0.25 mg, 0.5 mg and 1 mg alprazolam tablets 

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 it again.

– If you have any further questions, ask your doctor or pharmacist.

– 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 or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Alprazolam Orion is and what it is used for 
2. What you need to know before you use Alprazolam Orion 
3. How to use Alprazolam Orion 
4. Possible side effects 
5. How to store Alprazolam Orion 
6. Contents of the pack and other information 

What Alprazolam Orion is and what it is used for

The active substance is alprazolam and belongs to the group of drugs benzodiazepines. Alprazolam works by affecting the chemical activity of the brain, thus reducing anxiety and worry. It also has a calming, calming, and muscle relaxing effect.

Alprazolam Orion is used for treating:

• panic disorder

• physical symptoms of anxiety

Alprazolam should only be prescribed when severe anxiety is present, which causes concern and the individual may not have a functioning life.

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

What you need to know before you use Alprazolam Orion

Do not take Alprazolam Orion

  • if you are allergic to alprazolam or any of the other ingredients of this medicine (listed in section 6).
  • if you have a specific muscle weakness condition called myasthenia gravis
  • if you suffer from severe breathing problems
  • if you have repeated prolonged pauses in breathing during sleep ( sleep apnea )
  • if you suffer from severe liver failure.

Warnings and cautions

Talk to your doctor or pharmacist before taking this medicine, if you

  • notice that the effect of the tablets diminishes after a few weeks of use (development of tolerance to the drug)
  • concerned about symptoms suggestive of physical and mental dependence on alprazolam. If you notice that you have difficulty stopping taking the medicine, you may be mentally dependent on it. In case of physical dependence, withdrawal symptoms occur when treatment with this medicine is stopped (see section “If you stop taking Alprazolam Orion”). The risk of addiction increases with higher doses and longer treatment periods and is greater in patients who have previously abused alcohol, drugs, or medication. Therefore, the duration of treatment should be as short as possible.
  • have been addicted to alcohol, drugs, or medicines in the past
  • have had memory loss. This usually occurs several hours after you take the tablet.
  • notice some unexpected reactions, such as restlessness, agitation, irritability, outbursts of rage, nightmares, increased insomnia, hallucinations, psychosis, inappropriate behavior, sudden confusion ( delirium ), or other behavioral disorders. These unexpected reactions occur more often in children and the elderly.
  • have a long-term lung disease
  • while drinking alcohol and taking sedatives
  • is deeply depressed (there is a risk of suicide)
  • have been diagnosed with kidney or liver failure
  • have been diagnosed with a psychiatric illness
  • have some form of glaucoma .

If you are going to have surgery

Tell your doctor that you are taking Alprazolam Orion if you are going to have an operation.

Older

Benzodiazepines and similar medicines should be used with caution in the elderly, due to the risk of enhanced sedative effect and / or muscle weakness. This can increase the risk of falling, which can often have serious consequences in this patient group.

Children and young people

Ask your doctor if you are under 18 years of age. The safety of this medicine has not been established in patients under 18 years of age. 

Other medicines and Alprazolam Orion

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 medicines or other natural products. Remember to mention if you have recently taken any other medicines.

Some medicines may cause side effects when taken at the same time as alprazolam. If you are taking certain other medicines at the same time, this may affect the treatment. In such cases, your doctor may need to change your treatment or adjust the dose of one of your medicines. Such medications may be, for example:

Drugs that enhance the sedative effect of alprazolam:

  • sleeping pills and sedatives
  • medicines used to treat severe mental illness (antipsychotics) and severe depression (antidepressants)
  • medicines used to treat epilepsy
  • medications used under anesthesia
  • some strong painkillers that affect the central nervous system
  • Some medications are used to treat allergies , so-called sedative antihistamines .

Drugs that potentiate the effects of alprazolam, as they slow down the breakdown of alprazolam in the liver:

  • nefazodone, fluvoxamine, fluoxetine , sertraline (for the treatment of major depression)
  • cimetidine (for the treatment of stomach problems)
  • HIV drugs
  • dextropropoxyphene
  • birth control pills
  • diltiazem (for the treatment of high blood pressure and heart problems)
  • certain antibiotics (eg erythromycin and troleandomycin) and certain medicines used to treat fungal infections (eg itraconazole and ketconazole).

Drugs, which reduce the effect of alprazolam, as they increase its metabolism in the liver:

  • carbamazepine and phenytoin (for the treatment of epilepsy and other diseases)
  • St. John’s wort (Hypericum perforatum, a herbal medicine)
  • rifampicin (for the treatment of tuberculosis )

Alprazolam may potentiate the effects of the following medicines:

  • digoxin (for the treatment of heart problems)
  • muscle relaxants
  • imipramine and desimipramine (for the treatment of major depression)
  • clozapine (for the treatment of severe mental illness called psychosis ). The risk of respiratory and / or cardiac arrest increases.

Alcohol enhances the sedative effect of alprazolam.

Concomitant use of Alprazolam Orion 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 Orion 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.

Next time you see a doctor, tell them you are taking Alprazolam Orion.

Alprazolam Orion with food, drink and alcohol

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

Alcohol

Do not drink alcohol during treatment with Alprazolam Orion.

Alcohol enhances the drowsiness effect of alprazolam.

Pregnancy and breastfeeding

Do not use Alprazolam Orion during pregnancy unless your doctor considers it absolutely necessary for the mother’s treatment.

Experience with the use of alprazolam in pregnant women is insufficient.

Do not use Alprazolam Orion if you are pregnant or planning to become pregnant, unless your doctor considers it absolutely necessary. Human observations have shown that alprazolam may be harmful to the fetus. If you are pregnant or planning to become pregnant, talk to your doctor about stopping treatment. If you are using Alprazolam Orion until birth, tell your doctor as the newborn baby may experience withdrawal symptoms.

Do not breast-feed your baby during treatment with this medicine. This medicine may affect the breast-feeding baby.

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.

Driving and using machines

Due to its sedative, muscle-relaxing and calming effect, alprazolam may impair the ability to drive and other tasks that require extra attention, especially at the beginning of treatment or in case of insufficient sleep. Therefore, avoid driving and using machines when treating Alprazolam Orion.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 Orion contains lactose

One Alprazolam Orion tablet contains lactose: 85.7 mg (0.25 mg tablets), 85.5 mg (0.5 mg tablets) or 171.0 mg (1 mg tablets). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Alprazolam Orion

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The treatment is often started with a low dose , which is then gradually increased as needed. Do not change the dosage one, and discuss with your doctor regarding discontinuation of Alprazolam Orion treatment.

It is recommended that the same treating physician initiate, monitor and terminate treatment. The use of products such as Alprazolam Orion can lead to physical and mental dependence. The risk increases with dose and duration of treatment and is greater in patients with previous alcohol, drug and drug abuse. Do not give this medicine to anyone else.

Panic disorder

Usually 0.5 to 1 mg is given at bedtime when treatment is started. The therapeutic dose one (the lowest dose one that gives a desired effect) is usually a maximum of 6 mg per day divided into three or four doses . Lower than usual starting and therapeutic doses are recommended for the elderly, for those who are sensitive to the effects of this medicine and for patients with liver or kidney failure . The maximum dose is 4.5 mg per day divided into three doses .

Within four weeks of starting treatment, your doctor should re-examine the need for medication as well as the suitability of the medication for you.

Anxiety

Usually 0.25 to 0.5 mg is given 3 times daily when treatment is started. The therapeutic dose is usually 0.5 to 3 mg per day divided into three doses . Lower initial and therapeutic doses than usual are recommended for the elderly, for those sensitive to the effects of this medicine and for patients with liver or kidney failure .

The maximum duration of treatment is usually 8 to 12 weeks, including gradual dose reduction of the drug.

Alprazolam Orion should not be used as the only medicine for the treatment of depression or anxiety associated with depression.

The safety and efficacy of alprazolam in patients younger than 18 years have not been established. Therefore, the medicine should not be used by patients in this age group.

advice. If the patient is conscious, activated charcoal should be given first aid.

Take this pack with you when you see a doctor or hospital.

Too high a dose of alprazolam causes intense fatigue, problems with muscle coordination and reduced level of consciousness. Decreased blood pressure , unconsciousness and impaired breathing may also occur. Alcohol and other drugs that lead to reduced chemical activity in the brain increase the side effects of alprazolam.

If you forget to use Alprazolam Orion

Take the missed dose as soon as possible. If it is almost time to take the next dose , do not take the missed dose . Never take a double dose or two doses in a row. Before going on vacation or a trip, make sure you have enough Alprazolam Orion with you.

If you stop taking Alprazolam Orion tablets

The use of alprazolam may cause physical and mental dependence. The risk is greatest with higher doses and longer treatment times. The risk is greater in patients who have previously had an alcohol, drug or drug addiction.

Sudden cessation of treatment causes withdrawal symptoms (eg headache, muscle aches, severe anxiety and worry, sleep disturbances, restlessness, confusion and irritability). In severe cases depersonalization (loses the sense of one’s own reality and feels alienated from oneself), derealization (loses the sense of reality), exceptionally good hearing for normal sounds, numbness and tingling in arms and legs, hypersensitivity to light, sound and touch, hallucinations and seizures. Withdrawal symptoms may occur several days after stopping treatment.

Therefore , treatment with Alprazolam Orion should not be abruptly discontinued; dose one 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 side effects , if they occur, generally occur at the beginning of treatment and usually decrease or disappear after a period of use of the drug or of a reduced dose .

Stop taking Alprazolam Orion and contact a doctor immediately if you get any of the following symptoms

( angioedema ):

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

Angioedema has been observed but the frequency is not known.

Very common (may affect more than 1 user in 10)

  • drowsiness
  • somnolence
  • Depression
  • oblivion
  • impaired coordination of muscle movements and instability ( ataxia )
  • speech difficulties
  • dizziness
  • headache
  • constipation
  • dry mouth
  • fatigue
  • irritability

Common (may affect up to 1 in 10 people):

  • decreased appetite
  • confusion
  • disorientation
  • decreased or increased sexual desire
  • anxiety
  • difficulty sleeping
  • nervousness
  • shaking
  • balance disorders
  • coordination difficultiesconcentration difficulties
  • increased need for sleep
  • extreme fatigue
  • dimsyn
  • nausea
  • vomiting
  • dermatitis
  • sexual dysfunction
  • weight gain or weight loss

Uncommon (may affect up to 1 in 100 people):

  • morbidly elevated mood (mania)
  • hallucinations
  • anger
  • concern
  • partial or total memory loss ( amnesia )
  • muscle weakness
  • incontinence
  • irregular menstruation

No known frequency (can not be calculated from the available data )

  • high levels of prolactin in the blood (a peptide hormone secreted by the anterior pituitary gland )
  • hypomania (mild mania)
  • aggression
  • hostility
  • delusions
  • feeling of extreme restlessness
  • dysfunction of the autonomic nervous system (such as palpitations, increased salivation and nasal congestion)
  • abnormal muscle contractions
  • gastrointestinal problems
  • inflammation of the liver
  • liver problem
  • jaundice (causes yellowing of the skin and whites of the eyes)
  • sudden swelling of the skin, mucous membranes or internal organs ( angioedema)
  • photosensitivity
  • inability to empty the bladder ( urinary retention )
  • swelling affecting the arms and legs
  • increased fluid pressure in the eye.

Alprazolam can cause physical and mental dependence. See Section 2, Warnings and Precautions.

Sudden discontinuation of Alprazolam Orion treatment may lead to withdrawal symptoms, such as anxiety, insomnia and seizures (see section 3, If you stop taking Alprazolam Orion).

Reporting of side effects ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

SE-751 03 Uppsala

www.lakemedelsverket.se

5. How to store Alprazolam Orion

Do not store above 25 ° C.

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

Used before the expiration date specified after the Expiration Date. on the box and EXP on the blister card. 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. One tablet contains 0.25 mg, 0.5 mg or 1 mg of alprazolam.

The other ingredients are corn starch, gelatin, lactose monohydrate and magnesium stearate.

What the medicine looks like and contents of the pack

Alprazolam Orion 0.25 mg tablets

White or almost white, uncoated, oval with break notch, embossed with ORN51, size 9 x 6 mm.

Alprazolam Orion 0.5 mg tablets

White or almost white, uncoated, oval with break notch, embossed with ORN52, size 9 x 6 mm.

Alprazolam Orion 1 mg tablets

White or almost white, uncoated, flat, round, bevelled edges with break notches, embossed with ORN 50, Ø9 mm.

The sub-groove is only intended to facilitate division to facilitate swallowing and not to divide into equal parts.

Pack sizes

50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionvägen 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation, Orion Pharma

Orionvägen 1

FI-02200 Espoo

Finland

Muhammad Nadeem

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