Alprazolam EG

Patient Information Leaflet

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

Generic medicine
Please read all of this leaflet carefully before you take 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you should know before taking Alprazolam EG

Do not take Alprazolam EG if:

• you are allergic to alprazolam, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6);
• you have myasthenia gravis, a disease causing severe muscle weakness;
• you have severe breathing problems (respiratory failure);
• you have difficulty breathing during sleep ( sleep apnoea );
• you have severe liver problems (hepatic insufficiency) that may cause mental confusion (hepatic encephalopathy);
• you have intoxication caused by alcohol or other medicines acting on the central nervous system (hypnotic, analgesic, or psychotropic medicines);
• you suffer from an eye disease called closed-angle glaucoma, a condition caused by increased pressure inside the eyes. However, the medicine may be used if you have a form of the disease called open-angle glaucoma and are receiving appropriate treatment;
• the person taking the medicine is under 18 years of age (see section “Warnings and precautions”);
• you are in the first three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

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

• you are elderly and/or debilitated (see section 3 “How to take Alprazolam EG – Use in the elderly”). 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 and increase your risk of falls, often with serious consequences;
• you have chronic breathing problems (chronic respiratory insufficiency), as this medicine may worsen your condition. Your doctor may decide to reduce the dose;
• you have kidney problems (renal insufficiency) or liver problems of mild to moderate severity (mild to moderate hepatic insufficiency);
• you suffer from severe depression. Alprazolam EG, 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 affecting behaviour and causing difficulties in relating to others. Alprazolam EG is not recommended as primary treatment for this condition;
• you are being treated with other medicines acting on the brain and mind, as Alprazolam EG may enhance the effects of these medicines (see section “Other medicines and Alprazolam EG”);
• you have or have previously had problems with abuse and dependence on alcohol, drugs, or other medicines, as you have a higher risk of developing dependence on Alprazolam EG (see section “Development of dependence”).

Memory disturbances
A few hours after taking Alprazolam EG, you may have difficulty remembering events that occurred after taking the medicine.

Paradoxical reactions
Alprazolam EG 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, consult your doctor, as treatment with Alprazolam EG should be discontinued.

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

Development of dependence
Alprazolam EG causes dependence (i.e. you may experience an increasing desire to take the medicine or develop physical symptoms that decrease or disappear only after taking the medicine). The likelihood of developing dependence increases with higher doses, longer treatment duration, or concomitant use of multiple benzodiazepines. The risk is greater if you have previously abused drugs or alcohol or have personality disorders. Your doctor should reduce the dose gradually over several weeks. 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 in relation to Alprazolam EG therapy.

Incorrect use of Alprazolam EG
You must take this medicine ONLY if prescribed by a doctor and after purchasing it from a pharmacy.
Some people tend to abuse Alprazolam EG and other similar medicines known as benzodiazepines.
Moreover, some people obtain these medicines illegally (e.g. black market, internet, friends, family, etc.), sometimes to resell them. DO NOT take Alprazolam EG if it has not been prescribed by your doctor. DO NOT take Alprazolam EG if you are unsure whether the medicine was purchased from a pharmacy.
Withdrawal symptoms may occur when stopping this medicine, even if taken at recommended doses and for a short period (see section “If you stop taking Alprazolam EG”). To minimize these symptoms, a gradual dose reduction is recommended.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.

• During treatment with this medicine, you may experience behavioural disturbances such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, severe insomnia, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), behavioural changes, or sleepwalking. If you experience these symptoms, stop taking the medicine immediately. These reactions are more common in children and the elderly.

Benzodiazepines should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.

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

Other medicines and Alprazolam EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Concomitant use of Alprazolam EG and opioids (strong painkillers, substitution therapy medicines, 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 possible.
However, if your doctor prescribes Alprazolam EG 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 the doctor’s dosage recommendations. It may be helpful to inform friends or family members so they are aware of the above-mentioned signs and symptoms. Contact your doctor if such symptoms occur.
Caution is required when Alprazolam EG is taken with the following medicines:

• medicines acting on the brain and mind, such as:
• antipsychotics (neuroleptics), e.g. clozapine, used to treat certain mental illnesses;
• antidepressants such as nefazodone, fluvoxamine, fluoxetine, imipramine, desipramine, sertraline;
• hypnotics, medicines used to promote sleep;
• anxiolytics/sedatives, used to treat anxiety/tranquillisers;
• antidepressants (e.g. nefazodone, fluvoxamine, fluoxetine, imipramine, desipramine), medicines for treating depression;
• some strong painkillers ( narcotic analgesics such as propoxyphene, opioids), medicines for treating severe pain, which may cause increased feelings of well-being when taken with ALPRAZOLAM EG. This may increase your desire to continue taking these medicines (dependence);
• antiepileptics, used for epilepsy, such as carbamazepine and phenytoin;
• anaesthetics, used during surgical procedures. Anaesthetics, when administered with Alprazolam EG, may cause euphoria, increasing the likelihood of developing dependence on Alprazolam EG;
• sedating antihistamines, used to treat allergies;
• If you take Alprazolam EG together with one or more of these medicines or with alcoholic beverages, these substances may contribute to reduced brain and mind functions, potentially leading to reduced spontaneous breathing, coma, and death (see section “Warnings and precautions”).
• cough medicines with analgesic and sedative properties containing opium and its derivatives. These medicines, like Alprazolam EG, reduce spontaneous breathing capacity;
• cimetidine, a medicine used to reduce stomach acidity;
• propoxyphene, a medicine used for pain relief;
• oral contraceptives;
• diltiazem, used to reduce blood pressure;
• digoxin, a medicine used to increase the heart’s force of contraction. If you are elderly, taking Alprazolam EG may increase the likelihood of developing digoxin-related toxic effects;
• St. John’s wort, used to treat depression;
• muscle relaxants (muscle relaxants);
• warfarin, a medicine used to treat blood circulation problems;
• disulfiram, used to treat alcoholism;
• rifampicin, an antibiotic used to treat infections.

The following medicines may increase the effects of Alprazolam EG:

• ketoconazole, itraconazole, posaconazole, and voriconazole, medicines used to treat fungal infections;
• erythromycin, clarithromycin, telithromycin, and troleandomycin (antibiotics used against bacterial infections);
• 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 EG due to interaction with these medicines.

Alprazolam EG and alcohol
Do not drink alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine. This may affect your ability to drive vehicles and operate machinery.

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

Pregnancy
This medicine must not be taken during the first three months of pregnancy, as it may cause congenital malformations in the foetus. Your doctor will assess whether you may take this medicine during the second and third trimesters only if necessary and at low doses, always under strict medical supervision.
If you take this medicine during the last months of pregnancy or during labour, the newborn may show the following symptoms:
poor muscle tone (axial hypotonia), poor weight gain, breathing difficulties (respiratory depression or apnoea), difficulty feeding, and low body temperature (hypothermia). If Alprazolam EG has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms (see section 3 “If you stop taking Alprazolam EG”) such as hyperexcitability, agitation, and tremors. These effects are reversible and may last from a few days up to 1–3 weeks after birth.

Breastfeeding
Do not breastfeed while taking Alprazolam EG, as this medicine passes into breast milk.

Fertility
If you are of childbearing age, contact your doctor to discontinue the medicine if you plan to become pregnant or suspect you are pregnant.

Driving and using machines
Taking Alprazolam EG may affect your ability to drive vehicles and operate machinery, as you may experience sedation, amnesia (memory loss), difficulty concentrating, drowsiness, dizziness, and muscle weakness.
Do not drive or operate machinery if, during treatment with Alprazolam EG, 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 have consumed alcoholic beverages.

Alprazolam EG tablets contain lactose, sodium, and the colouring agent sunset yellow (E110)
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Alprazolam EG 0.50 mg tablets contain the colouring agent sunset yellow (E110), which may cause allergic reactions.

Alprazolam EG oral drops contain alcohol (ethanol), propylene glycol, and sodium saccharin
This medicine contains 16 vol% alcohol (ethanol), e.g. up to 130 mg per 1 ml (equivalent to 30 drops).
The amount in 1 ml of this medicine is equivalent to less than 3.2 ml of beer or 1.3 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 700 mg of propylene glycol per ml. If you are pregnant or breastfeeding, or suffer from liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Alprazolam EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor advises.
Your doctor will prescribe the appropriate dose based on the severity of your condition and your response to
the medicine.
Always use the lowest effective dose and do not exceed the maximum recommended dose to avoid unwanted effects.
The duration of treatment 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 be continued beyond the maximum recommended period.

Treatment of anxiety
The recommended starting dose is 0.25 to 0.50 mg (or 10–20 drops of oral solution) three times a day,
which may be gradually increased by your doctor up to a maximum of 4 mg per day, taken in divided 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 (or 10 drops of oral solution) two or three times a day, which may
be increased if necessary, provided it is well tolerated.

Use in children and adolescents
The use of Alprazolam EG is not recommended in children and adolescents under 18 years of age.

Instructions for opening the bottle of oral drops

• Press down on the plastic cap and simultaneously unscrew it

• To close, screw the cap tightly back on

If you take more Alprazolam EG than you should
If you (or someone else) have taken an excessive dose of Alprazolam EG, or if you suspect that a child may
have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
An overdose may cause marked depression of the central nervous system, with symptoms such as dizziness,
mental confusion, drowsiness, pathological deep sleep (lethargy), difficulty speaking, loss of motor coordination,
reduced muscle tone, low blood pressure, breathing difficulties, and rarely coma or, very rarely, death.

If you forget to take Alprazolam EG
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 EG
Do not stop treatment with Alprazolam EG suddenly or without first discussing it with your
doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, your dose will be gradually reduced (by no more than 0.5 mg every 3
days) to minimize withdrawal symptoms such as:

• mild low mood, insomnia;
• headache, muscle pain, tension;
• anxiety, confusion, restlessness, irritability;
• severe symptoms: derealization (feeling that things are not real), depersonalization (feeling detached from oneself or the external world), sound intolerance (hyperacusis), numbness and tingling in hands and feet, hypersensitivity to light, sound and physical touch, hallucinations (seeing or hearing things that are not real), epileptic seizures, muscle and abdominal cramps, vomiting, sweating, tremors and convulsions.

Treatment must be discontinued gradually; otherwise, the symptoms for which you were being treated may
reappear, even more intensely than before (rebound symptoms, e.g. anxiety). The risk of developing such
symptoms is greater if you stop taking Alprazolam EG abruptly.
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 because treatment with Alprazolam EG must be discontinued:

• restlessness,
• agitation,
• irritability,
• aggression,
• feelings of disappointment,
• anger,
• nightmares,
• severe insomnia,
• hallucinations (seeing or hearing things that are not real),
• disturbances in thinking,
• changes in behaviour,
• sleepwalking.

These reactions occur more frequently in children and elderly patients.

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 remembering events that occurred after taking 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 EG").

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

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

• drowsiness;
• sedation;
• depression;
• 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):

• blurred vision;
• nausea;
• decreased appetite, decreased or increased body weight;
• confusion, disorientation;
• increased or decreased sexual desire, sexual dysfunction;
• anxiety;
• insomnia, excessive sleepiness;
• nervousness;
• balance disorders, difficulty controlling movements (ataxia), problems with coordination of movements;
• loss of attention and concentration;
• excessive drowsiness (lethargy);
• tremors;
• vertigo;
• slurred speech;
• dermatitis;
• dizziness (lightheadedness);
• dependence (see section "Warnings and precautions").

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

• drug withdrawal syndrome;
• increased prolactin levels (hyperprolactinaemia);
• changes in blood test values (blood dyscrasias);
• double vision;
• vomiting and diarrhoea;
• increased liver enzyme levels and yellowing of the skin and whites of the eyes (jaundice);
• muscle weakness;
• inability to recall recent life events;
• difficulty maintaining posture (dystonia);
• obsessive thoughts and behaviours;
• hostile behaviour, hallucinations, anger, aggression, agitation;
• abnormal thoughts;
• increased psychomotor activity (stimulation);
• psychiatric disorders, paradoxical reactions (see section "Warnings and precautions");
• involuntary loss of urine (incontinence), inability to completely empty the bladder;
• menstrual cycle irregularities;
• increased pressure inside the eye.

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

• mood changes;
• impulsivity;
• disturbances in the autonomic nervous system responsible for bodily functions that cannot be controlled voluntarily (e.g. internal organ and gland functions);
• involuntary muscle contractions causing unnatural postures;
• stomach and intestinal disorders;
• skin reactions due to exposure to sunlight;
• reduced blood pressure (hypotension);
• changes in heart rate (tachycardia);
• increased salivation;
• digestive problems (dysphagia);
• inflammatory liver diseases (hepatitis);
• changes in liver function;
• anorexia;
• blunted emotions, reduced alertness;
• nerve problems (autonomic manifestations);
• stuffy nose (nasal congestion);
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing (angioedema);
• swelling of hands and feet due to fluid accumulation;
• misuse of this medicine (tendency to excessive or inappropriate use of Alprazolam EG).

The following side effects occur mainly at the beginning of treatment and usually disappear with repeated administration: drowsiness, sedation, mood changes, reduced attention, confusion, fatigue, headache, dizziness (lightheadedness), vertigo, muscle weakness, ataxia, double or blurred vision, insomnia, nervousness/anxiety, tremor, weight changes.

The use of benzodiazepines may unmask pre-existing depression. The use of this medicine may lead to physical dependence, and discontinuation of treatment may result in withdrawal or rebound symptoms. Abuse of benzodiazepines has been reported (see sections "Warnings and precautions" and "If you stop taking Alprazolam EG").

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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Oral drops should be used within 6 months of first opening the bottle.
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 EG contains
Alprazolam EG 0.25 mg tablets
The active substance is alprazolam. Each tablet contains 0.25 mg of alprazolam.
The other components are sodium docusate, monohydrate lactose, colloidal silicon dioxide, microcrystalline cellulose, maize starch, magnesium stearate.
Alprazolam EG 0.50 mg tablets
The active substance is alprazolam. Each tablet contains 0.50 mg of alprazolam.
The other components are sodium docusate, monohydrate lactose, colloidal silicon dioxide, microcrystalline cellulose, maize starch, magnesium stearate, sunset yellow (E 110) aluminium lake.
Alprazolam EG 1 mg tablets
The active substance is alprazolam. Each tablet contains 1 mg of alprazolam.
The other components are sodium docusate, monohydrate lactose, colloidal silicon dioxide, microcrystalline cellulose, maize starch, magnesium stearate, indigo carmine (E 132) aluminium lake.
Alprazolam EG 0.75 mg/ml oral drops solution
The active substance is alprazolam. 1 ml of solution contains 0.75 mg of alprazolam.
The other components are ethanol, propylene glycol, sodium saccharin, cherry flavour, purified water.

Description of the appearance of Alprazolam EG and contents of the pack
Tablets: packs of 20 tablets of 0.25 mg, 0.50 mg and 1 mg.
Oral drops, solution: 20 ml bottle.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan

Manufacturers
Tablets:
MIPHARM S.p.A., Via B. Quaranta, 12 - 20141 Milan
DOPPEL Farmaceutici S.r.l., Via Volturno, 20089 - Quinto de' Stampi, Rozzano - Milan
ICE S.p.A., Via Cantone Moretti, 29, Località San Bernardo – 10015 Ivrea (TO) - Italy

Oral drops, solution:
MIPHARM S.p.A., Via B. Quaranta, 12 - 20141 Milan
DOPPEL Farmaceutici S.r.l., Via Martiri delle Foibe, 1 - 29016 Cortemaggiore – Piacenza
ICE S.p.A., Via Cantone Moretti, 29, Località San Bernardo – 10015 Ivrea (TO) - Italy