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ARTHROTEC 75 TABLETS

Active substance(s): DICLOFENAC SODIUM / MISOPROSTOL

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Arthrotec® 75 Tablets

0557
20.08.15[12]

(diclofenac sodium/ misoprostol)
PATIENT INFORMATION LEAFLET
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, please 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.
Your medicine is available using the above name but will be referred to as
Arthrotec throughout the leaflet.
In this leaflet:
1. What Arthrotec is and what it is used for
2. Before you take Arthrotec
3. How to take Arthrotec
4. Possible side effects
5. How to store Arthrotec
6. Further information
1. WHAT ARTHROTEC IS AND WHAT IT IS USED FOR
Arthrotec helps to relieve the pain and swelling of rheumatoid arthritis and
osteoarthritis, and may help to protect patients at risk of irritation or
ulceration of the stomach or intestines.
Arthrotec contains diclofenac and misoprostol. Diclofenac belongs to a
group of medicinal products called Non-Steroidal Anti-Inflammatory drugs
(NSAIDs).
Although NSAIDs relieve the pain, they can reduce the amount of natural
protective substances called prostaglandins in the stomach lining.
This means that NSAIDs can lead to stomach upsets or stomach ulcers.
Arthrotec also contains misoprostol which is very similar to these
prostaglandins and may help protect your stomach.
2. BEFORE YOU TAKE ARTHROTEC
Do not take Arthrotec
If you:
- have had an allergic reaction such as a skin rash, swelling or itchiness of
the skin, severe nasal congestion, asthma or wheezing after taking
diclofenac or other NSAIDs such as aspirin (acetylsalicylic acid),
misoprostol or another prostaglandin medicine, or any of the other
ingredients in Arthrotec (see Further Information section 6)
- currently have an ulcer or perforation (hole) in your stomach or intestines
- currently suffer from bleeding in your stomach, intestines or brain
- are undergoing or you have just had coronary artery bypass graft (CABG)
surgery
- have severe kidney or liver failure
- have established heart disease and/or cerebrovascular disease e.g. if
you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
- have or have had problems with your blood circulation (peripheral arterial
disease)
- are pregnant, or trying to become pregnant, because it may cause a
miscarriage. Women who have not reached the menopause should use
reliable contraception while they are taking Arthrotec.
Take special care with Arthrotec
Make sure your doctor knows, before you are given Arthrotec
- If you smoke
- If you have diabetes
- If you have angina, blood clots, high blood pressure, raised cholesterol or
raised triglycerides
Check with your doctor if any of the following applies to you:
If you:
- have other health problems such as a disease of the liver or kidneys. Do
not take Arthrotec if you have severe kidney or liver failure
- previously had an ulcer or bleeding in your stomach or intestines. Do not
take Arthrotec if you currently have an ulcer or bleeding in your stomach
or intestines
- bleed or bruise easily
- have inflammation of the intestines (ulcerative colitis or Crohn’s disease)
- have, or have ever had asthma or an allergic disease
- have an infection, as Arthrotec may mask a fever or other signs of
infection
- are dehydrated
- are over the age of 65 as your doctor may want to keep a regular check
on you.

NSAID medicines such as Arthrotec can cause bleeding or ulceration. If
this occurs, treatment should be stopped.
Medicines such as Arthrotec 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.
Side effects may be minimised by using the lowest effective dose for the
shortest duration necessary.
As with other NSAIDs (e.g. ibuprofen) Arthrotec may lead to an increase in
blood pressure, and so your doctor may ask to monitor your blood pressure
on a regular basis.
If you have heart, liver or kidney problems, your doctor will want to monitor
you regularly.
Taking other medicines
Some medicines can affect the way other medicines work.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription:
- Aspirin (acetylsalicylic acid) or other NSAIDs (e.g. ibuprofen)
- Medicines used to treat osteoarthritis or rheumatoid arthritis known as
cyclo-oxygenase-2 (COX-2) inhibitors
- Diuretics (used to treat excess fluid in the body)
- Ciclosporin or tacrolimus (used for immune system suppression e.g. after
transplants)
- Lithium (used to treat some types of depression)
- Digoxin (a medicine for an irregular heart beat and/or heart failure)
- Warfarin or other oral anticoagulants (blood-thinning agents that reduce
blood clotting)
- Medicines used to treat anxiety and depression known as Serotonin
Selective Re-uptake Inhibitors (SSRIs)
- Medicines used to control your blood sugar (oral hypoglycaemics for
diabetes)
- Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
- Steroid medications (e.g. corticosteroids, which are often used as antiinflammatory medicines)
- Medicines for high blood pressure (anti-hypertensives)
- Magnesium containing antacids (used to treat heartburn, indigestion)
- Quinolone antibiotics (used to treat some infections)
- Ketoconazole (used to treat some fungal infections)
- If you have taken a medicine called mifepristone (used to terminate
pregnancy) within the last 12 days. Arthrotec 75 should not be taken
within 8-12 days of taking mifepristone.
Pregnancy and breast-feeding
Do not use Arthrotec if you are pregnant or trying to become pregnant.
Women who have not reached the menopause should use reliable
contraception while they are taking Arthrotec.
Do not use Arthrotec while you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy or drowsy after taking Arthrotec, do not drive and do not
use any tools or machines until these effects have worn off.
Important information about some ingredients of Arthrotec
Lactose or Sugar intolerance
Arthrotec contains lactose (a type of sugar). If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking Arthrotec.
3. HOW TO TAKE ARTHROTEC
Always take Arthrotec exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Take one tablet twice a day.
Arthrotec should be swallowed whole with a drink of water (not chewed),
taken during or after mealtimes.
In the elderly and patients with liver or kidney disorders, your doctor
may want to monitor you more closely. No change in dose is needed.
Children: Arthrotec is for adults only, it is not for use in children (under 18
years).
If you take more Arthrotec than you should
You should not take more tablets than your doctor tells you to. If you take
too many tablets contact your doctor, pharmacist or hospital as soon as
possible, and take your medicine with you.
If you forget to take Arthrotec
If you forget to take a tablet, take it as soon as you remember. Do not take
a double dose to make up for forgotten doses.

If you stop taking Arthrotec
Do not stop taking Arthrotec 75 unless your doctor tells you to. If you have
any questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Arthrotec can have side effects, although not everybody
gets them.
If you are worried about side effects, ask your doctor. It is important that
you know what can happen, so that you can take action if Arthrotec does
have a side effect. Arthrotec sometimes causes side effects but these
usually go away during treatment as your body gets used to the medicine.
If any of the following happen, stop taking Arthrotec and tell your
doctor immediately:
If you have
- severe stomach pain or any sign of bleeding or rupture in the
stomach or intestines, such as passing black or bloodstained
stools, or vomiting blood – this occurs very rarely
- a serious skin reaction such as rash, blistering or peeling of the
skin (Stevens-Johnson syndrome, exfoliative dermatitis and toxic
epidermal necrolysis) – this occurs very rarely
- a serious allergic reaction such as skin rash, swelling of the face,
wheezing or difficulty breathing (anaphylactic shock) – this occurs
rarely
- jaundice (your skin or the whites of your eyes look yellow) – this
occurs rarely
- Arthrotec can cause a decrease in a type of white blood cell
(these help protect the body from infection and disease) and lead
to infections with symptoms like chills, sudden fever, sore throat,
or flu-like symptoms. Immediately contact your doctor if any of
these symptoms develop - the frequency is unknown

Additionally, if any of the following side effects gets serious, or if you
notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
- Very common side effects
(affecting more than 1 in every 10):
- Stomach ache, diarrhoea, nausea (feeling sick), indigestion
Diarrhoea is the most common problem and is occasionally severe. You
have less chance of getting diarrhoea if you take Arthrotec with food. If you
use an antacid (something to reduce acid in the stomach) you should avoid
antacids with magnesium in them as these may make diarrhoea worse.
Your pharmacist can help you choose a suitable antacid. If this diarrhoea
continues and is severe tell your doctor.
- Common side effects
(affecting less than 1 person in every 10, but more than 1 in every 100):
- Rash, itching
- Vomiting, wind, constipation, burping, gastritis (indigestion, stomach
ache, vomiting)
- Ulcers in the stomach or intestines
- Headache, dizziness
- Difficulty sleeping
- Changes in blood tests relating to the liver
- Uncommon side-effects
(affecting less than 1 person in every 100, but more than 1 in every
1000):
Swelling of the mouth
Abnormal or unexpected bleeding from the vagina, menstrual
disturbances
Reduction in the number of blood platelets (increased chance of
bleeding or bruising)
Purpura (purple spots on the skin)
Urticaria (raised itchy rash)
- Rare side-effects
(affecting less than 1 person in every 1,000, but more than 1 in every
10,000):
- Inflammation of the liver (possible yellow discoloration of skin,
headache, fever, chills, general weakness)
- Very rare side effects
(affecting less than 1 person in every 10,000 patients):
- Severe liver disorders including liver failure

- Additional side effects experienced in actual use
(post-marketing experience, frequency unknown):
- Heart failure, chest pain, palpitations (awareness of your heartbeat)
- Damage to the gullet
- Worsening of ulcerative colitis or Crohn’s disease (inflammation of the
intestines)
- Kidney or liver problems
- Shortness of breath
- Seizures
- Allergic reaction, (including asthma, breathing problems, itching, hair
loss, inflamed blood vessels (can cause fever, aches, purple
blotches))
- Symptoms of meningitis (stiff neck, headache, nausea (feeling sick),
vomiting, fever or loss of consciousness) • Fluid build-up in the body
that can cause swollen ankles and legs
- Vomiting blood
- Psychotic reactions (mental disorder that features loss of contact with
reality)
- Swelling of the tongue, mouth ulcers, dry mouth
- Depression, feeling anxious, mood swings, irritability, memory
problems, feeling confused, feeling shaky, nightmares, drowsiness,
tiredness
- Difficulty seeing, impaired or blurred vision, ringing in the ears,
changes in the way things taste
- Chills, fever, increased sensitivity to light, inflammation
- Loss of appetite
- Abnormal contractions of the womb, rupture in the womb, retained
placenta after giving birth, a life-threatening reaction in the mother due
to the passage of amniotic fluid (fluid covering the fetus) or other
foetal material into the maternal blood stream, bleeding in the womb,
miscarriage, death of the unborn baby, birth defects, premature birth
- Low blood pressure, high blood pressure
- Anaemia (low number of red blood cells) which can lead to pale skin
and cause weakness or breathlessness.
Medicines such as Arthrotec may be associated with a small increased risk
of heart attack or stroke.
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 ARTHROTEC
Do not store above 25oC. Store in a dry place.
Do not take Arthrotec after the expiry date printed on the carton label or
blister strip.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF
CHILDREN.
If your doctor tells you to stop taking this medicine, please take it back to
your pharmacist for safe disposal. Only keep it if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Arthrotec 75 contains
Each Arthrotec 75 tablet contains the active ingredients:
75 milligrams diclofenac sodium and 200 micrograms misoprostol and also
contains inactive ingredients lactose, microcrystalline cellulose, maize
starch, povidone K-30, methylacrylic acid copolymer type C, sodium
hydroxide, triethyl citrate, methylhydroxypropylcellulose, crospovidone,
magnesium stearate, hydrogenated castor oil, colloidal anhydrous silica
and talc.
What Arthrotec 75 looks like and contents of the pack
Arthrotec 75 Tablets are available in blisters strips in packs of 30 or 60
tablets and are presented as white round tablets marked ‘SEARLE 1421’
on one side and a star logo on the reverse.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Arthrotec 75 Tablets are manufactured by Searle Division of Monsanto plc,
Morpeth, Northumberland NE61 3YA. Procured from within the EU and
Repackaged by Product Licence holder P.I.E. Pharma Ltd, 207 Kenton
Road, Harrow, Middlesex HA3 0HD
POM

Arthrotec 75 Tablets – PL 15361/0557

Leaflet revision and issue date (Ref.) 20.08.15[12]
Arthrotec® is a trademark of G. D. Searle LLC

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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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