ALPRAZOLAM NORMON 0.25 mg TABLETS

Introduction

Patient Information Leaflet

Alprazolam Normon 0.25 mg EFG tablets

Alprazolam

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it 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 leaflet. See section 4.

Contents of the 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. Package contents and additional information

1. What is Alprazolam Normon and what is it 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 cause significant distress to the patient. This medicine 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 medicine (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 gravischaracterized by muscle weakness.
• If you have severe liver damage.

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 medicine. 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 other people.
• Never increase the prescribed dose, nor prolong treatment for 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 you to start 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 your 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, 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may 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 inducers (hypnotics).
• Medicines used to treat depression.
• Medicines 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.
• Medicines used to treat anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medicines 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 dosage recommendation. 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 medicines that, due to their action in the body (cytochrome P450 inhibitors), may interact with this medicine and, in some cases, increase its activity. Some of the medicines that interact with alprazolam are:

• 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.
• Stomach protectors, such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (antihypertensive).
• Macrolide antibiotics, such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medicines used to treat AIDS, such as ritonavir, etc.
• Digoxin (medicine used to suppress or prevent heart rhythm disorders).

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 medicine.

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, and a withdrawal syndrome may occur 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 given to children unless strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam in children under 18 years have not been established.

Use in elderly patients (over 65 years)

This medicine 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 drowsiness, reduce your attention, or reduce 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 may be enhanced if you consume alcohol at the same time.

Alprazolam Normon contains lactose

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

3. How to take Alprazolam Normon

Follow your doctor's or pharmacist's instructions for taking this medicine exactly. If in doubt, consult your doctor or pharmacist again.

Dosage:

The tablet or part of it should be swallowed without chewing, with 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 a total daily dose of 0.5 mg to 0.75 mg, divided into 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 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 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 gradually reduce 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 leaflet with you.

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

Symptoms include drowsiness (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, lethargy (state of deep and prolonged drowsiness), decreased muscle tone (hypotonia), decreased blood pressure, respiratory depression, rarely coma, and very rarely death. Serious sequelae are rare, unless alprazolam is taken with other medicines or alcohol.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20, indicating the product 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 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

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

• Depression.
• Sedation, drowsiness, 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 drowsiness (lethargy), 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, 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:

• Drowsiness, lack of reaction to emotional stimuli (emotional blunting), reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena occur predominantly at the start of treatment and usually disappear with continued administration. Gastrointestinal disorders, changes in sexual desire, or skin reactions may occasionally 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, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. These reactions may 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 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 medicine.

5. Storage of Alprazolam Normon

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Alprazolam Normon

• The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other components are: povidone, lactose monohydrate, corn starch, and magnesium stearate.

Appearance of the Product and Packaging Content

Alprazolam Normon 0.25 mg are white or almost white, round, flat tablets, with a break line on one face and serigraphed with AP on the other.

They are presented in packages containing 30 tablets and clinical packages of 500 tablets. Each tablet contains 0.25 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 Leaflet: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 leaflet 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/63247/P_63247.html