Your medicine contains two active ingredients called ketoprofen and omeprazole. Ketoprofen is a non-steroidal anti-inflammatory agent (NSAID) which reduces inflammation. Omeprazole is a « proton pump inhibitor » which reduces the amount of acid produced in your stomach.

Axorid is used in adults and adolescents over the age of 15 years for treating the symptoms of rheumatoid arthritis, a condition called “ankylosing spondylitis” and osteoarthritis.

You will be given this medicine if you need to be treated with an anti-inflammatory medicine and:

• you have a history of stomach or duodenal ulcers,
• you are at risk of developing these types of ulcers

2. BEFORE YOU TAKE Axorid

Do not take Axorid

• if you are allergic to ketoprofen or to omeprazole
• if you are allergic to any of the other ingredients in this medicine (these are listed in section 6, Further Information),
• if you are in the last trimester (from the 7th month) of pregnancy,
• if you have a history of asthma caused by ketoprofen or similar substances, such as aspirin or other nonsteroidal anti-inflammatory medicines (NSAIDs),
• if you have severe liver, kidney or heart disease,
• if you have an active peptic ulcer,
• if you have bleeding in your stomach, intestine (gut) or brain,
• if you are under 15 years old.

3. HOW TO TAKE AXORID

Always take Axorid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The capsules should not be chewed or crushed; they should always be swallowed whole with a glass of water. The capsules should also be taken with food e.g. at meal times.

Your doctor may prescribe:

• One 100 mg/20 mg capsule daily
• One 150 mg/20 mg capsule daily
• One 200 mg/20 mg capsule daily

The dose depends on the severity of your symptoms.

The maximum daily dose is one 200 mg/20 mg capsule.

An initial dose of one 100 mg/20 mg capsule is recommended in elderly patients, and in patients with liver, kidney or heart disorders. The dose may be increased by your doctor up to one 200 mg/20 mg capsule if necessary.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Axorid can cause side effects, although not everybody gets them.

If you experience any of the following side effects, tell your doctor immediately or go to your nearest hospital casualty department.

• Serious allergic reaction which causes difficulty in breathing or dizziness, or swelling of the face or throat
• Blistering of the skin, mouth, eyes and genitals
• Red patches on the back of your hands and arms
• Inflammation of the blood vessels, often with a rash
• An asthma attack (breathing difficulties)
• Fever, severe chills, sore throat, mouth ulcers, bleeding or bruising easily (you may have a blood disorder)
• Blood in your stools

The following side effects have also been reported. If any of these get troublesome or serious, talk to your doctor.

Common side effects

(probably affecting less than 1 in 10 people):

• Sleepiness/ drowsiness
• Trouble sleeping
• Spinning sensation
• Headache
• Gastrointestinal effects included: nausea, vomiting, diarrhoea, constipation, flatulence (wind), abdominal pain, gastrointestinal discomfort and pain

Uncommon side effects

(probably affecting less than 1 in 100 people):

• Visual disturbances (e.g. blurred vision, problems focusing)
• Ringing in the ears (tinnitus) and deafness
• Changes in levels of liver enzymes in your blood
• Taste disorders
• Itching and skin rashes
• Unusual hair loss
• Skin sensitivity to light
• Increased sweating
• Swelling of the ankles, feet or hands
• Mood disorders

Rare side effects

(probably affecting less than 1 in 1,000 people)

• Changes in red blood cells
• Pins and needles
• Light headedness
• Mental confusion and hearing sounds or seeing things that are not real
• Brownish-black discoloration of the tongue whilst also taking clarithromycin (an antibiotic)
• Muscle weakness
• Muscle pain, joint pain
• Heart failure
• High blood pressure
• Gastrointestinal ulcer
• Gastrointestinal bleeding
• Kidney or liver problems
• Worsening of chronic urticaria (hives).

Very rare side effects

(probably affecting less than 1 in 10,000 patients)

• Nettle rash (hives)
• Fever
• Agitation and depression
• Dry mouth or inflammation of the mouth
• Thrush
• Inflammation of the pancreas which causes severe pain in the abdomen and back
• Low blood sodium
• Development of breasts in men

Medicines including Ketoprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Although not known with oral omeprazole, blindness and deafness have been reported with the injectable form.

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 Axorid

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original container in order to protect from moisture.

Do not take your capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Axorid contains

• The active substances are ketoprofen and omeprazole.
  Each 100mg/20mg modified release capsule contains 100 mg of ketoprofen and 20mg of omeprazole.
  Each 150mg/20mg modified release capsule contains 150 mg of ketoprofen and 20mg of omeprazole.
  Each 200mg/20mg modified release capsule contains 200 mg of ketoprofen and 20mg of omeprazole.
• The other ingredients are:
  Capsule contents:
  sucrose, maize starch, hypromellose, dimethicone emulsion (containing propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polysorbate 20, octylphenoxy polyethoxy ethanol and propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc, Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polyacrylate dispersion 30%, ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, triethyl citrate, stearoyl macrogolglycerides, colloidal anhydrous silica,
  Capsule shell:
  
  • Axorid 100mg/20mg: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin,
  • Axorid 150mg/20mg: black iron oxide (E 172), titanium dioxide (E 171), gelatin,
  • Axorid 200mg/20mg: titanium dioxide (E 171), gelatin.