ALPRAZOLAM GRINDEKS 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Alprazolam Grindeks 0.25mg tablets EFG

Alprazolam Grindeks 0.5mg tablets EFG

Alprazolam Grindeks 1mg tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Alprazolam Grindeks and what is it used for
2. What you need to know before you take Alprazolam Grindeks
3. How to take Alprazolam Grindeks
4. Possible side effects
5. Storage of Alprazolam Grindeks
6. Contents of the pack and further information

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

Alprazolam Grindeks is an anxiolytic medicine that belongs to the group of benzodiazepines.

Alprazolam Grindeks is used in adults for the treatment of symptoms of anxiety that are severe, disabling, or cause significant distress to the patient. This medicine is for short-term use only.

2. What you need to know before you take Alprazolam Grindeks

Do not take Alprazolam Grindeks

• if you are allergic to alprazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• if you have a disease called "myasthenia gravis" that causes muscle weakness and fatigue.
• if you have severe chest or breathing problems (e.g., chronic bronchitis or emphysema).
• if you have "sleep apnea", a disorder in which breathing becomes irregular during sleep and even stops for short periods of time.
• if you have severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take alprazolam:

• If you are addicted or have been addicted to alcohol, drugs, or medicines.
• If you have been taking alprazolam for a long time, as the effect may decrease.
• If you have a general health disorder.
• If you have any lung, kidney, or liver problems.
• If you are taking other medicines for mental disorders.

Dependence

Taking alprazolam can lead to physical and mental dependence on the medicine.

The risk of dependence increases with the dose and duration of treatment. Therefore, the duration of treatment should be as short as possible. Follow your doctor's recommendations regarding the dose (see section 3). Psychological dependence is noticed when you do not want to stop taking the medicine. Physical dependence means that withdrawal symptoms occur when treatment with this medicine is stopped abruptly. The risk is also higher in patients who suffer or have suffered from alcoholism or drug addiction (see also section 3, If you stop taking Alprazolam Grindeks). It is also known that alprazolam can cause drug dependence. If this medicine is abused, it can lead to overdose or death. Always follow your doctor's dosage recommendations. Patients who abuse prescription medicines may seek them, so you should keep them out of reach of others.

Memory disorders

During treatment with alprazolam, you may experience memory disorders. This usually occurs several hours after taking the medicine. If you notice this symptom, talk to your doctor. To reduce the risk, you should ensure you get enough sleep at night (7-8 hours) while taking this medicine.

Mental disorders (psychosis)

If you have psychosis, a severe mental disorder that affects behavior, actions, and self-control, alprazolam is not suitable for you.

Mood changes

Taking alprazolam can increase the risk of experiencing episodes of hypomania (a mild form of mania) and mania (a hyperactive mental state, euphoria, and excessive energy) in patients with depression. Contact your doctor immediately if you experience signs of hypomania or mania.

Depression, self-harming thoughts, or suicidal ideation

Treatment with alprazolam may increase the risk of developing self-harming thoughts or suicidal ideation if you have depression. Before starting treatment with alprazolam, talk to your doctor.

If treatment with alprazolam is necessary and you have depression or have had self-harming thoughts or suicidal ideation in the past, your doctor will closely monitor you. If at any time you think about harming yourself or taking your own life, contact your doctor or go to the hospital immediately.

Elderly patients

Alprazolam should be used with special caution in elderly patients because this medicine can increase fatigue or muscle weakness, which increases the risk of falls.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age because safety and efficacy have not been established in this age group.

Other medicines and Alprazolam Grindeks

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of treatment may be altered if alprazolam is used with other medicines for treating the following diseases. Your doctor may need to adjust the dose.

• mental disorders (antipsychotic medicines, including clozapine)
• sleep disorders (hypnotic medicines)
• allergies or hay fever (some antihistamines)
• if you are undergoing major surgery (anesthetics)
• severe pain (narcotic analgesics, e.g., dextropropoxyphene)
• treatment for addiction (substitution therapy)
• problems 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 for treating angina pectoris and hypertension, such as diltiazem
• HIV and AIDS infections (medicines called HIV protease inhibitors, such as ritonavir)
• heartburn and stomach ulcers, such as cimetidine or omeprazole
• asthma and bronchitis, such as theophylline
• epilepsy, such as carbamazepine
• muscle relaxants. When using these medicines with alprazolam, there may be an increased muscle relaxant effect, and therefore an increased risk of falls.

Taking alprazolam and opioids (strong painkillers, substitution treatment medicines, and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and can be fatal. As a result, taking them at the same time should only be considered when no other treatment options are possible.

However, if your doctor prescribes alprazolam with opioids, they will limit the dose and duration of concurrent treatment.

Tell your doctor about all opioid medicines you are taking and strictly follow the dosage recommendation given by your doctor. It may be helpful to inform your friends or family that they should be aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.

It is also possible that the effect of alprazolam treatment may be affected by concurrent treatment with any of the following medicines: oral contraceptives, rifampicin (for treating infections), or St. John's Wort (a plant called hypericum).

Using Alprazolam Grindeks and alcohol

You should avoid drinking alcohol during treatment with alprazolam, as alcohol can unpredictably alter and enhance the effect of alprazolam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor immediately if you are pregnant or plan to become pregnant. In humans, it has been observed that alprazolam can be harmful to the fetus (increased risk of malformations [cleft palate]). During pregnancy, alprazolam should only be used if your doctor decides that the benefits of treatment outweigh the risks to the fetus and that the medicine is suitable for you.

If you use alprazolam until the end of pregnancy, inform your doctor because your child may experience withdrawal symptoms after birth.

Breastfeeding

You should not take alprazolam during breastfeeding. Alprazolam is excreted in breast milk. If your doctor decides that you should receive this medicine, you will need to stop breastfeeding.

Driving and using machines

Alprazolam can affect your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce your reaction time. The occurrence of these effects is more likely at the start of treatment or when the dose is increased, when you do not sleep enough, or if you also consume alcohol or take other substances that act on the central nervous system. Do not drive or use machines if you experience any of these effects, as well as not engaging in any hazardous activities or at least during the first few days of treatment. The decision in each case will be made by the treating doctor.

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

Lactose: If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Sodium: This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Sodium benzoate: This medicine contains 0.12 mg of sodium benzoate in each tablet.

3. How to take Alprazolam Grindeks

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Unless your doctor tells you otherwise, the following dosage recommendation applies:

Initial dose: The dose at the start of treatment is usually 0.25-0.5 mg of alprazolam three times a day.

Maintenance dose: If necessary from a clinical point of view, your doctor may increase the dose up to 3-4 mg in small increments, divided into several individual doses.

Elderly patients and sensitive or weakened patients

If you are an elderly patient or a sensitive patient who needs a lower dose, you will usually start with a dose of 0.25 mg two to three times a day. This dose can be gradually increased if necessary and if you do not experience side effects.

Patient with kidney or liver problems

Your doctor will adjust the dose if you have kidney or liver problems.

Use in children and adolescents

Children and adolescents under 18 years of age should not take alprazolam.

Method of administration

Alprazolam is for oral use. Take the tablets with a little liquid (e.g., 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 addiction can increase with the dose and duration of treatment. Therefore, your doctor will prescribe the lowest effective dose and shortest duration of treatment and will regularly reassess the need for continued treatment.

The maximum duration of treatment should not exceed 2-4 weeks. Long-term treatment is not recommended. If you use the treatment for more than a few weeks, the effect of the medicine may decrease.

If you take more Alprazolam Grindeks than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

The signs of a mild overdose may be drowsiness, dizziness, vision changes, slurred speech, decreased blood pressure, unsteady walk/movements, and muscle weakness. In severe cases of poisoning, deep sleep and even unconsciousness, respiratory failure, and circulatory collapse may occur. In these cases, intensive care is essential.

Your doctor will assess the degree of poisoning and decide on the measures to treat it.

If you forget to take Alprazolam Grindeks

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, skip the missed dose and continue taking alprazolam as your doctor has prescribed.

If you stop taking Alprazolam Grindeks

Before stopping alprazolam, consult your doctor, as the dose needs to be reduced gradually. If you stop taking the tablets or reduce the dose abruptly, you may experience a "rebound" effect, which can make you feel more anxious or restless or have difficulty sleeping temporarily. Some people may also experience "withdrawal" effects (see section 4, Dependence and withdrawal symptoms). These symptoms will disappear as your body gets used to it. If you have any concerns, your doctor will provide more information about this. Therefore, your doctor will gradually reduce the dose when treatment is finished. The reduction of the dose is done according to individual needs, as gradual discontinuation depends on several factors (e.g., duration of treatment and daily dose). Consult your doctor about gradual dose reduction.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Reasons to see a doctor immediately

If you experience any of these symptoms, see your doctor immediately, as you may need to interrupt treatment. Your doctor will tell you how to interrupt treatment.

• Treatment with alprazolam may cause serious psychiatric behaviors or effects, such as agitation, restlessness, aggression, irritability, hostility, false beliefs, nightmares, and hallucinations or other inappropriate behaviors.
• Wheezing, difficulty swallowing or breathing, swelling of the eyelids, face, or lips, rash or itching (especially if it affects the whole body) sudden.

Reasons to see a doctor as soon as possible

Tell your doctor as soon as possible if you experience 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 develop dependence on medicines like alprazolam while taking them, which increases the likelihood of experiencing withdrawal symptoms when treatment is interrupted. Withdrawal symptoms are more frequent if:

• you stop treatment abruptly
• you have been taking high doses
• you have been taking this medicine for a prolonged period
• you have a history of alcoholism or drug addiction

This can cause effects such as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, mood changes, difficulty sleeping, and irritability.

In severe cases of withdrawal, you may also experience the following symptoms: nausea (vomiting), vomiting, sweating, stomach cramps, a feeling of unreality or disconnection, being exceptionally sensitive to sounds, light, or physical contact, numbness and tingling in the feet and hands, hallucinations (seeing or hearing things that do not exist while awake), tremors, or epileptic convulsions. If any of the withdrawal symptoms worsen or do not subside, inform your doctor.

Other Adverse Effects that May Occur:

Very Common:may affect more than 1 in 10people

• Depression
• Sleepiness and drowsiness
• Spasmodic and uncoordinated movements
• Inability to remember certain things
• Slurred speech
• Dizziness, feeling of dizziness
• Headache
• Constipation
• Dry mouth
• Fatigue
• Irritability

Common:may affect up to 1 in 10people

• Loss of appetite
• Confusion and disorientation
• Changes in sexual appetite (men and women)
• Nervousness, anxiety, or agitation
• Insomnia (inability to sleep or altered sleep)
• Balance and instability problems (such as feeling drunk) especially during the day
• Loss of alertness or concentration
• Inability to stay awake, feeling of slowness
• Agitation or tremors
• Double or blurred vision
• Feeling of dizziness
• Skin reactions
• Weight changes

Uncommon:may affect up to 1 in 100people

• Feeling of euphoria or overexcitement, causing unusual behavior
• Hallucinations (seeing or hearing things that do not exist)
• Feeling of agitation or anger
• Vomiting
• Muscle spasms or weakness
• Incontinence
• Pain of a colic type in the lumbar or thigh area, which may indicate menstrual disorders
• Drug addiction
• Drug withdrawal symptoms

Frequency Not Known: the frequency cannot be estimated from the available data

• In women, irregular periods or excessive prolactin production (the hormone that stimulates milk secretion)
• Feeling of hostility or aggression
• Anomalous thoughts
• Jerks or spasmodic movements
• Hyperactivity
• Stomach discomfort
• Liver function problems (detected by blood tests), liver inflammation (hepatitis)
• Imbalance of the nervous system. Symptoms may include: rapid heartbeat and unstable blood pressure (dizziness, drowsiness, 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 problems controlling the bladder
• Increased eye pressure, which can also affect vision
• Drug abuse

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Alprazolam Grindeks

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Alprazolam Grindeks

• The active ingredient is alprazolam.
• Alprazolam Grindeks 0.25 mg EFG tablets:

Each tablet contains 0.25 mg of alprazolam.

• Alprazolam Grindeks 0.5 mg EFG tablets:

Each tablet contains 0.5 mg of alprazolam.

• Alprazolam Grindeks 1 mg EFG tablets:

Each tablet contains 1 mg of alprazolam.

• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, sodium docusate, sodium benzoate (E211), magnesium stearate (E572), anhydrous colloidal silica (E551), red iron oxide (E172) (only in 0.5 mg tablets), aluminum carmine lacquer (E132) (only in 1 mg tablets).

Appearance of the Product and Package Contents

Alprazolam Grindeks 0.25 mg EFG is a white or off-white, oval-shaped tablet (10 mm x 5 mm), with a score line on one side and the mark "0.25" engraved on the other.

Alprazolam Grindeks 0.5 mg EFG is a pink to light pink, oval-shaped tablet (10 mm x 5 mm), with a score line on one side and the mark "0.5" engraved on the other.

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

Alprazolam Grindeks is available in OPA/Alu/PVC//Alu blisters of 10, 20, 30, 50, 60, or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS.

Krustpils iela 53, Riga, LV-1057, Latvia

phone: (+371) 67083205

e-mail: grindeks@grindeks.com

You can request more information about this medicine from the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 - 2º Dcha.

28003, Madrid, Spain

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

Date of the Last Revision of this Leaflet:May 2024.

Other Sources of Information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)