Alprazolam Ratiopharm Italia: detailed information

Package leaflet: Information for the patient

Alprazolam ratiopharm Italia 750 micrograms/ml oral drops, solution

Generic medicine
Please read all of this leaflet carefully before you start 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Alprazolam ratiopharm Italia contains alprazolam, a substance that belongs to a group of medicines called benzodiazepines (anxiolytic agents).
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 should know before taking Alprazolam ratiopharm Italia

Do not take Alprazolam ratiopharm Italia

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 problems during sleep (sleep apnoea);
if you suffer from a condition characterized by a marked increase in eye pressure (acute closed-angle glaucoma);
if you are taking medicines with central nervous system depressant activity (such as antipsychotics, antidepressants, hypnotics), unless your doctor considers it strictly necessary;
during pregnancy (in the 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 Italia.
Avoid taking this medicine if you are taking medicines that depress the central nervous system (central nervous system depressants), unless absolutely necessary (your doctor will advise you when it may be taken), as concomitant use of these medicines may cause excessive sedative effects (deep sedation).
Take particular care and consult your doctor before taking Alprazolam ratiopharm Italia:

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 the elderly due to the risk of sedation and/or musculoskeletal weakness, which may lead to falls, often with serious consequences in this population;
if your respiratory function is impaired (chronic respiratory insufficiency), as 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 Italia 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 states associated with depression. Alprazolam ratiopharm Italia, like other benzodiazepines, should not be used alone to treat depression or depression-related anxiety, 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 for you, based on your physical and clinical condition.
Moreover, you must stop treatment and contact your doctor immediately if you experience effects opposite to those expected (paradoxical reactions), such as:
behavioural disorders including restlessness, agitation, irritability, aggressiveness, confusion (delirium), anger, nightmares, hallucinations, psychosis, inappropriate behaviour and other behavioural disturbances. These reactions are more common in children and the elderly (see section “Possible side effects”).
Tolerance
If, after several weeks of treatment with this medicine, you feel that the medicine is no longer effective on your symptoms, consult your doctor.
Dependence and withdrawal
During treatment with 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 duration of treatment. Therefore, your doctor will prescribe the most suitable treatment for your condition, using the lowest effective dose for the shortest possible time. Your doctor will also advise you when to have follow-up visits to monitor your health in relation to Alprazolam ratiopharm Italia 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 because the following 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 of detachment from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, hypersensitivity to light, noise and physical contact, hallucinations (seeing or hearing things that do not exist), epileptic seizures (neurological disturbances causing sudden, uncontrolled 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 until treatment is discontinued, in order to minimize the occurrence of such symptoms (mood changes, anxiety, restlessness and sleep disturbances).
Amnesia
Benzodiazepines may cause anterograde amnesia (loss of memory that does not affect past memories, but greatly impairs the individual's ability to memorize new information).
This phenomenon occurs more frequently a few 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 Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Take particular care and inform your doctor if you are taking any of the following medicines:

opioids, especially if you are elderly. Concomitant use of Alprazolam ratiopharm Italia 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 Italia together with opioids, the dose and duration of concomitant treatment must be as low and as short as possible, and must be 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 and desipramine) used to treat depression;
hypnotics used to promote sleep;
anxiolytics/sedatives used to treat anxiety;
antiepileptics used for epilepsy;
anaesthetics used during surgical procedures;
narcotic analgesics (opioid painkillers). Narcotic analgesics 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 reduce blood pressure);
digoxin (used for treating cardiac function disorders). If you are elderly, taking alprazolam may increase the likelihood of developing toxic effects due to digoxin;
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 being treated with protease inhibitors, your doctor may advise you to discontinue alprazolam treatment due to interaction with these medicines;
antibiotics (used to treat bacterial infections) such as erythromycin, clarithromycin, telithromycin and troleandomycin;
medicines containing alcohol.

Alprazolam ratiopharm Italia 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Alprazolam ratiopharm Italia 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 Italia as directed by your doctor at low doses during the late stages of pregnancy, your baby may develop symptoms of "floppy infant syndrome", such as reduced muscle strength in the spine (axial hypotonia) and difficulties in sucking liquids, which may impair your baby's normal weight gain.
If, however, due to medical necessity and under your doctor's guidance, you take Alprazolam ratiopharm Italia at high doses during the final stage of pregnancy or during labour, your baby may develop low body temperature (hypothermia) and breathing difficulties (respiratory depression or apnoea). In addition, a few days after birth, your baby may experience withdrawal symptoms such as hyperexcitability, agitation and tremors, even if "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 Italia may impair your ability to drive or operate machinery, as amnesia, sedation, impaired concentration and altered muscle function may occur during treatment. Furthermore, if you have not had sufficient rest, the risk of impaired attention is higher.
Therefore, until it can be ruled out that drowsiness or dizziness occurs, 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 and may cause pronounced drowsiness and further reduced attention.
Alprazolam ratiopharm Italia contains:
This medicine contains 47.5 mg of alcohol (ethanol) per 0.25 mg dose (equivalent to 10 drops) and 190 mg of alcohol (ethanol) per 1 mg dose (equivalent to 40 drops). The amount in each 40-drop dose of this medicine is equivalent to less than 5 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
High-dose administration
The maximum daily dose of 4 mg (equivalent to 160 drops) contains approximately 760 mg of alcohol (ethanol). The amount in each 160-drop dose of this medicine is equivalent to about 18 ml of beer or 7 ml of wine.
The amount of alcohol in this medicine does not appear to have significant effects in adults and adolescents, and its effects in children are not evident. Some effects may occur in young children, for example drowsiness.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If you are alcohol-dependent, talk to your doctor before taking this medicine.
This medicine contains approximately 247 mg of propylene glycol per 0.25 mg dose (equivalent to 10 drops), equivalent to 0.004 mg/kg (assuming a body weight of 60 kg), and 988 mg per 1 mg dose (equivalent to 40 drops), equivalent to 16.46 mg/kg (assuming a body weight of 60 kg). Use of this medicine is not recommended in paediatrics.
High-dose administration
If you are pregnant or breastfeeding, or 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.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose (equal to 4 mg of alprazolam), i.e. essentially "sodium-free".
This medicine contains approximately 1 mg of benzyl alcohol per 1 mg dose (equivalent to 40 drops), equivalent to 0.016 mg/kg (assuming a body weight of 60 kg). Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease or if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Alprazolam ratiopharm Italia

Take this medicine exactly as stated in this leaflet or according to your doctor's or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor tells you to.
Your doctor will determine the correct dose for you, depending 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.

Anxiety
The recommended single dose may range from 0.25 mg (10 drops) to 0.50 mg (20 drops), taken three times daily. Your doctor may increase the dose according to your health condition, up to a maximum of 4 mg, 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 possible dose should be used, especially in elderly or debilitated patients. The duration of treatment with Alprazolam ratiopharm Italia should be as short as possible. The treatment period may be extended following frequent reassessments of your health condition by your doctor.

If you take more Alprazolam ratiopharm Italia than you should
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital without delay.
Taking an excessive dose of alprazolam together with other medicines that depress the central nervous system or with alcohol may result in a fatal outcome.
Symptoms of overdose are related to depression of the central nervous system and may include 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 Italia
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 Alprazolam ratiopharm Italia
Do not stop treatment with Alprazolam ratiopharm Italia abruptly 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 will experience them.
Stop taking this 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 the side effects, it may be helpful to inform a relative or close 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 may include:
Very common (may affect more than 1 in 10 people)

depression;
sedation;
drowsiness;
lack of muscle 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;
sexual dysfunction;
anxiety;
insomnia; sleep disorders (hypersomnia, lethargy);
nervousness;
disturbances in balance and coordination of movements;
loss of attention and concentration;
mental dullness;
tremors;
vertigo;
blurred vision;
nausea;
dermatitis;
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 sweats, anxiety or distress);
inflammation of the liver (hepatitis);
physical and psychological dependence, leading to a need for 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: 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 ratiopharm Italia

Keep in the original packaging to protect the medicine from light.
The product must be used within 3 months of first opening the bottle. Any unused product must be discarded.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Alprazolam ratiopharm Italia contains

The active substance is alprazolam. 1 ml of solution contains 750 micrograms of alprazolam.
The other components are: propylene glycol, ethanol 96 percent, sodium saccharin, black cherry flavour (containing ethanol, propylene glycol and benzyl alcohol), purified water.

Description of the appearance of Alprazolam ratiopharm Italia and package contents
Alprazolam ratiopharm Italia 750 micrograms/ml oral drops, solution is presented in a box containing a bottle with a dropper of 20 ml of solution.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy