Fenopron 300
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fenopron Tablets 300mg Fenoprofen calcium
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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.
In this leaflet:
1. What Fenopron is and what it is used for
2. Before you take Fenopron
3. How to take Fenopron
4. Possible side effects
5. How to store Fenopron
6. Further information
1. WHAT FENOPRON IS AND WHAT IT IS USED FOR
Fenopron is an anti-inflammatory medicine which does not contain steroids (a non-steroidal anti-inflammatory medicine or NSAID). Anti-inflammatory medicines help to reduce swelling and bone damage if you have arthritis. Fenopron is used to treat rheumatoid arthritis, osteoarthritis and a back problem called ankylosing spondylitis. It is also used as a pain killer.
2. BEFORE YOU TAKE FENOPRON Do not take Fenopron if you
• are allergic (hypersensitive) to fenoprofen calcium or any of the other ingredients of Fenopron (see section 6 for a full list of ingredients).
• have asthma or ever had symptoms of asthma (such as persistent cough or wheeze), a runny nose (rhinitis), an allergic reaction (which may include rash, itching, swelling or breathing difficulties) or kidney or bladder problems after taking aspirin, ibuprofen or another non-steroidal anti-inflammatory medicine.
• have or have ever had 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.
• have severe liver, kidney or heart problems.
• are in the last three months of pregnancy.
Take special care with Fenopron if you:
• have or have had bronchial asthma.
• have or have had high blood pressure.
• have any liver, kidney or heart problems.
• are taking other NSAIDs including COX-2 selective NSAIDs.
• have problems with indigestion, heartburn or any other digestive or bowel problems (Ulcerative colitis, Crohn's disease) including bleeding in your digestive tract.
• have difficulty passing or pass little urine or have blood in your urine.
• develop sores in your mouth and on your lips or a skin rash in the first month of taking Fenopron.
• have systemic lupus erythematosus or mixed connective tissue disease.
• are a woman trying to become pregnant or having treatment for infertility (see pregnancy and breast-feeding below for details)
• are anaemic or have had blood-clotting problems.
• have problems with your hearing.
• are elderly.
Medicines such as Fenopron 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.
Before having any kind of surgery, including dental surgery, tell the doctor, dentist or surgeon that you are taking Fenopron.
Taking other medicines
Please tell your doctor, dentist or pharmacist if you are taking, have recently taken or are intending to take any other medicines, including medicines obtained without a prescription, herbal and complimentary medicines.
Some medicines cannot be taken at the same time as Fenopron and some other medicines may need to have the dose changed. If you are taking any of the following you must tell your doctor.
• Other non-steroidal anti-inflammatory drugs such as aspirin
• Medicine for high blood pressure such as propranolol
• Diuretics (water tablets) such as furosemide
• Cardiac glycosides such as Digoxin
• Lithium (to treat mental disorders)
• Methotrexate (to treat arthritis)
• Ciclosporin or tacrolimus (for the prevention of rejection of transplanted organs)
• Mifepristone (now or at any time in the last 12 days)
• Corticosteroid tablets
• Medicine to prevent blood clots such as warfarin
• Antibiotics called quinolones such as ciprofloxacin
• SSRI antidepressants (to treat depression)
• Zidovudine (to treat HIV)
• Diabetes medicine (sulphonylureas)
• Sulphonamide type antibiotics (to treat urinary tract infections)
• Medicine for epilepsy (hydantoins) such as Phenytoin, Epanutin
If you are unsure about the medicines you are taking, take them to your pharmacist for advice.
Taking Fenopron with food and drink.
Fenopron should be taken with or immediately after food (see section 3).
Pregnancy and breast-feeding
Fenopron 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.
You should not take Fenopron during the first 6 months of pregnancy and you must not take Fenopron during the last 3 months of pregnancy or during labour.
You should not take Fenopron if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Fenopron can make some patients sleepy or dizzy. Make sure your reactions are normal before driving, operating machinery or doing other jobs that could be dangerous if you are not fully alert.
Important information about some of the ingredients of Fenopron.
Fenopron tablets contain the colourant Sunset yellow E110 which may cause allergic reactions in some patients.
Fenopron is not recommended for children.
Always take Fenopron exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take 2 tablets 3 times a day. Swallow the tablets whole with water or milk. Take Fenopron with or immediately after food. Do not take more than 10 Fenopron 300 tablets a day.
If you are elderly you may be given a smaller dose. You should take the tablets for as long as your doctor has told you to
If you take more Fenopron tablets than you should
Go to the nearest hospital casualty department or tell your doctor immediately. Take the Fenopron tablets with you.
If you forget to take Fenopron
If you forget to take your tablet, wait and take it as your next dose. Do not take a double dose to make up for a forgotten dose. Do not take more tablets than your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fenopron can cause side effects, although not everybody gets them.
If you suffer from any of the following at any time during your treatment STOP TAKING Fenopron and seek immediate medical help.
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds
• Have difficulty breathing
• Your face or throat swells
• You have chest pain or sudden numbness or confusion
STOP TAKING Fenopron and tell your doctor if you experience:
• indigestion or heartburn
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
This is especially important if you are elderly.
Common side effects
• loss of appetite
• diarrhoea
• mouth ulcers
• facial pain
• breast pain
• sleepy / drowsiness
■ feeling or being sick constipation headache
■ hearing loss
■ personality change nervous
■ a dry mouth or a metallic taste in the mouth
■ feeling dizzy or feeling that the room is spinning
■ inflammation of the pancreas (back pain accompanied with diarrhoea)
• stomach ache wind
• difficulty in sleeping
• hair loss fits
• trembly
• confusion
Less common side effects
• fever
• rash (for example, red bumps or blisters on the skin or in the mouth, peeling or blistering skin)
• itching and other allergic symptoms (such as swelling of the face, lips and throat)
• worsening of asthma, difficulty breathing or wheezing
• kidney problems including blood in the urine, pain or discomfort when passing urine
• passing less urine than normal
• kidney pain
Rarer side effects
• liver problems, including hepatitis and jaundice (yellowing of the skin and/or whites of the eyes)
• changes in the blood causing bruising
• bleeding or anaemia
• palpitations or other heart conditions
• increased sweating
• difficulties seeing
• ringing in the ears
• swollen hands and feet
Medicines such as Fenopron may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
Fenopron can affect the results of thyroid tests. If you have this test, tell your doctor that you are taking this medicine.
Fenopron may cause your skin to become more sensitive to sunlight. Avoid strong sunlight and sunbeds and use a high factor sun protection cream (spf 25+) until you know how your skin reacts.
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 FENOPRON
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Fenopron after the expiry date that is stated on the bottle and the carton after EXP. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking the tablets, please take any remaining back to the pharmacist for safe disposal. Only keep them if your doctor tells you to. Medicines should not be disposed of via household waste or wastewater. These measures will help to protect the environment.
6. FURTHER INFORMATION What Fenopron contains
- The active substance is fenoprofen calcium (300mg).
- The other ingredients are calcium hydrogen phosphate, maize starch, polacrilin potassium, magnesium stearate and stearic acid. The coating contains hydroxypropylmethyl cellulose, polyethylene glycol 8000 and propylene glycol. The colourings are Sunset yellow E110 and Titanium dioxide E171. What Fenopron looks like and contents of the pack
Fenopron 300 are orange tablets marked with 4019 and come in snap-on capped bottles containing 100 tablets.
Marketing Authorisation Holder:
Typharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH Manufacturer:
Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR Date of leaflet preparation: December 2011