0.5 mg, 1 mg, 2 mg prolonged-release tablet is 
alprazolam

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read about it.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Alprazolam Krka is and what it is used for 
2. What you need to know before you use Alprazolam Krka 
3. How to use 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 substance is alprazolam. It belongs to a group of medicines called benzodiazepines. Alprazolam has an anti-anxiety effect on the central nervous system. It also has a calming, muscle relaxing effect and causes drowsiness.

Alprazolam Krka tablets are used to treat:

  • Panic disorder
  • Anxiety symptoms

Alprazolam should only be prescribed when there is severe anxiety, which causes worries and difficulties in having a functioning life.

Alprazolam contained in Alprazolam Krka may also be approved for the treatment of other conditions not mentioned in this information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you use Alprazolam Krka

Do not use Alprazolam Krka

  • is allergic to alprazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
  • has been diagnosed with myasthenia gravis (a disease that causes muscle weakness)
  • have severe breathing problems
  • have sleep apnea syndrome (respiratory arrest while sleeping)
  • have severe liver problems

Warnings and cautions

Talk to your doctor before taking Alprazolam Krka if you

  • notice that the effect of the tablets decreases after you have used them for a few weeks (tolerance).
  • is concerned about the physical and mental dependence of alprazolam. If you do not want to stop treatment, you may be mentally dependent on this medicine. If there is a physical dependence, discontinuation of treatment will cause withdrawal symptoms (see section 3, If you stop taking Alprazolam Krka). The risk of addiction is greater the higher the dose and the longer the treatment time. It is also greater in patients with previous alcohol or drug dependence and if several different benzodiazepines are used. For this reason, the treatment should be as short as possible.
  • have abused alcohol, drugs, or medicines.
  • have memory disorders. Memory loss usually occurs several hours after taking the drug.
  • get unexpected reactions, such as restlessness, agitation, irritation, aggression, delusions, outbursts of rage, nightmares, hallucinations, psychosis, inappropriate behavior, confusion, and other behavioral disorders. These unexpected reactions occur much more often in children and elderly patients.
  • have a chronic lung disease.
  • at the same time using alcohol and sedatives.
  • have severe depression (suicide risk).
  • have been diagnosed with renal or hepatic impairment.
  • has contracted a mental illness.
  • have a certain type of glaucoma.

If you are going to have surgery

Tell your doctor that you are taking Alprazolam Krka.

Children and young people

The safety and efficacy of alprazolam in patients below 18 years of age have not been established. Alprazolam is therefore not recommended for this age group.

Other medicines and Alprazolam Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines can cause side effects if taken at the same time as alprazolam. Taking certain other medicines at the same time can affect the treatment effect. In these cases, your doctor may adjust your medication or dosing instructions.

These drugs include:

Drugs that increase the sedative effect of alprazolam:

  • sleeping pills and sedatives
  • antipsychotics and antidepressants
  • epilepsy medication
  • strong analgesics that act on the central nervous system
  • sedative antihistamine er

Drugs that increase the effect of alprazolam, because they reduce its degradation in the liver:

  • nefazodone, fluvoxamine, fluoxetine, sertraline (medicines for major depression)
  • cimetidine (used to treat stomach problems)
  • HIV drugs
  • dextropropoxyphene
  • birth control pills
  • diltiazem (blood pressure lowering and heart medicine)
  • certain antibiotics (eg erythromycin, clarithromycin, telithromycin, and troleandomycin) and certain medicines used to treat fungal infections (eg itraconazole, ketoconazole, posaconazole, voriconazole)

Drugs that reduce the effect of alprazolam, because they increase its degradation in the liver:

  • carbamazepine or phenytoin (antiepileptic drugs, which are also used for other treatments)
  • St. John’s wort ( Hypericum perforatum, an herbal medicine)
  • rifampicin (for tuberculosis )

Alprazolam may increase the effect of the following medicines:

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

Alcohol enhances the sedative effect of alprazolam.

Concomitant use of Alprazolam Krka with opioids (strong painkillers, opioid treatment drugs, and certain cough medicines) increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

If your doctor prescribes Alprazolam Krka at the same time as opioid medicines, the dose and treatment time should be limited by your doctor.

Tell your doctor if you are taking any opioid medication and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

Remember to tell your doctor the next time you visit him or her that you are taking Alprazolam Krka.

Alprazolam Krka with food, drink, and alcohol

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

Alcohol

Do not drink alcohol while taking Alprazolam Krka.

Pregnancy, breastfeeding, and fertility

Talk to your doctor before taking Alprazolam Krka if you are pregnant, planning to become pregnant, or breast-feeding.

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

There are no useful studies on 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 absolutely necessary. Observations in humans have shown that the substance alprazolam may be harmful to the fetus (increased risk of malformation ( cleft palate )). If you are pregnant or planning to become pregnant, talk to your doctor about stopping treatment. Tell your doctor if you are taking Alprazolam Krka until birth, as the newborn may experience withdrawal symptoms at birth. High- dose treatment during late pregnancy or during childbirth may cause decreased body temperature, respiratory distress, reduce muscle tension, and impair eating ability (“floppy infant syndrome ”) in newborns.

Do not breast-feed while taking Alprazolam Krka. There is a risk that it may affect the child.

Driving and using machines

Due to its calming, muscle-relaxing effect and drowsiness, alprazolam may impair your ability to react and concentrate, especially at the beginning of treatment and if you do not get enough sleep. For this reason, do not drive or use machines during treatment with Alprazolam Krka.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

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 medicine.

How to use Alprazolam Krka

Your doctor has prescribed an individual dose and treatment time that is tailored for you.

Always take Alprazolam Krka exactly as your doctor has told you. Treatment is often started with a low dose which is then increased as needed. Never change or stop self-dosing one of Alprazolam Krka without consulting your doctor. The treatment should preferably be started, followed up, and ended by one and the same doctor.

The use of products such as Alprazolam Krka can develop physical and mental dependence. The risk increases with dose one and the treatment time, and there is a greater risk for patients with previous alcohol and drug abuse. Do not give Alprazolam Krka to others.

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

Panic disorder:

The initial dose is usually 0.5-1 mg at bedtime. The therapeutic dose one (the lowest dose one giving the desired effect) is generally at most 6 mg daily, divided into two doses. The lower initial and therapeutic dose is recommended for the elderly and for those who are sensitive to the effect of the drug, generally 0.5 mg per day. The maximum maintenance dose is 4.5 mg daily divided into two doses.

Your doctor should re-evaluate your need and suitability of the medicine with you within four weeks of starting treatment.

Anxiety:

The initial dose is usually 0.5 mg daily. The therapeutic dose is generally 0.5-3 mg daily, either at one time or divided into two doses. The lower initial and therapeutic dose is recommended for elderly or debilitated patients, maximum 0.5-1 mg daily.

The maximum duration of treatment is generally 8-12 weeks, including gradual phasing out of the drug.

Use for children and adolescents

The safety and efficacy of alprazolam in patients below 18 years of age have not been established. Alprazolam is therefore not recommended for this age group.

Take this pack with you if you seek medical help.

An overdose of alprazolam causes severe fatigue, ataxia (difficulty coordinating body movements), and a decreased level of consciousness. Lowering blood pressure, unconsciousness, and severe breathing problems are also possible. Alcohol and other substances that suppress the central nervous system aggravate the side effects of alprazolam.

If you forget to use Alprazolam Krka

If you forget to take your medicine at the usual time, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Never take a double dose or two doses in close succession. Make sure you take enough of Alprazolam Krka with you when you are on holiday or going on a trip.

If you stop using Alprazolam Krka

Alprazolam can cause physical and mental dependence. The risk is greatest with high doses and longer treatment time, in patients with previous alcohol or drug abuse or if several benzodiazepines are combined.

Sudden discontinuation of treatment causes withdrawal symptoms (eg headache, muscle aches, severe anxiety, tension, restlessness, confusion, irritation and in severe cases altered personality, feeling unreal, increased sensitivity to sound or hearing, numbness, tingling in arms and legs, hypersensitivity to light and touch, hallucinations and epileptic seizures). Withdrawal symptoms may occur several days after the end of treatment.

For this reason, treatment with Alprazolam Krka should not be stopped abruptly, the dose should be gradually reduced according to the doctor’s instructions.

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 can be associated with ataxia(difficulty coordinating body movements), impaired muscle coordination, and confusion. Fatigue can occur in elderly patients in particular. Fatigue and exhaustion-related symptoms are greatest at the beginning of treatment. They will decrease or disappear with reduced dose or continued treatment.

Stop taking Alprazolam Krka and contact a doctor immediately if you get any of the following symptoms of angioedema (frequency not known):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing

The very common side effect is (can occur in more than 1 in 10):

  • sedation, drowsiness

Common side effects are (may affect up to 1 in 10):

  • decreased appetite
  • confusion, depression, motor restlessness
  • ataxia (difficulty coordinating body movements), memory problems, slurred speech, difficulty concentrating, dizziness, headache, intoxication
  • Tamsyn
  • tachycardia (rapid heartbeat), palpitations
  • nasal congestion
  • constipation, diarrhea, nausea, dry mouth, increased salivation, difficulty swallowing
  • allergic rash
  • fatigue
  • irritability

Less common side effects are (may affect up to 1 in 100):

  • hyperprolactinemia (abnormally high levels of prolactin in the blood)
  • loss of appetite
  • hallucinations, outbursts of rage, aggressive or threatening behavior, anxiety, restlessness, changes in sexual desire ( libido ), insomnia, abnormal thoughts, nervousness, agitation
  • amnesia (memory loss), altered muscle tension, tremor (tremors)
  • double vision
  • vomiting
  • jaundice, abnormal liver function
  • dermatitis, itching
  • muscle weakness
  • urinary tract problems, menstrual disorders, decreased sexual ability
  • weight changes
  • increase in pressure in the eye

Rare side effects are (may affect up to 1 in 1000 people):

  • low blood pressure
  • skin reactions
  • stimulation of appetite
  • loss of emotion decreased alertness

Has been reported (occurs in an unknown number of users):

  • liver inflammation ( hepatitis )
  • peripheral edema

Alprazolam can cause physical and mental dependence. See section “Warnings and Precautions”.

Abrupt discontinuation of Alprazolam Krka treatment may lead to withdrawal symptoms such as anxiety, insomnia, and seizures (see “If you stop taking Alprazolam Krka”).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Alprazolam Krka

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

No special storage instructions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is alprazolam. Each prolonged-release tablet contains 0.5 mg, 1 mg, or 2 mg of 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). See section 2 “Alprazolam Krka contains lactose”.

What the medicine looks like and the contents of the pack

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

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

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

Package sizes: 20, 30, 60, 100 and 100×1 release tablet s

Not all pack sizes may be marketed.

Muhammad Nadeem

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