XANAX 0.25 MG Coated tablet

Зміст інструкції

1. XANAX 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets, 0.75 mg/ml oral drops, solution
   1. Cos'è Xanax e a cosa serve
   2. Cosa deve sapere prima di prendere Xanax
   3. How to take Xanax
   4. Possible side effects
   5. How to store Xanax
   6. Package Contents and Other Information

XANAX 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets, 0.75 mg/ml oral drops, solution

alprazolam

Read this leaflet carefully before you start 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 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 Xanax is and what it is used for
• 2. What you need to know before you take Xanax
• 3. How to take Xanax
• 4. Possible side effects
• 5. How to store Xanax
• 6. Contents of the pack and other information

1. Cos'è Xanax e a cosa serve

Xanax contains the active ingredient alprazolam. Alprazolam belongs to a group of medicines
called benzodiazepines (anxiolytic medicines).
Xanax is used in adult patients for the treatment of anxiety symptoms when the disorder is
severe, disabling or subjects the individual to severe distress. This medicine is indicated only for
short-term use.

2. Cosa deve sapere prima di prendere Xanax

Do not take Xanax

• if you are allergicto alprazolam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);
• if you have myasthenia gravis, a disease that causes severe muscle weakness;
• if you have severebreathing problems(respiratory failure);
• if you have severeliver problems(hepatic failure);
• if you have trouble breathing during sleep (sleep apnea);
• if you suffer from an eye disease called acute angle-closure glaucoma, a problem caused by increased pressure inside the eyes;
• during the first 3 months of pregnancyand if you are breastfeeding(see section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine can reduce to cancel consciousness, can cause a considerable
reduction in the spontaneous ability to breathe, coma and death if taken together with
other medicines that act on the brain and mind (e.g. opioids, antipsychotics and hypnotic-
sedatives) (section Other medicines and Xanax).
Consult your doctor or pharmacist beforetaking Xanax if:

• you are elderlyand/or frail. The doctor will prescribe a reduced dose of this medicine; remember to use this medicine with caution as it may cause sedation and/or musculoskeletal weakness and expose you to falls, often with serious consequences;
• you have chronicbreathing problems(chronic respiratory failure), because this medicine may worsen your condition;
• you have kidneyproblems(renal failure) or liver problemsof mild to moderate degree (mild to moderate hepatic failure);
• you suffer from severe depression. Xanax, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression because it may worsen suicidal tendencies and cause mood changes;
• you suffer from psychosis, a serious mental illness that alters behavior and causes difficulty relating to others. Xanax is not recommended as the primary treatment for this condition;
• you are being treated with other medicinesthat act on the brain and mind, because Xanax may increase the effects of these medicines (see section “Other medicines and Xanax”);
• you have or have had problems with abuse and dependenceon alcohol, drugs or other medicines in the past, because there is a greater risk of developing dependence on Xanax (see section “Development of dependence”);
• you suffer from rare hereditary intolerance to a particular sugar (galactose).

Memory disorders
A few hours after taking Xanax, you may have difficulty remembering what happened

aftertaking the medicine.
Paradoxical reactions
Xanax can cause effects opposite to those expected (paradoxical effects) (see section 4
“Possible side effects”). These effects are more common in children and the elderly.
If you experience these effects, consult your doctor because treatment with Xanax must be
interrupted.
Development of tolerance
After a few weeks of treatment, a decrease in the effectiveness of Xanax may occur.
Development of dependence
Xanax causes dependence(i.e. you may experience an increasing desire to take the
medicine or you may develop physical disorders that decrease or disappear only after taking the
medicine). The likelihood of developing dependence increases with increasing dose and
duration of treatment. Therefore, the doctor will prescribe the most appropriate treatment based on your
disorders and conditions, using the lowest effective dose possible to be taken for the shortest possible period. The doctor will also indicate when to undergo check-ups to
assess the progress of your health in relation to therapy with Xanax.
Incorrect use of Xanax
You must take this medicine ONLYas prescribed by your doctor and after purchasing it in
pharmacy. Some people tend to abuse Xanax and other similar medicines,
called benzodiazepines.
In addition, some people obtain these medicines illegally (e.g. black market, internet,
friends, family, etc.), sometimes with the aim of reselling them to others. DO NOTtake Xanax if this medicine
has not been prescribed by your doctor. DO NOTtake Xanax if you are not sure that this medicine is
purchased from a pharmacy.

Children and adolescents
The efficacy and safety of Xanax in children and adolescents under 18 years of age are not known.
The doctor will decide whether Xanax can be administered to children and adolescents based on
their conditions.

Other medicines and Xanax
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
The concomitant use of Xanax 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.
For this reason, concomitant use should only be considered when other treatment options are not
possible.
However, if the doctor prescribes Xanax together with opioids, the dose and duration of concomitant therapy
must be limited by the doctor.
Tell the doctor about all opioid medicines you are taking and carefully follow
the doctor's recommendations on dosage. It may be helpful to inform friends or relatives to make them
aware of the signs and symptoms above. Contact your doctor if these
symptoms occur.
Caution is required when Xanax is taken together with the following medicines:

• medicinesthat act on the brainand mind*such as:
• antipsychotics, medicines for the treatment of some mental illnesses;
• hypnotics, sleep promoters;
• sedatives, tranquilizers;
• anxiolytics, medicines for the treatment of anxiety;
• antidepressants(e.g. nefazodone, fluvoxamine, fluoxetine, imipramine and desipramine), medicines for the treatment of depression;
• narcotic analgesics, opioids, medicines for the treatment of severe pain;
• antiepileptics, medicines for the treatment of seizures;
• anesthetics. Anesthetics, administered together with Xanax, can cause euphoria with an increased probability of developing dependence on Xanax;
• sedating antihistamines, medicines to counteract allergic reactions; * If you take Xanaxtogether with one or more of these medicines or together with alcoholic beverages, these substances can contribute to decreasing the functions of your brain and mind up to causing a reduction in the spontaneous ability to breathe, coma and death (section Warnings and precautions).
• analgesicsand cough suppressants, based on opium and its derivatives. These medicines, like Xanax, reduce the spontaneous ability to breathe;
• cimetidine, a medicine used to reduce stomach acidity;
• propoxyphene, a medicine used for pain;
• oral contraceptives;
• diltiazem, a medicine used to lower blood pressure;
• digoxin(a medicine used to increase the force of heart contraction). If you are elderly, taking Xanax may increase the likelihood of developing toxic effects due to digoxin.

The following medicines may increase the effects of Xanax:

• ketoconazole, itraconazole, posaconazoleand voriconazole, medicines for the treatment of fungal infections;
• erythromycin, clarithromycin, telithromycinand troleandomycin(antibiotics);
• protease inhibitors(e.g. ritonavir), medicines for the treatment of HIV infection. If you are being treated with protease inhibitors, your doctor may also advise you to discontinue treatment with Xanax due to the interaction with these medicines.

Xanax with alcohol
Donot drink alcohol while taking Xanax because alcohol increases the effects of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist before taking this medicine.
Pregnancy

This medicine should not be taken during the first 3 months of pregnancybecause it can cause
congenital malformations in the fetus. The doctor will assess whether you can take this medicine during
the second and third trimesters of pregnancy.
If you take this medicine in the last months of pregnancyor during labor, the newborn
may experience the following symptoms:

• poor muscle tone (axial hypotonia);
• difficulty breathing (respiratory depression or apnea) and taking milk;
• low body temperature (hypothermia);
• withdrawal symptoms (see section 3 “If you stop taking Xanax”). These effects are reversible and may last from a few days to 1-3 weeks after the baby is born.

Breastfeeding

Donot breastfeed while taking Xanax because this medicine passes into breast milk.

Driving and using machines
Donot drive or operate machinery if you experience loss of
concentration or muscle control or if you feel drowsy or dizzy while taking Xanax. These effects may
be increased if you have not slept enough or if you have consumed alcoholic beverages.

Xanax tablets contains lactose monohydrate
The 0.25 mg, 0.50 mg and 1 mg tablets of Xanax contain lactose monohydrate, a type of
sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.

Xanax tablets contains sodium benzoate
The 0.25 mg, 0.50 mg and 1 mg tablets of Xanax contain 0.11 mg of sodium benzoate per
tablet.

Xanax tablets contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

Xanax 0.50 mg tablets contains sunset yellow
Xanax 0.50 mg tablets contain the colorant sunset yellow, which may cause allergic
reactions.

Xanax 0.75 mg/ml oral drops, solution contains ethanol
This medicine contains alcohol (ethanol). This medicine contains 58 mg of alcohol (ethanol) in
each 0.25 mg dosage unit (10 drops), equivalent to 2 ml of beer and 1 ml of wine; and 116 mg of
alcohol (ethanol) per 0.50 mg dose (20 drops), equivalent to 3ml of beer and 2ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

Xanax 0.75 mg/ml oral drops, solution contains propylene glycol
This medicine contains 233 mg of propylene glycol per 0.25 mg dose (10 drops).
If the child is less than 5 years old, talk to your doctor or pharmacist before administering
this medicine, especially if the child is taking other medicines containing propylene
glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.

Xanax 0.75 mg/ml oral drops, solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.25 mg dose (10 drops), i.e.
it is essentially ‘sodium-free’.

3. How to take Xanax

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor.

• Treatment of anxietyThe recommended initial dose is from 0.25 mg to 0.5 mg 3 times a day. If you prefer the dropsformulation, the recommended initial dose is from 10 to 20 drops 3 times a day. The dose may be gradually increased, up to a maximum of 4 mg per day, to be divided into several doses. You should first increase the dose to be taken in the evening and then the dose to be taken during the day.

If you are elderly, have liver or kidney problems and/or are debilitated
The recommended initial dose is 0.25 mg (corresponding to 10 drops) 2-3 times a day.

The duration of treatment with Xanax should be as short as possible.The maximum duration of treatment should not exceed 2-4 weeks. Prolonged treatment is not recommended. The doctor will decide whether the treatment can be continued beyond the recommended maximum period.

Instructions for opening the drops bottle

• Press on the plastic cap and unscrew simultaneously

• To close, screw the cap on tightly

If you take more Xanax than you should
If you have taken an excessive dose of Xanax, contact your doctor immediately or go to the nearest emergency room.

• In mild cases, the symptoms may be: confusion, drowsiness, difficulty speaking.
• In more severe cases, the symptoms may be: loss of coordination, poor muscle tone, low blood pressure, breathing problems, coma, death.

If you forget to take Xanax
If you forget to take a dose, take it as soon as you remember unless it is almost time to take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Xanax
Donot suddenly stop taking Xanax. Always consult your doctor before stopping taking Xanax. You must gradually reduce the doses to avoid experiencing:

• withdrawal symptomssuch as:
• severe symptoms: feeling detached from oneself or from the outside world, numbness and tingling in the legs or arms, increased sensitivity to light, sounds and physical contact, hallucinations, seizures, muscle and abdominal cramps, vomiting, sweating, tremors, convulsions;
• other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, mild depression of mood, insomnia;
• rebound symptoms, e.g. anxiety. These symptoms are the same for which you have been advised to treat with Xanax and may temporarily reappear more intensely after abrupt discontinuation of treatment.

If you have any doubts 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 everybody gets them.
Contact your doctor immediatelyif you experience any of the following side effects because
the intake of Xanax must be stopped:

• effects opposite to those expected (paradoxical effects) (see paragraph 2 “Paradoxical reactions”) such as:
• restlessness
• agitation
• irritability
• aggression
• feeling of frustration
• anger
• nightmares
• hallucinations
• thought disorders
• behavioral changes

Contact your doctor immediatelyif you experience any of the following side effects because they can
be serious:

• swelling of the face, tongue and throat resulting in inability to swallow and breathe (angioedema)
• difficulty rememberingwhat happened after taking the medicine (see paragraph 2 “Memory problems”)
• unmasking of pre-existing depression
• dependence(see paragraph 2 “Development of dependence”)
• withdrawal symptomsand rebound symptoms(see paragraph 3 “If you stop taking Xanax”)

Contact your doctor if you experience any of the following side effects:

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

• depression
• sedation
• drowsiness
• loss of coordination
• memory problems
• difficulty speaking
• dizziness
• headache
• constipation
• dry mouth due to lack of saliva
• fatigue
• irritability

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

• decreased appetite, decrease or increase in body weight
• confusion, disorientation
• decreased or increased sexual desire, sexual dysfunction
• anxiety
• insomnia, excessive sleepiness
• nervousness
• balance disorders, problems with movement coordination
• loss of attention and concentration
• excessive drowsiness (lethargy)
• tremors
• vertigo
• slurred speech
• blurred vision
• nausea
• dermatitis
• irritability

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

• obsessive ideas and behaviors
• inability to remember recent life events
• vomiting
• muscle weakness
• incontinence
• irregular menstrual cycle
• drug dependence
• drug withdrawal syndrome

Frequency not known(frequency cannot be estimated from available data):

• increased levels of prolactin (a natural hormone) in the blood
• mood changes
• hostile behaviors, abnormal thoughts
• impulsivity and motor hyperactivity
• alterations of the nervous system responsible for the functions of the body that cannot be controlled voluntarily (e.g. the functions of internal organs and glands)
• involuntary muscle contractions that force you to assume unnatural positions
• stomach and intestinal diseases
• inflammatory liver diseases (hepatitis)
• impaired liver function
• yellowing/yellowish discoloration of the skin and mucous membranes (jaundice)
• skin reactions due to exposure to the sun
• inability to completely empty the bladder
• swelling of the hands and feet due to fluid accumulation
• increased pressure inside the eye
• abuse of this medicine (tendency to excessive or incorrect use of Xanax)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. 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 Xanax

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, blister and
bottle after “Exp.”. The expiry date refers to the last day of that month.
Tablets
Store at a temperature below 30°C.
Store in the original package to protect the medicine from light.
Drops
Validity after first opening: 90 days. You can write the date of first opening in the designated space
on the package.
Store in the original package to protect the medicine from light.
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 Xanax contains
The active ingredient is alprazolam.
Tablets
One Xanax 0.25 mg tablet contains 0.25 mg of alprazolam.
The other ingredients are: lactosemonohydrate, microcrystalline cellulose, sodium docusate, sodium
benzoate, anhydrous colloidal silica, corn starch, magnesium stearate.
One Xanax 0.5 mg tablet contains 0.5 mg of alprazolam.
The other ingredients are: lactosemonohydrate, microcrystalline cellulose, sodium docusate, sodium
benzoate, anhydrous colloidal silica, corn starch, magnesium stearate, sunset yellow(E110) aluminum lake.
One Xanax 1 mg tablet contains 1 mg of alprazolam.
The other ingredients are: lactosemonohydrate, microcrystalline cellulose, sodium docusate, sodium
benzoate, anhydrous colloidal silica, corn starch, magnesium stearate, indigotine (E132) aluminum lake.
Oral Drops
1 ml of Xanax oral drops, solution contains 0.75 mg of alprazolam.
The other ingredients are: alcohol, propylene glycol, sodium saccharinate, grapefruit aroma, purified water.

Description of the appearance of Xanax and contents of the packs
Xanax 0.25 mg tablets are oval-shaped, white tablets with a score line on one side and “Upjohn 29” on the other side. The tablets are available in PVC/aluminum blisters in packs of 20 tablets.
Xanax 0.5 mg tablets are oval-shaped, light orange tablets with a score line on one side and “Upjohn 55” on the other side. The tablets are available in PVC/aluminum blisters in packs of 20 tablets.
Xanax 1 mg tablets are oval-shaped, blue tablets with a score line on one side and “Upjohn 90” on the other side. The tablets are available in PVC/aluminum blisters in packs of 20 tablets.
Xanax oral drops solution is a clear, golden-yellow solution. The oral drops are available in 20 ml glass bottles with a cap and polyethylene dropper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan

Manufacturer
Tablets
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)
Oral drops, solution
Delpharm Orléans 5 Avenue de Concyr
45071 Orleans Cedex 2
France
Doppel Farmaceutici S.r.l
Via Martiri Delle Foibe 1
29016 Cortemaggiore (Piacenza)