Alprazolam Viatris

Italy
Brand name Alprazolam Viatris
Form tablets
Active substance / Dosage
ALPRAZOLAM
Prescription type Prescription only
ATC code
N05BA12
Registration number 028644
Manufacturer MYLAN S.P.A.
Alprazolam Viatris tablets

Table of Contents

Patient Information Leaflet

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

alprazolam
Please read this entire 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, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What ALPRAZOLAM VIATRIS is and what it is used for
  2. What you need to know before taking ALPRAZOLAM VIATRIS
  3. How to take ALPRAZOLAM VIATRIS
  4. Possible side effects
  5. How to store ALPRAZOLAM VIATRIS
  6. Contents of the pack and other information

1. What ALPRAZOLAM VIATRIS is and what it is used for

ALPRAZOLAM VIATRIS contains the active substance alprazolam. Alprazolam belongs to a group of
medicines called benzodiazepines (anxiolytic medicines).
ALPRAZOLAM VIATRIS is used in adults for the treatment of anxiety disorders when they are severe,
disabling, or causing significant distress to the patient. This medicine is indicated only for short-term use.

2. What you need to know before taking ALPRAZOLAM VIATIS

Do not take ALPRAZOLAM VIATIS:

  • 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;
  • if you have severe liver problems;
  • if you suffer from sleep apnea, meaning your breathing is irregular during sleep;
  • if you have acute closed-angle glaucoma, a condition caused by increased pressure inside the eyes;
  • during the first 3 months of pregnancy or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine may reduce or even eliminate consciousness, may cause a significant reduction in spontaneous breathing ability, coma, and death if taken together with other medicines acting on the brain and mind, such as opioids (see section “Other medicines and ALPRAZOLAM VIATIS”).

Talk to your doctor or pharmacist before taking ALPRAZOLAM VIATIS if:

  • you are elderly and/or debilitated. Your 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, increasing your risk of falls, which often have serious consequences;
  • you have chronic breathing problems, because this medicine may worsen your condition;
  • you have kidney problems or mild to moderate liver problems;
  • you suffer from severe depression, because ALPRAZOLAM VIATIS may worsen suicidal tendencies and cause mood changes;
  • you suffer from psychosis, a serious mental illness affecting behavior and causing difficulties in social interactions. ALPRAZOLAM VIATIS is not recommended as primary treatment for this condition;
  • you are being treated with other medicines acting on the brain and mind, because ALPRAZOLAM VIATIS may enhance the effects of these medicines (see section “Other medicines and ALPRAZOLAM VIATIS”);
  • you have or have previously had problems with alcohol, drug, or medicine abuse and dependence, as you have a higher risk of developing dependence on ALPRAZOLAM VIATIS (see section “Development of dependence”).

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

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

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

Development of dependence
ALPRAZOLAM VIATIS may lead to dependence (i.e., you may develop an increasing desire to take the medicine or experience physical symptoms that diminish or disappear only after taking the medicine). The likelihood of developing dependence increases with higher doses and longer treatment duration.

Children and adolescents
The efficacy and safety of ALPRAZOLAM VIATIS in children and adolescents under 18 years of age have not been established. Your doctor will decide whether ALPRAZOLAM VIATIS can be administered to children and adolescents based on their individual condition.

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

Caution is required when ALPRAZOLAM VIATIS 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 for treating anxiety;
  • antidepressants (e.g., nefazodone, fluvoxamine, fluoxetine, imipramine, and desipramine), medicines for treating depression;
  • narcotic analgesics, opioids, medicines for treating severe pain;
  • antiepileptics, medicines for treating epileptic seizures;
  • anesthetics. Anesthetics, when taken together with ALPRAZOLAM VIATIS, may cause euphoria and increase the risk of developing dependence on ALPRAZOLAM VIATIS;
  • sedating antihistamines, medicines used to treat allergic symptoms;
  • analgesics and cough suppressants containing opium (opiates) or their derivatives. These medicines, like ALPRAZOLAM VIATIS, reduce spontaneous breathing ability;
  • cimetidine, a medicine used to reduce stomach acidity;
  • propoxyphene, a medicine used for pain relief;
  • oral contraceptives;
  • diltiazem, a medicine used to lower blood pressure;
  • digoxin (a medicine used to increase the heart's contraction strength). If you are elderly, taking ALPRAZOLAM VIATIS may increase the risk of digoxin-related toxic effects.

Concomitant use of ALPRAZOLAM VIATIS and opioids (strong painkillers, medicines for addiction treatment, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes ALPRAZOLAM VIATIS together with opioids, the dose and duration of concomitant therapy must be strictly limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow their dosage recommendations carefully.
It may be helpful to inform family members or friends to watch for the symptoms listed above.
Contact your doctor immediately if you experience such symptoms.

The following medicines may increase the effects of ALPRAZOLAM VIATIS:

  • 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 ALPRAZOLAM VIATIS due to potential interactions with these medicines.

ALPRAZOLAM VIATIS and alcohol
Do not drink alcohol while taking ALPRAZOLAM VIATIS, as alcohol enhances the effects of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine must not be taken during the first 3 months of pregnancy, as it may cause congenital malformations in the fetus. Your doctor will assess whether you can 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;
  • breathing and feeding difficulties;
  • low body temperature;
  • withdrawal symptoms (see section 3 “If you stop taking ALPRAZOLAM VIATIS”). These effects are reversible and may last from several days up to 1–3 weeks after birth.

Breastfeeding
Do not breastfeed while taking ALPRAZOLAM VIATIS, as this medicine passes into breast milk.

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

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

ALPRAZOLAM VIATIS tablets contain sodium
The 0.25 mg, 0.50 mg, and 1 mg ALPRAZOLAM VIATIS tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e., they are essentially ‘sodium-free’.

ALPRAZOLAM VIATIS tablets contain sodium benzoate (E211)
The 0.25 mg, 0.50 mg, and 1 mg ALPRAZOLAM VIATIS tablets contain 0.11 mg of benzoate salt per tablet.

ALPRAZOLAM VIATIS 0.50 mg tablets contain sunset yellow
The 0.50 mg ALPRAZOLAM VIATIS tablets contain the colorant sunset yellow, which may cause allergic reactions.

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

ALPRAZOLAM VIATIS 0.75 mg/ml oral 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’.

ALPRAZOLAM VIATIS 0.75 mg/ml oral 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, consult 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 suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take ALPRAZOLAM VIATRIS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

  • Treatment of anxiety
    The recommended initial dose is 0.25 mg to 0.5 mg, taken 3 times daily. If you prefer the oral drops formulation, the recommended initial dose is 10 to 20 drops, taken 3 times daily.

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 initial dose is 0.25 mg (equivalent to 10 drops) 2–3 times daily.
The duration of treatment with ALPRAZOLAM VIATRIS should be as short as possible. The recommended treatment duration 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 dropper bottle

  • Press down on the plastic cap while unscrewing it.
A hand presses the cap of a bottle while a vertical arrow and a curved arrow indicate the downward pressing and rotating movement
  • To close, screw the cap back on tightly.

If you take more ALPRAZOLAM VIATRIS than you should
If you have taken an excessive dose of ALPRAZOLAM VIATRIS, 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 motor coordination, reduced muscle tone, low blood pressure, breathing difficulties, coma, death.

If you forget to take ALPRAZOLAM VIATRIS
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 missed dose.

If you stop taking ALPRAZOLAM VIATRIS
Do not stop taking ALPRAZOLAM VIATRIS abruptly. Always consult your doctor before stopping treatment. You must gradually reduce the dose to avoid withdrawal symptoms such as:

  • Withdrawal symptoms, including:
    • severe symptoms: feelings of detachment from oneself 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 low mood, insomnia;
  • Rebound symptoms, for example, anxiety. These are the same symptoms for which ALPRAZOLAM VIATRIS was prescribed and may temporarily reappear more intensely after abrupt discontinuation of treatment.

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 everybody will experience them.

Contact your doctor immediately if you experience any of the following side effects, as treatment with ALPRAZOLAM VIATRIS must be discontinued:

  • effects opposite to those expected (paradoxical effects) (see section 2, "Paradoxical reactions"), such as:
    • restlessness;
    • agitation;
    • irritability;
    • aggression;
    • 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);
  • difficulty in remembering events 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 ALPRAZOLAM VIATRIS").

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 in 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, deep sleep unresponsive to stimuli (lethargy);
  • nervousness;
  • balance disorders, problems with movement coordination;
  • attention and concentration difficulties;
  • tremors;
  • vertigo;
  • slurred speech;
  • blurred vision;
  • nausea;
  • dermatitis.

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.

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

  • increased levels of prolactin (a natural hormone) in the blood;
  • mood changes and abnormal thoughts;
  • hostile behaviours;
  • impulsivity and motor hyperactivity;
  • disturbances in the nervous system controlling bodily functions that cannot be voluntarily controlled (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 accumulation;
  • increased intraocular pressure.

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 ALPRAZOLAM VIATRIS

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 pack, and bottle after "Exp.". The expiry date refers to the last day of that month.
Tablets
Store in the original packaging to protect the medicine from light.
Oral drops
Validity after first opening: 90 days. You may record the date of first opening in the space provided on the outer carton.
Store 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 required. This will help protect the environment.

6. Package contents and other information

What ALPRAZOLAM VIATRIS contains
The active substance is alprazolam.
Tablets
One tablet of ALPRAZOLAM VIATRIS 0.25 mg contains 0.25 mg of alprazolam.
The other components are: lactose monohydrate, microcrystalline cellulose, sodium docusate, sodium benzoate, anhydrous colloidal silica, maize starch, magnesium stearate.
One tablet of ALPRAZOLAM VIATRIS 0.5 mg contains 0.5 mg of alprazolam.
The other components are: lactose monohydrate, microcrystalline cellulose, sodium docusate, sodium benzoate, anhydrous colloidal silica, maize starch, magnesium stearate, sunset yellow (E110), aluminium lake.
One tablet of ALPRAZOLAM VIATRIS 1 mg contains 1 mg of alprazolam.
The other components are: lactose monohydrate, microcrystalline cellulose, sodium docusate, sodium benzoate, anhydrous colloidal silica, maize starch, magnesium stearate, indigo carmine (E132), aluminium lake.
Oral drops
1 ml of ALPRAZOLAM VIATRIS oral drops solution contains 0.75 mg of alprazolam.
The other components are: alcohol, propylene glycol, sodium saccharin, grapefruit flavour, purified water.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., 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