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IBUPROFEN 200MG SOFT CAPSULES

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPROFEN 200mg
SOFT CAPSULES

READ ALL OF THIS LEAFLET CAREFULLY
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription.
However, you still need to take Ibuprofen 200mg
Soft Capsules 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.
You must contact a doctor if your symptoms
worsen or do not improve after 10 days.
If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Ibuprofen Soft Capsules are and
what they are used for
2. Before you take Ibuprofen Soft Capsules
3. How to take Ibuprofen Soft Capsules
4. Possible side effects
5. How to store Ibuprofen Soft Capsules
6. Further information

1. WHAT IBUPROFEN 200mg SOFT
CAPSULES ARE AND WHAT THEY ARE
USED FOR
The active ingredient is ibuprofen. It belongs to
a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDS). They provide
relief by changing the body’s response to pain,
swelling, and high temperature.

Ibuprofen 200mg Soft Capsules are used
for the relief of:






Headache and migraine pain
Dental pain and neuralgia
Period pain
Rheumatic, muscular and back pain
Feverishness and symptoms of cold & flu.

2. BEFORE YOU TAKE IBUPROFEN
200mg SOFT CAPSULES
Do not take Ibuprofen 200mg Soft
Capsules if you:

• are allergic to ibuprofen or any of the other
ingredients (see section 6) or to aspirin or
other painkillers
• have (or have had two or more episodes of ) a
stomach ulcer, perforation or bleeding
• have had a worsening of asthma, skin rash,
itchy runny nose or facial swelling when
previously taking ibuprofen, aspirin or similar
medicines
• have had gastrointestinal bleeding or
perforation when previously taking NSAIDS.
• are taking other NSAID painkillers or more
than 75mg aspirin per day
• have severe liver or kidney problems

• have heart problems, high blood pressure or
blood coagulation disorder
• have breathing difficulties
• are in the last 3 months of pregnancy
• are under 12 years old.

Check with your pharmacist or doctor
before taking Ibuprofen 200mg Soft
Capsules if you:

• have or have had asthma
• have kidney, liver, bowel or heart problems.
• have high cholesterol or have had a heart
attack or stroke
• have a history of gastrointestinal disease
such as ulcerative colitis or Crohn’s disease
• have Systemic Lupus Erythematosus (an
immune system condition causing joint pain,
skin changes and other organ disorders)
• are a smoker
• are in the first 6 months of pregnancy
• have hereditary problems of fructose
intolerance or are on a controlled potassium
diet (see end of section 2 – Important
information about some of the ingredients
of this medicine).

Taking other medicines

To reduce the risk of side effects, do not take this
medicine with other NSAID containing products
such as aspirin, ibuprofen, indometacin etc.
Avoid taking this medicine with corticosteroid
tablets, quinolone antibiotics or drugs that are
prescribed:
• to thin your blood or prevent clotting
(e.g. warfarin)
• to stimulate your heart (e.g. glycosides) or
prevent high blood pressure
• to help you pass water (diuretics)
• for the temporary suppression of your immune
system (e.g.methotrexate, cyclosporine,
tacrolimus)
• for mania or depression (e.g. lithium or SSRIs)
• for pregnancy termination (e.g. mifepristone)
• for HIV treatment (e.g. zidovudine)
Speak to your pharmacist or doctor before
taking ibuprofen with other medicines.

Other warnings

• Ibuprofen 200mg Soft Capsules belongs to
a group of medicines which may impair
fertility in women. This is reversible on
stopping taking the medicine. It is
unlikely that Ibuprofen 200mg 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.
• Medicines such as Ibuprofen 200mg Soft
Capsules may be associated with a small
increased risk of heart attack or stroke.
Any risk is more likely with high dose or
prolonged treatment. Do not exceed the
recommended dose.
• There is a risk of renal impairment in
dehydrated children and adolescents.
• If you have heart problems, previous stroke or
think that you might be at risk of these
conditions (e.g. if you have high blood

pressure, high cholesterol or are a smoker),
then discuss treatment with your doctor
or pharmacist.

Pregnancy and breast-feeding

Do not take
• in the last 3 months of pregnancy
• if you are breast-feeding.
Speak to your doctor if you are in the first 6
months of pregnancy.

Important information about some of the
ingredients of this medicine:

This medicine contains:
• Ponceau 4R red (E124).
May cause allergic reactions.
• 58.6 mg of sorbitol, a source of 14.7 mg
of fructose per capsule. Patients with rare
hereditary problems of fructose intolerance
should not take this medicine.
• 17.4 mg of potassium per capsule; to be taken
into consideration by patients on a controlled
potassium diet.

3. HOW TO TAKE IBUPROFEN 200mg
SOFT CAPSULES
This medicine is for short term use.
Take the lowest dose for the shortest time
needed to relieve your symptoms.

Adults, the elderly and adolescents of
12 to 17 years:

Take 1 or 2 capsules with water, up to three
times a day as required.
Leave at least four hours between doses.
Adults and the elderly:
If this medicinal product is required for more
than 10 days, or if symptoms persist or worsen,
contact your doctor.
Adolescents:
If this medicinal product is required for more
than 3 days, or if symptoms worsen a doctor
should be consulted
Do not take more than 6 capsules in 24 hours.
Do not give to children under 12 years.
Do not take for longer than 10 days unless your
doctor tells you to. If symptoms persist or pain or
fever worsen, or if any new symptoms occur,
consult your doctor or pharmacist.

If you take more Ibuprofen 200mg Soft
Capsules than you should, you may feel

drowsy or nauseous. You should seek immediate
medical advice in the event of an overdose, even
if you feel well.

• signs of serious allergic reaction such as:
- breathing difficulties or unexplained
wheezing
- dizziness or faster heartbeat
- severe skin reaction (rashes, itchiness,
peeling, flaking or blistering)
- swelling of your face or throat

Tell your doctor if you experience:

• fever, flu-like symptoms, sore throat, mouth
ulcers, headache, a stiff neck, vomiting,
unexplained bleeding and bruising, severe
exhaustion.
• indigestion, stomach or abdominal pain,
constipation, diarrhoea, flatulence, or if you
feel sick, chest pain or fast irregular heart beat.
• liver or kidney problems associated with
swelling in your arms and legs.
Medicines such as Ibuprofen 200mg Soft
Capsules may be associated with a small
increased risk of heart attack or stroke. (see
section 2 ‘Other warnings’).

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 side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard

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

6. FURTHER INFORMATION

What Ibuprofen 200mg Soft Capsules
contains

• Each capsule contains 200mg of the active
ingredient ibuprofen.
• The other ingredients are Macrogol 400,
sorbitan mono oleate, sorbitol (E420),
potassium hydroxide (E525), gelatin (E441),
Ponceau 4R red (E124), triglycerides, shellac,
titanium dioxide (E171), propylene glycol
and water.

What Ibuprofen 200mg Soft Capsules
looks like and contents of the pack

Wine red colour oval shaped soft gelatin
capsules containing pink to dark pink
viscous liquid, printed ‘142’ in white colour on
capsule shell. Available in blister packs of 10, 12
or 16 capsules.

If you forget to take Ibuprofen 200mg Soft
Capsules

Marketing Authorisation Holder and Manufacturer:
Bell, Sons & Co. (Druggists) Ltd.
Southport PR9 9AL. UK
PL 03105/0105

4. POSSIBLE SIDE EFFECTS

This leaflet is available in either large print or Braille
format upon request; telephone 0151 422 1200 or
write to the above address.

Refer to the directions above on how to take this
medicine and do not take more than advised.

STOP TAKING the medicine and seek
immediate medical help if you develop:

• signs of intestinal bleeding such as: bright
red faeces (stools), black tarry stools, vomiting
blood or dark particles that look like coffee
grounds.

C73-0006 Ver B Revised December 2015
D24-0385
D24-0380

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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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