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ALEXANDERS IBUPROFEN 200MG COATED TABLETS

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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Package leaflet: Information for the user
Health Essentials Ibuprofen 200mg Coated Tablets
Ibuprofen
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
– Keep this leaflet. You may need to read it
again.
– If you have any further questions, ask your
doctor or pharmacist.
– This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
– If you get any of the side effects, talk to
your doctor or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.
The name of your medicine is Health
Essentials Ibuprofen 200mg Coated Tablets.
In the rest of this leaflet it is referred to as
Ibuprofen tablets.
What is in this leaflet:
1. What Ibuprofen tablets are and what they
are used for
2. What you need to know before you take
Ibuprofen tablets
3. How to take Ibuprofen tablets
4. Possible side effects
5. How to store Ibuprofen tablets
6. Contents of the pack and other information
1. What Ibuprofen Tablets are and what
they are used for
The name of
your
medicine is
Ibuprofen
tablets. The
active
ingredient in
your
medicine is
ibuprofen.
Ibuprofen
belongs to a
group of

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medicines called Non-Steroidal
Anti-inflammatory Drugs (NSAIDs).
Ibuprofen works by reducing inflammation
and relieving pain including period pain,
nerve related pain (neuralgia), dental pain,
headaches and migraine, backache, swelling
and stiffness in the joints and muscles
(rheumatic and muscular pain), fever and
cold and flu symptoms.
2. What you need to know before you
take Ibuprofen Tablets
Do not take Ibuprofen tablets if you
• are allergic (hypersensitive), or have had
an allergic reaction to, ibuprofen, any other
NSAID, aspirin, or to any of the other
ingredients in this medicine (listed in
section 6). Symptoms of an allergic
reaction may include swollen eyelids, lips,
tongue, or throat
• have ever had a worsening of symptoms of
asthma (breathing difficulty), hayfever
(runny, itchy and inflamed nose with
sneezing), urticaria (an itchy rash), or
angioedema (swelling under the skin) when
taking ibuprofen, aspirin or similar painkillers
• currently have or have had a stomach ulcer
or bleeding in the stomach on two previous
occasions
• have ever had perforation or bleeding of
the gut when taking any NSAID
• suffer from severe liver, kidney or heart
problems
• are in the last 3 months of pregnancy
• have abnormal bleeding or problems with
abnormal bruising.
• are currently taking mifamurtide (a
medicine used to treat bone cancer).
Warnings and precautions
Take special care with Ibuprofen tablets if
you
• develop a skin rash or allergic reaction
after taking this medicine. If you have any
of these symptoms stop taking this medicine
and contact your doctor immediately.
• are elderly, as you may be more prone to
side effects (see section 4. Possible Side
Effects) which in some cases may be
extremely serious or even life threatening
• have a history of asthma or other allergy
disorders
• have liver, kidney, or bowel problems
• have Systemic Lupus Erythematosus
(SLE), a condition of the immune system
resulting in joint pains, skin rashes, kidney
or liver problems
• have or have had high blood pressure or
heart problems. Speak to your doctor who
will advise you on your treatment and may
wish to monitor you
• have a history of bleeding in the stomach
or gut. Speak to your doctor immediately if
you notice any problems with your
stomach, especially at the start of your
treatment
• smoke
• have an infection, as symptoms such as
fever, pain and swelling may be masked
• are a child with chickenpox
• are in the first 6 months of your pregnancy
• are taking other NSAID painkillers including
a specific type called COX-2 inhibitors, or
aspirin, with a daily dose above 75mg
• if you are on low-dose aspirin (up to 75mg).
There is a risk of renal impairment in
dehydrated adolescents.
Speak to your doctor or pharmacist before
you take this medicine.
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 Ibuprofen
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.
Other medicines and Ibuprofen tablets
Tell your doctor if you are taking, have
recently taken or might take any other
medicines, including medicines obtained
without a prescription. Ibuprofen may affect or
be affected by some other medicines. For
example:
• other pain killers including aspirin or other
NSAIDs
• medicines used to treat bacterial infections
• medicines that are anti-coagulants (i.e. thin
blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin
ticlopidine
• medicines used to treat depression, such
as selective serotonin re-uptake inhibitors
(SSRIs) and lithium
• medicines used to treat diabetes
• medicines used to treat epilepsy
• medicines that reduce high blood pressure
(ACE-inhibitors such as captopril,
beta-blockers such as atenolol medicines,
angiotensin-II receptor antagonists such as
losartan)
• medicines used to treat viral infections,
such as zidovudine and ritonavir
• medicines used to treat heart failure
• medicines used to treat various illnesses
that involve inflammation in the body
(corticosteroids)
• medicines used to treat cancer, such as
methotrexate and mifamurtide
• medicines used during abortion, such as
mifepristone
• medicines used to relax muscles
• pentoxyfylline, used to treat blood
circulation problems
• diuretics, medicines used to help you pass
water (urine)
• medicines used to suppress the immune
system in patients who have had a
transplant, such as ciclosporin and
tacrolimus.
• penicillamine, used to treat a number of
conditions such as rheumatoid arthritis,
Wilson’s disease.
• cardiac glycosides, such as digoxin, used
to treat heart conditions
• lithium
• antibiotics called quinolones such as
ciprofloxacin
• aminoglycosides (a type of antibiotic)
• cholestyramine (a drug used to lower
cholesterol)
• medicines known as sulphonylureas such
as glibenclamide (used to treat diabetes)
• voriconazole or fluconazole (type of
anti-fungal drugs)
• gingko biloba herbal medicine (there is a
chance you may bleed more easily if you
are taking this with ibuprofen).
Some other medicines may also affect or be
affected by the treatment of Ibuprofen. You
should therefore always seek the advice of
your doctor or pharmacist before you use
Ibuprofen with other medicines.
Ibuprofen tablets with food and drink and
alcohol
Do not drink alcohol whilst taking this
medicine.
Pregnancy, breast-feeding and fertility
Do not take Ibuprofen tablets if you are in the
last 3 months of pregnancy.
Ibuprofen Tablets should be avoided in the
first six months of pregnancy.
Ibuprofen tablets belong to a group of
medicines which may impair fertility in
women. This effect is reversible on stopping
the medicine. It is unlikely that Ibuprofen
tablets, used occasionally, will affect your
chances of becoming pregnant, however, tell
your doctor before taking this medicine if you
are having problems when trying to become
pregnant.
Ask your doctor or pharmacist for advice
before taking any medicine.
It is possible that this medicine can pass into
breast milk. If you are breastfeeding, speak to
your doctor or pharmacist for advice before
taking this, or any medicine.
Driving and using machines
This medicine may make you feel dizzy,
drowsy or tired. You may also experience
blurry vision. Do not drive or use tools or
machines if you are affected in any way after
taking this medicine.
Important information about some of the
ingredients of Ibuprofen tablets
This product contains sucrose. If you have
been told by your doctor that you have
intolerance to some sugars, contact your
doctor before taking thi s medicinal product.
3. How to take Ibuprofen Tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
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Ibuprofen 200mg Tablet (Aldi)
Wockhardt UK
FP3833
Daman (Bhimpore)
(w)128 x (h)420mm
2529
222023
8 pt. (5% condensed)
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- 22ND DEC. 2015
- 3RD FEB. 2016
- 9TH FEB. 2016
- 9TH MARCH 2017

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What Ibuprofen tablets contain
The active ingredient is ibuprofen.
Each Ibuprofen 200mg Coated Tablet
contains 200mg of ibuprofen.
The other ingredients are colloidal anhydrous
silica, starch, povidone, microcrystalline
cellulose, alginic acid, magnesium stearate,
sodium lauryl sulphate, sodium starch
glycollate and croscarmellose sodium.
The coating contains PVAP sealcote, purified
talc, sucrose, calcium carbonate, acacia,
titanium dioxide (E171) and carnauba wax.
What Ibuprofen tablets look like and
contents of the pack
Ibuprofen tablets are round, white, sugar
coated tablets.
Ibuprofen tablets are available in blister packs
of 8, 12 or 16 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North,
Wrexham LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following
information:
Product name
Reference number
Health Essentials
Ibuprofen 200mg
29831/0116
Coated Tablets
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in 03/2017

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6. Contents of the pack and other
information

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5. How to store Ibuprofen Tablets
Keep this medicine out of the sight and reach
of children.
Do not use Ibuprofen tablets after the expiry
date stated on the blister or carton. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original
package in order to protect from light and
moisture.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

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4. Possible side effects
Like all medicines, Ibuprofen tablets can
cause side effects, although not everybody
gets them. If any side effects become serious
or if you notice any side effects that are not
listed in this leaflet, please tell your doctor or
pharmacist. You can minimise the risk of side
effects by taking the least amount of tablets
for the shortest amount of time necessary to
control your symptoms.
STOP TAKING Ibuprofen Caplets and seek
immediate medical help if you experience:
• Signs of aseptic meningitis such as severe
headache, high temperature, stiffness of
the neck or intolerance to bright light.
• Signs of intestinal bleeding such as
Passing blood in your faeces (stools/motions)
Passing black tarry stools
Vomiting any blood or dark particles that
look like coffee grounds.
TELL YOUR DOCTOR AND STOP TAKING
IBUPROFEN CAPLETS IF YOU
EXPERIENCE:
• Unexplained stomach pain (abdominal
pain) or other abnormal stomach
symptoms, indigestion, heartburn, feeling
sick and/or vomiting.
• Unexplained wheezing, shortness of
breath, skin rash, itching or bruising (these
may be symptoms of an allergic reaction).
• Yellowing of the eyes and/or skin (jaundice).
• Severe sore throat with high fever (these
may be symptoms of a condition known as
agranulocytosis).
• Blurred or disturbed vision (visual
impairment) or seeing/hearing strange
things (hallucinations).
• Fluid retention e.g. swollen ankles (this
may be a sign of kidney problems).
• Severe spreading skin rash (Stevens –
Johnson Syndrome and erythema
multiforme, symptoms include severe skin
rash, blistering of skin, including inside
mouth, nose, and genitals, as well as skin
peeling which may be accompanied with
symptoms such as aching, headaches, and
feverishness).
Medicines such as Ibuprofen Caplets have
been associated with a small increased risk of
heart attack (myocardial infarction) or stroke.
Medicines such as Ibuprofen Caplets have in
exceptional cases been associated with
severe skin problems for patients with
chicken pox or shingles.
Blood disorders, kidney problems, liver
problems or severe skin reactions may occur
rarely with ibuprofen.
Very rarely Ibuprofen Caplets may cause
aseptic meningitis (inflammation of the
protective membrane surrounding the brain).
Ibuprofen has also been shown to sometimes
worsen the symptoms of Crohn’s disease or
colitis.
Other side effects
Common (affects up to 1 in 10 people):
• rash
• feeling dizzy or tired
• stomach pain, or indigestion, diarrhoea,
feeling sick, being sick, wind, constipation
• headache – if this happens while you are
taking this medicine it is important not to
take any other medicines for pain to help
with this.
• passing black tarry stools
• passing blood in your faeces
(stools/motions)
• vomiting any blood
Uncommon (affects up to 1 in 100 people):
• feeing drowsy
• feeling anxious
• feeling a tingling sensation or ‘pins and
needles’
• difficulty sleeping
• hives, itching
• skin becomes sensitive to light

• visual disturbances, hearing problems
• hepatitis, yellowing of your skin or eyes,
reduced liver function
• reduced kidney function, inflammation of
the kidneys, kidney failure
• sneezing, blocked, itchy or runny nose
(rhinitis)
• stomach or gut ulcer, hole in the wall of the
digestive tract
• inflammation of your stomach lining
• small bruises on your skin or inside your
mouth, nose or ears
• difficulty breathing, wheezing or coughing,
asthma or worsening of asthma
• 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
meningitis’
• loss of vision
• changes in blood count – the first signs
are: high temperature, sore throat, mouth
ulcers, flu – like symptoms, feeling very
tired, bleeding from the nose and the skin
• reduction in blood cells (anaemia)
• serious allergic reaction which causes
difficulty in breathing or dizziness
• severe sore throat with high fever
(agranulocytosis)
Very rare (affects up to 1 in 10,000
people):
• liver failure
• heart failure
• heart attack
• inflammation
of the
pancreas
• skin
problems
(which can
also affect
inside your
mouth, nose
or ears)
such as
‘Stevens –
Johnson
syndrome’, ‘toxic epidermal necrolysis’ or
‘erythema multoforme.’
• high blood pressure
Not known (frequency cannot be
estimated from available data):
• worsening of ulcerative colitis or Crohn’s
Disease (inflammation of the colon)
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.
By reporting side effects you can help provide
more information on the safety of this medicine.

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Adults, Elderly and Children over 12 years
This product is intended for short term use
only. You should take the lowest dose for the
shortest time necessary to relieve your
symptoms. You should not take Ibuprofen
tablets for longer than 10 days unless your
doctor tells you to. If symptoms persist or
worsen consult your doctor.
The usual dose is 200 or 400mg (1 or 2
tablets) to be taken with a drink of water,
preferably with or after food, up to three times
a day as required. The dose should not be
repeated more frequently than every 4 hours.
Do not take more than 1200mg (6 tablets) in
24 hours.
Taking this medicine with or after food or milk
may only partially reduce stomach side
effects such as indigestion (see section 4).
If in adolescents, this medicinal product is
required for more than 3 days, or if symptoms
worsen a doctor should be consulted.
If you take more Ibuprofen tablets than
you should
If you accidentally take too many Ibuprofen
tablets, you should contact your doctor or go
to your nearest hospital casualty department
immediately. Take this leaflet and any unused
tablets with you to show the doctor.
The symptoms of an overdose include
vomiting (being sick), nausea (feeling sick),
stomach pain and possibly diarrhoea.
Dizziness, ringing in the ears (tinnitus) and
fainting can also be signs of an overdose.
The doctor will assess your condition and
decide how to treat your overdose.
If you forget to take Ibuprofen tablets
If you forget to take your medicine take it as
soon as you remember. If it is almost time for
your next dose do not take the missed dose
at all. Do not take a double dose to make up
for a forgotten dose.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

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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