ALPRAZOLAM TEVA-RATIOPHARM 0.50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alprazolam Teva-ratiopharm 0.50 mg EFG Tablets

Contents of the pack:

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

1. What is Alprazolam Teva-ratiopharm and what is it used for

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

Alprazolam Teva-ratiopharm is used in adults for the treatment of severe, disabling or anxious symptoms that cause distress to the patient.

This medicine is for short-term use only.

2. What you need to know before you take Alprazolam Teva-ratiopharm

Do not take Alprazolam Teva-ratiopharm

• if you are allergic to alprazolam, benzodiazepines or any of the other ingredients of this medicine (listed in section 6),
• if you have breathing difficulties related or not to sleep (sleep apnea),
• if you have severe liver disorders,
• if you have a disease 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 continuous use of alprazolam, some loss of efficacy (tolerance) may be detected.
• There is a risk of developing addiction/dependence when using alprazolam.
• 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:

• Benzodiazepines will only be taken 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 in any way, nor prolong the treatment for longer than recommended.
• Consult your doctor regularly so that he can decide if you should continue 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 alprazolam (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 Alprazolam Teva-ratiopharm").
• Taking alprazolam with medicines of the opioid type can cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines can cause memory loss and reactions such as: restlessness, agitation, irritability, aggression, outbursts of anger, delirium, 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 Alprazolam Teva-ratiopharm 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 if you are taking any of the following medicines:

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

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medicines used to treat depression
• Medicines used to treat anxiety (anxiolytics/sedatives).
• Medicines for the treatment of epilepsy (antiepileptics).
• Antihistamine medicines (medicines for treating allergies).
• Narcotic analgesics and opioids (morphine derivatives), as they may increase the feeling of euphoria, which can lead to increased psychological dependence.
• Anesthetics.
• Sedating antihistamines (medicines for treating allergies) sedatives.
• The concomitant use of alprazolam and opioids (strong pain relievers, medicines for substitution treatment (treatment of opioid addiction) and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can put your life in danger. 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.
• Tell your doctor about all sedative medicines you are taking and follow the recommended dose strictly as indicated by your doctor. It may be useful to inform friends or family members to alert them to the signs and symptoms described above. Contact your doctor if you experience such symptoms.

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

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

• Medicines for the treatment of fungal infections, such as ketoconazole, itraconazole, posaconazole, voriconazole. It is not recommended to take them at the same time as alprazolam.
• Medicines used to treat AIDS, such as ritonavir.
• Digoxin (medicine used to suppress or prevent heart rhythm disorders).
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Stomach protectors such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (antihypertensive).

Taking Alprazolam Teva-ratiopharm with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol can 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.

Alprazolam Teva-ratiopharm should not be used during pregnancy or breastfeeding unless, in the doctor's opinion, the benefit outweighs the risk to the child.

If this medicine is administered during late pregnancy or during childbirth, effects on the newborn such as moderate respiratory depression, decreased body temperature (hypothermia), decreased muscle tone (hypotonia) 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.

Special patient groups

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

If you have respiratory disorders, inform your doctor.

Use in elderly patients (over 65 years)

Alprazolam Teva-ratiopharm 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 Alprazolam Teva-ratiopharm").

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 children and adolescents (under 18 years)

Alprazolam is not recommended for children and adolescents under 18 years of age. Benzodiazepines should not be given to children unless it is strictly necessary and prescribed by a doctor.

Driving and using machines

Alprazolam Teva-ratiopharm may alter your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce your reaction capacity. 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.

Alprazolam Teva-ratiopharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Alprazolam Teva-ratiopharm contains orange yellow S (E-110)

It may cause allergic reactions.

Alprazolam Teva-ratiopharm contains sodium

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

3. How to take Alprazolam Teva-ratiopharm

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

Dosage:

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

The score line is only for breaking the tablet if you find it difficult 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 disorders, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with the amount of alprazolam ingested per day being 0.5 mg to 0.75 mg in divided doses, and may 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 with frequent monitoring of 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 gradually reduce the dose until the end of treatment.

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

Overdose with benzodiazepines is generally manifested 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 medicines 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 Alprazolam Teva-ratiopharm

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 Alprazolam Teva-ratiopharm

Treatment with alprazolam can produce dependence, so when stopping the administration of alprazolam 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that may appear during treatment with Alprazolam Teva-ratiopharm occur predominantly at the start of treatment and generally disappear with continued administration or after a dose reduction.

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

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

Common (may affect up to 1 in 10 people):

• Feeling of confusion, disorientation, altered sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance disorder, difficulty concentrating, excessive sleepiness (hypersomnia), state of deep and prolonged drowsiness (lethargy), tremors.
• 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, outbursts of anger, 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 the available data):

• Increased prolactin levels in the blood (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, increased involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, altered liver function, yellowing of the skin and whites of the eyes (jaundice).
• Angioedema (swelling under the skin surface).
• Peripheral edema.
• Photosensitivity (exaggerated response to light).
• Urinary retention.
• Elevated intraocular pressure.

With the use of benzodiazepines, the following may appear:

• Drowsiness, lack of reaction to emotional stimuli (emotional bluntness), reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena occur predominantly at the start of treatment and generally disappear with continued administration. Gastrointestinal disorders, changes in sexual desire, or skin reactions may occasionally occur.
• A loss of memory (amnesia) may develop that may be associated with inappropriate behaviors.
• The use of benzodiazepines may unmask a pre-existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, outbursts of anger, delirium, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disorders may appear. These reactions can be severe and occur more frequently in children and elderly patients.
• 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 side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Teva-ratiopharm

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAlprazolam Teva-ratiopharm 0.50 mg tablets

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

The other ingredients are: lactose monohydrate, microcrystalline cellulose, corn starch, talc, sodium carboxymethylcellulose type A (derived from potato), magnesium stearate, orange-yellow S dye (E110), quinoline yellow dye (E104).

Appearance of the Product and Package Contents

Orange-pink tablets with a score line.

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

There are packages with 30 and 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer

LACER, S.A.

Boters, 5 – Parc Tecnológic del Vallés

08290 Cerdanyola del Vallés (Barcelona, Spain)

Date of the Last Revision of this Leaflet:April 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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