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IBUPROFEN PERRIGO 400 MG FILM-COATED TABLETS

Active substance(s): IBUPROFEN LYSINE

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1.3.1

PRODUCT INFORMATION.

Ibuprofen Perrigo 400mg Film-coated Tablets
For adults and adolescents weighing from 40 kg body weight (12 years of age and above)
Ibuprofen Lysine
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you. Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
ƒ Keep this leaflet. You may need to read it again.
ƒ Ask your pharmacist if you need more information or advice.
ƒ If you get any side effects talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
ƒ You must talk to a doctor if your symptoms worsen or do not improve after 3 days when
you are suffering from a fever or 4 days when you are suffering from pain.
In this leaflet:
1.
2.
3.
4.
5.
6.

What this medicine is for
Before you take the medicine
How to take the medicine
Possible side effects
Storing the medicine
Further information

1. WHAT THIS MEDICINE IS FOR
This medicine contains ibuprofen lysine which is the lysine salt of ibuprofen. Ibuprofen is one
of a group of non-steroidal anti-inflammatory drugs (known as NSAIDS) which work to
reduce pain and fever.
This medicine is used for the symptomatic treatment of:
• mild to moderate pain, such as headache, period pain and dental pain
• fever and pain associated with common cold.
2. BEFORE YOU TAKE THE MEDICINE
Do not take this medicine if you:
ƒ are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section
6)
ƒ have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after
using acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs)
ƒ have (or have had two or more episodes of) a stomach ulcer, or bleeding of the stomach
ƒ have a history of gastro-intestinal bleeding or perforation related to previous NSAID
therapy
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PRODUCT INFORMATION.

have severe kidney or severe heart failure or severe liver failure
are bleeding, including any bleeding within the brain (cerebrovascular bleeding)
are suffering from blood clotting disorders
suffer from a currently undiagnosed problem with your body’s ability to form blood
are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake)
are in the last 3 months of pregnancy
LOW DOSE ASPIRIN: Do not take this medicine if you are taking aspirin at doses of above
75mg daily. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist
before you take Ibuprofen Perrigo 400mg Film-coated Tablets.

Talk to your doctor or pharmacist before taking Ibuprofen Perrigo 400mg Film-coated
Tablets:
ƒ if you suffer from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson
syndrome and toxic epidermal necrolysis. The use of Ibuprofen Tablets should be stopped
immediately at the first appearance of skin rash, mucosal lesions, or any other signs of
allergic reactions
ƒ if you have hereditary blood formation disorder (acute intermittent porphyria)
ƒ if you are elderly because you may be at more risk of having side effects, particularly
stomach problems
ƒ if you have or have suffered from asthma or have allergies as shortness of breath may
occur
ƒ if you suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders an
increased risk of allergic reactions exists. The allergic reactions may present as asthma
attacks (so-called analgesic asthma), Quincke’s oedema or urticaria
ƒ during chickenpox (varicella) it is advisable to avoid use of Ibuprofen Perrigo 400mg Filmcoated Tablets

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if you have reduced liver or kidney function
directly after major surgery
if you have stomach or bowel disorders including Crohn’s disease or a condition known as
ulcerative colitis
if you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease –
illnesses which affects your immune system. They cause joint pains, skin changes and
problems with other parts of your body.
if you have, have previously had, or are at risk of heart problems, high blood pressure or
stroke. Medicines such as Ibuprofen Perrigo 400mg Film-coated Tablets may be associated
with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is
more likely with high doses and prolonged treatment. Do not exceed the recommended
dose or duration of treatment (3 days in the treatment of fever and 4 days in the treatment
of pain). If you have heart problems, previous stroke or think that you might be at risk of
these conditions (for example if you have high blood pressure, diabetes or high cholesterol
or are a smoker) you should discuss your treatment with your doctor or pharmacist
In prolonged administration of Ibuprofen Perrigo 400mg Film-coated Tablets regular
checking of your liver values, the kidney function, as well as of the blood count, is
required

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PRODUCT INFORMATION.

The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors,
increases risk of adverse reactions (see section “If you are taking other medicines” below)
and should be avoided.

Undesirable effects are minimised by using the minimum effective dose for the shortest
period of time.
In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney
problems. This risk may be increased under physical strain associated with loss of salt and
dehydration. Therefore it should be avoided.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation
is experienced or suspected, medical advice should be obtained and treatment should be
discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in
patients who have frequent or daily headaches despite (or because of) the regular use of
headache medications.
Consult a doctor before using Ibuprofen Perrigo 400mg Film-coated Tablets if any above
mentioned conditions concerns you.
If you are taking other medicines
What should you avoid when you are taking other medicines?
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid, warfarin,
ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g. captopril,
betareceptor blocking medicines, angiotensin II antagonists), and even some other medicines
may effect or be effected by the treatment of ibuprofen. Seek therefore always advice of a
doctor before you use ibuprofen with other medicines.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. In particular, tell them if you
are taking:
acetylsalicylic acid, or other NSAIDs (antiinflammatories and analgesics)

since this may increase the risk of
gastrointestinal ulcers or bleeding

digoxin (for heart insufficiency)

since the effect of digoxin may be enhanced

glucocorticoids (medicinal products
containing cortisone or cortisone-like
substances)

since this may increase the risk of
gastrointestinal ulcers or bleeding

anti-platelet agents

since this may increase the risk of bleeding

acetylsalicylic acid (low dose)

since the blood-thinning effect may be
impaired

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PRODUCT INFORMATION.

medicines for thinning the blood (such as
warfarin)

since ibuprofen may enhance the effects of
these medicines

phenytoin (for epilepsy)

since the effect of phenytoin may be
enhanced

selective serotonin reuptake inhibitors
(medicines used for depression)

as these may increase the risk of
gastrointestinal bleeding

lithium (a medicine for manic depressive
illness and depression)

since the effect of lithium may be enhanced

probenecid and sulfinpyrazones (medicines
for gout)

since the excretion of ibuprofen may be
delayed

medicines for high blood pressure and water
tablets

since ibuprofens may diminish the effects of
these medicines and there could be a possible
increased risk for the kidney

potassium sparing diuretics

since this may lead to hyperkalaemia

methotrexate (a medicine for cancer or
rheumatism)

since the effect of methotrexate may be
enhanced

tacrolimus and cyclosporine
(immunosuppressive medicines)

since kidney damage may occur

zidovudine: (a medicine for treating Aids)

since the use of Ibuprofen Tablets may result
in an increased risk of bleeding into a joint or
a bleeding that leads to swelling in HIV (+)
haemophiliacs

sulfonylureas (antidiabetic medicines)

interactions may be possible

quinolone antibiotics

since the risk for convulsions may be
increased

Taking Ibuprofen Perrigo 400mg Film-coated Tablets with food and drink
It is recommended that patients with sensitive stomachs take Ibuprofen Perrigo 400mg Filmcoated Tablets with food. Some side effects, such as those affecting the gastrointestinal system
can be more likely when alcohol is taken at the same time as Ibuprofen Perrigo 400mg Filmcoated Tablets.
Driving and using machines
For short-term use and at normal dosage this medicine has no or negligible influence on the
ability to drive and use machines.
Pregnancy, breast feeding and fertility
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PRODUCT INFORMATION.

Tell your doctor if you become pregnant during intake of this medicine. Do not take this
medicine if you are in the last 3 months of pregnancy. Talk to your doctor before taking
Ibuprofen Perrigo 400mg Film-coated Tablets if you are in the first 6 months of pregnancy.
This medicine may be used during breast feeding for a maximum of 3 days (when you are
treating a fever) or 4 days (for the treatment of pain), as only small amounts of this medicine
pass into breast milk.
The product belongs to a group of medicines (NSAIDs) which may impair the fertility in
women. This effect is reversible on stopping the medicine.
3. HOW TO TAKE THE MEDICINE
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
have told you. Check with doctor or pharmacist if you are not sure.
Age
Dose and how often to take
Adults, and adolescents weighing from 40 Take 1 tablet with water, every 6 hours, as
required. Do not take more often than every 6
kg (12 years old and above)
hours. Do not take more than 3 tablets in any
24 hour period.
The tablets are intended for short-term use only. Use them for the shortest time needed to
relieve symptoms. Always use the lowest dose that relieves your symptoms. Talk to your
doctor if symptoms worsen or you need to take these tablets for more than 3 days when you
have a fever or 4 days when you are suffering from pain.
Do not give to adolescents weighing under 40 kg or children under 12 years.
For oral use.
Please speak to the doctor or pharmacist if you feel that the effect of this medicine is greater
or less than you expected.
If you take too many tablets: Talk to a doctor straight away, or go to your nearest hospital
casualty department. Take the carton and this leaflet with you. The following signs may
occur: nausea, vomiting, stomach pain, diarrhoea, ringing in the ear, headache,
gastrointestinal bleeding, dizziness, drowsiness, confusion, disorientation. Rarely: loss of
consciousness.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibuprofen Perrigo 400mg Film-coated Tablets can cause side effects,
although not everybody gets them.

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PRODUCT INFORMATION.

Side effects may be minimised by taking the lowest dose for the shortest time necessary to
relieve the symptoms. You may suffer one of the known side effects of NSAIDs (see below).
If you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as
possible. Elderly people using this product are at increased risk of developing problems
associated with side effects.
The following frequencies are taken as a basis when evaluating side effects:
very common
common
uncommon
rare
very rare
not know

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than1 user in 10,000
frequency cannot be estimated from the available data.

STOP TAKING this medicine and seek immediate medical help if you develop:
• signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools,
vomiting blood or dark particles that look like coffee grounds.
• signs of very rare but serious allergic reaction such as worsening of asthma or
shortness of breath, swelling of the face, tongue or throat, difficulty breathing, racing
heart, drop in blood pressure leading to shock. These can happen even on first use of this
medicine.
• severe skin reactions such as rashes covering the whole body, peeling, blistering or
flaking skin.
Tell your doctor if you have any of the following side effects, they become worse or you
notice any effects not listed.
Common
• gastrointestinal complaints, such as heart burn, abdominal pain, feeling sick and
indigestion, vomiting, wind (flatulence), diarrhoea, constipation, and slight blood losses in
stomach and/or bowel that may cause anaemia in exceptional cases.
Uncommon
• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of
the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the
stomach (gastritis), worsening of colitis and Crohn's disease
• central nervous disturbances such as headache, dizziness, sleeplessness, agitation,
irritability or tiredness
• visual disturbances
• allergic reactions , such as skin rashes, itching and asthma attacks. You must stop taking
Ibuprofen Perrigo 400mg Film-coated Tablets and inform your doctor at once.
Rare
• tinnitus (ringing in the ears)
• kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood
Very rare

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PRODUCT INFORMATION.

swelling (oedema), high blood pressure (hypertension) and cardiac failure have been
reported in association with NSAID treatment.
inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in
the small and large intestines (intestinal, diaphragm-like strictures)
serious infections of the skin and soft-tissue complications have occurred during chicken
pox (varicella) infection.
passing less urine than normal and swelling (especially in patients with high blood
pressure or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic
syndrome); inflammatory kidney disease (interstitial nephritis) that my lead to acute
kidney failure. If one of the above mentioned symptoms occur or if you have a general
miserable feeling, stop taking Ibuprofen Perrigo 400mg Film-coated Tablets and consult
your doctor immediately as these could be first signs of a kidney damage or kidney
failure.
problems in the blood cell production - first signs are: fever, sore throat, superficial mouth
ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases you
must stop the therapy immediately and consult a doctor. Any self-treatment with pain
killers or medicinal products that reduce fever (antipyretic medicinal products) mustn’t be
done.
psychotic reactions and depression
exacerbation of infection-related inflammations (e.g. necrotising fasciitis) associated with
use of certain painkillers (NSAIDs) has been described. If signs of an infection occur or
get worse during use of Ibuprofen Tablets, you must go to a doctor without delay. It is to
be investigated whether there is an indication for an antiinfective/antibiotic therapy.
high blood pressure, palpitations, heart failure, heart attack.
liver dysfunction, liver damage, especially during long-term treatment, liver failure, acute
inflammation of the liver (hepatitis)
the symptoms of aseptic meningitis with neck stiffness, headache, feeling sick, being sick,
fever or consciousness clouding have been observed when using ibuprofen. Patients with
autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be
affected. Contact a doctor at once, if these occur.
severe forms of skin reactions such as skin rash with redness and blistering (e.g. StevensJohnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia).
severe general hypersensitivity reactions.
worsening of asthma, bronchospasm, dyspnoea.

Medicines such as Ibuprofen Perrigo 400mg Film-coated Tablets may be associated with a small
increased risk of heart attack ("myocardial infarction") or stroke.
5. STORING THE MEDICINE
Do not use after the expiry date shown on the pack.
Store in the original container.
Keep all medicines out of the reach and sight of children.

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PRODUCT INFORMATION.

6. FURTHER INFORMATION
What is in this medicine:
The active ingredient is: Ibuprofen 400 mg (as ibuprofen lysine 684mg) per coated tablet.
The other ingredients are: Crospovidone, copovidone, microcrystalline cellulose and
magnesium stearate. The tablet coating ingredient is: Opadry II White (contains polyvinyl
alcohol, titanium dioxide E171, macrogol and talc).
What this medicine looks like and contents of the pack
Each tablet is a film-coated white tablet, embossed with ‘L684’ on one side.
This product is available in a pack size of 8, 12, 16 or 24 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder: Wrafton Laboratories Limited, Wrafton, Braunton,
Devon, EX33 2DL, United Kingdom.
Manufacturer: Wrafton Laboratories Limited (Trading as Perrigo), Braunton, Devon, EX33
2DL, United Kingdom.
This medicinal product is authorised in the Member States of the EEA under the
following names:
Czech Republic : Ibuprofen Perrigo 400mg
Germany : Ibuprofen Perrigo 400mg Filmtabletten
Hungary : Ibuprofen APC 400 mg film-coated tablet
Italy: Dolipro
The Netherlands : Ibuprofen Wrafton 400mg, filmomhulde tabletten
Poland : Ibuprofen Lysine Perrigo
The leaflet was revised in: Jan 2013

Ibuprofen Lysine 684mg Film-coated Tablets / Module 1.3.1 / January 2013

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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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