Package Leaflet: Information for the User

Alprazolam Krka 1 mg Tablets EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

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

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

Do not take Alprazolam Krka:

• if you are allergic to alprazolam or any of the other ingredients of this medication (listed in section 6).
• if you have a condition called myasthenia gravis (which causes muscle weakness).
• if you have severe respiratory difficulties (such as chronic bronchitis or emphysema).
• if you suffer from sleep apnea (pauses in breathing that occur while sleeping).
• if you have severe liver disease.
• if you have an acute intoxication caused by alcohol or other substances that affect the central nervous system.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alprazolam Krka if you:

• have any kidney problems.
• have any liver problems.
• have general health problems.
• are taking any other medication for mental health conditions.
• are taking analgesics that contain dextropropoxifeno. This combination should be avoided as it may affect your breathing.
• have ever felt so depressed that you have had thoughts or ideas of suicide.
• have a history of abusing drugs or alcohol or find it difficult to stop taking medications, drinking or taking drugs (see also section 4. "Possible side effects?"). Your doctor may want to give you special help when stopping these tablets.
• have been prescribed medications for severe anxiety in the past, your body may quickly become accustomed to this type of medication and it may no longer help you.
• are an elderly patient, benzodiazepines and related medications should be used with caution due to the risk of sedation and/or muscle weakness that may cause falls, often with serious consequences in this group of patients.
• note that the effect of these tablets is reduced after taking them for several weeks (tolerance).

Dependence

The use of Alprazolam Krka may cause physical and mental dependence. If you notice that you have difficulty stopping taking this medication, you may be mentally dependent on it. Physical dependence means that withdrawal symptoms occur when treatment with this medication is stopped abruptly. The risk of dependence increases with the dose and duration of treatment. To reduce the risks, the lowest possible dose should be used and the duration of treatment should be the shortest possible. Follow your doctor's dosage recommendations. The risk is also higher in patients who abuse or have abused alcohol and drugs (see also section 3 "If you stop treatment with Alprazolam Krka”

Abuse

Drug abuse is a known risk when taking medication (see also section 4 “Possible side effects”). Drug abuse may cause an overdose and death. Always follow your doctor's dosage recommendations. This medication may be desirable for people who abuse prescribed medications and should be kept out of reach of other people.

Effects on memory

During treatment with Alprazolam Krka, your memory may be affected. This usually occurs several hours after taking this medication. Please ask 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. Consult your doctor immediately if you notice symptoms of mania or hypomania.

Treatment with Alprazolam Krka may increase the risk of developing thoughts of self-harm or suicide in patients with depression. Consult your doctor before starting treatment with Alprazolam Krka.

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

Children and adolescents

Alprazolam is not recommended for use in children and adolescents under 18 years old.

Other medications and Alprazolam Krka

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, especially the medications listed below, as the effect of Alprazolam Krka or the other medication may change when taken at the same time.

• Opioid medications (powerful analgesics, substitution therapy medications, and some cough medications). This increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may 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 along with opioids, the dose and duration of concomitant treatment should be limited by your doctor. Inform your doctor about all opioid medications you are taking and follow your doctor's dosage recommendations closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.
• Any other medication for treating anxiety or depression or to help you sleep (e.g. nefazodone, fluvoxamine, fluoxetine).
• Some strong analgesics (e.g. morphine, codeine, dextropropoxifeno).
• Antipsychotic medications used to treat mental health conditions such as schizophrenia (antipsychotic medications, including clozapine).
• Medications for sleep disorders (hypnotics).
• Medications used to treat epilepsy (e.g. carbamazepine).
• Antihistamines for allergy relief.
• Medications for fungal infections (e.g. ketoconazole, itraconazole, fluconazole, voriconazole).
• Oral contraceptives.
• Certain antibiotics (e.g. erythromycin, clarithromycin, telithromycin).
• Cimetidine (for treating stomach ulcers).
• Diltiazem (used for angina and high blood pressure).
• Digoxin (used for treating various heart conditions).
• Ritonavir or other similar medications used to treat HIV.
• Rifampicin, a medication for treating tuberculosis.
• Medications for asthma and bronchitis (e.g. theophylline).
• Muscle relaxants (when used with alprazolam, there may be an increase in muscle relaxation effect and a risk of falls).
• St. John's Wort (a herbal remedy).

Alprazolam Krka with food, drinks, and alcohol

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

It is essential not to take alcohol while taking Alprazolam Krka, as alcohol increases the adverse effects of this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Inform your doctor immediately if you are pregnant or intend to become pregnant. Human observations have indicated that alprazolam may be harmful to the fetus (increased risk of malformations, such as cleft palate). Do not take Alprazolam Krka if you are pregnant or intend 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 are taking Alprazolam Krka until the time of delivery, inform your doctor, as your newborn may experience withdrawal symptoms when born.

Breastfeeding

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

Driving and operating machinery

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

Alprazolam Krka contains lactose

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

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

Your doctor will decide what is the most suitable dose of alprazolam for you, taking into account the signs of your disease and your tolerance.The treatment is often started with a low dose, which is gradually increased if necessary according to your doctor's prescription. It takes 1 to 2 hours for the tablets to take effect. If you experience severe side effects after the first dose, your dose should be reduced. Do not change the dose without consulting your doctor first.

Anxiety Treatment

Initial recommended 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.

Patients of advanced age and patients sensitive to the sedative effects of alprazolam

The initial dose is 0.25 mg two or three times a day in the treatment of anxiety disorder. Your doctor may increase the dose as needed.

Treatment Duration

The risk of dependence and abuse may increase with the dose and duration of treatment. Your doctor will therefore prescribe the most effective dose and the shortest duration of treatment possible, and will frequently re-evaluate 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 decrease in effect may occur if used for more than a few weeks.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

Use in children and adolescents

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

If you take more Alprazolam Krka than you should

If you take more tablets than your doctor prescribed (or if someone else takes your tablets), seek medical attention or go to the nearest hospital. Bring the packaging of this medication with you.

The symptoms of an overdose may include:

• Dizziness,
• Drowsiness,
• Respiratory problems,
• Confusion,
• Loss of consciousness,
• Muscle weakness,
• Difficulty coordinating body movements (ataxia),
• Feeling of cold,
• Decreased blood pressure,
• Reactions such as aggression, hallucinations, agitation, and restlessness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 time for your next dose. Do not take a double dose to compensate for the missed dose. Take your next dose as usual.

If you interrupt treatment with Alprazolam Krka

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

Therefore, your doctor will reduce the dose gradually when treatment is interrupted. He/she will decide on the reduction of the dose individually, as the reduction of the dose depends on several factors (e.g. duration of treatment and daily dose). If you are concerned, your doctor may provide you with more information on this.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, consult your doctor immediately, as your treatment will need to be suspended:

• Unexpected wheezing (whistling 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 the following symptoms, as it may be necessary to change the dose or treatment:

• Yellowing of the skin and the white of the eyes (jaundice).
• Occasionally, treatment with this medicine can cause severe behavioral or psychiatric side effects, such as agitation, restlessness, aggression, irritability, violent anger, false beliefs, nightmares, and hallucinations, or other inappropriate behavior. These reactions occur more frequently in older patients.
• Depression/depressive thoughts.

Other possible side effects that may occur are:

Very common: may affect more than 1 in 10 people

• Depression
• Drowsiness and drowsiness
• Unsteady or uncoordinated movements (ataxia)
• Inability to remember fragments of information
• Difficulty articulating words (dysarthria)
• Dizziness, drowsiness
• 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 altered 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/lazy
• Tremor
• Blurred vision
• Feeling sick
• Dermatitis (inflammation of the skin)
• Sexual dysfunction
• Weight changes

Rare: may affect up to 1 in 100 people

• Feeling euphoric or overexcited (mania)
• Alucination (seeing or hearing things that do not exist)
• Feeling agitated or angry
• Memory loss (amnesia)
• Vomiting, diarrhea
• Muscle weakness
• Incontinence
• Irregular menstrual cycles
• Drug addiction
• Withdrawal symptoms

Unknown: the frequency cannot be estimated from available data

• Irregular periods or excessive prolactin production (the hormone that stimulates milk production) in women
• Increased appetite
• Loss of appetite (anorexia)
• Hypomania
• Feeling hostile or aggressive
• Abnormal thoughts
• Hypervigilance
• Neurological imbalance. Symptoms may include: rapid heartbeat and unstable blood pressure (sensation of dizziness, fainting).
• Torsion or twitching movements (dystonia)
• Stomach discomfort
• Difficulty swallowing
• Hepatitis (inflammation of the liver)
• Liver function problems (this appears in blood tests)
• Yellowing of the skin and the white of the eyes (jaundice)
• Severe allergic reaction causing swelling of the face or throat
• Skin reaction caused by sensitivity to sunlight
• Difficulty urinating or problems controlling the bladder
• Swelling of ankles, feet, or toes
• Increased pressure in the eyes, which may also affect your vision
• Drug abuse

Pre-existing depression may become apparent in susceptible individuals.

Dependence and withdrawal symptoms

You may become dependent on medicines like Alprazolam Krka while taking them, which increases the likelihood of withdrawal symptoms when you stop treatment.

Withdrawal symptoms are more frequent 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 symptoms such as headaches, muscle aches, extreme anxiety, tension, restlessness, confusion, mood changes, difficulty sleeping, and irritability. In severe cases of withdrawal, you may also experience the following symptoms: feeling unreal or indifferent, being unusually sensitive to sound, light, or physical contact, numbness and tingling in the feet and hands, hallucinations (seeing or hearing things that do not exist while awake), tremor, or seizures.Inform your doctor if withdrawal symptoms worsen or do not disappear.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alprazolam Krka 1 mg tablets.

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

Appearance of the product and contents of the package

Blue-greenish clear to light blue tablets, speckled, round, biconvex, with beveled edges. The tablet is scored on one face and marked with the engraving “1” on the other, 7 mm in diameter. The score is only for breaking and facilitating swallowing but not for dividing into equal doses.

Alprazolam Krka is available in packages of:

• 10, 20, 30, 50, 60, 100 tablets in blisters.
• 10x1, 20x1, 30x1, 50x1, 60x1, 100x1 tablets in pre-cut single-dose blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

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

Responsible for manufacturing

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

TAD Pharma GmbH

Heinz-Lohmann-Strabe 5

27472 Cuxhaven

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

This leaflet hasbeen approved in:March 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/