Alprazolam Normon 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alprazolam Normon 1 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 be harmful to them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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 severe, disabling, or distressing anxiety symptoms. 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 taking 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 reduction in effectiveness (tolerance) may occur.
• There is a risk of developing addiction/dependence when using alprazolam.
• If during treatment you notice symptoms of mania (a state of overexcitement, feelings of euphoria, or hyperirritability) or hypomania (a state of exaggerated excitement and activity).

1. Treatment with benzodiazepines, including alprazolam, may lead to dependence, mainly 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 you should never recommend them 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, abrupt discontinuation of treatment is not recommended; instead, the dose should be gradually reduced according to your doctor's instructions (see section “If you stop taking Alprazolam Normon”).
• The use of alprazolam together with opioid-type medications may cause profound 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

Inform 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. Tell 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 drugs (hypnotics).

• Medicines used to treat depression.

• Medicines used for epilepsy treatment (antiepileptics).

• Narcotic analgesics and opioids (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence.

• Medicines used for anxiety treatment (anxiolytics/sedatives).

• Anesthetics.

• Sedating antihistamines (medicines for allergies).

• The concomitant use of alprazolam and opioids (strong analgesics, medications 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 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 dosage 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 act on 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. Taking them together with this medicine is not recommended.

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

• Gastric protectors 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 Normon with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which could affect your level of alertness (see section “Driving and use of 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.

The use of 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 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 used 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 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 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 use a lower dose of Alprazolam Normon. 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, reduce attention, or decrease 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 Normon contains lactose

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

3. How to take Alprazolam Normon

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

Dosing:

The tablet or part of it should be swallowed whole, without chewing, with a little liquid. Your doctor will prescribe the most appropriate formulation of Alprazolam Normon depending on 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 if necessary and well tolerated.

No individual dose should exceed the stated limits, nor should 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 in limited periods, with frequent monitoring of your condition.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment based on the progression of your illness and will explain how you should gradually reduce the dose before stopping treatment completely.

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 causes 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 uncommon 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 product 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 shortly 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 taking Alprazolam Normon

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 sensations 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.

The 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 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), 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 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 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 behaviours.
• The use of benzodiazepines may unmask an 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 can 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 also 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 or household waste. Dispose of unused containers and medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly discard containers and medicines you no longer need. 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 1 mg of alprazolam.
• The other components are: povidone, monohydrate lactose, corn starch, magnesium stearate and indigo carmine (E-132).

Appearance of the product and contents of the pack

Alprazolam Normon 1 mg are blue, round, flat tablets with a break line on one side and printed with "AP" on the other.

They are available in packs containing 30 tablets and clinical packs containing 500 tablets. Each tablet contains 1 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63248/P_63248.html