Alprazolam Teva-Ratiopharm 0.50 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Alprazolam Teva-ratiopharm 0.50 mg Tablets EFG

Package leaflet contents:

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

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

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

Alprazolam Teva-ratiopharm is used in adults for the treatment of anxiety symptoms that are severe, disabling, or causing significant distress to the patient.

This medicine is intended for short-term use only.

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

Do not take Alprazolam Teva-ratiopharm

• if you are allergic to alprazolam, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6),
• if you have breathing difficulties, with or without sleep-related breathing problems (sleep apnea),
• if you have severe liver problems,
• if you have a disease called myasthenia gravis, which is characterized by muscle weakness.

Warnings and precautions

Talk to your doctor or pharmacist before taking Alprazolam Teva-ratiopharm

• If you have any lung, liver, or kidney problems.

• If you have felt or currently feel so depressed that you have had thoughts or ideas of suicide.

• With prolonged use of alprazolam, a certain loss of effectiveness (tolerance) may occur.

• There is a risk of developing addiction/dependence when using alprazolam.

• If during treatment you experience symptoms of mania (a state of overexcitement, feelings of euphoria, or hyperirritability) or hypomania (a state of exaggerated excitement and activity).

• Treatment with benzodiazepines, including alprazolam, may lead to dependence, especially after long-term, uninterrupted use. To minimize the risk of dependence, the following precautions should be observed:

• Benzodiazepines should only be taken on a doctor's prescription (never because they worked for someone else), and you should never recommend them to others.

• Do not increase the prescribed dose or extend the treatment beyond the recommended duration.

• Consult your doctor regularly so they can decide whether treatment should continue.

• Do not combine multiple benzodiazepines, regardless of their indication.

• When stopping treatment with alprazolam, symptoms similar to those that led you to start treatment may reappear (rebound effect). 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”).

• Using alprazolam together with opioid medicines may cause profound sedation, respiratory depression, coma, and death.

• Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggressiveness, rage attacks, delirium, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If this occurs, you must stop treatment and consult your doctor.

• It is very important that you inform your doctor if you have a history of drug or alcohol use.

Taking Alprazolam Teva-ratiopharm with other medicines

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

Alprazolam may interact with other medicines. Inform your doctor if you are taking any of the following:

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

• Major tranquilizers (antipsychotics).

• Sleep-inducing medicines (hypnotics).

• Medicines used to treat depression.

• Medicines used to treat anxiety (anxiolytics/sedatives).

• Medicines used to treat epilepsy (antiepileptics).

• Antihistamine medicines (medicines used to treat allergies).

• Narcotic analgesics and opioids (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence.

• Anesthetics.

• Sedating antihistamines (medicines used to treat allergies).

• Concomitant use of alprazolam and opioids (strong painkillers, opioid substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Due to these risks, concomitant use should only be considered when no other treatment options are available.

• However, if your doctor prescribes alprazolam together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

• Inform your doctor about all sedative medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform friends or family members so they can recognize the signs and symptoms described above. Contact your doctor if you experience any of these symptoms.

Certain groups of medicines that affect 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 include:

• Macrolide antibiotics such as erythromycin, clarithromycin, telithromycin, and troleandomycin.
• Oral contraceptives.
• Medicines used to treat fungal infections, for example, ketoconazole, itraconazole, posaconazole, voriconazole. It is not recommended to take these together with alprazolam.
• Medicines used to treat HIV/AIDS, such as ritonavir.
• Digoxin (a medicine used to suppress or prevent heart rhythm disturbances).
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Gastric protectors such as cimetidine.
• Dextropropoxyphene (a narcotic analgesic).
• Oral contraceptives.
• Diltiazem (an antihypertensive).

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

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which can affect your level of 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.

The use of Alprazolam Teva-ratiopharm is not recommended during pregnancy or breastfeeding, unless in the doctor’s judgment the benefits outweigh the risks to the child.

If, on the doctor’s advice, this medicine is administered during late pregnancy or during childbirth, effects on the newborn such as moderate respiratory depression, decreased body temperature (hypothermia), and reduced muscle tone (hypotonia) may occur. Infants born to mothers who have taken benzodiazepines chronically during the last stage of pregnancy may develop physical dependence and may experience a withdrawal syndrome in the postnatal period.

Special patient groups

If your liver or kidneys do not function properly, consult your doctor, who may advise you to take a lower dose of this medicine.

If you have respiratory disorders, inform your doctor.

Use in elderly patients (over 65 years of age)

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 monitor 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, which may lead to falls, often with serious consequences in this population.

Use in children and adolescents (under 18 years of age)

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

Driving and using machines

Alprazolam Teva-ratiopharm may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce your attention, or impair your reaction ability. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

These effects may be intensified if alcohol is consumed at the same time.

Alprazolam Teva-ratiopharm contains lactose

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

Alprazolam Teva-ratiopharm contains Sunset Yellow FCF (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; hence, it is essentially “sodium-free”.

3. How to take Alprazolam Teva-ratiopharm

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Dosing:

The tablet or part of it should be swallowed whole, with a little liquid. Your doctor will prescribe the alprazolam formulation most suitable for your required dose.

The score line is intended solely for dividing 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 daily.
• 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, or those with chronic respiratory insufficiency, or impaired liver or kidney function, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times daily, resulting in a total daily alprazolam intake of 0.5 mg to 0.75 mg in divided doses. This dose may be gradually increased if necessary and well tolerated.

No individual dose should exceed the limits indicated, nor should the total daily dose, unless specifically instructed otherwise by your doctor.

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 extend treatment in your case, it will be done in limited periods, with frequent monitoring of your condition.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment based on your clinical progress and will explain how you should gradually reduce the dose until treatment is completed.

If you feel that the effect 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 prescribed, contact your doctor or pharmacist immediately or go to the nearest hospital, taking this leaflet with you.

Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (sedation), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (a state of prolonged and deep drowsiness), decreased muscle tone (hypotonia), low blood pressure, respiratory depression, rarely coma, and very rarely death. Serious consequences are uncommon unless alprazolam is taken together with other drugs or alcohol.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Alprazolam Teva-ratiopharm

Do not take a double dose to make up for a missed dose. If you remember the missed dose soon after the scheduled time, take it immediately. Otherwise, wait until the next scheduled dose and do not take a double dose to compensate.

If you stop taking Alprazolam Teva-ratiopharm

Treatment with alprazolam may lead to dependence; therefore, abruptly stopping alprazolam may cause withdrawal symptoms.

Withdrawal symptoms may include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general discomfort (dysphoria), insomnia, sensitivity to light, sound, and physical touch, tingling and cramps in the limbs and abdomen, vomiting, sweating, tremor, depersonalization, hallucinations, and seizures. If this occurs, you should consult your doctor immediately.

If you have any further 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 everyone will experience them.

The adverse effects that may occur during treatment with Alprazolam Teva-ratiopharm occur predominantly at the beginning of treatment and usually disappear with continued administration or after a dose reduction.

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

• Depression.
• Sedation, somnolence, 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):

• Confusion, disorientation, altered sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), state of prolonged and profound drowsiness (lethargy), tremor.
• Blurred vision.
• Nausea, decreased appetite.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Uncommon (may affect up to 1 in 100 people):

• Mental and behavioural disorders (mania), hallucinations, angry 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 blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioural 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 beneath the skin 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:

• Somnolence, lack of response 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 usually disappear with continued administration. Gastrointestinal disturbances, changes in sexual desire, or skin reactions may occasionally occur.
• Memory loss (amnesia) may develop, which may be associated with inappropriate behaviours.
• The use of benzodiazepines may unmask an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behaviour, and other behavioural disturbances may occur. These reactions may be severe and occur more frequently in children and elderly individuals.
• Administration of the product (even at usual doses) may lead to physical dependence. Discontinuation of treatment may lead to withdrawal or rebound phenomena. Psychological dependence may also develop. 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 they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Teva-ratiopharm

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused or expired containers and medicines to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Alprazolam Teva-ratiopharm 0.50 mg tablets

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

The other components are: lactose monohydrate, microcrystalline cellulose, corn starch, talc, sodium carboxymethyl starch type A (derived from potato), magnesium stearate, sunset yellow FCF (E110), quinoline yellow (E104).

Appearance of the medicinal product and contents of the pack

Orange-salmon coloured, scored tablets.

The score line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

Packs containing 30 and 500 tablets are available.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer

LACER, S.A.

C/ Boters, 5 – Parc Tecnològic del Vallès

08290 Cerdanyola del Vallès (Barcelona, Spain)

Date of the most recent review of this leaflet: April 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning the QR code included on 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