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ARTHROTEC 75

Active substance(s): DICLOFENAC SODIUM / MISOPROSTOL

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PATIENT INFORMATION LEAFLET

Arthrotec
75
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.

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 NonSteroidal 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, ministroke (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.

• 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.

Taking other medicines

Important information about some
ingredients of Arthrotec

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)

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.

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.
Find more about ARTHROTEC on the back of this leaflet

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.
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.

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

The active substances are diclofenac sodium and
misoprostol.
One tablet contains 75 mg diclofenac sodium and 0.2 mg
misoprostol.
The other ingredients are:
Lactose monohydrate, microcrystalline cellulose, maize
starch, povidone K-30, magnesium stearate, methylacrylic
acid, sodium hydroxide, talc, triethyl citrate, hypromellose,
crospovidone, colloidal silicon dioxide and hydrogenated
castor oil.

What Arthrotec 75 looks like and contents
of the pack

Arthrotec 75 is available as white, round, biconvex tablets,
marked with 4 ‘A’s around ‘75’ on one side, and
‘SEARLE’ on ‘1421’ on the other side.
The tablets are packed in blister strips and supplied in
boxes of 10, 20, 30, 60, 90, 100 and 140 tablets.
Not all pack sizes may be marketed.

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 02/2015.
Ref: AE 14_2
20141112a

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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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