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IBULAR TABLETS 200MG

Active substance(s): IBUPROFEN

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Artwork No.

290514/4

Colours Used

Customer

Ennogen

Black

Description

Ibuprofen 200/400mg Leaflet

Keyline

Market

UK

Language

English

Size

160 x 440 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.

20

Date

24-08-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

A maintenance dose of 600mg to 1,200mg daily
may be prescribed.

!
Inflammation of your stomach lining
!
Small bruises on your skin or inside
your mouth, nose or ears
!
Difficulty breathing, wheezing or
For more severe conditions your doctor may
PACKAGE LEAFLET: INFORMATION FOR THE USER
coughing, asthma or worsening of
prescribe up to 1,600mg daily until your condition
asthma
is under control.
!
Ringing in ears (tinnitus)
Ibular Tablets 200mg and 400mg
!
Sensation of feeling dizzy or spinning
Use in children
(vertigo)
The recommended daily dosage is 20 mg per kg of
{Ibuprofen}
!
Mouth ulcers
bodyweight, given in divided doses.
!
Serious allergic reaction which causes
For children who weigh less than 30kg the
Read all of this leaflet carefully before you start
!
Have any kind of stroke or think that you might
swelling of the face or throat.
maximum dose in 24 hours is 500mg.
taking this medicine because it contains
be at risk of these conditions (e.g. if you have a
Your doctor will decide on the dose.
important information for you.
family history of heart disease or stroke, high
Rare (may affect up to 1 in a 1,000 people):
!
Keep this leaflet. You may need to read it
blood pressure, diabetes, high cholesterol or
!
Feeling depressed or confused
If you take more Ibular Tablets than you should
are a smoker).
again.
!
Fluid retention (oedema)
You should contact a doctor or go to the nearest
There is an increased risk of the elderly having
!
If you have any further questions, ask your
!
A brain infection called 'non-bacterial
hospital casualty department IMMEDIATELY taking
side effects.
doctor, pharmacist or nurse.
meningitis'
your tablets with you.
!
This medicine has been prescribed for you
!
Loss of vision
only. Do not pass it on to others. It may harm
If you are not sure if any of the above apply to
!
Changes in blood count - the first signs are:
If you forget to take Ibular Tablets
them, even if their signs of illness are the same
you, talk to your doctor, pharmacist or nurse
high temperature, sore throat, mouth ulcers,
Take them as soon as you remember, unless it is
as yours.
before taking this medicine.
flu-like symptoms, feeling very tired, bleeding
almost time for your next dose. If it is, do not take
!
If you get any side effects, talk to your doctor,
from the nose and the skin
the missed dose at all. Do not take a double dose
pharmacist or nurse. This includes any possible
Other medicines and Ibular Tablets
!
Reduction in blood cells (anaemia)
to make up for a forgotten dose.
side effects not listed in this leaflet, see section
Tell your doctor or pharmacist if you are taking,
!
Serious allergic reaction which causes difficulty
4.
have recently taken or might take any other
in breathing or dizziness
If you have any further questions on the use of this
medicines.
!
Severe sore throat with high fever
medicine, ask your doctor, pharmacist or nurse.
Some medicines that are anti-coagulants (i.e. thin
What is in this leaflet
(agranulocytosis).
1. What Ibular Tablets 200mg and 400mg are
blood/prevent clotting e.g. aspirin/acetylsalicylic
4. POSSIBLE SIDE EFFECTS
and what they are used for
acid, warfarin, ticlodipine), some medicines that
Very rare (may affect up to 1 in 10,000 people):
2. What you need to know before you take
reduce high blood pressure (ACE-inhibitors such
!
Liver failure
Like all medicines, this medicine can cause side
Ibular Tablets 200mg and 400mg
as captopril, beta-blockers such as atenolol, or
!
Heart failure
effects, although not everybody gets them.
3. How to take Ibular Tablets 200mg and
angiotensin-II receptor antagonists such as
!
Heart attack
400mg
losartan) and other medicines may affect or be
!
Inflammation of the pancreas
STOP TAKING Ibular Tablets and seek
4. Possible side effects
affected by treatment with ibuprofen. You should
!
Skin problems (which can also affect inside
immediate medical help if you experience:
5. How to store Ibular Tablets 200mg and
therefore always seek the advice of your doctor or
your mouth, nose or ears) such as 'Stevens!
Signs of aseptic meningitis such as severe
400mg
pharmacist before you use ibuprofen with other
Johnson syndrome', 'toxic epidermal necrolysis'
headache, high temperature, stiffness of the
6. Contents of the pack and other information
medicines. In particular you should tell your doctor
or 'erythema multiforme'
neck or intolerance to bright light
or pharmacist if you are taking any of the following
!
High blood pressure.
!
Signs of intestinal bleeding such as
1. WHAT IBULAR TABLETS 200MG AND
medicines in addition to those mentioned above.
?
Passing blood in your faeces
400MG ARE AND WHAT THEY ARE USED
Not known (frequency cannot be estimated
(stools/motions)
FOR
You should avoid taking these tablets with the
from available data):
?
Passing black tarry stools
following:
!
Worsening of ulcerative colitis or Crohn's
?
Vomiting any blood or dark particles that
Ibular Tablets belong to a group of medicines
!
Aspirin or other non-steroidal antiDisease (inflammation of the colon).
look like coffee grounds.
called non-steroidal anti-inflammatories (NSAIDs).
inflammatory drugs (NSAIDs) for pain relief
They work by relieving pain, reducing
!
Corticosteroids (e.g hydrocortisone) given to
Reporting of side effects
TELL YOUR DOCTOR AND STOP TAKING
inflammation, swelling and fever.
treat a variety of conditions such as allergies
If you get any side effects, talk to your doctor,
IBULAR TABLETS IF YOU EXPERIENCE:
and hormone imbalances
pharmacist or nurse. This includes side effects not
!
Unexplained stomach pain (abdominal pain) or
Ibular Tablets are used in the treatment of
!
Quinolones e.g ciprofloxacin (antibiotics
listed in this leaflet. You can also report side effects
other abnormal stomach symptoms,
rheumatoid arthritis, including juvenile rheumatoid
used to treat infections) may cause fits and
directly via the Yellow Card Scheme at:
indigestion, heartburn, feeling sick and/or
arthritis, ankylosing spondylitis, osteoarthrosis and
aminoglycosides (e.g. gentamicin) used to
www.mhra.gov.uk/yellowcard
vomiting
other non-rheumatoid arthropathies.
treat infections
By reporting side effects you can help provide
!
Unexplained wheezing, shortness of breath,
These tablets can also be used to treat capsulitis,
!
Gingko biloba the herbal extract used to treat
more information on the safety of this medicine.
skin rash, itching or bruising (these may be
bursitis, tendinitis, tenosynovitis, low back pain,
memory disturbances
symptoms of an allergic reaction)
and soft tissue injuries such as sprains and strains.
!
Cardiac glycosides such as digoxin (used for
5. HOW TO STORE IBULAR TABLETS 200MG
!
Yellowing of the eyes and/or skin (jaundice)
some heart conditions) may worsen heart
AND 400MG
!
Severe sore throat with high fever (these may
2. WHAT YOU NEED TO KNOW BEFORE YOU
failure
be symptoms of a condition known as
TAKE IBULAR TABLETS 200MG AND
!
Diuretics (water tablets) effects may be
agranulocytosis)
Keep this medicine out of the sight and reach
400MG
decreased. Potassium sparing diuretics may
!
Blurred or disturbed vision (visual impairment)
of children.
increase the blood level of potassium
or seeing/hearing strange things
Do not take Ibular Tablets:
!
Ciclosporin or tacrolimus (medicines used to
(hallucinations)
Do not use this medicine after the expiry date
!
If you are allergic to ibuprofen or any of the
prevent rejection after transplant) - may harm
!
Fluid retention e.g. swollen ankles (this may be
which is stated on the carton. The expiry date
other ingredients of this medicine (listed in
kidney function
a sign of kidney problems)
refers to the last day of that month.
section 6)
!
Lithium (medicine to treat depression) or
!
Severe spreading skin rash (Stevens-Johnson
!
If you are allergic to or have ever had an
digoxin (medicine to treat impaired heart
Syndrome and erythema multiforme, symptoms
Store in a cool dry place.
allergic reaction (e.g asthma, inflammation of
function) increase in blood levels of these
include severe skin rash, blistering of skin,
the insides of the nose, swelling of the skin) to
medicines
including inside mouth, nose, and genitals, as
Do not use this medicine if you notice visible signs
other NSAIDs like aspirin or diclofenac
!
Selective serotonin reuptake inhibitors
well as skin peeling which may be
of deterioration.
!
Have (or have had two or more episodes of) a
(SSRIs) e.g fluoxetine used to treat depression
accompanied with symptoms such as aching,
stomach ulcer, perforation or bleeding in the
!
Mifepristone (used to induce abortion).
headaches, and feverishness).
Do not throw away any medicines via wastewater
past
NSAIDs should not be used 8-12 days after
or household waste. Ask your pharmacist how to
!
Have had gastrointestinal bleeding or
taking mifepristone as NSAIDs can reduce
Medicines such as Ibular Tablets have been
throw away medicines you no longer use. These
perforation when previously taking NSAIDs
mifepristone's effectiveness
associated with a small increased risk of heart
measures will help protect the environment.
!
Suffer from severe liver, kidney or heart failure
!
Methotrexate (to treat psoriasis, rheumatoid
attack (myocardial infarction) or stroke.
!
Are in the last 3 months of pregnancy
arthritis and certain tumors)
6. CONTENTS OF THE PACK AND OTHER
!
You have a condition which increases your
!
Medicines to treat HIV (e.g. zidovudine)
INFORMATION
Medicines such as Ibular Tablets have in
tendency to bleeding.
!
Cholestyramine (a drug used to lower
exceptional cases been associated with severe
cholesterol)
skin problems for patients with chicken pox or
What Ibular Tablets contain
Warnings and precautions
!
Medicines known as sulphonylureas such as
shingles.
!
The active substance is Ibuprofen.
Talk to your doctor, pharmacist or nurse before
glibenclamide (used to treat diabetes)
!
Each Ibular 200mg Tablet contains 200mg of
taking Ibular Tablets if you:
!
Medicines to treat fungal infections such as
Blood disorders, kidney problems, liver problems
the active ingredient ibuprofen.
!
Have kidney, heart, liver or bowel problems
voriconazole or fluconazole.
or severe skin reactions may occur rarely with
!
Each Ibular 400mg Tablet contains 400mg of
!
Have Systemic Lupus Erythematosus (SLE) a
ibuprofen.
the active ingredient ibuprofen.
condition of the immune system affecting
Pregnancy, breast-feeding and fertility
connective tissue resulting in joint pain, skin
If you are pregnant or breast-feeding, think you
Very rarely Ibular Tablets may cause aseptic
The other ingredients are: Lactose (see section 2,
change and disorders of other organs
may be pregnant or are planning to have a baby,
meningitis (inflammation of the protective
"Ibular Tablets contain lactose and sucrose"),
!
Are asthmatic or suffer from allergic reactions
ask your doctor or pharmacist for advice before
membrane surrounding the brain).
Povidone, Maize starch, Purified talc, Magnesium
e.g. hayfever
taking this medicine.
stearate, Colloidal Anhydrous Silica,
!
Are in the first 6 months of pregnancy
Ibular Tablets have also been shown to sometimes
Croscarmellose sodium, Macrogol, Calcium
!
Have heart problems, have had a previous
Ibular Tablets should not be used in late pregnancy
worsen the symptoms of Crohn's disease or colitis.
Carbonate, Sucrose (see section 2, "Ibular Tablets
stroke or think that you may be at risk of these
(the last three months) and should only be taken in
contain lactose and sucrose"), Erythrosine E127,
conditions (for example if you have high blood
the first six months of pregnancy on the advice of
Other side effects
Titanium dioxide and Carnauba Wax.
pressure, diabetes or high cholesterol or are a
your doctor.
Common (may affect up to 1 in 10 people):
smoker)
!
Rash
What Ibular Tablets looks like and contents of
!
Have a history of gastrointestinal disease (such
Driving and using machines
!
Feeling dizzy or tired
the pack
as ulcerative colitis or Crohn's disease)
These tablets may make you feel dizzy, drowsy
!
Stomach pain, indigestion, diarrhoea, feeling
Ibular Tablets 200mg and 400mg are pink, circular
!
Are currently taking other NSAIDs.
and you may have a headache or visual
sick, being sick, wind, constipation
sugar coated tablets.
disturbances. If you think that you are affected
!
Headache - if this happens while you are taking
Other warnings:
after taking these tablets do not drive or operate
this medicine it is important not to take any
Coated tablets are supplied in securitainers
Ibular Tablets belongs to a group of medicines
machinery until you feel better.
other medicines for pain to help with this.
containing 14, 28, 30, 56, 60, 84, 90,100 and 500
which may impair female fertility. This is reversible
Tablets.
on stopping the medicine. It is unlikely that Ibular
Ibular Tablets contain lactose and sucrose
Uncommon (may affect up to 1 in a 100
Tablets used occasionally will affect your chances
If you have been told by your doctor that you have
people):
Not all pack sizes may be marketed.
of becoming pregnant. However, tell your doctor
an intolerance to some sugars, contact your doctor
!
Feeling drowsy
before taking this medicine if you have problems
before taking this medicinal product.
!
Feeling anxious
Marketing Authorisation Holder and
becoming pregnant.
!
Feeling a tingling sensation or 'pins and
Manufacturer
3. HOW TO TAKE IBULAR TABLETS 200MG
needles'
Ennogen Pharma Ltd
Medicines such as Ibular Tablets may be
AND 400MG
!
Difficulty sleeping
Unit G4, Riverside Industrial Estate
associated with a small increased risk of heart
!
Hives, itching
Riverside Way, Dartford, DA1 5BS, United
attack (myocardial infarction) or stroke. Any risk is
Always take this medicine exactly as your doctor
!
Skin becomes sensitive to light
Kingdom
more likely with high doses and prolonged
has told you. Check with your doctor or pharmacist
!
Visual disturbances, hearing problems
treatment. Do not exceed the recommended dose
if you are not sure.
!
Hepatitis, yellowing of your skin or eyes,
This leaflet was last revised in August 2017.
or duration of treatment. You should discuss your
Take your tablets with or after food, with a glass of
reduced liver function
treatment with your doctor or pharmacist before
water. The tablets should be swallowed whole.
!
Reduced kidney function, inflammation of the
taking Ibular Tablets if you:
kidneys, kidney failure
!
Have heart problems including heart failure,
Adults:
!
Sneezing, blocked, itchy or runny nose (rhinitis)
angina (chest pain) or you have had a heart
The recommended initial dose is 1,200mg daily in
!
Stomach or gut ulcer, hole in the wall of the
attack, bypass surgery or peripheral artery
divided doses.
digestive tract
disease (poor circulation in the legs or feet due
to narrow or blocked arteries)

+ 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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