Package Insert: Information for the User

TRANKIMAZIN RETARD3 mgtablets

Alprazolam

Read this package insert carefully before starting to take this medication, as it contains important information for you

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

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

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

3.How to take Trankimazin Retard

4.Possible adverse effects

5.Storage of Trankimazin Retard

6.Contents of the package and additional information

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

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

Do not take Trankimazin Retard

• if you are allergic to alprazolam, benzodiazepines, or any of the other components of this medication (listed in section 6)
• if you have respiratory difficulties related or unrelated to sleep (sleep apnea)
• if you have a condition calledmyasthenia gravischaracterized by muscle weakness
• if you have severe liver damage

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trankimazin Retard

• 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 prolonged use of alprazolam, there may be a certain loss of effectiveness (tolerance).
• There is a risk of developing addiction/dependence when using Trankimazin.
• If during treatment you notice symptoms of mania (a state of overexcitement, feeling of euphoria, or irritability) or hypomania (a state of excitement and excessive activity).

The treatment with benzodiazepines, including alprazolam, may cause dependence, mainly after taking the medication continuously for a long time. To minimize the risk of dependence, the following precautions should be taken:

• The use of benzodiazepines should be made only under medical prescription (never because they have worked in other patients) and never recommended to others.
• Do not increase the prescribed doses, or prolong the treatment longer than recommended.
• Consult your doctor regularly to decide if you should continue with the treatment.
• Do not combine several benzodiazepines regardless of their indication.
• When stopping treatment with alprazolam, rebound-like symptoms may appear similar to those that led you to start treatment with Trankimazin. 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 Retard”).
• The use of alprazolam with opioid medications may cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, you should discontinue treatment and consult your doctor.
• It is very important to inform your doctor if you have a history of drug and alcohol consumption.

Taking Trankimazin Retard 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:

• Central nervous system depressants, as they may potentiate the sedative effect of Trankimazin Retard:
• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Depression medications.
• Antiepileptic medications.
• Narcotic analgesics and opioids (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence.
• Anxiolytics/sedatives.
• Anesthetics.
• Sedating antihistamines (allergy medications).
• The concomitant use of Trankimazin Retard and opioids (powerful analgesics, addiction treatment medications, and some cough medications) increases the risk of drowsiness, breathing difficulty (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 Retard with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Inform your doctor about all opioid medications you are taking and follow your doctor's dosage recommendation closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• There are some groups of medications that, due to their action in the body (inhibitors of cytochrome P450), may interact with Trankimazin Retard and, in some cases, increase its activity. Some of the medications that may interact with Trankimazin Retard are:
• 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 Retard.
• 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).

Taking Trankimazin Retard 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, breastfeeding, and fertility

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

Trankimazin Retard is not recommended during pregnancy or breastfeeding, unless, at the doctor's discretion, the benefit outweighs the risk to the child.

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

Children born to 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.

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 Retard 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 Retard”).

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.

Special patient groups

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

If you have respiratory problems, inform your doctor.

Driving and operating machines

Trankimazin Retard may affect your ability to drive or operate machinery, 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 increasing the dose. Do not drive or operate machinery if you experience any of these effects.

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

Trankimazin Retard contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Dosage:

Trankimazin Retard tablets should be taken whole, with a little liquid. Do not chew, crush, or break them. If you are to take it once a day, it is best to take the dose in the morning.

Your doctor will prescribe the most suitable Trankimazin Retard presentation for you, according to the dose you need.

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 from 0.5 mg to 4 mg per day, divided into one or two doses.

In elderly patients, with chronic respiratory insufficiency, liver or kidney impairment, the recommended initial dose is 0.5 mg to 1 mg of alprazolam per day, divided into one or two doses, which may be increased by your doctor 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 indicates 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 the treatment in your case, they will do so for limited periods and will frequently monitor your situation.

You should never stop treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and will explain how to gradually reduce the dose until you finish treatment.

If you estimate that the action 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 you should, consult your doctor or pharmacist immediately or go to the nearest hospital with this leaflet.

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

Symptoms include drowsiness (somnolence), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (a state of deep and prolonged somnolence), muscle tone decrease, blood pressure drop, 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Trankimazin Retard

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 Retard

Alprazolam treatment can cause dependence, so when stopping Trankimazin Retard abruptly, withdrawal symptoms may appear.

Withdrawal symptoms that may occur include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of disgust (dysphoria), insomnia, intolerance to light, sounds, 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 can cause side effects, although not everyone will experience them.

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

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

• Depression.
• Drowsiness, 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.
• Abstinence symptoms.

Unknown frequency(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), aggression, hostility, abnormal thinking, 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).
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Drowsiness, emotional stimulus reaction reduction (emotional blunting), reduced 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 memory loss (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. Treatment interruption may lead to withdrawal or rebound phenomena. Psychological dependence may develop. Cases of abuse have been reported.

Reporting 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 prospectus. You can also report them directly through the Spanish System for the 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.

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

Composition of Trankimazin Retard

• The active ingredient is alprazolam, each tablet contains 3 mg.
• The other components are: lactose monohydrate, methylhydroxypropylcellulose, colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and contents of the packaging

It is presentedin white triangular convex tablets, with the VLE 68 imprint on one face.Each package (blister) contains 30 tablets.

Other presentations:

• 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.
• Trankimazin0.25mg in packages of 30 tablets.
• Trankimazin0.50mg in packages of 30 tablets.
• Trankimazin 1 mg in packages of 30 tablets.
• Trankimazin 2 mg in packages of 30 and 50 tablets.
• Trankimazin 0.75 mg/ml oral drops in solution.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Pfizer Italia S.r.L.

Località Marino del Tronto,

63100 Ascoli Piceno (AP)

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:November2021

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/