PATIENT INFORMATION LEAFLET

FROBEN SR

Each capsule contains 200 mg Flurbiprofen BP in a sustained-release form. Also contains glycerin (glycerol).

WHAT YOU SHOULD KNOW ABOUT FROBEN SR (sustained-release flurbiprofen)

Please read this leaflet carefully before you start to take your capsules. It provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The active ingredient in Froben SR is flurbiprofen in a sustained-release (slow-release) formulation.The capsules are yellow and are marked 'FSR' in black.

Each capsule contains 200 mg of Flurbiprofen BP with microcrystalline cellulose, acrylic/methacrylic acid ester copolymer, magnesium stearate, polyethylene glycol and colloidal silicon dioxide. The capsule shell is made of gelatin with small amounts of quinoline yellow (E104), titanium dioxide (E171), iron oxide (E172), shellac, glycerin, soya lecithin and polydimethylsiloxane.

Each pack contains 30 capsules.

Froben SR belongs to a group of medicines called anti-inflammatory pain killers.

What are your capsules for?

Froben SR capsules can be used to relieve pain and inflammation (swelling) in conditions such as osteoarthritis, rheumatoid disease, ankylosing spondylitis, swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back pain, sprains and strains.

Before you take Froben SR

• 1. Are you pregnant or planning to become pregnant, or are you breast feeding?
• 2. Are you sensitive (allergic) to any of the ingredients in the capsules (see above)?
• 3. Do you have, or have you previously had, a stomach ulcer or other gastric complaint?
• 4. Do you suffer from asthma or have you ever had an allergic reaction or wheezing after taking flurbiprofen, ibuprofen, aspirin or other anti-inflammatory pain killers?
• 5. Do you suffer from liver, kidney or heart disease?
• 6. Do you suffer from high blood pressure?
• 7. Have you been diagnosed as having a condition that affects the time it takes your blood to clot?
• 8. Are you taking any of the following medicines:
  • diuretics (water tablets)?
  • tablets for high blood pressure?
  • medicines such as warfarin, to prevent blood clots?
  • digoxin, lithium, steroid tablets, methotrexate or cyclosporin?
  • antibiotics called quinolones (such as ciprofloxacin)?
  • mifepristone (now or at any time within the last 12 days)?
  • any other anti-inflammatory pain killers?

If the answer to any of these questions is YES, please tell your doctor or pharmacist.

Medicines such as Froben SR 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 (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

 

How to take your capsules

Follow your doctor's directions about when and how to take your capsules and look at the label on the bottle. Your pharmacist will also help if you are not sure.

You should swallow your capsules whole with a drink of water. If you have difficulty swallowing the capsules, they may be opened up and the granules taken with some food or liquid. lt is important that you do not crush or chew the granules as this may affect the slow-release action.

Adults: The usual dose of Froben SR is one capsule each evening, after food.

Elderly: Some elderly patients may be more prone to side effects. Your doctor will take this into account when deciding the dose you will need and may monitor you for side effects.

Children: Froben SR is not recommended for children.

lt is important that you keep taking these capsules until your doctor tells you to stop. Don't stop just because you feel better. If you stop taking the capsules too soon, your condition may get worse.

Will Froben SR cause any problems?

As well as benefits, all medicines may sometimes have effects you do not want. If side effects occur with Froben SR, they are usually mild but if you experience any of the following, stop taking the capsules and tell your doctor:

• Unexplained stomach pain, indigestion, feeling sick and/or vomiting.
• Any sign of bleeding from the stomach or bowels (vomiting blood and/or passing black stools).
• Unexplained wheezing, shortness of breath, skin rash, itching or bruising.
• Yellowing of the eyes and/or skin.
• Severe sore throat with a high fever.
• Blurred or disturbed vision, or seeing/hearing strange things.
• Fluid retention, e.g. swollen ankles.
• Rarely, blood disorders and kidney problems may occur with flurbiprofen.
• Other unusual effects may include headache, dizziness, tingling of the hands and feet, ringing in the ears, diarrhoea, unexpected sensitivity of the skin to the sun, tiredness, malaise, mood swings and confusion. If any of these become troublesome or last more than a few days, tell your doctor.

Medicines such as Froben SR may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

If you experience any other unusual symptoms whilst taking your capsules, tell your doctor or pharmacist.

Storing your capsules

Do not take your capsules after the 'use by' date shown on the bottle. Keep them in a safe place where children cannot reach them. Your medicine could harm them.

If your doctor decides to stop the treatment, return any left over to your pharmacist. Only keep the capsules if your doctor tells you to.

Other information

Remember : This medicine is for you and has been prescribed for you by a doctor. Never give it to anybody else, even if their symptoms are the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.