condition and will explain how to gradually reduce the dose until you complete your treatment.

If you estimate that the action 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 with this leaflet.

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma.

Symptoms include drowsiness (somnolence), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (prolonged and deep 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 at telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Trankimazin

Do not take a double dose to compensate for the missed doses. If the missed dose is recent, take your dose immediately, and if not, wait for the next dose, without taking a double dose to compensate.

If you interrupt treatment with Trankimazin

Alprazolam treatment can cause dependence, so abruptly stopping Trankimazin administration may cause withdrawal symptoms.

Withdrawal symptoms that may occur include headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of disgust (dysphoria), insomnia, intolerance to light, sound, and physical contact, paresthesias and cramps in the extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and seizures. If this occurs, you should consult your doctor immediately.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Depression.
• Sedation, drowsiness, coordination disorder (ataxia), memory alteration, 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, alteration of sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance alteration, difficulty concentrating, excessive sleep (hypersomnia),deep and prolonged somnolence(lethargy),shaking.
• 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, anger reactions, agitation, dependence.
• Memory loss (amnesia).
• Loss of muscle strength.
• Inability to retain urine in the bladder (urinary incontinence).
• Irregular menstruation.
• Withdrawal symptoms.

Unknown frequency(cannot be estimated from available data):

• Increased levels of prolactin in theblood (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 white of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin's surface).
• Phototoxicity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Somnolence, lack of reaction to emotional stimuli (emotional numbing), reduced state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena predominantly occur at the beginning of treatment and generally disappear with continued administration. Occasionally, gastrointestinal alterations, 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 an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations may occur. 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 of side effects

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

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

Do not store at a temperature above30 °C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

The Trankimazin 0.75 mg/ml oral drops solution bottle must be discarded 90 days after it has been opened for the first time.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Trankimazin

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

Appearance of the product and contents of the package

It is presented in amber glass bottles with droppers containing 20 ml of solution.

Other presentations:

• 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 responsible manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet:November 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/