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-FORMS and PRESENTATION
UBSAFEN is a red oral pediatric suspension with strawberry-mixed
fruits flavor. It is supplied in an amber bottle containing 100ml.
The bottle is closed with a child-resistant plastic screw cap. Each pack
also contains a plastic oral dosing syringe.
2-COMPOSITION
Each 5ml of UBSAFEN oral suspension contains 100mg of Ibuprofen.
Excipients: Sucrose, Disodium EDTA, Glycerol, CMC, Sorbitol Solution70%,
Sodium Benzoate, Polysorbate 80, Xanthan Gum, Citric Acid, citrate
sodium, Sodium Saccharin, Strawberry Flavor, Mixed Fruits Flavor,
Allura red, Purified water.
3-THERAPEUTIC INDICATIONS
UBSAFEN oral suspension contains Ibuprofen which belongs to a group
of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs)
which act to relieve pain, swelling (inflammation) and reduce fever.
UBSAFEN oral suspension is for use in children from 3 months of age
who weigh more than 5 kg.
It can be used for the relief of mild to moderate pain such as sore
throat, teething pain, toothache, earache, headache, minor aches
and sprains. It can also be used to relieve the symptoms of colds and
flu and to reduce fever, including fever after vaccination at 3 months
of age.
4-POSOLOGY
Always give this medicine exactly as your doctor or pharmacist has
told you.
Check with your doctor or pharmacist if you are not sure.
Always shake the bottle thoroughly before use. Always use the syringe
supplied with the pack.
The syringe can be used to measure 2.5ml or 5ml by drawing the liquid
to the correct mark on the syringe.
Do not give to a child under 3 months of age, unless advised to do so
by your doctor. For Short-term use only
Do not give to babies aged 3-6 months for longer than 24 hours.
Do not give to children aged 6 months or over for longer than 3 days.
Consult your doctor if symptoms worsen or persist. The lowest
effective dose should be used for the shortest duration necessary to
relieve symptoms. If your child has
an infection, consult a doctor
without delay if symptoms (such as fever and pain) persist or worsen.
Do not give more than the amount recommended above.
If you use more UBSAFEN Oral Suspension than you should
If you have used more UBSAFEN oral suspension than you should, or if a
child has taken this medicine by accident, always contact a doctor or
your nearest hospital to get an opinion of the risk and advice on action
to be taken. The symptoms of overdose can include nausea, stomach
pain, vomiting (may be blood streaked), gastrointestinal bleeding,
diarrhea, headache, ringing in the ears, confusion and shaky eye
movement. Also agitation, somnolence, disorientation or coma may
occur. Occasionally patients develop convulsions. At high doses,
drowsiness, chest pain, palpitations, loss of consciousness, convulsions
(mainly in children), weakness and dizziness, blood in urine, low levels of
potassium in your blood, cold body feeling, and breathing problems
have been reported. Further, the prothrombin time/INR may be
prolonged, probably due to interference with the actions of circulating
clotting factors. Acute renal failure and liver damage may occur.
Exacerbation of asthma is possible in asthmatics. Furthermore, there
may be low blood pressure and reduced breathing.
If you forget to use UBSAFEN Oral Suspension
If you forget a dose, give the next dose when needed, provided that the
last dose was taken at least 6 hours ago. Do not take a double dose to
make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurs.
5-WARNINGS and PRECAUTIONS
This medicine is suitable for the majority
of people but certain people
should not use it. Talk to your doctor or pharmacist if you are at all
unsure.
Do not give this medicine to your child if they:
• are allergic to ibuprofen or any of the other ingredients of this
medicine (listed in section 2)
• have ever had a reaction (e.g. asthma, runny nose, rash, swelling of
the face, tongue, lips or throat) after taking ibuprofen, acetylsalicylic
acid (aspirin) or other non-steroidal-antiinflammatory (NSAID)
medicines
• weigh less than 5kg or are under 3 months of age
• are taking any other NSAID medicines, or aspirin with a daily dose
above 75mg (aspirin should not generally be given to children under 16,
but doctors may occasionally prescribe it)
• have a stomach ulcer, perforation or bleeding, or they have had one
twice or more in the past
• have had perforation or a bleeding ulcer after taking a NSAID
medicine (your child may have been sick and it contained blood or
dark particles that look like coffee grounds, passed blood in their stools
or passed black tarry stools)
• have severe kidney, heart or liver failure
• have a condition which increases their tendency to bleeding.
Signs of an allergic reaction to this medicine, including breathing
problems, swelling of the face and neck region (angioedema), chest
pain have been reported with ibuprofen. Stop immediately ibuprofen
oral solution and contact immediately your doctor or medical
emergencies if you notice any of these signs.
Talk to your doctor, pharmacist or nurse before giving Ibuprofen Oral
Suspension:
This is especially important if your child:
• has asthma, a history of asthma or other allergic disease
• has or has had kidney, liver or heart problems
• is dehydrated as there is a risk of kidney problems
•has connective tissue disorders such as SLE (Systemic Lupus
Erythematosus)
• suffers from chronic inflammatory bowel
disease such as Crohn’s
disease or ulcerative colitis • has chickenpox or shingles
• has an infection.
If your child is taking Ibuprofen Oral Suspension for longer than the
recommended time or at higher than recommended dose they are
at risk of serious harm. This includes serious harm to the stomach/gut
and kidneys, as well as very low levels of potassium in the blood. This
can be fatal .
Anti-inflammatory/pain-killer medicines like ibuprofen may be
associated with a small increased risk of heart attack or stroke,
particularly when used at high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss your child’s treatment with your doctor or
pharmacist before giving Ibuprofen Oral Suspension if your child:
• has heart problems including heart failure, angina (chest pain), or if
they have had a heart attack, bypass surgery, peripheral artery
disease (poor circulation in the legs or feet due to narrow or blocked
arteries), or any kind of stroke (including ‘mini-stroke’ or transient
ischaemic attack “TIA”).
• has high blood pressure, diabetes, high cholesterol, or has a family
history of heart disease or stroke.
Infections
Ibuprofen may hide signs of infections such as fever and pain. It is
therefore possible that Ibuprofen may delay appropriate treatment
of infection, which may lead to an increased risk of complications.
This has been observed in pneumonia caused by bacteria and
bacterial skin infections related to chickenpox. If the child takes this
medicine while they have an infection and their symptoms of the
infection persist or worsen, consult a doctor without delay.
Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema
multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
drug reaction with eosinophilia and systemic symptoms 3 (DRESS),
acute generalized exanthematous pustulosis (AGEP) have been
reported in association with ibuprofen treatment. Stop giving your
child Ibuprofen Oral Suspension and seek medical attention
immediately if you
notice any of the symptoms related to these
serious skin reactions.
Aseptic meningitis (inflammation of the brain membrane without
bacterial infection)
During treatment with ibuprofen, some cases of meningitis
(presenting as stiff 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 medicines and Ibuprofen Oral Suspension
Tell your doctor or pharmacist if your child is taking, has recently
taken or might take any other medicines.
Ibuprofen Oral Suspension may affect or be affected by some other
medicines. For example:
• Other medicines containing ibuprofen or other NSAIDs, including
those you can buy over the counter.
• Medicines that are anti-coagulants (i.e. thin blood/ prevent clotting
e.g. aspirin, warfarin, ticlopidine).
• Antiplatelet drugs (e.g. dipyridamole, clopidogrel).
• Mifepristone (for termination of pregnancy).
• Zidovudine (for HIV infection).
• Medicines known as sulfonylureas such as glibenclamide (used to
treat diabetes).
• Methotrexate (for psoriasis, arthritis and types of cancer).
• Cardiac glycosides (e.g. digoxin – used to treat particular heart
problems).
• Diuretics (‘water tablets’).
• Medicines that reduce high blood pressure (ACE-inhibitors such as
captopril, beta blockers such as atenolol medicines, angiotensin-II
receptor antagonists such as losartan).
• Corticosteroids (an anti-inflammatory drug).
• SSRI antidepressant drugs (for depression).
• Antibiotics called quinolones e.g. ciprofloxa-
cin.
• Aminoglycoside antibiotics (for infection).
• Lithium (for mood disorders).
• Ciclosporin or tacrolimus (to prevent organ
rejection after transplant).
• Cholestyramine (used to lower cholesterol).
• Voriconazole or fluconazole (types of
anti-fungal drugs).
• Gingko biloba herbal medicine (there is a
chance you may bleed more easily if you are
taking this with ibuprofen).
Seek the
advice of your doctor or pharmacist
if any of the above apply. Some other
medicines may also affect or be affected by
the treatment of Ibuprofen Oral Suspension.
You should therefore always seek the advice
of your doctor or pharmacist before your
child uses Ibuprofen Oral Suspension with
other medicines. If you are not sure what
types of medicines your child is taking, show
the medicine to the doctor or pharmacist.
If you are an adult intending to take this
medicine:
All the information in this leaflet applies to
you as well.
In addition:
-If you are elderly you may be more likely to
have some of the possible side effects listed
later in the leaflet. Talk to your doctor before
taking this medicine.
- If you are a smoker, you should discuss your
treatment with your doctor or pharmacist
before taking Ibuprofen Oral Suspension.
-Ibuprofen Oral Suspension may cause
some side effects including dizziness,
drowsiness and stomach problems such as
bleeding in the stomach. Drinking excessive
alcohol while taking Ibuprofen Oral
Suspension might make these side effects
worse.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Do not take Ibuprofen Oral Suspension if you
are in the last 3 months of pregnancy as it
could harm your unborn child or cause
problems at delivery. It can
cause kidney and
heart problems in your unborn baby. It may
affect your and your baby’s tendency to
bleed and cause labour to be later or longer
than expected. You should not take
Ibuprofen Oral Suspension during the first 6
months of pregnancy unless absolutely
necessary and advised by your doctor. If you
need treatment during this period or while
you are trying to get pregnant, the lowest
dose for the shortest time possible should be
used. If taken for more than a few days from
20 weeks of pregnancy onward, Ibuprofen
Oral Suspension can cause kidney problems
in your unborn baby that may lead to low
levels of amniotic fluid that surrounds the
baby (oligohydramnios) or narrowing of a
®
Oral Suspension
(Ibuprofen 100mg/5ml )
Age/weight
Frequency
Single dose*
3-6 months(5-7kg)
Up to 3 mes a day
2.5ml
1/2 teaspoonful (50mg)
6-12 months (7-10 mg)
3 mes a day
2.5ml
1/2 teaspoonful (50mg
1 to 2 years(10-14.5kg)
3 to 4 mes a day
2.5ml
1/2 teaspoonful (50mg)
3 to 7 years (14.5-25 kg)
3 to 4 mes a day
5 ml
1 teaspoonful (100mg)
8 to 12 years (25-40 kg)
3 to 4 mes a day
10ml
2 teaspoonfuls (200mg)
*Doses should be given every 6 - 8 hours. Leave at least 6 hours between doses.
1-FORMS and PRESENTATION
UBSAFEN is a red oral pediatric suspension with strawberry-mixed
fruits flavor. It is supplied in an amber bottle containing 100ml.
The bottle is closed with a child-resistant plastic screw cap. Each pack
also contains a plastic oral dosing syringe.
2-COMPOSITION
Each 5ml of UBSAFEN oral suspension contains 100mg of Ibuprofen.
Excipients: Sucrose, Disodium EDTA, Glycerol, CMC, Sorbitol Solution70%,
Sodium Benzoate, Polysorbate 80, Xanthan Gum, Citric Acid, citrate
sodium, Sodium Saccharin, Strawberry Flavor, Mixed Fruits Flavor,
Allura red, Purified water.
3-THERAPEUTIC INDICATIONS
UBSAFEN oral suspension contains Ibuprofen which belongs to a group
of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs)
which act to relieve pain, swelling (inflammation) and reduce fever.
UBSAFEN oral suspension is for use in children from 3 months of age
who weigh more than 5 kg.
It can be used for the relief of mild to moderate pain such as sore
throat, teething pain, toothache, earache, headache, minor aches
and sprains. It can also be used to relieve the symptoms of colds and
flu and to reduce fever, including fever after vaccination at 3 months
of age.
4-POSOLOGY
Always give this medicine exactly as your doctor or pharmacist has
told you.
Check with your doctor or pharmacist if you are not sure.
Always shake the bottle thoroughly before use. Always use the syringe
supplied with the pack.
The syringe can be used to measure 2.5ml or 5ml by drawing the liquid
to the correct mark on the syringe.
Do not give to a child under 3 months of age, unless advised to do so
by your doctor. For Short-term use only
Do not give to babies aged 3-6 months for longer than 24 hours.
Do not give to children aged 6 months or over for longer than 3 days.
Consult your doctor if symptoms worsen or persist. The lowest
effective dose should be used for the shortest duration necessary to
relieve symptoms. If your child has
an infection, consult a doctor
without delay if symptoms (such as fever and pain) persist or worsen.
Do not give more than the amount recommended above.
If you use more UBSAFEN Oral Suspension than you should
If you have used more UBSAFEN oral suspension than you should, or if a
child has taken this medicine by accident, always contact a doctor or
your nearest hospital to get an opinion of the risk and advice on action
to be taken. The symptoms of overdose can include nausea, stomach
pain, vomiting (may be blood streaked), gastrointestinal bleeding,
diarrhea, headache, ringing in the ears, confusion and shaky eye
movement. Also agitation, somnolence, disorientation or coma may
occur. Occasionally patients develop convulsions. At high doses,
drowsiness, chest pain, palpitations, loss of consciousness, convulsions
(mainly in children), weakness and dizziness, blood in urine, low levels of
potassium in your blood, cold body feeling, and breathing problems
have been reported. Further, the prothrombin time/INR may be
prolonged, probably due to interference with the actions of circulating
clotting factors. Acute renal failure and liver damage may occur.
Exacerbation of asthma is possible in asthmatics. Furthermore, there
may be low blood pressure and reduced breathing.
If you forget to use UBSAFEN Oral Suspension
If you forget a dose, give the next dose when needed, provided that the
last dose was taken at least 6 hours ago. Do not take a double dose to
make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurs.
5-WARNINGS and PRECAUTIONS
This medicine is suitable for the majority
of people but certain people
should not use it. Talk to your doctor or pharmacist if you are at all
unsure.
Do not give this medicine to your child if they:
• are allergic to ibuprofen or any of the other ingredients of this
medicine (listed in section 2)
• have ever had a reaction (e.g. asthma, runny nose, rash, swelling of
the face, tongue, lips or throat) after taking ibuprofen, acetylsalicylic
acid (aspirin) or other non-steroidal-antiinflammatory (NSAID)
medicines
• weigh less than 5kg or are under 3 months of age
• are taking any other NSAID medicines, or aspirin with a daily dose
above 75mg (aspirin should not generally be given to children under 16,
but doctors may occasionally prescribe it)
• have a stomach ulcer, perforation or bleeding, or they have had one
twice or more in the past
• have had perforation or a bleeding ulcer after taking a NSAID
medicine (your child may have been sick and it contained blood or
dark particles that look like coffee grounds, passed blood in their stools
or passed black tarry stools)
• have severe kidney, heart or liver failure
• have a condition which increases their tendency to bleeding.
Signs of an allergic reaction to this medicine, including breathing
problems, swelling of the face and neck region (angioedema), chest
pain have been reported with ibuprofen. Stop immediately ibuprofen
oral solution and contact immediately your doctor or medical
emergencies if you notice any of these signs.
Talk to your doctor, pharmacist or nurse before giving Ibuprofen Oral
Suspension:
This is especially important if your child:
• has asthma, a history of asthma or other allergic disease
• has or has had kidney, liver or heart problems
• is dehydrated as there is a risk of kidney problems
•has connective tissue disorders such as SLE (Systemic Lupus
Erythematosus)
• suffers from chronic inflammatory bowel
disease such as Crohn’s
disease or ulcerative colitis • has chickenpox or shingles
• has an infection.
If your child is taking Ibuprofen Oral Suspension for longer than the
recommended time or at higher than recommended dose they are
at risk of serious harm. This includes serious harm to the stomach/gut
and kidneys, as well as very low levels of potassium in the blood. This
can be fatal .
Anti-inflammatory/pain-killer medicines like ibuprofen may be
associated with a small increased risk of heart attack or stroke,
particularly when used at high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss your child’s treatment with your doctor or
pharmacist before giving Ibuprofen Oral Suspension if your child:
• has heart problems including heart failure, angina (chest pain), or if
they have had a heart attack, bypass surgery, peripheral artery
disease (poor circulation in the legs or feet due to narrow or blocked
arteries), or any kind of stroke (including ‘mini-stroke’ or transient
ischaemic attack “TIA”).
• has high blood pressure, diabetes, high cholesterol, or has a family
history of heart disease or stroke.
Infections
Ibuprofen may hide signs of infections such as fever and pain. It is
therefore possible that Ibuprofen may delay appropriate treatment
of infection, which may lead to an increased risk of complications.
This has been observed in pneumonia caused by bacteria and
bacterial skin infections related to chickenpox. If the child takes this
medicine while they have an infection
and their symptoms of the
infection persist or worsen, consult a doctor without delay.
Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema
multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
drug reaction with eosinophilia and systemic symptoms 3 (DRESS),
acute generalized exanthematous pustulosis (AGEP) have been
reported in association with ibuprofen treatment. Stop giving your
child Ibuprofen Oral Suspension and seek medical attention
immediately if you notice any of the symptoms related to these
serious skin reactions.
Aseptic meningitis (inflammation of the brain membrane without
bacterial infection)
During treatment with ibuprofen, some cases of meningitis
(presenting as stiff 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 medicines and Ibuprofen Oral Suspension
Tell your doctor or pharmacist if your child is taking, has recently
taken or might take any other medicines.
Ibuprofen Oral Suspension may affect or be affected by some other
medicines. For example:
• Other medicines containing ibuprofen or other NSAIDs, including
those you can buy over the counter.
• Medicines that are anti-coagulants (i.e. thin blood/ prevent clotting
e.g. aspirin, warfarin, ticlopidine).
• Antiplatelet drugs (e.g. dipyridamole, clopidogrel).
• Mifepristone (for termination of pregnancy).
• Zidovudine (for HIV infection).
• Medicines known as sulfonylureas such as glibenclamide (used to
treat diabetes).
• Methotrexate (for psoriasis, arthritis and types of cancer).
• Cardiac glycosides (e.g. digoxin – used to treat particular heart
problems).
• Diuretics (‘water tablets’).
• Medicines that reduce high blood pressure (ACE-inhibitors such as
captopril,
beta blockers such as atenolol medicines, angiotensin-II
receptor antagonists such as losartan).
• Corticosteroids (an anti-inflammatory drug).
• SSRI antidepressant drugs (for depression).
• Antibiotics called quinolones e.g. ciprofloxa-
cin.
• Aminoglycoside antibiotics (for infection).
• Lithium (for mood disorders).
• Ciclosporin or tacrolimus (to prevent organ
rejection after transplant).
• Cholestyramine (used to lower cholesterol).
• Voriconazole or fluconazole (types of
anti-fungal drugs).
• Gingko biloba herbal medicine (there is a
chance you may bleed more easily if you are
taking this with ibuprofen).
Seek the advice of your doctor or pharmacist
if any of the above apply. Some other
medicines may also affect or be affected by
the treatment of Ibuprofen Oral Suspension.
You should therefore always seek the advice
of your doctor or pharmacist before your
child uses Ibuprofen Oral Suspension with
other medicines. If you are not sure what
types of medicines your child is taking, show
the medicine to the doctor or pharmacist.
If you are an adult intending to take this
medicine:
All the information in this leaflet applies to
you as well.
In addition:
-If you are elderly you may be more likely to
have some of the possible side effects listed
later in the leaflet. Talk to your doctor before
taking this medicine.
- If you are a smoker, you should discuss your
treatment with your doctor or pharmacist
before taking Ibuprofen Oral Suspension.
-Ibuprofen Oral Suspension may cause
some side effects including dizziness,
drowsiness and stomach problems such as
bleeding in the stomach. Drinking excessive
alcohol while taking Ibuprofen Oral
Suspension might make these side effects
worse.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Do not take Ibuprofen Oral Suspension if you
are in the last 3 months of pregnancy as it
could harm your unborn child or cause
problems at delivery. It can cause kidney and
heart problems in your unborn baby. It may
affect your and your baby’s tendency to
bleed and cause labour to be later or longer
than expected. You should not take
Ibuprofen Oral Suspension during the first 6
months of pregnancy unless absolutely
necessary and advised by your doctor. If you
need treatment during this period or while
you are trying to get pregnant, the lowest
dose for the shortest time possible should be
used. If taken for more than a few days from
20 weeks of pregnancy onward, Ibuprofen
Oral Suspension can cause kidney problems
in your unborn baby that may lead to low
levels of amniotic fluid that surrounds the
baby (oligohydramnios) or narrowing of a
blood vessel (ductus arteriosus) in the heart of the baby. If you need
treatment for longer than a few days, your doctor may recommend
additional monitoring.
The use of Ibuprofen Oral Suspension whilst breast-feeding should be
avoided.
Driving and using machines
Since side effects such as dizziness, drowsiness and visual disturbanc-
es may be experienced, the ability to drive a car or operate machinery
may be impaired.
6-ADVERSE REACTIONS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If your child experiences any of the following serious side effects, stop
giving this medicine and seek immediate medical help:
-Reddish non-elevated, target-like or circular patches on the trunk,
often with central blisters, skin peeling, ulcers of mouth, throat, nose,
genitals and eyes. These serious skin rashes can be preceded by fever
and flu-like symptoms [exfoliative dermatitis, erythema multiforme,
Stevens-Johnson syndrome, toxic epidermal necrolysis].
-Widespread rash, high body temperature and enlarged lymph nodes
(DRESS syndrome).
-A red, scaly widespread rash with bumps under the skin and blisters
accompanied by fever. The symptoms usually appear at the initiation
of treatment (acute generalised exanthematous pustulosis).
-Signs of aseptic meningitis such as severe headache, high
temperature, stiffness of the neck or intolerance to bright light.
• Signs of intestinal bleeding such as:
- passing blood in your faeces (stools/motions)
- passing black tarry stools
- vomiting any blood or dark particles that look like coffee grounds
Tell your doctor or pharmacist if you notice any of the following:
• Liver, kidney problems or difficulty urinating UBSAFEN Oral Suspension,
especially when taken at higher than recommended doses or for a
prolonged period of time, can cause damage to the kidneys and affect
them removing acids properly from the blood
into the urine (renal
tubular acidosis). It can also cause very low levels of potassium in the
blood. This is a very serious condition and will require immediate
treatment. Signs and symptoms include muscle weakness and
light-headedness.
Tell a doctor and stop giving this medicine if your child experiences:
• Unexplained stomach pain (abdominal pain) or other abnormal
stomach symptoms, indigestion, heartburn, feeling sick and/or
vomiting.
• Unexplained wheezing, shortness of breath, skin rash, itching or
bruising (these may be symptoms of an allergic reaction).
• Loss of vision, blurred or disturbed vision (visual impairment) or
seeing/hearing strange things (hallucinations).
• Severe spreading skin rash (‘Stevens-Johnson Syndrome’, ‘toxic
epidermal necrolysis’ and ‘erythema multiforme’, symptoms include
severe skin rash, blistering of skin, including inside mouth, nose, and
genitals, as well as skin peeling which may be accompanied with
symptoms such as aching, headaches, and feverishness)
• A severe skin reaction known as DRESS syndrome can occur.
Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes
and an increase of eosinophils (a type of white blood cells).
• chest pain, which can be a sign of a potentially serious allergic
reaction called Kounis syndrome.
Medicines such as UBSAFEN Oral Suspension have been associated
with a small increased risk of high blood pressure, heart attack
(myocardial infarction), stroke or heart failure.
Medicines such as UBSAFEN Oral Suspension have in exceptional cases
been associated with severe skin problems for patients with chicken
pox or shingles.
Blood disorders such as reduction in blood cells and platelet counts –
the first signs are: high temperature,
sore throat, mouth ulcers, flu-like
symptoms, bleeding from the mouth, nose, ear and the skin. Kidney
problems such as reduced kidney function, fluid retention (oedema),
inflammation of the kidney and kidney failure, liver problems such as
inflammation of the liver, reduced liver function and yellowing of the
eyes and/or skin (jaundice) or severe skin reactions
may occur rarely with ibuprofen.
UBSAFEN Oral Suspension has also been shown to sometimes worsen
the symptoms of Crohn’s disease or colitis.
Other side effects Common (may affect up to 1 in 10 people):
Feeling dizzy or tired, Diarrhoea, wind, constipation,Headache - if this
happens while you are taking this medicine it is important not to take
any other medicines for pain to help with this.
Uncommon (may affect up to 1 in 100 people): Feeling drowsy, Feeling
anxious, Feeling a tingling sensation or ‘pins and needles’, Difficulty
sleeping, Hives, Hearing problems, Sneezing, blocked, itchy or runny
nose (rhinitis),Stomach or gut ulcer, hole in the wall of the digestive
tract,Inflammation of your stomach lining ,Ringing in ears
(tinnitus),Sensation of spinning (vertigo),Mouth ulcers
Rare (may affect up to 1 in 1,000 people): Feeling depressed or confused
Very rare (may affect up to 1 in 10,000 people): Inflammation of the
pancreas
Not known (frequency cannot be estimated from the available data):
Decreased appetite,Skin becomes sensitive to light, Painful urination,
Severe abdominal pain caused by a kidney stone (ureteric colic),A red,
scaly widespread rash with bumps under the skin and blisters mainly
localized on the skin folds, trunk, and upper extremities accompanied
by fever at the initiation of treatment (acute generalised exanthema-
tous pustulosis). Stop using UBSAFEN Oral Suspension if you develop
these symptoms and seek medical attention immediately.
7-STORAGE CONDITIONS
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store below 30 °C.
Store in the original package to protect from light.
Do not take your suspension after the expiry date on the container.
Manufacturer, Marketing Authorization Holder:
blood vessel (ductus arteriosus) in the heart of the baby. If you need
treatment for longer than a few days, your doctor may recommend
additional monitoring.
The use of Ibuprofen Oral Suspension whilst breast-feeding should be
avoided.
Driving and using machines
Since side effects such as dizziness, drowsiness and visual disturbanc-
es may be experienced, the ability to drive a car or operate machinery
may be impaired.
6-ADVERSE REACTIONS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If your child experiences any of the following serious side effects, stop
giving this medicine and seek immediate medical help:
-Reddish non-elevated, target-like or circular patches on the trunk,
often with central blisters, skin peeling, ulcers of mouth, throat, nose,
genitals and eyes. These serious skin rashes can be preceded by fever
and flu-like symptoms [exfoliative dermatitis, erythema multiforme,
Stevens-Johnson syndrome, toxic epidermal necrolysis].
-Widespread rash, high body temperature and enlarged lymph nodes
(DRESS syndrome).
-A red, scaly widespread rash with bumps under the skin and blisters
accompanied by fever. The symptoms usually appear at the initiation
of treatment (acute generalised exanthematous pustulosis).
-Signs of aseptic meningitis such as severe headache, high
temperature, stiffness of the neck or intolerance to bright light.
• Signs of intestinal bleeding such as:
- passing blood in your faeces (stools/motions)
- passing black tarry stools
- vomiting any blood or dark particles that look like coffee grounds
Tell your doctor or pharmacist if you notice any of the following:
• Liver, kidney problems or difficulty urinating UBSAFEN Oral Suspension,
especially when taken at higher than recommended doses or for a
prolonged period of time, can cause damage to the kidneys and affect
them removing acids properly from the blood
into the urine (renal
tubular acidosis). It can also cause very low levels of potassium in the
blood. This is a very serious condition and will require immediate
treatment. Signs and symptoms include muscle weakness and
light-headedness.
Tell a doctor and stop giving this medicine if your child experiences:
• Unexplained stomach pain (abdominal pain) or other abnormal
stomach symptoms, indigestion, heartburn, feeling sick and/or
vomiting.
• Unexplained wheezing, shortness of breath, skin rash, itching or
bruising (these may be symptoms of an allergic reaction).
• Loss of vision, blurred or disturbed vision (visual impairment) or
seeing/hearing strange things (hallucinations).
• Severe spreading skin rash (‘Stevens-Johnson Syndrome’, ‘toxic
epidermal necrolysis’ and ‘erythema multiforme’, symptoms include
severe skin rash, blistering of skin, including inside mouth, nose, and
genitals, as well as skin peeling which may be accompanied with
symptoms such as aching, headaches, and feverishness)
• A severe skin reaction known as DRESS syndrome can occur.
Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes
and an increase of eosinophils (a type of white blood cells).
• chest pain, which can be a sign of a potentially serious allergic
reaction called Kounis syndrome.
Medicines such as UBSAFEN Oral Suspension have been associated
with a small increased risk of high blood pressure, heart attack
(myocardial infarction), stroke or heart failure.
Medicines such as UBSAFEN Oral Suspension have in exceptional cases
been associated with severe skin problems for patients with chicken
pox or shingles.
Blood disorders such as reduction in blood cells and platelet counts –
the first signs are: high temperature,
sore throat, mouth ulcers, flu-like
symptoms, bleeding from the mouth, nose, ear and the skin. Kidney
problems such as reduced kidney function, fluid retention
(oedema),
inflammation of the kidney and kidney failure,
liver problems such as inflammation of the liver, reduced liver function
and yellowing of the eyes and/or skin (jaundice) or severe skin reactions
may occur rarely with ibuprofen.
UBSAFEN Oral Suspension has also been shown to sometimes worsen
the symptoms of Crohn’s disease or colitis.
Other side effects Common (may affect up to 1 in 10 people):
Feeling dizzy or tired, Diarrhoea, wind, constipation,Headache - if this
happens while you are taking this medicine it is important not to take
any other medicines for pain to help with this.
Uncommon (may affect up to 1 in 100 people): Feeling drowsy, Feeling
anxious, Feeling a tingling sensation or ‘pins and needles’, Difficulty
sleeping, Hives, Hearing problems, Sneezing, blocked, itchy or runny
nose (rhinitis),Stomach or gut ulcer, hole in the wall of the digestive
tract,Inflammation of your stomach lining ,Ringing in ears
(tinnitus),Sensation of spinning (vertigo),Mouth ulcers
Rare (may affect up to 1 in 1,000 people): Feeling depressed or confused
Very rare (may affect up to 1 in 10,000 people): Inflammation of the
pancreas
Not known (frequency cannot be estimated from the available data):
Decreased appetite,Skin becomes sensitive to light, Painful urination,
Severe abdominal pain caused by a kidney stone (ureteric colic),A red,
scaly widespread rash with bumps under the skin and blisters mainly
localized on the skin folds, trunk, and upper extremities accompanied
by fever at the initiation of treatment (acute generalised exanthema-
tous pustulosis). Stop using UBSAFEN Oral Suspension if you develop
these symptoms and seek medical attention immediately.
7-STORAGE CONDITIONS
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store below 30 °C.
Store in the original package to protect from light.
Do not take your suspension after the expiry date on the container.
Manufacturer, Marketing Authorization Holder:
Date of Revision: 24 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.
PI062/01
Ubsafen Oral Suspension 100mg/5ml Reg.N°:185125/1