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ARTHROTEC 75 TABLETS
Active substance(s): DICLOFENAC SODIUM / MISOPROSTOL
(diclofenac sodium/ misoprostol)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
Your medicine is available using the above name but will be referred to as
Arthrotec throughout the leaflet.
What is in this leaflet
1. What Arthrotec is and what it is used for
2. What you need to know before you take Arthrotec
3. How to take Arthrotec
4. Possible side effects
5. How to store Arthrotec
6. Contents of the pack and other 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
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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARTHROTEC
Do not take Arthrotec
- 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 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)
- 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
- 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.
Warnings and precautions
Talk to your doctor before taking Arthrotec
- 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
- 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
- are dehydrated
- are over the age of 65 as your doctor will want to monitor you regularly.
NSAID medicines such as Arthrotec can cause bleeding or ulceration. If this
occurs, treatment should be stopped.
Use of Arthrotec with another NSAID other than aspirin (e.g. ibuprofen) may
also increase frequency of ulcers or bleeding in your stomach or intestines.
Arthrotec may cause serious side effects, especially stomach and intestinal
complications, if you are using a corticosteroid (e.g. prednisone), an oral
anticoagulant, or a Selective Serotonin Re-uptake Inhibitor (e.g. sertaline) or
if you drink alcohol.
Make sure your doctor knows, before you are given Arthrotec
- have diabetes
- have angina, blood clots, high blood pressure, raised cholesterol or raised
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
Other medicines and Arthrotec
Some medicines can affect the way other medicines work.
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including:
- 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
- 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, e.g. aspirin)
- Medicines used to treat anxiety and depression known as Selective
Serotonin Re-uptake Inhibitors (SSRIs)
- Medicines used to control your blood sugar (oral hypoglycaemics for
- 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, fluconazole, miconazole and voriconazole (used to treat
some fungal infections)
- Amiodarone (used to treat an abnormal heart beat)
- Sulfinpyrazole (used to treat gout)
- If you have taken a medicine called mifepristone (used to terminate
pregnancy) within the last 12 days. Arthrotec should not be taken within 812 days of taking mifepristone.
Pregnancy, breast-feeding and fertility
Do not use if you are pregnant, think you may be pregnant or trying to
become pregnant. You should tell your doctor if you are planning to become
pregnant. Ask your doctor or pharmacist for advice before taking this
medicine if you are breast-feeding. Women who have not reached the
menopause should use reliable contraception while they are taking
Do not use Arthrotec while you are breast-feeding.
Ask your doctor or pharmacist for advice before taking this 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.
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
3. HOW TO TAKE ARTHROTEC
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is 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.
Use in 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 a forgotten dose.
If you stop taking Arthrotec
Do not stop taking Arthrotec unless your doctor tells you to. If you have any
further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause 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
If you have
- Weakness of or inability to move one side of body, slurred speech (stroke)
or chest pain (heart attack) – the occurrence is uncommon
- Shortness of breath – the occurrence is uncommon
- 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
- Heart failure, chest pain, palpitations (awareness of your heartbeat) – 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
- 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 - it is
not known how often this occurs
- Reduction in the number of blood platelets (increased chance of bleeding
or bruising) – it is not known how often this occurs
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
- Very common: may affect more than 1 in 10 people
- 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: may affect up to 1 in 10 people
- Rash, itching
- Vomiting, wind, constipation, burping, gastritis (indigestion, stomach
- Ulcers in the stomach or intestines
- Headache, dizziness
- Difficulty sleeping
- Changes in blood tests relating to the liver
- Inflammation of the digestive tract, including the intestines, such as
nausea, diarrhoea, abdominal pain
- Uncommon: may affect up to 1 in 100 people
- Swelling of the mouth
- Abnormal or unexpected bleeding from the vagina, menstrual
- Reduction in the number of blood platelets (increased chance of
bleeding or bruising)
- Purpura (purple spots on the skin)
- Urticaria (raised itchy rash)
- Infection of the vagina (itching, burning, soreness, pain especially during
intercourse and/or urination)
- Blurred vision
- High blood pressure
- Menstrual disorders such as usually heavy or light bleeding, or delayed
- Chills or fever
- Rare: may affect up to 1 in 1,000 people
- Inflammation of the liver (possible yellow discoloration of skin,
headache, fever, chills, general weakness)
- Inflammation of the pancreas, which causes severe pain in the
abdomen and back
- Inflammation of the lung such as coughing, increased sputum
- Breast pain
- Birth defects
- Very rare: may affect up to 1 in 10,000 people
- Severe liver disorders including liver failure
- Not known: frequency cannot be estimated from the available data
- Damage to the gullet
- Worsening of ulcerative colitis or Crohn’s disease (inflammation of the
- Kidney or liver problems
- 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
- Swelling of the tongue, mouth ulcers, dry mouth
- Depression, feeling anxious, mood swings, irritability, memory
problems, feeling confused, feeling shaky, drowsiness, tiredness
- Difficulty seeing, ringing in the ears, changes in the way things taste
- Increased sensitivity to light
- 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 fetal
material into the maternal blood stream, bleeding in the womb,
miscarriage, death of the unborn baby, premature birth
- Low blood pressure
- Anaemia (low number of red blood cells) which can lead to pale skin
and cause weakness or breathlessness
- Painful menstrual/period cramps
- Decreased fertility in females
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 or search for MHRA Yellow Card in the
Google Play or Apple App Store. 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
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. CONTENTS OF THE PACK AND OTHER 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
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
Arthrotec 75 Tablets – PL 15361/0557
Leaflet revision and issue date (Ref.) 19.10.17
Arthrotec® is a trademark of G. D. Searle LLC
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