MONORES 10 MCG Tablets

Зміст інструкції

1. MONORES 5 micrograms/5 ml Syrup
2. MONORES 10 micrograms tablets
3. MONORES 20 micrograms/5 ml Syrup
4. Monores inhibits uterine contractions. Do not use Monores before labor, unless
5. MONORES 20 micrograms tablets

MONORES 5 micrograms/5 ml Syrup

Clenbuterol
Equivalent Medicinal Product

PHARMACOTHERAPEUTIC CATEGORY
Drugs for obstructive syndromes of the airways. Selective agonists of the –
adrenergic receptors

THERAPEUTIC INDICATIONS
Prophylaxis and treatment of bronchial asthma and other conditions with reversible airway obstruction
e.g. chronic obstructive bronchopathy with an asthmatic component.
Concomitant anti-inflammatory therapy should be considered for patients with
asthma and/or chronic obstructive pulmonary disease.

CONTRAINDICATIONS
Do not use Monores in the following cases:

• hypertrophic obstructive cardiomyopathy
• tachyarrhythmia
• hypersensitivity to clenbuterol hydrochloride or to any of the other components of this medicine
• in cases of intolerance to sugars and particularly to fructose (component of sorbitol)

PRECAUTIONS FOR USE
Elderly patients and children require caution when using Monores.
Strictly adhere to the recommended doses and the duration of the recommended treatment.
Improper use of Monores can cause severe and potentially life-threatening side effects
and should be discouraged (see also section Overdosage). Following improper use of clenbuterol with other medicines for improving appearance and
performance, fatal outcomes have been observed even in young adults.
Bronchodilators anticholinergics can still be administered by inhalation in
concomitance with Monores.
Do not use Monores

• in concomitance with other sympathomimetic bronchodilators, unless under close medical supervision.
• for the treatment of symptoms of acute asthma attacks, as Monores is not suitable for this type of treatment.

Patients taking Monores must be particularly careful, especially in cases of
taking doses higher than those recommended, if affected by the following conditions:

• uncontrolled diabetes mellitus
• coronary disease, arrhythmias, arterial hypertension, recent myocardial infarction, severe heart failure or vascular disorders
• pheochromocytoma
• hyperthyroidism
• glaucoma
• prostatic hypertrophy. Monores, like other beta-2-agonists, can determine, albeit rarely, cardiac ischemia. Patients with pre-existing severe heart disease (e.g. ischemic heart disease, arrhythmia or severe heart failure) should consult a doctor if they experience chest pain or other symptoms of worsening heart disease.

In case of worsening bronchial obstruction, onset of breathing difficulties (dyspnea)
do not increase the recommended doses of Monores and immediately consult your
Doctor, for appropriate reassessments of the adequacy of therapy.
Regular increase in the use of beta-agonists to control symptoms of bronchial obstruction
may suggest a worsening of disease control.
Monores, like other beta-2-agonists, can cause hypokalemia (reduction of potassium levels in the blood) potentially severe. Particular caution is recommended:

• in severe asthma and its concomitant treatment with xanthine derivatives (theophylline), corticosteroids and diuretics, as hypokalemia may be potentiated
• in hypoxia (oxygen deficiency), which can worsen the effects of hypokalemia on heart rhythm.

In such situations, monitoring of blood potassium levels is recommended.

INTERACTIONS
It is recommended to inform your Doctor if you are taking or have recently taken
any other medicines, including those without a prescription.
This is particularly important for the following Drugs that can interact with
Monores:

• beta-adrenergic, non-inhalational anticholinergics, xanthine derivatives (theophylline) and corticosteroids, as they can potentiate its effect
• sympathomimetic drugs as, through synergism, undesirable effects at the cardiac level may manifest
• monoamine oxidase inhibitors or tricyclic antidepressants
• halogenated anesthetic hydrocarbons such as halothane, trichloroethylene and enflurane, as they can sensitize the myocardium to the arrhythmogenic effects of beta agonists
• beta-blockers as they antagonize the effect of Monores

SPECIAL WARNINGS
Inform your doctor before starting to take the medicine if you have a history of heart disease, irregular heartbeat or angina.

Pregnancy and Breastfeeding
Data relating to the use of Monores during pregnancy are limited.
Monores inhibits uterine contractions. Do not use Monores before delivery, unless
otherwise recommended by your Doctor.
Do not use Monores during pregnancy and breastfeeding.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and
may still result in positive doping tests.

Driving and operating machinery
Studies on the ability to drive vehicles and operate machinery have not been conducted.
During treatment with Monores, side effects such as dizziness may occur.
Therefore, caution is recommended when driving vehicles or operating machinery. If
dizziness occurs, avoid dangerous tasks or use machinery.

Important information about some excipients
Monores syrup contains sorbitol and para-hydroxybenzoates.
In case of intolerance to sugars and particularly to fructose (component of sorbitol)
contact your Doctor before taking this medicine.
Sorbitol may have a mild laxative effect. Caloric value 2.6 Kcal/g sorbitol.
Para-hydroxybenzoates may cause allergic reactions (even delayed).

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The individual dosage regimen of Monores must be determined by the doctor before starting
therapy. It is recommended to keep patients under medical control during treatment
(e.g. through regular peak flow monitoring)
Unless otherwise prescribed, the recommended total daily dose for adults and adolescents of
age over 12 years is 40 micrograms per day, divided into two administrations of 20
micrograms each, 12 hours apart
During therapy, this dose can often be reduced to 20 micrograms (10
micrograms twice a day). In severe bronchospasm, treatment may be started
with a dosage of up to 80 micrograms per day (40 micrograms twice a day).
The total daily dose in children is 1.2 micrograms/Kg of body weight, ranging from 0.8
micrograms to 1.5 micrograms/Kg of body weight, divided into two-three administrations.
Due to limited information on use in children under 6 years of age, the doses
recommended for this age group should only be given under medical supervision.
Note well

Adults and adolescents over 12 years of age

Normally:2 measuring spoons in the morning (20 ml) and 2 measuring spoons in the evening (20 ml) (equal to 40
micrograms/day)
During prolonged treatment, the dose may be reduced to 1 measuring spoon
in the morning (10 ml) and 1 measuring spoon in the evening (10 ml) (equal to 20 micrograms/day).

Children under 12 years of age

Normally: 1.2 micrograms/Kg of Clenbuterol, divided into two-three administrations
daily.
Unless otherwise prescribed by the Doctor:

infants up to 8 months (4-8Kg):
1 / 4 measuring spoon (2.5 ml) in the morning and 1 / 4 measuring spoon (2.5 ml) in the evening (equal to 5
micrograms/day)

8-24 months (8-12 Kg):
½ measuring spoon (5 ml) in the morning and ½ measuring spoon (5 ml) in the evening (equal to 10 micrograms/day)

• 2 - 4 years (12-16 Kg):3 / 4 measuring spoon (7.5 ml) in the morning and 3 / 4 measuring spoon (7.5 ml) in the evening, (equal to 15 micrograms/day)
• 4 - 6 years (16-22 Kg):1 measuring spoon (10 ml) in the morning and 1 measuring spoon (10 ml) in the evening (equal to 20 micrograms/day)
• 6 - 12 years (22-35 Kg):3 half measuring spoons (3 x 5 ml) in the morning and 3 half measuring spoons (3 x 5 ml) in the evening (equal to 30 micrograms/day)

During prolonged treatment, the dose may be reduced.

OVERDOSAGE
Symptoms:
The symptoms expected in case of overdose are those resulting from excessive beta-stimulation
for example any of the symptoms in the list of side effects: hyperglycemia, hypertension,
hypotension, increased heart rate, angina pain and arrhythmia.
Following improper use of clenbuterol, especially in association with other medicines for
improving appearance and performance, life-threatening and
fatal outcomes have been observed.
Treatment:
Discontinue administration of Monores
It is recommended to contact your Doctor or the nearest hospital to establish appropriate symptomatic therapy.
In cases of severe intensive care therapy, treatment may consist of the administration of sedatives
and tranquilizers.
Non-selective beta-blockers, such as propranolol, are suitable as specific antidotes. However
it must be considered an increase in bronchial obstruction and therefore the dose of the
beta blocker must be carefully modulated in patients with bronchial asthma.
Treatment for overdose with antidotes should be repeated at short intervals depending on the
symptoms.
It should be considered that the effects of Monores may persist beyond those of the antidote,
therefore repeated administration of beta-blocker may be necessary.
In case of accidental ingestion/intake of an excessive dose of Monores, immediately warn
your doctor or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF MONORES, ASK YOUR DOCTOR OR PHARMACIST.

SIDE EFFECTS
Like all medicines, Monores can cause side effects, although not everyone gets them.
a) General description
In analogy with other beta-adrenergic drugs, Monores can cause the following betamimetic undesirable effects
including severe hypokalemia:
b) List of side effects
The side effects listed by frequency are reported, using the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100);
rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), frequency not known (cannot be
evaluated based on available data).
COMMON side effects
: palpitations
D : restlessness
: headache, tremors

• : nausea

UNCOMMON side effects
D : Hypersensitivity
D : nervousness, hyperactivity in children
: dizziness
: arrhythmia, tachycardia
P : paradoxical bronchospasm

• : muscle spasm, mild tremors in the skeletal muscles, normally more evident in the hands, myalgia.

Side effects with NOT KNOWN frequency
: hyperglycemia
D : hypokalemia
: myocardial infarction, myocardial ischemia
c) Special population
In diabetic patients, an increase in blood glucose has been observed.
Although the frequency with which this happens is unknown, chest pain (due to heart problems such as angina) may occur occasionally in some people.
Immediately inform your doctor if you experience these symptoms during treatment with
Monores, but do not stop using the medicine unless advised by your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
Doctor or Pharmacist. You can also report side effects directly
through the national reporting system at the address:
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on
the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
Do not use the medicine after the expiry date that is reported on the packaging.
The expiry date refers to the last day of that month and the product in intact packaging,
stored correctly.
Store at a temperature not exceeding 25°C.
KEEP THE MEDICINE OUT OF THE REACH OF CHILDREN

COMPOSITION
MONORES 5 micrograms/5 ml syrup
100 ml of syrup contains as active ingredient Clenbuterol 0.1 mg,
as clenbuterol hydrochloride 0.113 mg
The excipients are: Methyl para-hydroxybenzoate, Ethyl para-hydroxybenzoate, Cherry Aroma,
Azorubine (E 122), Non-crystallizable liquid Sorbitol, Purified water.

PHARMACEUTICAL FORM AND CONTENT
120 mL bottle in opaque polyethylene with measuring spoon, together with the package leaflet, in a cardboard box.

MARKETING AUTHORISATION HOLDER
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan

MANUFACTURER
Valeas S.p.A. - Via Vallisneri, 10 – 20133 Milan

MONORES 10 micrograms tablets

Clenbuterol
Equivalent Medicinal Product

PHARMACOTHERAPEUTIC CATEGORY
Drugs for obstructive syndromes of the respiratory tract. Selective agonists of the beta2-adrenergic receptors.

THERAPEUTIC INDICATIONS
Prophylaxis and treatment of bronchial asthma and other conditions with reversible airway obstruction, for example: chronic obstructive bronchopathy with an asthmatic component.
Concomitant anti-inflammatory therapy should be considered for patients with asthma and/or chronic obstructive pulmonary disease.

CONTRAINDICATIONS
Do not use Monores in the following cases:

• hypertrophic obstructive cardiomyopathy
• tachyarrhythmia
• hypersensitivity to Clenbuterol hydrochloride or to any of the other components of this medicine.
• in cases of intolerance to sugars and in particular to galactose (component of lactose), e.g. galactosemia.

PRECAUTIONS FOR USE
Elderly patients and children require caution when using Monores
Strictly adhere to the recommended doses and the duration of the recommended treatment.
Improper use of Monores can cause severe and potentially life-threatening adverse effects and should be discouraged (see also section Overdose). Following the improper use of clenbuterol with other medicines for improving appearance and performance, lethal outcomes have been observed even in young adults.
Bronchodilators anticholinergics can still be administered by inhalation in conjunction with Monores.
Do not use Monores

• in conjunction with other sympathomimetic bronchodilators, unless under close medical supervision.
• for the treatment of symptoms of acute asthma attacks, as Monores is not suitable for this type of treatment. Patients taking Monores should be particularly careful, especially in cases of taking dosages higher than those recommended, if affected by the following conditions:
• uncontrolled diabetes mellitus
• coronary diseases, arrhythmias, arterial hypertension, recent myocardial infarction, severe heart failure or vascular disorders
• pheochromocytoma
• hyperthyroidism
• glaucoma
• prostatic hypertrophy.

Monores, like other beta-2-agonists, can determine, even if rarely, cardiac ischemia.
Patients with pre-existing severe cardiac pathology (e.g. ischemic heart disease, arrhythmia or severe heart failure) should consult their doctor if they experience chest pain or other symptoms of worsening cardiac pathology.
In case of worsening bronchial obstruction, onset of breathing difficulties (dyspnea), do not increase the recommended doses of Monores and immediately consult your doctor, for appropriate reassessments on the adequacy of the therapy.
Regular increase in the use of beta-agonists to control symptoms of bronchial obstruction may suggest a worsening of the control of the pathology.
Monores, like other beta-2-agonists, can cause hypokalemia (reduction of potassium levels in the blood) potentially severe. Particular caution is recommended:

• in severe asthma and its concomitant treatment with xanthine derivatives (theophylline), corticosteroids and diuretics because hypokalemia could be potentiated
• in hypoxia (oxygen deficiency), which can worsen the effects of hypokalemia on heart rhythm.

In such situations, monitoring of blood potassium levels is recommended.

INTERACTIONS
It is recommended to inform the Doctor if you are taking or if you have recently taken any other medicine, even those without a prescription.
This is particularly important for the following Drugs that can interact with Monores:

• beta-adrenergic, non-inhalational anticholinergics, xanthine derivatives (theophylline) and corticosteroids, as they can potentiate its effect
• sympathomimetic drugs because, through synergism, adverse effects at the cardiac level can occur
• monoamine oxidase inhibitors or tricyclic antidepressants
• halogenated anesthetic hydrocarbons such as halothane, trichloroethylene and enflurane, as they can sensitize the myocardium to the arrhythmogenic effects of beta agonists
• beta-blockers as they antagonize the effect of Monores

SPECIAL WARNINGS
Inform your doctor before starting to take the medicine if you have a history of heart disease, irregular heartbeat or angina.

Pregnancy and Breastfeeding
Data relating to the use of Monores during pregnancy are limited.
Monores inhibits uterine contractions. Do not use Monores before delivery, unless otherwise recommended by the Doctor.
Do not use Monores during pregnancy and breastfeeding
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may still result in positive doping tests.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and operate machinery.
During treatment with Monores, adverse effects such as dizziness may occur.
Therefore, caution is recommended when driving vehicles or operating machinery. If you experience dizziness, avoid dangerous tasks such as driving or operating machinery.

Important information on some excipients
Monores tablets contains lactose therefore in case of ascertained intolerance to sugars (in
particular to galactose, component of lactose) contact your treating physician before
taking the medicine
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The individual dosage regimen of Monores must be determined by the doctor before starting
therapy. It is recommended to have a medical check-up during treatment (e.g. through regular peak flow monitoring)
If not otherwise prescribed, the recommended total daily dose for adults and adolescents over 12 years of age is 40 micrograms per day, divided into two administrations of 20
micrograms each at 12-hour intervals
During therapy, this dose can often be reduced to 20 micrograms per day (10
micrograms twice a day). In severe bronchospasm, treatment can be started
with a dosage up to 80 micrograms per day (40 micrograms twice a day).
The total daily dose in children is 1.2 micrograms/kg of body weight, ranging from 0.8
micrograms to 1.5 micrograms/kg of body weight, divided into two-three administrations.
Due to limited information in children under 6 years of age, the recommended doses
for this age group should be given only under medical supervision

Adults and adolescents over 12 years

Normally: 2 tablets of 10 micrograms both in the morning and in the evening (equal to 40
micrograms/day).
During treatment for prolonged periods, the dose can be reduced to: 1 tablet in the
morning and 1 tablet in the evening (equal to 20 micrograms/day).
In more severe forms, in the first days of treatment, the dosage can be increased to: 4
tablets in the morning and 4 tablets in the evening (equal to 80 micrograms/day). Once the
desired improvement is achieved, adhere to the normally recommended doses.

Children under 12 yearsNormally: 1.2 micrograms/kg of Clenbuterol, divided into
two-three daily administrations.
Unless otherwise prescribed by the Doctor:

• 6 - 12 years: 1 tablet, two-three times a day (equal to 20 – 30 micrograms/day). During treatment for prolonged periods, the dose can be reduced.

OVERDOSE
Symptoms:
The expected symptoms in case of overdose are those resulting from excessive beta-stimulation
for example any of the symptoms in the list of adverse effects: hyperglycemia, hypertension,
hypotension, increased heart rate, angina pain and arrhythmia.
Following the improper use of clenbuterol, in particular in association with other medicines for
improving appearance and performance, life-threatening and
lethal outcomes have been observed.
Treatment:
Discontinue the administration of Monores
It is recommended to contact the Doctor or the nearest hospital to establish appropriate symptomatic therapy.
In cases of severe intensive care therapy, treatment may consist of the administration of sedatives
and tranquilizers.
Non-selective beta-blockers, such as propranolol, are suitable as specific antidotes. However
it must be considered an increase in bronchial obstruction and therefore the dose of
beta-blocker must be carefully modulated in patients with bronchial asthma.
Treatment for overdose with antidotes should be repeated at short intervals depending on the
symptoms.
It should be considered that the effects of Monores may persist beyond those of the antidote,
therefore repeated administration of beta-blocker may be necessary.

In case of ingestion/accidental intake of an excessive dose of Monores, immediately warn
your doctor or go to the nearest hospital.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF MONORES, ASK YOUR DOCTOR OR PHARMACIST.

UNDESIRABLE EFFECTS
Like all medicines, Monores can cause side effects, although not everyone
experiences them.
a) General description
In analogy with other beta-adrenergic, Monores can cause the following betamimetic
undesirable effects including severe hypokalemia.
b) List of side effects
The side effects listed by frequency are reported, using the following convention:
Very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1.000 to <1/100);
rare (from ≥1/10.000 to <1/1.000); very rare (<1/10.000), frequency not known (cannot be
evaluated based on available data).
COMMON side effects
: palpitations
D : restlessness
: headache, tremors

• : nausea

UNCOMMON side effects
D : Hypersensitivity
D : nervousness, hyperactivity in children
: dizziness
: arrhythmia, tachycardia
P : paradoxical bronchospasm

• : muscle spasm, mild tremors of the skeletal muscles, normally more evident in the hands, myalgia.

Side effects with NOT KNOWN frequency
: hyperglycemia
D : hypokalemia
: myocardial infarction, myocardial ischemia
c) Special population
In diabetic patients, an increase in blood glucose has been observed.
Although the frequency with which this happens is unknown, chest pain (due to heart problems such as angina) may occasionally occur in some people.
Immediately inform your doctor if you experience these symptoms during treatment with
Monores, but do not stop using the medicine unless advised by your doctor.
undesirable effects.
Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet, tell your
Doctor or Pharmacist. You can also report side effects directly
through the national reporting system at the address:
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on
the safety of this medicine.

Expiration and storage
Expiration: see the expiration date indicated on the packaging
Do not use the medicine after the expiration date which is reported on the packaging.
The expiration date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store at a temperature not exceeding 25°C.

KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

Medicines should not be disposed of via drains or household waste.

Ask your pharmacist how to dispose of medicines you no longer use. This will help protect

the environment.
COMPOSITION
Monores 10 micrograms tablets
One tablet contains as active ingredient:
Clenbuterol 10 micrograms
as Clenbuterol hydrochloride 11.3 micrograms
The excipients are:
Lactose, Microcrystalline Cellulose, Talc, Anhydrous Colloidal Silica, Magnesium Stearate,.

Pharmaceutical Form and content
30 tablets of 10 micrograms

MARKETING AUTHORISATION HOLDER
Neopharmed Gentili S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan

MANUFACTURER
Valeas S.p.A.- Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milan

MONORES 20 micrograms/5 ml Syrup

Clenbuterol
Equivalent Medicinal Product

PHARMACOTHERAPEUTIC CATEGORY
Drugs for obstructive syndromes of the airways. Selective agonists of the –
adrenergic receptors

THERAPEUTIC INDICATIONS
Prophylaxis and treatment of bronchial asthma and other conditions with reversible airway obstruction
e.g. chronic obstructive bronchopathy with an asthmatic component.
Concomitant anti-inflammatory therapy should be considered for patients with
asthma and/or chronic obstructive pulmonary disease.

CONTRAINDICATIONS
Do not use Monores in the following cases:

• obstructive hypertrophic cardiomyopathy
• tachyarrhythmia
• hypersensitivity to clenbuterol hydrochloride or any of the other components of this medicine
• in cases of intolerance to sugars and in particular to fructose (component of sorbitol)

PRECAUTIONS FOR USE
Elderly patients and children require caution when using Monores.
Strictly adhere to the recommended doses and the duration of the recommended treatment.
Improper use of Monores can cause severe and potentially life-threatening side effects
and should be discouraged (see also section Overdosage). Following the improper use of clenbuterol with other medicines to improve appearance and
performance, fatal outcomes have been observed even in young adults.
Bronchodilator anticholinergics can still be administered by inhalation in
conjunction with Monores.
Do not use Monores

• in conjunction with other sympathomimetic bronchodilators, unless under close medical supervision.
• for the treatment of symptoms of acute asthma attacks, as Monores is not suitable for this type of treatment.

Patients taking Monores should be particularly careful, especially in cases of
taking doses higher than those recommended, if they suffer from the following conditions:

• uncontrolled diabetes mellitus
• coronary diseases, arrhythmias, arterial hypertension, recent myocardial infarction, severe heart failure or vascular disorders
• pheochromocytoma
• hyperthyroidism
• glaucoma
• prostatic hypertrophy.

Monores, like other beta-2-agonists, can determine, albeit rarely, cardiac ischemia.
Patients with pre-existing severe heart disease (e.g. ischemic heart disease, arrhythmia or
severe heart failure) should consult their doctor if they experience chest pain or other
symptoms of worsening heart disease.
In case of worsening bronchial obstruction, onset of breathing difficulties (dyspnea)
do not increase the recommended doses of Monores and immediately consult your
Doctor, for appropriate re-evaluations of the adequacy of the therapy.
Regular increase in the use of beta-agonists to control symptoms of bronchial obstruction
may suggest a worsening of the control of the disease.
Monores, like other beta-2-agonists, can cause hypokalemia (reduction of potassium levels in the blood) potentially severe. Particular caution is recommended:

• in severe asthma and its concomitant treatment with xanthine derivatives (theophylline), corticosteroids and diuretics, as hypokalemia may be potentiated
• in hypoxia (oxygen deficiency), which can worsen the effects of hypokalemia on heart rhythm.

In such situations, monitoring of blood potassium levels is recommended.

INTERACTIONS
It is recommended to inform the Doctor if you are taking or have recently
taken any other medicines, including those without a prescription.
This is particularly important for the following Drugs that can interact with
Monores:

• beta-adrenergic, non-inhaled anticholinergics, xanthine derivatives (theophylline) and corticosteroids, as they can potentiate its effect
• sympathomimetic drugs as, due to synergism, adverse effects at the cardiac level may occur
• monoamine oxidase inhibitors or tricyclic antidepressants
• halogenated anesthetic hydrocarbons such as halothane, trichloroethylene and enflurane, as they can sensitize the myocardium to the arrhythmogenic effects of beta agonists
• beta-blockers as they antagonize the effect of Monores

SPECIAL WARNINGS
Inform your doctor before starting to take the medicine if you have a history of heart disease,
irregular heartbeat or angina.

Pregnancy and Breastfeeding
Data relating to the use of Monores during pregnancy are limited.

Monores inhibits uterine contractions. Do not use Monores before labor, unless

otherwise recommended by the Doctor.
Do not use Monores during pregnancy and breastfeeding.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and
may still result in positive doping tests.

Driving and operating machinery
Studies on the ability to drive vehicles and operate machinery have not been conducted.
During treatment with Monores, undesirable effects such as dizziness may occur.
Therefore, caution is recommended when driving vehicles or operating machinery. If
dizziness occurs, it is recommended to avoid dangerous tasks or operating machinery.

Important information about some excipients
Monores syrup contains sorbitol and para-hydroxybenzoates. In case of intolerance to sugars and
in particular to fructose (a component of sorbitol) contact your doctor before
taking this medicine.
Sorbitol may have a mild laxative effect. Caloric value 2.6 Kcal/g sorbitol.
Para-hydroxybenzoates may cause allergic reactions (also delayed).

DOSE, METHOD AND DURATION OF ADMINISTRATION
The individual dosage regimen of Monores must be determined by the doctor before starting
therapy. It is recommended to keep patients under medical supervision during treatment
(e.g. through regular peak flow monitoring)
Unless otherwise prescribed, the recommended total daily dose for adults and adolescents of
age over 12 years is 40 micrograms per day, divided into two administrations of 20
micrograms each at 12-hour intervals
During therapy this dose can often be reduced to 20 micrograms (10
micrograms twice a day). In severe bronchospasm, treatment may be started
with a dosage of up to 80 micrograms per day (40 micrograms twice a day).
The total daily dose in children is 1.2 micrograms/Kg of body weight, ranging from 0.8
micrograms to 1.5 micrograms/Kg of body weight, divided into two to three administrations.
Due to limited information on use in children under 6 years of age, the recommended doses for this age group should only be given under medical supervision.
Please note

Adults and adolescents over 12 years of age

Normally:1 / 2 measuring cup (5 ml) in the morning and 1 / 2 measuring cup (5 ml) in the evening (equal to
40 micrograms/day) .
During long-term treatment, the dose may be reduced to 1 / 4 of
measuring cup (2.5 ml) in the morning and 1 / 4 of measuring cup (2.5 ml) in the evening (equal to 20 micrograms/day) .
In more severe forms, in the first days of treatment, the dosage may be increased to
1 measuring cup (10 ml) in the morning and 1 measuring cup (10 ml) in the evening (equal to 80 micrograms/day) .
Once the desired improvement is achieved, follow the normally recommended doses.

Children under 12 years of age

Normally: 1.2 micrograms/Kg of Clenbuterol, divided into two-three administrations
daily.
If the Doctor does not prescribe otherwise:

• 4 - 6 years (16-22 Kg): 1 / 4 of measuring cup (2.5 ml) in the morning and 1 / 4 of measuring cup (2.5 ml) in the evening (equal to 20 micrograms/day) .
• 6 - 12 years (22-35 Kg): 1 / 4 of measuring cup (2.5 ml) three times a day (equal to 30 micrograms/day). During long-term treatment, the dose may be reduced.

OVERDOSE
Symptoms:
The expected symptoms in case of overdose are those resulting from excessive beta-stimulation
for example any of the symptoms in the list of side effects: hyperglycemia, hypertension,
hypotension, increased heart rate, angina pain and arrhythmia.
Following the improper use of clenbuterol, in particular in association with other medicines for
improving appearance and performance, life-threatening and
fatal outcomes have been observed.
Treatment:
Discontinue the administration of Monores
It is recommended to contact the Doctor or the nearest hospital to start appropriate symptomatic therapy.
In cases of severe intensive care, treatment may consist of the administration of sedatives
and tranquilizers.
Non-selective beta-blockers, such as propranolol, are suitable as specific antidotes. However
consideration must be given to an increase in bronchial obstruction and therefore the dose of
beta-blocker must be carefully modulated in patients with bronchial asthma.
Treatment for overdose with antidotes should be repeated at short intervals depending on
symptoms.
It should be considered that the effects of Monores may persist beyond those of the antidote,
therefore repeated administration of beta-blocker may be necessary.
In case of accidental ingestion/intake of an excessive dose of Monores, immediately notify
the doctor or go to the nearest hospital.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF MONORES, ASK YOUR DOCTOR OR PHARMACIST.

SIDE EFFECTS
Like all medicines, Monores can cause side effects, although not everyone gets them.
a) General description
In analogy with other beta-adrenergics, Monores can cause the following beta-mimetic undesirable effects
including severe hypokalemia:
b) List of side effects
The side effects listed by frequency are reported, using the following convention:
Very common (≥1/10); common (≥1/100 to <1>rare (≥1/10,000 to <1>evaluated based on available data).
COMMON side effects
: palpitations
D : restlessness
: headache, tremors

• : nausea

UNCOMMON side effects
D : Hypersensitivity
D : nervousness, hyperactivity in children
: dizziness
: arrhythmia, tachycardia
P : paradoxical bronchospasm

• : muscle spasm, mild tremors in the skeletal muscles, usually more evident in the hands, myalgia.

Side effects with NOT KNOWN frequency
: hyperglycemia
D : hypokalemia
: myocardial infarction, myocardial ischemia
c) Special population
An increase in blood sugar has been observed in diabetic patients.
Although the frequency with which this happens is unknown, chest pain (due to heart problems such as angina) may occasionally occur in some people.
Immediately inform your doctor if you experience these symptoms during treatment with
Monores, but do not stop using the medicine unless advised by your doctor.

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 the address:
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on
the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
Do not use the medicine after the expiry date which is reported on the packaging.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store at a temperature not exceeding 25°C.
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

The medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
COMPOSITION
MONORES 20 micrograms/5 ml syrup
100 ml of syrup contains as active ingredient Clenbuterol 0.4 mg,
as clenbuterol hydrochloride 0.452 mg
The excipients are: Methyl para-hydroxybenzoate, Ethyl para-hydroxybenzoate, Cherry Aroma,
Azorubine (E 122), Non-crystallizable liquid Sorbitol, Purified Water.

PHARMACEUTICAL FORM AND CONTENT
120 mL bottle made of opaque polyethylene, packaged with a measuring cup, together with the leaflet,
in a cardboard box.

MARKETING AUTHORISATION HOLDER
Neopharmed Gentili S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan

MANUFACTURER
Valeas S.p.A. - Via Vallisneri, 10 – 20133 Milan

MONORES 20 micrograms tablets

Clenbuterol
Equivalent Medicinal Product

PHARMACOTHERAPEUTIC CATEGORY
Drugs for obstructive syndromes of the airways. Selective beta2-adrenergic receptor agonists.

THERAPEUTIC INDICATIONS
Prophylaxis and treatment of bronchial asthma and other conditions with reversible airway obstruction, for example: chronic obstructive bronchopathy with an asthmatic component.
Concomitant anti-inflammatory therapy should be considered for patients with asthma and/or chronic obstructive pulmonary disease.

CONTRAINDICATIONS
Do not use Monores in the following cases:

• hypertrophic obstructive cardiomyopathy
• tachyarrhythmia
• hypersensitivity to Clenbuterol hydrochloride or to any of the other components of this medicine.
• in cases of intolerance to sugars and in particular to galactose (component of lactose), e.g. galactosemia.

PRECAUTIONS FOR USE
Elderly patients and children require caution when using Monores
Strictly adhere to the recommended doses and the duration of the recommended treatment.
Improper use of Monores can cause severe and potentially life-threatening side effects and should be discouraged (see also section Overdose). Following the improper use of clenbuterol with other medicines for improving appearance and performance, lethal outcomes have been observed even in young adults.
Bronchodilators anticholinergics can still be administered by inhalation in conjunction with Monores.
Do not use Monores

• in conjunction with other sympathomimetic bronchodilators, unless under close medical supervision.
• for the treatment of symptoms of acute asthma attacks, as Monores is not suitable for this type of treatment. Patients taking Monores should be particularly careful, especially if affected by the following conditions, if taking doses higher than those recommended:
• uncontrolled diabetes mellitus
• coronary disease, arrhythmias, high blood pressure, recent myocardial infarction, severe heart failure or vascular disorders
• pheochromocytoma
• hyperthyroidism
• glaucoma
• prostatic hypertrophy.

Monores, like other beta-2-agonists, can determine, albeit rarely, cardiac ischemia.
Patients with pre-existing severe heart disease (e.g. ischemic heart disease, arrhythmia or severe heart failure) should consult their doctor if they experience chest pain or other symptoms of worsening heart disease.
In case of worsening bronchial obstruction, onset of breathing difficulties (dyspnea), do not increase the recommended doses of Monores and immediately consult your doctor for appropriate re-evaluation of the adequacy of the therapy.
Regular increase in the use of beta-agonists to control symptoms of bronchial obstruction may suggest a worsening of disease control.
Monores, like other beta-2-agonists, can cause hypokalemia (reduction of potassium levels in the blood) potentially severe. Particular caution is recommended:

• in severe asthma and its concomitant treatment with xanthine derivatives (theophylline), corticosteroids and diuretics because hypokalemia could be potentiated
• in hypoxia (oxygen deficiency), which can worsen the effects of hypokalemia on heart rhythm.

In such situations, monitoring of blood potassium levels is recommended.

INTERACTIONS
It is recommended to inform your doctor if you are taking or have recently taken any other medicines, including those without a prescription.
This is particularly important for the following drugs that can interact with Monores:

• beta-adrenergic, non-inhalational anticholinergics, xanthine derivatives (theophylline) and corticosteroids, as they can potentiate its effect
• sympathomimetic drugs because, due to synergism, undesirable effects at the cardiac level may occur
• monoamine oxidase inhibitors or tricyclic antidepressants
• halogenated hydrocarbon anesthetics such as halothane, trichloroethylene and enflurane, as they can sensitize the myocardium to the arrhythmogenic effects of beta agonists
• beta-blockers as they antagonize the effect of Monores

SPECIAL WARNINGS
Inform your doctor before starting to take the medicine if you have a history of heart disease, irregular heartbeat or angina.

Pregnancy and Breastfeeding
Data relating to the use of Monores during pregnancy are limited.
Monores inhibits uterine contractions. Do not use Monores before delivery, unless otherwise recommended by your doctor.
Do not use Monores during pregnancy and breastfeeding.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may still result in positive doping tests.

Driving and using machinery
Studies on the ability to drive vehicles and operate machinery have not been conducted.
During treatment with Monores, side effects such as dizziness may occur.
Therefore, caution is recommended when driving vehicles or operating machinery. If you experience dizziness, avoid dangerous tasks such as driving or operating machinery.

Important information on some excipients
Monores tablets contains lactose therefore in case of ascertained intolerance to sugars (in
particular to galactose, component of lactose) contact your treating doctor before
taking the medicine.
DOSAGE, MODE AND TIME OF ADMINISTRATION
The individual dosage regimen of Monores must be determined by the doctor before starting
therapy. Medical control is recommended during treatment (e.g. through regular peak flow monitoring).
If not otherwise prescribed, the recommended total daily dose for adults and adolescents over 12 years of age is 40 micrograms per day, divided into two administrations of 20
micrograms each at 12-hour intervals.
During therapy, this dose can often be reduced to 20 micrograms per day (10
micrograms twice a day). In severe bronchospasm, treatment can be started
with a dosage up to 80 micrograms per day (40 micrograms twice a day).
The total daily dose in children is 1.2 micrograms/kg of body weight, ranging from 0.8
micrograms to 1.5 micrograms/kg of body weight, divided into two or three administrations.
Due to limited information in children under 6 years of age, the recommended doses
for this age group should be given only under medical supervision

Adults and adolescents over 12 years

Normally: 1 tablet in the morning and 1 tablet in the evening (equal to 40 micrograms/day).
During treatment for prolonged periods, the dose can be reduced to: 1/2 tablet in the
morning and 1/2 tablet in the evening (equal to 20 micrograms/day).
In more severe forms, in the first days of treatment, the dosage can be increased to:
2 tablets in the morning and 2 tablets in the evening (equal to 80 micrograms/day). Once the
desired improvement is achieved, follow the normally recommended doses.

Children under 12 years of age

Normally: 1.2 micrograms/kg of Clenbuterol, divided into two or three administrations
daily.
If the doctor does not prescribe otherwise:

• 6 - 12 years: 1/2 tablet, two or three times a day (equal to 20 – 30 micrograms/day). During treatment for prolonged periods, the dose may be reduced.

OVERDOSE
Symptoms:
The expected symptoms in case of overdose are those resulting from excessive beta-stimulation
for example any of the symptoms in the list of side effects: hyperglycemia, hypertension,
hypotension, increased heart rate, angina pain and arrhythmia.
Following the improper use of clenbuterol, especially in association with other medicines for
improving appearance and performance, life-threatening and
lethal outcomes have been observed.
Treatment:
Discontinue the administration of Monores
It is recommended to contact the doctor or the nearest hospital to establish appropriate symptomatic therapy.
In cases of severe intensive care, treatment may consist of the administration of sedatives
and tranquilizers.
Non-selective beta-blockers, such as propranolol, are suitable as specific antidotes. However
an increase in bronchial obstruction must be considered and therefore the dose of
beta-blocker must be carefully modulated in patients with asthma bronchiale.
Treatment for overdose with antidotes should be repeated at short intervals depending on
symptoms.
It should be considered that the effects of Monores may persist beyond those of the antidote,
therefore repeated administration of beta-blocker may be necessary.

In case of ingestion/accidental intake of an excessive dose of Monores, immediately warn
your doctor or go to the nearest hospital.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF MONORES, ASK YOUR DOCTOR OR PHARMACIST.

SIDE EFFECTS
Like all medicines, Monores can cause side effects, although not everyone
experiences them.
c) General description
In analogy with other beta-adrenergic drugs, Monores can cause the following beta-mimetic side effects
undesirable including severe hypokalemia.
d) List of side effects
The side effects listed by frequency are reported, using the following convention:
Very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1,000 to <1/100);
rare (from ≥1/10,000 to <1/1,000); very rare (<1/10,000), frequency not known (cannot be
evaluated based on available data).
COMMON side effects
: palpitations
D : restlessness
: headache, tremors

• : nausea

UNCOMMON side effects
D : Hypersensitivity
D : nervousness, hyperactivity in children
: dizziness
: arrhythmia, tachycardia
P : paradoxical bronchospasm

• : muscle spasm, mild tremors in the skeletal muscles, normally more evident in the hands, myalgia.

Side effects with NOT KNOWN frequency
: hyperglycemia
D : hypokalemia
: myocardial infarction, myocardial ischemia
c) Special population
In diabetic patients, an increase in blood glucose has been observed.
Although the frequency with which this happens is unknown, chest pain (due to heart problems such as angina) may occur occasionally in some people.
Immediately inform your doctor if you experience these symptoms during treatment with
Monores, but do not stop using the medicine unless advised by your doctor.
undesirable.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at the address:
w ww.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on
the safety of this medicine.

Expiration and storage
Expiration: see the expiration date indicated on the packaging.
Do not use the medicine after the expiration date which is reported on the packaging.
The expiration date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store at a temperature not exceeding 25°C.

KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

Medicines should not be disposed of via drains and household waste.

Ask your pharmacist how to dispose of medicines you no longer use. This will help protect

the environment.
COMPOSITION
Monores 20 micrograms tablets
One tablet contains as active ingredient:
Clenbuterol 20 micrograms
as Clenbuterol hydrochloride 22.6 micrograms
The excipients are:
Lactose, Microcrystalline cellulose, Talc, Anhydrous colloidal silica, Magnesium stearate, E 132.

Pharmaceutical form and content
30 tablets of 20 micrograms

MARKETING AUTHORISATION HOLDER
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan

MANUFACTURER
VALEAS S.p.A. - Industria Chimica e Farmaceutica - Via Vallisneri, 10 - 20133 Milan