FLARIN 200 MG SOFT CAPSULES

POSITIONAL ONLY

200 mg SOFT CAPSULES
IBUPROFEN
PACKAGE LEAFLET:
INFORMATION FOR THE USER

2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FLARIN 200 mg SOFT CAPSULES

Read all of this leaflet carefully before
you start taking this product.

Do not take these capsules if you:
• are allergic to ibuprofen or any of the
other ingredients of this product, aspirin
or other related painkillers (see end of
section 2 and section 6)
• have had a worsening of asthma, allergic
rash or itchy, runny nose when taking
similar medicines
• have (or have had) two or more episodes
of a stomach ulcer, perforation or bleeding
• ever had stomach bleeding or a perforation
due to NSAIDs
• are already taking other drugs that belong
to the NSAIDs group
• are taking aspirin at doses of above 75 mg daily
• are in the last 3 months of pregnancy
• suffer from severe heart, liver or kidney disease.

This medicine is available without prescription.
However, you still need to take this product
carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more

information or advice.
• 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 Flarin 200 mg Soft Capsules are
and what they are used for
2. What you need to know before you
take Flarin 200 mg Soft Capsules
3. How to take Flarin 200 mg Soft Capsules
4. Possible side effects
5. How to store Flarin 200 mg Soft Capsules
6. Contents of the pack and other information

1 WHAT FLARIN 200 mg SOFT
CAPSULES ARE AND WHAT THEY
ARE USED FOR
This medicine contains ibuprofen, which belongs
to a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs).
Your capsules are used for the relief from
rheumatic or muscular pain, also for the relief
of pain of non-serious arthritic conditions
(caused by swelling, stiffness and inflammation
of joints), joint pain, back pain, neuralgia
(sharp pain along nerves), migraine, headache,
dental pain, period pain, feverishness, cold
and flu symptoms.

Warnings and precautions
Please see your doctor or pharmacist
before taking this medicine if you:
• are elderly, as you may be more
likely to suffer from side effects
• have or have had asthma, diabetes,
high cholesterol, high blood pressure, a stroke,
heart, liver, kidney or bowel problems
• are allergic to any other painkiller
• suffer from systemic lupus erythematosus
(a chronic rheumatic disease)
• suffer from an allergy
• suffer from inflammation of the intestines
(ulcerative colitis, Crohn’s disease)
• are on low-dose aspirin (up to 75 mg daily)
• are a smoker
• are in the first 6 months of pregnancy
• are 12-18 years old and have not been drinking
fluids or have lost fluids due to continuous
vomiting or diarrhoea, as there is a risk of
kidney damage.
If symptoms persist or worsen, consult your doctor.

POSITIONAL ONLY

Anti-inflammatory/pain-killer medicines like
ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly
when used at high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss your treatment with your
doctor or pharmacist before taking Flarin 200 mg
Soft Capsules if you:
• have heart problems including heart failure,
angina (chest pain), or if you have had
a heart attack, bypass surgery, peripheral
artery disease (poor circulation in the legs
or feet due to narrow or blocked arteries),
or any kind of stroke (including ‘mini-stroke’
or transient ischaemic attack “TIA”).
• have high blood pressure, diabetes,
high cholesterol, have a family history of
heart disease or stroke, or if you are a smoker.
Very rare reports of potentially life threatening
skin rashes (Stevens Johnson Syndrome, toxic
epidermal necrolysis) have been reported with
the use of ibuprofen. Patients are at a higher
risk of such reactions during the first month of
therapy. STOP TAKING Flarin and seek medical
assistance from your doctor or pharmacist if you
notice a skin rash, lesions or any other signs of
allergic reaction (see Section 4).
Other medicines and Flarin 200 mg
Soft Capsules
Flarin 200 mg Soft Capsules may affect
or be affected by some other medicines.
For example:
• any other painkillers (or other NSAIDs)
• corticosteroids (anti-inflammatory) which
can increase the risk of side effects in the
stomach including bleeding
• serotonin reuptake inhibitors and lithium
(for treatment of depression - bipolar
disease and mania)
• cardiac glycosides (treatment of heart failure
and cardiac arrhythmia)
• methotrexate (anti-cancer and psoriasis)
• zidovudine (HIV/AIDS infection)
• cyclosporine (prevent rejection after
organ transplant)

• mifepristone (emergency contraceptive).

•
•
•

•

Do not take this medicine for 8 – 12 days
after mifepristone administration as it
can reduce its effect.
tacrolimus (prevent rejection after organ
transplant, treatment of skin diseases)
quinolone (antibiotics)
medicines that are anti-coagulants
(i.e. thin blood/prevent clotting e.g. aspirin/
acetylsalicylic acid, warfarin, ticlopidine)
medicines that reduce high blood pressure
(ACE-inhibitors such as captopril, beta-blockers
such as atenolol medicines, angiotensin-II
receptor antagonists such as losartan).

Some other medicines may also affect or be
affected by the treatment of Flarin 200 mg
Soft Capsules. You should therefore always
seek the advice of your doctor or pharmacist
before you use Flarin 200 mg Soft Capsules
with other medicines.
Pregnancy and breast-feeding
Ask your doctor or pharmacist before taking
this medicine if you are in the first 6 months
of pregnancy. DO NOT TAKE the capsules if
you are in the last 3 months of pregnancy.
Ask your doctor or pharmacist for advice before
taking any medicine if you are breast-feeding.
Female fertility
Flarin 200 mg Soft Capsules belong to a
group of medicines which may impair fertility
in women. This effect is reversible on stopping
the medicine. It is unlikely that Flarin 200 mg
Soft Capsules used occasionally, will affect your
chances of becoming pregnant, however, tell
your doctor before taking this medicine if
you have problems becoming pregnant.
Driving and using machines
Flarin 200 mg Soft Capsules are unlikely to cause
any effect on your ability to drive or use machines.
Important information about some of the
ingredients of Flarin 200 mg Soft Capsules.
• Contains sorbitol. If you have an intolerance
to some sugars, contact your doctor before
taking this product.
• Brilliant blue (E133) and Allura Red (E129)
may cause allergic reactions.

4 POSSIBLE SIDE EFFECTS

Swallow the capsules whole with water.
Do not chew.

Like all medicines, Flarin 200 mg Soft Capsules
can cause side effects, although not
everybody gets them.

Adults, the elderly and children over 12 years:
Take one or two capsules (200 mg – 400 mg),
up to three times a day as required.

If you experience any of the following
side effects, or anything unusual happens,
stop taking the medicine immediately,
and see your doctor or pharmacist.

Leave at least 4 hours between doses and
do not take more than 1200 mg (6 capsules)
in any 24 hour period.
This medicine is intended for short-term use only.
You should take the lowest dose for the shortest
time necessary to relieve your symptoms.
If you are over 18 years of age do not take
this medicine for longer than 10 days unless
your doctor tells you to.
If you are aged between 12 and 18 years and
this medicinal product is required for more
than 3 days, or if symptoms worsen you
should contact your doctor.
If symptoms persist or worsen consult
your doctor, who may instruct you to
continue taking the medicine.
Not suitable for children under 12 years.
If you take more Flarin 200 mg
Soft Capsules than you should:
If you have taken more Flarin 200 mg
Soft Capsules than you should, or if children
have taken the medicine by accident
always contact a doctor or nearest hospital
to get an opinion of the risk and advice
on action to be taken.
The symptoms can include nausea,
stomach pain, vomiting (may be blood streaked),
headache, ringing in the ears, confusion and
shaky eye movement. At high doses,
drowsiness, chest pain, palpitations,
loss of consciousness, convulsions
(mainly in children), weakness and dizziness,
blood in urine, cold body feeling, and
breathing problems have been reported.
If you forget to take Flarin 200 mg
Soft Capsules:
Do not take a double dose to make up for a
forgotten dose.
If you have any question on the use of this
product, ask your doctor or pharmacist.

If you suffer from any of the following,
at any time, during your treatment
STOP TAKING the medicine and
seek immediate medical help:
• pass blood in your faeces (stools/motions)
• pass black tarry stools
• vomit any blood or dark particles that
look like coffee grounds
• severe hypersensitivity reactions signs could include swelling of the face,
tongue and throat, causing difficulty
in swallowing or breathing; breathing
problems e.g. unexplained wheezing,
shortness of breath, worsening of
asthma, accelerated heart rate,
low blood pressure, severe shock.
• severe forms of skin reactions
including rash, itching, hives, redness,
blistering and peeling of the skin
(Stevens Johnson syndrome).
STOP taking the medicine and tell your
doctor if you experience:
• indigestion or heartburn
• abdominal pains (pains in your stomach)
or other abnormal stomach symptoms.
Uncommon: may affect up to 1 in 100 people:
• Hypersensitivity reactions such as urticaria
(hives) and pruritus (itchy skin)
• Abdominal pain, nausea (feeling sick) and
dyspepsia (indigestion)
• Headache
• Various skin rashes.
Rare: may affect up to 1 in 1,000 people
• Diarrhoea, flatulence (wind), constipation

and vomiting.

POSITIONAL ONLY

3 HOW TO TAKE FLARIN 200 mg
SOFT CAPSULES

POSITIONAL ONLY

Very rare: may affect up to 1 in 10,000 people:
• Problems in blood cell production: the
first signs are tiredness and lethargy (lack
of energy), shortness of breath, pale skin,
fever, sore throat, mouth ulcers, flu-like
symptoms, unexplained bleeding and bruising.
• Peptic ulcer, perforation or gastrointestinal

haemorrhage, melaena (black tarry stools),
vomit of blood or dark particles, ulcerative
stomatitis (inflammation of the mouth),
gastritis (inflammation of the stomach
lining), worsening of existing bowel disease
(ulcerative colitis or Crohn’s disease).

• Meningitis symptoms such as fever and

chills, severe headache, nausea and vomiting
and stiff neck (in patients with inflammatory
disease of connective tissue in the skin or
joints [systemic lupus erythematosus]).

• Kidney failure, liver problems.

5 HOW TO STORE FLARIN 200 mg
SOFT CAPSULES
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry date
which is stated on the blister or carton after EXP.
The expiry date refers to the last day of that month.
Keep the capsules in the original pack.
Do not store above 25°C.

6 CONTENTS OF THE PACK AND
OTHER INFORMATION
What Flarin 200 mg Soft Capsules contain:
The active ingredient is: ibuprofen 200 mg.
The other ingredients are: Hard fat, glycerol
monolinoleate, macrogol 400, gelatin, sorbitol,
purified water, brilliant blue (E133) and allura red
(E129). Hard fat and glycerol monolinoleate are lipids.

Not known: frequency cannot be
estimated from the available data

Ink ingredients: Titanium dioxide,
isopropyl alcohol, propylene glycol, hypromellose.

• Cardiac failure (heart problem),

(See also end of Section 2 “Important
information about some of the ingredients
of “Flarin 200 mg Soft Capsules”).

hypertension (high blood pressure),
oedema (fluid retention).

• A severe skin reaction known as

DRESS syndrome can occur. Symptoms
of DRESS include: skin rash, fever, swelling
of lymph nodes and an increase of
eosinophils (a type of white blood cells).

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.
Medicines such as Flarin 200 mg Soft Capsules
may be associated with a small increased risk
of heart attack (myocardial infarction) 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 at: www.mhra.gov.
uk/yellowcard. By reporting side effects you
can help provide more information on
the safety of this medicine.

What Flarin 200 mg Soft Capsules look
like and contents of the pack
Each Flarin 200 mg Soft Capsule is an oval red
and blue capsule printed in white with ‘Flarin’.
This product is available in packs of 4, 10, 12, 16 and
30 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
infirst HEALTHCARE Ltd.
Central Point
45 Beech Street
London
EC2Y 8AD
Manufacturer:
Patheon Softgels B.V.
De Posthoornstraat 7
5048 AS Tilburg
The Netherlands
PL 42459/0002
This leaflet was last revised in December 2017.
If you have any queries or comments about
your medicine or any other infirst Healthcare Ltd
products, ring our UK customer line 0808 281 0143.
1054/PIL/010