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.

What information does this leaﬂet provide?

1.What Ibufast

is and what it's commonly used for?

2.What should you know before taking Ibufast

tablets?

3.How should you take Ibufast

tablets?

4.What are the possible side eects of Ibufast

tablets?

5.How should you store Ibufast

tablets?

6.Further information about Ibufast

tablets.

1. WHAT IBUFAST

IS AND WHAT IT'S COMMONLY USED FOR?

Ibufast

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.

Ibufast

has antipyretic, analgesic, and anti-inﬂammatory 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.

Ibufast

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 eects of Ibufast

tablets within 20-30

minutes, and they typically last for4-6 hours.

2.WHAT SHOULD YOU KNOW BEFORE TAKING IBUFAST

TABLETS?

CONTRAINDICATIONS

•If you are allergic to ibuprofen or any of the other ingredients of this

medicine.

•Ibufast

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.

• Ibufast

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 Ibufast

As with other NSAIDs, Ibufast

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

eective 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 Ibufast

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:

Ibufast

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 eects necessitates administering the minimal eective 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 Ibufast

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.

Eects on the kidneys:

Ibufast

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 Ibufast

however, generally leads to recovery. Aseptic

meningitis (inﬂammation of the brain membrane without bacterial

infection) During treatment with Ibufast

, 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.

Ibufast

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.

Ibufast

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.

Ibufast

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

Ibufast

may make you feel dizzy or drowsy. If it aects you in this way

do not drive, operate machinery, or do anything that requires you to

be alert.

Ibufast

with alcohol

Drowsiness, and stomach problems such as bleeding in the stomach.

Drinking excessive alcohol with Ibufast

might make these side

effects worse.

Ibufast

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 Ibufast

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 aminoglyco-

sides.

•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 IBUFAST

TABLETS?

Always take Ibufast

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 Ibufast

tablets with or after food,

with a glass of water.

• Ibufast

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 Ibufast

. Tell your doctor if you have been

having headaches while taking this

medicine.

Dosage and administration of Ibufast

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.

Ibufast

tablets should not be taken by children less than 7kg. Ibufast

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

Ibufast

must be used, employ the lowest effective dose for the

shortest duration possible in patients with mild kidney impairment.

If you take more Ibufast

tablets than you should (an overdose)

Contact your doctor, pharmacist, or nearest hospital in case of an

Ibufast

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, disorienta-

tion, 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 600 mg/kg body weight.

There is no speciﬁc antidote for Ibuprofen.

If you forget to take your Ibufast

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 OF IBUFAST

TABLETS?

Ibufast

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 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.

•Hematologic effects: associated with prolonged bleeding time and an

increased risk for hemorrhage.

•Hepatic effects: Ibufast

may cause mild transaminase elevations,

especially with higher doses.

•Kidney effects: Use of nonesteroidal anti-inflammatory drugs (NSAIDs)

including Ibufast

, is associated with an increased risk



Ibuprofen 600 mg

Film-Coated Tablets

Anti-inﬂammatory, Analgesic, Antipyretic, Antirheumatic

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 IBUFAST

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 IBUFAST

TABLETS.

Each film coated tablet of Ibufast

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.

Ibufast

600 mg

Box of 20 Film Coated Tablets