Alprazolam grindeks

Package leaflet: Information for the user

Alprazolam Grindeks, 0.25 mg, tablets
Alprazolam Grindeks, 0.5 mg, tablets
Alprazolam Grindeks, 1 mg, tablets
Alprazolamum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Alprazolam Grindeks is and what it is used for
2. Important information before taking Alprazolam Grindeks
3. How to take Alprazolam Grindeks
4. Possible side effects
5. How to store Alprazolam Grindeks
6. Contents of the pack and other information

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

Alprazolam Grindeks is a tranquilizer belonging 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, interfere with normal functioning, or are particularly distressing to the patient. This medicine is intended for short-term use only.

2. Information before using Alprazolam Grindeks

When not to use Alprazolam Grindeks

• 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 a condition called myasthenia gravis, characterized by weak and easily fatigued muscles,
• if the patient has severe respiratory problems or difficulty breathing (e.g. chronic bronchitis or emphysema),
• if the patient suffers from sleep apnoea – a condition in which breathing becomes irregular or even stops briefly during sleep,
• if the patient has severe liver function disorders.

Warnings and precautions
Before starting treatment with Alprazolam Grindeks, discuss this with your doctor or
pharmacist:

• if the patient abuses or has previously abused alcohol, drugs, or medicines,
• if the medicine is used long-term, as its effect may diminish over time,
• if the patient is debilitated,
• if the patient has lung, kidney, or liver problems,
• if the patient is taking other medicines used to treat psychiatric disorders.

Dependence
Treatment with Alprazolam Grindeks may lead to physical and psychological dependence on
this medicine. The risk of dependence increases with higher doses and longer duration of treatment. Therefore,
treatment should last as short as possible. This medicine should be used at the dose
recommended by the doctor (see section 3). Psychological dependence is characterized by a lack of willingness
to stop taking the medicine. Physical dependence means withdrawal symptoms may occur after
sudden discontinuation of treatment with this medicine. The risk of dependence is also higher in patients who
abuse or have previously abused alcohol or medicines (see section 3, “Discontinuing Alprazolam Grindeks”).
Abuse of medicines is a common risk factor associated with Alprazolam Grindeks. Misuse of this medicine may lead to
overdose and death. This medicine should always be taken at the dose recommended by the doctor. This medicine
may be sought after by individuals who abuse prescription medicines and should be stored
in a place inaccessible to others.

Memory impairment
During treatment with alprazolam, memory may be impaired. This usually occurs several hours after
taking the medicine. If this symptom occurs, contact your doctor. To reduce the risk, ensure the patient
has uninterrupted night sleep (7–8 hours) while taking this medicine.

Psychotic disorders (psychosis)
If the patient suffers from psychosis, a serious mental disorder affecting behaviour, actions, and self-control,
Alprazolam Grindeks is not recommended.

Effect on mood
Alprazolam treatment may increase the risk of hypomanic (a milder form of mania) or manic episodes (a state of mental overexcitement, excessive excitement, and increased energy) in patients with depression. If symptoms of hypomania or mania occur, contact your doctor immediately.

Depression, self-harm or suicidal thoughts
In patients with depression, treatment with alprazolam may increase the risk of self-harm or suicidal thoughts.
Before starting treatment with alprazolam, consult your doctor.
If treatment with alprazolam is necessary and the patient has depression or has previously had thoughts of self-harm or suicidal ideation, the doctor should closely monitor the patient's condition.
Immediately contact your doctor or go to hospital if any thoughts of self-harm or suicide occur.

Elderly patients
Exercise particular caution when using alprazolam in elderly patients, as it may cause excessive drowsiness and/or muscle weakness, increasing the risk of falls.

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

Alprazolam Grindeks and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The effectiveness of treatment may change if Alprazolam Grindeks is taken simultaneously
with other medicines used to treat the conditions listed below. In such cases, the doctor may adjust the dosing regimen.

• Psychiatric disorders (antipsychotics, including clozapine)
• Sleep disorders (sleeping pills)
• Allergies or hay fever (some antihistamines)
• Planned major surgery (anaesthetics)
• Severe pain (strong analgesics, e.g. dextropropoxyphene)
• Drug addiction treatment (substitution therapy)
• Conditions such as anxiety or depression, including certain antidepressants containing fluoxetine, fluvoxamine, nefazodone, or imipramine
• Heart failure (digoxin)
• Infections (antibiotics containing erythromycin, clarithromycin, or telithromycin)
• Fungal infections (itraconazole, fluconazole, ketoconazole, posaconazole, voriconazole)
• Medicines used to treat angina and hypertension, 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 relaxation and increase the risk of falls.

Concomitant use of Alprazolam Grindeks and opioids (strong painkillers, medicines used in substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Alprazolam Grindeks together with opioids, the dose and duration of concurrent treatment should be minimized.
Inform your doctor about all opioid medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform friends or family members so they are aware of the symptoms listed above. If such symptoms occur, contact your doctor.

The therapeutic effect of alprazolam may also be affected by concomitant use of any of the following: oral contraceptives ("the pill"), rifampicin (used to treat infections), or St. John's wort (herbal remedy).

Alprazolam Grindeks and alcohol
Avoid drinking alcohol while taking Alprazolam Grindeks, as alcohol may unpredictably alter and intensify the effect of Alprazolam Grindeks.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
If the patient is pregnant or planning pregnancy, she should inform her doctor immediately.
Observations in humans indicate that alprazolam use may be harmful to the fetus (increased risk of developmental malformations, such as cleft palate). During pregnancy, alprazolam should only be used if the doctor determines that the benefits of treatment outweigh the risks to the unborn child and that the medicine is appropriate for the patient. If the patient takes Alprazolam Grindeks up to the day of delivery, she should inform her doctor, as the newborn may experience certain withdrawal symptoms.

Breastfeeding
Alprazolam Grindeks should not be used during breastfeeding. Alprazolam passes into breast milk. If the doctor decides that the patient should take this medicine, breastfeeding must be discontinued.

Driving and operating machinery
Even when used as directed, Alprazolam Grindeks may affect reaction speed to an extent that impairs the ability to drive vehicles and operate machinery. This risk is particularly high at the beginning of treatment, after dose increase, with insufficient sleep, or when consuming alcohol or taking other substances acting on the central nervous system. Therefore, complete avoidance of driving, operating machinery, or engaging in other potentially hazardous activities is recommended, at least during the first few days of treatment. The decision in each individual case is made by the treating physician.

Alprazolam Grindeks contains lactose, sodium, and sodium benzoate (E 211)
Lactose: If the patient has previously been diagnosed with intolerance to certain sugars,
the patient should contact the doctor before taking the medicine.
Sodium: The medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning 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 taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the following dosage guidelines apply:
Initial dose: The usual starting dose is 0.25 to 0.5 mg of alprazolam three times daily.
Maintenance dose: If clinically justified, your doctor may gradually increase the dose up to 3 to 4 mg daily, divided into several smaller doses taken at intervals.
Elderly patients, particularly sensitive patients, or weakened patients
Elderly, particularly sensitive, or weakened patients who require a lower dose usually start treatment with 0.25 mg two to three times daily. This dose may be slowly increased if needed and if no adverse effects occur.
Patients with impaired kidney or liver function
In case of kidney or liver problems, your doctor will adjust the dosage accordingly.
Use in children and adolescents
Alprazolam Grindeks must not be used in children and adolescents under 18 years of age.
Method of administration
Alprazolam Grindeks is intended for oral use. Tablets should be taken with a small amount of liquid (e.g. half a glass of water). The tablets have a score line and can be divided into equal doses.
Duration of treatment
The risk of dependence and abuse may increase with dose and duration of treatment. Therefore, your doctor will prescribe the lowest effective dose for the shortest possible duration and will regularly assess the need for continued treatment.
The maximum duration of treatment should not exceed 2 to 4 weeks. Long-term treatment is not recommended. If the medicine is used for longer than a few weeks, a reduction in its effectiveness may occur.
Taking more Alprazolam Grindeks than prescribed
If you have taken too much Alprazolam Grindeks, you should immediately contact your doctor or go to hospital.
Symptoms of (mild) overdose may include drowsiness, dizziness, blurred vision, slurred speech, low blood pressure, unsteady gait/movement, and muscle weakness. In cases of severe poisoning, deep sedation, loss of consciousness, breathing difficulties, and circulatory collapse may occur. Monitoring of the patient in an intensive care unit is required.
The degree of poisoning should be assessed by a doctor, who will decide on appropriate treatment measures.
Missed dose of Alprazolam Grindeks
Do not take a double dose to make up for a missed dose. If you miss a dose, skip the missed dose and continue taking Alprazolam Grindeks as prescribed by your doctor.
Stopping Alprazolam Grindeks
You must always consult your doctor before stopping Alprazolam Grindeks, as the dose should be gradually reduced. Stopping the tablets abruptly or rapidly reducing the dose may lead to "rebound" effects, which may temporarily increase feelings of anxiety or restlessness, or cause sleep difficulties. Some individuals may also experience withdrawal symptoms (see section 4. "Dependence and withdrawal symptoms").
These symptoms will resolve as the body readjusts. If you have concerns, your doctor can provide further information. Your doctor will therefore gradually reduce the dose after completion of treatment.
Dose reduction should be tailored to individual needs, as gradual discontinuation depends on several factors (e.g. duration of treatment and daily dose). Please consult your doctor for advice on how to taper the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Reasons to see a doctor immediately
If any of the following symptoms occur, consult a doctor immediately, as treatment may need to be discontinued. The doctor will advise how the treatment should be stopped.

• Treatment with alprazolam may cause serious behavioural or psychiatric effects – for example, feelings of agitation, anxiety, aggression, irritability, sudden anger, delusions, nightmares, hallucinations, or other inappropriate behaviours.
• Sudden wheezing, difficulty swallowing or breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body).

Reasons to contact a doctor as soon as possible
Inform your doctor as soon as possible if any of the following symptoms occur, as a change in dose or treatment may be necessary:

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

Dependence and withdrawal symptoms
Dependence on medicines such as alprazolam may occur during treatment, increasing the likelihood of withdrawal symptoms when treatment is stopped. Withdrawal symptoms are more likely if the patient:

• suddenly stops treatment,
• has taken high doses,
• has taken the medicine for a long time,
• has previously abused alcohol or drugs.

This may result in effects such as headaches, muscle pain, severe anxiety, tension, restlessness, disorientation, mood swings, sleep disturbances and irritability.
In severe cases of withdrawal, the following symptoms may also occur: nausea, vomiting, sweating, stomach cramps, muscle cramps, feelings of derealisation or depersonalisation, extreme sensitivity to sound, light or physical touch, numbness and tingling in the feet and hands, hallucinations (seeing or hearing things that are not there), tremor or seizures.
Inform your doctor if withdrawal symptoms worsen or do not go away.

Other possible adverse effects include:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Loss of appetite
• Confusion and disorientation
• Changes in sexual desire (in men and women)
• Nervousness, feeling of anxiety or agitation
• Insomnia (inability to sleep or sleep disturbances)
• Problems with balance and instability (similar to feeling intoxicated), especially during the day
• Loss of alertness or concentration
• Inability to remain awake, feeling drowsy
• Unsteadiness or tremor
• Double or blurred vision
• Nausea
• Skin reactions
• Changes in body weight

Uncommon: may affect up to 1 in 100 people

• Feeling of excitement or excessive stimulation leading to unusual behaviour
• Hallucinations (seeing or hearing things that do not exist)
• Feelings of agitation or anger
• Vomiting
• Muscle spasms or weakness
• Urinary incontinence
• Cramping pain in the lower back and thighs, which may indicate menstrual disorders
• Drug dependence
• Drug withdrawal syndrome

Frequency not known: cannot be estimated from available data

• In women: irregular menstruation or excessive production of prolactin (the hormone stimulating milk production)
• Feelings of hostility or aggression
• Disordered thinking
• Jerky and sudden movements
• Hyperactivity
• Stomach upset
• Problems with liver function (seen 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 ankles, feet or fingers
• Skin reaction due to sensitivity to sunlight
• Difficulty urinating or problems controlling the urinary bladder
• Increased intraocular pressure, which may also affect vision
• Drug abuse

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse effects helps provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Alprazolam Grindeks

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP". The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Alprazolam Grindeks contains
The active substance 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.

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

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 score line on one side and engraved with the number "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 score line on one side and engraved with the number "0.5" on the other side.
Alprazolam Grindeks 1 mg is a light blue to blue, oval tablet (10 mm x 5 mm) with a score line on one side and engraved with the number "1" on the other side.

Alprazolam Grindeks is available in blisters made of OPA/Aluminium/PVC//Aluminium foil, containing 10, 20, 30, 50, 60 or 100 tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area under the following names: