ALPRAZOLAM 0.25 MG Coated tablet

Зміст інструкції

1. Alprazolam Grindeks 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets
   1. What you need to know before taking Alprazolam Grindeks
   2. How to take Alprazolam Grindeks
   3. Possible side effects
   4. How to store Alprazolam Grindeks
   5. Contents of the pack and other information

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

alprazolam

Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any 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 you, as it could be harmful.
• If you get any side effects, even 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 you take 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 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 cause significant distress to the patient.
This medicine is indicated 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, 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 graviswhich 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 apnea syndrome - a condition in which breathing during sleep becomes irregular, even for short periods;
• if you suffer from severe liver problems.

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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 the effect may diminish
• if your general health condition is impaired
• if you have problems with your lungs, kidneys or liver
• if you are taking other medicines for mental illnesses.

Dependence
The use of Alprazolam Grindeks can lead to physical and psychological dependence.
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 on dosage (see section 3).
Psychological dependence manifests as an unwillingness to stop taking the medicine. Physical dependence involves the appearance of withdrawal symptoms when treatment with this medicine is stopped
suddenly. The risk is also higher in patients who abuse alcohol or medicines (see also
section 3. "If you stop taking Alprazolam Grindeks"). Drug abuse is a known risk
with Alprazolam Grindeks. Abuse of this medicine can lead to overdose and death. Always follow your
doctor's recommendations on dosage. This medicine may be sought after by people who abuse
prescription medicines and must be kept out of the reach of others.

Memory disorders
During treatment with alprazolam, memory may be impaired. This usually occurs a few
hours after taking the medicine. See your doctor if you notice such a symptom.
To reduce this risk, uninterrupted sleep of sufficient duration (7-8 hours) is necessary during the intake
of this medicine.

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

Impact on mood
The use of alprazolam may increase the risk of episodes of hypomania (a milder form of mania) and
mania (hyperactive mental state, excessive euphoria and energy) in patients suffering from depression. Contact
your doctor immediately if you experience signs of hypomania or mania.

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 if you are depressed or have previously had thoughts of self-harm or
suicide, your doctor will closely monitor the patient. If at any time you experience thoughts
of self-harm or suicide, contact your doctor or go to the hospital immediately.

Elderly
Take particular care when using alprazolam if you are elderly, as it may cause increased
fatigue and/or muscle weakness which may increase the risk of falls.
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Children and adolescents
Do not give the medicine to children and adolescents under the age of 18 because safety and
efficacy have not been established.

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 the treatment may be compromised if Alprazolam Grindeks is used together with other
drugs for the treatment of the conditions listed. Your doctor may need to adjust the dose.

• mental problems (antipsychotics, including clozapine)
• sleep disorders (sleeping pills)
• allergies or hay fever (some antihistamines)
• if you are to undergo major surgery (anaesthetics)
• severe pain (narcotic analgesics, e.g. dextropropoxyphene)
• therapy for drug addiction (substitution treatment)
• problems 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 (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
• medicines that relax the muscles. In case of concomitant use with alprazolam, an increase in the relaxing effect on the muscles and a risk of falls may occur.

The concomitant use of Alprazolam Grindeks and opioids (strong painkillers, medicines for substitution therapy and
some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression),
coma and can be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Alprazolam Grindeks together with opioids, the dose and duration of concomitant treatment
must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or family members to make them aware of the symptoms
described above. Contact your doctor if these symptoms occur.
It is also possible that the therapeutic effect of alprazolam is affected by concomitant treatment with
one of the following medicines: birth control pill, rifampicin (for infections) or St. John's wort
(herbal medicine).

Alprazolam Grindeks with alcohol
Do not drink alcohol during treatment with Alprazolam Grindeks as alcohol can alter and increase
Pag. 3
the effects of this medicine in an unpredictable way.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must immediately inform your doctor if you are pregnant or planning a pregnancy.
Observations in humans have shown that alprazolam can be harmful to the fetus (increased risk
of malformations (cleft palate)). During pregnancy, alprazolam may only be used if the doctor has
determined that the benefits of treatment outweigh the risks to the unborn child and that the medicine is indicated for you.
If you use Alprazolam Grindeks until the time of delivery, inform your doctor as the newborn may
develop withdrawal symptoms after birth.
Breastfeeding
Alprazolam Grindeks should not be taken if you are breastfeeding. Alprazolam passes into breast milk. If
your doctor has decided to administer this medicine to you, you will need to stop breastfeeding.

Driving and using machines
Even when used as directed, Alprazolam Grindeks can alter your reaction abilities to such an extent
as to impair 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 get enough sleep or if, in addition, you consume
alcohol or take other substances that affect the central nervous system. Therefore, you should completely refrain
from driving, operating machinery or any other dangerous activity at least during the first
few days of treatment. The decision in each individual case is up to the treating doctor.

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 your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Unless otherwise prescribed by your doctor, the following guidelines apply to dosage
Initial dose: in general, the recommended dose is between 0.25 mg and 0.5 mg three times a day.
Maintenance dose: if clinically necessary, your doctor may increase the dose up to 3-4 mg in small
increments, divided into several single doses.
Elderly and sensitive or debilitated patients
If you are an elderly and sensitive patient and need a lower dose, you will normally start with a dose of
0.25 mg two to three times a day. This dose may be gradually increased if necessary and if no
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undesirable effects occur.
Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will adjust the dose.

Use in children and adolescents
Children and adolescents under the age of 18 should 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 fracture line and can be divided into equal doses.

Duration of treatment
The risk of dependence and abuse increases with increasing dose and duration of treatment. Therefore, your
doctor will prescribe the lowest possible effective dose for the shortest possible period, frequently reassessing
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 taken for more than a few weeks, the effect of the medicine 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, visual disturbances, difficulty in
speaking, low blood pressure, unsteady gait/movements and muscle weakness. In more severe cases,
deep sleep and even unconsciousness, breathing problems and circulatory collapse may occur. The
monitoring in intensive care is essential.
The assessment of the degree of intoxication must be carried out by the doctor, who will decide the measures to be taken
for treatment.

If you forget to take Alprazolam Grindeks
Do not take a double dose to make up for a missed 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 taking Alprazolam Grindeks, as the dose must
be gradually reduced. If you stop taking the tablets or suddenly reduce the dose, you
may experience "rebound" symptoms that can cause a temporary increase in anxiety or
restlessness or difficulty sleeping. Some people may also experience "withdrawal" symptoms
(see paragraph 4. "Dependence and withdrawal symptoms"). These symptoms will disappear as the
body readjusts. If you are concerned, your doctor will give you more information about this. At the end of
treatment, your doctor will gradually reduce the dose. The dose reduction is carried out according to
individual needs, as gradual discontinuation depends on several factors (e.g., the duration of
treatment and the daily dose). Ask your doctor how to gradually reduce the dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
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Reasons to see a doctor immediately
If you experience any of these symptoms, see your doctor immediately, as treatment needs to be stopped. The doctor will advise you on how to stop the treatment.

• Treatment with alprazolam can cause serious changes in behaviour or psychiatric effects, such as agitation, restlessness, aggression, irritability, violent anger, false beliefs, nightmares and hallucinations, or other inappropriate behaviours.
• Sudden shortness of breath, difficulty swallowing or breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if it affects the whole body).

Reasons to see a doctor as soon as possible
Inform your doctor as soon as possible if you experience the following symptoms, as it may be necessary to
change the dose or treatment:

• 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 experiencing withdrawal symptoms when treatment is stopped. Withdrawal symptoms
are more common if:

• you stop treatment suddenly
• you are taking high doses
• you have been taking the medicine for a long time
• you have a history of alcohol or drug abuse.

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

Other side effects that may occur are:
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
• fatigue
• Irritability.

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Common:may affect up to 1 in 10 people

• decreased appetite
• Confusion and disorientation
• Changes in sexual desire (men and women)
• Nervousness or feeling anxious or agitated
• Insomnia (inability to sleep or disturbed sleep)
• Problems with balance and instability (similar to feeling drunk) especially during the day
• Loss of alertness or concentration
• Inability to stay awake, feeling weak
• Tremors or shaking
• Blurred or double vision
• Feeling unwell
• Skin reactions
• Weight changes.

Uncommon(may affect up to 1 in 100 people)

• Feeling of euphoria or overexcitement, causing unusual behaviour
• Hallucination (seeing or hearing things that don't exist)
• Feeling agitated or angry
• Vomiting
• Muscle spasms or weakness
• Incontinence
• Cramping pains in the lower back and thighs, which may indicate a menstrual disorder.
• Drug dependence
• Drug withdrawal symptoms.

Not known (frequency cannot be estimated from available data)

• In women, irregular periods or excessive production of prolactin (the hormone that stimulates milk production)
• Feeling hostile or aggressive
• Abnormal thoughts
• Rotatory or jerky movements
• Hyperactivity
• Stomach disorders
• Problems with liver function (which show up in blood tests), liver inflammation (hepatitis)
• Imbalance of the nervous system. Symptoms may include: rapid heartbeat and unstable blood pressure (feeling dizzy, lightheaded 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 pressure in the eyes, which can also affect vision.
• Drug abuse.

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Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 the bottle after “Exp”. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Alprazolam Grindeks contains
The active ingredient 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 (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); indigo carmine lacquer (E132) ( only in the

1 mg tablets) (

Description of Alprazolam Grindeks and contents of the pack
Alprazolam Grindeks 0.25 mg tablets are white or off-white, oval-shaped tablets (10 mm x
5 mm) with a fracture line on one side and the inscription "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 fracture line on one side and the inscription "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 fracture line on one side and the inscription "1" on the other side.
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Alprazolam Grindeks is available in OPA/Alu/PVC/Alu blisters 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 Member States of the European Economic Area with the following names:

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