Alprazolam Krka

Package leaflet: Information for the patient

Alprazolam Krka 0.25 mg tablets, 0.5 mg tablets, 1 mg tablets

alprazolam
Generic medicine
Read this leaflet carefully before 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 side 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. This belongs to a group of medicines
called benzodiazepines.
Alprazolam Krka is indicated for the symptomatic treatment of:

• anxiety.
• panic attacks with or without agoraphobia (fear of places or situations that may cause panic).

Alprazolam Krka is indicated only when the disorder is severe, disabling, or subjecting the individual
to extreme distress.

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 suffer from a disease called myasthenia gravis (which causes muscle weakness).
• if you have severe breathing difficulties (e.g. chronic bronchitis or emphysema).
• if you suffer from sleep apnoea (breathing becomes irregular, stops for short periods while asleep).
• if you have severe hepatic impairment.

Warnings and precautions
Tell your doctor or pharmacist before taking Alprazolam Krka if:

• you have ever felt so depressed that you thought of taking your own life.
• you have kidney or liver problems.
• you have previously abused drugs or alcohol or have difficulties stopping medicines, drinking, or taking drugs (see also section 4. "Possible side effects"). Your doctor may decide to provide you with special support when discontinuing these tablets.
• you have previously been prescribed medicines for severe anxiety, because your body may rapidly become accustomed to this type of medicine so that they no longer work.
• Benzodiazepines and related products must 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.

The use of Alprazolam Krka may lead to physical and psychological dependence on the medicine. The risk of
dependence increases with dose and duration of treatment. The risk is also higher in patients
who abuse or have abused alcohol and drugs (see also section 3. "If you stop taking Alprazolam Krka").
Children and adolescents
Alprazolam is not recommended for children and adolescents under 18 years of age.
Other medicines and Alprazolam Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, especially the medicines listed below, because the effect of Alprazolam Krka or other medicines may change when taken at the same time:

• any other medicine used to treat anxiety, depression, or insomnia (e.g. nefazodone, fluvoxamine, fluoxetine).
• Some strong painkillers (e.g. morphine, codeine, propoxyphene).
• Antipsychotic medicines used to treat mental illnesses such as schizophrenia.
• Medicines used to treat epilepsy.
• Antihistamines to relieve allergies.
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole).
• Oral contraceptives.
• Some 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. If you are about to undergo surgery during which a general anaesthetic will be administered, inform your doctor or anaesthetist that you are taking Alprazolam Krka.

Concomitant use of Alprazolam Krka and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Alprazolam Krka together with opioids, the dose and duration of concomitant therapy must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s dosage recommendations. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if these symptoms occur.
Alprazolam Krka with food, drinks and alcohol
You may take the tablets with or without food.
It is important not to drink alcohol while taking Alprazolam Krka, as alcohol increases the effects of this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Do not breastfeed while taking Alprazolam Krka, as this medicine passes into breast milk.
Driving and using machines
Alprazolam Krka may make you feel drowsy or dizzy and may impair your concentration, and it is therefore very important not to drive or operate machinery until you know how the tablets affect you. Consult your doctor if you are unsure.
Alprazolam Krka contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Alprazolam Krka

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the most suitable dose of Alprazolam Krka for you based on the symptoms of your illness and your tolerance. If you experience severe adverse effects after the first dose, the dose should be reduced. You may take the tablets with or without food. Swallow the tablet with a small amount of liquid.
The score line is only intended to facilitate breaking the tablet to aid swallowing if you have difficulty swallowing the whole tablet. The score line is not intended for dividing the tablet into equal doses.

Treatment of anxiety
Recommended starting dose: take 0.25–0.5 mg three times daily.
Recommended dose: your doctor may increase the dose according to need, up to a maximum of 4 mg daily, taken in divided doses throughout the day.

Treatment of panic attacks
Recommended starting dose: take 0.5 mg–1 mg immediately before bedtime.
Recommended dose: your doctor may adjust the dose according to need. The dose may be increased by no more than 1 mg every 3–4 days, up to a maximum of 10 mg daily.

Elderly patients
For elderly patients and those sensitive to the sedative effects of this medicine, the starting dose is 0.25 mg two or three times daily. Your doctor may gradually adjust the dose according to your tolerance to the medicine.

Hepatic impairment or renal damage
Lower doses are recommended.
Your doctor may gradually adjust the dose according to your tolerance to the medicine.
Do not take Alprazolam Krka if you have severe liver failure.

Duration of treatment
Alprazolam Krka is intended only for short-term treatment (no longer than 12 weeks, including gradual dose reduction until the end of treatment). The duration of treatment will be determined by your doctor.

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), consult your doctor or go to the nearest hospital immediately. Take the medicine pack with you.
Symptoms of overdose may include: dizziness, drowsiness, breathing difficulties, confusion, unconsciousness, muscle weakness, and difficulty coordinating body movements (ataxia).

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 forgotten dose. Take your next dose as usual.

If you stop taking Alprazolam Krka
Always consult your doctor before stopping Alprazolam Krka, as the dose must be gradually reduced. If you stop treatment with the tablets or suddenly reduce the dose, you may experience "rebound" effects, which could temporarily cause anxiety, restlessness, or difficulty sleeping. Some people may also experience withdrawal symptoms (see section 4. Possible side effects). These symptoms disappear as your body readjusts.
Usually, the dose should be gradually reduced by no more than 0.5 mg every 3 days. For some individuals, a slower reduction may be necessary. If you are concerned, your doctor can provide further information.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects, contact your doctor immediately as your
treatment needs to be stopped:

• Severe allergic reaction causing swelling of the face or throat, swelling of the ankles, feet or fingers.
• Very rarely, treatment with this medicine may cause serious behavioural or psychiatric effects – for example, agitation, restlessness, aggression, irritability, violent rage, false perceptions, nightmares and hallucinations, or other inappropriate behaviours.

Other possible side effects:
Very common: may affect more than 1 in 10 people

• Depression
• Drowsiness and feeling tired
• Jerky or uncoordinated movements (ataxia)
• Inability to remember small pieces of information
• Slurred speech (dysarthria)
• Dizziness, feeling of emptiness in the head
• Headache
• Constipation
• Dry mouth
• Fatigue
• Irritability

Common: may affect up to 1 in 10 people

• Decreased appetite
• Confusion
• Disorientation
• Changes in your sex drive (decreased libido, increased libido)
• Feeling nervous or anxious
• Insomnia (inability to sleep or sleep disturbances)
• 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 sluggish
• Vibration or tremor
• Blurred vision
• Feeling unwell
• Skin inflammation (dermatitis)
• Sexual dysfunction
• Changes in weight

Uncommon: may affect up to 1 in 100 people

• Feeling of euphoria or excitement (mania)
• Hallucinations (seeing or hearing things that are not there)
• Feeling agitated or angry
• Memory loss (amnesia)
• Vomiting
• Muscle weakness
• Incontinence
• Irregular menstrual cycle

Not known: frequency cannot be estimated from the available data

• In women, irregular periods or overproduction of prolactin (the hormone that stimulates milk production)
• Hypomania
• Feeling of hostility or aggression
• Abnormal thoughts
• Hyperactivity
• Imbalance of the nervous system. Symptoms may include: rapid heartbeat and unstable blood pressure (feeling dizzy, lightheaded or weak).
• Twisting or jerky movements (dystonia)
• Stomach disorders
• Inflammation of the liver (hepatitis)
• Problems with liver function (this appears 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 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 may also affect vision

Dependence and withdrawal symptoms
You may develop dependence on medicines such as Alprazolam Krka during treatment, which increases the likelihood of experiencing withdrawal symptoms when treatment is stopped.
Withdrawal symptoms are more common if:

• you stop treatment suddenly
• you have taken high doses of this medicine
• you have taken this medicine for a long time
• you have a history of alcohol or drug abuse. This may cause effects such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, mood changes, difficulty sleeping and irritability. In severe cases of withdrawal, the following symptoms may also occur: a feeling of unreality or detachment, unusual sensitivity to sound, physical touch or light, numbness and tingling in the hands and feet, hallucinations (seeing or hearing things that are not there while awake), tremor or epileptic seizures. Inform your doctor if withdrawal symptoms worsen or do not go away.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Alprazolam Krka contains

• The active substance is alprazolam. Each tablet contains 0.25 mg, 0.5 mg or 1 mg of alprazolam.
• The other ingredients of the 0.25 mg tablets are monohydrate lactose, maize starch, crospovidone (type A), povidone K 25, magnesium stearate (E470b), polysorbate 80.
• The other ingredients of the 0.5 mg tablets are monohydrate lactose, maize starch, crospovidone (type A), povidone K 25, carmine (E120), magnesium stearate (E470b), polysorbate 80.
• The other ingredients of the 1 mg tablets are monohydrate lactose, maize starch, crospovidone (type A), povidone K 25, patent blue V (E131), magnesium stearate (E470b), polysorbate 80.
• See section 2 "Alprazolam Krka contains lactose".

Description of the appearance of Alprazolam Krka and pack contents

• 0.25 mg tablets: white to almost white, round, biconvex tablets with bevelled edges. The tablet is scored on one side and marked with "0.25" on the other, 7 mm in diameter. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.
• 0.5 mg tablets: pale pink, mottled, round, biconvex tablets with bevelled edges. The tablet is scored on one side and marked with "0.5" on the other, 7 mm in diameter. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.
• 1 mg tablets: greenish-blue to pale blue, mottled, round, biconvex tablets with bevelled edges. The tablet is scored on one side and marked with "1" on the other, 7 mm in diameter. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Alprazolam Krka is available in boxes of 20, 30, 50 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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