Randelhoff Design SPECIFICATION BOX PATIENT INFO
COUNTRY	United Kingdom	COMPONENT SIZE	148 x 400 mm	FONTS USED
PRODUCT	Axorid 100/20, 150/20, 200/20 mg	LAETUS CODE	785	Helvetica Neue LT 55 Roman Helvetica Neue LT 56 Italic Helvetica Neue LT 75 Bold
PACK SIZE	10, 28, 30 Caps.	EAN/ PRODUCTION CODE
MAT.-NR. mfs.	XXXXXX	VIEW BRAND
MAT.-NR. MEDA	56UK1944130-03-R	FONT SIZE	7pt minimum
ARTWORK STUDIO	Randelhoff Design	COLORS USED 1 Black
ORIGINAL FILE	Adobe InDesign CS6
ARTWORK CONNECTIONS / CHANGES (DATE)	1.    AK 28.09.2015 2.    AK 09.11.2015 3.    AK 10.11.2015
MEDA APPROVAL-PDF (date):		PRINT-FILES SENT OUT (DATE):		COMMENTS: PM

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

modified-release capsules

Ketoprofen / Omeprazole MGDQ

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.

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,

•    if you have ever had a skin reaction after treatment with a medicine similar to Axorid that reduces stomach acid.

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Axorid. Remember to also mention any other ill-effects like pain in your joints.

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.

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,

•    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.

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-hydroxyben-zoate (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

•    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

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)

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).

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).

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

•    rash, possibly with pain in the joints

If you are on Axorid 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.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

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 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, octylphen-oxy polyethoxy ethanol and propylene glycol), poly-sorbate 80, mannitol, diacetylated monoglycerides, talc, Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 %, polyacrylate dispersion 30 %, ammonio methacrylate copolymer type A, ammo-nio 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 {MM/YYYY}.

56UK1944130-03-R

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