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.
What information does this leaflet provide?
1.What MOTRYFEN
® is and what it's commonly used for?
2.What should you know before taking MOTRYFEN
® tablets?
3.How should you take MOTRYFEN
® tablets?
4.What are the possible side eects of MOTRYFEN
® tablets?
5.How should you store MOTRYFEN
® tablets?
6.Further information about MOTRYFEN
® tablets.
1. WHAT MOTRYFEN® IS AND WHAT IT'S COMMONLY USED FOR?
MOTRYFEN
® belongs to a group of medicines called Nonsteroidal
anti-inflammatory drug (NSAID), which reversibly inhibits
cyclooxygenase -1and -2 (COX-1and -2) enzymes, which results
in decreased formation of prostaglandin precursors.
MOTRYFEN
® has antipyretic, analgesic, and anti-inflammatory
properties and can be used to relieve pain and inflammation in
conditions such as osteoarthritis, rheumatoid arthritis (includ-
ing juvenile rheumatoid arthritis or Still’s disease), arthritis of
the spine (ankylosing spondylitis), swollen joints, frozen shoulder,
bursitis, tendinitis, tenosynovitis, lower back pain, sprains,
and strains.
MOTRYFEN
® can also be used to treat other painful
conditions such as toothache, pain after operations, period pain, and
headaches, including migraines.
You should start feeling the eects of MOTRYFEN
® tablets within 20-30
minutes, and they typically last for4-6 hours.
2.WHAT SHOULD YOU KNOW BEFORE TAKING MOTRYFEN® TABLETS?
CONTRAINDICATIONS
•If you are allergic to ibuprofen or any of the other ingredients of this
medicine.
•MOTRYFEN
® tablets should not be given to patients who have
experienced a history of asthma, urticaria, or allergic-type reactions
after taking aspirin or other NSAIDs (such as asthma, runny nose, itchy
skin rash, or swelling of the lips, face, tongue, or throat).
• Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been
reported in such patients.
• If you experience bleeding (especially those with active intracranial
hemorrhage or GI bleeding); thrombocytopenia; coagulation defects.
• If you have an active gastric/duodenal/peptic ulcer.
• MOTRYFEN
® tablets are contraindicated for the treatment of peri-
operative pain in the setting of coronary artery bypass graft (CABG)
surgery.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking MOTRYFEN®:
As with other NSAIDs, MOTRYFEN
® should be used with caution in
patients having renal, hepatic, or cardiac impairment.
Hepatic impairment:
Since NSAIDs have generally been reported to increase the risk of
gastrointestinal bleeding and can cause fluid retention, they should be
used with caution in patients having hepatic impairment and should
be avoided in those having severe liver disease.
Renal impairment:
Since NSAIDs have generally been reported to cause sodium and
water retention and may cause deterioration in renal function that
may progress to renal failure, these agents should be given at the
lowest eective dose in patients with mild renal impairment and renal
function should be carefully monitored; they should be avoided, if
possible, in patients with moderate to severe renal impairment.
Pregnancy:
As with other NSAIDs, it is advisable to avoid the use of MOTRYFEN
®
during pregnancy unless the potential benefit to the mother outweighs
any possible risk to the fetus. Regular use of NSAIDs during the third
trimester of pregnancy may result in the closure of fetal ductus
arteriosus in utero and possibly persistent pulmonary hypertension of
the newborn. The onset of labour may be delayed and its duration
increased.
Lactation:
MOTRYFEN
® appears in breast milk in an amount that is considered
too small to be harmful to a breastfed infant.
Elderly:
Older adults do not require dosage adjustments unless affected by
renal or hepatic impairment in such cases, dosages must be
individually tailored.
Elderly patients are at increased risk of serious gastrointestinal side
effects, including bleeding and perforation. which can be lethal. Those
with a history of gastrointestinal ulcers, particularly with complications
of bleeding or perforation, should monitor for and promptly report any
abdominal symptoms, especially at the onset of treatment, due to the
elevated risk. If gastrointestinal bleeding or perforation occurs,
treatment must be discontinued.
Even without a prior history, gastrointestinal bleeding, ulceration, or
perforation can manifest suddenly and with potential fatality. The
incidence of these events escalates with higher dosages of ibuprofen
and concurrent use of certain other medications. The minimization of
adverse eects necessitates administering the minimal eective dose
for the briefest feasible duration to manage symptoms.
Skin reactions:
You should stop taking Ibuprofen immediately and seek urgent
medical care if you notice any skin rashes, mucosal lesions, blisters, or
signs of an allergy since this can be the first signs of a very serious skin
reaction.
Avoid MOTRYFEN
® during chickenpox. This medication can slightly
increase the risk of heart attacks or strokes, especially at high doses.
Follow the prescribed dosage and consult your healthcare provider or
pharmacist before using Ibuprofen if you have heart conditions,
circulatory issues, high blood pressure, diabetes, high cholesterol, a
family history of cardiovascular diseases, or if you smoke.
Eects on the kidneys:
MOTRYFEN
® may cause problems with kidney function even in patients
who have not had kidney problems before. This may result in swelling
of the legs and may even lead to heart failure or high blood pressure
in predisposed individuals. Ibuprofen may cause kidney damage,
especially in patients who already have kidney, heart, or liver
problems,or are taking diuretics or ACEinhibitors, as well as in the
elderly.
Stopping MOTRYFEN
® however, generally leads to recovery. Aseptic
meningitis (inflammation of the brain membrane without bacterial
infection) During treatment with MOTRYFEN
®, some cases of
meningitis (presenting as sti neck, headache, nausea, vomiting,
fever, or disorientation) have been seen. Although it is probably more
likely to occur in patients with existing autoimmune disorders such as
systemic lupus erythematosus or mixed connective tissue diseases,
it has been reported in patients who do not have an existing
long-term disease. Other precautions Very rarely,severe acute
hypersensitivity reactions (e.g., anaphylactic shock) have been
observed. Stop treatment immediately at the first signs of a
hypersensitivity reaction after taking Ibuprofen and tell immediately
to your doctor.
MOTRYFEN
® can temporarily inhibit blood platelet function (blood
platelet aggregation). Patients with blood clotting disorders should
therefore be carefully monitored. Prolonged use of any type of
painkiller for headaches can make them worse. If this situation is
experienced or suspected, stop taking ibuprofen and consult your
doctor. The diagnosis of medication overuse headache (MOH)
should be suspected in patients who have frequent or daily
headaches despite (or because of) the regular use of headache
medications.
The habitual use of painkillers may cause permanent damage to the
kidneys and a risk of kidney failure.
MOTRYFEN
® may hide the symptoms or signs of an infection (fever,
pain, and swelling) and temporarily prolong bleeding time. Ibuprofen
may decrease your chance of becoming pregnant.
You should inform your doctor if you are planning to become
pregnantorif you have problems becoming pregnant.
MOTRYFEN
® 600mg is contraindicated in children and adolescents
younger than 15 years of age. Ibuprofen may cause kidney problems
in children and adolescents who are dehydrated.
Driving and using machines
MOTRYFEN
® may make you feel dizzy or drowsy. If it aects you in this
way do not drive, operate machinery, or do anything that requires
you to be alert.
MOTRYFEN® with alcohol
Drowsiness, and stomach problems such as bleeding in the
stomach. Drinking excessive alcohol with MOTRYFEN
® might make
these side effects worse.
MOTRYFEN® and Other medicines
Some medicines that are anti-coagulants (i.e., thin blood/prevent
clotting e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine), some
medicines that reduce high blood pressure (ACE-inhibitors such as
captopril, beta-blockers such as atenolol, or angiotensin-II receptor
antagonists such as losartan) and other medicines may affect or be
affected by treatment with ibuprofen.
You should therefore always seek the advice of your doctor or
pharmacist before you use MOTRYFEN
® with other medicines. In
particular, you should tell your doctor or pharmacist if you are taking
any of the following medicines in addition to those mentioned above:
• Diuretics (water tablets).
• Cardiac glycosides, such as digoxin, are used to treat heart
conditions.
• Lithium (ibuprofen increases levels of lithium by decreasing renal
clearance. Use Caution/Monitor).
• Steroids (used in the treatment of inflammatory conditions).
• Methotrexate (used to treat certain cancers and rheumatoid
arthritis).
• Medicines known as immunosuppressants such as ciclosporin and
tacrolimus (used to dampen down your immune response).
• Medicines known as selective serotonin reuptake inhibitors (SSRIs)
(escitalopram), are used for the treatment of depression.
•Antibiotics called quinolones such as
ciprofloxacin, and aminoglycosides.
•Mifepristone.
•Any other ibuprofen, such as those you can
buy without a prescription.
•Any other anti-inflammatory painkiller,
including aspirin.
•Cholestyramine (a drug used to lower
cholesterol).
•Medicines known as Sulphonylureas such
as glibenclamide (anti-diabetic drug).
•Voriconazole or fluconazole (type of
anti-fungal drug).
•Ginkgo biloba herbal medicine (there is a
chance you may bleed more easily if you
are taking this with ibuprofen).
3.HOW SHOULD YOU TAKE MOTRYFEN®
TABLETS?
Always take MOTRYFEN
® exactly as
instructed on this leaflet. Use the lowest
effective dose for the shortest duration of
time or as recommended by your doctor or
pharmacist.
Take your MOTRYFEN
® tablets with or after
food, with a glass of water.
• MOTRYFEN
® tablets should be swallowed
whole and not chewed, broken, crushed, or
sucked to help prevent discomfortin the
mouth or irritation in the throat.
• This product is intended for short term use
only. You should take the lowest dose for the
shortest time necessary to relieve your
symptoms.
• Adults and the elderly: If this medicinal
product is required for more than 10 days, or
if symptoms persist or worsen, consultyour
doctororpharmacist.
• Adolescents: If this medicinal product is
required for more than 3 days, or if
symptoms persist or worsen, consult your
doctor.
• You should avoid excessive use of
painkillers. If you usually take painkillers,
especially combination of different
painkillers, you may damage your kidneys,
tell your doctor if you are already taking
another painkiller before taking this
medicine and your doctor will decide
whether you should take this medicine. This
risk may be increased if you are dehydrated.
• The use of painkillers for a long period has
in some patients been linked to headaches,
a condition called medication overuse
headache (MOH). Patients who have
frequent or daily headaches despite (or
because of) the regular use of painkillers
should not be treated with increased doses
of MOTRYFEN
®. Tell your doctor if you have
been having headaches while taking this
medicine.
Dosage and administration of MOTRYFEN®
600 mg tablets:
Adults:
The recommended initial dosage of ibuprofen is 1200 mg-1800 mg
daily in divided doses. Some patients can be maintained
on 600-1200mg daily. In severe or acute conditions, it can be
advantageous to increase the dosage until the acute phase is
broughtundercontrol,providing that the total daily dosage does not
exceed 2400mg in divided doses.
Elderly:
In elderly patients receiving 600mg-1200 mg daily Ibuprofen appeared
to be well tolerated.
However, since elderly patients may have a degree of impaired liver or
renal function the adult dosage should be used with caution.
Adolescents:
The recommended dose is 20mg/kg each day given individed doses.
MOTRYFEN
® tablets should not be taken by children less than 7kg.
MOTRYFEN
® 600 mg tablets should not be given to children under the
age of 15 years. In the case of juvenile arthritis,your doctor may
increase the dosage up to 40mg/kg in divided doses.
In cases of kidney impairment: Non-NSAID analgesics are preferable. If
MOTRYFEN
® must be used, employ the lowest effective dose for the
shortest duration possible in patients with mild kidney impairment.
If you take more MOTRYFEN
® tablets than you should (an overdose)
Contact your doctor, pharmacist, or nearest hospital in case of an
MOTRYFEN
® overdose. The symptoms can include nausea, stomach
pain, vomiting (may be blood-streaked), and more rarely diarrhea. In
addition, headache, gastrointestinal bleeding, blurred vision ringing in
the ears, confusion, shakey eye movement, and exacerbation of
asthma in asthmatics. At high doses, drowsiness, excitation,
disorientation, chestpain, palpitation, loss of consciousness,
convulsions (mainly in children), vertigo, weakness and dizziness,
blood in urine, low blood pressure, hyperkaliemia, metabolic acidosis,
increased prothrombin time/INR, acute renal failure, liver damage,
respiratory depression, cyanosis, cold body feeling, and breathing
problems have been reported.
More serious toxicity is uncommon, but gastric emptying
followed by supportive measures is recommended if the quantity
ingested within the previous hour exceeds 400/600 mg/kg body
weight. There is no specific antidote for Ibuprofen.
If you forget to take your MOTRYFEN® tablets
If you are using this drug on a regular schedule (not just "as needed")
and you miss a dose, take it as soon as you remember. If it is near the
time of the next dose, skip the missed dose. Take your next dose at the
regular time. Do not double the dose to catch up.
If you have any further questions about the use of this medicine, ask
your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EECTS OF MOTRYFEN® TABLETS?
MOTRYFEN
® tables may cause side effects, although they are
generally mild, and not everyone with eperience them. If any side
effects that are not listed in this leaflet please tell your doctor or
pharmacist. To reduce the risk of side effects, take the lowest possible
number of tablets for the shortest duration required to manage your
symptoms.
Significant adverse reactions:
•Cardiovascular effects: Use of nonsteroidal anti-inflamatory drugs
(NSAIDs) is associated with an increased risk of serious adverse
cardiovascular (CV) events, including acute myocardial infarction
(MI), cerebrovascular accident, New-onset hypertension or exacerba-
tion of hypertension.
•Gastrointestinal events: Use of nonsteroidal anti-inflammatory drugs
(NSAIDs) is associated with an increased risk of serious GI adverse
events, including gastrointestinal inflammation, gastrointestinal
hemorrhage, gastrointestinal ulcer, and gastrointestinal perforation;
severity may range from asymptomatic to fatal.
Ibuprofen 600 mg
Film-Coated Tablets
Anti-inflammatory, Analgesic, Antipyretic, Antirheumatic
•Hematologic effects: associated with prolonged bleeding time and
an increased risk for hemorrhage.
•Hepatic effects: MOTRYFEN
® may cause mild transaminase
elevations, especially with higher doses.
•Kidney effects: Use of nonesteroidal anti-inflammatory drugs
(NSAIDs) including MOTRYFEN
®, is associated with an increased risk of
several kidney-specific effects:
Hemodynamically-mediated acute kidney injury,
interstitial nephritis (with or without nephrotic syndrome), and renal
papillary necrosis in all ages.
Insignificant adverse reactions
•Gastrointestinal side effects: abdominal cramps; constipation
/diarrhea; decreased appetite; epigastric pain and flatulence.
•Hypersensitivity reactions: (immediate and delayed) involving
the skin (e.g., angioedema, urticaria), and airways (e.g., dyspnea,
rhinorrhea).
This is not a complete list of side effects and others may
occur. Call your doctor for medical advice about side
effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW SHOULD YOU STORE MOTRYFEN® TABLETS?
• 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.
• Do not 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.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. FURTHER INFORMATION ABOUT MOTRYFEN® TABLETS.
Each film coated tablet of MOTRYFEN
® contains: 600 mg of Ibuprofen
Excipients: Croscarmellose Sodium, Magnesium Stearate, Povidone K
90, Pregelatinized Starch, Microcrystalline Cellulose PH-101, Colloidal
silicon Dioxide, Sodium lauryl sulphate.
MOTRYFEN
® 600 mg
Box of 20 Film Coated Tablets
What information does this leaflet provide?
1.What MOTRYFEN
® is and what it's commonly used for?
2.What should you know before taking MOTRYFEN
® tablets?
3.How should you take MOTRYFEN
® tablets?
4.What are the possible side eects of MOTRYFEN
® tablets?
5.How should you store MOTRYFEN
® tablets?
6.Further information about MOTRYFEN
® tablets.
1. WHAT MOTRYFEN® IS AND WHAT IT'S COMMONLY USED FOR?
MOTRYFEN
® belongs to a group of medicines called Nonsteroidal
anti-inflammatory drug (NSAID), which reversibly inhibits
cyclooxygenase -1and -2 (COX-1and -2) enzymes, which results
in decreased formation of prostaglandin precursors.
MOTRYFEN
® has antipyretic, analgesic, and anti-inflammatory
properties and can be used to relieve pain and inflammation in
conditions such as osteoarthritis, rheumatoid arthritis (includ-
ing juvenile rheumatoid arthritis or Still’s disease), arthritis of
the spine (ankylosing spondylitis), swollen joints, frozen shoulder,
bursitis, tendinitis, tenosynovitis, lower back pain, sprains,
and strains.
MOTRYFEN
® can also be used to treat other painful
conditions such as toothache, pain after operations, period pain, and
headaches, including migraines.
You should start feeling the eects of MOTRYFEN
® tablets within 20-30
minutes, and they typically last for4-6 hours.
2.WHAT SHOULD YOU KNOW BEFORE TAKING MOTRYFEN® TABLETS?
CONTRAINDICATIONS
•If you are allergic to ibuprofen or any of the other ingredients of this
medicine.
•MOTRYFEN
® tablets should not be given to patients who have
experienced a history of asthma, urticaria, or allergic-type reactions
after taking aspirin or other NSAIDs (such as asthma, runny nose, itchy
skin rash, or swelling of the lips, face, tongue, or throat).
• Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been
reported in such patients.
• If you experience bleeding (especially those with active intracranial
hemorrhage or GI bleeding); thrombocytopenia; coagulation defects.
• If you have an active gastric/duodenal/peptic ulcer.
• MOTRYFEN
® tablets are contraindicated for the treatment of peri-
operative pain in the setting of coronary artery bypass graft (CABG)
surgery.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking MOTRYFEN®:
As with other NSAIDs, MOTRYFEN
® should be used with caution in
patients having renal, hepatic, or cardiac impairment.
Hepatic impairment:
Since NSAIDs have generally been reported to increase the risk of
gastrointestinal bleeding and can cause fluid retention, they should be
used with caution in patients having hepatic impairment and should
be avoided in those having severe liver disease.
Renal impairment:
Since NSAIDs have generally been reported to cause sodium and
water retention and may cause deterioration in renal function that
may progress to renal failure, these agents should be given at the
lowest eective dose in patients with mild renal impairment and renal
function should be carefully monitored; they should be avoided, if
possible, in patients with moderate to severe renal impairment.
Pregnancy:
As with other NSAIDs, it is advisable to avoid the use of MOTRYFEN
®
during pregnancy unless the potential benefit to the mother outweighs
any possible risk to the fetus. Regular use of NSAIDs during the third
trimester of pregnancy may result in the closure of fetal ductus
arteriosus in utero and possibly persistent pulmonary hypertension of
the newborn. The onset of labour may be delayed and its duration
increased.
Lactation:
MOTRYFEN
® appears in breast milk in an amount that is considered
too small to be harmful to a breastfed infant.
Elderly:
Older adults do not require dosage adjustments unless affected by
renal or hepatic impairment in such cases, dosages must be
individually tailored.
Elderly patients are at increased risk of serious gastrointestinal side
effects, including bleeding and perforation. which can be lethal. Those
with a history of gastrointestinal ulcers, particularly with complications
of bleeding or perforation, should monitor for and promptly report any
abdominal symptoms, especially at the onset of treatment, due to the
elevated risk. If gastrointestinal bleeding or perforation occurs,
treatment must be discontinued.
Even without a prior history, gastrointestinal bleeding, ulceration, or
perforation can manifest suddenly and with potential fatality. The
incidence of these events escalates with higher dosages of ibuprofen
and concurrent use of certain other medications. The minimization of
adverse eects necessitates administering the minimal eective dose
for the briefest feasible duration to manage symptoms.
Skin reactions:
You should stop taking Ibuprofen immediately and seek urgent
medical care if you notice any skin rashes, mucosal lesions, blisters, or
signs of an allergy since this can be the first signs of a very serious skin
reaction.
Avoid MOTRYFEN
® during chickenpox. This medication can slightly
increase the risk of heart attacks or strokes, especially at high doses.
Follow the prescribed dosage and consult your healthcare provider or
pharmacist before using Ibuprofen if you have heart conditions,
circulatory issues, high blood pressure, diabetes, high cholesterol, a
family history of cardiovascular diseases, or if you smoke.
Eects on the kidneys:
MOTRYFEN
® may cause problems with kidney function even in patients
who have not had kidney problems before. This may result in swelling
of the legs and may even lead to heart failure or high blood pressure
in predisposed individuals. Ibuprofen may cause kidney damage,
especially in patients who already have kidney, heart, or liver
problems,or are taking diuretics or ACEinhibitors, as well as in the
elderly.
Stopping MOTRYFEN
® however, generally leads to recovery. Aseptic
meningitis (inflammation of the brain membrane without bacterial
infection) During treatment with MOTRYFEN
®, some cases of
meningitis (presenting as sti neck, headache, nausea, vomiting,
fever, or disorientation) have been seen. Although it is probably more
likely to occur in patients with existing autoimmune disorders such as
systemic lupus erythematosus or mixed connective tissue diseases,
it has been reported in patients who do not have an existing
long-term disease. Other precautions Very rarely,severe acute
hypersensitivity reactions (e.g., anaphylactic shock) have been
observed. Stop treatment immediately at the first signs of a
hypersensitivity reaction after taking Ibuprofen and tell immediately
to your doctor.
MOTRYFEN
® can temporarily inhibit blood platelet function (blood
platelet aggregation). Patients with blood clotting disorders should
therefore be carefully monitored. Prolonged use of any type of
painkiller for headaches can make them worse. If this situation is
experienced or suspected, stop taking ibuprofen and consult your
doctor. The diagnosis of medication overuse headache (MOH)
should be suspected in patients who have frequent or daily
headaches despite (or because of) the regular use of headache
medications.
The habitual use of painkillers may cause permanent damage to the
kidneys and a risk of kidney failure.
MOTRYFEN
® may hide the symptoms or signs of an infection (fever,
pain, and swelling) and temporarily prolong bleeding time. Ibuprofen
may decrease your chance of becoming pregnant.
You should inform your doctor if you are planning to become
pregnantorif you have problems becoming pregnant.
MOTRYFEN
® 600mg is contraindicated in children and adolescents
younger than 15 years of age. Ibuprofen may cause kidney problems
in children and adolescents who are dehydrated.
Driving and using machines
MOTRYFEN
® may make you feel dizzy or drowsy. If it aects you in this
way do not drive, operate machinery, or do anything that requires
you to be alert.
MOTRYFEN® with alcohol
Drowsiness, and stomach problems such as bleeding in the
stomach. Drinking excessive alcohol with MOTRYFEN
® might make
these side effects worse.
MOTRYFEN® and Other medicines
Some medicines that are anti-coagulants (i.e., thin blood/prevent
clotting e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine), some
medicines that reduce high blood pressure (ACE-inhibitors such as
captopril, beta-blockers such as atenolol, or angiotensin-II receptor
antagonists such as losartan) and other medicines may affect or be
affected by treatment with ibuprofen.
You should therefore always seek the advice of your doctor or
pharmacist before you use MOTRYFEN
® with other medicines. In
particular, you should tell your doctor or pharmacist if you are taking
any of the following medicines in addition to those mentioned above:
• Diuretics (water tablets).
• Cardiac glycosides, such as digoxin, are used to treat heart
conditions.
• Lithium (ibuprofen increases levels of lithium by decreasing renal
clearance. Use Caution/Monitor).
• Steroids (used in the treatment of inflammatory conditions).
• Methotrexate (used to treat certain cancers and rheumatoid
arthritis).
• Medicines known as immunosuppressants such as ciclosporin and
tacrolimus (used to dampen down your immune response).
• Medicines known as selective serotonin reuptake inhibitors (SSRIs)
(escitalopram), are used for the treatment of depression.
•Antibiotics called quinolones such as
ciprofloxacin, and aminoglycosides.
•Mifepristone.
•Any other ibuprofen, such as those you can
buy without a prescription.
•Any other anti-inflammatory painkiller,
including aspirin.
•Cholestyramine (a drug used to lower
cholesterol).
•Medicines known as Sulphonylureas such
as glibenclamide (anti-diabetic drug).
•Voriconazole or fluconazole (type of
anti-fungal drug).
•Ginkgo biloba herbal medicine (there is a
chance you may bleed more easily if you
are taking this with ibuprofen).
3.HOW SHOULD YOU TAKE MOTRYFEN®
TABLETS?
Always take MOTRYFEN
® exactly as
instructed on this leaflet. Use the lowest
effective dose for the shortest duration of
time or as recommended by your doctor or
pharmacist.
Take your MOTRYFEN
® tablets with or after
food, with a glass of water.
• MOTRYFEN
® tablets should be swallowed
whole and not chewed, broken, crushed, or
sucked to help prevent discomfortin the
mouth or irritation in the throat.
• This product is intended for short term use
only. You should take the lowest dose for the
shortest time necessary to relieve your
symptoms.
• Adults and the elderly: If this medicinal
product is required for more than 10 days, or
if symptoms persist or worsen, consultyour
doctororpharmacist.
• Adolescents: If this medicinal product is
required for more than 3 days, or if
symptoms persist or worsen, consult your
doctor.
• You should avoid excessive use of
painkillers. If you usually take painkillers,
especially combination of different
painkillers, you may damage your kidneys,
tell your doctor if you are already taking
another painkiller before taking this
medicine and your doctor will decide
whether you should take this medicine. This
risk may be increased if you are dehydrated.
• The use of painkillers for a long period has
in some patients been linked to headaches,
a condition called medication overuse
headache (MOH). Patients who have
frequent or daily headaches despite (or
because of) the regular use of painkillers
should not be treated with increased doses
of MOTRYFEN
®. Tell your doctor if you have
been having headaches while taking this
medicine.
Dosage and administration of MOTRYFEN®
600 mg tablets:
Adults:
The recommended initial dosage of ibuprofen is 1200 mg-1800 mg
daily in divided doses. Some patients can be maintained
on 600-1200mg daily. In severe or acute conditions, it can be
advantageous to increase the dosage until the acute phase is
broughtundercontrol,providing that the total daily dosage does not
exceed 2400mg in divided doses.
Elderly:
In elderly patients receiving 600mg-1200 mg daily Ibuprofen appeared
to be well tolerated.
However, since elderly patients may have a degree of impaired liver or
renal function the adult dosage should be used with caution.
Adolescents:
The recommended dose is 20mg/kg each day given individed doses.
MOTRYFEN
® tablets should not be taken by children less than 7kg.
MOTRYFEN
® 600 mg tablets should not be given to children under the
age of 15 years. In the case of juvenile arthritis,your doctor may
increase the dosage up to 40mg/kg in divided doses.
In cases of kidney impairment: Non-NSAID analgesics are preferable. If
MOTRYFEN
® must be used, employ the lowest effective dose for the
shortest duration possible in patients with mild kidney impairment.
If you take more MOTRYFEN
® tablets than you should (an overdose)
Contact your doctor, pharmacist, or nearest hospital in case of an
MOTRYFEN
® overdose. The symptoms can include nausea, stomach
pain, vomiting (may be blood-streaked), and more rarely diarrhea. In
addition, headache, gastrointestinal bleeding, blurred vision ringing in
the ears, confusion, shakey eye movement, and exacerbation of
asthma in asthmatics. At high doses, drowsiness, excitation,
disorientation, chestpain, palpitation, loss of consciousness,
convulsions (mainly in children), vertigo, weakness and dizziness,
blood in urine, low blood pressure, hyperkaliemia, metabolic acidosis,
increased prothrombin time/INR, acute renal failure, liver damage,
respiratory depression, cyanosis, cold body feeling, and breathing
problems have been reported.
More serious toxicity is uncommon, but gastric emptying
followed by supportive measures is recommended if the quantity
ingested within the previous hour exceeds 400/600 mg/kg body
weight. There is no specific antidote for Ibuprofen.
If you forget to take your MOTRYFEN® tablets
If you are using this drug on a regular schedule (not just "as needed")
and you miss a dose, take it as soon as you remember. If it is near the
time of the next dose, skip the missed dose. Take your next dose at the
regular time. Do not double the dose to catch up.
If you have any further questions about the use of this medicine, ask
your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EECTS OF MOTRYFEN® TABLETS?
MOTRYFEN
® tables may cause side effects, although they are
generally mild, and not everyone with eperience them. If any side
effects that are not listed in this leaflet please tell your doctor or
pharmacist. To reduce the risk of side effects, take the lowest possible
number of tablets for the shortest duration required to manage your
symptoms.
Significant adverse reactions:
•Cardiovascular effects: Use of nonsteroidal anti-inflamatory drugs
(NSAIDs) is associated with an increased risk of serious adverse
cardiovascular (CV) events, including acute myocardial infarction
(MI), cerebrovascular accident, New-onset hypertension or exacerba-
tion of hypertension.
•Gastrointestinal events: Use of nonsteroidal anti-inflammatory drugs
(NSAIDs) is associated with an increased risk of serious GI adverse
events, including gastrointestinal inflammation, gastrointestinal
hemorrhage, gastrointestinal ulcer, and gastrointestinal perforation;
severity may range from asymptomatic to fatal.
This is a medicament:
- A medicament 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 sold the
medicament.
- 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 medicaments out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
Date of Revision: May 05, 2026
PI073/01
•Hematologic effects: associated with prolonged bleeding time and
an increased risk for hemorrhage.
•Hepatic effects: MOTRYFEN
® may cause mild transaminase
elevations, especially with higher doses.
•Kidney effects: Use of nonesteroidal anti-inflammatory drugs
(NSAIDs) including MOTRYFEN
®, is associated with an increased risk of
several kidney-specific effects:
Hemodynamically-mediated acute kidney injury,
interstitial nephritis (with or without nephrotic syndrome), and renal
papillary necrosis in all ages.
Insignificant adverse reactions
•Gastrointestinal side effects: abdominal cramps; constipation
/diarrhea; decreased appetite; epigastric pain and flatulence.
•Hypersensitivity reactions: (immediate and delayed) involving
the skin (e.g., angioedema, urticaria), and airways (e.g., dyspnea,
rhinorrhea).
This is not a complete list of side effects and others may
occur. Call your doctor for medical advice about side
effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW SHOULD YOU STORE MOTRYFEN® TABLETS?
• 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.
• Do not 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.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. FURTHER INFORMATION ABOUT MOTRYFEN® TABLETS.
Each film coated tablet of MOTRYFEN
® contains: 600 mg of Ibuprofen
Excipients: Croscarmellose Sodium, Magnesium Stearate, Povidone K
90, Pregelatinized Starch, Microcrystalline Cellulose PH-101, Colloidal
silicon Dioxide, Sodium lauryl sulphate.
MOTRYFEN
® 600 mg
Box of 20 Film Coated Tablets
Marketing Authorisation Holder,
Manufacturer
® 600mg, 20 coated tablets Reg. N°: 195325/1
