ALPRAZOLAM STADAFARMA 0.25 mg TABLETS

2. What you need to know before taking Alprazolam Stadafarma

Do not take Alprazolam Stadafarma:

• 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.

• 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 uninterrupted use of the medication for a long time.

To minimize the risk of dependence, the following precautions should be taken into account:

• • Benzodiazepines should only be taken under medical prescription (never because they have worked for other patients) and should never be recommended to other people.
  • Do not increase the prescribed doses by your doctor, nor prolong treatment for longer than recommended.
  • Consult your doctor regularly so that they can 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 (rebound effect) may appear. To avoid this, it is recommended not to interrupt treatment abruptly, but to gradually reduce the dose, according to your doctor's instructions (see section "If you stop taking Alprazolam Stadafarma").
• Taking alprazolam with opioid medications can cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines can cause memory loss and reactions such as restlessness, agitation, irritability, aggression, delirium, outbursts of anger, 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.

Other Medications and Alprazolam Stadafarma

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 alprazolam:

• 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 for the treatment of anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medications for treating allergies).
• The concomitant use of alprazolam and opioids (potent analgesics, medications for substitution therapy (treatment of opioid addiction), 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 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 dose recommendation. It may be helpful to inform friends or family members so they are 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 alprazolam and, in some cases, increase its activity. Some medications that may 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 alprazolam.
• 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 Stadafarma with Food, Drinks, and Alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol can enhance sedation, and this 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.

It is not recommended to take alprazolam 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 appear.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, and a withdrawal syndrome may be triggered in the postnatal period.

Use in Children and Adolescents (Under 18 Years)

Alprazolam is not recommended for children and adolescents under 18 years of age. 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 of age have not been established.

Use in Elderly Patients (Over 65 Years)

Alprazolam may affect this group of patients more than younger 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 the section "How to Take Alprazolam Stadafarma").

Benzodiazepines and related products should be used with caution in elderly patients due to the risk of sedation and/or musculoskeletal weakness that 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.

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, 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 alcohol is consumed simultaneously.

Alprazolam Stadafarma Contains Lactose

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

Alprazolam Stadafarma Contains Sodium Benzoate (E211)

This medication contains 0.15 mg of sodium benzoate (E211) per tablet.

Alprazolam Stadafarma Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free."

3. How to Take Alprazolam Stadafarma

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

Dosage:

The tablet or its part should be swallowed without chewing, with the help of a little liquid. Your doctor will prescribe the most suitable presentation of alprazolam, 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 daily amount of alprazolam 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 so.

The score line is only for breaking and facilitating swallowing but not for dividing the tablet into equal doses.

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 is too strong or too weak, inform your doctor or pharmacist.

If You Take More Alprazolam Stadafarma Than You Should

If you have taken more alprazolam than you should, consult your doctor or pharmacist immediately or go to the nearest hospital, bringing this package leaflet.

Overdose with benzodiazepines is generally manifested by different degrees of central nervous system depression, which can range from drowsiness to coma. Symptoms include drowsiness (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, lethargy (state of deep and prolonged sleep), 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 medications or alcohol.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Alprazolam Stadafarma

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 Stadafarma

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, sounds, 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 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 sleep (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, outbursts of anger, 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 appear:

• 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 alterations, changes in sexual desire, or skin reactions may occasionally occur.
• A loss of memory (amnesia) may develop, which can be associated with inappropriate behavior.
• The use of benzodiazepines may unmask existing depression.
• The use of benzodiazepines or similar compounds may cause reactions such as restlessness, agitation, irritability, aggression, delirium, outbursts of anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral alterations. 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 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 possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Alprazolam Stadafarma

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton, after "CAD". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAlprazolam Stadafarma

• The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium docusate, sodium benzoate (E211), anhydrous colloidal silica, pregelatinized corn starch, magnesium stearate, and yellow colorant (composed of lactose monohydrate and quinoline yellow (E104)).

Appearance of the Product and Package Contents

Alprazolam Stadafarma 0.25 mg tablets are presented in yellow, biconvex, round, and scored on one side with a diameter of 7.2 mm.

The score line is only for fractioning and facilitating swallowing, but not for dividing into equal doses.

Alprazolam Stadafarma 0.25 mg tablets are presented in packages of 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the Last Revision of this Leaflet: January 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.