Package Insert: Information for the User

Alprazolam Teva-ratiopharm 0.50 mg Tablets

Alprazolam belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

Alprazolam Teva-ratiopharm is used in adults for the treatment of severe, debilitating or anxiety-provoking symptoms of anxiety.

This medicine is only for short-term use.

Do not take Alprazolam Teva-ratiopharm

• if you are allergic to alprazolam, benzodiazepines, or any of the other ingredients in this medication (listed in section 6),
• if you have breathing difficulties related or unrelated to sleep (sleep apnea),
• if you have severe liver damage,
• if you have a condition called myasthenia gravis characterized by muscle weakness.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alprazolam Teva-ratiopharm

• If you have any lung, liver, or kidney problems
• If you have felt or feel so depressed that you have had thoughts or ideas of suicide.
• After prolonged use of alprazolam, certain loss of effectiveness (tolerance) may be detected.
• There is a risk of developing addiction/dependence when using alprazolam.
• If during treatmentyou note 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, consider these precautions:

• The use of benzodiazepines will be made only under medical prescription (never because they have worked in other patients) and will never be 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 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 alprazolam. 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 Alprazolam Teva-ratiopharm").
• The use of alprazolam with opioid-type medications may cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggression, anger attacks, delirium, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, 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 Alprazolam Teva-ratiopharm 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 if you are taking any of the following medications:

• Central nervous system depressants, as they may potentiate the sedative effect of alprazolam

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medications used to treat depression
• Medications used to treat anxiety (anxiolytics/sedatives).
• Medications used to treat epilepsy (antiepileptics).
• Antihistamines (allergy medications).
• Opioid analgesics and narcotics (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence.
• Anesthetics.
• Sedating antihistamines.
• The concomitant use of alprazolam and opioids (strong analgesics, medication for opioid addiction treatment, and some cough medications) increases the risk of drowsiness, breathing difficulty (respiratory depression), coma, and may put your life at risk. Due to these risks, concomitant use should only be considered when other treatment options are not possible.
• However, if your doctor prescribes alprazolam with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Inform your doctor about all sedating medications you are taking and follow your doctor's recommended dose strictly. It may be helpful to inform friends or family members to alert them to the symptoms described above. Contact your doctor if you experience these symptoms.

• There are some groups of medications that, due to their action in the body (inhibitors of cytochrome P450), may interact with Alprazolam Teva-ratiopharm and, in some cases, may increase alprazolam activity. Some medications that interact with alprazolam are:

• Macrolide antibiotics such as erythromycin, clarithromycin, telithromycin, and troleandomycin.
• Oral contraceptives

• Medications used to treat fungal infections, for example ketoconazole, itraconazole, posaconazole, voriconazole. It is not recommended to take them at the same time as alprazolam.
• Medications used to treat HIV/AIDS, for example ritonavir.
• Digoxin (a medication used to suppress or prevent heart rhythm disturbances).
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Gastric protectors such as cimetidine.
• Dextropropoxyphene (a strong analgesic).
• Oral contraceptives.
• Diltiazem (an anti-hypertensive).

Taking Alprazolam Teva-ratiopharm 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 machinery").

Pregnancy, breastfeeding, and fertility

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

Alprazolam Teva-ratiopharm is not recommended during pregnancy or breastfeeding, unless, in the doctor's opinion, the benefits outweigh the risks for the baby.

If, by the doctor's decision, this medication is administered during a late stage of pregnancy or during delivery, certain effects may appear in the newborn, such as moderate respiratory depression, decreased body temperature (hypothermia), decreased muscle tone (hypotonia). Newborns 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.

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 this medication.

If you have respiratory problems, inform your doctor.

Use in elderly patients (over 65 years)

Alprazolam Teva-ratiopharm 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 Alprazolam Teva-ratiopharm").

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 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 strictly necessary and prescribed by a doctor.

Driving and operating machinery

Alprazolam Teva-ratiopharm may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. These effects are more likely to occur 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.

Alprazolam Teva-ratiopharm contains lactose

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

Alprazolam Teva-ratiopharm contains Yellow S (E-110)

It may cause allergic reactions.

Alprazolam Teva-ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Dosage:

The tablet or its part will be ingested without chewing, with the help of a little liquid. Your doctor will prescribe the alprazolam presentation most suitable for you, according to the dose you need.

The groove is only used to break the tablet if it is difficult for you to swallow it whole.

The usual doses are as follows:

• The initial dose is 0.25 mg to 0.5 mg of alprazolam three times a day.
• The usual dose ranges from 0.5 mg to a maximum of 4 mg per day, 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, 2 or 3 times a day, with a daily dose of 0.5 mg to 0.75 mg in divided 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 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 that in your case it is necessary to prolong the treatment, 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 your treatment.

If you estimate that the action of alprazolam is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam Teva-ratiopharm than you should

If you have taken more alprazolam 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), muscle tone decrease (hypotonia), 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 forgot to take Alprazolam Teva-ratiopharm

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 Alprazolam Teva-ratiopharm

Treatment with alprazolam can cause dependence, so when stopping alprazolam administration abruptly, withdrawal symptoms may appear.

The withdrawal symptoms that may occur are: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of disgust (dysphoria), insomnia, intolerance to light, sounds, and physical contact, paresthesia and cramps in the limbs and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and convulsions. 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 Alprazolam Teva-ratiopharm predominantly occur at the beginning of treatment and generally disappear with continued administration or after a dose reduction.

Very common (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 (may affect up to 1 in 10 people):

• Sensation 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), tremor.
• Blurred vision.
• Nausea, decreased appetite.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Uncommon (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.

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), 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).
• Angioedema (swelling under the skin's surface).
• Peripheral edema.
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Drowsiness, 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. Discontinuation of treatment may lead to the development of withdrawal or rebound phenomena. It may cause psychological dependence. 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 an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse 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.

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAlprazolam Teva-ratiopharm 0.50 mg tablets

The active ingredient is alprazolam. Each tablet contains 0.50 mg of alprazolam.

The other components are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, carboxymethylcellulose sodium type A (from potato), magnesium stearate, yellow-orange S (E110) colorant, and quinoline yellow (E104) colorant.

Appearance of the product and contents of the packaging

Orange salmon-colored scored tablets.

The score is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

There are packaging with 30 and 500 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer

LACER, S.A.

C/ Boters, 5 – Parc Tecnológic del Vallés

08290 Cerdanyola del Vallés (Barcelona, Spain)

Last review date of this leaflet:April 2022

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/

You can access detailed and updated information about this medication by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63875/P_63875.html