UBSAFEN

Ibuprofen 400/600 mg

Film-Coated Tablets

Anti-inﬂammatory, Analgesic, Antipyretic, Antirheumatic

WHAT UBSAFEN AND AND WHAT IT'S COMMONLY

USED FOR?

Ubsafen belongs to a group of medicines called

Nonsteroidal anti-inﬂammatory drug (NSAID), which

reversibly inhibits cyclooxygenase -1 and -2 (COX-1 and -2)

enzymes, which results in decreased formation of

prostaglandin precursors;

Ubsafen has antipyretic, analgesic, and anti-inﬂamma-

tory properties and can be used to relieve pain and

inﬂammation in conditions such as osteoarthritis,

rheumatoid arthritis (including 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.

Ubsafen 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 eﬀects of Ubsafen tablets

within 20-30 minutes, and they typically last for 4-6 hours.

What information does this leaﬂet provide?

1.What Ubsafen is and what it's commonly used for?

2.What should you know before taking Ubsafen tablets?

3.How should you take Ubsafen ta

blets?

What are the possible side eﬀects of Ubsafen tablets?4.

5.How should you store Ubsafen tablets?

6.Further information about Ubsafen tablets.

2.WHAT SHOULD YOU KNOW BEFORE TAKING

UBSAFEN TABLETS?

CONTRAINDICATIONS

If you are allergic to ibuprofen or any of the other

ingredients of this medicine.

• Ubsafen 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); thrombocytope-

nia; coagulation defects.

•

• If you have an active gastric/duodenal/peptic ulcer.

• Ubsafen 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 Ubsafen:

As with other NSAIDs, Ubsafen 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 eﬀective 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 o

Ubsafen 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:

Ubsafen 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

dosages must be individually tailored.

Elderly patients are at increased risk of serious gastroin-

which can be lethal. Those with a history of gastrointesti-

nal 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

eﬀects necessitates administering the minimal eﬀective

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 Ubsafen 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 h

ealthcare 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.

Eﬀects on the kidneys

Ubsafen 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 ACE inhibitors, as

well as in the elderly.

Stopping Ubsafen however, generally leads to recovery.

Aseptic meningitis (inﬂammation of the brain membrane

without bacterial infection) During treatment with

Ubsafen, some cases of meningitis (presenting as stiﬀ

neck, headache, nausea, vomiting, fever, or disorienta-

tion) 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 hypersensitiv-

ity 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.

Ubsafen 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.

Ubsafen 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

pregnant or if you have problems becoming pregnant.

Ubsafen 400/600mg 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

you in this way do not drive, operate machinery, or do

Ubsafen may make you feel dizzy or drowsy. If it aﬀects

anything that requires you to be alert.

Ubsafen with alcohol

drowsiness, and stomach problems such as bleeding in

the stomach. Drinking excessive alcohol with Ubsafen

Ubsafen 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

should therefore always seek the advice of your doctor or

pharmacist before you use Ubsafen 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 UBSAFEN TABLETS?

Always take Ubsafen exactly as instructed on this leaﬂet. Use

recommended by your doctor or pharmacist.

Take your Ubsafen tablets with or after food, with a glass of water.

• Ubsafen tablets should be swallowed whole and not

chewed, broken, crushed, or sucked to help prevent

discomfort in 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 s

ymptoms persist or worsen,

consult your doctor or pharmacist.

• 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

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 Ubsafen. Tell your doctor if you

have been having headaches while taking this medicine.

Dosage and administration of Ubsafen

400/600 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 brought under control, providing that

the total daily dosage does not exceed 2400mg in divided

doses.

Elderly:

In elderly patients receiving 600 mg-1200 mg daily Ibuprofen

peared 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 in divided

doses. Ubsafen tablets should not be taken by children less

than 7kg. Ubsafen 400/600 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 impairm

ent: Non-NSAID analgesics are

preferable. If Ubsafen must be used, employ the lowest

with mild kidney impairment.

If you take more

Ubsafen tablets than you should (an overdose)

Contact your doctor, pharmacist, or nearest hospital in case

of an Ubsafen 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, chest pain,

alpitation, 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 Ubsafen 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 EﬀECTS

UBSAFEN TABLETS?

are generally mild, and not everyone will experience

tell your doctor or pharmacist. To reduce the risk of side

the shortest duration required to manage your

symptoms.

Signiﬁcant adverse reactions:

matory drugs (NSAIDs) is associated with an increased

risk of serious adverse cardiovascular (CV) events,

including acute myocardial infarction (MI), cerebrovascu-

lar accident, New-onset hypertension or exacerbation 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.

bleeding time and an increased risk for hemorrhage.

nase elevations, especially with higher doses.

drugs (NSAIDs), including Ubsafen, is associated with

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

information on the safety of this medicine.

5. HOW SHOULD YOU STORE UBSAFEN 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 UBSAFEN

TABLETS.

Each ﬁlm coated tablet of Ubsafen contains:

Excipients:

,etaraetS muisengaM ,muido

S esollemracsorC

Povidone K 90, Pregelatinized Starch, Microcrystalline

Cellulose PH-101, Colloidal silicon Dioxide, Sodium

lauryl sulphate, Puriﬁed Water.

UBSAFEN 400/600 mg

Box of 20 Film Coated Tablets

Marketing Authorisation Holder,

Manufacturer

Date of Revision: 4/10/2024

This is a medicament

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 experts in

medicine, its beneﬁts, and risks.

- Do not by yourself interrupt the period of treatment

prescribed for you.

- Do not repeat the same prescription without

consulting your doctor.

- Keep all medicaments out of the sight and reach of

children.

Council of Arab Health Ministers

Union of Arab Pharmacists

PI008/01

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.

See section 4.

Ubsafen

400/600 mg of Ibuprofen