Patient Information Leaflet: Information for the Patient

Alprazolam Normon 0.25 mg Tablets EFG

Alprazolam

Read this leaflet carefully before you start taking 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 for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Alprazolam Normon

3. How to take Alprazolam Normon

4. Possible side effects

5. Storage of Alprazolam Normon

6. Contents of the pack and additional information

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

This medicine is used in adults for the treatment of severe, debilitating, or extremely distressing anxiety symptoms. This medicine is only for short-term use.

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 respiratory difficulties related or unrelated to sleep.Associated with sleep apnea.
• If you have a condition called myasthenia gravis, which is characterized 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 prolonged use of alprazolam, certain loss of effectiveness (tolerance) may be detected. There is a risk of developing addiction/dependence when using alprazolam.
• If during treatment you notice symptoms of mania (a state of overexcitement, feeling of euphoria, or irritability) or hypomania (a state of excessive excitement and activity).
• The treatment with benzodiazepines, including alprazolam, may cause dependence mainly after prolonged use of the medication. To minimize the risk of dependence, the following precautions should be taken:

• The use of benzodiazepines should be made only under medical prescription (never because they have been effective in other patients) and never recommended to others.
• Never increase the prescribed doses, nor prolong the treatment longer than recommended,
• Consult your doctor regularly so that they can decide if you should continue with the treatment.

• When stopping treatment with alprazolam, rebound-like symptoms may appear similar to those that led you to start treatment with Alprazolam Normon. 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").
• The use of 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, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, you should discontinue treatment and consult your doctor.
• It is very important to inform your doctor if you have a history of drug and alcohol consumption.

Taking Alprazolam Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 potentiate the sedative effect of this medication:

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Depression medications.
• Antiepileptic medications.
• Narcotic analgesics and opioids (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence.
• Anxiety medications (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (allergy medications).
• The concomitant use of alprazolam and opioids (potent analgesics, medication for opioid addiction treatment, and some cough medications) increases the risk of drowsiness, breathing difficulty (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.
• However, if your doctor prescribes Alprazolam Normon along with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Inform your doctor about all opioid medications you are taking and follow your doctor's dosage recommendation closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• There are some groups of medications that, due to their action in the body (inhibitors of cytochrome P450), may interact with this medication and, in some cases, increase its activity. Some of the 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 protectors such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (anti-hypertensive).
• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medications used to treat HIV/AIDS such as ritonavir, etc.
• Digoxin (medication used to suppress or prevent heart rhythm alterations).

Taking Alprazolam Normon with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect your alertness (see section "Driving and operating machines").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Alprazolam is not recommended during pregnancynor during breastfeeding, unless, at the doctor's discretion, the benefit outweighs the risk for the child.

If, at the doctor's discretion, alprazolam is administered during a late stage of pregnancy or during delivery, the newborn may experience effects such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression. Children born to mothers who take benzodiazepines chronically during the last stage of pregnancy may develop physical dependence, which may trigger 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 in children under 18 years have not been established.

Use in elderly patients (over 65 years)

This medication may affect this group of patients more than young patients. If you belong to this group, your doctor may reduce the dose and check 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 muscle weakness that may cause falls, often with serious consequences in this population.

Special patient groups

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

Driving and operating machines

Alprazolam may affect your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is 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 potentiated if you consume alcohol at the same time.

Alprazolam Normon contains lactose

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

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

Dosage:

The tablet or its part will be ingested without chewing, with the help of a little liquid. Your doctor will prescribe the Alprazolam Normon presentation most suitable for you, according to the dose you need.

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 amount of alprazolam ingested per day ranging from 0.5 mg to 0.75 mg in divided doses, which can be gradually increased as needed and well tolerated.

No individual dose should exceed the indicated limits, and the total daily dose should not either, unless your doctor 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, they will do so for limited periods and will frequently monitor your situation.

Never discontinue treatment abruptly. Your doctor will indicate the duration of treatment based on the evolution of your disease and will explain how to gradually reduce the dose until treatment is completed.

If you estimate that the action 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 with this leaflet.

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma.

Symptoms include drowsiness (somnolence), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (prolonged and deep sleep), muscle tone decrease (hypotonia), blood pressure drop, respiratory depression, rarely coma, and very rarely death. Serious sequelae are rare, unless alprazolam is taken with other medications or alcohol.

In case of overdose or accidental ingestion, consult the Toxicological Information Service at phone 91 562 04 20, indicating the product and the amount ingested.

If you forgot to take Alprazolam Normon

Do not take a double dose to compensate for the missed doses. If the missed dose is recent, take your dose immediately, and if not, wait for the next dose, without taking a double dose to compensate.

If you interrupt treatment with Alprazolam Normon

Alprazolam treatment can cause dependence, so when discontinuing alprazolam administration abruptly, withdrawal symptoms may appear.

Withdrawal symptoms that may occur include headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of disgust (dysphoria), insomnia, intolerance to light, sounds, and physical contact, paresthesias and cramps in the extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and seizures. In case of this occurring, you should consult your doctor immediately.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Depression.
• Drowsiness, drowsiness, coordination disorder (ataxia), memory alteration, 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, alteration of sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance alteration, difficulty concentrating, excessive sleep (hypersomnia), deep and prolonged somnolence (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Rare side 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.
• Abstinence symptoms.

Unknown frequency (cannot be estimated from available data):

• Increased levels of prolactin 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 white of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin's 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 reaction to emotional stimuli (affective obtundation), reduced state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena predominantly occur at the beginning of treatment and generally disappear with continued administration. Occasionally, gastrointestinal alterations, 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 an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations may occur. These reactions can be severe and occur more frequently in children and the elderly.
• The administration of the product (even at usual doses) may lead to the development of physical dependence. Discontinuation of treatment may lead to the development of withdrawal or rebound phenomena. It may produce psychological dependence. Cases of abuse have been reported.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alprazolam Normon

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

Appearance of the product and contents of the packaging

Alprazolam Normon 0.25 mg are white or almost white, round, flat, tablets with a breaking bar on one face andengraved with APon the other.

They are presented in packaging containing 30 tablets and clinical packaging of 500 tablets. Each tablet contains 0.25 mg of alprazolam. Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:April 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/63247/P_63247.html