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ARTHROTEC 75 MODIFIED-RELEASE TABLETS

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

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To move the position of the sub-heading for uncommon side effects in section 4.
Package leaflet: Information for the patient



Arthrotec® 75
modified-release tablets



(diclofenac sodium and 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.
The name of your medicine is Arthrotec 75 modified-release
tablets but will be referred to as Arthrotec throughout this
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 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. 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, ministroke (TIA) or blockages to blood vessels to the heart or
brain or an operation to clear or bypass blockages

Previously assessed against UK PIL dated March 2017

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.












Mock-up

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.

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

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.

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.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

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)

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









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.






3. How to take Arthrotec

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.

By Aneela Mahmood at 1:48 pm, Sep 01, 2017

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 lifethreatening 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 anyside 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. Store in
the original package.
Do not take the tablets after the expiry date which is
stated on the carton and blister labels after ‘Exp’. The
expiry date refers to the last day of that month.
If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
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. Contents of the pack and other
information
What Arthrotec contains
The active substances in Arthrotec are diclofenac sodium
and misoprostol.
Each tablet contains 75mg diclofenac sodium and 0.2mg
misoprostol.
The other ingredients are lactose, microcrystalline cellulose,
maize starch, povidone K-30, methacrylic acid, sodium
hydroxide, talc, triethyl citrate, hypromellose, crospovidone,
magnesium stearate, hydrogenated castor oil and colloidal
anhydrous silica (these are known as inactive ingredients).
What Arthrotec looks like and contents
Arthrotec is available as white, round, biconvex tablet,
marked ‘AAAA75’ on one side, and ‘Searle 1421’ on the
other side.
The tablets are packed in blister strips and supplied in boxes
of 30 tablets.
Manufactured by: Piramal Healthcare UK Limited, Morpeth,
Northumberland, NE61 3YA, UK.
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® 75 modified-release tablets, PL 18799/0206
Leaflet date: 22.08.2017

POM

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

Expand Transcript

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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