ALPRAZOLAM 0.25 mg Film-coated tablets

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1. ALPRAZOLAM HEXAL AG 0.25 mg tablets, 0.5 mg tablets, 1 mg tablets
   1. What is Alprazolam Hexal AG and what is it used for?
   2. What you need to know before you take Alprazolam Hexal AG
   3. How to take Alprazolam Hexal AG
   4. Possible side effects
   5. How to store Alprazolam Hexal AG
   6. Package contents and other information

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

Alprazolam

Generic medicine

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 pass it on to others even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is ALPRAZOLAM HEXAL AG and what it is used for
• 2. What you need to know before you take 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 is Alprazolam Hexal AG and what is it used for?

ALPRAZOLAM HEXAL AG is used:

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

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

Do not take ALPRAZOLAM HEXAL AG if

• you are allergic to alprazolam or other similar benzodiazepine 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 breathing problems (e.g. chronic bronchitis or emphysema);
• you suffer from respiratory arrest during sleep (sleep apnea syndrome);
• you suffer from severely reduced 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 a possible physical and psychological dependence on alprazolam. Psychological dependence becomes evident as soon as you realize you no longer want to stop taking the medicine. Physical dependence, on the other hand, involves the appearance of withdrawal symptoms when treatment with this medicine is stopped abruptly (see section “If you stop taking ALPRAZOLAM HEXAL AG”). The risk of dependence increases with increasing doses and the prolongation of the treatment period, which must therefore be as short as possible;
• if you have previously suffered from alcohol and/or drug addiction: in this case, the risk of dependence on alprazolam increases;
• when you stop treatment.

Any disorders that existed before starting treatment may reappear temporarily
in a more intense form. 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 this case, treatment with alprazolam does not necessarily need to be resumed. The doctor must
instead gradually reduce the dosage over several weeks (see section “How
to take ALPRAZOLAM HEXAL AG”);

• if you experience memory loss. This symptom occurs predominantly a few hours after taking the tablet (see section 4); To reduce the risk, patients should ensure they get 7-8 hours of uninterrupted sleep.
• if you experience paradoxical reactions, such as
• anxiety
• irritability
• outbursts of anger
• nightmares
• worsening of insomnia
• hallucinations (perception of things that do not exist)
• severe mental disorders that alter control of behavior and actions (psychosis)
• inappropriate behavior and other behavioral disorders.

These paradoxical reactions occur more frequently in children and the elderly. If these symptoms occur, tell your doctor, as it may be necessary to stop treatment;

• if you suffer from chronic chest tightness, you should be aware that ALPRAZOLAM HEXAL AG may worsen this condition;
• if you are taking alcohol or sedatives at the same time, as the sedative effect of ALPRAZOLAM HEXAL AG may be intensified; if you suffer from a severe form of depression. ALPRAZOLAM HEXAL AG can sometimes be the cause of an excessively lively mood (mania) or an increase in suicidal tendencies;
• if you suffer from a severe mental disorder that alters your behavior, actions and self-control (psychosis); in this case ALPRAZOLAM HEXAL AG is not an appropriate medicine;
• if you suffer from a particular form of sudden increase in eye pressure (narrow-angle glaucoma) or if you are at risk of this disorder.
• if you have impaired kidney function or mild to moderate liver failure
• if you are elderly, because you are more likely to fall and may break your hip bone.

If any of the situations described above apply to you, tell your doctor.

Children and adolescents
Alprazolam is not indicated for children and adolescents under the age of 18 years.

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

The concomitant use of Alprozolam Hexal AG and opioids (strong painkillers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if the doctor prescribes Alprozolam Hexal AG together with opioids, the dose and duration of concomitant therapy must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow the doctor's recommendations
on dosage. It may be helpful to inform friends or family that you are aware of the signs and
symptoms described above. Contact your doctor if these symptoms occur.
These painkillers can also increase the risk of euphoria and dependence.

Medicines that increase the effect of ALPRAZOLAM HEXAL AG, due to the suppression of
the breakdown of alprazolam in the liver

• nefazodone, fluvoxamine, fluoxetine, sertraline (medicines used to treat severe forms of depression)
• cimetidine, a medicine used to treat stomach disorders
• some medicines used to treat AIDS (known as “HIV protease inhibitors”, for example ritonavir, saquinavir, indinavir)
• dextropropoxyphene, used to treat pain
• oral contraceptive pills
• diltiazem, a medicine used to treat high blood pressure 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 the increase in
the breakdown of alprazolam in the liver

• carbamazepine or phenytoin, used to treat epilepsy and other disorders
• St. John's wort, a herbal medicine 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 heart rhythm disorders. The risk of digoxin poisoning is particularly high in the elderly and in cases where the dosage exceeds 4 tablets (1 mg) of ALPRAZOLAM HEXAL AG per day;
• muscle relaxants, such as pancuronium and atracurium. The muscle-relaxant 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 with alcohol
It is important not to drink alcohol while taking ALPRAZOLAM HEXAL AG, as alcohol can
increase 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 the substance alprazolam can be harmful to the fetus.
If you are pregnant or planning a pregnancy, consult your doctor about the possibility of stopping
treatment. If you take ALPRAZOLAM HEXAL AG until birth, tell your doctor as the newborn
may have some withdrawal symptoms at birth.

Breastfeeding
There is a risk of an effect on the baby. Therefore, do not breastfeed during treatment with
ALPRAZOLAM HEXAL AG.

Driving and using machines
ALPRAZOLAM HEXAL AG can cause side effects such as:

• drowsiness
• memory loss
• muscle relaxation and
• reduced concentration Therefore, your ability to concentrate may be affected, especially if you have not slept enough. These effects may be increased if you drink alcohol. Do not drive or use machines while taking ALPRAZOLAM HEXAL AG.

ALPRAZOLAM HEXAL AG contains lactose, sodium and sodium benzoate
If your doctor has diagnosed you with an intolerance to certain sugars, contact 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 following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Adults

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

Elderly, debilitated patients and patients with impaired renal function or mild hepatic dysfunction
Initial dosage: 0.25 mg two to three times a day (= 24 hours).

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

There is a reduction in the clearance of the active ingredient and increased sensitivity to the active ingredient in
elderly patients.
ALPRAZOLAM HEXAL AG is not recommended for patients with severely impaired hepatic 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 every day at the same time with a glass of water. The tablet can
be taken independently of meals and can be divided into equal doses.

Duration of treatment
ALPRAZOLAM HEXAL AG tablets is used only for short-term treatment (no more than 8-12
weeks including discontinuation of treatment). In some cases, the doctor may decide to extend the
duration of treatment. Treatment with ALPRAZOLAM HEXAL AG should not last more than 12 weeks
without monitoring of your condition by the doctor. This is because the use of benzodiazepines can
lead to the development of physical and psychological dependence on these products. The risk of dependence increases with
the dose and duration of treatment; but it is also higher in patients with a history of alcohol or drug
abuse. Talk to your doctor if this worries you.

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 the event of a severe overdose, symptoms may include coordination problems, for
example:

• unsteady gait
• reduced muscle tone
• decreased blood pressure
• difficulty breathing
• in rare cases coma
• in very rare cases, a severe overdose can be fatal.

If you forget to take ALPRAZOLAM HEXAL AG
If you have forgotten to take a dose, you can still take it unless it is almost time to take the
next one; in this case, follow the normal dosage schedule.

Do not take a double dose of ALPRAZOLAM HEXAL AG to make up for the forgotten
dose.
If you stop taking ALPRAZOLAM HEXAL AG
Always consult your doctor before stopping taking ALPRAZOLAM HEXAL
AG tablets as the dose must be reduced gradually. If you stop taking the tablets or reduce the dose
suddenly, you may experience "rebound" effects that may temporarily make you more anxious or
restless or cause you to have difficulty sleeping. These symptoms will gradually disappear as your body
recovers. If you are concerned, your doctor will provide you with more information about this.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest 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 stop treatment.

• Treatment with ALPRAZOLAM HEXAL AG can cause serious behavioral or psychiatric effects - for example agitation, restlessness, aggression, irritability, violent anger, false beliefs, nightmares and hallucinations or other inappropriate behaviors.
• Sudden shortness of breath, difficulty swallowing or breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if it affects the whole body).

Reasons to consult your doctor immediately
Tell your doctor immediately if you experience the following symptoms as it may be necessary to change
the dose or treatment:

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

Symptoms of dependence and withdrawal

• It is possible to become dependent on medicines like ALPRAZOLAM HEXAL AG while you are taking these medicines which increases the likelihood of experiencing withdrawal symptoms when treatment is stopped.
• Withdrawal symptoms are more common if: you stop treatment suddenly you have taken high doses you have taken the medicine for a long time you have a history of alcohol or drug abuse. This can cause effects such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, mood swings, sleep disturbances and irritability. In severe cases of withdrawal, you may also experience the following symptoms: nausea (feeling sick), vomiting, sweating, stomach cramps, muscle cramps, a feeling of unreality or detachment, being particularly sensitive to sound, light or physical contact, numbness and tingling in the feet and hands, hallucinations (seeing or hearing things that are not there while awake), tremors or seizures.

Other side effects that may occur are:
Very common: may affect more than 1 in 10 people

• Depression
• Drowsiness and sleepiness
• Twitches, uncoordinated movements
• Inability to remember small pieces of information
• Slurred speech
• Dizziness, feeling lightheaded
• 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 (men and women) and sexual dysfunction
• Nervousness or anxiety or agitation
• Insomnia (inability to sleep or disturbed sleep)
• Problems with balance and instability (similar to the feeling of drunkenness), especially during the day
• Loss of attention or concentration
• Inability to stay awake, feeling weak
• Agitation or tremors
• Double vision or blurred vision
• Feeling unwell
• Skin reactions
• Changes in body weight

Uncommon: may affect up to 1 in 100 people

• Feeling of euphoria or overexcitement, causing unusual behavior
• Hallucinations (seeing or hearing things that do not exist)
• Feeling agitated 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 periods or production of an excess of prolactin (the hormone that stimulates milk production)
• Feeling hostile and aggressive
• Abnormal thoughts
• Twisting movements or jerking movements
• Being hyperactive
• Stomach disorders
• Problems with liver function (shown by blood tests), liver inflammation (hepatitis)
• Imbalance in the part of the nervous system. Symptoms may include: fast heartbeat and unstable blood pressure (feeling dizzy, lightheaded or fainting)
• Severe allergic reaction causing swelling of the face or throat
• Swelling of the ankles, feet and toesSkin reaction caused by sensitivity to sunlight
• Difficulty urinating or problems controlling the bladder
• Increased pressure in the eyes, which can also affect vision
• Drug abuse

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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, which is stated on the blisters and the packaging, after the
wording EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect from light.
Do not dispose of any medicine in 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 ingredient is alprazolam.
Each tablet contains 0.25 mg of alprazolam.
Each tablet contains 0.5 mg of alprazolam
Each tablet contains 1mg of alprazolam.
The other ingredients are: sodium docusate, sodium benzoate, pregelatinized potato starch, microcrystalline
cellulose, lactose, magnesium stearate, anhydrous colloidal silica, aluminum lake erythrosine E127 (only
for 0.5 mg), aluminum lake indigo carmine E132 (only for 1 mg).

Description of the appearance of ALPRAZOLAM HEXAL AG and package contents

0.25 mg tablets:
Oblong tablet of white color, with a fracture line and bearing the inscription “APZM 0.25”.

0.5 mg tablets:
Oblong tablet of pink color, with a fracture line and bearing the inscription “APZM 0.5”.

1 mg tablets:
Oblong tablet of light blue color, with a fracture line and bearing the inscription “APZM 1”.
The tablets are packaged in aluminum/PVC blisters inserted in a cardboard box of 20, 30, 40, 50,
60 tablets.

Marketing authorization holder
HEXAL AG
Industriestrasse, 25 – 83607 Holzkirchen (Germany)
Representative for 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 is authorized in the member states of the EEA with the following denominations:

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