1-DESCRIPTION:
REGLOCID
®
is a white color, round shaped, tablets. Box of 30.
2-COMPOSITION:
Each tablet of REGLOCID
®
contains metoclopramide hydrochloride
10mg.
Inactive ingredient: microcrystalline cellulose, lactose monohydrate,
sodium starch glycolate, magnesium stearate.
3-THERAPEUTIC INDICATIONS
Adult population
Metoclopramide is indicated in adults for:
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV).
- Prevention of radiotherapy induced nausea and vomiting (RINV).
- Symptomatic treatment of nausea and vomiting, including acute
migraine induced nausea and vomiting. Metoclopramide can be
used in combination with oral analgesics to improve the absorption of
analgesics in acute migraine.
Pediatric population
Metoclopramide 10mg tablets are indicated in children (aged 15-18
years) for:
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV) as a second line option.
4- PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: REGLOCID
®
belongs to the family of
dopamine antagonists, drugs for functional gastrointestinal disorders,
propulsive.
ATC CODE: A03FA01
The action of metoclopramide is closely associated with parasympa-
thetic nervous control of the upper gastro-intestinal tract where it has
the effect of encouraging normal peristaltic action. This provides for a
fundamental approach to the control of those conditions where
disturbed gastrointestinal motility is a common underlying factor.
PHARMACOKINETIC PROPERTIES
Metoclopramide is metabolized in the liver and the predominant
route of elimination of metoclopramide and its metabolites is via the
kidney.
Renal impairment
The clearance of metoclopramide is reduced by up to 70% in patients
with severe renal impairment, while the plasma elimination half-life is
increased (approximately 10 hours for a creatinine clearance of 10-50
mL/minute and 15 hours for a creatinine clearance <10 hours).
Hepatic impairment
In patients with cirrhosis of the liver, accumulation of metoclopramide
has been observed, associated with a 50% reduction in plasma
clearance.
5-POSOLOGY
Adult patient (all indications)
-The recommended single dose is 10 mg, repeated up to three times
daily.
- The maximum recommended daily dose is 30 mg or 0.5mg/kg body
weight.
-The maximum recommended treatment duration is 5 days.
Pediatric population
Metoclopramide is contraindicated in children aged less than 1 year.
Pediatric patients aged 15-18 years
Prevention of delayed chemotherapy induced nausea and vomiting
(CINV). The recommended dose is 0.1 to 0.15 mg/kg body weight,
repeated up to three times daily by oral route. The maximum dose in 24
hours is 0.5 mg/kg body weight.
Age Body weight Dose Frequency
15-18 years Over 60kg 10mg
Up to 3 times daily
The maximum treatment duration is 5 days for prevention of delayed
chemotherapy induced nausea and vomiting (CINV).
Tablets are not suitable for use in children weighing less than 61kg.
Other pharmaceutical forms/strengths may be more appropriate for
administration to this population.
A minimal interval of 6 hours between two administrations is to be
respected, even in case of vomiting or rejection of the dose.
6-WARNINGS AND PRECAUTIONS
Never take REGLOCID
®
10 mg tablets in the following cases:
• children aged under 18 years,
• history of allergy to metoclopramide or to another ingredient of this
medicine,
• stomach and intestine stimulation potentially dangerous for the
patient (gastrointestinal bleeding, obstruction, perforation),
• previous abnormal muscle movements during treatment with
neuroleptics or metoclopramide,
• pheochromocytoma (a tumor of the adrenal medulla causing severe
high blood pressure),
• in combination with antiparkinsonian medicines (levodopa,
dopamine agonists and selegiline),
• known history of hemoglobin abnormalities related to metoclopra-
mide or to a hereditary disease of the red blood cells associated with
the absence of an enzyme.
SPECIAL WARNINGS
If unexplained fever occurs, with or without other symptoms (paleness,
disorders of involuntary functions, impaired consciousness, muscle
stiffness), stop treatment and inform your doctor immediately. Large
amounts of water and mineral salts are lost with repeated vomiting.
They must be replaced by liquid food (oral rehydration solution) taken
regularly and in small amounts.
cases of hemoglobin abnormalities, which could be related to a
hereditary disease of the red blood cells associated with the absence
of an enzyme, have been reported. If the skin and mucous
membranes develop a bluish color, stop treatment and inform your
doctor immediately.
INFORM YOUR DOCTOR:
- if you have epilepsy (this medicine may increase the frequency of
seizures),
- if you have kidney or liver disease. IF YOU ARE UNSURE OF ANYTHING,
DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
TAKING/USING OTHER MEDICINES:
This medicine must not be used with antiparkinsonian medicines
(levodopa, dopamine agonists and selegiline).
TO AVOID POSSIBLE INTERACTIONS BETWEEN MEDICINES, particularly with
medicines containing alcohol and alcoholic drinks, ALWAYS INFORM
YOUR DOCTOR OR PHARMACIST OF ANY OTHER MEDICINES YOU MAY BE
TAKING.
FOOD AND DRINK :
This medicine can cause increased drowsiness when used along with
alcohol. It is strongly recommended to avoid consuming alcohol
during treatment.
7-SPECIAL POPULATION
ELDERLY
In elderly patients a dose reduction should be considered, based on
renal and hepatic function and overall frailty.
RENAL IMPAIRMENT
In patients with end stage renal disease (Creatinine clearance ≤ 15
ml/min), the daily dose should be reduced by 75%. In patients with
moderate to severe renal impairment (Creatinine clearance 15-60
ml/min), the dose should be reduced by 50%.
HEPATIC IMPAIRMENT
In patients with severe hepatic impairment, the dose should be
reduced by 50% .Other pharmaceutical forms/strengths may be
more appropriate for administration to these populations.
PREGNANCY
Metoclopramide can be used during pregnancy if clinically needed.
Due to pharmacological properties (as other neuroleptics), in case of
metoclopramide administration at the end of pregnancy, extrapyra-
midal syndrome in newborn cannot be excluded. Metoclopramide
should be avoided at the end of pregnancy. If metoclopramide is
used, neonatal monitoring should be undertaken.
BREAST-FEEDING
Metoclopramide is excreted in breast milk at low level. Adverse
reactions in the breast-fed baby cannot be excluded. Therefore
metoclopramide is not recommended during breast-feeding.
Discontinuation of metoclopramide in breast-feeding women should
be considered.
FERTILITY
No data available.
8-ADVERSE REACTIONS
Like all medicines, REGLOCID
®
can cause side effects, although not
everybody gets them.
Frequencies are defined using the following convention: very
common (≥1/10), common (≥1/100 to<1/10, uncommon (≥1/1,000 to<1/100,
rare e (≥1/10,000 to<1/1000, very rare (1<10,000) not known (cannot be
estimated from the available data).
Very common: Somnolence
Common: hypotension( particularly with intravenous formulation),
diarrhea, asthenia, Depression, extrapyramidal disorders (particularly
in children and young adults and/or when
the recommended dose is exceeded, even
following administration of a single dose of
the drug), Parkinsonism; Akathisia,
Hypotension(particularly with intravenous
formulation).
Uncommon: Hypersensitivity, amenorrhea;
hyperprolactinemia, hallucination, dystonia
(including visual disturbances and
oculogyric crisis); dyskinesia; depressed level
of consciousness, bradycardia (particularly
with intravenous formulation).
Rare: galactorrhea, confusional state,
convulsion especially in epileptic patients.
Not known : methemoglobinemia, aphylactic
reaction (including anaphylactic shock
particularly with intravenous formulation,
gynecomastia, tardive dyskinesia which may
be persistent, during or after prolonged
treatment, particularly in elderly patients,
neuroleptic malignant syndrome, cardiac
arrest, occurring shortly after injectable use,
and which can be subsequent to
bradycardia, atrioventricular block, sinus
arrest( particularly with intravenous
formulation), electrocardiogram QT
prolonged; torsade de Pointe, shock,
syncope (after injectable use),acute
hypertension in patients with phaeochromo-
cytoma ,transient increase in blood pressure.
9-CONTRAINDICATIONS
-Hypersensitivity to the active substance or
to any of the excipients listed in section 2.
-Gastrointestinal hemorrhage, mechanical
obstruction or gastro-intestinal perforation
for which the stimulation of gastrointestinal
motility constitutes a risk
- Confirmed or suspected pheochromocy-
toma, due to the risk of severe hypertension
episodes
- History of neuroleptic or metoclopra-
mide-induced tardive dyskinesia
- Epilepsy (increased crises frequency and
intensity)
- Parkinson’s disease
- Combination with levodopa or dopaminer-
gic agonists
- Known history of methaemoglobinaemia
with metoclopramide or of NADH
cytochrome-b5 deficiency
- Use in children less than 1 year of age due
to an increased risk of extrapyramidal
disorders
- Metoclopramide should not be used during
the first three to four days following
operations such as pyloroplasty or gut
anastomosis as vigorous muscular
contractions may not help healing.
10-DRUG INTERACTIONS
-Levodopa or dopaminergic agonists and
metoclopramide are contraindicated.
- Alcohol potentiates the sedative effect of
metoclopramide.
-Anticholinergics and morphine derivatives
may have both a mutual antagonism with metoclopramide on the
digestive tract motility.
-Central nervous system depressants (morphine derivatives,
anxiolytics, sedative H1 antihistamines, sedative antidepressants,
barbiturates, clonidine and related) :sedative effects of Central
Nervous System depressants and metoclopramide are potentiated.
-Neuroleptics: metoclopramide may have an additive effect with other
neuroleptics on the occurrence of extrapyramidal disorders.
-Serotonergic drugs such as SSRI with the use of metoclopramide may
increase the risk of serotonin syndrome.
-Digoxin: Metoclopramide may decrease digoxin bioavailability.
Careful monitoring of digoxin plasma concentration is required.
-Cyclosporine :Metoclopramide increases cyclosporine bioavailability
(Cmax by 46% and exposure by 22%). Careful monitoring of
cyclosporine plasma concentration is required.
Mivacurium and suxamethonium: metoclopramide injection may
prolong the duration of neuromuscular block (through inhibition of
plasma cholinesterase).
Strong CYP2D6 inhibitors: metoclopramide exposure levels are
increased when co-administered with strong CYP2D6 inhibitors such
as fluoxetine and paroxetine. Although the clinical significance is
uncertain, patients should be monitored for adverse reactions.
11-OVERDOSE
Symptoms Extrapyramidal disorders, drowsiness, decreased level of
consciousness, confusion, hallucination, and cardio-respiratory arrest
may occur.
Management In case of extrapyramidal symptoms related or not to
overdose, the treatment is only symptomatic (benzodiazepines in
children and/or anticholinergic antiparkinsonian medicinal products in
adults). A symptomatic treatment and a continuous monitoring of the
cardiovascular and respiratory functions should be carried out
according to clinical status.
12- DRIVE AND USE MACHINES
Metoclopramide may cause drowsiness, dizziness, dyskinesia and
dystonia which could affect the vision and also interfere with the ability
to drive and operate machinery
13-STORAGE CONDITIONS
Store below 30 C, in a dry place
Keep out of the reach and sight of children.
MANUFACTURER:
UNIZA LIFECARE PRIVATE LTD. Mehsana 382 715,Gujarat State, India
MARKETING AUTHORIZATION HOLDER, PACKED BY
REGLOCID
®
may cause abnormal movements of the head and
neck particularly in young adults and/or following an overdose. It is
therefore essential to comply with the recommended dosage and
to allow an interval of at least 6 hours between doses. These
reactions generally occur at the beginning of treatment, between 1
and 3 hours after the previous dose. They may appear after a
single dose. If these symptoms appear, stop using this medicine
AND INFORM YOUR DOCTOR IMMEDIATELY. These effects are generally
reversible after stopping treatment, but may require symptomatic
treatment. Allow an interval of at least 6 hours between each dose,
even if vomiting or partial or total rejection of the dose occurs.
Occasionally irreversible abnormal movements predominantly
affecting the face and tongue may occur during long-term
treatment, especially in elderly subjects. The risk of developing
these effects increases with treatment duration and the
cumulative dose administered. Treatment with REGLOCID should
not last more than 3 months. If these symptoms appear, stop using
this medicine AND INFORM YOUR DOCTOR IMMEDIATELY.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or
pharmacist.
* This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet
.
®
metoclopramide Tablets
1-DESCRIPTION:
REGLOCID
®
is a white color, round shaped, tablets. Box of 30.
2-COMPOSITION:
Each tablet of REGLOCID
®
contains metoclopramide hydrochloride
10mg.
Inactive ingredient: microcrystalline cellulose, lactose monohydrate,
sodium starch glycolate, magnesium stearate.
3-THERAPEUTIC INDICATIONS
Adult population
Metoclopramide is indicated in adults for:
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV).
- Prevention of radiotherapy induced nausea and vomiting (RINV).
- Symptomatic treatment of nausea and vomiting, including acute
migraine induced nausea and vomiting. Metoclopramide can be
used in combination with oral analgesics to improve the absorption of
analgesics in acute migraine.
Pediatric population
Metoclopramide 10mg tablets are indicated in children (aged 15-18
years) for:
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV) as a second line option.
4- PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: REGLOCID
®
belongs to the family of
dopamine antagonists, drugs for functional gastrointestinal disorders,
propulsive.
ATC CODE: A03FA01
The action of metoclopramide is closely associated with parasympa-
thetic nervous control of the upper gastro-intestinal tract where it has
the effect of encouraging normal peristaltic action. This provides for a
fundamental approach to the control of those conditions where
disturbed gastrointestinal motility is a common underlying factor.
PHARMACOKINETIC PROPERTIES
Metoclopramide is metabolized in the liver and the predominant
route of elimination of metoclopramide and its metabolites is via the
kidney.
Renal impairment
The clearance of metoclopramide is reduced by up to 70% in patients
with severe renal impairment, while the plasma elimination half-life is
increased (approximately 10 hours for a creatinine clearance of 10-50
mL/minute and 15 hours for a creatinine clearance <10 hours).
Hepatic impairment
In patients with cirrhosis of the liver, accumulation of metoclopramide
has been observed, associated with a 50% reduction in plasma
clearance.
5-POSOLOGY
Adult patient (all indications)
-The recommended single dose is 10 mg, repeated up to three times
daily.
- The maximum recommended daily dose is 30 mg or 0.5mg/kg body
weight.
-The maximum recommended treatment duration is 5 days.
Pediatric population
Metoclopramide is contraindicated in children aged less than 1 year.
Pediatric patients aged 15-18 years
Prevention of delayed chemotherapy induced nausea and vomiting
(CINV). The recommended dose is 0.1 to 0.15 mg/kg body weight,
repeated up to three times daily by oral route. The maximum dose in 24
hours is 0.5 mg/kg body weight.
Age Body weight Dose Frequency
15-18 years Over 60kg 10mg
Up to 3 times daily
The maximum treatment duration is 5 days for prevention of delayed
chemotherapy induced nausea and vomiting (CINV).
Tablets are not suitable for use in children weighing less than 61kg.
Other pharmaceutical forms/strengths may be more appropriate for
administration to this population.
A minimal interval of 6 hours between two administrations is to be
respected, even in case of vomiting or rejection of the dose.
6-WARNINGS AND PRECAUTIONS
Never take REGLOCID
®
10 mg tablets in the following cases:
• children aged under 18 years,
• history of allergy to metoclopramide or to another ingredient of this
medicine,
• stomach and intestine stimulation potentially dangerous for the
patient (gastrointestinal bleeding, obstruction, perforation),
• previous abnormal muscle movements during treatment with
neuroleptics or metoclopramide,
• pheochromocytoma (a tumor of the adrenal medulla causing severe
high blood pressure),
• in combination with antiparkinsonian medicines (levodopa,
dopamine agonists and selegiline),
• known history of hemoglobin abnormalities related to metoclopra-
mide or to a hereditary disease of the red blood cells associated with
the absence of an enzyme.
SPECIAL WARNINGS
If unexplained fever occurs, with or without other symptoms (paleness,
disorders of involuntary functions, impaired consciousness, muscle
stiffness), stop treatment and inform your doctor immediately. Large
amounts of water and mineral salts are lost with repeated vomiting.
They must be replaced by liquid food (oral rehydration solution) taken
regularly and in small amounts.
cases of hemoglobin abnormalities, which could be related to a
hereditary disease of the red blood cells associated with the absence
of an enzyme, have been reported. If the skin and mucous
membranes develop a bluish color, stop treatment and inform your
doctor immediately.
INFORM YOUR DOCTOR:
- if you have epilepsy (this medicine may increase the frequency of
seizures),
- if you have kidney or liver disease. IF YOU ARE UNSURE OF ANYTHING,
DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
TAKING/USING OTHER MEDICINES:
This medicine must not be used with antiparkinsonian medicines
(levodopa, dopamine agonists and selegiline).
TO AVOID POSSIBLE INTERACTIONS BETWEEN MEDICINES, particularly with
medicines containing alcohol and alcoholic drinks, ALWAYS INFORM
YOUR DOCTOR OR PHARMACIST OF ANY OTHER MEDICINES YOU MAY BE
TAKING.
FOOD AND DRINK :
This medicine can cause increased drowsiness when used along with
alcohol. It is strongly recommended to avoid consuming alcohol
during treatment.
7-SPECIAL POPULATION
ELDERLY
In elderly patients a dose reduction should be considered, based on
renal and hepatic function and overall frailty.
RENAL IMPAIRMENT
In patients with end stage renal disease (Creatinine clearance ≤ 15
ml/min), the daily dose should be reduced by 75%. In patients with
moderate to severe renal impairment (Creatinine clearance 15-60
ml/min), the dose should be reduced by 50%.
HEPATIC IMPAIRMENT
In patients with severe hepatic impairment, the dose should be
reduced by 50% .Other pharmaceutical forms/strengths may be
more appropriate for administration to these populations.
PREGNANCY
Metoclopramide can be used during pregnancy if clinically needed.
Due to pharmacological properties (as other neuroleptics), in case of
metoclopramide administration at the end of pregnancy, extrapyra-
midal syndrome in newborn cannot be excluded. Metoclopramide
should be avoided at the end of pregnancy. If metoclopramide is
used, neonatal monitoring should be undertaken.
BREAST-FEEDING
Metoclopramide is excreted in breast milk at low level. Adverse
reactions in the breast-fed baby cannot be excluded. Therefore
metoclopramide is not recommended during breast-feeding.
Discontinuation of metoclopramide in breast-feeding women should
be considered.
FERTILITY
No data available.
8-ADVERSE REACTIONS
Like all medicines, REGLOCID
®
can cause side effects, although not
everybody gets them.
Frequencies are defined using the following convention: very
common (≥1/10), common (≥1/100 to<1/10, uncommon (≥1/1,000 to<1/100,
rare e (≥1/10,000 to<1/1000, very rare (1<10,000) not known (cannot be
estimated from the available data).
Very common: Somnolence
Common: hypotension( particularly with intravenous formulation),
diarrhea, asthenia, Depression, extrapyramidal disorders (particularly
in children and young adults and/or when
the recommended dose is exceeded, even
following administration of a single dose of
the drug), Parkinsonism; Akathisia,
Hypotension(particularly with intravenous
formulation).
Uncommon: Hypersensitivity, amenorrhea;
hyperprolactinemia, hallucination, dystonia
(including visual disturbances and
oculogyric crisis); dyskinesia; depressed level
of consciousness, bradycardia (particularly
with intravenous formulation).
Rare: galactorrhea, confusional state,
convulsion especially in epileptic patients.
Not known : methemoglobinemia, aphylactic
reaction (including anaphylactic shock
particularly with intravenous formulation,
gynecomastia, tardive dyskinesia which may
be persistent, during or after prolonged
treatment, particularly in elderly patients,
neuroleptic malignant syndrome, cardiac
arrest, occurring shortly after injectable use,
and which can be subsequent to
bradycardia, atrioventricular block, sinus
arrest( particularly with intravenous
formulation), electrocardiogram QT
prolonged; torsade de Pointe, shock,
syncope (after injectable use),acute
hypertension in patients with phaeochromo-
cytoma ,transient increase in blood pressure.
9-CONTRAINDICATIONS
-Hypersensitivity to the active substance or
to any of the excipients listed in section 2.
-Gastrointestinal hemorrhage, mechanical
obstruction or gastro-intestinal perforation
for which the stimulation of gastrointestinal
motility constitutes a risk
- Confirmed or suspected pheochromocy-
toma, due to the risk of severe hypertension
episodes
- History of neuroleptic or metoclopra-
mide-induced tardive dyskinesia
- Epilepsy (increased crises frequency and
intensity)
- Parkinson’s disease
- Combination with levodopa or dopaminer-
gic agonists
- Known history of methaemoglobinaemia
with metoclopramide or of NADH
cytochrome-b5 deficiency
- Use in children less than 1 year of age due
to an increased risk of extrapyramidal
disorders
- Metoclopramide should not be used during
the first three to four days following
operations such as pyloroplasty or gut
anastomosis as vigorous muscular
contractions may not help healing.
10-DRUG INTERACTIONS
-Levodopa or dopaminergic agonists and
metoclopramide are contraindicated.
- Alcohol potentiates the sedative effect of
metoclopramide.
-Anticholinergics and morphine derivatives
may have both a mutual antagonism with metoclopramide on the
digestive tract motility.
-Central nervous system depressants (morphine derivatives,
anxiolytics, sedative H1 antihistamines, sedative antidepressants,
barbiturates, clonidine and related) :sedative effects of Central
Nervous System depressants and metoclopramide are potentiated.
-Neuroleptics: metoclopramide may have an additive effect with other
neuroleptics on the occurrence of extrapyramidal disorders.
-Serotonergic drugs such as SSRI with the use of metoclopramide may
increase the risk of serotonin syndrome.
-Digoxin: Metoclopramide may decrease digoxin bioavailability.
Careful monitoring of digoxin plasma concentration is required.
-Cyclosporine :Metoclopramide increases cyclosporine bioavailability
(Cmax by 46% and exposure by 22%). Careful monitoring of
cyclosporine plasma concentration is required.
Mivacurium and suxamethonium: metoclopramide injection may
prolong the duration of neuromuscular block (through inhibition of
plasma cholinesterase).
Strong CYP2D6 inhibitors: metoclopramide exposure levels are
increased when co-administered with strong CYP2D6 inhibitors such
as fluoxetine and paroxetine. Although the clinical significance is
uncertain, patients should be monitored for adverse reactions.
11-OVERDOSE
Symptoms Extrapyramidal disorders, drowsiness, decreased level of
consciousness, confusion, hallucination, and cardio-respiratory arrest
may occur.
Management In case of extrapyramidal symptoms related or not to
overdose, the treatment is only symptomatic (benzodiazepines in
children and/or anticholinergic antiparkinsonian medicinal products in
adults). A symptomatic treatment and a continuous monitoring of the
cardiovascular and respiratory functions should be carried out
according to clinical status.
12- DRIVE AND USE MACHINES
Metoclopramide may cause drowsiness, dizziness, dyskinesia and
dystonia which could affect the vision and also interfere with the ability
to drive and operate machinery
13-STORAGE CONDITIONS
Store below 30 C, in a dry place
Keep out of the reach and sight of children.
MANUFACTURER:
UNIZA LIFECARE PRIVATE LTD. Mehsana 382 715,Gujarat State, India
MARKETING AUTHORIZATION HOLDER, PACKED BY
Date of Revision: 3 september, 2025
Council of Arab Health Ministers
Union of Arab pharmacists
This is a medicine:
- A medicine is a product which affects
your health and its consumption
contrary to instructions is dangerous
for you.
- Follow strictly the doctor's
prescription, the method of use and
the instructions of the pharmacist who
dispensed the medicine.
- The doctor and the pharmacist are
the experts in medicine, their benefits
and risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicine out of reach of
children.
®10mg metoclopramide Tablets Reg. N°:149725/1
PI043/01