AXORID 100 MG/20 MG MODIFIED-RELEASE CAPSULES

Active substance: OMEPRAZOLE

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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 get serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Axorid is and what it is used for
2. Before you take Axorid
3. How to take Axorid
4. Possible side effects
5. How to store Axorid
6. Further Information
1. WHAT AXORID IS AND WHAT IT IS USED FOR
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 any bleeding in your brain,
• if you have an active peptic ulcer,
• if you have or have a history of bleeding, ulceration or
perforation of your stomach,
• if you are under 15 years old.
Take special care with Axorid
Tell your doctor before taking this medicine if you:
• have asthma or a history of asthma – this medicine
may cause an asthma attack
• have previously had a severe skin reaction caused by
sunlight ,
• have a history of Crohn’s disease or “ulcerative colitis” (Your doctor will have told you),
• have liver, kidney or heart disease,
• are pregnant or are trying to get pregnant.
Medicines such as ketoprofen 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.

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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.
If you are taking this medicine for a long period of time,
your doctor may need to do blood tests e.g. kidney and
liver function tests, and blood counts.
Your doctor may also check your hearing and eyesight.
If you have any sign of bleeding in the stomach or intestine (gut), stop taking the capsules and tell your doctor
immediately.
Taking other medicines
Do not take Axorid if you are taking the following medicines:
• atazanavir (anti-HIV medicine)
• a herbal remedy called St John’s wort
• an antibiotic called clarithromycin if you have liver
problems
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Tell your doctor before taking Axorid if you are being
treated with any of the following:
• aspirin or other non steroidal anti inflammatory agents
(for treating pain and inflammation),
• medicines used to reduce clotting of the blood
(called thrombolytics, anticoagulants and anti-platelet
agents) e.g. clopidogrel,
• corticosteroid anti-inflammatory medicines (to reduce
inflammation),
• phenytoin (used to treat epilepsy),
• methotrexate (used to treat cancer),
• lithium or medicines called “selective serotonin
reuptake inhibitors” (SSRIs), which are used to treat
some psychiatric disorders,

Taking Axorid with food and drink
The capsules should always be swallowed whole with
a glass of water. They should also be taken with food
e.g. at meal times
Pregnancy
Your doctor may prescribe this medicine for you during
the first 6 months of your pregnancy, when strictly
necessary.
From the 7th month of pregnancy, you must not
under any circumstances take this medicine on your
own initiative, as it may have serious consequences
for your child’s health, particularly for the child’s heart,
lungs and kidneys, even after only one dose.
Nevertheless, your gynaecologist might prescribe this
medicine for you in certain very special cases. If
this happens, you should follow strictly your doctor’s
prescription.
Ask your doctor or pharmacist for advice before taking
any medicine.
Breast-feeding
This medicine passes into breast milk. You should
therefore avoid taking the capsules if you are breastfeeding a baby.
Fertility
Ketoprofen may impair fertility and is not recommended
in women attempting to conceive.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
This medicine may cause sleepiness/ drowsiness, dizziness and visual disturbances.
If you are affected, you should not drive or operate
machinery.
Important information about some of the ingredients
of Axorid
This medicine contains, sucrose, propyl-p-hydroxybenzoate (E216) and methyl-p-hydroxy benzoate (E218)
(parahydroxybenzoates)
• If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine,
• Parahydroxybenzoates may cause allergic reactions
(possibly delayed).
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.
If you take more Axorid than you should
Contact your doctor or pharmacist immediately.
If you forget to take Axorid
Take it as soon as you remember. However, if it is
almost time for your next dose, do not take a double
dose to make up for forgotten individual doses, just take
the next dose on time.
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

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modified-release capsules
Ketoprofen / Omeprazole

• medicines to treat high blood pressure (called diuretics, ACE inhibitors and beta-blockers)
• zidovudine (used to treat HIV infection),
• ciclosporine and tacrolimus (used after an organ transplant to prevent rejection),
• an intrauterine contraceptive device (“coil”),
• medicines to treat depression and/or sleeping disorders (e.g. diazepam, triazolam, flurazepam, antidepressants and barbiturates),
• disulfiram (used to treat chronic alcoholism),
• digoxin (used to treat heart disorders),
• ketoconazole and itraconazole (used to treat fungal
infections),
• vitamin B12 (taken by mouth) for treating vitamin B12
deficiency.

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Axorid 100 mg/20 mg,
Axorid 150 mg/20 mg,
Axorid 200 mg/20 mg,

• Gastrointestinal effects including: blood in stools,
vomiting blood, nausea, vomiting, diarrhoea,
constipation, flatulence (wind), dyspepsia, abdominal
pain, gastrointestinal discomfort and pain, ulcerative
stomatitis (inflammation of the oral mucosa with
ulcers on the cheeks, tongue, and lips), worsening
of colitis and Crohn’s disease

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

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
• Gastritis (inflammation of the stomach)

Keep out of the reach and sight of children.

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
Frequency not known
If you are on [Tradename] for more than three months,
it is possible that the levels of magnesium in your blood
may fall. Low levels of magnesium can cause fatigue,
involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any
of these symptoms, please tell your doctor promptly.
Low levels of magnesium can also lead to a reduction
in potassium or calcium levels in the blood. Your doctor
may decide to perform regular blood tests to monitor
your levels of magnesium.
Medicines including Ketoprofen may be associated
with a small increased risk of heart attack (“myocardial
infarction”) or stroke.

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 100 mg/20 mg modified release capsule contains 100 mg of ketoprofen and 20 mg of omeprazole.
Each 150 mg/20 mg modified release capsule contains 150 mg of ketoprofen and 20 mg of omeprazole.
Each 200 mg/20 mg modified release capsule contains 200 mg of ketoprofen and 20 mg of omeprazole.
• The other ingredients are:
Capsule contents:
sucrose, maize starch, hypromellose, dimethicone
emulsion (containing propyl-p-hydroxybenzoate
(E 216), methyl-p-hydroxybenzoate (E 218), 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 100 mg/20 mg: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin,
– Axorid 150 mg/20 mg: black iron oxide (E 172), titanium dioxide (E 171), gelatin,
– Axorid 200 mg/20 mg: titanium dioxide (E 171), gelatin.
What Axorid looks like and content of the packs
Axorid comes in three strengths containing 100 mg/
20 mg, 150 mg/20 mg and 200 mg/20 mg of Ketoprofen/
Omeprazole. Each strength of capsule is a different
colour:
• 100 mg/20 mg capsules have yellow caps and white
bodies;
• 150 mg/20 mg capsules have grey caps and white
bodies;
• 200 mg/20 mg capsules have white caps and bodies.
Axorid comes in a bottle containing 10, 28 and 30
capsules.
Marketing Authorisation Holder:
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road,
Takeley, Bishop‘s Stortford, CM22 6PU
Manufacturer:
Meda Pharma GmbH & Co. KG
Benzstrasse 1,
D-61352 Bad Homburg (Germany)
Tel: + 49 (0) 6172 888 – 01
Fax: + 49 (0) 6172 888 – 2740
This leaflet was last approved in 08/2012

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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 or perforation (sometimes
fatal), particularly in the elderly
• Kidney or liver problems
• Worsening of chronic urticaria (hives).

5. HOW TO STORE Axorid

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Taking a proton pump inhibitor like that included in
Axorid, especially over a period of more than one year,
may slightly increase your risk of fracture of the hip,
wrist or spine. Tell your doctor if you have osteoporosis
or if you are taking corticosteroids (which can increase
the risk of osteoporosis).

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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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