ALPRAZOLAM 0.25 MG Tabletki

Treść ulotki

1. Alprazolam Aurobindo Italia 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets
   1. What is Alprazolam Aurobindo Italia and what is it used for
   2. What you need to know before you use Alprazolam Aurobindo Italia
   3. How to use Alprazolam Aurobindo Italia
   4. Possible side effects
   5. How to store Alprazolam Aurobindo Italia
   6. Package Contents and Other Information

Alprazolam Aurobindo Italia 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets

alprazolam

Generic medicine
Read this leaflet carefully before taking this medicine because 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 because it may 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 Aurobindo Italia is and what it is used for
• 2. What you need to know before you use Alprazolam Aurobindo Italia
• 3. How to use Alprazolam Aurobindo Italia
• 4. Possible side effects
• 5. How to store Alprazolam Aurobindo Italia
• 6. Contents of the pack and other information

1. What is Alprazolam Aurobindo Italia and what is it used for

Its tablets contain alprazolam, which belongs to a group of medicines called
benzodiazepines.
It is believed that alprazolam increases the action of a substance naturally present in the brain, called
GABA.
Alprazolam is used for the short-term treatment of severe anxiety disorders. Alprazolam should be
used only for a short time, as it can cause dependence.

2. What you need to know before you use Alprazolam Aurobindo Italia

Do not take AlprazolamAurobindo Italia:

• if you are allergic to alprazolam, to 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 failure or lung problems;
• if you suffer from sleep apnea syndrome (irregular breathing during sleep);
• if you suffer from severe liver failure;
• if you suffer from alcoholism or drug abuse;
• if you are taking other medicines known to have effects on the central nervous system (e.g. benzodiazepines, neuroleptics);
• if you suffer from glaucoma.

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

• if you suffer from chronic lung problems, mild or moderate liver problems or kidney problems;
• if you suffer from depression, or anxiety associated with depression, as alprazolam may increase your suicidal thoughts;
• if you are taking other medicines for anxiety or insomnia;
• if you have abused drugs or alcohol in the past or find it difficult to stop taking medicines, drinking or taking medicines. Your doctor may want to give you special help to stop taking these tablets;
• if you suffer from personality disorders;
• if you are elderly, as alprazolam can cause drowsiness or muscle weakness that can lead to falls, often with serious consequences in this population.

A temporary loss of memory may occur during the use of this medicine. To reduce
this risk, make sure you are able to have a full night's sleep (7-8 hours) during
the use of this medicine.
Alprazolam has been associated with unusual reactions such as restlessness, agitation, irritability, aggression,
delirium, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (loss of
contact with reality) and eccentric behavior.
If you notice any of these changes in your behavior while taking this
medicine, tell your doctor, as you will need to stop taking your medicine.
Children and adolescents
Alprazolam is not recommended in children and adolescents under the age of 18 years.

Other medicines and Alprazolam Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription. It is important to tell your doctor
especially if you are using any of the following medicines:

• Antipsychotics (medicines used to treat mental problems) such as haloperidol and chlorpromazine, hypnotics (medicines used to induce sleep) such as phenobarbital and zolpidem, sedatives (medicines used to treat anxiety) such as diazepam and lorazepam, narcotic analgesics (a class of pain relievers) such as propoxyphene, antitussives (medicines used to treat cough) such as dextromethorphan and codeine, medicines such as methadone (which can be used as a pain reliever or to help those addicted to opioids, anesthetics (medicines used for anesthesia) such as halothane and bupivacaine or some antidepressants, as they can enhance the effects of alprazolam
• Clozapine (a medicine used to treat mental illnesses such as schizophrenia). This medicine can increase the amount of alprazolam in the blood.
• Medicines known as selective serotonin reuptake inhibitors (SSRIs) used to treat depression (e.g. fluoxetine and sertraline)
• Medicines used to treat epilepsy (e.g. phenytoin and carbamazepine)
• Medicines for allergies (antihistamines such as cetirizine, cyclizine)
• Medicines used for fungal infections (e.g. ketoconazole, itraconazole, posaconazole, voriconazole and other azole-derived medicines)
• Cimetidine (for the treatment of stomach ulcers), nefazodone (for the treatment of depression) or fluvoxamine (for the treatment of Obsessive Compulsive Disorder, OCD), as the dose of alprazolam may need to be adjusted
• Imipramine or desimipramine, medicines known as tricyclic antidepressants (TCAs), used to treat depression, as it may be necessary to adjust the dose of these medicines
• Oral contraceptives (the “pill”)
• Diltiazem (used for angina and high blood pressure)
• Some antibiotics (e.g. erythromycin, clarithromycin, telithromycin, troleandomycin and rifampicin)
• Medicines used to treat HIV known as protease inhibitors (e.g. ritonavir)
• Digoxin (a medicine used to treat heart disease). You may suffer from digoxin toxicity (symptoms include irregular heartbeat, confusion, delirium, visual disturbances, headache, abdominal pain, nausea and vomiting) when using digoxin with this medicine.

The concomitant use of this medicine with opioids (strong painkillers, medicines for substitution therapy and
some medicines to treat cough) increases the risk of sedation, difficulty breathing (respiratory
depression), coma and can be life-threatening. Deaths have been reported. Because of this,
concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Alprazolam tablets together with opioids, the dose and duration of
concomitant treatment must be limited by the doctor.
Please inform your doctor about all opioid medicines you are taking and carefully follow
your doctor's recommendations regarding the dose. It may be helpful to inform friends or
family so they are aware of the symptoms described above. Contact your doctor if these
symptoms occur.
If you are about to undergo surgery where you will be given a general anesthetic, tell
your doctor that you are taking alprazolam.

Alprazolam Aurobindo Italia with food and alcohol
Do not drink alcohol while taking alprazolam; alcohol increases the effects of this medicine and
therefore must be avoided. Do not drink excessive amounts of grapefruit juice while taking this
medicine as it can increase the amount of alprazolam in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine. If you are pregnant do nottake Alprazolam Aurobindo Italia unless you and your doctor have discussed the
risks and benefits involved.
If you have been taking alprazolam regularly during the last 3 months of pregnancy, your baby may
develop a dependence on alprazolam and be at risk of withdrawal symptoms after birth.
If your doctor has decided that you must take this medicine during the last period of pregnancy or
during labor, your baby may suffer from low body temperature, weakness, difficulty
breathing and feeding, tremors, increased excitability and agitation.
Do not take Alprazolam Aurobindo Italia if you are breastfeeding as the medicine can pass into
breast milk.

Driving and using machines
Do not drive or use machines after taking Alprazolam Aurobindo Italia, as it may impair your
concentration or muscle control, cause you to lose memory, make you feel
dizzy, sleepy or confused.

Alprazolam Aurobindo Italia contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact him/her before taking this
medicine.

Alprazolam Aurobindo Italia contains sodium
This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘’sodium-free’’.

Alprazolam Aurobindo Italia contains sodium benzoate
This medicinal product contains 0.1 mg of sodium benzoate in each tablet.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4
weeks of age).

3. How to use Alprazolam Aurobindo Italia

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Adults (over 18 years of age)
The recommended dose is between 0.25 mg and 0.50 mg three times a day.
The doctor may decide to increase your dose, if necessary, up to a maximum of 3 mg per day.
Ask your doctor or pharmacist if you are not sure. Dosage increases should be carried out with
caution and the evening dose should be increased before the daytime dose.
A lower dose may be required if you have never taken this type of medicine before, or if you have
a history of alcoholism.

Elderly patients
The recommended dose in elderly patients is 0.25 mg two or three times a day. If you are in good physical condition, the
doctor may decide to increase the dose by 0.5 mg every three days up to a maximum of 1.5 mg per day if
necessary. Frail elderly patients should not exceed 0.75 mg per day.
Alprazolam Aurobindo Italia must be taken orally. The score line is only to help you
break the tablets if you have difficulty swallowing them whole.

Patients with liver or kidney problems
If you have liver or kidney problems, your doctor may recommend that you take a lower dose than
recommended. The maximum recommended dose for patients with liver or kidney problems ranges from 0.75 mg to
1.5 mg per day.

Duration of treatment
Alprazolam Aurobindo Italia should not be taken for longer than your doctor has advised you and
generally should not exceed 8-12 weeks. This is because taking alprazolam for too
long and at too high a dose can lead to physical and mental dependence.

If you take more Alprazolam Aurobindo Italia than you should
Contact your doctor or the nearest Emergency Room immediately. Bring the medicine package
and any remaining tablets with you. Symptoms of overdose include drowsiness, confusion, lack of
coordination or unusual movements, respiratory distress, decreased blood pressure,
fatigue, loss of consciousness and very rarely death.

If you forget to take Alprazolam Aurobindo Italia
Do not take a double dose to make up for a missed dose, just take the next tablet
at the correct time.

If you stop taking Alprazolam Aurobindo Italia
Treatment with alprazolam should be gradually reduced before being stopped. Your doctor will tell you
how to do this. If you stop or discontinue treatment with alprazolam prematurely, you may suffer from
side effects such as anxiety or restlessness, seizures, headache, muscle pain, tension,
confusion, irritability, involuntary movements and may have trouble sleeping. In extreme cases, this may
also include symptoms such as lack of self-awareness, loss of contact with reality, increased
sensitivity to light, sounds and physical contact, a feeling of numbness or tingling in the extremities,
seeing or hearing things that are not real, seizures, stomach and muscle cramps, vomiting, sweating
and tremors.

Contact your doctor if you experience any of these symptoms and mood changes.
If you have any further questions on 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.
Dangerous or hostile behaviors have been observed in people with a history of violence, borderline personality disorders, a history of alcohol abuse, and in people taking medicines for the Central Nervous System (CNS). If you suffer from post-traumatic stress disorder, discontinue treatment with alprazolam, which may cause irritability, hostility, and unpleasant ideas and thoughts.
Some common side effects are observed at the beginning of therapy. These symptoms generally disappear with continued treatment.

Tell your doctor immediatelyif you experience any of the following side effects, which
may be serious:

Uncommon(may affect up to 1 in 100 people)

• Epileptic seizure or convulsions
• Seizures in the brain that can affect muscle activity, one of your senses, bodily functions, or can change the way you think, perceive, or understand things
• Memory loss (amnesia)
• An unusual reaction to this medicine that may consist of one or more of the following symptoms: restlessness, agitation, irritability, aggressiveness, having fixed and irrational ideas (delusions), anger, nightmares, seeing or hearing things that do not exist (hallucinations), loss of contact with reality (psychosis) or strange behavior, drug withdrawal symptoms Not known(frequency cannot be estimated based on available data)
• Increased number of infections, which can be observed with symptoms such as fever, severe chills, mouth ulcers, or sore throat. These may be signs of low levels of white blood cells in the blood
• Blockage of the airways, causing difficulty breathing
• Inflammation of the liver (hepatitis), which can cause nausea, vomiting, loss of appetite, general feeling of illness, fever, itching, yellowing of the skin or whites of the eyes, pale stools, dark urine
• Signs of a severe allergic reaction, which may include symptoms such as a itchy rash, swelling of eyelids, face, lips, mouth, tongue or throat, which can cause difficulty swallowing or breathing.
• Poor or no urine production, with possible pain.
• Drug abuse.

You must stop taking the medicine. Your doctor will tell you how to do so.

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

• Drowsiness or sedation
• Problems with sleep
• Dizziness, difficulty controlling movements (ataxia)
• Headache
• Difficulty speaking
• Severe constipation, dry mouth
• Fatigue
• Weight gain or loss
• Depression
• Memory problems

Common(may affect up to 1 in 10 people):

• Increased or decreased appetite
• Blurred vision
• Feeling detached from one's body (depersonalization)
• Seeing other people and the surrounding environment as in a dream or as unreal (derealization)
• Fear
• Nervousness or anxiety
• Confusion
• Disorientation
• Tingling
• Involuntary contractions, jerky or convulsive movements, abnormal coordination, tremors or shaking
• Problems with balance
• Difficulty concentrating
• Lack of energy
• Rapid heartbeat that feels like pounding in the chest (palpitations)
• Hot flashes
• Blocked nose, sore throat, or chest cough. These may be signs of an infection
• Rapid breathing
• Increased or decreased sexual desire
• Inability to sleep (insomnia)
• Excessive sleepiness
• Sexual dysfunction
• Increased salivation
• Feeling sick (vomiting)
• Stomach disorders, diarrhea
• Feeling unwell (nausea)
• Stomach pain
• Excessive sweating
• Skin rash
• Itchy skin
• Muscle contractions or spasms
• Back, muscle, or joint pain
• Chest pain
• Unusual weakness
• Swelling due to excessive fluid retention in the body (edema)
• Ringing in the ears.
• Risk of traffic accidents

Uncommon(may affect up to 1 in 100 people):

• Increased tendency to bruise
• Disturbing dreams
• Talkativeness
• Impulsivity
• Slowed thinking
• Muscle weakness
• Reduced movements
• Double vision or other vision problems
• Euphoria or feeling of overexcitement
• Inability to derive pleasure from normally pleasurable activities
• Persistent inability to reach orgasm
• Mood swings
• Panic attacks
• Fainting
• Clumsiness
• Problems with taste
• A state close to unconsciousness (stupor)
• Joint stiffness, pain in the extremities
• Involuntary urination (incontinence)
• Frequent or abnormal urination during the day
• Problems with ejaculation, inability to obtain or maintain an erection
• Irregular menstruation
• Abnormal sensations
• Change in the way of walking, feeling of drunkenness, nervousness or tension, feeling of relaxation, feeling of a hangover
• Flu-like symptoms
• Thirst
• Increased levels of bilirubin, which can be seen with a blood test
• Falls, injuries to the extremities
• Overdose
• Drug addiction

Not known(frequency cannot be estimated based on available data)

• Elevated levels of prolactin in the blood, observed with a blood test (hyperprolactinemia)
• Hostile behavior
• Inability to sit or stand, hyperactivity
• Abnormal thoughts
• Problems with learning and problem-solving
• Problems with blood vessels
• Swelling of the hands and legs (peripheral edema)
• Excessive alertness
• Increased sensitivity to light
• Rapid heartbeat (tachycardia)
• Low blood pressure
• Decreased saliva
• Abnormal liver function, which can be observed with a blood test
• Problems with muscle tone
• Feeling of warmth
• Increased intraocular pressure.
• Drug abuse

Reporting of side effects
If you get any side effects, even 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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25° C. Store in the original packaging, to protect the
medicine from light.

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 dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Alprazolam Aurobindo Italia contains

• The active ingredient is alprazolam. Each tablet contains 0.25 mg, 0.5 mg or 1.0 mg of alprazolam.
• The other ingredients are: lactose monohydrate (see section 2 “Alprazolam Aurobindo Italia contains lactose”), microcrystalline cellulose, corn starch, sodium benzoate, sodium docusate, povidone, anhydrous colloidal silica, sodium starch-glycolate and magnesium stearate.
• The 0.5 mg tablets also contain the colorant indigo carmine (E132) and erythrosine (E127).
• The 1 mg tablets also contain the colorant indigo carmine (E 132).

Description of the appearance of Alprazolam Aurobindo Italia and package contents
Alprazolam Aurobindo Italia 0.25 mg tablets are white, oval tablets with “AL fracture line 0.25” imprinted on one side and “G” on the other.
Alprazolam Aurobindo Italia 0.5 mg tablets are pink, oval tablets with “AL fracture line 0.5” imprinted on one side and “G” on the other.
Alprazolam Aurobindo Italia 1 mg tablets are light blue, oval tablets with “AL fracture line 1.00” imprinted on one side and “G” on the other.
Alprazolam Aurobindo Italia is available in plastic containers containing 20, 28, 30, 50, 56, 60, 84 and 100 tablets and in blisters containing 20, 28, 30, 50, 56, 60, 84 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102

• 21047 – Saronno (VA)

Manufacturer Responsible for Batch Release:
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13
Ireland

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Denmark: Alprazolam Mylan 0.25 mg, 0.5 mg, 1.0 mg
Greece: Alprazolam/Generics TAB 0.5 mg, 1.0 mg
Italy: Alprazolam Aurobindo Italia (0.25, 0.5 mg, 1.0 mg)
Netherlands: Alprazolam Mylan 0.25 mg Tablets, 0.5 mg Tablets, 1.0 mg Tablets
Portugal: Alprazolam Mylan 0.25 mg Tablets, 0.5 mg, 1.0 mg
Spain: Alprazolam Mylan 0.25 mg, 0.5 mg, 1.0 mg