Alprazolam Grindeks

Leaflet attached to the packaging: patient information

Alprazolam Grindeks, 0.25 mg, tablets

Alprazolam Grindeks, 0.5 mg, tablets

Alprazolam Grindeks, 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 you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 Alprazolam Grindeks and what is it used for
• 2. Important information before using Alprazolam Grindeks
• 3. How to use Alprazolam Grindeks
• 4. Possible side effects
• 5. How to store Alprazolam Grindeks
• 6. Contents of the packaging and other information

1. What is Alprazolam Grindeks and what is it used for

Alprazolam Grindeks has a calming effect and belongs to a group of medicines called benzodiazepines.
Alprazolam Grindeks is used to treat symptoms of anxiety disorders in adults, in situations where 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 Alprazolam Grindeks

When not to use Alprazolam Grindeks

Warnings and precautions

Before starting treatment with Alprazolam Grindeks, you should discuss it with your doctor or pharmacist:

Dependence
Using Alprazolam Grindeks can lead to physical and psychological dependence on this medicine. The risk of dependence increases with the dose and duration of treatment. Therefore, treatment should last as short as possible. This medicine should be used in the dose recommended by the doctor (see section 3). Psychological dependence is characterized by a lack of desire to stop taking the medicine. Physical dependence means the occurrence of withdrawal symptoms after sudden cessation of treatment with this medicine. The risk of dependence is also higher in patients who have abused or previously abused alcohol or medicines (see section 3, "Discontinuation of Alprazolam Grindeks"). Abuse of medicines is a common risk factor associated with Alprazolam Grindeks. Abuse of this medicine can lead to overdose and death. This medicine should always be used in the dose recommended by the doctor. The medicine may be sought after by people who abuse prescription medicines and should be stored in a place inaccessible to others.
Memory disorders
During treatment with alprazolam, memory may worsen. This usually occurs a few hours after taking the medicine. If such a symptom occurs, you should contact your doctor. To reduce the risk, you should ensure that the patient will have uninterrupted nighttime sleep (for 7-8 hours) while taking this medicine.
Psychiatric disorders (psychosis)
If the patient has psychosis, a serious mental disorder affecting behavior, actions, and self-control, it is not recommended to use Alprazolam Grindeks.
Mood effects
Using alprazolam can increase the risk of episodes of hypomania (a milder form of mania) and mania (a state of mental overexcitement, excessive excitement, and increased energy) in patients with depression. If symptoms of hypomania or mania occur, you should immediately contact your doctor.
Depression, thoughts of self-harm or suicide
In patients with depression, treatment with alprazolam may increase the risk of thoughts of self-harm or suicide. Before starting treatment with alprazolam, you should consult a doctor.
If treatment with alprazolam is necessary, and the patient has depression or has had thoughts of self-harm or suicidal thoughts in the past, the doctor should carefully monitor the patient's condition.
You should immediatelycontact your doctor or go to the hospital if thoughts of self-harm or suicide occur.
Elderly patients
Particular caution should be exercised when using alprazolam in elderly patients, as it may cause excessive fatigue and/or muscle weakness, which can increase the risk of falls.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as its safety and efficacy have not been established.

Alprazolam Grindeks and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about medicines you plan to take.
The effectiveness of treatment may change if Alprazolam Grindeks is used at the same time as other medicines used to treat the mentioned conditions. In this case, the doctor may adjust the dosage.

• Mental problems (antipsychotic medicines, including clozapine)
• Sleep disorders (sleeping pills)
• Allergies or hay fever (some antihistamine medicines)
• Planned major surgery (anesthetics)
• Severe pain (strong painkillers, e.g., dextropropoxyphene)
• Drug addiction therapy (substitution therapy)
• Problems such as anxiety disorders or depression, including some antidepressant medicines containing fluoxetine, fluvoxamine, nefazodone, or imipramine
• Heart failure (digoxin)
• Infections (antibiotics containing erythromycin, clarithromycin, and telithromycin)
• Fungal infections (itraconazole, fluconazole, ketoconazole, posaconazole, voriconazole)
• Medicines used to treat angina and high blood pressure, such as diltiazem
• HIV and AIDS (medicines called HIV protease inhibitors, such as ritonavir)
• Heartburn and stomach ulcers, medicines such as cimetidine or omeprazole
• Asthma and bronchitis, medicines such as theophylline
• Epilepsy, medicines such as carbamazepine
• Muscle relaxants. Concurrent use of such medicines with alprazolam may enhance muscle relaxant effects and increase the risk of falls

Concomitant use of Alprazolam Grindeks and opioids (strong painkillers, medicines used for substitution therapy, 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 options are not possible.
However, if the doctor prescribes Alprazolam Grindeks together with opioids, they should limit the dose and duration of concomitant treatment.
You should inform your doctor about all opioid medicines you are taking and strictly follow the dose of the medicine prescribed by the doctor. It may be helpful to inform friends or relatives so that they are aware of the above symptoms. If such symptoms occur, you should contact your doctor.
The therapeutic effect of alprazolam may also be affected by concomitant use of any of the following medicines: "the pill" (combined oral contraceptive pill), rifampicin (used to treat infections), or St. John's Wort (a herbal preparation).

Alprazolam Grindeks with alcohol

You should avoid drinking alcohol while using Alprazolam Grindeks, as alcohol may change and enhance the effect of Alprazolam Grindeks in an unpredictable way.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant or plan to become pregnant, you should immediately inform your doctor.
Observations in humans indicate that the use of alprazolam may be harmful to the fetus (increased risk of developmental abnormalities (cleft palate). During pregnancy, alprazolam may only be used if the doctor determines that the benefits of treatment outweigh the risk to the unborn child and that the medicine is suitable for the patient. If you use Alprazolam Grindeks until the day of delivery, you should inform your doctor, as the newborn may experience some withdrawal symptoms.
Breastfeeding
You should not use Alprazolam Grindeks during breastfeeding. Alprazolam passes into breast milk. If the doctor decides that you should take this medicine, you should stop breastfeeding.

Driving and using machines

Even when used as recommended, Alprazolam Grindeks may affect reaction speed to the extent that it impairs the ability to drive vehicles and operate machines.
This risk is particularly high at the beginning of treatment, after dose increase, in case of insufficient sleep, or after consuming alcohol or taking other substances that act on the central nervous system. Therefore, you should completely avoid driving, operating machines, or taking other risky activities, at least during the first few days of treatment. The decision in each individual case is made by the attending physician.

Alprazolam Grindeks contains lactose, sodium, and sodium benzoate (E 211)

Lactose:
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
Sodium:
The medicine contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".
Sodium benzoate:
The medicine contains 0.12 mg of sodium benzoate in each tablet.

3. How to use Alprazolam Grindeks

This medicine should always be used exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Unless the doctor has prescribed otherwise, the following dosage guidelines apply

Initial dose: the usual dose at the start of treatment is 0.25 to 0.5 mg of alprazolam three times a day.
Maintenance dose: if clinically justified, the doctor may increase the dose to 3 to 4 mg in small intervals, divided into several single doses.
Elderly patients, particularly sensitive or weakened patients
Elderly patients and particularly sensitive patients who require a lower dose usually start treatment with a dose of 0.25 mg two to three times a day. This dose may be slowly increased if necessary and if no side effects occur.
Patients with kidney or liver function disorders
In case of kidney or liver problems, the doctor will adjust the dose of the medicine.

Use in children and adolescents

Alprazolam Grindeks should not be used in children and adolescents under 18 years of age.

Method of administration

Alprazolam Grindeks is intended for oral use. The tablets should be taken with a small amount of liquid (e.g., half a glass of water). The tablets have a dividing line and can be divided into equal doses.

Duration of treatment

The risk of dependence and abuse may increase with the dose and duration of treatment. Therefore, the doctor will prescribe the lowest effective dose and duration of treatment, and will frequently assess the need to continue treatment.
The maximum duration of treatment should not exceed 2-4 weeks. Long-term treatment is not recommended. If the medicine is used for more than a few weeks, the effect of the medicine may weaken.

Using a higher than recommended dose of Alprazolam Grindeks

If you have taken too much Alprazolam Grindeks, you should immediately contact your doctor or go to the hospital.
Symptoms of (mild) overdose may include drowsiness, dizziness, vision disturbances, slurred speech, low blood pressure, unsteady gait/movements, and muscle weakness. In case of severe poisoning, deep sleep, and even loss of consciousness, breathing difficulties, and circulatory collapse may occur. It is necessary to monitor the patient's condition in the intensive care unit.
The assessment of the degree of poisoning should be made by a doctor, who will decide on the measures to be taken to treat it.

Missing a dose of Alprazolam Grindeks

You should not take a double dose to make up for a missed dose. If you miss a dose of the medicine, you should skip the missed dose and continue taking Alprazolam Grindeks as prescribed by your doctor.

Stopping treatment with Alprazolam Grindeks

Before stopping treatment with Alprazolam Grindeks, you should always consult your doctor, as the dose should be gradually reduced. If you stop taking the tablets or suddenly reduce the dose, you may experience rebound effects, which can cause a temporary increase in anxiety or insomnia. In some people, withdrawal symptoms may also occur (see section 4, "Dependence and withdrawal symptoms").
These symptoms will disappear when the body readjusts. If you are concerned, your doctor can provide more information on this. The doctor will then gradually reduce the dose after the end of treatment.
The reduction of the dose is done according to individual needs, as the gradual withdrawal of the medicine depends on several factors (e.g., duration of treatment and daily dose). You should ask your doctor about the way to gradually reduce the dose.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Reasons to immediately contact a doctor

If you experience any of these symptoms, you should immediately contact your doctor, as treatment may need to be discontinued. The doctor will inform you how to discontinue treatment.

• Treatment with alprazolam may cause serious behavioral or psychiatric effects - such as feelings of agitation, anxiety, aggression, irritability, violent anger, false beliefs, nightmares, and hallucinations or other inappropriate behaviors.
• Sudden wheezing, difficulty swallowing or breathing, swelling of the eyelids, face, or lips, rash, or itching (especially all over the body).

Reasons to contact a doctor as soon as possible

You should contact your doctor as soon as possible if you experience any of the following symptoms, as the dose or treatment may need to be changed:

• Memory loss (amnesia).
• Yellowing of the skin and whites of the eyes (jaundice).

Dependence and withdrawal symptoms

It is possible to become dependent on medicines like alprazolam during their use, which increases the likelihood of withdrawal symptoms after stopping treatment. Withdrawal symptoms occur more frequently if the patient:

• stops treatment suddenly,
• takes high doses,
• takes the medicine for a long time,
• has abused alcohol or medicines in the past.

This may cause such effects as headaches, muscle pain, severe anxiety, tension, restlessness, confusion, mood swings, sleep disturbances, and irritability.
In severe cases of withdrawal, the following symptoms may also occur: nausea (vomiting), vomiting, sweating, stomach cramps, muscle cramps, feelings of detachment or separation, exceptional sensitivity to sound, light, or physical contact, numbness and tingling of the feet and hands, hallucinations (seeing or hearing things that do not exist), tremors, or seizures.
You should inform your doctor if withdrawal symptoms worsen or do not disappear.

Other side effects that may occur are:

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

• Depression
• Drowsiness and lethargy
• Sudden, uncoordinated movements
• Inability to remember pieces of information
• Slurred speech
• Dizziness, feeling of emptiness in the head
• Headaches
• Constipation
• Dry mouth
• Fatigue
• Irritability

Common: may occur in up to 1 in 10 people

• Lack of appetite
• Confusion and disorientation
• Changes in sex drive (men and women)
• Nervousness, feelings of anxiety or agitation
• Insomnia (inability to sleep or sleep disturbances)
• Problems with balance and instability (similar to the feeling of intoxication), especially during the day
• Lack of alertness or concentration
• Inability to stay awake, feeling of drowsiness
• Shakiness or tremors
• Double or blurred vision
• Nausea
• Skin reactions
• Weight changes

Uncommon: may occur in up to 1 in 100 people

• Feeling of excitement or overstimulation, which causes unusual behavior
• Hallucinations (seeing or hearing things that do not exist)
• Feeling of agitation or anger
• Vomiting
• Muscle cramps or weakness
• Urinary incontinence
• Painful cramps in the lower back and thighs, which may indicate menstrual disorders
• Dependence on the medicine
• Withdrawal syndrome

Frequency not known: cannot be estimated from the available data

• In women, irregular menstrual periods or excessive production of prolactin (a hormone that stimulates milk production)
• Feeling of hostility or aggression
• Disturbed thoughts
• Jerky and sudden movements
• Overexcitement
• Upset stomach
• Liver function disorders (visible in blood tests), hepatitis
• Imbalance of the nervous system. Symptoms may include: rapid heartbeat and unstable blood pressure (dizziness, feeling of emptiness in the head or fainting)
• Severe allergic reaction causing swelling of the face or throat
• Swelling of the ankles, feet, or toes
• Skin reaction caused by sensitivity to sunlight
• Difficulty urinating or problems with bladder control
• Increased intraocular pressure, which can also affect vision
• Abuse of the medicine

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Alprazolam Grindeks

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Alprazolam Grindeks contains

The active substance of the medicine is alprazolam.

• Alprazolam Grindeks, 0.25 mg, tablets Each tablet contains 0.25 mg of alprazolam.
• Alprazolam Grindeks, 0.5 mg, tablets

Each tablet contains 0.5 mg of alprazolam.

• Alprazolam Grindeks, 1 mg, tablets Each tablet contains 1 mg of alprazolam.

Other ingredients are: lactose monohydrate; microcrystalline cellulose (E 460); maize starch, pre-gelatinized; sodium docusate; sodium benzoate (E 211); magnesium stearate (E 572); silica, colloidal, anhydrous (E 551); iron oxide red (E 172) (only 0.5 mg tablets); indigo carmine, lake (E 132) (only 1 mg tablets).

What Alprazolam Grindeks looks like and contents of the pack

Alprazolam Grindeks, 0.25 mg, is a white or almost white, oval tablet (10 mm x 5 mm) with a dividing line on one side and the inscription "0.25" on the other side.
Alprazolam Grindeks, 0.5 mg, is a light pink to pink, oval tablet (10 mm x 5 mm) with a dividing line on one side and the inscription "0.5" on the other side.
Alprazolam Grindeks, 1 mg, is a light blue to blue, oval (10 mm x 5 mm) tablet with a dividing line on one side and the inscription "1" on the other side.
Alprazolam Grindeks is available in blisters of OPA/Aluminum/PVC//Aluminum foil, containing 10, 20, 30, 50, 60, or 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Phone: +371 67083205
Fax: +371 67083505
Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: