FRONTAL 0.25 mg Tablet

Зміст інструкції

1. FRONTAL 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets, 0.75 mg/ml oral drops, solution
   1. What is FRONTAL and what is it used for
   2. What you need to know before you take FRONTAL
   3. How to take FRONTAL
   4. Possible side effects
   5. How to store FRONTAL
   6. Contents of the pack and other information

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

Alprazolam
Generic medicine

Read this leaflet carefully before taking this medicine as 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 their symptoms are the same as yours, as it could 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 FRONTAL is and what it is used for
• 2. What you need to know before you take FRONTAL
• 3. How to take FRONTAL
• 4. Possible side effects
• 5. How to store FRONTAL
• 6. Contents of the pack and other information

1. What is FRONTAL and what is it used for

FRONTAL contains the active ingredient alprazolam. Alprazolam belongs to a group of medicines
called benzodiazepines (medicines with an anxiolytic action).
FRONTAL is used in adult patients for the treatment of anxiety symptoms when the disorder is severe,
disabling or subjects the individual to severe distress. This medicine is indicated only for short-term use.

2. What you need to know before you take FRONTAL

Do not take FRONTAL

• if you are allergicto alprazolam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);
• if you have myasthenia gravis, a disease that causes severe muscle weakness;
• if you have serious breathing problems(respiratory failure);
• if you have serious liver problems(hepatic failure);
• if you have trouble breathing during sleep (sleep apnea);
• if you suffer from an eye disease called acute angle-closure glaucoma, a problem caused by increased pressure inside the eyes;
• during the first 3 months of pregnancyand if you are breastfeeding(see section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine can reduce to completely eliminate the state of consciousness, can cause a significant reduction
in the ability to breathe spontaneously, coma and death if taken together with other medicines
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that act on the brain and mind (e.g. opioids, antipsychotics and hypnotic-sedatives) (section
“Other medicines and FRONTAL”).
Consult your doctor or pharmacist beforetaking FRONTAL if:

• you are elderlyand/or frail. The doctor will prescribe you a reduced dose of this medicine; remember to use this medicine with caution because it can cause sedation and/or musculoskeletal weakness and expose you to falls, often with serious consequences;
• you have chronic respiratory problems(chronic respiratory failure), because this medicine may worsen your condition;
• you have kidney problems(renal failure) or liver problemsof mild or moderate severity (mild to moderate hepatic failure);
• you suffer from severe depression. FRONTAL, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression because it can worsen suicidal tendencies and cause mood changes;
• you suffer from psychosis, a serious mental illness that alters behavior and causes difficulty relating to others. FRONTAL is not recommended as the primary treatment for this condition;
• you are being treated with other medicinesthat act on the brain and mind, because FRONTAL can increase the effects of these medicines (see section “Other medicines and FRONTAL”);
• you have or have had in the past problems with abuse and dependenceon alcohol, drugs or other medicines, because there is a greater risk of developing dependence on FRONTAL (see section “Development of dependence”);
• you suffer from rare hereditary intolerance to a particular sugar (galactose).

Memory disturbances
A few hours after taking FRONTAL, you may have difficulty remembering what happened

aftertaking the medicine.
Paradoxical reactions
FRONTAL can cause effects opposite to those expected (paradoxical effects) (See section 4
“Possible side effects”). These effects are more common in children and the elderly. If
you experience these effects, consult your doctor because treatment with FRONTAL should be discontinued.
Development of tolerance
After a few weeks of treatment, a decrease in the effectiveness of FRONTAL may occur.
Development of dependence
FRONTAL causes dependence(i.e. you may experience an increasing desire to take the medicine or
you may develop physical disturbances that decrease or disappear only after taking the medicine). The
probability of developing dependence increases with increasing dose and duration of treatment.
Therefore, the doctor will prescribe the most appropriate treatment based on your disorders and conditions, using
the lowest effective dose possible to be taken for the shortest possible period. The doctor will also indicate
when to undergo check-ups to assess the progress of your health in relation to
therapy with FRONTAL.
Incorrect use of FRONTAL
You should take this medicine ONLYif prescribed by your doctor and after purchasing it from a pharmacy.
Some people tend to abuse FRONTAL and other similar medicines, called
benzodiazepines.
In addition, some people obtain such medicines illegally (e.g. black market, internet, friends,
family, etc.), sometimes with the aim of reselling them to others. DO NOTtake FRONTAL if this medicine has not been prescribed by your doctor. DO NOTtake FRONTAL if you are not sure that this medicine has been
purchased from a pharmacy.
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Children and adolescents
The efficacy and safety of FRONTAL in children and adolescents under 18 years of
age have not been established. The doctor will decide whether FRONTAL can be given to children and adolescents based on their
conditions.

Other medicines and FRONTAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concomitant use of FRONTAL and opioids (strong painkillers, medicines for addiction therapy
and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be
considered only when other treatment options are not possible.
However, if your doctor prescribes FRONTAL together with opioids, the dose and duration of treatment
concomitant must be limited by the doctor.
Tell your doctor about all the opioid medicines you are taking and carefully follow
the doctor's dosage recommendations. It may be helpful to inform friends or family to pay attention to
the above symptoms.
Contact your doctor if you experience these symptoms.
Caution is required when FRONTAL is taken together with the following medicines:

• medicinesthat act on the brainand mind* such as: o antipsychotics, medicines for the treatment of some mental illnesses; o hypnotics, sleep promoters; o sedatives, tranquilizers; o anxiolytics, medicines for the treatment of anxiety; o antidepressants(e.g. nefazodone, fluvoxamine, fluoxetine, imipramine and desipramine), medicines for the treatment of depression; o narcotic analgesics, opioids,medicines for the treatment of severe pain; o antiepileptics,medicines for the treatment of seizures; o anesthetics. Anesthetics, when administered together with FRONTAL, can cause euphoria with an increased probability of developing dependence on FRONTAL; o sedative antihistamines, medicines to counteract allergic reactions; * If you take FRONTALtogether with one or more of these medicines or together with alcoholic beverages, these substances can contribute to reducing the functions of your brain and mind to the point of causing a reduction in spontaneous breathing capacity, coma and death (section Warnings and precautions).
• analgesicsand cough suppressants,based on opium and its derivatives. These medicines, like FRONTAL, reduce the ability to breathe spontaneously;
• cimetidine, a medicine used to reduce stomach acidity;
• propoxyphene, a medicine used for pain relief;
• oral contraceptives;
• diltiazem, a medicine used to lower blood pressure;
• digoxin(a medicine used to increase the force of heart contraction). If you are elderly, taking FRONTAL may increase the likelihood of developing toxic effects due to digoxin.

The following medicines may increase the effects of FRONTAL:

• ketoconazole, itraconazole, posaconazoleand voriconazole, medicines for the treatment of fungal infections;
• erythromycin, clarithromycin, telithromycinand troleandomycin(antibiotics);
• protease inhibitors(e.g. ritonavir), medicines for the treatment of HIV infection. If you are being treated with protease inhibitors, your doctor may also advise you to discontinue treatment with FRONTAL due to the interaction with these medicines.

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FRONTAL with alcohol
Donot drink alcohol while taking FRONTAL because alcohol increases the effects of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

This medicine should not be taken during the first 3 months of pregnancybecause it can cause
congenital malformations in the fetus. The doctor will assess whether you can take this medicine during
the second and third trimesters of pregnancy.
If you take this medicine in the last months of pregnancyor during labor, the newborn may
manifest the following symptoms:

• poor muscle tone (axial hypotonia);
• difficulty breathing (respiratory depression or apnea) and feeding;
• low body temperature (hypothermia);
• withdrawal symptoms (see section 3 “If you stop taking FRONTAL”). These effects are reversible and can last from a few days to 1-3 weeks after the baby is born.

Breastfeeding

Donot breastfeed while taking FRONTAL because this medicine passes into breast milk.

Driving and operating machinery
Donot drive or operate machinery if you experience loss of
concentration or muscle control while taking FRONTAL, or if you feel drowsy or dizzy. These effects may be
increased if you have not slept enough or if you have consumed alcoholic beverages.

FRONTALtablets contains lactose and sunset yellow (E110)
The 0.25 mg, 0.50 mg and 1 mg tablets of FRONTAL contain lactose, a type of sugar. If
your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
The 0.50 mg tablets of FRONTAL contain the colorant sunset yellow (E110) which may cause
allergic reactions.

FRONTALoral drops, solution contains ethanol and propylene glycol
This medicine contains 16 vol % ethanol (alcohol), e.g. up to 172 mg per dose, equivalent to 4 ml of
beer and 2 ml of wine per dose.
It may be harmful to alcoholics.
To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups, such as people affected by liver disease or epilepsy.
This medicine contains 467 mg of propylene glycol per 20 drops equivalent to 700 mg/ml.
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this
medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended
by your doctor. The doctor may perform further checks during therapy.

FRONTAL contains sodium
The 0.25 mg, 0.50 mg, 1 mg tablets and oral drops of FRONTAL contain less than 1 mmol
(23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
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3. How to take FRONTAL

Take this medicine following strictly the instructions of your doctor. If you have any doubts, consult your
doctor.

• Treatment of anxietyThe recommended starting dose is from 0.25 to 0.50 mg 3 times a day. If you prefer the dropsformulation, the recommended starting dose is from 10 to 20 drops 3 times a day. The dose may be gradually increased, up to a maximum of 4 mg per day, to be divided into several doses. You should first increase the dose to be taken in the evening and then the dose to be taken during the day.

If you are elderly, have liver or kidney problems and/or are debilitated
The recommended starting dose is 0.25 mg (corresponding to 10 drops) 2-3 times a day.
.

The duration of treatment with FRONTAL should be as short as possible.
The maximum treatment duration should not exceed 2-4 weeks. Prolonged treatment is not
recommended. The doctor will decide whether the treatment can be continued beyond the maximum
recommended period.

Instructions for opening the drop bottle

• Press on the plastic cap and simultaneously unscrew.
• To close, screw the cap on tightly.

If you take more FRONTALthan you should
If you have taken an excessive dose of FRONTAL, contact your doctor immediately or go to the nearest
Emergency Room.

• In milder cases, symptoms may include: mental confusion, drowsiness, difficulty speaking;
• In more severe cases, symptoms may include: loss of coordination, poor muscle tone, low blood pressure, breathing problems, coma, death.

If you forget to take FRONTAL
If you forget to take a dose, take it as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking FRONTAL
Donot stop taking FRONTAL suddenly. Always consult your doctor before
stopping taking FRONTAL. You must reduce the doses gradually to avoid experiencing:

• withdrawal symptomssuch as: o severe symptoms: feeling detached from oneself or from the outside world, numbness and tingling in the legs or arms, increased sensitivity to light, sounds and physical contact, hallucinations, seizures, muscle and abdominal cramps, vomiting, sweating, tremors, convulsions;

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or other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion,
irritability, mild depression, insomnia;

• rebound symptoms, for example anxiety. These symptoms are the same for which you have been advised to treat with FRONTAL and may temporarily reappear more intensely after abrupt discontinuation of treatment.

If you have any further questions on 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.
Contact your doctor immediatelyif you experience any of the following side effects because the intake
of FRONTAL must be stopped:

• Opposite effects to those expected (paradoxical effects) (see section 2 “Paradoxical reactions”) such as:
• restlessness
• agitation
• irritability
• aggression
• feeling of frustration
• anger
• nightmares
• hallucinations
• thought disorders
• behavioral changes

Contact your doctor immediatelyif you experience any of the following side effects because they can
be serious:

• swelling of the face, tongue and throat resulting in inability to swallow and breathe (angioedema);
• difficulty rememberingwhat happened after taking the medicine (see section 2 “memory disorders”);
• unmasking of pre-existing depression;
• dependence(see section 2 “Development of dependence”);
• withdrawal symptomsand rebound symptoms(see section 3 “If you stop taking FRONTAL”).

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

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

• depression
• sedation
• drowsiness
• loss of coordination
• memory disorders
• difficulty speaking
• dizziness
• headache
• constipation
• dry mouth due to lack of saliva
• fatigue
• irritability.

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Common(may affect up to 1 in 10 people)

• decreased appetite, decrease or increase in body weight
• confusion, disorientation
• decreased or increased sexual desire, sexual dysfunction
• anxiety
• insomnia, excessive sleepiness
• nervousness
• balance disorders, problems with coordination
• loss of attention and concentration
• excessive drowsiness (lethargy)
• tremors
• vertigo
• slurred speech
• blurred vision
• nausea
• dermatitis Uncommon(may affect up to 1 in 100 people)
• obsessive ideas and behaviors
• inability to remember recent life events
• hallucinations
• agitation
• anger
• vomiting
• muscle weakness
• incontinence
• irregular menstrual cycle
• drug dependence
• drug withdrawal syndrome.

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

• increased levels of prolactin (a natural hormone) in the blood
• mood changes
• hostile behaviors, abnormal thoughts
• aggression
• impulsivity and motor hyperactivity
• alterations of the nervous system responsible for the functions of the body that cannot be controlled voluntarily (e.g. the functions of internal organs and glands)
• involuntary muscle contractions that force you to assume unnatural positions
• stomach and intestinal diseases
• inflammatory liver diseases (hepatitis)
• impaired liver function
• yellowing/yellowish discoloration of the skin and mucous membranes (jaundice)
• skin reactions due to exposure to the sun
• angioedema
• inability to completely empty the bladder
• swelling of the hands and feet due to fluid accumulation
• increased pressure inside the eye
• abuse of this medicine (tendency to excessive or incorrect use of FRONTAL).

Reporting ofside effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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.
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5. How to store FRONTAL

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.

Tablets
Store in the original package to protect the medicine from light.

Drops
Validity after first opening: 90 days. Excess medicine must be discarded. You can write the
date of first opening in the designated space on the package.
Store in the original package to protect the medicine 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. Contents of the pack and other information

What FRONTAL contains
The active ingredient is alprazolam.
Tablets
One FRONTAL 0.25 mg tablet contains 0.25 mg of alprazolam.
The other ingredients are lactose, microcrystalline cellulose, sodium docusate, colloidal silicon dioxide, corn
starch, magnesium stearate.
One FRONTAL 0.50 mg tablet contains 0.50 mg of alprazolam.
The other ingredients are lactose, microcrystalline cellulose, sodium docusate, colloidal silicon dioxide, corn
starch, magnesium stearate, sunset yellow( E110).
One FRONTAL 1 mg tablet contains 1 mg of alprazolam.
The other ingredients are lactose, microcrystalline cellulose, sodium docusate, colloidal silicon dioxide, corn
starch, magnesium stearate, indigotine (E132).
Oral drops, solution
1 ml of FRONTAL oral drops, solution contains 0.75 mg of alprazolam.
The other ingredients are ethyl alcohol, propylene glycol, sodium saccharin, grapefruit aroma, purified
water.

Description of the appearance of FRONTAL and contents of the pack
0.25 mg tablets: packs of 20 and 30 oval, white, shiny tablets with a smooth surface, with
a score line on one side and with “F” on the other side.
0.50 mg tablets: packs of 20 and 30 oval, orange, shiny tablets with a smooth surface,
with a score line on one side and with “F” on the other side.
1 mg tablets: pack of 20 oval, blue, shiny tablets with a smooth surface, with a
score line on one side and with “F” on the other side.
Oral drops, solution: 20 ml and 30 ml bottle containing a clear and colorless solution.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 – Saronno (VA)

Manufacturer
Tablets
ABC Farmaceutici S.p.A. - Canton Moretti, 29 - 10015 San Bernardo d’Ivrea (TO)
Doppel Farmaceutici S.p.A. - Via Volturno, 48 - Quinto de’ Stampi - 20089 Rozzano (MI)
Oral drops, solution
ABC Farmaceutici S.p.A. - Canton Moretti, 29 - 10015 San Bernardo d’Ivrea (TO)
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