ALPROX 1 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Alprox, 0.25 mg, tablets
3. Alprox, 0.5 mg, tablets
4. Alprox, 1 mg, tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Alprox and what is it used for
6. Important information before using Alprox
   1. When not to use Alprox
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients
   5. Alprox with other medicines
   6. Alprox with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and operating machinery
   9. Alprox contains lactose
7. How to use Alprox
   1. Using a higher than recommended dose of Alprox
   2. Missing a dose of Alprox
   3. Discontinuation of Alprox
8. Possible side effects
   1. Reporting side effects
9. How to store Alprox
10. Contents of the packaging and other information
    1. What Alprox contains
    2. What Alprox looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer

Leaflet attached to the packaging: information for the user

Alprox, 0.25 mg, tablets

Alprox, 0.5 mg, tablets

Alprox, 1 mg, tablets

Alprazolam

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Alprox and what is it used for
• 2. Important information before using Alprox
• 3. How to use Alprox
• 4. Possible side effects
• 5. How to store Alprox
• 6. Contents of the packaging and other information

1. What is Alprox and what is it used for

The active substance of the medicine is alprazolam. It belongs to a group of medicines called benzodiazepines.
Alprazolam acts on the central nervous system, reducing anxiety and depression. It also has a
calming, soothing, and muscle-relaxing effect.
Alprox is used to treat symptoms of anxiety disorders in adults, in situations where the symptoms are severe, prevent normal functioning, or are very troublesome for the patient. This medicine is intended for short-term use only.

2. Important information before using Alprox

When not to use Alprox

• if the patient is allergic to alprazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has been diagnosed with muscle weakness (myasthenia gravis)
• if the patient has severe respiratory failure
• if the patient experiences recurring prolonged pauses in breathing during sleep (sleep apnea)
• if the patient has severe liver failure.

Warnings and precautions

Before starting to use this medicine, you should discuss it with your doctor or pharmacist if:

• the patient notices that the effect of the tablets has weakened after using them for a period of several weeks (development of tolerance to the medicine)
• the patient experiences unexpected reactions: such as restlessness, excitement, irritability, aggression, nightmares, sudden insomnia, hallucinations, psychosis, inappropriate behavior, sudden disorientation (confusion) or other behavioral disorders. These unexpected reactions occur more frequently in children and elderly patients.
• the patient has chronic lung disease
• the patient is also drinking alcohol and taking sedatives
• the patient has severe depression (risk of suicide)
• the patient has been diagnosed with kidney or liver dysfunction
• the patient has a certain type of glaucoma.

Dependence
Using Alprox may lead to physical and psychological dependence on the medicine.
If the patient notices that they have difficulty stopping the use of this medicine, it may indicate
psychological dependence on it. If physical dependence has occurred, sudden cessation of treatment
may cause withdrawal symptoms (see section 3 "Discontinuation of Alprox"). The risk of dependence increases with the increase in dose and duration of treatment and is greater in patients who abuse alcohol, drugs, and medicines. In order to reduce this risk, the smallest possible dose should be used, and the duration of treatment should be as short as possible. The patient should follow the doctor's recommendations (see section 3). The risk of dependence is also greater in patients who have abused or previously abused prescription drugs or alcohol.
Abuse
A known risk associated with the use of this medicine is its abuse (see section 4).
Abuse of this medicine may lead to overdose and death. The patient should always follow the doctor's recommendations regarding dosage. This medicine may be sought after by people who abuse prescription drugs and should be stored in a place inaccessible to others.
Effect on memory
During treatment with Alprox, memory may be impaired. This usually occurs a few hours after taking the medicine. If such symptoms occur, the patient should contact their doctor.
Effect on mood
Using Alprox may increase the risk of episodes of hypomania (a milder form of mania) and mania (a state of excessive mental excitement, excessive excitement, and increased energy) in patients with depression. If hypomania or mania occurs, the patient should contact their doctor immediately.
In patients with depression, treatment with Alprox may increase the risk of suicidal thoughts or behaviors.
Before starting treatment with Alprox, the patient should consult their doctor.
If treatment with Alprox is necessary and the patient has depression or has had suicidal thoughts or behaviors in the past, the doctor may closely monitor the treatment. The patient should contact their doctor or go to the hospital immediately if they experience any suicidal thoughts or behaviors.
If the patient is scheduled for surgery
The patient should inform their doctor that they are taking Alprox if they are scheduled for surgery.

Children and adolescents

The patient should consult their doctor if they are under 18 years old. The safety of using this medicine in patients under 18 years old has not been confirmed.

Elderly patients

In elderly patients, benzodiazepines and similar medicines should be used with caution due to the existing risk of excessive sedation and/or muscle weakness. This may lead to falls, which can have serious health consequences in this group of patients.

Alprox with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes both prescription and over-the-counter medicines, as well as herbal preparations or natural products. The patient should remember to mention all other medicines they have taken recently.
Some medicines may cause side effects if taken with alprazolam. The effectiveness of treatment may change if the patient is also taking other medicines. In such cases, the doctor may adjust the treatment or dosage.
Such medicines include, for example:
Medicines that enhance the sedative effect of alprazolam:

• sleeping pills, sedatives
• antipsychotic, antidepressant medicines
• antiepileptic medicines
• anesthetics
• strong painkillers acting on the central nervous system
• antihistamines with a sedative effect.

Medicines that enhance the effect of alprazolam because they delay its breakdown in the liver:

• nefazodone, fluvoxamine, fluoxetine, sertraline (used to treat severe depression)
• cimetidine and omeprazole (used to treat stomach disorders)
• HIV medicines
• dextropropoxyphene
• oral contraceptives
• diltiazem (used to treat high blood pressure and heart disorders)
• certain antibiotics (e.g., erythromycin and troleandomycin) and certain antifungal medicines (e.g., itraconazole, ketoconazole).

Medicines that weaken the effect of alprazolam because they increase its breakdown in the liver:

• carbamazepine and phenytoin (used to treat epilepsy and other diseases)
• St. John's Wort (Hypericum perforatum - a herbal preparation)
• rifampicin (used to treat tuberculosis)
• theophylline.

Alprazolam may enhance the effect of medicines such as:

• digoxin (used to treat heart disorders)
• muscle relaxants
• imipramine and desipramine (used to treat severe depression)
• clozapine (used to treat psychosis). The risk of respiratory depression and/or cardiac arrest increases.

Alcohol enhances the sedative effect of alprazolam.
Concomitant use of Alprox with opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment methods are not possible. If the doctor has prescribed Alprox with opioids, the patient should use the smallest effective dose, and the duration of treatment should be as short as possible.
The patient should tell their doctor about all opioid medicines they are taking and follow the doctor's recommendations strictly. It may be helpful to inform friends or relatives about the possibility of the patient experiencing the above symptoms. If such symptoms occur, the patient should contact their doctor.
During the next visit, the patient should tell their doctor about taking Alprox.

Alprox with food, drink, and alcohol

Tablets should be taken with a glass of water or other liquid.
Alcohol
Alcohol should not be consumed during treatment with Alprox. Alcohol enhances the sedative effect of alprazolam.

Pregnancy and breastfeeding

Alprox should not be used during pregnancy, unless the doctor considers it absolutely necessary for the treatment of the mother.
Experience with the use of alprazolam in pregnant women is insufficient. Alprox should not be used in case of pregnancy, suspected pregnancy, or planned pregnancy, unless the doctor considers it absolutely necessary. Observations in humans indicate that the use of alprazolam may be harmful to the fetus. If the patient is pregnant or plans to become pregnant, they should discuss the possibility of stopping treatment with their doctor. If the patient is taking Alprox on the day of delivery, they should inform their doctor, as the newborn may experience some withdrawal symptoms from the medicine .
Alprox should not be used during breastfeeding. The medicine may have a harmful effect on the breastfed baby.
If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and operating machinery

Since alprazolam causes relaxation, muscle relaxation, and sedation, it may impair the ability to drive vehicles and perform tasks that require attention, especially at the beginning of treatment and in case of insufficient sleep. Therefore, the patient should avoid driving vehicles and operating machinery while taking Alprox.

Alprox contains lactose

One Alprox tablet contains lactose (in the form of monohydrate): 85.7 mg (0.25 mg tablets), 85.5 mg (0.5 mg tablets), or 171 mg (1 mg tablets). If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Alprox.

3. How to use Alprox

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Treatment often starts with a small dose, which is gradually increased if necessary, according to the doctor's recommendations. The patient should not change the dosage or stop treatment with Alprox without consulting their doctor. It is recommended that the same doctor starts, conducts, and ends the treatment. The use of medicines such as Alprox may lead to the development of physical and psychological dependence. This risk increases with the increase in dose and duration of treatment and is greater in patients who abuse alcohol, drugs, and medicines. The patient should not give this medicine to others.
Anxiety:
Usually, the initial dose is 0.25 to 0.5 mg three times a day. The maintenance dose usually ranges from 0.5 to 3 mg per day in three divided doses. In elderly patients and patients sensitive to the sedative effect of the medicine, as well as in patients with liver or kidney failure, smaller initial and maintenance doses are recommended than those usually recommended.
The longest treatment duration should not exceed 2 to 4 weeks. Long-term treatment is not recommended.
Alprox should not be used as monotherapy (as the only medicine) in the treatment of depression or in the treatment of anxiety with accompanying depression.
The safety and efficacy of using alprazolam in patients under 18 years old have not been established. Alprox should not be used in this group of patients.

Using a higher than recommended dose of Alprox

If the patient or someone else, e.g., a child, has taken too much of this medicine by mistake, they should immediately go to the doctor or hospital. If the patient is conscious, they should quickly administer activated charcoal.
When going to the doctor or hospital, the patient should take the medicine packaging with them.
Taking an overdose of alprazolam causes severe fatigue, muscle weakness (coordination disorders), and decreased level of consciousness. It is also possible to experience decreased blood pressure, loss of consciousness, and respiratory depression. Alcohol and other factors that depress the central nervous system potentiate the adverse effects of alprazolam.

Missing a dose of Alprox

The patient should take the missed dose as soon as possible. However, if it is almost time for the next dose, they should not take the missed dose. The patient should not take a double dose to make up for the missed dose. The patient should make sure they have enough Alprox before going on vacation or traveling.

Discontinuation of Alprox

Alprazolam may cause physical and psychological dependence. The risk of dependence is greatest during the use of high doses and long-term treatment. The risk of dependence is greater in patients who abuse alcohol, drugs, and medicines.
Sudden cessation of treatment causes withdrawal symptoms (e.g., headache, muscle pain, severe anxiety, and tension, sleep disturbances, restlessness, confusion, and irritability), and in severe cases - depersonalization (feeling of detachment from one's own person and identity), derealization (feeling of detachment from reality), increased hearing acuity, loss of sensation, tingling in the limbs, hypersensitivity to light, sounds, and touch, hallucinations, seizures. Withdrawal symptoms may occur several days after the end of treatment. Therefore, the patient should not suddenly stoptreatment with Alprox. The dose should be gradually reduced, according to the doctor's recommendations.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Alprox can cause side effects, although not everybody gets them.
Side effects, if they occur, are usually observed at the beginning of therapy and usually disappear as treatment continues or when the dose is reduced.
The patient should stop using Alprox and immediately contact their doctor if they experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing. Angioedema has been reported with an unknown frequency (frequency cannot be estimated from the available data).

Very common( may occur in more than 1 in 10 people):

• sedation
• drowsiness
• depression
• memory disorders
• poor coordination and inability to stand (ataxia)
• speech disorders
• dizziness
• headache
• constipation
• dry mouth
• fatigue
• irritability.

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

• decreased appetite
• increased appetite
• loss of appetite (anorexia)
• confusion
• disorientation
• decreased or increased libido (sexual desire)
• anxiety
• insomnia (difficulty falling asleep)
• nervousness
• tremors
• balance disorders
• coordination disorders
• difficulty concentrating
• excessive drowsiness
• extreme fatigue
• blurred vision
• nausea
• vomiting
• skin rash
• sexual disorders
• weight gain or loss.

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

• mania
• hallucinations
• anger
• excitement
• dependence on the medicine
• partial or complete amnesia (memory loss)
• feeling of intoxication
• muscle weakness
• urinary incontinence
• irregular menstrual cycles
• withdrawal symptoms.

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

• increased prolactin levels in the blood (a peptide hormone secreted by the anterior pituitary gland)
• hypomania (mild mania)
• aggressive behavior
• hostile behavior
• abnormal thinking
• increased psychomotor activity
• abuse of the medicine
• autonomic nervous system imbalance
• muscle tone disorders
• shortened reaction time
• speech disorders
• low blood pressure
• gastrointestinal disorders
• difficulty swallowing
• hepatitis
• liver function disorders
• jaundice
• photosensitivity reactions
• inability to empty the bladder (urinary retention)
• edema of the limbs
• increased intraocular pressure.

During the use of benzodiazepines, such as Alprox, existing depression may be revealed.
Alprazolam may cause physical and psychological dependence. See section 2 "Warnings and precautions".
Sudden cessation of Alprox may cause withdrawal symptoms, such as anxiety, insomnia, and seizures (see section 3 "Discontinuation of Alprox").
Memory disorders may occur, leading to inappropriate behavior (see section 2 "Warnings and precautions").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309. Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Alprox

Store in a temperature below 25°C.
The container contains a desiccant that protects the tablet from moisture. The patient should not remove the desiccant from the container. The patient should not swallow the desiccant.
The medicine should be stored in a place out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Alprox contains

• The active substance is alprazolam. One tablet contains 0.25 mg, 0.5 mg, or 1 mg of alprazolam.
• The other ingredients of the medicine are: cornstarch, gelatin, lactose monohydrate, magnesium stearate.

What Alprox looks like and contents of the pack

0.25 mg tablets: white or almost white uncoated tablets, oval, with a dividing line and marked with "ORN 51", measuring 9 x 6 mm.
0.5 mg tablets: white or almost white uncoated tablets, oval, with a dividing line and marked with "ORN 52", measuring 9 x 6 mm.
1 mg tablets: white or almost white uncoated tablets, round, flat, with beveled edges, with a dividing line and marked with "ORN 50", with a diameter of 9 mm.
The tablet can be divided into equal doses.
Pack sizes:
20, 30, 50, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the leaflet:29.11.2024