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IBULAR TABLETS 400MG

Active substance(s): IBUPROFEN / IBUPROFEN / 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.

14

Date

06-08-16

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

For more severe conditions your doctor may
prescribe up to 1,600mg daily until your condition
is under control.
PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibular Tablets 200mg and 400mg

Children:
The usual daily dosage is 20 mg per kg of
bodyweight, given in divided doses.
For children who weigh less than 30kg the
maximum dose in 24 hours is 500mg.
Your doctor will decide on the dose.

!
Ringing in ears (tinnitus)
!
Sensation of feeling dizzy or spinning
(vertigo)
!
Mouth ulcers
!
Serious allergic reaction which
causes swelling of the face or throat.

Rare (affects up to 1 in a 1000 people):
!
Feeling depressed or confused
!
Fluid retention (oedema)
!
A brain infection called 'non-bacterial
Read all of this leaflet carefully before you start
!
Have any kind of stroke or think that you might
If you take more Ibular Tablets than you should
meningitis'
taking this medicine because it contains
be at risk of these conditions (e.g. if you have a
You should contact a doctor or go to the nearest
!
Loss of vision
important information for you.
family history of heart disease or stroke, high
hospital casualty department IMMEDIATELY taking
!
Changes in blood count - the first signs are:
!
Keep this leaflet. You may need to read it
blood pressure, diabetes, high cholesterol or
your tablets with you.
high temperature, sore throat, mouth ulcers,
are a smoker).
again.
flu-like symptoms, feeling very tired, bleeding
There is an increased risk of the elderly having
!
If you have any further questions, ask your
from the nose and the skin
If you forget to take your tablets
side effects.
doctor, pharmacist or nurse.
!
Reduction in blood cells (anaemia)
Take them as soon as you remember, unless it is
!
This medicine has been prescribed for you
!
Serious allergic reaction which causes difficulty
almost time for your next dose. If it is, do not take
only. Do not pass it on to others. It may harm
If you are not sure if any of the above apply to
in breathing or dizziness
the missed dose at all. Never double up on a dose
them, even if their signs of illness are the same
you, talk to your doctor, or pharmacist or nurse
!
Severe sore throat with high fever
to make up for the one you have missed.
as yours.
before taking this medicine.
(agranulocytosis).
!
If you get any side effects, talk to your doctor,
If you have any further questions on the use of this
pharmacist or nurse. This includes any possible
Other medicines and Ibular
Very rare (affects up to 1 in 10,000 people):
medicine, ask your doctor, or pharmacist or nurse.
side effects not listed in this leaflet, see section
Some medicines that are anti-coagulants (i.e. thin
!
Liver failure
4.
blood/prevent clotting e.g. aspirin/acetylsalicylic
4. POSSIBLE SIDE EFFECTS
!
Heart failure
acid, warfarin, ticlodipine), some medicines that
!
Heart attack
reduce high blood pressure (ACE-inhibitors such
What is in this leaflet
!
Inflammation of the pancreas
Like all medicines, this medicine can cause side
1. What Ibular Tablets 200mg and 400mg are
as captopril, beta-blockers such as atenolol, or
!
Skin problems (which can also affect inside
effects, although not everyone gets them.
and what they are used for
angiotensin-II receptor antagonists such as
your mouth, nose or ears) such as 'Stevens2. What you need to know before you take
losartan) and other medicines may affect or be
Johnson syndrome', 'toxic epidermal necrolysis'
STOP TAKING Ibular Tablets and seek
Ibular Tablets 200mg and 400mg
affected by treatment with ibuprofen. You should
or 'erythema multiforme'
immediate medical help if you experience:
3. How to take Ibular Tablets 200mg and
therefore always seek the advice of your doctor or
!
High blood pressure.
!
Signs of aseptic meningitis such as severe
400mg
pharmacist before you use ibuprofen with other
headache, high temperature, stiffness of the
4. Possible side effects
medicines. In particular you should tell your doctor
Not known (frequency cannot be estimated
neck or intolerance to bright light.
5. How to store Ibular Tablets 200mg and
or pharmacist if you are taking any of the following
from available data):
!
Signs of intestinal bleeding such as
400mg
medicines in addition to those mentioned above.
!
Worsening of ulcerative colitis or Crohn's
?
Passing blood in your faeces
6. Contents of the pack and other information
Disease (inflammation of the colon).
(stools/motions)
You should avoid taking these tablets with the
?
Passing black tarry stools
1. WHAT IBULAR TABLETS 200MG AND
following:
Reporting of side effects
?
Vomiting any blood or dark particles that
400MG ARE AND WHAT THEY ARE USED
!
Aspirin or other non-steroidal antiIf you get any side effects, talk to your doctor,
look like coffee grounds
FOR
inflammatory drugs (NSAIDs) for pain relief
pharmacist or nurse. This includes side effects not
!
Corticosteroids (e.g hydrocortisone) given to
listed in this leaflet. You can also report side effects
TELL YOUR DOCTOR AND STOP TAKING
Ibular Tablets belong to a group of medicines
treat a variety of conditions such as allergies
directly via the Yellow Card Scheme at:
IBULAR TABLETS IF YOU EXPERIENCE:
called non-steroidal anti-inflammatories (NSAIDs).
and hormone imbalances
www.mhra.gov.uk/yellowcard
!
Unexplained stomach pain (abdominal pain) or
They work by relieving pain, reducing
!
Quinolones e.g ciprofloxacin (antibiotics
By reporting side effects you can help provide
other abnormal stomach symptoms,
inflammation, swelling and fever.
used to treat infections) may cause fits and
more information on the safety of this medicine.
indigestion, heartburn, feeling sick and/or
aminoglycosides (e.g. gentamicin) used to
vomiting
Ibular Tablets are used in the treatment of
treat infections
5. HOW TO STORE IBULAR TABLETS 200MG
!
Unexplained wheezing, shortness of breath,
rheumatoid arthritis, including juvenile rheumatoid
!
Gingko biloba the herbal extract used to treat
AND 400MG
skin rash, itching or bruising (these may be
arthritis, ankylosing spondylitis, osteoarthrosis and
memory disturbances
symptoms of an allergic reaction)
other non-rheumatoid arthropathies.
!
Cardiac glycosides such as digoxin (used for
Keep this medicine out of the sight and reach
!
Yellowing of the eyes and/or skin (jaundice)
These tablets can also be used to treat capsulitis,
some heart conditions) may worsen heart
of children.
!
Severe sore throat with high fever (these may
bursitis, tendinitis, tenosynovitis, low back pain,
failure
be symptoms of a condition known as
and soft tissue injuries such as sprains and strains.
!
Diuretics (water tablets) effects may be
agranulocytosis)
Do not use this medicine after the expiry date
decreased. Potassium sparing diuretics may
!
Blurred or disturbed vision (visual impairment)
which is stated on the carton. The expiry date
2. WHAT YOU NEED TO KNOW BEFORE YOU
increase the blood level of potassium
or seeing/hearing strange things
refers to the last day of that month.
TAKE IBULAR TABLETS 200MG AND
!
Ciclosporin or tacrolimus (medicines used to
(hallucinations)
400MG
prevent rejection after transplant) - may harm
!
Fluid retention e.g. swollen ankles (this may be
Store in a cool dry place.
kidney function
a sign of kidney problems)
Do not take Ibular Tablets:
!
Lithium (medicine to treat depression) or
!
Severe spreading skin rash (Stevens-Johnson
Do not use this medicine if you notice visible signs
!
If you are allergic to or have ever had an
digoxin (medicine to treat impaired heart
Syndrome and erythema multiforme, symptoms
of deterioration.
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 throw away any medicines via wastewater
other NSAIDs like aspirin or diclofenac or any
!
Selective serotonin reuptake inhibitors
or household waste. Return any left over tablets to
well as skin peeling which may be
other ingredients in this medicine
(SSRIs) e.g fluoxetine used to treat depression
your pharmacist. These measures will help protect
accompanied with symptoms such as aching,
!
Have (or have had two or more episodes of) a
!
Mifepristone (used to induce abortion).
the environment.
headaches, and feverishness).
stomach ulcer, perforation or bleeding in the
NSAIDs should not be used 8-12 days after
past
taking mifepristone as NSAIDs can reduce
6. CONTENTS OF THE PACK AND OTHER
Medicines such as Ibular Tablets have been
!
Have had gastrointestinal bleeding or
mifepristone's effectiveness
INFORMATION
associated with a small increased risk of heart
perforation when previously taking NSAIDs
!
Methotrexate (to treat psoriasis, rheumatoid
attack (myocardial infarction) or stroke.
!
Suffer from severe liver, kidney or heart failure
arthritis and certain tumors)
What Ibular Tablets contain
!
Are in the last 3 months of pregnancy
!
Medicines to treat HIV (e.g. zidovudine)
!
The active substance is Ibuprofen.
Medicines such as Ibular Tablets have in
!
You have a condition which increases your
!
Cholestyramine (a drug used to lower
!
Each Ibular 200mg Tablet contains 200mg of
exceptional cases been associated with severe
tendency to bleeding.
cholesterol)
the active ingredient ibuprofen.
skin problems for patients with chicken pox or
!
Medicines known as sulphonylureas such as
!
Each Ibular 400mg Tablet contains 400mg of
shingles.
Warnings and precautions
glibenclamide (used to treat diabetes)
the active ingredient ibuprofen.
Talk to your doctor, pharmacist or nurse before
!
Medicines to treat fungal infections such as
Blood disorders, kidney problems, liver problems
taking this medicine if you:
voriconazole or fluconazole.
The other ingredients are: lactose, povidone,
or severe skin reactions may occur rarely with
!
Have kidney, heart, liver or bowel problems
maize starch, talc, magnesium stearate, colloidal
ibuprofen.
!
Have Systemic Lupus Erythematosus (SLE) a
Pregnancy, breast-feeding and fertility
sodium, gelatin, macrogol 1540, calcium
condition of the immune system affecting
If you are pregnant or breast-feeding, think you
carbonate, sucrose, erythrosine E127.
Very rarely Ibular Tablets may cause aseptic
connective tissue resulting in joint pain, skin
may be pregnant or are planning to have a baby,
meningitis (inflammation of the protective
change and disorders of other organs
ask your doctor or pharmacist for advice before
What Ibular Tablets looks like and contents of
membrane surrounding the brain).
!
Are asthmatic or suffer from allergic reactions
taking this medicine.
the pack
e.g. hayfever
Ibular Tablets 200mg and 400mg are pink, circular
Ibular Tablets have also been shown to sometimes
!
Are in the first 6 months of pregnancy
Ibular Tablets should not be used in late pregnancy
sugar coated tablets.
worsen the symptoms of Crohn's disease or colitis.
!
Have heart problems, have had a previous
(the last three months) and should only be taken in
stroke or think that you may be at risk of these
the first six months of pregnancy on the advice of
Coated tablets are supplied in securitainers
Other side effects
conditions (for example if you have high blood
your doctor.
containing 14, 28, 30, 56, 60, 84, 90, 100 and 500
Common (affects up to 1 in 10 people):
pressure, diabetes or high cholesterol or are a
tablets.
!
Rash
smoker)
Driving and using machines
!
Feeling dizzy or tired
!
Have a history of gastrointestinal disease (such
These tablets may make you feel dizzy, drowsy
Marketing Authorisation Holder
!
Stomach pain, indigestion, diarrhoea, feeling
as ulcerative colitis or Crohn's disease)
and you may have a headache or visual
Ennogen Pharma Ltd
sick, being sick, wind, constipation
!
Are currently taking other NSAIDs.
disturbances. If you think that you are affected
Unit G4, Riverside Industrial Estate
!
Headache - if this happens while you are taking
after taking these tablets do not drive or operate
Riverside Way, Dartford, DA1 5BS, United
this medicine it is important not to take any
machinery until you feel better.
Other warnings:
Kingdom
other medicines for pain to help with this.
Ibular Tablets belongs to a group of medicines
which may impair female fertility. This is reversible
Ibular Tablets contain lactose and sucrose
Manufacturer
Uncommon (affects up to 1 in a 100 people):
on stopping the medicine. It is unlikely that Ibular
If you have been told by your doctor that you have
Sofar SPA
!
Feeling drowsy
Tablets used occasionally will affect your chances
an intolerance to some sugars you should talk to
Via Firenze 40, Trezzano Rosa (MI)
!
Feeling anxious
your doctor before taking this medicine.
of becoming pregnant. However, tell your doctor
I-20060, ITALY
!
Feeling a tingling sensation or 'pins and
before taking this medicine if you have problems
needles'
3. HOW TO TAKE IBULAR TABLETS 200MG
becoming pregnant.
This leaflet was last revised in August 2016.
!
Difficulty sleeping
AND 400MG
!
Hives, itching
Medicines such as Ibular Tablets may be
!
Skin becomes sensitive to light
associated with a small increased risk of heart
Always take this medicine exactly as your doctor
!
Visual disturbances, hearing problems
attack (myocardial infarction) or stroke. Any risk is
has told you. Check with your doctor or pharmacist
!
Hepatitis, yellowing of your skin or eyes,
more likely with high doses and prolonged
if you are not sure.
reduced liver function
Take your tablets with or after food, with a glass of
treatment. Do not exceed the recommended dose
!
Reduced kidney function, inflammation of the
water. The tablets should be swallowed whole.
or duration of treatment. You should discuss your
kidneys, kidney failure
treatment with your doctor or pharmacist before
!
Sneezing, blocked, itchy or runny nose (rhinitis)
Adults:
taking Ibular Tablets if you:
!
Stomach or gut ulcer, hole in the wall of the
The recommended initial dose is 1,200mg daily in
!
Have heart problems including heart failure,
digestive tract
divided doses.
angina (chest pain) or you have had a heart
!
Inflammation of your stomach lining
attack, bypass surgery or peripheral artery
!
Small bruises on your skin or inside your
disease (poor circulation in the legs or feet due
A maintenance dose of 600mg to 1,200mg daily
mouth, nose or ears
to narrow or blocked arteries)
may be prescribed.
!
Difficulty breathing, wheezing or coughing,
asthma or worsening of asthma
{Ibuprofen}

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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