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ARTHROTEC 50 TABLETS

Active substance(s): DICLOFENAC SODIUM / MISOPROSTOL

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PATIENT INFORMATION LEAFLET
®

ARTHROTEC 50 TABLETS

Revision date: 11.09.2015
Leaflet Reference: ART50/UT

(diclofenac sodium / misoprostol)
Your medicine is known by the above name, but will be referred to as
Arthrotec ® throughout this leaflet.

 If you have angina, blood clots, high blood pressure, raised cholesterol
or raised triglycerides

Read all of this leaflet carefully before you start taking this medicine

Check with your doctor if any of the following applies to you:

 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.

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.

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

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.

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.

Side effects may be minimised by using the lowest effective dose for the
shortest duration necessary.

®

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

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:

®

Do not take Arthrotec®

 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® should not be taken
within 8-12 days of taking mifepristone.

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

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Pregnancy and breast-feeding

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.

®

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®.

 Very common side effects
(affecting more than 1 in every 10):

Do not use Arthrotec® while you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

 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.

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®

Your pharmacist can help you choose a suitable antacid. If this diarrhoea
continues and is severe tell your doctor.

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

 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

®

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 two or three times a day, or as directed by your doctor.
®

Arthrotec should be swallowed whole with a drink of water (not chewed),
taken during or after mealtimes.

 Uncommon side effects
(affecting less than 1 person in every 100, but more than 1 in every
1000):

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).

 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)

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.

 Rare side effect
(affecting less than 1 person in every 1,000, but more than 1 in every
10,000):

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.

 Inflammation of the liver (possible yellow discoloration of skin,
headache, fever, chills, general weakness)

If you stop taking Arthrotec®
Do not stop taking Arthrotec® unless your doctor tells you to. If you have
any questions on the use of this product ask your doctor or pharmacist.

 Very rare side effects
(affecting less than 1 person in every 10,000 patients):

4. POSSIBLE SIDE EFFECTS

 Severe liver disorders including liver failure
 Additional side effects experienced in actual use
(post-marketing experience, frequency unknown):

Like all medicines, Arthrotec® can have side effects, although not
everybody gets them.

 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

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








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®
 Keep out of the sight and reach of children.
 Do not store above 25C. Store in a dry place, in the original container.
 Do not use this medicine after the expiry date (This is printed on both
the carton and foil). The expiry date refers to the last day of that month.
 If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine,
if your doctor tells you to.
 If your tablets show signs of deterioration or discolouration, you should
seek the advice of your pharmacist who will tell you what to do.
 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

If you forget to take Arthrotec®



 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.

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 flulike symptoms. Immediately contact your doctor if any of these
symptoms develop - the frequency is unknown

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What Arthrotec® contains
Each gastro-resistant tablet contains 50 milligrams of diclofenac sodium
and 200 micrograms of misoprostol as the active ingredients.
The tablets also contain lactose, microcrystalline cellulose, maize starch,
povidone, magnesium stearate, diethyl phthalate, cellulose acetate
phthalate, hydrogenated castor oil, crospovidone, colloidal anhydrous
silica, and hypromellose.
What Arthrotec® looks like and contents of the pack
Each white round, gastro-resistant biconvex tablet is marked with four ‘A’s
engraved on one side and ‘Searle 1411’ on the other.
Arthrotec ® is available as blister packs of 40 tablets.
Who manufactured your medicine
Manufactured by Pharmacia Limited, Whalton Road, Morpeth,
Northumberland, NE61 3YA UK. Procured from within the EU and
repackaged by the Product Licence Holder: Beachcourse Limited, 20
Alliance Court, Alliance Road, London W3 ORB.
PL

16378/ 0219

POM

Revision date: 10.09.2015
Leaflet Reference: ART50/UT
Arthrotec ® is a registered trademark.

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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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