ALPRAZOLAM KRKA 1 mg TABLETS

2. What you need to know before you take Alprazolam Krka

Do not take Alprazolam Krka:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Alprazolam Krka if you:

• have any kidney problems.
• have any liver problems.
• have any general health problems.
• are taking any other medicine for mental illness.
• are taking painkillers that contain dextropropoxyphene. This combination should be avoided as it can affect your breathing.
• have ever felt so depressed that you have had thoughts of suicide or self-harm.
• have abused drugs or alcohol in the past or find it difficult to stop taking medicines, drinking or taking drugs (see also section 4 “Possible side effects”). Your doctor may want to give you special help when you stop taking these tablets.
• have been prescribed medicines for severe anxiety in the past, your body may quickly get used to this type of medicine and it may no longer help.
• are an elderly patient, benzodiazepines and related medicines should be used with caution, due to the risk of sedation and/or musculoskeletal weakness which can cause falls, often with serious consequences in this group of patients.
• note that the effect of these tablets wears off after taking them for several weeks (tolerance).

Dependence

Taking Alprazolam Krka can lead to physical and mental dependence. If you notice that you are having difficulty stopping taking this medicine, you may be mentally dependent on it. Physical dependence means that withdrawal symptoms occur when treatment with this medicine is stopped suddenly. The risk of dependence increases with dose and duration of treatment. To reduce the risks, the lowest effective dose should be used for the shortest possible time. Follow your doctor's dosage recommendations. The risk is also greater in patients who abuse or have abused 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 can lead to overdose and death. Always follow your doctor's dosage recommendations. This medicine may be desirable to people who abuse prescription medicines and should be kept out of the 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 medicine. 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 if you suffer from depression. Consult your doctor before starting treatment with Alprazolam Krka.

If treatment with Alprazolam Krka is necessary and you are depressed or have had previous thoughts of 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 hospital immediately.

Children and adolescents

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

Other medicines and Alprazolam Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the medicines listed below, as the effect of Alprazolam Krka or the other medicine may change when taken at the same time.

• Opioid medicines (strong painkillers, medicines for substitution therapy and some cough medicines). This increases the risk of drowsiness, 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. Inform your doctor about all opioid medicines you are taking and follow your doctor's dosage recommendation closely. It may be useful to inform friends or family to be aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.
• Any other medicine for treating anxiety or depression or for helping you sleep (e.g. nefazodone, fluvoxamine, fluoxetine).
• Certain strong painkillers (e.g. morphine, codeine, dextropropoxyphene).
• Antipsychotic medicines used to treat mental illnesses such as schizophrenia (antipsychotic medicines, including clozapine).
• Medicines for sleep disorders (hypnotics).
• Medicines used to treat epilepsy (e.g. carbamazepine).
• Antihistamines for allergy relief.
• Medicines used to treat 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 medicines used to treat HIV.
• Rifampicin, a medicine for treating tuberculosis.
• Medicines for treating asthma and bronchitis (e.g. theophylline).
• Muscle relaxants (when used with alprazolam, there may be an increased muscle relaxant effect and a risk of falls).
• St John's Wort (a herbal remedy).

Taking 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 important that you do not drink alcohol while taking Alprazolam Krka, as alcohol increases the adverse effects of this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor immediately if you are pregnant or plan to become pregnant. Observations in humans have indicated that alprazolam may be harmful to the foetus (increased risk of malformations, such as cleft 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 is greater than the risk to the foetus.

If you are taking Alprazolam Krka until the time of delivery, inform your doctor, as your newborn baby may have some withdrawal symptoms when born.

Breast-feeding

Do not take Alprazolam Krka during breast-feeding, 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 decreased concentration. Therefore, your ability to react may be affected, especially if you have not slept sufficiently. These effects may increase if you drink alcohol. Do not drive or use machines while taking Alprazolam Krka.

Alprazolam Krka contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Alprazolam Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will decide what dose of alprazolam is suitable for you, taking into account the symptoms of your illness and your tolerance. Preferably, treatment should be started, controlled and stopped by the same doctor. Treatment often starts 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.

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 a day in the treatment of anxiety disorder. Your doctor may increase the dose as needed.

Duration of treatment

The risk of dependence and abuse may increase with dose and duration of treatment. Your doctor will therefore prescribe the lowest effective dose for the shortest possible time 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 decrease in effect may develop if used for more than a few weeks.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Use in children and adolescents

The safety and efficacy of alprazolam in patients under 18 years have not been established. 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. Take the medicine package with you.

Symptoms of an overdose may include:

• dizziness,
• drowsiness,
• breathing difficulties,
• 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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 make up for a forgotten dose. Take your next dose as usual.

If you stop taking Alprazolam Krka

Always consult your doctor before stopping taking alprazolam, as the dose should be reduced gradually. If you stop treatment suddenly, 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 feeling in which you find yourself outside your own body), tingling and numbness of the arms and legs, intolerance to light, sounds and physical contact, hallucinations or epileptic fits (convulsions). These symptoms may occur for several days after stopping the tablets. When treatment with alprazolam is stopped, the symptoms that were initially the reason for treatment with this medicine may return and with greater intensity 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 stopped. He/she will decide on the reduction of the dose individually, as the decrease in dose depends on various factors (e.g. duration of treatment and daily dose). If you are concerned, your doctor can give you more information about this.

If you have any further questions on 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 all people suffer from them.

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

• Sudden 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 whites of the eyes (jaundice).
• Very occasionally, 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 are:

Very frequent: may affect more than 1 in 10 people

• Depression
• Drowsiness and drowsiness
• Uneven or uncoordinated movements (ataxia)
• Inability to remember fragments of information
• Difficulty articulating words (dysarthria)
• Dizziness, dizziness
• Headache
• Constipation
• Dry mouth
• Fatigue
• Irritability

Frequent: 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
• Tremors
• Blurred vision
• Feeling sick
• Skin inflammation (dermatitis)
• Sexual dysfunction
• Weight changes

Infrequent: may affect up to 1 in 100 people

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

Unknown: frequency cannot be estimated from available data

• In women, irregular periods or excessive prolactin production (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 upset
• Difficulty swallowing
• Liver inflammation (hepatitis)
• Liver function problems (this appears in blood tests)
• Yellowing of the skin and the whites 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 the ankles, feet, or fingers
• Increased pressure in the eyes, which can 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 like Alprazolam Krka while taking them, which increases the likelihood of having withdrawal symptoms when treatment is discontinued.

Withdrawal symptoms are more frequent if you:

• suddenly stop treatment
• 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 can cause effects 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), tremors, or epileptic seizures .Inform your doctor if withdrawal symptoms worsen or do not disappear.

Reporting Adverse Effects

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

5. Conservation of Alprazolam Krka

Keep this medicine out of sight and reach of children.

Do not use this medicine 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.

Keep in the original packaging to protect it from moisture.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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), polysorbate 80.
• See section 2 "Alprazolam contains lactose"

Appearance of the Product and Package Contents

Light blue-green to light blue, scored, round, biconvex tablets, with beveled edges. The tablet is scored on one side and marked with the engraving "1" on the other, 7 mm in diameter. The score line 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 precut unit-dose blisters.

Only some package 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 medicine is authorized in the member states of the European Economic Area with the following names:

This prospectus has been approved in:March 2024

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