ALPRAZOLAM KERN PHARMA 0.25 mg TABLETS

2. What you need to know before you take Alprazolam Kern Pharma

Do not take Alprazolam Kern Pharma

• if you are allergic to alprazolam, benzodiazepines, or any of the other ingredients 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 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 continued 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 medicine for a long time. To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines will only be taken under medical prescription (never because they have worked for other patients) and will never be recommended to other people.
• Do not increase the prescribed doses in any way, nor prolong treatment for longer than recommended.
• Consult your doctor regularly so that he 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 to starting 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 the doctor's instructions (see section "If you stop taking Alprazolam Kern Pharma").
• Taking alprazolam with opioid-type 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 rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this happens, 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 Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 alprazolam:
  • 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 for the treatment of anxiety (anxiolytics/sedatives).
  • Anesthetics.
  • Sedating antihistamines (medicines 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 must 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 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 alprazolam 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 alprazolam.
  • 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 AIDS, such as ritonavir, etc.
  • Digoxin (medicine used to suppress or prevent heart rhythm disturbances).

Taking Alprazolam 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 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 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. Benzodiazepines should not be given 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)

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 Kern Pharma")

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 work well, 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, 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 can be enhanced if alcohol is consumed simultaneously.

Alprazolam 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 Kern Pharma

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

Dosage:

The tablet or its part will 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 recommended 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 being 0.5 mg to 0.75 mg in divided doses, and may 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 expressly indicates so.

The tablet can be divided into equal doses.

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 that, in your case, it is necessary to prolong treatment, it will be for limited periods, and you will be closely monitored.

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 reduce the dose until the end of treatment.

If you think the effect of alprazolam is too strong or too weak, tell your doctor or pharmacist.

If you take more Alprazolam Kern Pharma 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 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 medicines or alcohol.

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

If you forget to take Alprazolam Kern Pharma

Do not take a double dose to make up for forgotten doses. If the forgotten dose is recent, take your dose immediately and do not wait for the next dose.

If you stop taking Alprazolam Kern Pharma

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 happens, 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 everybody gets them.

The side effects that may appear 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, 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 rage, agitation, dependence.
• Memory loss (amnesia).
• Muscle weakness.
• Urinary incontinence.
• Irregular menstruation.
• Withdrawal symptoms.

Frequency not known (cannot be estimated from the 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, altered liver function, 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 generally 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.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, outbursts of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral changes may appear. 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Kern Pharma

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

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Alprazolam Kern Pharma 0.25 mg tablets

• The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, corn starch, talc, sodium carboxymethylcellulose (type A) (from potato), and magnesium stearate.

Appearance of the Product and Packaging Contents

Alprazolam Kern Pharma 0.25 mg tablets are scored, white tablets. They are packaged in blisters, in containers containing 30 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Lacer, S.A.

Parc Tecnològic del Vallès

Boters, 5

08290 Cerdanyola del Vallès (Barcelona)

Date of the Last Revision of this Leaflet:April 2022

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/