Alprazolam Ratiopharm

Package leaflet: Information for the patient

Alprazolam ratiopharm 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets

Equivalent medicinal product
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, as it could be harmful.
• 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 Alprazolam ratiopharm is and what it is used for
2. What you need to know before taking Alprazolam ratiopharm
3. How to take Alprazolam ratiopharm
4. Possible side effects
5. How to store Alprazolam ratiopharm
6. Contents of the pack and other information

1. What Alprazolam ratiopharm is and what it is used for

Alprazolam ratiopharm contains alprazolam, a substance that belongs to a group of medicines called benzodiazepines (anxiolytic medicines).
This medicine is indicated 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 must know before taking Alprazolam ratiopharm

Do not take Alprazolam ratiopharm

• if you are allergic to alprazolam, to other similar medicines (other benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe breathing problems (severe respiratory insufficiency);
• if you have severe liver problems (severe hepatic insufficiency);
• if you suffer from a disease causing muscle weakness and fatigue (myasthenia gravis);
• if you have breathing difficulties during sleep (sleep apnea);
• if you suffer from a condition characterized by a marked increase in eye pressure (acute angle-closure glaucoma);
• if you are taking medicines with central nervous system depressant effects (such as antipsychotics, antidepressants, hypnotics), unless your doctor considers it strictly necessary;
• during pregnancy (first 3 months) or breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• together with alcoholic beverages.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alprazolam ratiopharm.
Avoid taking this medicine if you are taking medicines that depress the central nervous system (calming effect on the brain), unless absolutely necessary (your doctor will advise you when it may be taken), as concomitant use of these medicines could cause excessive calming effects (profound sedation).
Pay special attention and consult your doctor before taking Alprazolam ratiopharm:

• if you are elderly and/or debilitated. Your doctor will prescribe a reduced dose of this medicine. Benzodiazepines and benzodiazepine-like substances should be used with caution in elderly patients due to the risk of sedation and/or musculoskeletal weakness, which may increase the risk of falls, often with serious consequences in this population;
• if your respiratory function is impaired (chronic respiratory insufficiency), because this medicine may worsen your condition;
• if your liver function is impaired (mild or moderate hepatic insufficiency);
• if your kidney function is impaired (renal insufficiency);
• if you suffer from a psychotic disorder (a severe mental condition in which a person loses contact with reality and the ability to think and judge clearly). Alprazolam ratiopharm is not recommended as primary treatment for this condition;
• if you are being treated with other psychotropic medicines;
• if you suffer from depression or anxiety associated with depression. Alprazolam ratiopharm, like other benzodiazepines, should not be used alone to treat depression or anxiety related to depression, as it may worsen suicidal tendencies or cause mood changes;
• if you have previously abused alcohol or drugs (see section 2 “Dependence and withdrawal”). Your doctor will prescribe the most appropriate dose based on your physical and clinical condition.

Additionally, you must stop treatment and contact your doctor immediately if you experience effects opposite to those expected (paradoxical reactions), such as:
behavioral disorders such as restlessness, agitation, irritability, aggressiveness, confusion (delirium), anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disturbances. These reactions are more common in children and elderly patients (see section “Possible side effects”).

Tolerance
If, after several weeks of treatment with this medicine, you feel that the medicine no longer has an effect on your symptoms, consult your doctor.

Dependence and withdrawal
While taking benzodiazepines, such as alprazolam, there may be a risk of developing dependence, i.e., an uncontrollable need to continue taking the medicine. This risk increases with higher doses and longer treatment duration. Therefore, your doctor will prescribe the most appropriate treatment based on your condition, using the lowest effective dose for the shortest possible duration. Your doctor will also advise you when to schedule follow-up visits to monitor your health during Alprazolam ratiopharm therapy. This phenomenon is more likely if you have previously abused drugs or alcohol, if you suffer from severe personality disorders, or if you are taking multiple benzodiazepines simultaneously.
If you develop dependence, you must avoid stopping treatment abruptly, as withdrawal symptoms may occur:

• headache;
• muscle pain;
• extreme anxiety, tension, restlessness, confusion, and irritability;
• insomnia. In severe cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling detached from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, hypersensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that do not exist), or epileptic seizures (neurological disturbances causing sudden, uncontrollable movements), muscle and abdominal cramps, vomiting, sweating, tremors.

Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one (such as alprazolam). Therefore, switching from one benzodiazepine to another is not recommended. Your doctor will advise you on the most appropriate treatment for your case.
It is important to know that after stopping treatment with this medicine, the same symptoms for which you were being treated may reappear, sometimes even more intensely than before (rebound symptoms).
Since withdrawal or rebound symptoms are more likely when treatment is stopped abruptly, it is recommended to gradually reduce the dose before stopping treatment completely, in order to minimize the occurrence of such symptoms (mood changes, anxiety, restlessness, and sleep disturbances).

Amnesia
Benzodiazepines may cause anterograde amnesia (memory loss that does not affect past memories but severely impairs the ability to memorize new information).
This phenomenon occurs more frequently several hours after taking the medicine.

Children and adolescents
The use of benzodiazepines in children and adolescents under 18 years of age is not recommended.

Other medicines and Alprazolam ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pay particular attention and inform your doctor if you are taking any of the following medicines:

• opioids, especially if you are elderly. Concomitant use of Alprazolam ratiopharm and opioids (strong analgesics, substitution therapy drugs, or cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, potentially endangering the patient’s life. Therefore, concomitant use should only be considered when no alternative therapies are available. However, if your doctor prescribes Alprazolam ratiopharm together with opioids, the dose and duration of concomitant treatment must be as low and as short as possible, as determined by your doctor. Inform your doctor about all opioid medicines you are taking and carefully follow their dosage recommendations. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience these symptoms;
• antipsychotics (neuroleptics) used to treat mental disorders;
• antidepressants (e.g., nefazodone, fluvoxamine, fluoxetine, imipramine, desipramine), used to treat depression;
• hypnotics (used to promote sleep);
• anxiolytics/sedatives (used to treat anxiety);
• antiepileptics (used for epilepsy);
• anesthetics (used during surgical procedures);
• narcotic analgesics (opioid painkillers). Narcotic analgesics, when administered together with alprazolam, may cause euphoria, increasing the likelihood of developing dependence;
• antihistamines (used to treat allergies);
• antifungals (used for fungal infections) such as ketoconazole, itraconazole, posaconazole, voriconazole;
• diltiazem (used to lower blood pressure);
• digoxin (used to treat cardiac function disorders). If you are elderly, taking alprazolam may increase the risk of digoxin-related toxic effects;
• cimetidine (used to reduce stomach acidity);
• propoxyphene (used for pain relief);
• oral contraceptives;
• protease inhibitors (e.g., ritonavir), medicines used to treat HIV infection. If you are taking protease inhibitors, your doctor may advise discontinuing alprazolam due to potential interactions with these medicines;
• antibiotics (used to treat bacterial infections) such as erythromycin, clarithromycin, telithromycin, and troleandomycin.

Alprazolam ratiopharm and alcohol
DO NOT consume alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine.

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

Pregnancy
Do not take Alprazolam ratiopharm during the first 3 months of pregnancy, as 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 Alprazolam ratiopharm as prescribed by your doctor at low doses during the final stages of pregnancy, your baby may develop symptoms of the “Floppy Infant Syndrome,” such as reduced muscle strength in the spine (axial hypotonia) and difficulties with sucking, which may impair your baby’s normal weight gain. If, however, you take Alprazolam ratiopharm at high doses during late pregnancy or during labor, as medically necessary and under medical supervision, your baby may develop low body temperature (hypothermia) and breathing difficulties (respiratory depression or apnea). Additionally, a few days after birth, your baby may experience withdrawal symptoms such as hyperexcitability, agitation, and tremors, even if the “Floppy Infant Syndrome” does not occur.

Breastfeeding
Do not take this medicine if you are breastfeeding, as alprazolam passes into breast milk.

Driving and using machines
Alprazolam ratiopharm may impair your ability to drive vehicles and operate machinery, as memory impairment, sedation, concentration disturbances, and muscle function alterations may occur during treatment. Furthermore, if you have not had sufficient rest, the risk of impaired attention is higher.
Therefore, until you can rule out drowsiness or dizziness, it may be dangerous to engage in activities requiring full mental alertness, such as operating dangerous machinery or driving vehicles.
Finally, remember that consuming alcohol during treatment with this medicine enhances the sedative effect of alprazolam, causing pronounced drowsiness and further reducing your level of alertness.

Alprazolam ratiopharm tablets contain:

• lactose: if your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine;
• sodium: this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”;
• sodium benzoate: this medicine contains 0.1125 mg of sodium benzoate per tablet.

Alprazolam ratiopharm 0.50 mg tablets also contain Sunset Yellow (E110): may cause allergic reactions.

3. How to take Alprazolam ratiopharm

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
You must continue taking this medicine until your doctor tells you otherwise.
Your doctor will determine the correct dose for you based on your health condition and your response to the medicine. Never exceed the dose prescribed by your doctor.
During treatment, your doctor may adjust the dosage: always follow the prescribed dosage carefully.

Alprazolam ratiopharm 0.50 mg and 1 mg tablets
The score line is intended to facilitate tablet splitting if you have difficulty swallowing it whole.

Anxiety
The recommended single dose may range from 0.25 mg to 0.50 mg, taken three times daily. Your doctor may increase the dose according to your health condition, up to a maximum of 4 mg daily, divided into several doses.

The duration of treatment should be as short as possible.
The maximum 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.

Special populations
The lowest dose should be used, especially in elderly or debilitated patients. The duration of treatment with Alprazolam ratiopharm should be as short as possible. The treatment period may be extended only after frequent reassessment of your health condition by your doctor.

If you take more Alprazolam ratiopharm than you should
If you accidentally take an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department without delay.
Taking an excessive dose of alprazolam together with other medicines that depress the central nervous system or with alcohol may result in fatal outcomes.
Symptoms of overdose may include central nervous system depression, such as drowsiness, mental confusion, lethargy (deep sleep), and in more severe cases, muscle problems (ataxia, hypotonia), low blood pressure (hypotension), breathing difficulties, rarely coma, and very rarely death.

If you forget to take Alprazolam ratiopharm
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 ratiopharm
Do not stop treatment with Alprazolam ratiopharm suddenly or without first discussing it with your doctor, as withdrawal or rebound symptoms may occur (see section “Warnings and precautions”).

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 gets them.
Stop taking the medicine and contact your doctor immediately if you experience:

• behavioural disorders such as restlessness, agitation, irritability, aggression, confusion (delirium), anger, nightmares, hallucinations, psychosis, inappropriate behaviour and other behavioural disturbances. These reactions are more frequent in children and elderly patients (see section 2 “Warnings and precautions”);
• skin rashes, itching, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema). These may be signs of serious allergic reactions (anaphylactic shock).

To help you recognise some of these side effects, it may be helpful to inform a close family member or friend
that you are taking this medicine, and ask them to read this leaflet. You may ask them to let you know if they notice any changes in your behaviour.

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

• depression;
• sedation;
• drowsiness;
• lack of muscular coordination (ataxia);
• memory impairment;
• speech disorder (dysarthria);
• dizziness;
• headache;
• constipation;
• dry mouth;
• fatigue;
• irritability.

Common (may affect up to 1 in 10 people)

• decreased appetite;
• confusion and disorientation;
• decreased or increased sexual desire;
• anxiety;
• insomnia;
• nervousness;
• disturbances in balance and movement coordination;
• loss of attention and concentration;
• sleep disorders (hypersomnia, lethargy);
• mental dullness;
• tremors;
• vertigo;
• blurred vision;
• nausea;
• dermatitis;
• sexual dysfunction;
• tiredness and weakness (asthenia);
• decrease or increase in body weight.

Uncommon (may affect up to 1 in 100 people)

• increased blood levels of prolactin (hyperprolactinaemia);
• hallucinations;
• anger, aggression, hostile behaviour and agitation;
• altered sexual desire (libido);
• abnormal thoughts;
• excitement;
• development of obsessive thoughts (mania);
• amnesia;
• motor difficulty (dystonia);
• vomiting;
• abnormal liver function;
• yellowing of the skin and whites of the eyes (jaundice);
• muscle weakness;
• involuntary loss of urine (incontinence);
• difficulty urinating (urinary retention);
• irregular menstruation;
• increased pressure in the eye (intraocular pressure);
• substance abuse dependence;
• drug withdrawal syndrome.

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

• mood disorder (hypomania);
• increased physical and mental activity (psychomotor hyperactivity);
• stomach and intestinal problems;
• angioedema (swelling of the face, lips and tongue, airway obstruction);
• abnormal and exaggerated reaction to sunlight exposure (photosensitivity reaction);
• peripheral oedema (fluid accumulation in the lower limbs);
• autonomic nervous system disturbances (nausea, vomiting, palpitations, cold sweating, anxiety or distress);
• inflammation of the liver (hepatitis);
• physical and psychological dependence, leading to excessive and uncontrolled use (abuse) of the medicine (see also section “Warnings and precautions”);
• withdrawal or rebound phenomena upon discontinuation of treatment (see also section “Warnings and precautions”).

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 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 ratiopharm

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “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 ratiopharm contains
Alprazolam ratiopharm 0.25 mg tablets

• The active substance is alprazolam. One tablet contains 0.25 mg of alprazolam.
• The other components are: sodium docusate, sodium benzoate, maize starch, microcrystalline cellulose, monohydrate lactose, magnesium stearate, anhydrous colloidal silica.

Alprazolam ratiopharm 0.50 mg tablets

• The active substance is alprazolam. One tablet contains 0.5 mg of alprazolam.
• The other components are: sodium docusate, sodium benzoate, maize starch, microcrystalline cellulose, monohydrate lactose, magnesium stearate, anhydrous colloidal silica, sunset yellow (E110) aluminium lake.

Alprazolam ratiopharm 1 mg tablets

• The active substance is alprazolam. One tablet contains 1 mg of alprazolam.
• The other components are: sodium docusate, sodium benzoate, maize starch, microcrystalline cellulose, monohydrate lactose, magnesium stearate, anhydrous colloidal silica, indigo carmine (E132) aluminium lake.

Description of the appearance of Alprazolam ratiopharm and package contents
Alprazolam ratiopharm is presented in a box containing 20 tablets in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH - Graf-Arco Strasse 3 - 89079 Ulm (Germany)
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy