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ARTHROTEC 50MG TABLETS

Active substance(s): DICLOFENAC SODIUM / MISOPROSTOL

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PATIENT INFORMATION LEAFLET

®

Arthrotec 50
modified-release tablets
(diclofenac sodium, misoprostol)

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.
The name of your medicine is Arthrotec 50 modified-release
tablets but will be referred to as Arthrotec throughout this
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.

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.

Pregnancy and breast-feeding

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.

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.

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

Ask your doctor or pharmacist for advice before taking any
medicine.

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.

Driving and using machines

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 anti-inflammatory medicines)
Medicines for high blood pressure (anti-hypertensives)
Magnesium containing antacids (used to treat heartburn,
indigestion)

Do not use Arthrotec while you are breast-feeding.

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 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.
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.
Find more about ARTHROTEC on the back of this leaflet

If you forget to take Arthrotec

Very common side effects

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.

(affecting more than 1 in every 10):
Stomach ache, diarrhoea, nausea (feeling sick),
indigestion

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.

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.

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 heart-beat)
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 lifethreatening 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.
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.

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 25ºC.
Store in original pack.
Do not use Arthrotec after the expiry date stated on the blister
and 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 Arthrotec 50 contains
Each Arthrotec 50mg tablet contains:
50 milligrams diclofenac sodium and 200 micrograms
misoprostol (these are the active ingredients); and
lactose, microcrystalline cellulose, maize starch, povidone
K-30, cellulose acetate phthalate, diethyl phthalate,
hypromellose, crospovidone, magnesium stearate,
hydrogenated castor oil and colloidal anhydrous silica
(inactive ingredients).

What Arthrotec looks like and contents of the
pack
Arthrotec 50 is available as white, round, biconvex tablets,
marked ‘AAAA’ on one side, and ‘SEARLE 1411’ on the other
side.
Arthrotec 50mg Tablets are packed in blister strips and
supplied in boxes of 30 tablets.
Manufactured by: Searle Industrie, Evreux, France.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK
®

Arthrotec 50 modified-release tablets
PL 18799/ 0460
Leaflet date: 14.09.2015

POM

Arthrotec is a registered trademark of Pfizer group.

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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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