ALPRAZOLAM GRINDEKS 1 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 the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are 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 taking Alprazolam Grindeks
3. How to take Alprazolam Grindeks
4. Possible side effects
5. Storage of Alprazolam Grindeks
6. Package contents and additional information

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

Alprazolam Grindeks is an anxiolytic medication belonging to the benzodiazepine group.

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

2. What you need to know before taking Alprazolam Grindeks

Do not take Alprazolam Grindeks

• if you are allergic to alprazolam, other benzodiazepines, or any of the other components of this medication (listed in section 6).
• if you have a disease called "myasthenia gravis" that causes muscle weakness and fatigue.
• if you have severe chest problems or breathing difficulties (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.
• if you have severe liver disease.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take alprazolam:

• If you are addicted or have been addicted to alcohol, drugs, or medications.
• If you have been taking alprazolam for a long period, 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 medications for mental disorders.

Dependence

The use of alprazolam may cause physical and mental dependence on the medication.

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

Memory Impairment

During treatment with alprazolam, you may experience memory impairment. This usually occurs several hours after taking the medication. If you notice this symptom, consult your doctor. To reduce the risk, you should ensure you get the necessary hours of sleep at night (7-8 hours) while taking this medication.

Mental Disorders (Psychosis)

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

Mood Changes

The use of alprazolam may 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, consult 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, as this medication may increase fatigue or muscle weakness, which increases the risk of falls.

Children and Adolescents

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

Other Medications and Alprazolam Grindeks

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

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

• mental disorders (antipsychotic medications, including clozapine)
• sleep disorders (hypnotic medications)
• 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)
• medications for angina pectoris and hypertension, such as diltiazem
• HIV and AIDS infections (medications 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 medications with alprazolam, there may be an increased muscle relaxant effect, and therefore, an increased risk of falls.

The simultaneous use of alprazolam and opioids (potent analgesics, substitution treatments, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma, and can be fatal. As a consequence, simultaneous use should only be considered when no other therapeutic options are possible.

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

Tell your doctor about all opioid medications you are taking and strictly follow the dosage recommendation indicated by your doctor. It may be helpful to inform your friends or family members to be alert to 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 simultaneous treatment with any of the following medications: oral contraceptives, rifampicin (for treating infections), or St. John's Wort (a plant called hypericum).

Use of Alprazolam Grindeks and Alcohol

You should avoid consuming 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor immediately if you are pregnant or plan to become pregnant. In humans, it has been observed that alprazolam may be harmful to the fetus (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 fetus and that the medication is suitable for you.

If you use alprazolam until the end of pregnancy, inform your doctor, as 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 medication, you will need to stop breastfeeding.

Driving and Using Machines

Alprazolam may alter 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 certain sugars, consult with them before taking this medication.

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

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

3. How to Take Alprazolam Grindeks

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

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

Initial dose: The initial dose is usually 0.25-0.5 mg of alprazolam three times a day.

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

Elderly patients and sensitive or debilitated 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.

Patients 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., with 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 may increase with the dose and duration of treatment. Therefore, your doctor will prescribe the effective dose and the shortest duration of treatment and will frequently 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 medication 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 medication and the amount ingested.

The signs of a mild overdose may be drowsiness, dizziness, vision changes, slurred speech, decreased blood pressure, unsteady gait/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 treatment with Alprazolam Grindeks

Before stopping alprazolam, consult your doctor, as the dose needs to be gradually reduced. 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 carried out according to individual needs, as the gradual suspension depends on several factors (e.g., duration of treatment and daily dose). Consult your doctor about the gradual reduction of the dose.

If you have any other questions about the use of this medication, 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 dissociation, 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 seizures. 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

• Lack 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
• Lack 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, which causes 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: frequency cannot be estimated from 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)
• Nervous system imbalance. Symptoms may include: rapid heartbeat and unstable blood pressure (dizziness, drowsiness, or fainting)
• Severe allergic reaction that causes 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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 away through wastewater or household waste. 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 way, you 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 components are lactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, sodium docusate, sodium benzoate (E211), magnesium stearate (E572), anhydrous colloidal silica (E551), red iron oxide (E172) (only in 0.5 mg tablets), aluminum lake carmine indigo (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 package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS.

Krustpils iela 53, Riga, LV-1057, Latvia

phone: (+371) 67083205

e-mail: [email protected]

You can request more information about this medicine by contacting 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 Last Revision of this Prospectus: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)