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IBUPROFEN DERMOGEN 600 MG FILM COATED TABLETS

Active substance(s): IBUPROFEN / IBUPROFEN

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Package leaflet: Information for the patient
Ibuprofen Dermogen 600 mg film-coated tablets
For use in adults and adolescents from 15 years of age
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 side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

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

1.

What Ibuprofen Dermogen is and what it is used for

Ibuprofen Dermogen belongs to a group of medicines called “Non-Steroidal Anti-Inflammatory
Drugs” or NSAIDs.
Ibuprofen Dermogen is used for:
Ibuprofen Dermogen
[Ibuprofen Dermogen 600 mg film-coated tablets]:
- the symptomatic treatment of pain and inflammation in arthritic diseases (e.g.
rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) .

2.

What you need to know before you take Ibuprofen Dermogen

Do not take Ibuprofen Dermogen:
- 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 suffer from severe kidney, liver or heart failure.
- If you suffer from unclarified blood-formation disturbances.
- If you suffer from unclarified blood-formation disturbances.
- If you are suffering from bleeding in the brain (cerebrovascular bleeding) or other active
bleeding.
- If you have ever had bleeding or perforation in your stomach or gut when taking NSAIDs.

- If you have active, or history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding
(at least two different episodes of confirmed ulcers or bleeding).
- If you are suffering from severe dehydration (caused by vomiting, diarrhea or insufficient fluid
intake).
- If you are in the last three months of pregnancy.
Ibuprofen Dermogen[ Ibuprofen Dermogen 600 mg film-coated tablets]:
- If the patient is a child or an adolescent below 15 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen Dermogen.
Side effects may be minimised by using the lowest effective dose for the shortest possible
duration necessary to control symptoms.
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
Dermogen] 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.

have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective
tissue disease (autoimmune diseases affecting connective tissue)

have certain hereditary blood formation disorders (e.g. acute intermittent porphyria).

suffer from reduced liver or kidney function

have just had major surgery

are sensitive (allergic) to other substances

suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders, because
you are at higher risk of allergic reactions. The allergic reactions may present as asthma
attacks (so-called analgesic asthma), rapid swelling (Quincke’s oedema) or a nettle rash.
Gastrointestinal safety
Avoid using Ibuprofen Dermogen at the same time as other non-steroidal anti-inflammatory
drugs (NSAIDs), including so-called cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Elderly:
In the elderly, side effects occur more frequently after the use of NSAIDs. In particular,
gastrointestinal bleeding and perforation, which can be life-threatening in some cases.
Gastrointestinal bleeding, ulceration and perforation:
Gastrointestinal bleeding, ulceration or perforation, in some cases fatal, have been reported
during treatment with all NSAIDs. Such effects occurred at any time during therapy, with or
without warning symptoms or a previous history of serious events in the gastrointestinal tract.
The risk of developing gastrointestinal bleeding, ulcers and perforation is higher with the
increasing NSAID doses and is higher in patients with a history of ulcer, especially with
complications of bleeding or perforation (see section 2: “DO NOT take Ibuprofen Dermogen”)

and in elderly patients. These patients should start treatment at the lowest available dose. For
these patients, as well as patients who require additional therapy with low-dose acetylsalicylic
acid or other medicines likely to increase gastrointestinal risk, combination treatment with
protective active substances (e.g. misoprostol or proton pump inhibitors) should be considered.
If you have a history of side effects affecting the gastrointestinal tract, particularly if you are
elderly, you should report all unusual abdominal symptoms (especially gastrointestinal
bleeding), especially in the initial stages of therapy.
Caution is advised if you are receiving other medicines that can increase the risk of ulcers or
bleeding, such as oral corticosteroids, anticoagulants (blood-thinners) such as warfarin, selective
serotonin reuptake inhibitors (used to treat psychiatric disorders including depression) or
platelet aggregation inhibitors such as acetylsalicylic acid (see section 2: “Other medicines and
Ibuprofen Dermogen”).
Treatment must be stopped and a doctor consulted if you develop gastrointestinal bleeding or
ulcers during treatment with Ibuprofen Dermogen.
NSAIDs should be used with caution in patients with a history of gastrointestinal disease
(ulcerative colitis, Crohn’s disease), as their condition may get worse (see section 4).
Skin reactions
During therapy with NSAIDs, there have been very rare reports of serious skin reactions, some
of them fatal, with redness and blistering (e.g. exfoliative dermatitis, Stevens-Johnson syndrome
and toxic epidermal necrolysis/Lyell's syndrome; see section 4). Patients appear to be at highest
risk of these reactions early in the course of therapy, the onset of the reaction occurring in the
majority of cases within the first month of treatment. You should discontinue the intake of
Ibuprofen Dermogen at the first appearance of skin rash, mucosal lesions, or any other sign of
allergy (hypersensitivity).
During chicken pox (varicella) it is advisable to avoid the use of Ibuprofen Dermogen.
Other notes
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been
observed. Stop treatment immediately at the first signs of hypersensitivity reaction after taking
Ibuprofen Dermogen and tell immediately to your doctor.
Ibuprofen can temporarily inhibit blood platelet function (blood platelet aggregation). Patients
with blood clotting disorders should therefore be carefully monitored.
In prolonged administration of Ibuprofen Dermogen regular checking of the liver values, the
kidney function, as well as of the blood count, is required.
Whilst taking Ibuprofen Dermogen, you should consult/inform your doctor or dentist before
you undergo any surgery.
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 medicines.
In general terms, the habitual intake of painkillers, particularly on combination of several painrelieving active substances, may lead to permanent renal damage (kidney damage) with the risk

of renal failure (analgesic nephropathy). This risk may be increased under physical strain
associated with loss of salt and dehydration. Therefore it should be avoided.

The risk of renal failure is increased in dehydrated patients, the elderly and those taking
diuretics and ACE inhibitors
Ibuprofen may mask signs of infections.
Patients who report eye disorders during treatment with Ibuprofen should discontinue therapy
and be submitted to eye examinations.

Other medicines and Ibuprofen Dermogen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Ibuprofen Dermogen may affect or be affected by some other medicines. For example:
- Medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. acetylsalicylic acid,
warfarin, ticlopidine)
- Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers
such as atenolol, or angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of [Ibuprofen Dermogen].
You should therefore always seek the advice of your doctor or pharmacist before you use
[Ibuprofen Dermogen] with other medicines.
In particular, you should tell your doctor or pharmacist if you are taking any of the following
medicines:
 Other nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (e.g.
celecoxib) or glucocorticoids, as they may increase the risk of gastrointestinal ulcers
and bleeding due to an additive effect.
 Diuretics (water tablets) and high blood pressure medicines (antihypertensive
medicines), as NSAIDs may reduce the effects of these medicines and it may increase
the risk of kidney problems. Moreover, the use of potassium sparing diuretics (certain
water tablets) can lead to an increase in blood potassium levels. Therefore, monitoring
of serum potassium levels is recommended.
 Ibuprofen Dermogen can weaken the effect of ACE inhibitors (used to treat heart failure
and high blood pressure). Furthermore, if used at the same time, there is an increased
risk that kidney dysfunction may occur.
 Digoxin (used to treat heart failure), phenytoin (used to treat epilepsy) or lithium (used
to treat depression), as they may increase their blood levels when taking with ibuprofen.
Monitoring of serum lithium levels is required. Monitoring of the serum digoxin and
serum phenytoin levels is recommended.
 Methotrexate (used to treat certain types of cancers or rheumatism), since the effect of
methotrexate may be enhanced.
 Anticoagulant (blood thinners). NSAIDs may enhance the effects of these medicines.
 Platelet aggregation inhibitors such as acetylsalicylic acid and certain antidepressants
(selective serotonin reuptake inhibitors/SSRIs) may increase the risk of bleeding of
stomach and intestines.
 Medicines containing probenecid and sulfinpyrazone (used to treat gout) may delay the
excretion of ibuprofen.











Medicines known as immunosuppressants like ciclosporin and tacrolimus as kidney
damage may occur.
Cholestyramine (a medicine used to lower cholesterol), as it may reduce the absorption
of ibuprofen in the gastrointestinal tract. However, clinical significance is unknown.
Sulfonylureas (medicines used to treat diabetes), such as glibenclamide. Control of
blood glucose values is recommended when these medicines are used together.
Antibiotics called quinolones, such as ciprofloxacin, due to an increased risk for
developing seizures (fits).
Voriconazole or fluconazole (CYP2C9 inhibitors) used to treat fungal infections, as they
can increase blood levels of ibuprofen. Reduction of the ibuprofen dose should be
considered particularly when high-dose ibuprofen is used with either voriconazole or
fluconazole.
Zidovudine (an anti-viral drug used to treat HIV infection) due to increased risk of
blood accumulation in joints (haemarthrosis) and bruises in HIV-positive
haemophiliacs.
Aminoglycosides (a type of antibiotics). NSAIDs may decrease the excretion of
aminoglycosides.
Gingko biloba (an herbal medicine) may increase the risk of bleeding.

Ibuprofen Dermogen with alcohol
If you consume alcohol, you may suffer more likely from adverse reactions such as
gastrointestinal and central nervous system disorders.

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.

Pregnancy
Tell your doctor if you become pregnant during intake of Ibuprofen Dermogen.
During the first and second trimester of pregnancy, your doctor will only prescribe ibuprofen if
it is clearly necessary. In this case, the dose, the dose should be kept as low and the duration of
treatment as short as possible.
During the last 3 months of pregnancy, you should NEVER take this medicine, as ibuprofen can
have severe or even fatal effects on your child’s heart and kidneys, even with a single
administration.
Breast-feeding
This medicine passes into the breast milk but may be used during breast-feeding if it is used at
the recommended dose and during the shortest possible time.
Fertility
Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if
you are planning to become pregnant or if you have problems to become pregnant
Driving and using machines

Ibuprofen generally has no or negligible influence on the ability to drive and use machines.
However, since at higher dose central nervous side effects such as tiredness and dizziness may
occur, the ability to react and the ability to take part actively in road traffic and to operate
machines may be impaired in individual cases. This is especially important when combined
with alcohol.
Ibuprofen Dermogen contains lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your
doctor before taking this medicine.
3. How to take Ibuprofen Dermogen
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The dose should be adjusted on patient’s age or body weight.
The recommended dose is:
Ibuprofen Dermogen
[Ibuprofen Dermogen 600 mg film-coated tablets]:
Adults
The recommended dose is 1200 – 1800 mg daily in divided doses. Some patients can be
maintained on 600 – 1200 mg daily. In severe or acute conditions, it can be advantageous to
increase the dose until the acute phase is brought under control, provided that the total daily
dose does not exceed 2400 mg in divided doses

Age

Adults

Single dose

Maximum daily dose

600 mg ibuprofen
(1 tablet)

1200 - 2400
ibuprofen
(2 – 4 tablets)

mg

Adolescents from 15 to 17 years of age
The recommended dose should be adjusted by weight: 20-40 mg/kg daily (max 2400 mg daily)
in 3-4 divided doses.

Side effects may be minimized by using the lowest effective dose for the shortest duration
necessary to control symptoms (see section 4.4).
Special populations
Elderly:
No special dose adjustments are required. Due to possible side-effect profile, it is recommended
to monitor the elderly particularly carefully.
Renal insufficiency:
No dose adjustments is required in patients with mild to moderate impairment to renal function
(patients with severe renal impairment see section 2: “DO NOT take Ibuprofen Dermogen”).

Hepatic insufficiency:
No dose adjustments is required in patients with mild to moderate impairment to hepatic
function (patients with severe hepatic impairment see section 2: “DO NOT take Ibuprofen
Dermogen”)
Children and adolescents
Ibuprofen Dermogen[Ibuprofen Dermogen 600 mg film-coated tablets]:
Ibuprofen Dermogen 600 mg film-coated tablets is contraindicated in children and adolescents
below 15 years of age.
Method of administration
Ibuprofen Dermogen is for oral use. The tablets should be swallowed whole with a glass of
water.
It is recommended that patients with a sensitive stomach take Ibuprofen Dermogen with food.
Duration of treatment
The treating physician decides on the duration of treatment.
In rheumatic diseases the use of Ibuprofen Dermogen can be required for a longer period.

If you take more Ibuprofen Dermogen than you should:
If an overdose with Ibuprofen Dermogen is suspected, immediately consult your doctor.
Problems such as headache, dizziness, drowsiness and loss of consciousness (including
myoclonic convulsions in children), as well as abdominal pain, nausea and vomiting, bleeding
into stomach (the gastrointestinal tract), liver dysfunction and kidney dysfunction are also
possible. In addition, a drop in blood pressure, reduced breathing (respiratory depression) and
purple discolouration of the skin and mucous membranes (cyanosis) may occur.
There is no specific antidote for ibuprofen overdose.

If you forget to take Ibuprofen Dermogen
Do not take a double dose to make up for a forgotten tablet
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 Dermogen can cause side effects, although not everybody gets
them.
With regard to the following side effects, it must be considered that they are largely dependent
on the dose and that they vary from patient to patient.
The most commonly observed side effects affect the digestive tract. Stomach/duodenal ulcers
(peptic ulcers), perforation or bleeding, sometimes fatal, may occur, especially in elderly
patients (see section 2: “Warnings and precautions”). Nausea, vomiting, diarrhoea, flatulence,
constipation, digestive complaints, abdominal pain, tarry stools, vomiting of blood, wounds
(ulceration) in the mouth and throat region (ulcerative stomatitis), worsening of colitis and
Crohn’s disease (see section 2: “Warnings and precautions”) have been reported after use. Less

commonly, inflammation of the stomach lining (gastritis) has been observed. In particular, the
risk of developing gastrointestinal bleeding depends on the dose level and duration of treatment.
Tissue fluid accumulation (oedema), high blood pressure and heart failure have been reported in
association with treatment with NSAIDs.
Medicines such as Ibuprofen Dermogen may be associated with a small increased risk of heart
attack ("myocardial infarction") or stroke.
Very common side effects (may affect more than 1 in 10 people):
 Gastrointestinal complaints such as heartburn, abdominal pain, nauseas, vomiting,
flatulence, diarrhea, constipation and slight blood losses in stomach and intestines that
may cause anemia in exceptional cases. Stop taking Ibuprofen Dermogen if you
experience relatively severe pain in the upper abdomen, vomiting blood, bloody stools
and/or black bowel movements and tell your doctor immediately.
Common side effects (may affect up to 1 in 10 people):
 Central nervous disturbances such as dizziness, headache, sleeplessness, agitation,
irritability or tiredness.
 Stomach or gut ulcer, potentially with bleeding and perforation (hole in the wall of the
digestive tract). Ulcerative stomatitis, worsening of colitis or Crohn’s disease
(inflammation of the colon).
Uncommon side effects (may affect up to 1 in 100 people):
 Visual disturbances.
 Tissue fluid accumulation (oedemas), particularly in patients with high blood pressure
(hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis that may
be accompanied by acute renal insufficiency (kidney failure). Renal function should
therefore be checked regularly.
 Inflammation of the stomach lining (gastritis).
 Allergic reactions such as skin rashes and itching, as well as asthma attacks (possibly
with drop of blood pressure). If you have any of these symptoms you should
immediately tell to your doctor.
Rare side effects (may affect up to 1 in 1,000 people):
 Ringing or buzzing in the ears (tinnitus).
 Difficulty hearing (hearing loss)
 Damage of kidney tissue (papillary necrosis), elevated uric acid concentration in the
blood, elevated urea concentration in the blood.
Very rare side effects (may affect up to 1 in 10,000 people):
 Disorders of blood cell formation, such as decrease in the amount of red blood cells or
hemoglobin (anemia), white blood cells (leukopenia) or in the platelets level
(thrombocytopenia); and other disorders of the blood (pancytopenia, agranulocytosis,
eosinophilia, coagulopathy, neutropenia, coagulopathy, aplastic anemia or hemolytic
anemia). The first symptoms may be fever, sore throat, superficial wounds in the mouth,
flu-like symptoms, severe fatigue, nasal and skin bleeding. The blood count should be
checked regularly in long-term therapy.
 Severe general allergic (hypersensitivity) reactions. These may manifest as: face
oedema, swelling of the tongue, laryngeal swelling with constriction of the airways,
difficulty breathing, rapid heartbeat and drop in blood pressure up to life threatening
shock. If you have any of these symptoms you should immediately seek medical help.
 Low level of blood sugar (hypoglycemia).
 Low level of sodium in blood (hyponatremia).













Palpitations (rapid heartbeat), heart failure, myocardial infraction.
Hypertension (high blood pressure).
Vascular inflammation (vasculitis).
Worsening of infection-related inflammations (e.g. 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 Dermogen, you must go to a doctor without delay.
Your doctor will study if you need an antibiotic therapy.
The symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting,
fever or clouding of consciousness have been observed under ibuprofen. Patients with
autoimmune disorders (SLE, mixed connective-tissue disease) appear to be predisposed.
Inflammation of oesophagus (gullet) or pancreas, narrowing of the bowel (intestinal
diaphragm-like strictures).
Psychotic reactions, hallucinations, confusion, depression and anxiety.
Asthma, difficulty breathing (dyspnea), bronchospasm.
Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage,
particularly in long-term therapy, acute hepatitis (inflammation of the liver).
Bullous reactions including Stevens-Johnson Syndrome and toxic epidermal necrolysis
(Lyell syndrome); Erythema multiforme; Severe skin infections and soft-tissue
complications may occur during a varicella infection, alopecia (losing hair), red or
purple discolored spots on the skin (purpura) or photosensitivity reactions (triggered by
sunlight).

Frequency not known (frequency cannot be estimated from the available data):
 Inflammation of nasal mucus (rhinitis).
 Pins and needles (paresthesia) and inflammation of the optic nerve (optic neuritis).
 Malfunction of the kidney.
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 Website: 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 Dermogen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer carton
after EXP. The expiry date refers to the last day of that month.

Ibuprofen Dermogen 600 mg film-coated tablets
Do not store above 30ºC
Do not throw away any medicines via wastewater. 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 Dermogen contains
-

The active substance is ibuprofen.

Each film-coated tablet contains 600 mg ibuprofen.
-

The other ingredients are:
Tablet core
Hypromellose, croscarmelose sodium, lactose monohydrate, microcrystalline cellulose,
pregelatinized starch (maize), colloidal anhydrous silica and magnesium stearate
Film-coating
Hypromellose, titanium dioxide (E171), talc and propylene glycol

What Ibuprofen Dermogen looks like and contents of the pack
Film-coated tablet.
White, oblong, biconvex film-coated tablets scored on both sides. The score line is not intended
for breaking the tablet.
Ibuprofen Dermogen 600 mg film-coated tablets is available in blisters in packs of 20, 30, 40
and 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dermogen Farma, S.A.
C/ Aragoneses, 15 Polígono
Ind. Alcobendas
28108 Alcobendas (Madrid),
Spain

Manufacturer
Frosst Ibérica, S.A.
Vía Complutense, 140, Alcalá de Henares,
28805 Madrid
Spain
Farmalider, S.A
C/Aragoneses, Alcobendas 15
28108 Madrid
Spain
This leaflet was last revised in May 2017.

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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