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IBUPROFEN PERRIGO 200MG FILM-COATED TABLETS

Active substance(s): IBUPROFEN LYSINE / IBUPROFEN LYSINE / IBUPROFEN LYSINE

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Ibuprofen Perrigo 200mg 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.
 Keep this leaflet. You may need to read it again.
 Ask your pharmacist if you need more information or advice.
 If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
 In Adults: 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 Adolescents between 12 and 18 years: If in adolescents this medicinal product is
required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What this medicine is and what it is used for
What you need to know before you take this medicine
How to take this medicine
Possible side effects
How to store this medicine
Contents of the pack and other information

1. What this medicine is and what it is used 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. What you need to know before you take this medicine
Do not take this medicine if you:
 are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
 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)
 have (or have had two or more episodes of) a stomach ulcer, or bleeding of the stomach
 have a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy
 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
Warning and Precautions
Talk to your doctor or pharmacist before taking ibuprofen tablets if you:






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
if you have hereditary blood formation disorder (acute intermittent porphyria)
if you are elderly because you may be at more risk of having side effects, particularly stomach
problems
if you have or have suffered from asthma or have allergies as shortness of breath may occur
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
during chickenpox (varicella) it is advisable to avoid use of Ibuprofen Tablets
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.
In prolonged administration of Ibuprofen Tablets regular checking of your liver values, the kidney
function, as well as of the blood count, is required
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.

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 Perrigo 200mg Filmcoated Tablets 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 of 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.

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 Tablets if any above mentioned conditions concerns you.
Children and Adolescents
There is a risk of renal impairment in dehydrated children and adolescents.
Other medicines and Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Ibuprofen Tablets may affect or be affected by some other medicines. For example:



medicines that are anti-coagulants (i.e thin blood/ prevent clotting e.g aspirin/ acetylsalicylic acid,
warfarin, ticlopidine)
medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as
atenolol medicines, angiotensin-II receptor antagonist such as losartan).

Some other medicines may also affect or be affected by the treatment of Ibuprofen Tablets. You should therefore
always seek the advice of your doctor or pharmacist before you use Ibuprofen Tablets 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

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

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 Tablets with food and drink
It is recommended that patients with sensitive stomachs take Ibuprofen 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 Tablets.
Pregnancy and Breast feeding
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 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 passes into breast
milk.
These tablets belong to a group of medicines, which may impair fertility in women. This is reversible
on stopping the medicine. It is unlikely that the tablets, used occasionally, will affect your chances of
becoming pregnant. However, tell your doctor before taking this medicine if you have problems
becoming pregnant.
3. How to take this 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.
Body weight (Age)

Dose and how often to take

Adults, and adolescents weighing from 40 kg
(12 years old and above)

Take 1 or 2 tablets with water, every 6 hours, as
required. Do not take more often than every 6
hours. Do not take more than 6 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.
In Adults: 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.
In Adolescents between 12 and 18 years: If in adolescents this medicinal product is required
for more than 3 days, or if symptoms worsen, a doctor should be consulted.
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 more Ibuprofen Tablets than you should:
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 Tablets can cause side effects, although not everybody gets them.
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

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

very rare
not known

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 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
• 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
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 Tablets may be associated with a small increased risk of heart attack
("myocardial infarction") or stroke.
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 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.

5. How to store this medicine
Do not use after the expiry date shown on the pack.
Store in the original container.
Keep out of the reach and sight of children.
6. Contents of the pack and other information
What is in this medicine:
The active ingredient is: Ibuprofen 200 mg (as ibuprofen lysine 342 mg) per coated tablet.
The other tablet core 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 ‘IBL’ on one side.
This product is available in a pack size of 8, 12 or 16 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder: [To be completed nationally]
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:
Poland: Ibuprofen Lysine Perrigo, 200 mg, tabletki powlekane
Italy: DOLIPRO200 mg compresse rivestite con film
Hungary: Ibuprofen APC 200 mg filmtabletta
Netherlands: Ibuprofen Wrafton 200 mg, filmomhulde tabletten
This leaflet was revised in October 2016

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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