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MISOFEN 75MG/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

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.

Shortness of breath,
!
Seizures,
!
Allergic reaction, [including asthma, breathing
!
Misofen 75mg/200microgram modified release Tablets
problems, itching, hair loss, inflamed blood vessels
Diclofenac sodium/misoprostol
(can cause fever, aches, purple blotches)],
Symptoms of meningitis (stiff neck, headache, nausea
!
Read all of this leaflet carefully before you start
Medicines such as Misofen Tablets may be associated
If you forget to take Misofen Tablets
(feeling sick), vomiting, fever or loss of
taking this medicine because it contains important
with a small increased risk of heart attack (myocardial
If
you
forget
to
take
a
tablet,
take
it
as
soon
as
you
consciousness),
information for you.
infarction) or stroke. Any risk is more likely with high
remember.
Do
not
take
a
double
dose
to
make
up
for
a
!
Fluid build-up in the body that can cause swollen
!
Keep this leaflet. You may need to read it again.
doses and prolonged treatment. Do not exceed the
forgotten
dose.
ankles and legs,
!
If you have any further questions, ask your doctor or
recommended dose or duration of treatment.
!
Vomiting blood,
pharmacist.
If you stop taking Misofen Tablets
!
Psychotic reactions (mental disorder that features loss
!
This medicine has been prescribed for you only. Do
As with other NSAIDs (e.g. ibuprofen) Misofen Tablets
Do
not
stop
taking
Misofen
Tablets
unless
your
doctor
of contact with reality),
not pass it on to others. It may harm them, even if
may lead to an increase in blood pressure, and so your
tells
you
to.
!
Swelling of the tongue, mouth ulcers, dry mouth,
their signs of illness are the same as yours.
doctor may ask to monitor your blood pressure on a
!
Depression, feeling anxious, mood swings, irritability,
If you get any side effects, talk to your doctor or
regular basis.
If you have any further questions on the use of this
memory problems, feeling confused, feeling shaky,
pharmacist. This includes any possible side effects not
medicine
ask
your
doctor
or
pharmacist.
nightmares, drowsiness, tiredness,
listed in this leaflet. See section 4.
If you have heart, liver or kidney problems, your doctor
!
Difficulty seeing, impaired or blurred vision, ringing in
will want to monitor you regularly.
4. Possible side effects
the ears, changes in the way things taste,
What is in this leaflet
!
Chills, fever, increased sensitivity to light,
1. What Misofen Tablets are and what they are used for
Vision disorders: If symptoms of vision disorders occur
Like
all
medicines,
this
medicine
can
cause
side
effects,
inflammation,
2. What you need to know before you take Misofen
during treatment with Misofen Tablets, contact your doctor
although
not
everybody
gets
them.
!
Loss of appetite,
Tablets
as an eye examination may be considered to exclude
If you are worried about side effects, ask your doctor. It is
!
Abnormal contractions of the womb, rupture in the
3. How to take Misofen Tablets
other causes.
important that you know what can happen, so that you
womb, retained placenta after giving birth, clotting in
4. Possible side effects
can
take
action
if
Misofen
Tablets
does
have
a
side
effect.
the amniotic fluid (fluid covering the foetus), bleeding
5. How to store Misofen Tablets
Other medicines and Misofen Tablets
Misofen
Tablets
sometimes
cause
side
effects
but
these
in the womb, miscarriage, death of the unborn baby,
6. Contents of the pack and other information
Please tell your doctor or pharmacist if you are taking or
usually
go
away
during
treatment
as
your
body
gets
used
birth defects, premature birth,
have recently taken or might take any other medicines.
to the medicine.
!
Low blood pressure, high blood pressure,
1. What Misofen Tablets are and what they are used
This includes medicines that you buy without a
!
Reduction in the number of white blood cells (these
for
prescription or herbal medicines.
If any of the following happen, stop taking Misofen
help protect the body from infection and disease),
Tablets
and
tell
your
doctor
immediately:
!
Anaemia (low number of red blood cells) which can
Misofen Tablets help to relieve the pain and swelling of
In particular, tell your doctor or pharmacist if you are
lead to pale skin and cause weakness or
rheumatoid arthritis and osteoarthritis, and may help to
taking any of the following:
If you have
breathlessness.
protect patients at risk of irritation or ulceration of the
Aspirin (acetylsalicylic acid) or other NSAIDs (e.g.
!
severe
stomach
pain
or
any
sign
of
bleeding
or
!
stomach or intestines.
ibuprofen),
rupture in the stomach or intestines, such as passing
Medicines such as Misofen Tablets may be associated
Misofen Tablets contain diclofenac and misoprostol.
Medicines used to treat osteoarthritis or rheumatoid
!
black or bloodstained stools, or vomiting blood this
with a small increased risk of heart attack or stroke.
Diclofenac belongs to a group of medicinal products
arthritis known as cyclo-oxygenase-2 (COX-2)
occurs very rarely,
called Non-Steroidal Anti-Inflammatory drugs (NSAIDs).
inhibitors,
a serious skin reaction such as rash, blistering or
!
Reporting of side effects
Although NSAIDs relieve the pain, they can reduce the
Diuretics (used to treat excess fluid in the body),
!
peeling
of
the
skin
(Stevens-Johnson
syndrome,
If you get any side effects, talk to your doctor or
amount of natural protective substances called
Ciclosporin or tacrolimus (used for immune system
!
exfoliative dermatitis and toxic epidermal necrolysis)
pharmacist. This includes any possible side effects not
prostaglandins in the stomach lining.
suppression e.g. after transplants),
this occurs very rarely,
listed in this leaflet. You can also report side effects
This means that NSAIDs can lead to stomach upsets or
Lithium (used to treat some types of depression),
!
a
serious
allergic
reaction
such
as
skin
rash,
swelling
!
directly via Yellow Card Scheme at:
stomach ulcers. Misofen Tablets also contain misoprostol
Digoxin (a medicine for an irregular heart beat and/or
!
of
the
face,
wheezing
or
difficulty
breathing
www.mhra.gov.uk/yellowcard
which is very similar to these prostaglandins and may
heart failure),
(anaphylactic
shock)
this
occurs
rarely),
By reporting side effects you can help provide more
help protect your stomach.
Warfarin or other oral anticoagulants (blood-thinning
!
jaundice (your skin or the whites of your eyes look
!
information on the safety of this medicine.
agents that reduce blood clotting),
yellow) this occurs rarely.
2. What you need to know before you take Misofen
Medicines used to treat anxiety and depression known
!
5. How to store Misofen Tablets
Tablets
as Serotonin Selective Re-uptake Inhibitors (SSRIs),
Frequency
unknown
Medicines (such as metformin) used to control your
!
!
Stomach pain, passage of dark brownish red or bright
Keep this medicine out of the sight and reach of children.
Do not take Misofen Tablets
blood sugar (oral hypoglycaemics for diabetes) except
red blood or blood clots in the stool (signs of
This medicine does not require any special storage
if you have had an allergic reaction such as a skin
!
insulin,
gastrointestinal
ulcer
with
bleeding
or
perforation),
conditions.
rash, swelling or itchiness of the skin, severe nasal
Methotrexate (used to treat rheumatoid arthritis,
!
!
Rapid
onset
of
mild
cramping
abdominal
pain
and
Do not use this medicine after the expiry date which is
congestion, asthma or wheezing after taking
psoriasis and leukaemia),
tenderness over the affected bowel. Mild to moderate
stated on the blister and carton, after the EXP. The expiry
diclofenac or other NSAIDs such as aspirin
Steroid medications (e.g. corticosteroids, which are
!
amounts of rectal bleeding or bloody diarrhoea usually
date refers to the last day of that month.
(acetylsalicylic acid), misoprostol or another
often used as anti-inflammatory medicines),
develop
within
24
hours
of
the
onset
of
abdominal
Do not throw away any medicines via wastewater or
prostaglandin medicine, or any of the other ingredients
Medicines for high blood pressure (anti!
pain,
though
bleeding
without
prior
abdominal
pain
household waste. Ask your pharmacist how to throw away
in Misofen Tablets (see Further Information section 6),
hypertensives),
also
occurs
frequently
(signs
of
ischemic
colitis).
medicines you no longer use. These measures will help
if
you
currently
have
an
ulcer
or
perforation
(hole)
in
!
Magnesium containing antacids (used to treat
!
protect the environment.
your stomach or intestines,
heartburn, indigestion),
Additionally,
if
any
of
the
following
side
effects
get
if you currently suffer from bleeding in your stomach,
!
Quinolone antibiotics (used to treat some infections),
!
serious, or if you notice any side effects not listed in
6. Contents of the pack and other information
intestines or brain,
Ketoconazole (used to treat some fungal infections),
!
this
leaflet,
please
tell
your
doctor
or
pharmacist.
if you are undergoing or you have just had coronary
!
If you have taken a medicine called mifepristone (used
!
What Misofen Tablets contain
artery bypass graft (CABG) surgery,
to terminate pregnancy) within the last 12 days.
Very common (may affect up to 1 in 10 people)
The active substances are Diclofenac sodium and
if you have severe kidney or liver failure,
!
Misofen Tablets should not be taken within 8-12 days
Stomach
ache,
diarrhoea,
nausea
(feeling
sick),
!
misoprostol, each tablet contains 75 mg diclofenac
if you have established heart disease and /or
!
of taking mifepristone.
indigestion
sodium and 200 micrograms misoprostol.
cerebrovascular disease e.g. if you have had a heart
attack, stroke, mini-stroke (TIA) or blockages to blood
Pregnancy and breast-feeding
vessels to the heart or brain or an operation to clear or
bypass blockages,
Pregnancy
if you have or have had problems with your blood
!
Do not use Misofen Tablets if you are pregnant or trying to
circulation (peripheral arterial disease),
become pregnant. Women who have not reached the
if you are pregnant, or trying to become pregnant,
!
menopause should use reliable contraception while they
because it may cause a miscarriage. Women who
are taking Misofen Tablets.
have not reached the menopause should use reliable
contraception while they are taking Misofen Tablets,
Breast-feeding
if you are allergic to diclofenac sodium and/or
!
Do not use Misofen Tablets while you are breast-feeding.
misoprostol or any of the other ingredients of this
Ask your doctor or pharmacist for advice before taking
medicine (listed in section 6).
any medicine.
Warnings and precautions
Driving and using machines
Talk to your doctor or pharmacist before taking
If you feel dizzy or drowsy after taking Misofen Tablets, do
Misofen Tablets:
not drive and do not use any tools or machines until these
if you have any heart problems, previous stroke or
!
effects have worn off.
think you might be at risk of these conditions,
if you smoke,
!
Misofen Tablets contain lactose
if you have diabetes,
!
Misofen Tablets contain lactose. If your doctor has told
if you have angina, blood clots, high blood pressure,
!
you that you are intolerant of some sugars, discuss it
raised cholesterol or raised triglycerides,
with them before taking this medicine.
if you have other health problems such as a disease
!
of the liver or kidneys. Do not take Misofen Tablets if
3. How to take Misofen Tablets
you have severe kidney or liver failure,
!
if you have previously had an ulcer or bleeding in your
Always take this medicine exactly as your doctor has told
stomach or intestines. Do not take Misofen Tablets if
you. Check with your doctor or pharmacist if you are not
you currently have an ulcer or bleeding in your
sure.
stomach or intestines,
!
if you bleed or bruise easily,
The recommended dose is one tablet twice a day, or as
!
if you have inflammation of the intestines (ulcerative
directed by your doctor.
colitis or Crohn's disease),
!
if you have, or have ever had asthma or an allergic
Misofen Tablets should be swallowed whole with a drink
disease,
of water (not chewed), taken during or after mealtimes.
!
if you have an infection, as Misofen Tablets may mask
Do not take if the tablet is broken or damaged.
a fever or other signs of infection,
!
if you are dehydrated,
In the elderly and patients with liver or kidney
!
if you are over the age of 65 as your doctor may want
disorders, your doctor may want to monitor you more
to keep a regular check on you.
closely. No change in dose is needed.
NSAID medicines such as Misofen Tablets can cause
bleeding or ulceration. If this occurs, treatment should be
stopped.

Use in Children and adolescents: Misofen Tablets are
for adults only, they are not for use in children (under 18
years).

Diarrhoea is the most common problem and is
occasionally severe. You have less chance of getting
diarrhoea if you take Misofen Tablets 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.

The other ingredients are:
Core:
lactose monohydrate, microcrystalline cellulose, maize
starch, povidone K-30, magnesium stearate and purified
talc.
Mantle/Coat:
hypromellose, methylacrylic acid copolymer type C,
purified talc, triethylcitrate, sodium starch glycolate,
hydrogenated castor oil and microcrystalline cellulose.

Common (may affect less than 1 in every 10 people,
but more than 1 in every 100 people)
Rash, itching,
!
What Misofen Tablets look like and contents of the
Vomiting, wind, constipation, burping, gastritis
!
pack
(indigestion, stomach ache, vomiting),
White circular, uncoated tablets plain on one side and
Ulcers in the stomach or intestines,
!
embossed with “DM1” on the other side.
Headache, dizziness,
!
Difficulty sleeping,
!
Misofen Tablets are available in blister packs of 7, 10, 14,
Changes in blood tests relating to the liver.
!
15, 20, 28, 30, 50, 60, 90, 100, 140.
Uncommon (may affect less than 1 in every 100
Not all pack sizes may be marketed.
people, but more than 1 in every 1,000 people)
Swelling of the mouth,
!
Marketing Authorisation Holder:
Abnormal or unexpected bleeding from the vagina,
!
Morningside Healthcare Ltd.
menstrual disturbances,
115 Narborough Road
,
Reduction in the number of blood platelets (increased
!
Leicester, LE3 0PA,
chance of bleeding or bruising),
UK
Purpura (purple spots on the skin),
!
Urticaria (raised itchy rash).
!
Manufacturer:
Morningside Pharmaceuticals Ltd
Rare (may affect less than 1 in every 1,000 people, but
5 Pavilion Way,
more than 1 in every 10,000 people)
Loughborough, LE11 5GW,
Inflammation of the liver (possible yellow discoloration
!
UK
of skin, headache, fever, chills, general weakness).
This medicinal product is authorised in the Member
Additional side effects experienced in actual use
States of the EEA under the following names:
(post-marketing experience, frequency unknown):
Ireland: Diclofenac/Misoprostol modified release tablets
Heart failure, chest pain, palpitations (awareness of
!
UK: Misofen
your heartbeat),
Damage to the gullet,
!
This leaflet was last revised in August 2016.
Worsening of ulcerative colitis or Crohn's disease
!
(inflammation of the intestines),
Kidney or liver problems,
!

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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