Skip to Content

UK Edition. Click here for US version.

IBUPROFEN LYSINE 342 MG FILM-COATED TABLETS

Active substance(s): IBUPROFEN LYSINE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

IBUPROFEN LYSINE

342 mg film-coated tablets
Ibuprofen lysine

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.
- You must talk to a doctor if you do not feel better or if you
feel worse after 3 days (for adolescents).
- You must talk to a doctor if you do not feel better or if you
feel worse after 3 days in fever and after 4 days in the
treatment of pain (for adults).
What is in this leaflet
1. What Ibuprofen Lysine tablets is and what it is used for
2. What you need to know before you take Ibuprofen Lysine
tablets
3. How to take Ibuprofen Lysine tablets
4. Possible side effects
5. How to store Ibuprofen Lysine tablets
6. Contents of the pack and other information
1. What Ibuprofen Lysine tablets is and what it is used
for
This medicine contains ibuprofen lysine which is the
lysine salt of ibuprofen. Ibuprofen belongs to a group of
medicines known as non-steroidal anti-inflammatory drugs
(NSAIDs) which relieve pain and lower temperature when
you have a fever.
Ibuprofen Lysine tablets 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.
You must talk to a doctor if you do not feel better or if you
feel worse after 3 days (for adolescents).
You must talk to a doctor if you do not feel better or if you
feel worse after 3 days in fever and after 4 days in the
treatment of pain (for adults).
2. What you need to know before you take Ibuprofen
Lysine tablets
Do not take Ibuprofen Lysine tablets:
- if you are allergic to ibuprofen or any of the other
ingredients of this medicine (listed in section 6);
- if you have ever suffered from shortness of breath,
asthma, a runny nose, swelling or hives after using
acetylsalicylic acid or other similar painkillers (NSAIDs);
- if you have (or have had two or more episodes of) a
stomach or duodenal ulcer or bleeding of the stomach;
- if you have ever had gastrointestinal bleeding or
perforation related to previous use of NSAIDs ;
- if you have severe liver, kidney or heart failure;
- if you suffer from blood clotting disorders;
- if you have any active bleeding (including bleeding in the
brain);
- if you suffer from a currently undiagnosed problem with
your body’s ability to form blood;
- if you are severely dehydrated (caused by vomiting,
diarrhoea or insufficient fluid intake);
- if you are in the last 3 months of pregnancy;
- if you are adolescent weighing under 40 kg or you are
younger than 12 years.
Ibuprofen Lysine 342 mg film-coated tablets contains
soya lecithin:
If you are allergic to peanut or soya, do not use this
medicinal product.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen
Lysine tablets:
- if you have or have had asthma or allergic disease as
shortness of breath may occur;
- if you suffer from hayfever, nasal polyps or chronic
obstructive respiratory disorders as an increased risk
of allergic reactions exists. The allergic reactions may
present as asthma attacks (so-called analgesic asthma),
Quincke’s oedema or urticaria;
- if you have kidney or liver problems;
- if you have or have ever had high blood pressure or heart
failure;
- if you have or have ever had stomach or bowel disorders
(including ulcerative colitis or Crohn’s disease);
- if you have certain hereditary blood formation disorder
(e.g. acute intermittent porphyria);
- if you have systemic lupus erythematosus (SLE) or
mixed connective tissue disease - illnesses that affect
the immune system causing joint pain, skin changes and
disorders of other organs;
- if you have chicken pox (varicella) - it is advisable to avoid
the use of Ibuprofen Lysine tablets;
- if you have recently had major surgery;
- if you are taking other NSAIDs. The use with concomitant
NSAIDs, including cyclo-oxygenase-2 specific inhibitors,
increases the risk of adverse reactions (see section
“Other medicines and Ibuprofen Lysine tablets” 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 (3
days in adolescents or in adults 3 days in the treatment of
fever and 4 days in the treatment of pain).
You should discuss your treatment with your doctor or
pharmacist before taking 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.
Very rare reports of potentially life-threatening skin rashes
(exfoliative dermatitis, Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported with the use
of NSAIDs. Patients are at higher risk of such reactions
during the first month of therapy. Stop taking Ibuprofen
Lysine tablets and talk to your doctor or pharmacist if you
notice a skin rash, mucosal lesions, or any other signs of
allergic reactions.
Undesirable effects may be minimised by using the
minimum effective dose for the shortest period of time. The
elderly are at increased risk of side effects.
The habitual use of several sorts of painkillers may cause
permanent damage to the kidneys and a risk of kidney
failure. This risk may be increased under physical strain
associated with loss of salt and dehydration. Therefore, the
habitual use of painkillers 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.

Ibuprofen Lysine_UK_mock-up_ verzija 4.indd 1

In prolonged administration of Ibuprofen Lysine tablets
regular checking of your liver values, the kidney function,
as well as of the blood count, is required.
NSAIDs may mask symptoms of infection and fever.
Children and adolescents
There is a risk of renal impairment in dehydrated adolescents.
Do not give this medicine to adolescents weighing under
40 kg or children under 12 years of age.
Other medicines and Ibuprofen Lysine tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Ibuprofen Lysine tablets may affect or be affected by some
other medicines. For example:
- acetylsalicylic acid, or other NSAIDs - since they 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
gastrointestinal bleeding;
- acetylsalicylic acid (low dose) - since the blood-thinning
effect may be impaired;
- medicines that are anti-coagulants, (i.e thin blood/
prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin,
ticlopidine) - 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) - since this 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 that reduce high blood pressure (ACEinhibitors such as captopril, beta-blockers such as atenolol
medicines, angiotensin-II receptor antagonists such as
losartan) and water tablets (diuretics) - since ibuprofen
may diminish the effects of these medicines and there
could be a possible increased risk for the kidney;
- potassium spearing diuretics - since this may lead to high
potassium levels in the blood;
- 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;
- mifepristone (for pregnancy termination) - since the effect
of mifepristone may be reduced;
- zidovudine (a medicine for treating HIV/AIDS) - since
the use of ibuprofen 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;
- medicines that inhibit CYP2C9 enzyme such as the
antifungals voriconazole or fluconazole - since exposure
to ibuprofen may be increased;
- a herbal remedy called ginkgo biloba - there is a chance
that you may bleed more easily if you are taking ibuprofen
and ginkgo biloba at the same time.
Some other medicines may also affect or be affected by
the treatment of Ibuprofen Lysine tablets. You should
therefore always seek the advice of your doctor or
pharmacist before you use Ibuprofen Lysine tablets with
other medicines.
Ibuprofen Lysine tablets with food, drink and alcohol
It is recommended that patients with sensitive stomachs
take Ibuprofen Lysine 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 Lysine tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take this medicine in the last 3 months of pregnancy.
Avoid the use of this medicine in the first 6 months of
pregnancy unless the doctor advises otherwise.
Only small amounts of ibuprofen and its decomposition
products pass into breast milk. This medicine may be taken
during breast-feeding if it is used at the recommended
dose and for the shortest possible time.
Ibuprofen Lysine tablets belongs to a group of medicines
which may impair fertility in women. This effect is reversible
on stopping the medicine. It is unlikely that Ibuprofen Lysine
tablets, used occasionally, will affect your chances of
becoming pregnant, however, tell your doctor before taking
this medicine if you have problems becoming pregnant.
Driving and using machines
For short-term use and at the recommended dosage, this
medicine has little or no influence on the ability to drive and
use machines. If side-effects such as tiredness, dizziness,
drowsiness and visual disturbances occur, do not drive or
operate machines. Alcohol consumption increases the risk
of these side effects.
Ibuprofen Lysine 342 mg film-coated tablets contains
colour Sunset yellow aluminium lake (E110) and colour
Ponceau 4R aluminium lake (E124)
This medicine contains colours (E110 and E124), which
may cause allergic reactions.
Ibuprofen Lysine 342 mg film-coated tablets contains
glucose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take Ibuprofen Lysine tablets
Always take this medicine exactly as described in this
leaflet or as your doctor, or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
This product is for short term only. You should take the
lowest dose for the shortest time necessary to relieve your
symptoms.
Adults and adolescents weighing from 40 kg (12 years
of age and above)
Take 1 or 2 tablets with water, up to three times a day as
required. Leave at least 6 hours between doses. Do not
take more than 6 tablets in any 24 hour period.
If you are an adult and need to take Ibuprofen Lysine
tablets for more than 3 days if you have fever or for more
than 4 days for the treatment of pain or if your symptoms
worsen consult your doctor.
Use in children and adolescents
Do not give to adolescents weighing under 40 kg or children
under 12 years.
If in adolescents this medicinal product is required for more
than 3 days, or if symptoms worsen a doctor should be
consulted.
The film-coated tablets should be swallowed whole with
water.
The score line is only there to help you break the tablet if
you have difficulty swallowing it whole.
It is recommended that patients with sensitive stomachs
take Ibuprofen Lysine tablets with food.
If you take more Ibuprofen Lysine tablets than you
should
You may experience, nausea, stomach ache or headache,
vomiting, diarrhoea, ringing in the ears, dizziness, vomiting
blood and blood in stools. More serious poisoning can
lead to drowsiness, excitation, disorientation, low blood
pressure, kidney failure, liver damage, reduced breathing

14-Oct-15 10:52:02 AM

(respiratory depression), blue discolouring of the skin
and mucosa (cyanosis), loss of consciousness, coma,
convulsions, myoclonic cramps in children, metabolic
acidosis and increased bleeding tendency. Worsening of
asthma in asthmatics may occur.
You should seek immediate medical advice in the event of
an overdose, even if you feel well.
If you forget to take Ibuprofen Lysine tablets
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Ibuprofen Lysine tablets are oblong, biconvex, pastel-pink
film-coated tablets with shiny effect and break mark on
one side. The dimensions of each tablet are approximately
20.0 mm x 8.0 mm.
The film coated tablets are blister-packed in
transparent PVC/Al foil or in child-resistant
opaque PVC/Al foil fortified with polyester layer.
blister contains 10 tablets.
Lithographed cardboard box with 1 (10 tablets) or
tablets) blisters and a leaflet inside.

hard
white
Each
2 (20

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

4. Possible side effects
Like all medicines, this medicine 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.
Elderly people using this product are at increased risk of
developing problems associated with side effects.
Medicines such as Ibuprofen Lysine tablets may be
associated with a small increased risk of heart attack
("myocardial infarction") or stroke.
If you suffer from any of the following at any time during your
treatment stop taking the medicine and seek immediate
medical help:
- Pass blood in your faeces (stools/motions)
- Pass black tarry stools
- Vomit any blood or dark particles that look like coffee
grounds.
Stop taking the medicine and tell your doctor if you
experience:
- Indigestion or heartburn
- Abdominal pain (pains in your stomach) or other abnormal
stomach symptoms.
If any of the following occurs, stop taking this medicine
and consult your doctor immediately or go to the
emergency department of the nearest hospital:
- signs of very rare (may affect up to 1 in 10,000 people)
but serious allergic reaction such as, 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.
- signs of uncommon (may affect up to 1 in 100 people)
but serious allergic reaction such as asthma attacks
(possibly with drop in blood pressure), worsening of
asthma, unexplained wheezing or shortness of breath.
- severe very rare skin reactions (may affect up to 1 in
10,000 people) such as rashes covering the whole body,
peeling, blistering or flaking skin (e.g. Stevens-Johnson
syndrome, toxic epidermal necrolysis).
- inflammation of the pancreas with severe upper
stomach pain, often with nausea and vomiting, which
occurs very rarely (may affect up to 1 in 10,000 people).
- problems in the blood cell production (first signs
are fever, sore throat, superficial mouth ulcers, flu-like
symptoms, severe exhaustion, nose and skin bleeding)
which occur very rarely (may affect up to 1 in 10,000
people).

Marketing Authorisation Holder
INN-FARM d.o.o., Maleševa ulica 014, 1000 Ljubljana,
Slovenia
Tel.: +386 70 390 711
Fax: +386 5191 116
e-mail: info@innfarm.si
Manufacturer
ALKALOID-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana –
Črnuče, Slovenia
Tel.: +386 1 300 42 90
Fax: +386 1 300 42 91
e-mail: info@alkaloid.si
and
TERAPIA S.A., 124 Fabricii Street, Cluj-Napoca, 400632,
Romania
Tel.: +40 (264) 501 500
Fax: +40 (264) 415 097
e-mail: office@ sunpharma.com
This medicinal product is authorised in the Member
States of the EEA under the following names:
UK: IBUPROFEN LYSINE 342 mg film-coated tablets
Czech Republic: IBUPROFEN InnFarm 200 mg,
potahované tablety
Germany: Ibuprofen INN-FARM 200 mg Filmtabletten
Spain: Ibuprofeno (lisina) InnFarm 200 mg comprimidos
recubiertos con película EFG
Hungary: IBUPROFEN LYSINE InnFarm 342 mg
filmtabletta
Italy: IBUPROFENE Inn-Farm, 200 mg compresse rivestite
con film
Netherlands: IBUPROFEN InnFarm 200 mg filmomhulde
tabletten
Poland: IBUPROFEN LYSINE InnFarm
Romania: PADUDEN Rapid 200 mg comprimate filmate
Slovenia: Ibuprofen INN-FARM 200 mg filmsko obložene
tablete
Slovac Republic: IBUPROFEN InnFarm 200 mg, filmom
obalené tablety
This leaflet was last revised in

Tell your doctor if you experience any of the below side
effects:
Common (may affect up to 1 in 10 people):
- gastrointestinal complaints, such as heart burn, abdominal
pain, feeling sick, being sick, wind (flatulence), diarrhoea,
constipation and slight blood losses in stomach and/or
bowel that may cause anaemia in exceptional cases.
Uncommon (may affect up to 1 in 100 people):
- 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 system disturbances such as headache,
dizziness, sleeplessness, agitation, irritability or tiredness;
- visual disturbances;
- allergic reactions, such as skin rashes and itching;
- various skin rashes.
Rare (may affect up to 1 in 1,000 people):
- ringing in the ears;
- kidney damage (papillary necrosis) and elevated uric
acid concentrations in the blood.
Very rare (may affect up to 1 in 10,000 people):
- inflammation of the oesophagus, narrowing of intestines;
- severe skin infections and soft tissue complications may
occur if you have chicken pox;
- fluid build-up in the body's tissues especially in patients
with high blood pressure or kidney problems, swelling
and foamy urine (nephrotic syndrome), inflammatory
kidney disease (interstitial nephritis) that may lead to
acute kidney failure;
- psychotic reactions, depression;
- worsening of infection-related inflammations (e.g.
development of flesh eating bacteria syndrome –
necrotizing fasciitis) associated with use of certain
painkillers (NSAIDs) has been described. If signs of an
infection occur or get worse during use of ibuprofen, you
must go to a doctor without delay. It is to be investigated
whether there is an indication for an anti-infective/
antibiotic therapy;
- high blood pressure, inflammation of blood vessels,
palpitations, heart failure, heart attack;
- liver dysfunction, liver damage (especially in longterm use), liver failure, acute inflammation of the liver
(hepatitis);
- aseptic meningitis (inflammation of the linings of the
brain with symptoms including neck stiffness, headache,
feeling sick, being sick, fever or clouding of the mental
state). Patients with autoimmune disorders (SLE, mixed
connective-tissue disease) may be more likely to be
affected;
- hair loss.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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.
5. How to store Ibuprofen Lysine tablets
Keep this medicine out of the sight and reach of children.
Store below 25º C.
Do not use this medicine after the expiry date which is
stated on the carton after {EXP}. The expiry date refers to
the last day of that month.
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.
6. Contents of the pack and other information
What Ibuprofen Lysine tablets contains
The active substance is ibuprofen lysine. Each tablet
contains 342 mg ibuprofen lysine equivalent to 200 mg
ibuprofen.
The other ingredients are:
Tablet core: silicified microcrystalline cellulose (contains:
Cellulose, microcrystalline and Silica, colloidal anhydrous);
copovidone; croscarmellose sodium (E468); silica colloidal
anhydrous; magnesium stearate (E470b); talc (E553b).
Film coating: hypromellose (E464), titanium dioxide (E171),
polydextrose, talc (E553b), maltodextrin, medium chain
triglycerides, colour ponceau 4R aluminium lake (E124),
color Sunset yellow aluminium lake (E110), colour Indigo
carmine aluminium lake (E132), carmellose sodium (E466),
glucose monohydrate, mica-based pearlescent pigment
(Mica/Titanium dioxide) (E555/E171), soya lecithin (E322).
What Ibuprofen Lysine tablets looks like and contents
of the pack

Ibuprofen Lysine_UK_mock-up_ verzija 4.indd 2

14-Oct-15 10:52:02 AM

Expand view ⇕

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.

Hide