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MISOFEN 50MG/200MICROGRAM MODIFIED RELEASE TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Misofen 50mg/200microgram modified release Tablets
Diclofenac sodium/misoprostol
Read all of this leaflet carefully before you start
Medicines such as Misofen Tablets may be associated
taking this medicine because it contains important
with a small increased risk of heart attack (myocardial
information for you.
infarction) or stroke. Any risk is more likely with high
!
Keep this leaflet. You may need to read it again.
doses and prolonged treatment. Do not exceed the
!
If you have any further questions, ask your doctor or
recommended dose or duration of treatment.
pharmacist.
!
This medicine has been prescribed for you only. Do
As with other NSAIDs (e.g. ibuprofen) Misofen Tablets
not pass it on to others. It may harm them, even if
may lead to an increase in blood pressure, and so your
their signs of illness are the same as yours.
doctor may ask to monitor your blood pressure on a
If you get any side effects, talk to your doctor or
regular basis.
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
If you have heart, liver or kidney problems, your doctor
will want to monitor you regularly.
What is in this leaflet
1. What Misofen Tablets are and what they are used for
Side effects may be minimised by using the lowest
2. What you need to know before you take Misofen
effective dose for the shortest duration necessary.
Tablets
3. How to take Misofen Tablets
Vision disorders: If symptoms of vision disorders occur
4. Possible side effects
during treatment with Misofen Tablets, contact your doctor
5. How to store Misofen Tablets
as an eye examination may be considered to exclude
6. Contents of the pack and other information
other causes.
1. What Misofen Tablets are and what they are used
for
Misofen Tablets help 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.
Misofen Tablets contain 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. Misofen Tablets also contain misoprostol
which is very similar to these prostaglandins and may
help protect your stomach.

Other medicines and Misofen Tablets
Please tell your doctor or pharmacist if you are taking or
have recently taken or might take any other medicines.
This includes medicines that you buy without a
prescription or herbal medicines.

Use in Children and adolescents: Misofen Tablets are
for adults only, they are not for use in children (under 18
years).
If you take more Misofen Tablets 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 Misofen Tablets
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 Misofen Tablets
Do not stop taking Misofen Tablets 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 Misofen Tablets does have a side effect.
Misofen Tablets sometimes cause side effects but these
usually go away during treatment as your body gets used
to the medicine.

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, 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.

If any of the following happen, stop taking Misofen
In particular, tell your doctor or pharmacist if you are
Tablets and tell your doctor immediately:
taking any of the following:
Aspirin (acetylsalicylic acid) or other NSAIDs (e.g.
!
If you have
ibuprofen),
severe stomach pain or any sign of bleeding or
!
Medicines such as Misofen Tablets may be associated
Medicines used to treat osteoarthritis or rheumatoid
!
rupture
in
the
stomach
or
intestines,
such
as
passing
with a small increased risk of heart attack or stroke.
arthritis known as cyclo-oxygenase-2 (COX-2)
black or bloodstained stools, or vomiting blood this
inhibitors,
occurs very rarely,
Reporting of side effects
Diuretics (used to treat excess fluid in the body),
!
a
serious
skin
reaction
such
as
rash,
blistering
or
!
If you get any side effects, talk to your doctor or
Ciclosporin or tacrolimus (used for immune system
!
peeling
of
the
skin
(Stevens-Johnson
syndrome,
pharmacist. This includes any possible side effects not
suppression e.g. after transplants),
exfoliative
dermatitis
and
toxic
epidermal
necrolysis)
listed in this leaflet. You can also report side effects
Lithium (used to treat some types of depression),
!
this occurs very rarely,
directly via Yellow Card Scheme at:
Digoxin (a medicine for an irregular heart beat and/or
!
a serious allergic reaction such as skin rash, swelling
!
www.mhra.gov.uk/yellowcard
2. What you need to know before you take Misofen
heart failure),
of
the
face,
wheezing
or
difficulty
breathing
By reporting side effects you can help provide more
Tablets
Warfarin or other oral anticoagulants (blood-thinning
!
(anaphylactic
shock)
this
occurs
rarely),
information on the safety of this medicine.
agents that reduce blood clotting),
jaundice (your skin or the whites of your eyes look
!
Do not take Misofen Tablets
Medicines used to treat anxiety and depression known
!
yellow) this occurs rarely.
5. How to store Misofen Tablets
if you have had an allergic reaction such as a skin
!
as Serotonin Selective Re-uptake Inhibitors (SSRIs),
rash, swelling or itchiness of the skin, severe nasal
Medicines (such as metformin) used to control your
!
Frequency unknown
Keep this medicine out of the sight and reach of children.
congestion, asthma or wheezing after taking
blood sugar (oral hypoglycaemics for diabetes) except
!
Stomach pain, passage of dark brownish red or bright
This medicine does not require any special storage
diclofenac or other NSAIDs such as aspirin
insulin,
red blood or blood clots in the stool (signs of
conditions.
(acetylsalicylic acid), misoprostol or another
Methotrexate (used to treat rheumatoid arthritis,
!
gastrointestinal
ulcer
with
bleeding
or
perforation),
Do not use this medicine after the expiry date which is
prostaglandin medicine, or any of the other ingredients
psoriasis and leukaemia),
!
Rapid
onset
of
mild
cramping
abdominal
pain
and
stated on the blister and carton, after the EXP. The expiry
in Misofen Tablets (see Further Information section 6),
Steroid medications (e.g. corticosteroids, which are
!
tenderness
over
the
affected
bowel.
Mild
to
moderate
date refers to the last day of that month.
if
you
currently
have
an
ulcer
or
perforation
(hole)
in
!
often used as anti-inflammatory medicines),
amounts of rectal bleeding or bloody diarrhoea usually
Do not throw away any medicines via wastewater or
your stomach or intestines,
Medicines for high blood pressure (anti!
develop
within
24
hours
of
the
onset
of
abdominal
household waste. Ask your pharmacist how to throw away
if you currently suffer from bleeding in your stomach,
!
hypertensives),
pain,
though
bleeding
without
prior
abdominal
pain
medicines you no longer use. These measures will help
intestines or brain,
Magnesium containing antacids (used to treat
!
also
occurs
frequently
(signs
of
ischemic
colitis).
protect the environment.
if you are undergoing or you have just had coronary
!
heartburn, indigestion),
artery bypass graft (CABG) surgery,
Quinolone antibiotics (used to treat some infections),
!
Additionally, if any of the following side effects get
6. Contents of the pack and other information
if you have severe kidney or liver failure,
!
Ketoconazole (used to treat some fungal infections),
!
serious,
or
if
you
notice
any
side
effects
not
listed
in
if you have established heart disease and /or
!
If you have taken a medicine called mifepristone (used
!
this leaflet, please tell your doctor or pharmacist.
What Misofen Tablets contain
cerebrovascular disease e.g. if you have had a heart
to terminate pregnancy) within the last 12 days.
The active substances are Diclofenac sodium and
attack, stroke, mini-stroke (TIA) or blockages to blood
Misofen Tablets should not be taken within 8-12 days
Very common (may affect up to 1 in 10 people)
misoprostol, each tablet contains 50 mg diclofenac
vessels to the heart or brain or an operation to clear or
of taking mifepristone.
Stomach
ache,
diarrhoea,
nausea
(feeling
sick),
!
sodium and 200 micrograms misoprostol.
bypass blockages,
indigestion
if you have or have had problems with your blood
!
Pregnancy and breast-feeding
Other ingredients:
circulation (peripheral arterial disease),
Diarrhoea is the most common problem and is
Core:
if you are pregnant, or trying to become pregnant,
!
Pregnancy
occasionally
severe.
You
have
less
chance
of
getting
lactose monohydrate, microcrystalline cellulose, maize
because it may cause a miscarriage. Women who
Do not use Misofen Tablets if you are pregnant or trying to
diarrhoea
if
you
take
Misofen
Tablets
with
food.
If
you
use
starch, povidone K-30, magnesium stearate and purified
have not reached the menopause should use reliable
become pregnant. Women who have not reached the
an
antacid
(something
to
reduce
acid
in
the
stomach)
you
talc.
contraception while they are taking Misofen Tablets,
menopause should use reliable contraception while they
should avoid antacids with magnesium in them as these
if you are allergic to diclofenac sodium and/or
!
are taking Misofen Tablets.
may make diarrhoea worse. Your pharmacist can help
Mantle/Coat:
misoprostol or any of the other ingredients of this
you
choose
a
suitable
antacid.
If
this
diarrhoea
continues
hypromellose, methylacrylic acid copolymer type C,
medicine (listed in section 6).
Breast-feeding
and
is
severe
tell
your
doctor.
purified talc, triethylcitrate, sodium starch glycolate,
Do not use Misofen Tablets while you are breast-feeding.
hydrogenated castor oil and microcrystalline cellulose.
Warnings and precautions
Ask your doctor or pharmacist for advice before taking
Common (may affect less than 1 in every 10 people,
Talk to your doctor or pharmacist before taking
any medicine.
but more than 1 in every 100 people)
What Misofen Tablets look like and contents of the
Diclofenac/Misoprostol Tablets:
Rash,
itching,
!
pack
if you have any heart problems, previous stroke or
!
Driving and using machines
Vomiting, wind, constipation, burping, gastritis
!
White circular, uncoated tablets plain on one side and
think you might be at risk of these conditions,
If you feel dizzy or drowsy after taking Misofen Tablets, do
(indigestion, stomach ache, vomiting),
embossed with “DM2” on the other side.
if you smoke,
!
not drive and do not use any tools or machines until these
Ulcers
in
the
stomach
or
intestines,
!
if you have diabetes,
!
effects have worn off.
Headache, dizziness,
!
Misofen Tablets are available in blister packs of 6, 7, 56,
if you have angina, blood clots, high blood pressure,
!
Difficulty sleeping,
!
60, 84, 100, 120 and 140.
raised cholesterol or raised triglycerides,
Misofen Tablets contain lactose
Changes in blood tests relating to the liver.
!
if you have other health problems such as a disease
!
Misofen Tablets contain lactose. If your doctor has told
Not all pack sizes may be marketed.
of the liver or kidneys. Do not take Misofen Tablets if
you that you are intolerant of some sugars, discuss it
Uncommon
(may
affect
less
than
1
in
every
100
you have severe kidney or liver failure,
with them before taking this medicine.
people, but more than 1 in every 1,000 people)
Marketing Authorisation Holder:
!
if you have previously had an ulcer or bleeding in your
Swelling of the mouth,
!
Morningside Healthcare Ltd.
stomach or intestines. Do not take Misofen Tablets if
3. How to take Misofen Tablets
Abnormal or unexpected bleeding from the vagina,
!
115 Narborough Road
,
you currently have an ulcer or bleeding in your
menstrual
disturbances,
Leicester,
LE3
0PA,
stomach or intestines,
Always take this medicine exactly as your doctor has told
Reduction in the number of blood platelets (increased
!
UK
!
if you bleed or bruise easily,
you. Check with your doctor or pharmacist if you are not
chance of bleeding or bruising),
!
if you have inflammation of the intestines (ulcerative
sure.
Purpura (purple spots on the skin),
!
Manufacturer:
colitis or Crohn's disease),
Urticaria
(raised
itchy
rash).
!
Morningside Pharmaceuticals Ltd
!
if you have, or have ever had asthma or an allergic
The recommended dose is one tablet two or three times a
5 Pavilion Way,
disease,
day, or as directed by your doctor.
Rare (may affect less than 1 in every 1,000 people, but
Loughborough, LE11 5GW,
!
if you have an infection, as Misofen Tablets may mask
more than 1 in every 10,000 people)
UK
a fever or other signs of infection,
Misofen Tablets should be swallowed whole with a drink
Inflammation
of
the
liver
(possible
yellow
discoloration
!
!
if you are dehydrated,
of water (not chewed), taken during or after mealtimes.
of skin, headache, fever, chills, general weakness).
This medicinal product is authorised in the Member
!
if you are over the age of 65 as your doctor may want
Do not take if the tablet is broken or damaged.
States of the EEA under the following names:
to keep a regular check on you.
Additional side effects experienced in actual use
Ireland: Diclofenac/Misoprostol modified release tablets
In the elderly and patients with liver or kidney
(post-marketing
experience,
frequency
unknown):
UK: Misofen
NSAID medicines such as Misofen Tablets can cause
disorders, your doctor may want to monitor you more
Heart
failure,
chest
pain,
palpitations
(awareness
of
!
bleeding or ulceration. If this occurs, treatment should be
closely. No change in dose is needed.
your heartbeat),
This leaflet was last revised in August 2016.
stopped.
Damage to the gullet,
!

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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