Alprazolam Krka 1 mg tablet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Alprazolam Krka 1 mg tablets EFG

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 you should not give it to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Alprazolam Krka

3. How to take Alprazolam Krka

4. Possible adverse effects

5. How to store Alprazolam Krka

6. Contents of the pack and other information

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

Alprazolam Krka contains the active substance alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

Alprazolam Krka 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 Krka

Do not take Alprazolam Krka:

• if you are allergic to alprazolam or to any of the other ingredients of this medicine (listed in section 6).
• if you have a condition called myasthenia gravis (which causes muscle weakness).
• if you have severe breathing difficulties (such as chronic bronchitis or emphysema).
• if you suffer from sleep apnea (pauses in breathing that occur while you sleep).
• if you have severe liver failure.
• if you have acute intoxication due to alcohol or other drugs affecting the central nervous system.

Warnings and precautions

Talk to your doctor or pharmacist before taking Alprazolam Krka if you:

• have any kidney problems.
• have any liver problems.
• have general health issues.
• are taking any other medicines for mental health conditions.
• are taking painkillers containing dextropropoxyphene. This combination should be avoided as it may affect your breathing.
• have ever felt so depressed that you had thoughts or ideas about suicide.
• have previously abused drugs or alcohol, or find it difficult to stop taking medicines, drinking, or using drugs (see also section 4. "Possible side effects"). Your doctor may want to provide you with special support when stopping these tablets.
• have previously been prescribed medicines for severe anxiety, as your body may become used to this type of medicine quickly, making it less effective.
• are an elderly patient, benzodiazepines and related medicines should be used with caution due to the risk of sedation and/or musculoskeletal weakness, which may lead to falls—often with serious consequences in this patient group.
• notice that the effect of these tablets weakens after taking them for several weeks (tolerance).

Dependence

The use of Alprazolam Krka may lead to physical and mental dependence. If you find it difficult to stop taking this medicine, you may be mentally dependent on it. Physical dependence means that withdrawal symptoms occur when treatment with this medicine is stopped abruptly. The risk of dependence increases with dose and duration of treatment. To reduce risks, the lowest possible dose should be used, and treatment duration should be as short as possible. Follow your doctor's dosing recommendations. The risk is also higher in patients who currently abuse or have a history of abusing alcohol and drugs (see also section 3 "If you stop taking Alprazolam Krka").

Abuse

Drug abuse is a known risk when taking this medicine (see also section 4 "Possible side effects"). Abuse of this drug may lead to overdose and death. Always follow your doctor's dosing instructions. This medicine may be sought after by individuals who abuse prescription medicines and should be kept out of reach of others.

Effects on memory

During treatment with Alprazolam Krka, your memory may be affected. This usually occurs several hours after taking the medicine. Please consult your doctor if you notice this symptom.

Effects on mood

Treatment with Alprazolam Krka may increase the risk of hypomania or mania in patients with depression. Contact your doctor immediately if you experience symptoms of mania or hypomania.

Treatment with Alprazolam Krka may increase the risk of developing thoughts of self-harm or suicide if you suffer from depression. Talk to your doctor before starting treatment with Alprazolam Krka.

If Alprazolam Krka treatment is necessary and you are depressed or have previously had thoughts about suicide or self-harm, your doctor will monitor you closely. If you develop thoughts of self-harm or suicide at any time, contact your doctor or go to a hospital immediately.

Children and adolescents

The use of alprazolam is not recommended in children and adolescents under 18 years of age.

Other medicines and Alprazolam Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially those listed below, as the effect of Alprazolam Krka or the other medicine may change when taken together.

• Opioid medicines (strong painkillers, medicines for substitution therapy, and some cough medicines). This increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, 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 are aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.
• Any other medicine for treating anxiety or depression or to help you sleep (e.g., nefazodone, fluvoxamine, fluoxetine).
• Some strong painkillers (e.g., morphine, codeine, dextropropoxyphene).
• Antipsychotic medicines used to treat mental illnesses such as schizophrenia (antipsychotics, including clozapine).
• Medicines for sleep disorders (hypnotics).
• Medicines used to treat epilepsy (e.g., carbamazepine).
• Antihistamines for relief of allergies.
• Medicines for treating fungal infections (e.g., ketoconazole, itraconazole, fluconazole, voriconazole).
• Oral contraceptives.
• Certain antibiotics (e.g., erythromycin, clarithromycin, telithromycin).
• Cimetidine (used to treat stomach ulcers).
• Diltiazem (used for angina and high blood pressure).
• Digoxin (used to treat various heart conditions).
• Ritonavir or similar medicines used to treat HIV.
• Rifampicin, a medicine used to treat tuberculosis.
• Medicines for treating asthma and bronchitis (e.g., theophylline).
• Muscle relaxants (when used together with alprazolam, there may be an increased muscle-relaxing effect and a risk of falls).
• St. John's wort (an herbal remedy).

Taking Alprazolam Krka with food, drinks, and alcohol

You may take the tablets with or without food. Swallow each tablet with a small amount of liquid.

It is important not to drink alcohol while taking Alprazolam Krka, as alcohol increases the adverse effects of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor immediately if you are pregnant or plan to become pregnant. Observations in humans have indicated that alprazolam may be harmful to the fetus (increased risk of malformations, such as cleft lip/palate). Do not take Alprazolam Krka if you are pregnant or plan to become pregnant unless your doctor considers it strictly necessary. Your doctor will decide whether the potential benefit of treatment outweighs the risk to the fetus.

If you take Alprazolam Krka up to the time of delivery, inform your doctor, as your newborn may experience some withdrawal symptoms after birth.

Breastfeeding

Do not take Alprazolam Krka during breastfeeding, as this medicine may pass into breast milk.

Driving and using machines

Alprazolam Krka may cause adverse effects such as drowsiness, memory loss, muscle relaxation, and reduced concentration. Therefore, your ability to react may be impaired, especially if you have not had enough sleep. These effects may be worsened by alcohol. Do not drive or operate machinery during treatment with Alprazolam Krka.

Alprazolam Krka 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 Krka

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.

Your doctor will decide the most appropriate dose of alprazolam for you, taking into account the symptoms of your condition and your tolerance. Ideally, treatment should be initiated, monitored, and discontinued by the same physician. Treatment often starts with a low dose, which may be gradually increased if necessary, as prescribed by your doctor. It takes 1 to 2 hours for the tablets to take effect. If you experience serious adverse effects after the first dose, your dose should be reduced. Do not change the dose without first consulting your doctor.

Treatment of anxiety

Recommended initial dose: take 0.25–0.5 mg three times a day.

Your doctor may increase the dose as needed. The recommended maintenance dose is 0.5 mg to 3 mg per day, divided into several doses.

Elderly patients and patients sensitive to the sedative effects of alprazolam

The initial dose is 0.25 mg two or three times daily for the treatment of anxiety disorder. Your doctor may increase the dose as necessary.

Duration of treatment

The risk of dependence and abuse may increase with dose and duration of treatment. Therefore, your doctor will prescribe the lowest effective dose and the shortest possible treatment duration, and will frequently reassess the need to continue treatment (see section 2 “Warnings and precautions”).

The maximum duration of treatment should not exceed 2–4 weeks. Long-term treatment is not recommended. A reduction in effect may occur if used for more than a few weeks.

The score line is intended solely for splitting the tablet if you find it difficult to swallow it whole.

Use in children and adolescents

The safety and efficacy have not been established in patients under 18 years of age. Therefore, the use of alprazolam is not recommended.

If you take more Alprazolam Krka than you should

If you take more tablets than prescribed by your doctor (or if someone else takes your tablets), seek medical attention or go to the nearest hospital. Take the medicine package with you.

Symptoms of overdose may include:

• dizziness,
• drowsiness,
• breathing difficulties,
• confusion,
• loss of consciousness,
• muscle weakness,
• difficulty coordinating body movements (ataxia),
• feeling cold,
• decreased blood pressure,
• reactions such as aggression, hallucinations, agitation, and restlessness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alprazolam Krka

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose. Take your next dose at the usual time.

If you stop taking Alprazolam Krka

Always consult your doctor before stopping alprazolam, as the dose must be gradually reduced. If you stop treatment abruptly, withdrawal symptoms may occur, such as headache, muscle pain, severe anxiety, restlessness, confusion, irritability, and sleep disturbances. In severe cases, the following symptoms may occur: altered perception of reality, depersonalization (a sensation of being detached from your own body), tingling and numbness in arms and legs, intolerance to light, sound, and physical touch, hallucinations, or epileptic seizures (convulsions). These symptoms may last for several days after stopping the tablets. When treatment with alprazolam is discontinued, the symptoms that initially prompted treatment may return, and may be more intense than before. In addition to the symptoms mentioned above, mood changes may also occur.

Therefore, your doctor will gradually reduce the dose when stopping treatment. Your doctor will decide on the dose reduction individually, as the rate of reduction depends on several factors (e.g., duration of treatment and daily dose). If you are concerned, your doctor can provide further information on this.

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.

If you experience any of the following effects, consult your doctor immediately, as your treatment should be discontinued:

• Sudden wheezing (whistling sounds when breathing), difficulty swallowing or breathing, swelling of the eyelids, face or lips, rash or itching (especially all over the body).

Inform your doctor as soon as possible if you experience any of the following symptoms, as it may be necessary to adjust the dose or discontinue treatment:

• Yellowing of the skin and whites of the eyes (jaundice).
• Very rarely, treatment with this medicine may cause serious behavioral or psychiatric effects, such as agitation, restlessness, aggression, irritability, violent anger, false beliefs, nightmares and hallucinations, or other inappropriate behavior. These reactions occur more frequently in elderly patients.
• Depression / depressive thoughts.

Other possible side effects that may occur include:

Very common: may affect more than 1 in 10 people

• Depression
• Drowsiness and sedation
• Uneven or uncoordinated movements (ataxia)
• Inability to recall pieces of information
• Difficulty speaking clearly (dysarthria)
• Dizziness, lightheadedness
• Headache
• Constipation
• Dry mouth
• Fatigue
• Irritability

Common: may affect up to 1 in 10 people

• Decreased appetite
• Confusion
• Disorientation
• Changes in sexual desire (decreased libido, increased libido)
• Feeling nervous or anxious
• Insomnia (inability to sleep or disturbed sleep)
• Problems with balance and instability (similar to feeling drunk), especially during the day
• Abnormal coordination
• Loss of alertness or concentration
• Inability to stay awake, feeling slow/lethargic
• Tremor
• Blurred vision
• Feeling sick
• Skin inflammation (dermatitis)
• Sexual dysfunction
• Weight changes

Uncommon: may affect up to 1 in 100 people

• Feeling euphoric or overexcited (mania)
• Hallucination (seeing or hearing things that are not real)
• Feeling agitated or angry
• Memory loss (amnesia)
• Vomiting, diarrhea
• Muscle weakness
• Incontinence
• Menstrual irregularities
• Drug dependence
• Withdrawal symptoms

Unknown: frequency cannot be estimated from available data

• In women, irregular periods or excessive production of prolactin (the hormone that stimulates milk production)
• Increased appetite
• Loss of appetite (anorexia)
• Hypomania
• Feeling hostile or aggressive
• Abnormal thoughts
• Hyperactivity
• Imbalance of the nervous system. Symptoms may include: rapid heartbeat and unstable blood pressure (feeling dizzy, fainting).
• Twisting or jerking movements (dystonia)
• Stomach discomfort
• Difficulty swallowing
• Inflammation of the liver (hepatitis)
• Problems with liver function (detected in blood tests)
• Yellowing of the skin and whites of the eyes (jaundice)
• Severe allergic reaction causing swelling of the face or throat
• Skin reaction due to sensitivity to sunlight
• Difficulty urinating or problems controlling the bladder
• Swelling of ankles, feet or fingers
• Increased pressure in the eyes, which may also affect vision
• Drug abuse

Previously undetected depression may become apparent in susceptible individuals.

Dependence and withdrawal symptoms

It is possible to become dependent on medicines such as Alprazolam Krka while taking them, increasing the likelihood of experiencing withdrawal symptoms when stopping treatment.

Withdrawal symptoms are more likely if you:

• stop treatment abruptly
• have been taking high doses of this medicine
• have been taking this medicine for a long time
• have a history of alcohol or drug abuse.

This may cause effects such as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, mood changes, difficulty sleeping, and irritability. In severe cases of withdrawal, the following symptoms may also occur: feelings of unreality or detachment, unusual sensitivity to sound, light, or physical touch, numbness and tingling in the hands and feet, hallucinations (seeing or hearing things that are not real while awake), tremor, or epileptic seizures. Inform your doctor if withdrawal symptoms worsen or do not go away.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 Krka

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.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alprazolam Krka 1 mg tablets.

• The active substance is alprazolam. Each tablet contains 1 mg of alprazolam.
• The other components are: lactose monohydrate, corn starch, crospovidone (type A), povidone K 25, patent blue V (E131), magnesium stearate (E470b), polysorbate 80.
• See section 2 "Alprazolam contains lactose".

Appearance of the product and contents of the container

Light bluish-green to light blue, mottled, round, biconvex tablets with bevelled edges. The tablet is scored on one side and marked with the imprint “1” on the other, 7 mm in diameter. The score is intended only to facilitate breaking the tablet for ease of swallowing, and not for dividing the tablet into equal doses.

Alprazolam Krka is available in pack sizes of:

• 10, 20, 30, 50, 60, 100 tablets in blister packs.
• 10x1, 20x1, 30x1, 50x1, 60x1, 100x1 tablets in single-dose perforated blister packs.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH

Heinz-Lohmann-Strabe 5

27472 Cuxhaven

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

This leaflet was approved in: March 2024

Detailed 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/