Xanax

Package leaflet: Information for the patient

XANAX 0,25 mg tablets, 0,50 mg tablets, 1 mg tablets, 0,75 mg/ml oral drops, solution

alprazolam
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking Xanax
3. How to take Xanax
4. Possible side effects
5. How to store Xanax
6. Contents of the pack and other information

1. What Xanax is and what it is used for

Xanax contains the active substance 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 causes the individual severe distress. This medicine is indicated only for
short-term use.

2. What you should know before taking Xanax

Do not take Xanax

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

Warnings and precautions
This medicine may reduce or even abolish consciousness, may cause a significant reduction in spontaneous breathing, coma, and death if taken together with other medicines acting on the brain and mind (e.g. opioids, antipsychotics, hypnotics-sedatives) (see section “Other medicines and Xanax”).
Talk to your doctor or pharmacist before taking Xanax if:

• you are elderly and/or debilitated. Your doctor will prescribe a lower dose of this medicine; remember to use this medicine with caution as it may cause sedation and/or musculoskeletal weakness, increasing your risk of falls, often with serious consequences;
• you have chronic breathing problems (chronic respiratory insufficiency), because this medicine may worsen your condition;
• you have kidney problems (renal failure) or liver problems of mild to moderate degree (mild to moderate hepatic insufficiency);
• you suffer from severe depression. Xanax, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression, as it may worsen suicidal tendencies and cause mood changes;
• you suffer from psychosis, a serious mental illness altering behavior and causing difficulties in social interactions. Xanax is not recommended as the primary treatment for this condition;
• you are being treated with other medicines acting on the brain and mind, because Xanax may enhance the effects of these medicines (see section “Other medicines and Xanax”);
• you have or have previously had problems with abuse and dependence on alcohol, drugs, or other medicines, as the risk of developing dependence on Xanax is higher (see section “Development of dependence”);
• you suffer from rare hereditary problems of intolerance to a particular sugar (galactose).

Memory disturbances
A few hours after taking Xanax, you may experience difficulty remembering events that occurred after taking the medicine.

Paradoxical reactions
Xanax may cause effects opposite to those expected ( paradoxical effects ) (see section 4 “Possible side effects”). These effects are more common in children and elderly people.
If you experience these effects, contact your doctor, as treatment with Xanax should be discontinued.

Development of tolerance
After several weeks of treatment, the effectiveness of Xanax may decrease.

Development of dependence
Xanax causes dependence (i.e., you may feel a growing desire to take the medicine or develop physical symptoms that diminish or disappear only after taking the medicine). The likelihood of developing dependence increases with higher doses and longer duration of treatment. Therefore, your doctor will prescribe the most appropriate treatment based on your condition, using the lowest effective dose for the shortest possible time. Your doctor will also advise you on when to attend follow-up visits to monitor your health in relation to Xanax therapy.

Incorrect use of Xanax
You must take this medicine ONLY if prescribed by your doctor and purchased from a pharmacy. Some people tend to abuse Xanax and other similar medicines known as benzodiazepines.
In addition, some people obtain these medicines illegally (e.g., black market, internet, friends, family, etc.), sometimes with the intent to resell them. DO NOT take Xanax if it has not been prescribed to you by a doctor. DO NOT take Xanax if you are unsure whether the medicine was purchased from a pharmacy.

Children and adolescents
The efficacy and safety of Xanax in children and adolescents under 18 years of age are unknown. Your doctor will decide whether Xanax can be administered to children and adolescents based on their individual conditions.

Other medicines and Xanax
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The concomitant use of Xanax and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening.

For this reason, concomitant use should only be considered when no other treatment options are available.

However, if your doctor prescribes Xanax together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.

Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above. Contact your doctor if these symptoms occur.

Caution is required when Xanax is taken together with the following medicines:

• medicines acting on the brain and mind* such as:
• antipsychotics, medicines used to treat certain mental illnesses;
• hypnotics, sleep-inducing medicines;
• sedatives, tranquillizers;
• anxiolytics, medicines used to treat anxiety;
• antidepressants (e.g. nefazodone, fluvoxamine, fluoxetine, imipramine, and desipramine), medicines used to treat depression;
• narcotic analgesics, opioids, medicines used to treat severe pain;
• antiepileptics, medicines used to treat epileptic seizures;
• anesthetics. Anesthetics, when administered together with Xanax, may cause euphoria, increasing the likelihood of developing dependence on Xanax;
• sedating antihistamines, medicines used to treat allergic symptoms; * If you take Xanax together with one or more of these medicines or together with alcoholic beverages, these substances may contribute to reduced brain and mental function, potentially leading to reduced spontaneous breathing, coma, and death (see section Warnings and precautions).
• analgesics and cough suppressants containing opium and its derivatives. These medicines, like Xanax, reduce spontaneous breathing;
• cimetidine, a medicine used to reduce stomach acidity;
• propoxyphene, a medicine used to treat 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 digoxin-related toxic effects.

The following medicines may increase the effects of Xanax:

• ketoconazole, itraconazole, posaconazole, and voriconazole, medicines used to treat fungal infections;
• erythromycin, clarithromycin, telithromycin, and troleandomycin (antibiotics);
• protease inhibitors (e.g. ritonavir), medicines used to treat HIV infection. If you are being treated with protease inhibitors, your doctor may advise discontinuing Xanax due to interaction with these medicines.

Xanax and alcohol
Do not drink alcohol while taking Xanax because alcohol increases the effects of this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine must not be taken during the first 3 months of pregnancy because it may cause congenital malformations in the fetus. Your doctor will assess whether you may take this medicine during the second and third trimesters of pregnancy.

If you take this medicine during the last months of pregnancy or during labor, the newborn may show the following symptoms:

• poor muscle tone (axial hypotonia);
• breathing difficulties (respiratory depression or apnea) and difficulty feeding;
• low body temperature (hypothermia);
• withdrawal symptoms (see section 3 “If you stop taking Xanax”). These effects are reversible and may last from several days up to 1–3 weeks after birth.

Breastfeeding
Do not breastfeed while taking Xanax because this medicine passes into breast milk.

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

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

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

Xanax tablets contain 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 contain sunset yellow
Xanax 0.50 mg tablets contain the colouring agent 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) per 0.25 mg dose (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 3 ml of beer and 2 ml 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 under 5 years of age, speak with 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. Your doctor may perform additional monitoring during treatment.
If you have liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.

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 exactly as your doctor has told you. If you are unsure, consult your doctor.

• Treatment of anxiety
  The recommended starting dose is 0.25 mg to 0.5 mg, taken 3 times a day. If you prefer the drops formulation, the recommended starting dose is 10 to 20 drops, taken 3 times a day. The dose may be gradually increased up to a maximum of 4 mg per day, divided into several doses. You should first increase the evening dose, followed by the daytime doses.

If you are elderly, have liver or kidney problems and/or are debilitated
The recommended starting dose is 0.25 mg (equivalent to 10 drops), taken 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. Your doctor will decide whether treatment may continue beyond the recommended maximum period.

Instructions for opening the bottle of drops

• Press down on the plastic cap and simultaneously unscrew it

• To close, screw the cap back 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 department.

• In mild cases, symptoms may include: mental confusion, drowsiness, difficulty speaking.
• In more severe cases, symptoms may include: loss of coordination, reduced muscle tone, low blood pressure, breathing difficulties, 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 for your next dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Xanax
Do not stop taking Xanax suddenly. Always consult your doctor before stopping Xanax. You must gradually reduce the dose to avoid withdrawal symptoms:

• Withdrawal symptoms such as:
  • severe symptoms: feeling detached from yourself or the external world, numbness and tingling in arms or legs, increased sensitivity to light, sound, and physical touch, hallucinations, epileptic seizures, muscle and abdominal cramps, vomiting, sweating, tremors, convulsions;
  • other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, mild depression, insomnia;
• Rebound symptoms, for example, anxiety. These are the same symptoms for which Xanax was prescribed, and they may temporarily reappear more intensely after abrupt discontinuation of treatment.

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 everybody gets them.
Contact your doctor immediately if you experience any of the following side effects, as treatment with Xanax must be discontinued:

• effects opposite to those expected ( paradoxical effects ) (see section 2 “Paradoxical reactions”) such as:
  • restlessness
  • agitation
  • irritability
  • aggressiveness
  • feelings of disappointment
  • anger
  • nightmares
  • hallucinations
  • disturbances in thinking
  • behavioural changes

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

• swelling of the face, tongue and throat leading to difficulty in swallowing and breathing ( angioedema )
• memory difficulties following administration of the medicine (see section 2 “Memory disturbances”)
• unmasking of pre-existing depression
• dependence (see section 2 “Development of dependence”)
• withdrawal symptoms and rebound symptoms (see section 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 ability to coordinate movements
• memory disturbances
• 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
• increased or decreased sexual desire, sexual dysfunction
• anxiety
• insomnia, excessive sleepiness
• nervousness
• loss of balance, problems with coordination of movements
• 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 thoughts and behaviours
• inability to recall recent life events
• vomiting
• muscle weakness
• incontinence
• irregular menstrual cycle
• drug dependence
• drug withdrawal syndrome

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

• increased levels of prolactin (a natural hormone) in the blood
• mood changes
• hostile behaviours, abnormal thoughts
• impulsiveness and motor hyperactivity
• disturbances in the nervous system controlling involuntary body functions (e.g. internal organs and glands)
• involuntary muscle contractions causing unnatural postures
• stomach and intestinal disorders
• inflammatory liver diseases (hepatitis)
• altered liver function
• yellow/yellowish discoloration of the skin and mucous membranes (jaundice)
• skin reactions due to exposure to sunlight
• inability to completely empty the bladder
• swelling of the hands and feet due to fluid retention
• increased pressure inside the eye
• misuse of this medicine (tendency to excessive or inappropriate use of Xanax)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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 Xanax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle after "Exp.". The expiry date refers to the last day of that month.
Tablets
Store below 30°C.
Keep in the original packaging to protect the medicine from light.
Oral solution
Use within 90 days after first opening. You may write down the date of first opening in the designated space on the carton.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Xanax contains
The active substance is alprazolam.
Tablets
One 0.25 mg Xanax tablet contains 0.25 mg of alprazolam.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, docusate sodium, sodium
benzoate, anhydrous colloidal silica, maize starch, magnesium stearate.
One 0.5 mg Xanax tablet contains 0.5 mg of alprazolam.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, docusate sodium, sodium
benzoate, anhydrous colloidal silica, maize starch, magnesium stearate, sunset yellow (E110)
aluminium lake.
One 1 mg Xanax tablet contains 1 mg of alprazolam.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, docusate sodium, sodium
benzoate, anhydrous colloidal silica, maize starch, magnesium stearate, indigo carmine (E132)
aluminium 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 flavour, purified water.

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

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

Manufacturer
Tablets
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP), Italy

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), Italy