Alprazolam Krka

Document: Alprazolam Krka modified-release tablet ENG PL change

PACKAGE LEAFLET

Package leaflet: Information for the patient user

Alprazolam Krka 0.5 mg prolonged release tablets

Alprazolam Krka 1 mg prolonged release tablets

Alprazolam Krka 2 mg prolonged release tablets

Alprazolam

Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is inthis 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 Alprazolam Krka is and what it is used for

The active ingredient is alprazolam. It belongs to the group of medicines called benzodiazepines. Alprazolam acts through the central nervous system, reducing anxiety. It also has sedative, drowsiness-inducing and muscle relaxant effects.

Alprazolam Krka tablets are used for the treatment of

panic disorders
symptomatic treatment of anxiety.

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

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

Do not take Alprazolam Krka if you

are allergic to alprazolam, other benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
have been diagnosed with myasthenia gravis (a disease causing muscle weakness)
suffer from severe respiratory failure
have sleep apnoea syndrome (prolonged transient cessations of breathing during sleep)
suffer from severe liver insufficiency.

Warnings and precautions

Talk to your doctor before taking Alprazolam Krka tablets, if you

notice that the effect of the tablets will weaken after you have used them several weeks (tolerance)
are worried of the physical and mental dependence caused by aprazolam. If you do not want to suspend the treatment, you may be mentally dependent to this medicine. If there is physical dependence, the suspension of treatment is accompanied by withdrawal symptoms (see section 3, If you stop taking Alprazolam Krka tablets). The risk of dependence is greater as the dose and the length of treatment increase in patients with history of alcohol or drug abuse or if several benzodiazepines are combined. For that reason the treatment should be as short as possible.
a history of alcohol, drug or narcotic abuse
have had memory disorders. Loss of memory usually occurs several hours after the product has been taken.
get unexpected reactions e.g. restlessness, agitation, irritability, aggresivness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour, delirium and other behaviour disorders. These unexpected reactions occur more often in children and elderly patients.
a chronic lung disease
if you are using concomitantly alcohol and sedative drugs
if you have severe depression (risk of suicide)
been diagnosed with renal or liver function impairment
been diagnosed with some psychiatric illness
have a certain type of glaucoma.

If you are going to have an operation

Tell your doctor that you are taking Alprazolam Krka.

Children and adolescents

The safety and efficacy of alprazolam in patients under 18 years old has not been established. Therefore, use of alprazolam is not recommended in this age group.

Other medicines andAlprazolam Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, herbal remedies and natural products.

Some medicines may cause undesirable effects if taken at the same time as alprazolam. If you are simultaneously taking certain other medicines, this may affect the efficacy of the treatment. In this case, your doctor may adjust your medication or the dosage instructions.

Such medicines include:

Medicines, which increase the sedative effect of alprazolam:

sleeping pills and sedatives
antipsychotics and antidepressants
antiepileptics
strong painkillers that act through the central nervous system
sedative antihistamines

Medicines, which increase the effect of alprazolam, because they reduce its metabolism in the liver:

nefazodone, fluvoxamine , fluoxetine, sertralin (medicines for severe depression)
cimetidine (used for treating stomach problems)
medicines used for treating HIV
dextropropoxyphene
oral contraceptives
diltiazem (blood pressure and heart medicine)
certain antibiotics (e.g., erythromycin, clarithromycin, telithromycin and troleandomycin) and certain medicines for treating fungal infections (e.g., itraconazole, ketoconazole, posaconazole, voriconazole)

Medicines, which decrease the effect of alprazolam, because they increase its metabolism in the liver:

carbamazepine or phenytoine (antiepileptics, which are used also for other treatments)
St John’s wort (Hypericum perforatum, a herbal remedy)
rifampicin (antituberculosis drug)

Alprazolam can increase the effect of the following medicines:

digoxin (heart medicine)
muscle relaxants
imipramine and desipramine (medicines for severe depression)
clozapine (psychosis medicine). There is an increased risk of respiratory and/or cardiac arrest.

Alcohol potentiates the sedative effect of alprazolam.

The next time you visit your doctor, please rememberto tell him or her you are taking Alprazolam Krka tablets.

Alprazolam Krka with food, drink and alcohol

Take the tablet with a glass of water or some other fluid.

Alcohol

Do not drink any alcohol while you are taking Alprazolam Krka tablets.

Pregnancy and breast-feeding

If you are pregnant or planning to get pregnant, or if you are breast-feeding, ask your doctor for advice before taking Alprazolam Krka.

Alprazolam Krka should not be used during pregnancy unless the doctor considers it absolutely necessary for the mother’s treatment.

There are no adequate experiences from the use of alprazolam in pregnant women. Do not take Alprazolam Krka if you are pregnant or planning to become pregnant, unless your doctor considers it strictly indicated. Observations in humans have indicated that the substance alprazolam can be harmful to the unborn child(increased risk of malformations (oral clefts ). If you are pregnant or planning a pregnancy, consult your doctor about the possibility to stop the treatment.If you are taking Alprazolam Krka until birth, let your doctor know as your newborn might have some withdrawal symptoms when it is born.A high-dose use in late pregnancy or during labor may cause the newborn also lowered body temperature, cause respiratory depression, decreased muscle tone and poor feeding (floppy infant syndrome).

Do not breast-feed while taking Alprazolam Krka. There is a risk of an effect on the baby.

Driving and using machines

Because of its sedative, muscle relaxing and drowsiness-inducing effect, alprazolam may impair performance in traffic and in other tasks requiring special alertness, especially at the beginning of treatment and if insufficient sleep. For this reason, do not drive or operate machines during treatment with Alprazolam Krka.

Alprazolam Krka contains lactose

Alprazolam Krka contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Alprazolam Krka

Your doctor has prescribed an individual dosage and duration of therapy suited to your condition. Always take Alprazolam Krka exactly as your doctor has told you. Treatment is often started with a low dose, which is gradually increased as necessary. Do not change the dosage or stop taking Alprazolam Krka without talking to your doctor. It is recommended that the doctor prescribing, monitoring and stopping the treatment be the same one. Use of products like Alprazolam Krka may lead to the development of physical and psychic dependence. The risk increases with the dose and duration of treatment, and is greater in patients with history of alcohol or drug abuse. Do not pass Alprazolam Krka tablets to others.

Please note that Alprazolam Krka prolonged release tablets should be swallowed whole, they should not be divided or crushed!

Panic disorders:

The initial dose is usually 0.5–1 mg at bedtime. The therapeutic dose (the lowest dose that produces the desired effect) is generally at most 6 mg daily, divided in two doses. Lower initial and therapeutic doses are recommended for elderly and those who are sensitive to the effects of the medicine, generaly of 0.5 mg per day. The maximal maintenance dose is 4.5 mg daily divided in two doses.

Your doctor should re-evaluate the need for medication and the suitability of the medicine with you within four weeks of the start of the therapy.

Anxiety:

The initial dose is usually 0.5 mg once daily. The therapeutic dose is generally 0.5–3 mg daily, taken in one or divided in two doses. Lower initial and therapeutic doses are recommended for elderly or debilitated patients, a maximum of 0.5 - 1 mg per day.

The maximum duration of the treatment is generally 8–12 weeks, including gradual withdrawal of the medication.

Use in children and adolescents

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

If you take more Alprazolam Krka than you should

If you take, or if someone else (e.g. a child) takes, too large dose of the medicine, immediately contact your doctor or a hospital. Activated charcoal should be given as emergency medication if the patient is conscious.

Take this carton with you if you seek medical help.

An overdose of alprazolam causes heavy fatigue, ataxia (incoordination) and a reduced level of consciousness. Lowering of blood pressure, unconsciousness and respiratory depression are also possible. Alcohol and other central nervous system depressants increase the undesirable effects of alprazolam.

If you forget to take Alprazolam Krka

Take the forgotten dose as soon as possible. If it is close to the time of your next dose, do not take the missed dose. Never take a double dose or two doses in rapid succession. Before going on holiday or taking a trip, ensure that you take enough Alprazolam Krka with you.

If you stop taking Alprazolam Krka

Alprazolam may cause physical and psychic dependence. The risk is greatest with high doses and long treatment periods, in patients with history of alcohol or drug abuse or if several benzodiazepines are combined.

Abruptly stopping treatment causes withdrawal symptoms (e.g. headache, muscle pain, severe anxiety, tension, restlessness, confusion, irritability and in severe cases depersonalisation, derealisation, hyperacusis, numbness, tingling sensations in the limbs, hypersensitivity to light, noice and touch, hallucinations and epileptic seizures). Withrawal symptoms can appear several days after the end of treatment.

For this reason, Alprazolam Krka therapy must not be terminated abruptly; the dose should be reduced gradually according to the instructions of your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effect is fatigue, which may be associated with ataxia (incoordination), impaired muscle co‑ordination and confusion. Fatigue may occur in elderly patients in particular. Fatigue and fatigue‑related symptoms are strongest at the beginning of treatment. They will lessen or disappear with dose reduction or continued treatment.

Very common effects (affects more than 1 in 10 users):

sedation, drowsiness

Common side effects (affects 1 to 10 users in 100):

decreased appetite,

confusion, depression, motor restlessness,
ataxia (difficulty in controlling movements.), memory impairment, slurred speech, concentration difficulties, dizziness, headache, light-headedness,
blurred vision
tachycardia (rapid heartbeat), palpitations
nasal stuffiness
constipation, diarrhoea, nausea, dry mouth, increased salivation, difficulty swalloving
allergic rash
tiredness
irritability

Uncommon side effects (affects 1 to 10 users in 1,000):

hyperprolactinaemia (abnormally-high levels of prolactin in the blood)
loss of appetite,
hallucinations, rage, aggressive or hostile behaviour, anxiety, restlessness, changes in sexual drive (libido), sleeplessness, abnormal thinking, nervousness, excitement
amnesia (loss of memory), muscle tone disturbances, tremor (shaking),

double vission,

vomiting,
jaundice, abnormal liver function,
skin inflamation, itching,
muscle weakness,
urinary problems, menstrual irregularities, sexual dysfunction,

weight changes,

increase in intraocular pressure.

Rare side effects (affects 1 to 10 users in 10,000):

low blood pressure,

skin disorders,
stimulation of appetite,
numbness of feelings, reduced alertness.

Not known(frequency cannot be estimated from the available data):

inflamaation of the liver (hepatitis)
peripheral oedema
serious allergic reaction which causes swelling of the face or throat (angioedema).

Alprazolam may cause physical and psychic dependence. See section “Warnings and precautions”.

Abrupt termination of Alprazolam Krka therapy may cause withdrawal symptoms such as anxiety, sleeplessness and convulsions (see 'If you stop taking Alprazolam Krka tablets’).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. 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 reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Alprazolam Krka contains

The active substance is alprazolam. Each prolonged release tablet contains 0.5 mg, 1 mg or 2 mg alprazolam.
The other ingredients are lactose monohydrate, hypromellose, magnesium stearate, indigo carmine (E132) (only in 0.5 mg and 2 mg tablets), quinoline yellow (E104) (only in 0.5 mg tablets).

What Alprazolam Krka looks like and contents of the pack

Alprazolam Krka 0.5 mg: greenish-yellow, round, slightly biconvex.

Alprazolam Krka 1 mg: white, round, slightly biconvex.

Alprazolam Krka 2 mg: light blue, round, slightly biconvex.

Pack sizes: 20, 30, 60, 100 and 100x1 prolonged release tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

[To be completed nationally]

This leaflet was last revisedin 2013-12-18