1. What Prof is and what it is used for

Prof belongs to a group of medicines called Non-steroidal Anti-inflammatory Drugs.

They 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.

Prof is also used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.

Prof oral suspension can also be used for the short term treatment of fever in children over the age of 1 year.

2. Before you take Prof

Do not take Prof

- If you are allergic (hypersensitive) to Ibuprofen, or to any of the ingredients of Prof.

- If you are in last 3 months of your pregnancy.

- If you have ever had a stomach ulcer, perforation or other gastric problems in the past while taking NSAIDs.

- If you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past.

- If you suffer from a condition which increases your tendency to bleeding.

- If you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking Prof, aspirin or other anti-inflammatory pain killers.

- If you suffer from severe heart problems.

- If you suffer from severe liver, kidney or heart failure.

Take special care with Prof

Talk to your doctor or pharmacist before taking this medicine:

- If you have a history of ulcerative colitis or crohn’s disease.

- If you suffer from kidney or liver problems.

- If you suffer from heart problems.

Medicines such as Prof may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

- If you are suffering or have a previous history of bronchial asthma.

- If you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue).

- If you are elderly, you may get more side effects.

-If you are pregnant or planning to become pregnant, or breast-feeding, Prof oral suspension may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Prof can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Prof is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In nonhospital settings, consult your doctor if symptoms persist or worsen.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those medicines obtained without a prescription.

In particular you should tell your doctor or pharmacist if you are taking any of the following medicines:

- Anti-coagulants (used to thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine).

- ACE-inhibitors (used to reduce high blood pressure such as captopril), beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan.

- Diuretics (water tablets).

- Cardiac glycosides (used to treat heart conditions e.g. digoxin).

- Lithium (used to treat depression and bipolar).

- Zidovudine (an anti-viral drug).

- Steroids (used in the treatment of inflammatory conditions).

- Methotrexate (used to treat certain cancers).

- Ciclosporin and tacrolimus (used to dampen down your immune response).

- Selective serotonin reuptake inhibitors (SSRIs) (used to treat depression).

- Antibiotics called quinolones such as ciprofloxacin.

- Aminoglycosides (a type of antibiotic).

- Mifepristone (used to induce abortion).

- Any other ibuprofen preparations, such as those you can buy without a prescription.

- Any other anti-inflammatory pain killer, including aspirin.

- Cholestyramine (a drug used to lower cholesterol).

- Glibenclamide (used to treat diabetes).

- Voriconazole or fluconazole (used to reduce fungal infection).

- Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with Prof).

Pregnancy and Breastfeeding

The use of Prof whilst pregnant or breast feeding should be avoided. Prof should not be used in late (the last three months) of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Taking with Food and Drink

Prof can be taken with or after food.

Driving and using Machines

Prof may make you feel dizzy or drowsy. If it affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

Important information about some of the ingredients of Prof

Prof oral suspension contains sorbitol and sucrose, if you have been told by your doctor that you have intolerance to some sugars, it is not recommended for those with hereditary fructose intolerance, glucose malabsorption syndrome or sucrase isomaltase deficiency.

Prof oral suspension contains small amounts of glycerin (glycerol). In high doses, glycerin may sometimes cause headache, stomach upset and diarrhea. As such, you should not take more than the stated dose unless your doctor advises you to.

3. How to take Prof

Dosage: To be taken orally.

Always take Prof exactly as your doctor has told you.

If you are not sure refer to the label on the carton or check with your doctor or pharmacist.

The following dosage guidelines are only for patients taking this medicine on prescription from the doctor.

Adults

Usually 1200 to 1800 mg daily in divided doses. Some patients can be maintained on 600 to 1200 mg daily. The total daily dose must not be more than 2400 mg.

Children

Prof oral suspension should NOT be taken by children  weighing less than 7 kg. When used to treat fever, the oral suspension should not be used long term or given to children under the age of 1 year. The usual dose in children is 20 mg per kg of body weight each day, in divided doses.

This can be given as follows:

1-2 years: One 2.5 ml (50 mg) dose three/four times a day.

3-7 years: One 5 ml (100 mg) dose three/four times a day.

8-12 years: Two 5 ml (200 mg) doses three/four times a day.

The doctor may choose to increase this dose in children with juvenile rheumatoid arthritis.

This dose should not exceed 40 mg/kg body weight daily in divided doses.

Shake well the oral suspension before use.

Elderly:

As for adults, unless there are kidney or liver problems, if so your doctor may decide to prescribe you a lower dose.

The elderly are at increased risk of the serious consequences of adverse reactions.

If Prof is considered necessary your doctor may use the lowest dose and may decide to monitor you regularly for GI bleeding during NSAID therapy.

If you take more Prof than you should

If you or someone else take too many doses, contact your doctor or pharmacist or hospital emergency department immediately. Always take this leaflet and pack with you.

If you forget to take Prof

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Prof can cause side effects, although not everybody gets them.
If any of the following happens, stop taking Prof and tell your doctor immediately or go to the casualty department at your nearest hospital.
- Swelling of the face, neck, lips, tongue or throat, leading to difficulty breathing or swallowing; skin rash, hives (allergic reaction).
- Severe headache, high temperature, stiffness of the neck or intolerance to light.
- 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 and stop taking Prof if you experience:
- Unexplained stomach pain or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting.
- Unexplained wheezing, shortness of breath, skin rash, itching or bruising.
- Yellowing of the eyes and/or skin.
- Severe sore throat with high fever.
- Blurred or disturbed vision or seeing/hearing strange things.
- Fluid retention (e.g. swollen ankles).
- Severe spreading skin rash (Stevens-Johnson Syndrome 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).
“Medicines such as Prof tablets have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles.”
Medicines such as Prof have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely with Prof.
Very rarely Prof may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).
Other side effects 
Common (affects up to 1 in 10 people):
- Rash
- Feeling dizzy or tired.
- Stomach pain, indigestion, diarrhea, feeling sick, being sick, 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.
- Passing black tarry stools. 
- Passing blood in your faeces (stools/motions).
- Vomiting any blood.  
Uncommon (affects up to 1 in a 100 people):
- Feeling drowsy.
- Feeling anxious.
- Feeling a tingling sensation or 'pins and needles'.
- Difficulty sleeping.
- Hives, itching.
- Skin becomes sensitive to light.
- Visual disturbances, hearing problems.
- Hepatitis, yellowing of your skin or eyes, reduced liver function.
- Reduced kidney function, inflammation of the kidneys, kidney failure.
- Sneezing, blocked, itchy or runny nose (rhinitis).
- Stomach or gut ulcer, hole in the wall of the digestive tract.
- Inflammation of your stomach lining.
- Small bruises on your skin or inside your mouth, nose or ears.
- Difficulty breathing, wheezing or coughing, asthma or worsening of asthma.
- Ringing in ears (tinnitus).
- Sensation of feeling dizzy or spinning (vertigo).
- Mouth ulcers.
- Serious allergic reaction which causes swelling of the face or throat.
Rare (affects up to 1 in a 1000 people):
- Feeling depressed or confused.
- Fluid retention (edema).
- A brain infection called 'non-bacterial meningitis'.
- Loss of vision.
- Changes in blood count, the first signs are: High temperature, sore throat, mouth ulcers, flu-like symptoms, feeling very tired, bleeding from the nose and the skin.
- Reduction in blood cells (anaemia).
- Serious allergic reaction which causes difficulty in breathing or dizziness.
- Severe sore throat with high fever (agranulocytosis).
Very rare (affects up to 1 in 10,000 people):
- Liver failure.
- Heart failure.
- Heart attack.
- Inflammation of the pancreas.
- Skin problems (which can also affect inside your mouth, nose or ears) such as 'Stevens-Johnson syndrome', 'toxic epidermal necrolysis' or 'erythema multiforme'.
- High blood pressure.
Not known (frequency cannot be estimated from available data):
- Worsening of ulcerative colitis or Crohn's Disease (inflammation of the colon)”.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Prof
Keep out of reach of children.
Store below 30°C.
Prof oral suspension:
Once the bottle is opened, the suspension must be used within 3 months.
Do not use beyond the expiry date or if the product shows any sing of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help to protect the environment.