Alprazolam Cinfa 0.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

alprazolam cinfa 0.25 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What alprazolam cinfa is and what it is used for

The active substance of this medicine is alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

Alprazolam is used in adults for the treatment of anxiety symptoms that are severe, disabling, or cause significant distress to the patient. This medicine is intended for short-term use only.

2. What you need to know before taking alprazolam cinfa

Do not take alprazolam cinfa

• 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 issues (sleep apnea).
  • If you have a disease called myasthenia gravis, which is characterized by muscle weakness.
• If you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take alprazolam cinfa.

• If you have any lung, kidney, or liver problems.
• If you have felt or currently feel so depressed that you have had thoughts or ideas of suicide.
• After 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 notice 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, continuous use of the medicine.

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 another patient), and should never be recommended to others.

• Do not increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.

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

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

• When stopping treatment with alprazolam, symptoms similar to those that led you to start treatment (rebound effects) may appear. 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 3 “If you stop taking alprazolam cinfa”).

• 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, aggression, delusions, rage attacks, 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.

Other medicines and alprazolam cinfa

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 or pharmacist 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-inducing medicines (hypnotics).

• Medicines used to treat depression.

• Medicines used to treat epilepsy (antiepileptics).

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

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

• Anesthetics.

• Sedating antihistamines (medicines used to treat allergies).

• The concomitant use of alprazolam and opioids (strong analgesics, medicines for substitution therapy (opioid addiction treatment), and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Because of this, 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 must be limited by your doctor.

• Inform your doctor about all opioid medicines you are taking and closely follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• Certain groups of medicines, due to their action in the body (cytochrome P450 inhibitors), may interact with alprazolam and in some cases increase its activity. Some of the medicines that may interact with alprazolam include:

• Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. Taking these together with alprazolam is not recommended.

• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.

• Gastric protectors such as cimetidine.

• Dextropropoxyphene (a narcotic analgesic).

• Oral contraceptives.

• Diltiazem (an antihypertensive).

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

• Medicines used to treat HIV/AIDS such as ritonavir, etc.

• Digoxin (a medicine used to suppress or prevent heart rhythm disturbances).

Taking alprazolam cinfa with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which could affect your ability to drive or operate machinery (see section 2 “Driving and use of machines”).

Pregnancy and breastfeeding

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 is not recommended during pregnancy or breastfeeding unless, in the doctor’s judgment, the benefit outweighs the risk to the child.

If alprazolam is administered during late pregnancy or during childbirth, effects in the newborn may occur, such as decreased body temperature (hypothermia), reduced muscle tone (hypotonia), and moderate respiratory depression.

Infants born to mothers who chronically take benzodiazepines during the last stage of pregnancy may develop physical dependence, potentially leading to a withdrawal syndrome in the postnatal period.

Children and adolescents (under 18 years of age)

Alprazolam is not recommended for children and adolescents under 18 years of age. Benzodiazepines should not be given to children unless strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam have not been established in individuals under 18 years of age.

Elderly patients (over 65 years of age)

Alprazolam may have a greater effect on this group of patients than on younger patients. If you belong to this group, your doctor may reduce your dose and monitor your response to treatment. Please follow their instructions carefully (see section 3 “How to take alprazolam cinfa”).

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.

Special patient groups

If you have impaired liver or kidney function, consult your doctor, who may advise you to use a lower dose of alprazolam.

If you have respiratory disorders, inform your doctor.

Driving and use of machines

Alprazolam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduced attention, or decreased reaction time. 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 enhanced if alcohol is consumed simultaneously.

alprazolam cinfa contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult them before taking this medicine.

alprazolam cinfa contains sodium benzoate

This medicine contains 0.224 mg of sodium benzoate in each tablet.

alprazolam cinfa contains sodium

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

3. How to take alprazolam cinfa

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

Swallow the tablet or part of it without chewing, with water or another non-alcoholic drink. If necessary, and as directed by your doctor or pharmacist, you may break the tablet along the score line.

The tablet can be divided into equal doses.

Your doctor will prescribe the most appropriate alprazolam formulation according to the dose you require.

The recommended doses are as follows:

The initial dose is 0.25 mg to 0.5 mg of alprazolam three times daily.

The recommended dose ranges from 0.5 mg up to a maximum of 4 mg per day, divided into 2 or 3 doses.

In elderly patients with chronic respiratory insufficiency, or with liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam 2 or 3 times daily, resulting in a total daily intake of 0.5 mg to 0.75 mg in divided doses. This dose may be gradually increased if necessary and well tolerated.

Each individual dose must not exceed the recommended limits, nor must the total daily dose, unless otherwise specifically instructed 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 for limited periods and your condition will be monitored regularly.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment depending on the progression of your illness and will explain how you should gradually reduce the dose until treatment is discontinued.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more alprazolam cinfa than you should

If you have taken more alprazolam than you should, 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 (drowsiness), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (a state of deep and prolonged drowsiness), decreased muscle tone (hypotonia), low blood pressure, respiratory depression, rarely coma, and very rarely death. Serious consequences are rare unless alprazolam is taken together with other drugs or alcohol.

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

If you forget to take alprazolam cinfa

Do not take a double dose to make up for missed doses. If you remember the missed dose recently, take it immediately; otherwise, wait until your next scheduled dose, without taking a double dose to compensate.

If you stop taking alprazolam cinfa

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

Withdrawal symptoms that may occur include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discomfort (dysphoria), insomnia, sensitivity to light, sound, and physical touch, tingling sensations 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 experiences them.

Adverse effects that may occur during treatment with alprazolam predominantly appear at the beginning of treatment and usually disappear with continued administration or after a dose reduction.

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

• Depression.
• Sedation, drowsiness, coordination disorder (ataxia), memory impairment, difficulty in 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, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), state of prolonged and profound 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 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 the 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, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, alteration of liver function, 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 occur:

• Drowsiness, 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 pre-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 can be severe and occur more frequently in children and elderly patients.
• 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 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of alprazolam cinfa

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

Do not store above 25°C.

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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of alprazolam cinfa

• The active substance is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch (type A) (from potato), maize starch, povidone, magnesium stearate, colloidal anhydrous silica, sodium docusate, sodium benzoate (E-211) and hydrated aluminum oxide.

Appearance of the product and contents of the package

White, cylindrical, biconvex tablets, scored on one side and marked with the code "A025" on the other side.

Presented in PVC-PVDC/ALU blisters. Each package contains 30 tablets.

Other presentations:

alprazolam cinfa 0.5 mg tablets EFG, package containing 30 tablets.

alprazolam cinfa 1 mg tablets EFG, package containing 30 tablets.

alprazolam cinfa 2 mg tablets EFG, packages containing 30 and 50 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of latest revision of this leaflet: June 2022

Detailed information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64214/P_64214.html

QR code to: https://cima.aemps.es/cima/dochtml/p/64214/P_64214.html