TRANKIMAZIN 0.75 mg/ml ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the User

TRANKIMAZIN0.75mg/mloral drops in solution

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Trankimazin and what is it used for
2. What you need to know before you take Trankimazin
3. How to take Trankimazin
4. Possible side effects
5. Storage of Trankimazin
6. Contents of the pack and other information

1. What is Trankimazin and what is it 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 anxious symptoms that cause significant distress to the patient. This medicine is for short-term use only.

2. What you need to know before you take Trankimazin

Do not take Trankimazin

• if you are allergic to alprazolam, other benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
• if you have breathing problems related or not to sleep (sleep apnea)
• if you have a disease called myasthenia gravischaracterized by muscle weakness

• if you have severe liver disorders

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 medicine 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 worked for other patients) and will never be advised 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 decides 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 the doctor's instructions (see section "If you stop taking Trankimazin").
• The use of alprazolam along with opioid-type medications can cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines can cause memory loss and reactions such as: restlessness, agitation, irritability, aggression, delirium, fits of rage, 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 medicines

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

Alprazolam may interact with other medicines. Tell 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 inducers (hypnotics).
• Medicines used to treat depression.
• Medicines 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.
• Medicines used for the treatment of anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medicines for treating allergies).
• The concomitant use of Trankimazin and opioids (potent analgesics, medications for substitution therapy (treatment of opioid addiction) and some cough medications) increases the risk of drowsiness, 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 the recommended dose of your doctor. It may be useful to inform friends or family members to be aware of the signs and symptoms indicated 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 and, in some cases, increase its activity. Some of the medicines that may interact with Trankimazin are:

• Medicines 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.
• Medicines used to treat AIDS such as ritonavir, etc.
• Digoxin (medicine used to suppress or prevent heart rhythm disorders).

Taking Trankimazin with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may 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 medicine.

Trankimazin should not be used during pregnancy or breastfeeding unless, in the opinion of the doctor, the benefit outweighs the risk to the child.

If Trankimazin is administered during late pregnancy or during childbirth, 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.

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

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

Use in children and adolescents (under 18 years)

Alprazolam is not recommended in children and adolescents under 18 years. Benzodiazepines should not be given 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 check 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 that can cause falls, often with serious consequences in this population.

Use in athletes

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

Special patient groups

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

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

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, decrease your attention, or decrease your reaction ability. 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 propylene glycol

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

It can produce symptoms similar to those of alcohol, which can decrease the ability to drive or operate machinery.

To see the effect of propylene glycol on pregnancy, see the section on pregnancy, fertility, and breastfeeding.

If you have liver or kidney failure, do not take this medicine unless it is recommended by your doctor. Your doctor may perform additional checks 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% (v/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 contained in this medicine will have any noticeable effect on adults or adolescents. It may have some effects on small 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 have an alcohol addiction, consult your doctor or pharmacist before taking this medicine.

Trankimazin contains sodium

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

3. How to take Trankimazin

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

Dosage:

Trankimazin 0.75 mg/ml oral drops in 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 failure, liver or kidney disorders, the recommended initial dose is 0.25 mg of alprazolam (10 drops) two or three times a day, being the amount of alprazolam ingested per day 0.5 mg (20 drops) to 0.75 mg (30 drops) 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 so.

Duration and suppression of treatment:

The maximum duration of treatment should not exceed 2-4 weeks. Long-term treatment is not recommended. If your doctor considers that, in your case, it is necessary to prolong the treatment, it will be for limited periods and will frequently monitor your situation.

Never stop treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and will explain how to progressively decrease the dose until the end of treatment.

If you think the effect of Trankimazin is too strong or too weak, tell 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.

Overdose with benzodiazepines is generally characterized by different degrees of central nervous system depression, which can range from drowsiness to coma.

Symptoms include drowsiness (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, lethargy (state of deep and prolonged drowsiness), 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 Toxicology Information Service, 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 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 can 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 limbs 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

• Depression.
• Sedation, somnolence, coordination disorder (ataxia), memory alteration, difficulty articulating words (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

Common adverse 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 sleepiness (hypersomnia), state of deep and prolonged 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 behavioral disorders (mania), hallucinations, anger reactions, 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 levels of prolactin in the blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioral disorders (hypomania), aggressiveness, 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 whites of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin surface).
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Elevated intraocular pressure.

With the use of benzodiazepines, the following may appear:

• Somnolence, 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 beginning of treatment and generally disappear with continued administration. Gastrointestinal alterations, changes in sexual desire, or skin reactions may occasionally 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, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral alterations may appear. 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 the development of physical dependence. Interruption of treatment may lead to the development of 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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Trankimazin

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30 °C.

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

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

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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, grapefruit flavor (contains ethanol), and purified water.

Appearance of the Product and Package Contents

It is presented in amber glass bottles with droppers that contain 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 marketed.

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

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 Prospectus: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/