Alprazolam Hexal AG

Italy
Brand name Alprazolam Hexal AG
Form tablets
Active substance / Dosage
ALPRAZOLAM
Prescription type Prescription only
ATC code
N05BA12
Registration number 036860
Manufacturer HEXAL AG

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

ALPRAZOLAM HEXAL AG 0.25 mg tablets, 0.5 mg tablets, 1 mg tablets

Alprazolam
Generic medicine
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 may be harmful.
  • If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Alprazolam Hexal AG is and what it is used for

ALPRAZOLAM HEXAL AG is used:

  • to treat severe symptoms of anxiety that may cause distress or interfere with normal daily activities. ALPRAZOLAM HEXAL AG belongs to a group of medicines called benzodiazepines, whose sedative and muscle-relaxant effects help reduce anxiety.

2. What you need to know before taking Alprazolam Hexal AG

Do not take ALPRAZOLAM HEXAL AG if

  • you are allergic to alprazolam or other benzodiazepine-like medicines, or to any of the excipients of this medicine (listed in section 6);
  • you suffer from a particular form of muscle weakness (myasthenia gravis);
  • you suffer from severe respiratory disorders (e.g. chronic bronchitis or emphysema);
  • you suffer from breathing interruptions during sleep (sleep apnoea syndrome);
  • you suffer from severely impaired liver function.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALPRAZOLAM HEXAL AG

  • if you notice that the effect of the tablets decreases after a few weeks of use;
  • if you are concerned about symptoms indicating possible physical and psychological dependence on alprazolam. Psychological dependence becomes evident as soon as you feel you do not want to stop taking the medicine. Physical dependence occurs when withdrawal symptoms appear after abruptly stopping treatment with this medicine (see section “If you stop taking ALPRAZOLAM HEXAL AG”). The risk of dependence increases with higher doses and longer treatment duration, which should therefore be kept as short as possible;
  • if you have previously suffered from alcohol and/or drug dependence: in this case, the risk of dependence on alprazolam increases;
  • when stopping treatment.

Any pre-existing conditions may temporarily reappear, often more intensely. You may also experience, among others, symptoms such as mood changes, insomnia, and restlessness. This risk increases if the dosage is reduced too rapidly or if treatment is stopped abruptly.
In such cases, treatment with alprazolam does not necessarily need to be resumed. Instead, your doctor should gradually reduce the dosage over several weeks (see section “How to take ALPRAZOLAM HEXAL AG”);

  • if you experience memory loss. This symptom mainly occurs a few hours after taking the tablet (see section 4). To reduce the risk, patients should ensure they have an uninterrupted sleep of 7–8 hours.
  • if you experience paradoxical reactions, such as:
    • anxiety
    • irritability
    • rage attacks
    • nightmares
    • worsening of insomnia
    • hallucinations (perception of things that do not exist)
    • severe mental disorders affecting behavioural control and actions (psychosis)
    • inappropriate behaviour and other behavioural disturbances.

These paradoxical reactions occur more frequently in children and elderly patients. If these symptoms occur, inform your doctor, as discontinuation of treatment may be necessary;

  • if you suffer from chronic chest tightness, you should be aware that ALPRAZOLAM HEXAL AG may worsen this condition;
  • if you consume alcoholic beverages or tranquilisers concurrently, as the sedative effect of ALPRAZOLAM HEXAL AG may be intensified;
  • if you suffer from severe depression. ALPRAZOLAM HEXAL AG may occasionally cause excessively elevated mood (mania) or increased suicidal tendencies;
  • if you suffer from a severe mental disorder affecting your behaviour, actions, and self-control (psychosis); in this case, ALPRAZOLAM HEXAL AG is not an appropriate medicine;
  • if you have a particular form of sudden increase in intraocular pressure (narrow-angle glaucoma) or are at risk of this condition;
  • if you have impaired renal function or mild to moderate hepatic insufficiency;
  • if you are elderly, as you are more likely to fall and may fracture a hip bone.

If any of the above situations apply to you, inform your doctor.
Children and adolescents
Alprazolam is not indicated for children and adolescents under 18 years of age.
Other medicines and ALPRAZOLAM HEXAL AG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially the medicines listed below, as the effect of ALPRAZOLAM HEXAL AG may be stronger when taken at the same time.
Medicines that increase the sedative effect of ALPRAZOLAM HEXAL AG:

  • sedatives and tranquilisers
  • medicines used to treat severe mental disorders (antipsychotics)
  • medicines used to treat severe forms of depression
  • medicines used to treat epilepsy
  • medicines used for anaesthesia
  • some medicines used to treat allergies, the so-called sedative antihistamines.

Concomitant use of Alprazolam Hexal AG 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 possible.
However, if your doctor prescribes Alprazolam Hexal AG together with opioids, the dose and duration of concomitant therapy must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members to be aware of the signs and symptoms listed above. Contact your doctor if such symptoms occur.
These painkillers may also increase the risk of euphoria and dependence.
Medicines that increase the effect of ALPRAZOLAM HEXAL AG due to inhibition of alprazolam breakdown in the liver:

  • nefazodone, fluvoxamine, fluoxetine, sertraline (medicines used to treat severe forms of depression)
  • cimetidine, a medicine used to treat gastrointestinal disorders
  • some medicines used to treat AIDS (known as “HIV protease inhibitors”, e.g. ritonavir, saquinavir, indinavir)
  • dextropropoxyphene, used to treat pain
  • oral contraceptive pills
  • diltiazem, a medicine used to treat hypertension and heart disorders
  • macrolide antibiotics, such as erythromycin, used to treat infections
  • some medicines used to treat fungal infections, such as ketoconazole and itraconazole.

Medicines that decrease the effect of ALPRAZOLAM HEXAL AG due to increased breakdown of alprazolam in the liver:

  • carbamazepine or phenytoin, used to treat epilepsy and other disorders
  • St. John’s wort, a herbal remedy used to treat depression
  • rifampicin, a medicine used to treat tuberculosis.

Medicines whose effects may be intensified by ALPRAZOLAM HEXAL AG

  • digoxin, a medicine used to treat heart failure and cardiac rhythm disorders. The risk of digoxin poisoning is particularly high in the elderly and when the dosage exceeds 4 tablets (1 mg) of ALPRAZOLAM HEXAL AG per day;
  • muscle relaxants, such as pancuronium and atracurium. The muscle-relaxing effect may increase, especially at the beginning of treatment with ALPRAZOLAM HEXAL AG;
  • imipramine and desipramine, used to treat severe forms of depression.

ALPRAZOLAM HEXAL AG and alcohol
It is important not to drink alcohol while taking ALPRAZOLAM HEXAL AG, as alcohol can enhance the effects of the medicine.
Pregnancy and breastfeeding
Pregnancy
There is insufficient experience with the use of alprazolam in pregnant women. Do not take ALPRAZOLAM HEXAL AG if you are pregnant or planning a pregnancy, unless your doctor considers it strictly necessary.
Observations in humans have shown that alprazolam may be harmful to the fetus.
If you are pregnant or planning a pregnancy, consult your doctor about the possibility of discontinuing treatment. If you take ALPRAZOLAM HEXAL AG up to delivery, inform your doctor, as the newborn may experience withdrawal symptoms at birth.
Breastfeeding
There is a risk of effects on the infant. Therefore, you must not breastfeed during treatment with ALPRAZOLAM HEXAL AG.
Driving and using machines
ALPRAZOLAM HEXAL AG may cause adverse effects such as:

  • drowsiness
  • memory loss
  • muscle relaxation
  • reduced concentration

Therefore, your ability to concentrate may be impaired, especially if you have not slept sufficiently. These effects may be increased if you consume alcohol. Do not drive or operate machinery during treatment with ALPRAZOLAM HEXAL AG.

ALPRAZOLAM HEXAL AG contains lactose, sodium, and sodium benzoate
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
This medicine contains 0.12 mg of sodium benzoate per tablet. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Alprazolam Hexal AG

Take this medicine exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Adults

  • Initial dose: 0.25–0.5 mg three times daily.
  • If the effect is insufficient, your doctor may increase the dose up to a maximum of 3 mg per day (= 24 hours), divided into several doses.

Elderly patients, debilitated patients, and patients with impaired renal function or mild hepatic impairment

Initial dose: 0.25 mg two to three times daily (= 24 hours).

  • If the effect is insufficient, your doctor may increase the dose up to a maximum of 0.75 mg per day (= 24 hours), divided into several doses.

There is reduced clearance of the active substance and increased sensitivity to the active substance in elderly patients.

ALPRAZOLAM HEXAL AG is not recommended for patients with severely impaired liver function (see section 2).

Use in children and adolescents

ALPRAZOLAM HEXAL AG is not recommended for children and adolescents under 18 years of age.

Method of administration

The tablets should be taken at the same time each day with a glass of water. The tablet may be taken independently of meals and may be divided into equal doses.

Duration of treatment

ALPRAZOLAM HEXAL AG tablets are intended only for short-term treatment (no longer than 8–12 weeks, including tapering off the treatment). In some cases, your doctor may decide to extend the duration of treatment. Treatment with ALPRAZOLAM HEXAL AG should not exceed 12 weeks without reassessment of your condition by your doctor. This is because the use of benzodiazepines may lead to the development of physical and psychological dependence on these products. The risk of dependence increases with dose and duration of treatment; it is also higher in patients with a history of alcohol or drug abuse. Speak with your doctor if you are concerned about this.

If you take more ALPRAZOLAM HEXAL AG than you should

In this case, contact your doctor or pharmacist immediately. Symptoms of overdose may include:

  • drowsiness
  • confusion
  • lethargy.

In cases of severe overdose, symptoms may include coordination problems, such as:

  • staggering gait
  • reduced muscle tone
  • lowered blood pressure
  • breathing difficulties
  • in rare cases, coma
  • in very rare cases, a severe overdose may be fatal.

If you forget to take ALPRAZOLAM HEXAL AG

If you have forgotten to take a dose, you may still take it unless it is almost time for your next dose; in that case, continue with your regular dosing schedule.

Do not take a double dose of ALPRAZOLAM HEXAL AG to make up for a missed dose.

If you stop taking ALPRAZOLAM HEXAL AG

Always consult your doctor before stopping ALPRAZOLAM HEXAL AG tablets, as the dose must be gradually reduced. If you stop taking the tablets or reduce the dose suddenly, rebound effects may occur, which could temporarily make you more anxious or restless, or cause sleep difficulties. These symptoms will gradually disappear as your body readjusts. If you are concerned, your doctor will provide further information.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Reasons to stop treatment with ALPRAZOLAM HEXAL AG immediately
If you experience any of these symptoms, consult your doctor immediately, as treatment must be stopped.
Your doctor will then advise you on how to discontinue the treatment.

  • Treatment with ALPRAZOLAM HEXAL AG may cause severe behavioural or psychiatric effects – for example agitation, restlessness, aggressiveness, irritability, violent rage, delusions, nightmares and hallucinations, or other inappropriate behaviours.
  • Sudden shortness of breath, difficulty swallowing or breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if affecting the entire body).

Reasons to consult your doctor immediately
Inform your doctor immediately if you experience any of the following symptoms, as your dose or treatment may need to be changed:

  • Memory loss (amnesia) (uncommon)
  • Yellowing of the skin and whites of the eyes (jaundice) (frequency not known).

Dependence and withdrawal symptoms

  • You may become dependent on medicines such as ALPRAZOLAM HEXAL AG while taking them, increasing the likelihood of experiencing withdrawal symptoms when stopping treatment.
  • Withdrawal symptoms are more likely if: you stop treatment suddenly, you have taken high doses, you have taken the medicine for a long time, or you have a history of alcohol or drug abuse. This may cause effects such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, mood changes, sleep disturbances and irritability. In severe cases of discontinuation, the following symptoms may also occur: nausea (feeling unwell), vomiting, sweating, stomach cramps, muscle cramps, feelings of unreality or detachment, increased sensitivity to sound, light or physical touch, numbness and tingling in the feet and hands, hallucinations (seeing or hearing things that are not there while awake), tremors or seizures.

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

  • Depression
  • Drowsiness and lethargy
  • Twitching, uncoordinated movements
  • Inability to remember small details
  • Slurred speech
  • Dizziness, feeling of emptiness in the head
  • Headache
  • Constipation
  • Dry mouth
  • Fatigue
  • Irritability

Common: may affect up to 1 in 10 people

  • Decreased appetite
  • Confusion and disorientation
  • Depression
  • Increased or decreased sexual desire (in men and women) and sexual dysfunction
  • Nervousness, anxiety or agitation
  • Insomnia (inability to sleep or disturbed sleep)
  • Problems with balance and instability (similar to feeling drunk), especially during the day
  • Loss of attention or concentration
  • Inability to stay awake, feeling weak or sluggish
  • Agitation or tremors
  • Double vision or blurred vision
  • Malaise
  • Skin reactions
  • Changes in body weight

Uncommon: may affect up to 1 in 100 people

  • Feelings of euphoria or overexcitement leading to unusual behaviour
  • Hallucinations (seeing or hearing things that do not exist)
  • Feeling restless and angry
  • Incontinence
  • Painful cramps in the lower back and thighs, which may indicate menstrual disorders
  • Muscle spasms or weakness
  • Vomiting
  • Drug dependence
  • Withdrawal syndrome

Not known: frequency cannot be estimated from available data

  • In women, irregular menstruation or excessive production of prolactin (the hormone that stimulates milk production)
  • Feelings of hostility and aggressiveness
  • Abnormal thoughts
  • Twisting movements or jerking movements
  • Hyperactivity
  • Stomach disturbances
  • Liver function problems (shown by blood tests), inflammation of the liver (hepatitis)
  • Imbalance in part of the nervous system. Symptoms may include: rapid heartbeat and unstable blood pressure (dizziness, lightheadedness or fainting)
  • Severe allergic reaction causing swelling of the face or throat
  • Swelling of the ankles, feet and fingers
  • Skin reaction caused by sensitivity to sunlight
  • Difficulty urinating or problems controlling the bladder
  • Increased pressure in the eyes, which may also affect vision
  • Medication abuse

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 Hexal AG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging, following the term EXPIRES. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect from light.
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 HEXAL AG contains
The active substance is alprazolam.
Each tablet contains 0.25 mg of alprazolam.
Each tablet contains 0.5 mg of alprazolam.
Each tablet contains 1 mg of alprazolam.
The other components are: sodium docusate, sodium benzoate, pregelatinized potato starch, microcrystalline cellulose, lactose, magnesium stearate, anhydrous colloidal silica, erythrosine aluminium lake E127 (only for 0.5 mg), indigo carmine aluminium lake E132 (only for 1 mg).

Description of the appearance of ALPRAZOLAM HEXAL AG and contents of the pack
0.25 mg tablets:
White, oval-shaped tablets, with a score line and marked "APZM 0.25".
0.5 mg tablets:
Pink, oval-shaped tablets, with a score line and marked "APZM 0.5".
1 mg tablets:
Blue, oval-shaped tablets, with a score line and marked "APZM 1".

The tablets are packed in aluminium/PVC blisters placed in cardboard boxes containing 20, 30, 40, 50, or 60 tablets.

Marketing Authorization Holder
HEXAL AG
Industriestrasse, 25 – 83607 Holzkirchen (Germany)
Representative in Italy:
Sandoz SpA
Largo U. Boccioni 1 – 21040 Origgio (VA)

Manufacturer responsible for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben (Germany)
Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana
Slovenia
Lek Pharmaceuticals d.d.,
Trimlini 2D,
9220 Lendava
Slovenia

This medicinal product has been authorized in the EEA Member States under the following names:
ALPRAZOLAM HEXAL AG 0.25 mg
Belgium: Alprazolam Sandoz 0.25 mg tabletten
Finland: Gealpra 0.25 mg tabletit
Italy: Alprazolam Hexal AG 0.25 mg compresse
Netherlands: Alprazolam Sandoz tablet 0.25 mg, tabletten
Portugal: Alprazolam Sandoz 0.25 mg comprimidos

ALPRAZOLAM HEXAL AG 0.5 mg
Belgium: Alprazolam Sandoz 0.5 mg tabletten
Finland: Gealpra 0.5 mg tabletit
Italy: Alprazolam Hexal AG 0.5 mg compresse
Netherlands: Alprazolam Sandoz tablet 0.5 mg, tabletten
Portugal: Alprazolam Sandoz 0.5 mg comprimidos

ALPRAZOLAM HEXAL AG 1 mg
Belgium: Alprazolam Sandoz 1 mg tabletten
Finland: Gealpra 1 mg tabletit
Italy: Alprazolam Hexal AG 1 mg compresse
Netherlands: Alprazolam Sandoz tablet 1 mg, tabletten
Portugal: Alprazolam Sandoz 1 mg comprimidos