Alprazolam Aurobindo Italia: detailed information

Package leaflet: information for the patient

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

alprazolam
Generic medicine
Read this entire 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 give it to others, even if they have the same symptoms as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Alprazolam Aurobindo Italia is and what it is used for
What you need to know before taking Alprazolam Aurobindo Italia
How to take Alprazolam Aurobindo Italia
Possible side effects
How to store Alprazolam Aurobindo Italia
Contents of the pack and other information

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

Its tablets contain alprazolam, which belongs to a group of medicines called benzodiazepines.
Alprazolam is thought to enhance the action of a naturally occurring substance in the brain called GABA.
Alprazolam is used for the short-term treatment of severe anxiety disorders. Alprazolam should only be used short-term because it may lead to dependence.

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

Do not take Alprazolam Aurobindo 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 have severe respiratory insufficiency or lung problems;
if you have sleep apnoea syndrome (irregular breathing during sleep);
if you have severe hepatic insufficiency;
if you suffer from alcoholism or drug abuse;
if you are taking other medicines known to affect the central nervous system (e.g. benzodiazepines, neuroleptics);
if you have glaucoma.

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

if you have 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 suicidal thoughts;
if you are taking other medicines for anxiety or insomnia;
if you have previously abused drugs or alcohol, or if you find it difficult to stop taking medicines, drinking alcohol, or taking other drugs. Your doctor may want to provide special support when stopping these tablets;
if you have personality disorders;
if you are elderly, as alprazolam may cause drowsiness or muscle weakness, which could lead to falls, often with serious consequences in this population.

A temporary loss of memory may occur while taking this medicine. To reduce
this risk, ensure you are able to have a full night’s sleep (7–8 hours) when
taking this medicine.
Alprazolam has been associated with unusual reactions such as restlessness, agitation, irritability, aggression,
delirium, rage, nightmares, hallucinations (seeing or hearing things that are not real), psychosis (loss of
contact with reality), and bizarre behaviour.
If you notice any of these behavioural changes while taking this medicine, inform your doctor immediately, as you may need to stop taking this medicine.
Children and adolescents
Alprazolam is not recommended for children and adolescents under 18 years of age.
Other medicines and Alprazolam Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. It is especially important to inform your doctor if you are taking any of the following medicines:

Antipsychotics (medicines used to treat mental disorders) 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 painkillers) such as propoxyphene, antitussives (medicines used to treat cough) such as dextromethorphan and codeine, medicines such as methadone (which may be used as an analgesic or to help opioid-dependent individuals), anaesthetics (medicines used for anaesthesia) such as halothane and bupivacaine, or certain antidepressants, as they may enhance the effects of alprazolam;
Clozapine (a medicine used to treat mental illnesses such as schizophrenia). This medicine may 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 derivatives);
Cimetidine (for treating stomach ulcers), nefazodone (for treating depression), or fluvoxamine (for treating Obsessive-Compulsive Disorder, OCD), as the dose of alprazolam may need to be adjusted;
Imipramine or desipramine, medicines known as tricyclic antidepressants (TCAs), used to treat depression, as the dose of these medicines may need to be adjusted;
Oral contraceptives ("the pill");
Diltiazem (used for angina and high blood pressure);
Certain 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 conditions). You may experience digoxin toxicity (symptoms include irregular heartbeat, confusion, delirium, visual disturbances, headache, abdominal pain, nausea, and vomiting) when taking digoxin with this medicine.

Concomitant use of this medicine with opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of sedation, breathing difficulties (respiratory depression), coma, and may be life-threatening. Deaths have been reported. Because of this, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Alprazolam tablets together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Please inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the symptoms described above. Contact your doctor if these symptoms occur.
If you are about to undergo surgery where a general anaesthetic will be administered, inform the 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 should therefore be avoided. Do not drink excessive amounts of grapefruit juice while taking this medicine, as it may increase the amount of alprazolam in the blood.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take Alprazolam Aurobindo Italia during pregnancy unless you and your doctor have discussed the risks and benefits involved.
If you have taken alprazolam regularly during the last three months of pregnancy, your baby may become dependent on alprazolam and may be at risk of withdrawal symptoms after birth.
If your doctor has decided that you should take this medicine during the final stages of pregnancy or during labour, your baby may experience low body temperature, weakness, breathing difficulties, feeding problems, tremors, increased excitability, and agitation.
Do not take Alprazolam Aurobindo Italia while breastfeeding, as the medicine may pass into breast milk.
Driving and using machines
Do not drive or operate machinery after taking Alprazolam Aurobindo Italia, as it may impair your concentration or muscle control, cause memory loss, dizziness, drowsiness, or confusion.
Alprazolam Aurobindo Italia contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor 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 instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults (over 18 years of age)
The recommended dose is between 0.25 mg and 0.50 mg three times daily.
Your doctor may decide to increase your dose, if necessary, up to a maximum of 3 mg per day.
Ask your doctor or pharmacist for advice if you are unsure. Dose 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 for elderly patients is 0.25 mg two or three times daily. If you are in good physical condition,
your 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 should be taken orally. The break line is only intended to help you split 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 a lower dose than the standard recommendation. 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, and generally should not exceed 8–12 weeks. This is because taking alprazolam for too long and at too high a dose may lead to physical and psychological dependence.
If you take more Alprazolam Aurobindo Italia than you should
Contact your doctor or the nearest Emergency Department immediately. Take the medicine pack and any remaining tablets with you. Symptoms of overdose include drowsiness, confusion, lack of coordination or unusual movements, respiratory depression, low 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 the missed dose; take only the next tablet at the correct time.
If you stop treatment with Alprazolam Aurobindo Italia
Treatment with alprazolam should be gradually reduced before being discontinued. Your doctor will advise you on how to do this. If you interrupt or stop treatment with alprazolam prematurely, you may experience adverse effects such as anxiety or restlessness, seizures, headache, muscle pain, tension, confusion, irritability, involuntary movements, and may have difficulty sleeping. In extreme cases, this may also include symptoms such as lack of self-awareness, loss of contact with reality, increased sensitivity to light, sound and physical touch, a sensation 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 or changes in mood.
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 everyone gets them.

Dangerous or hostile behaviours 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, stop treatment with alprazolam, which may cause irritability, hostility, and unpleasant thoughts or ideations.

Some common side effects occur at the beginning of therapy. These symptoms usually disappear if treatment is continued.

Contact your doctor immediately if you experience any of the following side effects, which may be serious:

Uncommon (may affect up to 1 in 100 people)

Seizure or convulsions
Epileptic fits in the brain that may affect muscle activity, one of your senses, bodily functions, or may alter the way you think, perceive, or understand things
Memory loss (amnesia)
An unusual reaction to this medicine which may include one or more of the following symptoms: restlessness, agitation, irritability, aggression, fixed and irrational ideas (delirium), anger, nightmares, seeing or hearing things that do not exist (hallucinations), loss of contact with reality (psychosis), or strange behaviour, drug withdrawal symptoms

Not known (frequency cannot be estimated from the available data)

Increased number of infections, which may present 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 breathing difficulties
Inflammation of the liver (hepatitis), which may cause nausea, vomiting, loss of appetite, general feeling of malaise, 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 an itchy rash, swelling of the eyelids, face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing
Little or no urine production, possibly with pain
Drug abuse

You must stop taking the medicine. Your doctor will advise you on how to do this.

Other possible side effects include

Very common (may affect more than 1 in 10 people):

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

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

Increased or decreased appetite
Blurred vision
Feeling detached from your body (depersonalization)
Seeing other people and the surrounding environment as if in a dream or unreal (derealization)
Fear
Nervousness or anxiety
Confusion
Disorientation
Tingling sensations
Uncontrolled contractions, jerky or convulsive movements, abnormal coordination, tremors or tremulousness
Balance problems
Difficulty concentrating
Lack of energy
Rapid heartbeat that feels like pounding in the chest (palpitations)
Hot flushes
Stuffy nose, sore throat, or chesty 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
Malaise (vomiting)
Gastrointestinal disturbances, diarrhoea
Feeling unwell (nausea)
Stomach pain
Excessive sweating
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 (oedema)
Ringing in the ears
Risk of traffic accidents

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

Increased tendency to bruise
Disturbed dreams
Talkativeness
Impulsiveness
Slowed thinking
Muscle weakness
Reduced movement
Double vision or other vision problems
Euphoria or feeling overexcited
Persistent inability to achieve orgasm
Mood changes
Panic attacks
Fainting
Clumsiness
Problems with sense of taste
A state close to unconsciousness (stupor)
Joint stiffness, pain in extremities
Uncontrolled urination (incontinence)
Frequent or abnormal urination during the day
Ejaculation problems, inability to achieve or maintain an erection
Irregular menstruation
Abnormal sensations
Changes in walking pattern, feeling of drunkenness, nervousness or tension, feeling of relaxation, hangover-like feeling
Flu-like symptoms
Thirst
Increased bilirubin levels, detectable by blood test
Falls, injuries to extremities
Overdose
Drug dependence

Not known (frequency cannot be estimated from the available data):

Elevated levels of prolactin in the blood, detected by blood test (hyperprolactinaemia)
Hostile behaviour
Inability to sit or stand still, hyperactivity
Abnormal thoughts
Problems with learning and problem-solving
Blood vessel problems
Swelling of hands and feet (peripheral oedema)
Excessive wakefulness
Increased sensitivity to light
Rapid heartbeat (tachycardia)
Low blood pressure
Decreased saliva
Abnormal liver function, detectable by blood test
Problems with muscle tone
Feeling of warmth
Increased intraocular pressure
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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging, in order to protect the medicine from light.
Do not use this medicine after the expiry date stated on the packaging or container following
"Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 substance is alprazolam. Each tablet contains 0.25 mg, 0.5 mg or 1.0 mg of alprazolam.
The other components are: monohydrate lactose (see section 2 “Alprazolam Aurobindo Italia contains lactose”), microcrystalline cellulose, maize starch, sodium benzoate, sodium docusate, povidone, anhydrous colloidal silica, sodium starch glycolate and magnesium stearate.
The 0.5 mg tablets also contain the colouring agents indigo carmine (E132) and erythrosine (E127).
The 1 mg tablets also contain the colouring agent indigo carmine (E132).

Description of the appearance of Alprazolam Aurobindo Italia and package contents
Alprazolam Aurobindo Italia 0.25 mg tablets are white, oval tablets with “AL – 0.25” engraved on one side and “G” on the other.
Alprazolam Aurobindo Italia 0.5 mg tablets are pink, oval tablets with “AL – 0.5” engraved on one side and “G” on the other.
Alprazolam Aurobindo Italia 1 mg tablets are light blue, oval tablets with “AL – 1.00” engraved 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 Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 – Saronno (VA), Italy

Responsible manufacturer for batch release:
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13
Ireland

This medicinal product is authorized in the European Economic Area Member States 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 Tabletten, 0.5 mg Tabletten, 1.0 mg Tabletten
Portugal: Alprazolam Mylan 0,25 mg Comprimidos, 0.5 mg, 1.0 mg
Spain: Alprazolam Mylan 0.25 mg, 0.5 mg, 1.0 mg