Package leaflet: Information for the patient

Ibuprofen Dermogen, 400 mg, film-coated tablets
For use in adults and adolescents over 12 years of age (with body weight ≥ 40 kg)
Ibuprofenum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Ibuprofen Dermogen is and what it is used for
Important information before taking 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 known as non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen Dermogen is used for:

symptomatic treatment of mild to moderate pain and (or) fever.
symptomatic treatment of pain and inflammation in inflammatory joint diseases (e.g. rheumatoid arthritis), degenerative joint diseases, and painful swelling and inflammation following soft tissue injuries.

2. Important information before using Ibuprofen Dermogen

When not to use Ibuprofen Dermogen:

if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
if the patient has ever experienced asthma, bronchial asthma, hay fever, angioedema or urticaria after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
if the patient has kidney, liver or heart failure.
if the patient has unexplained blood disorders.
if the patient has bleeding in the brain or any other active bleeding.
if the patient has ever had gastrointestinal bleeding or perforation after taking NSAIDs.
if the patient currently has or has a history of recurrent peptic ulcers and/or duodenal ulcers or gastrointestinal bleeding (at least two confirmed episodes of ulcers or bleeding).
if the patient has severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
if the patient is in the last trimester of pregnancy.
if the patient is a child under 12 years of age or an adolescent weighing less than 40 kg.

Warnings and precautions
Before starting treatment with Ibuprofen Dermogen, discuss this with your doctor or pharmacist.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a slightly increased risk of myocardial infarction or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before starting treatment with Ibuprofen Dermogen, discuss this with your doctor or pharmacist:

if the patient has heart disease, including heart failure, angina pectoris, a history of myocardial infarction, coronary artery bypass grafting, peripheral arterial disease (circulatory disorders in legs or feet due to narrowed or blocked arteries), or any stroke (including mini-stroke or transient ischaemic attack "TIA").
if the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or smokes tobacco.
if the patient has systemic lupus erythematosus (SLE) or connective tissue disease (autoimmune disorders affecting connective tissue).
if the patient has certain inherited blood disorders (e.g. acute intermittent porphyria).
if the patient has impaired liver or kidney function.
if the patient has recently undergone major surgery.
if the patient has hypersensitivity (allergy) to other substances.
if the patient has hay fever, nasal polyps or chronic obstructive respiratory diseases, as there is a higher risk of allergic reactions. These may include asthma attacks (analgesic-induced asthma), Quincke's oedema or urticaria.
if the patient has an infection – see below, section titled “Infections”.

Infections
Ibuprofen Dermogen may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen Dermogen may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient takes this medicine during an existing infection and symptoms persist or worsen, consult a doctor immediately.
Gastrointestinal safety
Avoid using Ibuprofen Dermogen concomitantly with other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors.
Elderly patients:
Adverse effects associated with NSAIDs are more frequently observed in elderly patients. In particular, gastrointestinal bleeding and perforation, which in some cases may be life-threatening, may occur.
Gastrointestinal bleeding, ulcers and perforation:
Cases of gastrointestinal bleeding, ulceration and perforation have been reported with all NSAIDs. These events may occur at any time during treatment, with or without warning symptoms or previous serious gastrointestinal adverse reactions.
The risk of gastrointestinal bleeding, ulceration or perforation increases with higher NSAID doses and in patients with a history of peptic ulcer disease, especially with complications such as bleeding or perforation (see section 2: “When not to use Ibuprofen Dermogen”) and in elderly patients. In these patients, treatment should be initiated at the lowest available dose. In such patients, and in those requiring additional treatment with low-dose acetylsalicylic acid or other drugs increasing gastrointestinal risk, consider concomitant treatment with gastroprotective agents (e.g. misoprostol or proton pump inhibitors).
If the patient has ever experienced gastrointestinal adverse effects, especially if elderly, the patient should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment.
Caution is advised if the patient is taking other medicines that may increase the risk of ulcers or bleeding, e.g. oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (used to treat psychiatric disorders such as depression) or antiplatelet agents (e.g. salicylic acid) (see section 2: “Ibuprofen Dermogen and other medicines”).
If gastrointestinal bleeding or ulcers occur during treatment with Ibuprofen Dermogen, treatment should be discontinued and medical advice sought immediately.
NSAIDs should be used with caution in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), as these conditions may worsen (see section 4).
Skin reactions
Severe skin reactions associated with the use of Ibuprofen Dermogen have been reported. If any skin rash, mucosal lesions, blisters or other signs of hypersensitivity appear, discontinue Ibuprofen Dermogen immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. See section 4.
Avoid using Ibuprofen Dermogen in cases of chickenpox.
Other precautions
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. If the first signs of hypersensitivity occur after taking Ibuprofen Dermogen, treatment must be stopped immediately and a doctor must be informed without delay.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be closely monitored.
Regular monitoring of liver function, kidney function and blood morphology is required during long-term treatment with Ibuprofen Dermogen.
Patients should inform their doctor or dentist about taking Ibuprofen Dermogen before undergoing any surgical procedure.
Long-term use of all painkillers for headache may lead to worsening of headaches. If such a situation occurs or is suspected, consult a doctor and discontinue the medicine. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of painkillers.
Regular use of painkillers, especially combinations of several active analgesic substances, may lead to permanent kidney damage and risk of organ failure (analgesic nephropathy). This risk may increase with physical exertion associated with loss of salts and dehydration. Therefore, it should be avoided.
The risk of kidney failure is higher in dehydrated patients, elderly patients and those taking diuretics and ACE inhibitors.
Ibuprofen may mask symptoms of infection.
Patients reporting eye disturbances during treatment with ibuprofen should discontinue treatment and undergo ophthalmological examination.

Ibuprofen Dermogen and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Ibuprofen Dermogen may affect other medicines, and other medicines may affect the action of this medicine. For example:

Anticoagulants (i.e. blood thinners or agents preventing clots, e.g. acetylsalicylic acid, warfarin, ticlopidine)
Medicines lowering blood pressure (ACE inhibitors, e.g. captopril, beta-blockers, e.g. atenolol, or angiotensin II receptor antagonists, e.g. losartan)

Ibuprofen Dermogen may also interact with other medicines, and other medicines may affect the action of this medicine. Always consult a doctor or pharmacist before using Ibuprofen Dermogen with other medicines.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

Other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (e.g. celecoxib) or glucocorticoids, as they may increase the risk of gastric and duodenal ulcers and bleeding due to additive effects.
Diuretics and antihypertensive medicines, as NSAIDs may reduce the effectiveness of these drugs and increase the risk of kidney disease. Furthermore, using potassium-sparing diuretics may lead to increased potassium levels. Therefore, serum potassium levels should be monitored.
Ibuprofen Dermogen may reduce the effectiveness of ACE inhibitors (used to treat heart failure and high blood pressure). Moreover, when these drugs are used concomitantly, there is an increased risk of kidney dysfunction.
Digoxin (used to treat heart failure), phenytoin (used to treat epilepsy) or lithium (used to treat depression), as ibuprofen may increase blood levels of these medicines. Serum lithium levels should be monitored. Serum digoxin and phenytoin levels should also be monitored.
Methotrexate (used to treat certain cancers and rheumatism), as its effects may be enhanced.
Anticoagulant medicines (blood thinners). NSAIDs may enhance the effect of these drugs.
Antiplatelet agents, e.g. acetylsalicylic acid and certain antidepressants (selective serotonin reuptake inhibitors, SSRIs), which may increase the risk of gastrointestinal bleeding.
Medicines containing probenecid and sulfinpyrazone (used to treat gout), as they may delay the elimination of ibuprofen.
Immunosuppressants, e.g. cyclosporine and tacrolimus, as they may cause kidney damage.
Cholestyramine (a medicine used to lower cholesterol levels), as it may inhibit the absorption of ibuprofen from the gastrointestinal tract. However, the clinical significance of this observation is unknown.
Sulfonylurea derivatives (medicines used to treat diabetes), e.g. glibenclamide. When used concomitantly, blood glucose levels should be monitored.
Antibiotics known as quinolones, e.g. ciprofloxacin, due to an increased risk of seizures.
Voriconazole or fluconazole (CYP2C9 inhibitors) used to treat fungal infections, as they may increase ibuprofen blood levels. Consider reducing the ibuprofen dose, especially if ibuprofen is administered at high doses with voriconazole or fluconazole.
Zidovudine (an antiviral medicine used to treat HIV infection), due to increased risk of haemarthrosis and purpura in HIV-positive patients with haemophilia.
Aminoglycosides (a class of antibiotics). NSAIDs may inhibit the excretion of aminoglycosides.
Ginkgo biloba (herbal preparation) may increase the risk of bleeding.

Using Ibuprofen Dermogen with alcohol
Patients who consume alcohol are more susceptible to adverse effects, such as gastrointestinal and central nervous system disturbances.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
If the patient becomes pregnant while taking Ibuprofen Dermogen, inform the doctor immediately.
During the first and second trimesters of pregnancy, ibuprofen should be used only if absolutely necessary. In such cases, the lowest possible dose should be used and treatment duration kept to a minimum.
During the last three months of pregnancy, this medicine MUST NEVER be taken, as ibuprofen may have very serious, even fatal, effects on the baby's heart and kidneys, even after a single dose.
Breastfeeding
The medicine passes into breast milk but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.
Fertility
Ibuprofen may impair fertility. Inform the doctor if the patient plans to become pregnant or has difficulty conceiving.
Driving and operating machinery
Ibuprofen has no effect or a negligible effect on the ability to drive motor vehicles and operate machinery. However, since adverse effects affecting the central nervous system, such as fatigue and dizziness, may occur when high doses are used, reaction time and the ability to actively participate in road traffic and operate machinery may be limited in individual cases. This is particularly important when alcohol is consumed concurrently.
Ibuprofen Dermogen contains lactose
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before using this medicine.

3. How to use Ibuprofen Dermogen

This medicine should always be used as directed by a physician. In case of doubt, consult a doctor or pharmacist.
The dose should be adjusted according to the patient's age or body weight.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Recommended dose:
Pain and (or) fever
Adults and adolescents over 12 years of age (body weight ≥ 40 kg):
Initial dose: 400 mg of ibuprofen. Additional doses of 400 mg ibuprofen may be administered if needed. The interval between doses should be based on observed symptoms and the maximum recommended daily dose. The interval between doses should not be less than 6 hours. Do not exceed a total daily dose of 1200 mg ibuprofen.

Rheumatic diseases
Adults
Recommended dose: 1200–1800 mg per day in divided doses. For some patients, a maintenance dose of 600–1200 mg per day may be sufficient. In severe or acute conditions, the dose may be increased until the acute phase is controlled, provided that the total daily dose does not exceed 2400 mg in divided doses.

Age Single dose Maximum daily dose
400–800 mg 1200–2400 mg
Adults
ibuprofen ibuprofen
(1–2 tablets) (3–6 tablets)

Adolescents aged 15 to 17 years
The recommended dose should be adjusted based on body weight: 20–40 mg/kg body weight per day (maximum 2400 mg per day) in 3 to 4 divided doses.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see section 4.4).

Special patient groups
Elderly patients:
Dose adjustment is not necessary. Due to the possible adverse effect profile, close monitoring of elderly patients is recommended.

Renal impairment:
Dose adjustment is not necessary in patients with mild to moderate renal dysfunction (for patients with severe renal dysfunction, see section 2: "When not to use Ibuprofen Dermogen").

Hepatic impairment:
Dose adjustment is not necessary in patients with mild to moderate hepatic dysfunction (for patients with severe hepatic dysfunction, see section 2: "When not to use Ibuprofen Dermogen").

Children and adolescents
The use of Ibuprofen Dermogen 400 mg film-coated tablets is contraindicated in children under 12 years of age and adolescents with body weight below 40 kg.

Method of administration
Ibuprofen Dermogen is intended for oral use. Tablets should be swallowed whole with a glass of water.
Patients with a sensitive stomach are advised to take Ibuprofen Dermogen with food.

Duration of treatment
The duration of treatment should be determined by the treating physician.
In rheumatic diseases, long-term use of Ibuprofen Dermogen may be required.

Accidental overdose of Ibuprofen Dermogen
In case of suspected overdose, contact a doctor immediately.
Symptoms may include headache, dizziness, drowsiness, and loss of consciousness (including myoclonic seizures in children), as well as abdominal pain, nausea, vomiting, gastrointestinal bleeding, liver and kidney dysfunction. Additionally, hypotension, respiratory depression (slowed breathing), and bluish discoloration of the skin and mucous membranes (cyanosis) may occur.

If a patient has taken more than the recommended dose of Ibuprofen Dermogen, or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.

Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties have been reported.
There is no specific antidote for ibuprofen overdose.

Missed dose of Ibuprofen Dermogen
Do not take a double dose to make up for a missed tablet.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects largely depend on the dose administered and may vary in severity among different patients.
The most commonly observed adverse effects involve the gastrointestinal tract. Gastric and (or) duodenal ulcers, perforation or bleeding, sometimes leading to death, may occur, particularly in elderly patients (see section 2: "Warnings and precautions"). After administration of the medicine, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, oral and pharyngeal lesions (ulceration of the oral mucosa), and exacerbation of colitis or Crohn's disease (see section 2: "Warnings and precautions") have been reported. Gastritis has been observed less frequently.
The risk of gastrointestinal bleeding particularly depends on the dose and duration of treatment.
Fluid retention (oedema), hypertension, and heart failure have been reported with the use of NSAIDs.
Medicines such as Ibuprofen Dermogen may be associated with a slightly increased risk of myocardial infarction or stroke.

Very common adverse effects (may affect more than 1 in 10 people):

Gastrointestinal disturbances, e.g. heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, and minor gastrointestinal blood loss, which in rare cases may lead to anaemia. If moderate or severe upper abdominal pain, haematemesis, or bloody and (or) melaena stools occur, Ibuprofen Dermogen should be discontinued immediately and a doctor should be consulted without delay.

Common adverse effects (may affect up to 1 in 10 people):

Central nervous system disturbances, e.g. dizziness, headache, insomnia, restlessness, irritability, or fatigue.
Gastric or duodenal ulcers, potentially with bleeding and perforation (a hole in the gastrointestinal wall). Ulcerative inflammation of the oral mucosa, exacerbation of colitis or Crohn's disease (inflammatory condition of the large intestine).

Uncommon adverse effects (may affect up to 1 in 100 people):

Visual disturbances.
Fluid retention (oedema), particularly in patients with hypertension, renal insufficiency, nephrotic syndrome, or interstitial nephritis, which may be accompanied by acute renal failure. Therefore, renal function should be monitored regularly.
Gastritis.
Allergic reactions with skin rash and itching, and also bronchospastic attacks (possibly with hypotension). If any of these symptoms occur, a doctor should be informed immediately.

Rare adverse effects (may affect up to 1 in 1000 people):

Tinnitus (ringing or buzzing in the ears).
Hearing disturbances (hearing loss).
Renal tissue damage (papillary necrosis), increased blood uric acid levels, increased blood urea levels.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Blood cell formation disorders, e.g. reduced number of red blood cells or haemoglobin concentration (anaemia), reduced number of white blood cells (leukopenia) or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anaemia or haemolytic anaemia). Initial symptoms may include fever, sore throat, superficial oral lesions, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. Blood morphology should be checked regularly during long-term treatment.
Severe generalized allergic (hypersensitivity) reactions. These may manifest as facial, tongue, or laryngeal oedema with airway constriction, respiratory failure, rapid heart rate, decreased blood pressure, and even life-threatening shock. If any of these symptoms occur, immediate medical attention is required.
Low blood sugar levels (hypoglycaemia).
Low blood sodium levels (hyponatraemia).
Palpitations (rapid heartbeat), heart failure, myocardial infarction.
Hypertension (high blood pressure).
Vasculitis (inflammation of blood vessels).
Exacerbation of infection-related inflammatory conditions (e.g. necrotizing fasciitis) has been reported during treatment with certain analgesic medicines (NSAIDs). If signs of infection occur or worsen during treatment with Ibuprofen Dermogen, immediate medical advice should be sought. The doctor will perform an examination and assess whether antibiotic treatment is necessary.
During ibuprofen treatment, subjective symptoms of aseptic meningitis have been observed, including neck stiffness, headache, nausea, vomiting, fever, or altered consciousness. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be particularly at risk.
Oesophagitis or pancreatitis, intestinal stricture (formation of diaphragm-like constrictions in the intestine).
Psychotic reactions, hallucinations, disorientation, depression, and anxiety.
Bronchial asthma, breathing disturbances (dyspnoea), bronchospasm.
Yellowing of the eyes and (or) skin (jaundice), liver function disturbances, liver damage, particularly with long-term treatment, acute hepatitis.
Bullous dermatitis, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome); erythema multiforme; severe skin infections and soft tissue complications may occur during varicella virus infection; alopecia; red or purple skin spots (purpura); or photosensitivity reactions (triggered by sunlight).

Frequency not known (frequency cannot be estimated from available data):

Inflammation of the nasal mucosa (rhinitis).
Tingling and numbness (paraesthesiae) and optic neuritis.
Renal function disturbances.
Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, lymphadenopathy, and increased eosinophil count (a type of white blood cell).
Erythematous, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, Ibuprofen Dermogen should be discontinued immediately and medical help should be sought without delay. See also section 2.
Skin becomes sensitive to light.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the representative of the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Ibuprofen Dermogen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after "Expiry date". The expiry date refers to the last day of the specified month.
Ibuprofen Dermogen, 400 mg, coated tablets:
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Ibuprofen Dermogen contains

The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
The other ingredients are:

Tablet core
Hypromellose 2910 (6 mPa·s), sodium croscarmellose, lactose monohydrate, microcrystalline cellulose,
pregelatinized corn starch, colloidal anhydrous silica and magnesium stearate.

Coating of the tablet
Hypromellose 2910 (6 mPa·s), titanium dioxide (E 171), talc and propylene glycol.

What Ibuprofen Dermogen looks like and contents of the pack

Film-coated tablet.
White, elongated, biconvex film-coated tablets with a score line on both sides. The score line is not intended to divide the tablet into equal doses.
Ibuprofen Dermogen 400 mg film-coated tablets are available in blister packs (Aluminium/PVC/PVDC) containing 20, 30 and 60 film-coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Dermogen Farma, S.A.
C/ Aragoneses, 15
28108 Alcobendas, Madrid
Spain

Manufacturer
Frosst Ibérica, S.A.
Vía Complutense, 140,
E-28805 Alcalá de Henares, Madrid
Spain
Farmalider, S.A
C/Aragoneses, 15
28108 Alcobendas, Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Ibuprofen Dermogen

Ibuprofen dermogen