ALPRAZOLAM 0.25 MG Coated tablet

Зміст інструкції

1. Alprazolam Krka 0.25 mg tablets, 0.5 mg tablets, 1 mg tablets
   1. What is Alprazolam Krka and what is it used for
   2. How to take Alprazolam Krka
   3. Possible side effects
   4. How to store Alprazolam Krka
   5. Contents of the pack and other information

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

alprazolam

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Alprazolam Krka and what is it 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 can create panic).

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

• 2.What you need to know before you take AlprazolamKrka

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 apnea (breathing becomes irregular, stops even for short periods, while you are asleep).
• if you have severe liver impairment.

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

• you have ever felt so depressed that you have thought about taking your own life.
• you have problems with your kidneys or liver.
• you have abused drugs or alcohol in the past or have difficulty stopping taking medicines, drinking or taking drugs (see also section 4. "Possible side effects"). Your doctor may decide to provide you with special help to stop taking these tablets.
• you have been prescribed medicines for severe anxiety before, because your body can quickly become accustomed to this type of medicine so that it no longer has an effect.
• Benzodiazepines and related products should be used with caution in the elderly, due to the risk of sedation and/or musculoskeletal weakness that can promote falls, often with serious consequences in this population.

The use of Alprazolam Krka can lead to physical and mental dependence on the medicine. The risk of
dependence increases with the 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 AlprazolamKrka
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 other medicines may change when they are taken at the same time:

• any other medicine used to treat anxiety or 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 (for the treatment of stomach ulcers).
• Diltiazem (used for angina and high blood pressure).
• Digoxin (used to treat various heart conditions).
• Ritonavir or other similar medicines used to treat HIV. If you are about to have an operation during which you will be given a general anesthetic, tell your doctor or anesthesiologist that you are taking Alprazolam Krka.

The 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 can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if the doctor prescribes Alprazolam Krka together with opioids, the dose and duration of
concomitant therapy must be limited by the doctor.
Tell your doctor about all the opioid medicines you are taking and carefully follow
the doctor's dosage recommendations. It may be helpful to inform friends or relatives that you are
aware of the signs and symptoms described above. Contact your doctor when such symptoms occur.

AlprazolamKrka with food, drinks and alcohol
You can 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, suspect you may be pregnant or are planning to become pregnant, 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 operating machinery
Alprazolam Krka can make you feel sleepy or dizzy and make you lose concentration and is therefore
very important not to drive or operate machinery until you are aware of how the tablets
affect you. Ask your doctor if you are not sure.

Alprazolam Krka contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Alprazolam Krka

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, ask your doctor or pharmacist.
The doctor will determine the most suitable dose of Alprazolam Krka for you based on the signs of the disease and your
tolerance. If you experience serious side effects after the first dose, the dose should be reduced. You can
take the tablets with or without food. Swallow the tablet with a small amount of liquid.
The score line is only to facilitate breaking to aid swallowing if you have difficulty
swallowing the tablet whole. The score line is not intended to divide the tablet into equal
doses.

Treatment of anxiety
The recommended starting dose: take 0.25 – 0.5 mg three times a day.
The recommended dose: the doctor may increase the dose as needed, up to a maximum
of 4 mg per day, taken in divided doses throughout the day.

Treatment of panic attacks
The recommended starting dose: take 0.5 mg – 1 mg immediately before bedtime.
The recommended dose: the doctor may adjust the dose as needed. The dose may be
increased, by no more than 1 mg every 3 – 4 days up to a maximum of 10 mg per day.

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

Hepatic impairment or renal damage
It is recommended to use lower doses.
The doctor may adjust the dose gradually according to the tolerance of the medicine.
Do not take Alprazolam Krka if you have severe hepatic insufficiency.

Duration of treatment
Alprazolam Krka is used only for short-term treatment (no more than 12 weeks, including
gradual dose reduction until the end of treatment). The duration of treatment will be
determined by the 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 the tablets),
consult your doctor or go to the nearest hospital. Bring the medicine package with you.
Symptoms of overdose may include: dizziness, drowsiness, breathing problems, confusion,
loss of consciousness, muscle weakness, 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 time to
take the next dose. Do not take a double dose to make up for a missed dose.
Take the next dose as usual.

If you stop taking Alprazolam Krka
Always ask your doctor before stopping taking Alprazolam Krka as the dose must
be reduced gradually. If you stop treatment with the tablets or suddenly reduce
the dose, you may experience "rebound" effects that may cause temporary anxiety or
restlessness or difficulty sleeping. Some people may also experience "withdrawal" effects (see section 4. Possible side effects). These symptoms disappear when
the body readjusts.
Usually, the dose should be reduced gradually by no more than 0.5 mg every 3 days. For some
people, it may be necessary to reduce the dose even more slowly. If you are concerned, your doctor
can give you more information.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 toes.
• Very rarely, treatment with this medicine may cause serious behavioral or psychiatric effects - e.g. agitation, restlessness, aggression, irritability, violent anger, false perceptions, nightmares and hallucinations or other inappropriate behaviors.

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 lightheaded
• Headache
• Constipation
• Dry mouth
• Fatigue
• Irritability

Very common: may affect up to 1 in 10 people

• Decreased appetite
• Confusion
• Disorientation
• Changes in your sexual 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 trembling
• Blurred vision
• Feeling unwell
• Skin inflammation (dermatitis)
• Sexual dysfunction
• Weight changes

Not common: may affect up to 1 in 100 people

• Feeling euphoric or excited (mania)
• Hallucinations (seeing or hearing things that do not exist)
• 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 production of too much prolactin (the hormone that stimulates milk production)
• Hypomania
• Feeling hostile or aggressive
• Abnormal thoughts
• Hyperactivity
• Imbalance of the nervous system. Symptoms may include: fast 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 shows up 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 toes
• Increased pressure in the eyes, which can also affect vision

Dependence and withdrawal symptoms
It is possible to develop dependence on medicines like Alprazolam Krka during their use,
this increases the likelihood of having 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 can cause effects such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, mood swings, difficulty sleeping and irritability. In severe cases of withdrawal, you may also experience the following symptoms: a feeling of unreality or detachment, being unusually sensitive to sound, physical contact or light, numbness and tingling in the feet and hands, hallucinations (seeing or hearing things that are not there while awake), tremors or seizures. Tell your doctor if withdrawal symptoms worsen or do not go away.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 which is stated on the pack. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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 lactose monohydrate, corn starch, crospovidone (type A), povidone K 25, magnesium stearate (E470b), polysorbate 80.
• The other ingredients of the 0.5 mg tablets are lactose monohydrate, corn starch, crospovidone (type A), povidone K 25, carmine (E120), magnesium stearate (E470b), polysorbate
• 80.
• The other ingredients of the 1 mg tablets are lactose monohydrate, corn 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 contents of the pack

• 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 only to facilitate splitting to aid swallowing and not to divide 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 only to facilitate splitting to aid swallowing and not to divide 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 only to facilitate splitting to aid swallowing and not to divide into equal doses.

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

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

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italia

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 authorised in the Member States of the European Economic Area with the
following denominations: