Alprazolam Grindex

Patient Information Leaflet

Alprazolam Grindeks 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets

alprazolam
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. 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 pass it on to others, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What you need to know 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

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

Alprazolam Grindeks is a sedative and belongs to a group of medicines called benzodiazepines.
Alprazolam Grindeks is used in adults for the treatment of anxiety symptoms when they are severe, disabling, or causing significant distress to the patient.
This medicine is indicated only for short-term use.

2. What you need to know before taking Alprazolam Grindeks

Do not take Alprazolam Grindeks:

• if you are allergic to alprazolam, to other benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a condition known as myasthenia gravis, which causes muscle weakness;
• if you suffer from severe respiratory insufficiency or serious breathing problems (e.g. chronic bronchitis or emphysema);
• if you suffer from sleep apnoea syndrome – a condition in which breathing during sleep becomes irregular, even for short periods;
• if you suffer from severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alprazolam Grindeks:

• if you abuse alcohol, drugs, or medicines;
• if you have been taking alprazolam for a long time, as its effect may decrease;
• if your general condition is poor;
• if you have lung, kidney, or liver problems;
• if you are taking other medicines for mental illnesses.

Dependence
The use of Alprazolam Grindeks may lead to physical and psychological dependence.
The risk of dependence increases with dose and duration of treatment. Therefore, the duration of treatment should be as short as possible. Follow your doctor's recommendations regarding dosage (see section 3).
Psychological dependence is characterized by an inability or unwillingness to stop taking the medicine. Physical dependence results in withdrawal symptoms when treatment with this medicine is stopped abruptly. The risk is even higher in patients who abuse alcohol or medicines (see also section 3. "If you stop taking Alprazolam Grindeks"). Medication abuse is a known risk with Alprazolam Grindeks. Abuse of this medicine may lead to overdose and death. Always follow your doctor's dosage recommendations. This medicine may be sought after by individuals who abuse prescription medicines and must be stored out of reach of others.

Memory disturbances
During treatment with alprazolam, memory may be impaired. This usually occurs several hours after taking the medicine. Consult your doctor if you notice such a symptom.
To reduce this risk, uninterrupted sleep of sufficient duration (7–8 hours) is necessary while taking this medicine.

Mental illness (psychosis)
If you suffer from psychosis, a serious mental illness that alters your behaviour, actions, and self-control, Alprazolam Grindeks is not appropriate.

Impact on mood
The use of alprazolam may increase the risk of hypomanic (a milder form of mania) or manic episodes (a state of hyperactivity, excessive euphoria, and energy) in patients with depression. Contact your doctor immediately if signs of hypomania or mania appear.

Depression, thoughts of self-harm or suicide
Treatment with alprazolam may increase the risk of developing thoughts of self-harm or suicide if you suffer from depression. Talk to your doctor before starting treatment with alprazolam.
If treatment with alprazolam is necessary and you are depressed or have previously had thoughts of self-harm or suicide, your doctor will closely monitor you. If at any time you experience thoughts of self-harm or suicide, contact your doctor or go to hospital immediately.

Elderly
Exercise particular caution when using alprazolam if you are elderly, as it may cause increased tiredness and/or muscle weakness, which could increase the risk of falls.

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as safety and efficacy have not been established.

Other medicines and Alprazolam Grindeks
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be compromised if Alprazolam Grindeks is used together with other medicines for the conditions listed below. Your doctor may need to adjust the dose.

• mental disorders (antipsychotics, including clozapine)
• sleep disorders (sleeping pills)
• allergies or hay fever (some antihistamines)
• if you are undergoing major surgery (anaesthetics)
• severe pain (narcotic analgesics, e.g. dextropropoxyphene)
• substance addiction therapy (substitution treatment)
• conditions such as anxiety or depression, including some 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 for the treatment of angina pectoris and hypertension, such as diltiazem
• HIV and AIDS (HIV-protease inhibitors such as ritonavir)
• heartburn and gastric ulcer, such as cimetidine or omeprazole
• asthma and bronchitis, such as theophylline
• epilepsy, such as carbamazepine
• medicines that relax muscles. When used concomitantly with alprazolam, an increased muscle-relaxing effect and risk of falls may occur.

The concomitant use of Alprazolam Grindeks and opioids (strong analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Because of this, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Alprazolam Grindeks together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or family members about the symptoms described above. Contact your doctor if these symptoms occur.

The therapeutic effect of alprazolam may also be affected by concomitant treatment with any of the following medicines: oral contraceptives, rifampicin (for infections), or St. John’s wort (phytotherapy).

Alprazolam Grindeks and alcohol
Do not drink alcohol during treatment with Alprazolam Grindeks, as alcohol can unpredictably alter and enhance the effects of this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor immediately if you are pregnant or planning a pregnancy.
Human observations have shown that alprazolam may harm the unborn child (increased risk of malformations (cleft palate)). During pregnancy, alprazolam should only be used if your doctor determines that the benefits of treatment outweigh the risks to the unborn child and that the medicine is indicated for you.
If you take Alprazolam Grindeks up to the time of delivery, inform your doctor, as the newborn may develop withdrawal symptoms after birth.

Breastfeeding
Alprazolam Grindeks must not be taken if you are breastfeeding. Alprazolam passes into breast milk. If your doctor decides to prescribe this medicine, you must stop breastfeeding.

Driving and using machines
Even when used as directed, Alprazolam Grindeks may impair your reaction abilities and thus affect your ability to drive or operate machinery. This risk is particularly high at the beginning of treatment, whenever the dose is increased, if you do not sleep enough, or if you additionally consume alcohol or take other substances acting on the central nervous system. Therefore, you must completely refrain from driving, operating machinery, or engaging in any other potentially dangerous activities, especially during the first few days of treatment. The decision in each individual case rests with your treating physician.

Alprazolam Grindeks contains lactose, sodium, and sodium benzoate (E211)
Lactose: If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Sodium: This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".
Sodium benzoate: This medicinal product contains 0.12 mg of sodium benzoate in each tablet.

3. How to take Alprazolam Grindeks

Always take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
If not otherwise prescribed by your doctor, the following dosage guidelines apply
Starting dose: generally, the recommended dose is between 0.25 mg and 0.5 mg three times daily.
Maintenance dose: if clinically necessary, your doctor may gradually increase the dose up to 3–4 mg, divided into several individual doses.
Elderly or sensitive or debilitated patients
If you are an elderly, sensitive, or debilitated patient requiring a lower dose, treatment will usually start at 0.25 mg two to three times daily. This dose may be gradually increased if necessary and if no adverse effects occur.
Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will adjust the dose accordingly.
Use in children and adolescents
Children and adolescents under 18 years of age must not take Alprazolam Grindeks.
Method of administration
Alprazolam Grindeks is for oral use. Take the tablets with some 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 increases with higher doses and longer duration of treatment. Therefore, your doctor will prescribe the lowest effective dose for the shortest possible time, frequently reassessing the need for continued treatment.
The maximum duration of treatment should not exceed 2–4 weeks. Long-term treatment is not recommended. If the medicine is taken for more than a few weeks, its effect may decrease.
If you take more Alprazolam Grindeks than you should
If you have taken too much Alprazolam Grindeks, contact your doctor immediately or go to the nearest emergency room. Symptoms of mild overdose include drowsiness, dizziness, blurred vision, difficulty speaking, low blood pressure, unsteady gait/movement, and muscle weakness. In more severe cases, deep sleep and even unconsciousness, breathing difficulties, and circulatory collapse may occur. Monitoring in an intensive care unit is essential.
The degree of intoxication must be assessed by a doctor, who will decide on the necessary treatment measures.
If you forget to take Alprazolam Grindeks
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take the next tablet as prescribed by your doctor.
If you stop taking Alprazolam Grindeks
Always consult your doctor before stopping Alprazolam Grindeks, as the dose must be gradually reduced. If you stop taking the tablets or suddenly reduce the dose, "rebound" symptoms may occur, causing a temporary increase in anxiety or restlessness or difficulty sleeping. Some people may also experience withdrawal symptoms (see section 4. "Dependence and withdrawal symptoms"). These symptoms will gradually disappear as the body readjusts. If you are concerned, your doctor will provide further information. At the end of treatment, your doctor will gradually reduce the dose. Dose reduction is individualized, as gradual discontinuation depends on several factors (e.g., duration of treatment and daily dose). Ask your doctor how to taper the dose gradually.
If you have any questions about the use of this medicine, 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 contact a doctor immediately
If you experience any of the following symptoms, contact your doctor immediately, as treatment must be stopped. Your doctor will advise you on how to discontinue the treatment.

• Treatment with alprazolam may cause severe behavioural changes or psychiatric effects, such as agitation, restlessness, aggression, irritability, violent anger, delusions, nightmares and hallucinations, or other inappropriate behaviours.
• Sudden breathlessness, difficulty swallowing or breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if widespread throughout the body).

Reasons to contact a doctor as soon as possible
Inform your doctor as soon as possible if you experience any of the following symptoms, as your 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 such as alprazolam during treatment, increasing the likelihood of experiencing withdrawal symptoms when treatment is stopped. Withdrawal symptoms are more common:

• if treatment is stopped suddenly
• if high doses are taken
• if the medicine has been taken for a long time
• if you have a history of alcohol or drug abuse.

This may cause effects such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, mood changes, difficulty sleeping and irritability.
In more severe cases of withdrawal, the following symptoms may also occur: nausea (feeling unwell), vomiting, sweating, stomach cramps, muscle cramps, feelings of unreality or detachment, unusual sensitivity to sound, light or physical touch, numbness and tingling in the feet and hands, hallucinations (seeing or hearing things that are not there when awake), tremors or seizures.
Inform your doctor if withdrawal symptoms worsen or do not go away.

Other possible side effects include:
Very common: may affect more than 1 in 10 people

• Depression
• Drowsiness and fatigue
• Jerky and uncoordinated movements
• Inability to remember certain information
• Difficulty speaking
• Dizziness, lightheadedness
• Headache
• Constipation
• Dry mouth
• Tiredness
• Irritability

Common: may affect up to 1 in 10 people

• Decreased appetite
• Confusion and disorientation
• Changes in sexual desire (in men and women)
• Nervousness or feelings of anxiety or agitation
• Insomnia (inability to sleep or disturbed sleep)
• Balance problems and instability (similar to feeling drunk), especially during the day
• Loss of alertness or concentration
• Inability to stay awake, feeling weak or lethargic
• Tremors or shaking
• Blurred or double vision
• Feeling unwell
• Skin reactions
• Weight changes

Uncommon: may affect up to 1 in 100 people

• Feelings of euphoria or overexcitement leading to unusual behaviour

• Hallucinations (seeing or hearing things that do not exist)

• Feelings of agitation or anger

• Vomiting

• Muscle spasms or weakness

• Incontinence

• Cramp-like pains in the lower back and thighs, which may indicate a menstrual disorder.

• Drug dependence

• Drug withdrawal symptoms

Not known (frequency cannot be determined from available data)

• In women, irregular menstruation or excessive production of prolactin (the hormone that stimulates milk production)
• Feelings of hostility or aggression
• Abnormal thoughts
• Rotatory or jerky movements
• Hyperactivity
• Stomach disturbances
• Liver function problems (detected in blood tests), liver inflammation (hepatitis)
• Imbalance of the nervous system. Symptoms may include: rapid heartbeat and unstable blood pressure (dizziness, lightheadedness or fainting).
• Severe allergic reaction causing swelling of the face or throat
• Swelling of the ankles, feet or fingers
• Skin reaction caused by sensitivity to sunlight
• Difficulty urinating or bladder control problems
• Increased pressure in the eyes, which may also affect vision
• Drug abuse

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alprazolam Grindeks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or on the bottle after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 components are: lactose monohydrate; microcrystalline cellulose (E460); maize starch,
pregelatinized; docusate sodium; sodium benzoate (E211); magnesium stearate (E572); anhydrous colloidal silica
(E551); iron oxide red (E172) ( only 0.5 mg tablets ); indigo carmine lake (E132) ( only 1 mg tablets ) (

Description of the appearance of Alprazolam Grindeks and contents of the pack
Alprazolam Grindeks 0.25 mg tablets are white or almost white, oval-shaped tablets (10 mm x 5 mm), with a break line on one side and the imprint "0.25" on the other side.
Alprazolam Grindeks 0.5 mg tablets are light pink to pink, oval-shaped tablets (10 mm x 5 mm), with a break line on one side and the imprint "0.5" on the other side.
Alprazolam Grindeks 1 mg tablets are light blue to blue, oval-shaped tablets (10 mm x 5 mm), with a break line on one side and the imprint "1" on the other side.
Alprazolam Grindeks is available in blisters made of OPA/Alu/PVC/Alu containing 10, 20, 30, 50, 60, or 100 tablets.
Not all pack sizes may be marketed.

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

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