Alprazolam Kern Pharma 0.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Alprazolam Kern Pharma 0.25 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Alprazolam Kern Pharma is and what it is used for
2. What you need to know before taking Alprazolam Kern Pharma
3. How to take Alprazolam Kern Pharma
4. Possible side effects
5. How to store Alprazolam Kern Pharma
6. Contents of the pack and other information

1. What Alprazolam Kern Pharma is and what it is used for

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

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

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

Do not take Alprazolam Kern Pharma

• 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 impairment.

Warnings and precautions

Talk to your doctor or pharmacist before starting alprazolam.

• 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.

• With prolonged use of alprazolam, a certain loss of effectiveness (tolerance) may occur.

• There is a risk of developing addiction/dependence when using alprazolam.

• If during treatment you experience symptoms of mania (a state of overexcitement, feelings of euphoria, or hyperirritability) or hypomania (a state of exaggerated excitement and activity).

• Treatment with benzodiazepines, including alprazolam, may lead to dependence, mainly after long-term, uninterrupted 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 other patients) and should never be recommended to others.

• Do not increase the dose 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 treatment may occur (rebound effect). To avoid this, it is recommended not to abruptly discontinue treatment, but to gradually reduce the dose according to your doctor's instructions (see section “If you stop taking Alprazolam”).

• Using alprazolam together with opioid-type medicines 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 any of these occur, 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 Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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-inducing agents (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 used to treat allergies).

• Concomitant use of alprazolam and opioids (strong analgesics, medicines for opioid substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are available.

• However, if your doctor prescribes alprazolam 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 dosing recommendations. It may be helpful to inform friends or family members so they can watch for 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 alprazolam and, in some cases, increase its activity. Some of the medicines that interact with alprazolam include:

  • Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. Concurrent use with alprazolam is not recommended.
  • The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
  • Gastric protectants such as cimetidine.
  • Dextropropoxyphene (a narcotic analgesic).
  • Oral contraceptives.
  • Diltiazem (an 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 with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 judgment, the benefit outweighs the risk to the child.

If alprazolam is administered during late pregnancy or during childbirth based on the doctor’s decision, 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 use benzodiazepines during the last stage of pregnancy may develop physical dependence, potentially leading to a withdrawal syndrome in the postnatal period.

Use in children and adolescents (under 18 years of age)

Alprazolam is not recommended for use in children and adolescents under 18 years of age. Benzodiazepines should not be administered 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)

Alprazolam may have a greater effect in this patient group than in younger patients. If you belong to this group, your doctor may reduce your dose and monitor your response to treatment. Please follow their instructions carefully (see 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, which may lead to 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 take a lower dose of alprazolam.

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, reduced attention, or decreased 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 contains lactose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Alprazolam Kern Pharma

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

Dosing:

The tablet or part thereof should be swallowed whole, with a little liquid. Your doctor will prescribe the most suitable alprazolam formulation according to the dose you require.

The recommended 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 liver or kidney impairment, the initially recommended dose is 0.25 mg of alprazolam, taken 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.

Each individual dose must not exceed the recommended limits, nor must the total daily dose, unless expressly instructed otherwise by your doctor.

The tablet may be divided 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 extend treatment in your case, it will be done only for limited periods, with frequent monitoring of your condition.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment depending on the progression of your illness and will explain how you should gradually reduce the dose until treatment is discontinued.

If you feel that the effect of alprazolam is too strong or too weak, inform 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 generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (sedation), speech disturbances (dysarthria), coordination disturbances, confusion, lethargy (a state of deep and prolonged drowsiness), decreased muscle tone (hypotonia), low blood pressure, respiratory depression, rarely coma, and very rarely death. Serious consequences are rare unless alprazolam is taken together with other drugs or alcohol.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 a missed dose. If the missed dose was recent, take it immediately and do not wait until the next scheduled dose.

If you stop taking Alprazolam Kern Pharma

Treatment with alprazolam may lead to dependence; therefore, abruptly stopping alprazolam may result in 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 using 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 occur predominantly 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 articulating words (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

Common adverse 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, 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, alteration of 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 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 behaviour.
• 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 the elderly.
• 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 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Kern Pharma

Keep this medicine out of sight and reach of children.

Store below 30°C.

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 you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alprazolam Kern Pharma 0.25 mg tablets

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

Appearance of the product and contents of the container

Alprazolam Kern Pharma 0.25 mg tablets are scored tablets, white in colour. 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 latest revision of this leaflet: April 2022

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/