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.
1-DESCRIPTION:
MOTILCURE Orally Disintegrating Tablets 10 mg are white to off-white,
round, flat tablets, plain on both sides, packed in Alu-Alu blister strip.
Box of 30 tablets
2-COMPOSITION:
Each oral dispersible tablet contains 10 mg of Domperidone.
Excipients: Mannitol granular, Colloidal silicon dioxide, Microcrystalline
cellulose, Aspartame, Crospovidone, Flavor peppermint, Magnesium
stearate.
3-THERAPEUTIC INDICATIONS
Symptomatic treatment of the dyspeptic symptom complex that
may be associated with delayed gastric emptying such as epigastric
sense of fullness, abdominal distension or swelling, or epigastric pain
or discomfort.
Treatment of acute symptoms of nausea and vomiting
4-PHARMACOLOGICAL PROPERTIES
Mechanism of action
Domperidone is a dopamine antagonist with antiemetic properties.
Domperidone does not readily cross the blood-brain barrier. It
seldom causes extrapyramidal side effects, but does cause a rise in
prolactin levels. Its antiemetic effect may be due to a combination of
peripheral (gastrokinetic) effects and antagonism of central
dopamine receptors in the chemoreceptor trigger zone which lies in
the area postrema and is regarded as being outside the blood-brain
barrier. It also antagonizes the behavioral effects of dopamine much
more effectively when administered intracerebrally than when given
systemically. These findings, together with the low concentrations
found in the brain, indicate a predominantly peripheral effect of
domperidone on dopamine receptors.
Domperidone intravenous and oral domperidone increase lower
esophageal pressure, improve intraduodenal motility and accelerate
gastric emptying. Domperidone has no effect on gastric secretion.
5-PHARMACOKINETICS
Absorption
In fasting subjects, domperidone is rapidly absorbed following oral
administration with peak plasma concentrations occurring at
approximately 30 to 60 minutes. The low oral bioavailability
(approximately 15%) is due to extensive first pass metabolism in the
gut wall and liver. Although the bioavailability of domperidone is
enhanced in normal subjects when taken after a meal, patients with
gastro-intestinal complaints should take domperidone 15 to 30
minutes before a meal. Oral bioavailability of domperidone base is
decreased by prior concomitant administration of cimetidine and
sodium bicarbonate. The time of peak absorption is slightly delayed
and the AUC somewhat increased when the oral medicine is taken
after a meal.
Distribution
Oral domperidone does not appear to accumulate or induce its own
metabolism; a peak plasma level after 90 minutes of 21 ng/mL after
two weeks oral administration of 30 mg per day was almost the same
as that of 18 ng/mL after the first dose. Domperidone is 91 to 93% bound
to plasma proteins.
Metabolism
Domperidone undergoes rapid and extensive hepatic metabolism by
hydroxylation and N-dealkylation. In vitro metabolism experiments with
diagnostic inhibitors revealed that CYP3A4 is a major form of
cytochrome P-450 involved in the N-dealkylation of domperidone,
whereas CYP3A4, CYP1A2 and CYP2E1 are involved in domperidone
aromatic hydroxylation.
Excretion
Urinary and faecal excretion amounts to 31 and 66%, respectively, of
the oral dose. The proportion of the medicine excreted unchanged is
small (10% of faecal excretion and approximately 1% of urinary
excretion). The plasma half-life after a single oral dose is 7-9 hours in
healthy subjects but is prolonged in patients with severe renal
insufficiency.
6-CONTRAINDICATIONS
MOTILCURE® is contraindicated in the following situations:
• Known hypersensitivity to domperidone or any of the excipients
• Prolactin-releasing pituitary tumor (prolactinoma)
• Use in children under 2 years of age.
• Co-administration with potent CYP3A4 inhibitors has been shown to
increase domperidone concentrations to the point where QT interval
prolongation may occur. Examples of potent CYP3A4 inhibitors include
some azole antifungals (itraconazole, voriconazole, posaconazole),
some macrolide antibiotics (clarithromycin, telithromycin), and some
protease inhibitors (ritonavir, saquinavir, telaprevir).
• Co-administration with medicines that prolong the QTc interval.
• MOTILCURE® should not be used whenever stimulation of gastrointes-
tinal motility might be dangerous such as in the presence of
gastrointestinal hemorrhage, mechanical obstruction, or perforation.
• In patients with moderate or severe hepatic impairment.
7-POSOLOGY
MOTILCURE® should be taken 15-30 minutes before meals and, if
necessary, before retiring. If taken after meals, absorption is somewhat
delayed.
Adults and adolescents ≥ 12 years of age and weighing ≥ 35 kg
1 tablet three to four times daily.
The dose of MOTILCURE® should be the lowest effective dose for the
individual situation (typically 30 mg/day). The dose may be increased,
if necessary, to a maximum daily oral dose of 40 mg (1 tablet four
times daily). Usually, the maximum treatment duration should not
exceed one week for the treatment of acute nausea and vomiting. If
nausea and vomiting persist for longer than one week, patients should
consult their physician. For other indications, the initial duration of
treatment is up to four weeks. If treatment exceeds four weeks, patients
should be re-evaluated and the need for continued treatment
re-assessed.
MOTILCURE® tablets are unsuitable for use in adults and adolescents
weighing < 35 kg.
Infants and children < 12 years of age
MOTILCURE® should not be used in children < 12 years of age.
Use in renal impairment It is unlikely that the dose needs to be
adjusted for single administration in patients with renal insufficiency.
However, since the elimination half-life of domperidone is prolonged in
severe renal impairment, on repeated administration the dosing
frequency of MOTILCURE® should be reduced to once or twice daily
depending on the severity of the impairment. Generally, patients on
prolonged therapy should be reviewed regularly.
Hepatic impairment MOTILCURE® is contraindicated for patients with
moderate or severe hepatic impairment.
8-WARNINGS AND PRECAUTIONS
Cardiovascular effects
MOTILCURE® should be used with caution in older patients or those
with current or history of cardiac disease. An increase in the risk of
serious ventricular arrhythmias and sudden cardiac death has been
reported in epidemiology studies. Those studies suggest this
increased risk may be higher in patients older than 60 years or at
total daily doses of more than 30mg. Therefore, MOTILCURE® should
be used with caution in older patients. MOTILCURE® should be used
at the lowest effective dose in adults.
Treatment with domperidone should be stopped if signs or
symptoms occur that may be associated with cardiac arrhythmia,
and the patient should consult their physician. Use of MOTILCURE®
and other drugs which prolong QTc intervals requires that caution be
exercised in patients who have existing prolongation of cardiac
conduction intervals, particularly QTc, patients with significant
electrolyte disturbances (hypokalemia, hyperkaliemia, hypomagne-
saemia), or bradycardia, or in patients with underlying cardiac
diseases such as congestive heart failure. Electrolyte disturbances
(hypokalemia, hyperkaliemia, hypomagnesaemia) and bradycardia
are known to be conditions increasing the proarrhythmic risk. Other
risk factors for sudden cardiac arrest include a family history of
coronary artery disease, high blood pressure, high blood cholesterol,
obesity, diabetes, smoking and excessive alcohol consumption. It is
desirable to optimize electrolyte levels prior to starting domperidone.
9-SPECIFIC PATIENT POPULATIONS
Renal impairment Since the elimination half-life of domperidone is
prolonged in severe renal impairment, the dosing frequency of
MOTILCURE® should to be reduced to once or twice daily depending
on the severity of the impairment. The dose may also need to be
reduced. Such patients with severe renal impairment should be
reviewed regularly.
Hepatic Impairment MOTILCURE® is contraindicated for patients with
moderate or severe hepatic impairment. Dose adjustment is not
required for patients with mild hepatic impairment.
Infants MOTILCURE® tablets are unsuitable for use in children <
12years of age.
Pregnancy There are limited post-marketing data on the use of
domperidone in pregnant women. The potential risk for humans is
unknown. Therefore, MOTILCURE® should only be used during
pregnancy when justified by the anticipated therapeutic benefit.
Lactation
The amount of domperidone that could be ingested by an infant
through breast milk is low. The maximal relative infant dose (%) is
estimated to be about 0.1% of the maternal weight adjusted dosage.
It is not known whether this is harmful to the newborn. Therefore
breast-feeding is not recommended for women who are taking
MOTILCURE®.
10-DRUG INTERACTIONS
The main metabolic pathway of domperidone is through CYP3A4. In
vitro and human data show that the concomitant use of drugs that
significantly inhibit this enzyme may result in increased plasma levels
of domperidone. Co-administration of
domperidone with potent CYP3A4 inhibitors
which have been shown to cause QT interval
prolongation is contraindicated. Caution
should be exercised when domperidone is
co-administered with potent CYP3A4
inhibitors which have not been shown to
cause QT interval prolongation such as
indinavir and patients should be monitored
closely for signs or symptoms of adverse
reactions. Caution should be exercised when
domperidone is co-administered with drugs
which have been shown to cause QT interval
prolongation and patients should be
monitored closely for signs or symptoms of
cardiovascular adverse reactions.
Examples include:
• anti arrhythmics class IA (e.g.,
disopyramide, quinidine)
• anti arrhythmics class III (e.g., amiodarone,
dofetilide, dronedarone, ibutilide, sotalol)
• certain antipsychotics (e.g., haloperidol,
pimozide, sertindole)
• certain antidepressants (e.g., citalopram,
escitalopram)
• certain antibiotics (e.g., levofloxacin,
moxifloxacin)
• certain antifungal agents (e.g.,
pentamidine)
• certain antimalarial agents (e.g.,
halofantrine)
• certain azole antifungals, (e.g., itraconazole,
ketoconazole, voriconazole)
• certain calcium antagonists, (e.g.,
diltiazem, verapamil)
• certain gastro intestinal drugs (e.g.,
dolasetron)
• certain HIV protease inhibitors (e.g.,
amprenavir, atazanavir, fosamprenavir,
indinavir, nelfinavir, ritonavir, saquinavir)
• certain drugs used in cancer (e.g.,
toremifene, vandetanib)
• certain macrolide antibiotics (e.g.,
clarithromycin, erythromycin)
• certain other drugs (e.g., aprepitant,
bepridil, methadone, nefazodone,
telithromycin) Antacids or antisecretory
agents should not be taken simultaneously
with MOTILCURE®, as they lower the oral
bioavailability of domperidone . When used
concomitantly, MOTILCURE® should be taken
before meals and antacids or antisecretory
agents after meals.
11-ADVERSE REACTIONS
Common (reported by at least 1 in
100patients but less than 1 in 10 patients):
• Dry Mouth
Uncommon (reported by at least 1 in 1000
patients but by less than 1 in 100 patients) :
• Anxiety, Restlessness, Nervousness, Loss of
libido or decreased interest in sex,
Headache, Drowsiness, Diarrhea, Rash,
Itching.
• Painful or sensitive breasts, Lactation from
the breasts, General feeling of weakness,
Feeling dizzy.
• Involuntary movements of the face, arms
or legs, excessive trembling, excessive
®
Domperidone 10mg
muscle rigidity or muscle spasms.
Stop the MOTILCURE® treatment and
immediately contact your doctor if you notice
the adverse reactions described below:
• Convulsions
• Reaction which may occur soon after administration and which can
be recognized by rash, itching, shortness of breath, and/or swollen
face.
• Disorders of the heart and the blood vessels (cardiovascular
system): cardiac arrythmias (fast or irregular heartbeat) have been
reported. Should this occur, the treatment must be stopped
immediately. Domperidone may be associated with a higher risk of
cardiac arrythmias and cardiac arrest. Chances of this may be
greater in people over 60years old, or in people taking a dose higher
than 30mg per day. The lowest dose of domperidone must be used.
12-STORAGE CONDITIONS
Keep this medicine out of the sight and reach of children
Store below 30°C
Keep your medicine in a cool dry place and away from light in the
original package to protect it from moisture
Don’t use this medicine after the expiry date which is stated on the
outer packaging. The expiry date refers to the last day of that month.
Don’t use this medicine if you notice any visible signs of deterioration.
Don’t throw away any medicines via wastewater. Ask your pharmacist
how to throw away medicines you no longer use. These measures will
help protect the environment.
Manufacturer:
Athena Drug Delivery Solutions Pvt Ltd. Plot No-Al To A5 , MIDC,
Chemical Zone, Ambernath (W), Thane 421501 Maharashtra State, India
Marketing Authorization Holder, Packed by:
1-DESCRIPTION:
MOTILCURE Orally Disintegrating Tablets 10 mg are white to off-white,
round, flat tablets, plain on both sides, packed in Alu-Alu blister strip.
Box of 30 tablets
2-COMPOSITION:
Each oral dispersible tablet contains 10 mg of Domperidone.
Excipients: Mannitol granular, Colloidal silicon dioxide, Microcrystalline
cellulose, Aspartame, Crospovidone, Flavor peppermint, Magnesium
stearate.
3-THERAPEUTIC INDICATIONS
Symptomatic treatment of the dyspeptic symptom complex that
may be associated with delayed gastric emptying such as epigastric
sense of fullness, abdominal distension or swelling, or epigastric pain
or discomfort.
Treatment of acute symptoms of nausea and vomiting
4-PHARMACOLOGICAL PROPERTIES
Mechanism of action
Domperidone is a dopamine antagonist with antiemetic properties.
Domperidone does not readily cross the blood-brain barrier. It
seldom causes extrapyramidal side effects, but does cause a rise in
prolactin levels. Its antiemetic effect may be due to a combination of
peripheral (gastrokinetic) effects and antagonism of central
dopamine receptors in the chemoreceptor trigger zone which lies in
the area postrema and is regarded as being outside the blood-brain
barrier. It also antagonizes the behavioral effects of dopamine much
more effectively when administered intracerebrally than when given
systemically. These findings, together with the low concentrations
found in the brain, indicate a predominantly peripheral effect of
domperidone on dopamine receptors.
Domperidone intravenous and oral domperidone increase lower
esophageal pressure, improve intraduodenal motility and accelerate
gastric emptying. Domperidone has no effect on gastric secretion.
5-PHARMACOKINETICS
Absorption
In fasting subjects, domperidone is rapidly absorbed following oral
administration with peak plasma concentrations occurring at
approximately 30 to 60 minutes. The low oral bioavailability
(approximately 15%) is due to extensive first pass metabolism in the
gut wall and liver. Although the bioavailability of domperidone is
enhanced in normal subjects when taken after a meal, patients with
gastro-intestinal complaints should take domperidone 15 to 30
minutes before a meal. Oral bioavailability of domperidone base is
decreased by prior concomitant administration of cimetidine and
sodium bicarbonate. The time of peak absorption is slightly delayed
and the AUC somewhat increased when the oral medicine is taken
after a meal.
Distribution
Oral domperidone does not appear to accumulate or induce its own
metabolism; a peak plasma level after 90 minutes of 21 ng/mL after
two weeks oral administration of 30 mg per day was almost the same
as that of 18 ng/mL after the first dose. Domperidone is 91 to 93% bound
to plasma proteins.
Metabolism
Domperidone undergoes rapid and extensive hepatic metabolism by
hydroxylation and N-dealkylation. In vitro metabolism experiments with
diagnostic inhibitors revealed that CYP3A4 is a major form of
cytochrome P-450 involved in the N-dealkylation of domperidone,
whereas CYP3A4, CYP1A2 and CYP2E1 are involved in domperidone
aromatic hydroxylation.
Excretion
Urinary and faecal excretion amounts to 31 and 66%, respectively, of
the oral dose. The proportion of the medicine excreted unchanged is
small (10% of faecal excretion and approximately 1% of urinary
excretion). The plasma half-life after a single oral dose is 7-9 hours in
healthy subjects but is prolonged in patients with severe renal
insufficiency.
6-CONTRAINDICATIONS
MOTILCURE® is contraindicated in the following situations:
• Known hypersensitivity to domperidone or any of the excipients
• Prolactin-releasing pituitary tumor (prolactinoma)
• Use in children under 2 years of age.
• Co-administration with potent CYP3A4 inhibitors has been shown to
increase domperidone concentrations to the point where QT interval
prolongation may occur. Examples of potent CYP3A4 inhibitors include
some azole antifungals (itraconazole, voriconazole, posaconazole),
some macrolide antibiotics (clarithromycin, telithromycin), and some
protease inhibitors (ritonavir, saquinavir, telaprevir).
• Co-administration with medicines that prolong the QTc interval.
• MOTILCURE® should not be used whenever stimulation of gastrointes-
tinal motility might be dangerous such as in the presence of
gastrointestinal hemorrhage, mechanical obstruction, or perforation.
• In patients with moderate or severe hepatic impairment.
7-POSOLOGY
MOTILCURE® should be taken 15-30 minutes before meals and, if
necessary, before retiring. If taken after meals, absorption is somewhat
delayed.
Adults and adolescents ≥ 12 years of age and weighing ≥ 35 kg
1 tablet three to four times daily.
The dose of MOTILCURE® should be the lowest effective dose for the
individual situation (typically 30 mg/day). The dose may be increased,
if necessary, to a maximum daily oral dose of 40 mg (1 tablet four
times daily). Usually, the maximum treatment duration should not
exceed one week for the treatment of acute nausea and vomiting. If
nausea and vomiting persist for longer than one week, patients should
consult their physician. For other indications, the initial duration of
treatment is up to four weeks. If treatment exceeds four weeks, patients
should be re-evaluated and the need for continued treatment
re-assessed.
MOTILCURE® tablets are unsuitable for use in adults and adolescents
weighing < 35 kg.
Infants and children < 12 years of age
MOTILCURE® should not be used in children < 12 years of age.
Use in renal impairment It is unlikely that the dose needs to be
adjusted for single administration in patients with renal insufficiency.
However, since the elimination half-life of domperidone is prolonged in
severe renal impairment, on repeated administration the dosing
frequency of MOTILCURE® should be reduced to once or twice daily
depending on the severity of the impairment. Generally, patients on
prolonged therapy should be reviewed regularly.
Hepatic impairment MOTILCURE® is contraindicated for patients with
moderate or severe hepatic impairment.
8-WARNINGS AND PRECAUTIONS
Cardiovascular effects
MOTILCURE® should be used with caution in older patients or those
with current or history of cardiac disease. An increase in the risk of
serious ventricular arrhythmias and sudden cardiac death has been
reported in epidemiology studies. Those studies suggest this
increased risk may be higher in patients older than 60 years or at
total daily doses of more than 30mg. Therefore, MOTILCURE® should
be used with caution in older patients. MOTILCURE® should be used
at the lowest effective dose in adults.
Treatment with domperidone should be stopped if signs or
symptoms occur that may be associated with cardiac arrhythmia,
and the patient should consult their physician. Use of MOTILCURE®
and other drugs which prolong QTc intervals requires that caution be
exercised in patients who have existing prolongation of cardiac
conduction intervals, particularly QTc, patients with significant
electrolyte disturbances (hypokalemia, hyperkaliemia, hypomagne-
saemia), or bradycardia, or in patients with underlying cardiac
diseases such as congestive heart failure. Electrolyte disturbances
(hypokalemia, hyperkaliemia, hypomagnesaemia) and bradycardia
are known to be conditions increasing the proarrhythmic risk. Other
risk factors for sudden cardiac arrest include a family history of
coronary artery disease, high blood pressure, high blood cholesterol,
obesity, diabetes, smoking and excessive alcohol consumption. It is
desirable to optimize electrolyte levels prior to starting domperidone.
9-SPECIFIC PATIENT POPULATIONS
Renal impairment Since the elimination half-life of domperidone is
prolonged in severe renal impairment, the dosing frequency of
MOTILCURE® should to be reduced to once or twice daily depending
on the severity of the impairment. The dose may also need to be
reduced. Such patients with severe renal impairment should be
reviewed regularly.
Hepatic Impairment MOTILCURE® is contraindicated for patients with
moderate or severe hepatic impairment. Dose adjustment is not
required for patients with mild hepatic impairment.
Infants MOTILCURE® tablets are unsuitable for use in children <
12years of age.
Pregnancy There are limited post-marketing data on the use of
domperidone in pregnant women. The potential risk for humans is
unknown. Therefore, MOTILCURE® should only be used during
pregnancy when justified by the anticipated therapeutic benefit.
Lactation
The amount of domperidone that could be ingested by an infant
through breast milk is low. The maximal relative infant dose (%) is
estimated to be about 0.1% of the maternal weight adjusted dosage.
It is not known whether this is harmful to the newborn. Therefore
breast-feeding is not recommended for women who are taking
MOTILCURE®.
10-DRUG INTERACTIONS
The main metabolic pathway of domperidone is through CYP3A4. In
vitro and human data show that the concomitant use of drugs that
significantly inhibit this enzyme may result in increased plasma levels
of domperidone. Co-administration of
domperidone with potent CYP3A4 inhibitors
which have been shown to cause QT interval
prolongation is contraindicated. Caution
should be exercised when domperidone is
co-administered with potent CYP3A4
inhibitors which have not been shown to
cause QT interval prolongation such as
indinavir and patients should be monitored
closely for signs or symptoms of adverse
reactions. Caution should be exercised when
domperidone is co-administered with drugs
which have been shown to cause QT interval
prolongation and patients should be
monitored closely for signs or symptoms of
cardiovascular adverse reactions.
Examples include:
• anti arrhythmics class IA (e.g.,
disopyramide, quinidine)
• anti arrhythmics class III (e.g., amiodarone,
dofetilide, dronedarone, ibutilide, sotalol)
• certain antipsychotics (e.g., haloperidol,
pimozide, sertindole)
• certain antidepressants (e.g., citalopram,
escitalopram)
• certain antibiotics (e.g., levofloxacin,
moxifloxacin)
• certain antifungal agents (e.g.,
pentamidine)
• certain antimalarial agents (e.g.,
halofantrine)
• certain azole antifungals, (e.g., itraconazole,
ketoconazole, voriconazole)
• certain calcium antagonists, (e.g.,
diltiazem, verapamil)
• certain gastro intestinal drugs (e.g.,
dolasetron)
• certain HIV protease inhibitors (e.g.,
amprenavir, atazanavir, fosamprenavir,
indinavir, nelfinavir, ritonavir, saquinavir)
• certain drugs used in cancer (e.g.,
toremifene, vandetanib)
• certain macrolide antibiotics (e.g.,
clarithromycin, erythromycin)
• certain other drugs (e.g., aprepitant,
bepridil, methadone, nefazodone,
telithromycin) Antacids or antisecretory
agents should not be taken simultaneously
with MOTILCURE®, as they lower the oral
bioavailability of domperidone . When used
concomitantly, MOTILCURE® should be taken
before meals and antacids or antisecretory
agents after meals.
11-ADVERSE REACTIONS
Common (reported by at least 1 in
100patients but less than 1 in 10 patients):
• Dry Mouth
Uncommon (reported by at least 1 in 1000
patients but by less than 1 in 100 patients) :
• Anxiety, Restlessness, Nervousness, Loss of
libido or decreased interest in sex,
Headache, Drowsiness, Diarrhea, Rash,
Itching.
• Painful or sensitive breasts, Lactation from
the breasts, General feeling of weakness,
Feeling dizzy.
• Involuntary movements of the face, arms
or legs, excessive trembling, excessive
Date of Revision: August 11, 2025
PI041/01
muscle rigidity or muscle spasms.
Stop the MOTILCURE® treatment and
immediately contact your doctor if you notice
the adverse reactions described below:
• Convulsions
• Reaction which may occur soon after administration and which can
be recognized by rash, itching, shortness of breath, and/or swollen
face.
• Disorders of the heart and the blood vessels (cardiovascular
system): cardiac arrythmias (fast or irregular heartbeat) have been
reported. Should this occur, the treatment must be stopped
immediately. Domperidone may be associated with a higher risk of
cardiac arrythmias and cardiac arrest. Chances of this may be
greater in people over 60years old, or in people taking a dose higher
than 30mg per day. The lowest dose of domperidone must be used.
12-STORAGE CONDITIONS
Keep this medicine out of the sight and reach of children
Store below 30°C
Keep your medicine in a cool dry place and away from light in the
original package to protect it from moisture
Don’t use this medicine after the expiry date which is stated on the
outer packaging. The expiry date refers to the last day of that month.
Don’t use this medicine if you notice any visible signs of deterioration.
Don’t throw away any medicines via wastewater. Ask your pharmacist
how to throw away medicines you no longer use. These measures will
help protect the environment.
Manufacturer:
Athena Drug Delivery Solutions Pvt Ltd. Plot No-Al To A5 , MIDC,
Chemical Zone, Ambernath (W), Thane 421501 Maharashtra State, India
Marketing Authorization Holder, Packed by:
10mg, 30 oral dispersible tablets Reg. N°: 98825/1
Council of Arab Health Ministers
Union of Arab pharmacists
This is a medicine:
- A medicine is a product which
affects your health and its consump-
tion contrary to instructions is
dangerous for you.
- Follow strictly the doctor's prescrip-
tion, 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.
Distributed by: Tami Pharm s.a.r.l
