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MASIDEMEN 50MG/200MICROGRAM MODIFIED-RELEASE TABLETS

Active substance(s): DICLOFENAC SODIUM / MISOPROSTOL

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Package leaflet: Information for the user

Masidemen 50mg/200microgram
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 What Masidemen is and what it is used for
2 What you need to know before you take
Masidemen
3 How to take Masidemen
4 Possible side effects
5 How to store Masidemen
6 Contents of the pack and other information
1 What Masidemen is and what it is used for
Masidemen 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.
Masidemen 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. Masidemen 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

Masidemen

Do not take Masidemen if you:

• a
 re 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 Masidemen
• are allergic to diclofenac sodium/misoprostol or any of
the other ingredients of this medicine (listed in
section 6)
• 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
• 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)
• have had bleeding from your stomach or intestines after
taking diclofenac or other NSAIDs
• 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.

Warnings and precautions

Make sure your doctor knows, before you are given
diclofenac if you:
• smoke
• have diabetes
• have angina, blood clots, high blood pressure, raised
cholesterol or raised triglycerides
• h
 ave other health problems such as a disease of the liver
or kidneys. Do not take Masidemen if you have severe
kidney or liver failure
• previously had an ulcer or bleeding in your stomach or
intestines. Do not take Masidemen 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 Masidemen may mask a fever or
other signs of infection

• a re dehydrated
• are over the age of 65 as your doctor may want to keep a
regular check on you.
NSAID medicines such as Masidemen can cause bleeding or
ulceration. If this occurs, treatment should be stopped.
Medicines such as Masidemen are linked to an increased
risk of heart attack (myocardial infarction) or stroke. Side
effects may be minimised by using the lowest effective
dose for the shortest duration necessary. Do not exceed the
recommended dose or duration of treatment.
As with other NSAIDs (e.g. ibuprofen) Masidemen 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 Masidemen

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.
• 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)
• 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.
Masidemen should not be taken within 8-12 days of
taking mifepristone.

Pregnancy and breast-feeding

Do not use Masidemen if you are pregnant or trying to
become pregnant. Women who have not reached the
menopause should use reliable contraception while they
are taking Masidemen.
Do not use Masidemen while you are breast-feeding.

Driving and using machines

If you feel dizzy or drowsy after taking Masidemen, do not
drive and do not use any tools or machines until these
effects have worn off.

Masidemen contains lactose

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking Masidemen.

3 How to take Masidemen
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 Masidemen
50mg/200microgram tablet taken two to three times a day.
Masidemen should be swallowed whole with a drink of
water (not chewed), taken during or after mealtimes.

Elderly and patients with liver or kidney disorders:
The doctor may want to monitor these patients more
closely. No change in dose is needed.

Use in children and adolescents
Children:

Masidemen is for adults only. It is not for use in children and
adolescents (under 18 years).

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Diclofenac Misoprostol 50mg/200mcg tablet leaflet - UK

colours/plates:
1. Black

item no:

AAAG4136

dimensions:

print proof no:

5

pharmacode:

origination date: 03.01.14
approved for print/date

min pt size:

190 x 450

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9, 10, 11

5.
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originated by:

jh

revision date:

03.02.14

Technical Approval

revised by:

jh

date sent:

supplier:

Cipla

technically app. date: 07.01.14

03.01.14

Non Printing Colours
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If you take more Masidemen 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 Masidemen

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 Masidemen

Do not stop taking Masidemen 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 Masidemen does have a side effect.
Masidemen sometimes causes side effects but these usually
go away during treatment as your body gets used to the
medicine.

Stop taking Masidemen and tell your doctor
immediately if you experience any of the
following symptoms:

• V
 omiting 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, clotting in
the amniotic fluid (fluid covering the foetus), bleeding in
the womb, miscarriage, death of the unborn baby, birth
defects, premature birth
• Low blood pressure, high blood pressure
• Reduction in the number of white blood cells (these
help protect the body from infection and disease)
• Anaemia (low number of red blood cells) which can lead
to pale skin and cause weakness or breathlessness.
Medicines such as Masidemen may be associated with a
small increased risk of heart attack or stroke.

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, Website: www.mhra.gov.uk/
yellowcard. By reporting side effects, you can help provide
more information on the safety of this medicine.

• s evere stomach pain or any sign of bleeding or rupture
in the stomach or intestines, such as passing black or
blood stained 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.

5 How to store Masidemen

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.

6 Contents of the pack and other information

Very common side effects (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
Masidemen 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 (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.
Uncommon side effects (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).
Rare side effects (may affect up to 1 in 1,000 people):
• Inflammation of the liver (possible yellow discoloration
of skin, headache, fever, chills, general weakness).
Very rare side effects (may affect up to 1 in 10,000 people)
• Severe liver disorders including liver failure.
Additional side effects experienced in actual use (postmarketing experience, frequency cannot be estimated from
the available data):
• 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

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is
stated on the blister and carton after EXP. 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.

What Masidemen contains

• T he active substances are diclofenac sodium and
misoprostol.
Each Masidemen 50mg/200microgram modifiedrelease tablet contains 50mg diclofenac sodium and
200microgram misoprostol.
• T he other ingredients are:
Core tablet: microcrystalline cellulose (E460), lactose
monohydrate, maize starch, povidone K30, magnesium
stearate (E470b), purified talc (E553b)
Tablet coating: hydroxypropylmethylcellulose type 2910
(E464), methacrylic acid-ethyl acrylate copolymer (1:1),
purified talc (E553b), triethyl citrate (E1505), sodium
starch glycolate and hydrogenated castor oil.

What Masidemen looks like and contents of the
pack

The tablets are white, circular, biconvex and uncoated, plain
on one side and embossed “DM2” on the other side.
The tablets are packed in blisters and supplied in cartons of
60 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel Str 10 und Mittelstr.15,
40789 Monheim am Rhein,
North Rhine Westphalia
Germany
This leaflet was last revised in February 2014

If you would like a
leaflet with larger text,
please contact
01271 385257.

Continued top of next column
AAAG4136

Actavis, Barnstaple, EX32 8NS, UK

Diclofenac Misoprostol 50mg/200mcg tablet leaflet - UK

colours/plates:
1. Black

item no:

AAAG4136

dimensions:

print proof no:

5

pharmacode:

origination date: 03.01.14
approved for print/date

min pt size:

190 x 450

2.
3.
4.

9, 10, 11

5.
6.

originated by:

jh

revision date:

03.02.14

Technical Approval

revised by:

jh

date sent:

supplier:

Cipla

technically app. date: 07.01.14

03.01.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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