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ARTHROTEC 50 MODIFIED- RELEASE TABLETS

Active substance(s): DICLOFENAC SODIUM / MISOPROSTOL / DICLOFENAC SODIUM / MISOPROSTOL

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Package leaflet: Information for the patient

Arthrotec 50
®

modified-release tablets
diclofenac sodium, misoprostol
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 as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Arthrotec is and what it is used for
What you need to know before you take Arthrotec
How to take Arthrotec
Possible side effects
How to store Arthrotec
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 AntiInflammatory 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. What you need to know 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 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

Warnings and precautions
Talk to your doctor before taking Arthrotec
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 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
If you:
• smoke
• have diabetes
• have angina, blood clots, high blood pressure, raised cholesterol
or raised triglycerides
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.

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 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, 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 diabetes)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and
leukaemia)

• Steroid medications (e.g. corticosteroids, which are often used as
anti-inflammatory 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 8-12 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 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 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.
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 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 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.
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).
Find more about ARTHROTEC on the back of this leaflet

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 doctor immediately:
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 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 – 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 ache, vomiting)
• 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
disturbances
• 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 periods
• 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
• Nightmares

• 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 intestines)
• Kidney or liver problems
• 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, drowsiness,
tiredness
• Difficulty seeing, ringing in the ears, changes in the way
things taste
• 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 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 or pharmacist. 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.

Do not use this medicine after the expiry date which is stated on
the blister and carton. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other
information
What Arthrotec contains

The active substances are diclofenac sodium and misoprostol.
One tablet contains 50 mg diclofenac sodium and 0.2 mg
misoprostol.
The other ingredients are:
Lactose monohydrate, microcrystalline cellulose, corn starch,
povidone, magnesium stearate, methylacrylic acid copolymer type C,
sodium hydroxide, talc, triethylcitrate, hypromellose, crospovidone,
hydrogenated castor oil and colloidal silicon dioxide.

What Arthrotec looks like and contents of the pack

Arthrotec is available as white, round, biconvex tablets, marked with
four ‘A’s on one side, and ‘Searle 1411’ on the other side.
The tablets are packed in blister strips and supplied in boxes of
60 tablets.

Marketing Authorisation Holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United
Kingdom.

Manufacturer

Piramal Healthcare UK Limited, Morpeth,
Northumberland, NE61 3YA, United Kingdom.

For any information about this medicine, please
contact:

Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey,
KT20 7NS. Tel: 01304 616161.
This leaflet was last revised in 03/2017.
Ref: AE 21_3

5. How to store Arthrotec
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.

20170215L

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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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