Alprazolam Normon 0.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alprazolam Normon 0.5 mg tablets EFG

Alprazolam

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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

This medicine 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 Normon

Do not take Alprazolam Normon

• 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 disorders (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 Normon.

• 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 someone else) and should never be recommended to others.

• Never increase the doses prescribed by your doctor or extend 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 you to start Alprazolam Normon 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 Normon").

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

• Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggressiveness, delirium, 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.

Taking Alprazolam Normon with other medicines

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

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 this medicine:

• 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 (treatment of opioid addiction), and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are available.

• However, if your doctor prescribes Alprazolam Normon 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 this medicine and, in some cases, increase its activity. Some medicines that interact with alprazolam include:

• Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. It is not recommended to take them at the same time as this medicine.

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

• Gastric protectants 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 Normon with food, drinks, and alcohol

Avoid alcoholic beverages during treatment. Alcohol may enhance sedation, which can affect your alertness (see section "Driving and using machines").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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 opinion, the benefit outweighs the risk to the child.

If, on the doctor's advice, 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 postnatal withdrawal syndrome.

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 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.

Use in elderly patients (over 65 years of age)

This medicine may affect this patient group more than 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 Normon").

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 take a lower dose of Alprazolam Normon. If you have respiratory disorders, inform your doctor.

Driving and using machines

Alprazolam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or impair 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 enhanced if alcohol is consumed at the same time.

Alprazolam Normon contains lactose and orange lacquer (E-110)

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

This medicine may cause allergic-type reactions.

3. How to take Alprazolam Normon

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

Dosage:

The tablets or parts thereof should be swallowed whole, with a little liquid.

Your doctor will prescribe the most suitable Alprazolam Normon formulation according to the dose you require.

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 with liver or kidney impairment, the initially recommended 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 as necessary and well tolerated.

Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless your doctor specifically instructs 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 it necessary to extend treatment in your case, it will be done for limited periods, with frequent monitoring of your condition.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment depending on the course 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 Normon is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam Normon 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 sequelae are rare unless alprazolam is taken together with other drugs or alcohol.

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

If you forget to take Alprazolam Normon

Do not take a double dose to make up for a missed dose. If you remember the missed dose soon after, 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 Normon

Treatment with alprazolam may lead to dependence; therefore, abruptly stopping alprazolam administration 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 contact, tingling and cramps in the limbs and abdomen, vomiting, sweating, tremor, depersonalization, hallucinations, and seizures. If this occurs, you should contact 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 everybody gets them.

Adverse effects that may occur during treatment with alprazolam occur predominantly 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):

• Confusion, disorientation, altered sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), prolonged drowsy state (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, altered 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.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Drowsiness, reduced responsiveness 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 behaviour.
• 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 may 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 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 Normon

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

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 drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alprazolam Normon

• The active substance is alprazolam. Each tablet contains 0.5 mg of alprazolam.

• The other components are: povidone, monohydrate lactose, corn starch, magnesium stearate and orange lake (E-110).

What Alprazolam Normon looks like and contents of the pack

Alprazolam Normon 0.5 mg are orange-colored, round, flat tablets, with a break line on one side and printed with "AP" on the other.

It is available in packs containing 30 tablets and in hospital packs of 500 tablets. Each tablet contains 0.5 mg of alprazolam. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: April 2023

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63246/P_63246.html