Alprazolam Combix 0.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alprazolam Combix 0.5 mg tablets EFG

Read the entire 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 must 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, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Alprazolam Combix is and what it is used for

Alprazolam belongs to a group of medicines called benzodiazepine-derived tranquilizers (anxiolytics).

It is indicated for the treatment of:

• Generalized anxiety and anxiety associated with symptoms of depression.
• Panic disorders with or without agoraphobia (fear of places where escape may be difficult or embarrassing, or help may not be available).

Benzodiazepines are only indicated for the treatment of severe disorders that either limit the patient's activity or subject them to extreme stress.

Benzodiazepines should not be used alone to treat anxiety associated with depression. Alprazolam is not recommended for the treatment of depression.

2. What you need to know before taking Alprazolam Combix

Do not take Alprazolam Combix

• 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, with or without sleep-related breathing problems (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 Alprazolam Combix

• 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 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 continuous use. To minimize the risk of dependence, the following precautions should be observed:

• Benzodiazepines should only be taken under medical prescription (never because they worked for other patients) 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 multiple benzodiazepines regardless of their indication.

• When stopping treatment with alprazolam, symptoms similar to those that led to starting alprazolam 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 Combix”).

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

• Benzodiazepines may cause memory loss and reactions such as:

anxiety, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If this occurs, you should 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 Combix

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:

• 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 for treating 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 possible.

• 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 that affect the body (cytochrome P450 inhibitors) may interact with alprazolam and, in some cases, increase its activity. Some of the medicines that interact with alprazolam include:

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

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

• Gastric protectants such as cimetidine.

• Dextropropoxyphene (narcotic analgesic).

• Oral contraceptives.

• Diltiazem (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 Combix with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, and this may affect your alertness (see section “Driving and use of machines”).

Pregnancy, breastfeeding, and fertility

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

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

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

Use in 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 administered 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.

Use in elderly patients (over 65 years of age)

Alprazolam may have a greater effect in this patient group than in 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 “How to take Alprazolam Combix”).

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 your liver or kidneys are not functioning properly, 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 capacity. 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 simultaneously.

Alprazolam Combix contains lactose monohydrate, carmine red A (E-124), sunset yellow FCF (E-110), and sodium benzoate (E-211)

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

This medicine contains 0.04 mg of carmine red A (E-124) and 0.26 mg of sunset yellow FCF (E-110), which may cause allergic-type reactions.

This medicine contains 0.15 mg of sodium benzoate (E-211) per tablet. If you need further information on this point, consult your doctor or pharmacist.

3. How to take Alprazolam Combix

Follow exactly the instructions given by your doctor 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 most suitable alprazolam formulation according to the dose you require.

The recommended dose is:

• For the treatment of anxiety states and anxiety associated with depressive symptoms:

• 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 3 or 4 doses.

• For the treatment of panic disorders:

• An initial dose of 0.5 mg to 1 mg of alprazolam at bedtime is recommended.

• Subsequently, your doctor will adjust the dose according to your response to treatment. Dose adjustments should be made by increments of no more than 1 mg every 3 or 4 days. Additional doses may be added until reaching a dosing schedule of 3 or 4 times daily.

In elderly patients, or those 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 dose of 0.5 mg to 0.75 mg given in divided doses. This dose may be gradually increased as necessary and if well tolerated.

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

Duration and discontinuation of treatment:

The treatment duration should be as short as possible (should not exceed 12 weeks, including the withdrawal period). If your doctor considers it necessary to extend treatment in your case, it will be done only for limited periods, and your condition will be monitored frequently.

You must never stop treatment abruptly. Your doctor will determine the treatment duration based 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 alprazolam is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam Combix 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 (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 rare unless alprazolam is taken together with other drugs or alcohol.

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

If you forget to take Alprazolam Combix

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 treatment with Alprazolam Combix

Treatment with alprazolam may lead to dependence; therefore, abruptly stopping alprazolam may cause 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 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 speaking (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

Common adverse effects (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.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Uncommon adverse 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.
• Withdrawal symptoms.

Frequency not known (cannot be estimated from available data):

• Increased levels of prolactin in the blood (a 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, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, liver function impairment, yellowing of the skin and whites of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling beneath the skin surface).
• 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 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 behavior.
• The use of benzodiazepines may unmask an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations,

psychosis, inappropriate behavior, and other behavioral 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 the development of physical dependence. Discontinuation of treatment may lead to withdrawal or rebound phenomena. Psychological dependence may 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: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Alprazolam Combix Storage

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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alprazolam Combix 0.5 mg tablets EFG

• The active substance is alprazolam. Each tablet contains 0.5 mg.
• The other components are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, sodium docusate, sodium benzoate (E-211), colloidal anhydrous silica, magnesium stearate and orange dye PB-23062 (composed of monohydrate lactose, carmine red A (E-124) and orange-yellow S (E-110)).

Appearance of the product and contents of the pack

Alprazolam Combix 0.5 mg are orange-colored, uncoated, biconvex, round, and scored tablets on one side.

The tablets are presented in PVC-aluminum blisters in boxes containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

• Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the most recent revision of this leaflet: February 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/