ALPRAZOLAM NORMON 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Alprazolam Normon 0.5 mg Tablets EFG

Alprazolam

Read the entire package leaflet carefully before starting to take the medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

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

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

This medication is used in adults for the treatment of anxiety symptoms that are severe, disabling, or cause significant distress to the patient. This medication is 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, benzodiazepines, or any of the other components of this medication (listed in section 6).
• If you have breathing difficulties related to or not related to sleep (sleep apnea).
• If you have a disease called myasthenia gravis, characterized by muscle weakness.
• If you have severe liver impairment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alprazolam Normon.

• If you have any lung, kidney, or liver 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 prolonged continuous use of the medication. To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines should only be taken under medical prescription (never because they have worked for other patients) and should never be recommended to others.
• Never increase the prescribed dose, nor prolong treatment longer than recommended.
• Regularly consult your doctor to 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 to starting treatment with Alprazolam Normon (rebound effect) may appear. To avoid this, it is recommended not to stop treatment abruptly, but to gradually reduce the dose, according to the doctor's instructions (see section "If you stop taking Alprazolam Normon").
• Taking alprazolam with opioid medications may cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines may cause memory loss and reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. 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 and alcohol use.

Taking Alprazolam Normon with other medications

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

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

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

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medications used to treat depression.
• Medications for the treatment of epilepsy (antiepileptics).
• Narcotic analgesics and opioids (morphine derivatives), as they may increase the feeling of euphoria, which can lead to increased psychological dependence.
• Medications used to treat anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medications for treating allergies).
• The concomitant use of alprazolam and opioids (potent analgesics, medications for substitution therapy, and some cough medications) increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.
• However, if your doctor prescribes Alprazolam Normon with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Tell your doctor about all opioid medications you are taking and closely follow your doctor's recommended dose. It may be helpful to inform friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.

• There are groups of medications that, due to their action in the body (cytochrome P450 inhibitors), may interact with this medication and, in some cases, increase its activity. Some medications that interact with alprazolam are:

• Medications 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 medication.
• 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.
• Medications used to treat AIDS, such as ritonavir, etc.
• Digoxin (medication used to suppress or prevent heart rhythm disturbances).

Taking Alprazolam Normon with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of 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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

If alprazolam is administered during late pregnancy or during childbirth, effects on the newborn, such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression, may occur. Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which can lead to a withdrawal syndrome in the postnatal period.

Use in children and adolescents (under 18 years)

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

Use in elderly patients (over 65 years)

This medication 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 the 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 can cause falls, often with serious consequences in this population.

Special patient groups

If your liver or kidneys do not function properly, consult your doctor, who may advise you to use a lower dose of Alprazolam Normon. If you have respiratory disorders, inform your doctor.

Driving and using machines

Alprazolam may alter your ability to drive or operate machinery, as it can cause somnolence, decrease your attention, or decrease 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 Normon contains lactose and orange dye (E-110)

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

This medication may cause allergic reactions.

3. How to take Alprazolam Normon

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

Dosage:

The tablets or their parts should be swallowed without chewing, with the help of a little liquid.

Your doctor will prescribe the most suitable presentation of Alprazolam Normon, according to the dose you need.

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 impairment, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with the total amount of alprazolam ingested per day being 0.5 mg to 0.75 mg in divided doses, which can 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 otherwise.

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 it necessary to prolong treatment in your case, it will be for limited periods, and they will closely monitor 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 progressively decrease the dose until the end of treatment.

If you think 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, consult your doctor or pharmacist immediately or go to the nearest hospital, taking this package leaflet with you.

Overdose with benzodiazepines is usually characterized by different degrees of central nervous system depression, ranging from somnolence to coma.

Symptoms include somnolence (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, disorientation, fatigue, headache, dizziness, weakness, ataxia, or double vision. These phenomena occur predominantly at the start of treatment and generally disappear with continued administration. Occasionally, gastrointestinal disorders, changes in sexual desire, or skin reactions may occur.

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

If you forget to take Alprazolam Normon

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 Normon

Treatment with alprazolam may produce dependence, so when stopping alprazolam administration 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, sound, and physical contact, tingling and cramps in the limbs and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and convulsions. If this occurs, you should consult your doctor immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Very common side effects (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 side effects (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 sleepiness (letargia), tremors.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

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

• Mental and behavioral disorders (mania), hallucinations, rage attacks, agitation, dependence.
• Memory loss (amnesia).
• Muscle weakness.
• Urinary incontinence.
• Irregular menstruation.
• Withdrawal symptoms.

Frequency not known (cannot be estimated from 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, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, liver function alteration, 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.
• Elevated intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Somnolence, 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. Occasionally, gastrointestinal disorders, changes in sexual desire, or skin reactions may occur.
• A loss of memory (amnesia) may develop, which may be associated with inappropriate behavior.
• The use of benzodiazepines may unmask a pre-existing depression.
• The use of benzodiazepines or similar compounds may cause reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. These reactions can be severe and occur more frequently in children and the elderly.
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Alprazolam Normon

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Alprazolam Normon

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

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

Product Appearance and Packaging Content

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

They are available in packages containing 30 tablets and clinical packages of 500 tablets. Each tablet contains 0.5 mg of alprazolam. Only some package 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 Last Revision of this Prospectus:April 2023

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

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