Ibuprofen Dermogen

Leaflet accompanying the packaging: patient information

Ibuprofen Dermogen, 400 mg, coated tablets

For use in adults and adolescents over 12 years of age (with a body weight of ≥ 40 kg)
Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ibuprofen Dermogen and what is it used for
• 2. Important information before taking Ibuprofen Dermogen
• 3. How to take Ibuprofen Dermogen
• 4. Possible side effects
• 5. How to store Ibuprofen Dermogen
• 6. Contents of the pack and other information

1. What is Ibuprofen Dermogen and what is it used for

Ibuprofen Dermogen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen Dermogen is used for:

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

2. Important information before taking Ibuprofen Dermogen

When not to 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 had breathing difficulties, asthma, hay fever, swelling, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• if you have kidney, liver, or heart failure.
• if you have unexplained blood disorders.
• if you have bleeding in the brain or other active bleeding.
• if you have ever had bleeding or perforation of the stomach or intestines after taking NSAIDs.
• if you have, currently or in the past, recurring stomach or duodenal ulcers or gastrointestinal bleeding (at least two confirmed cases of ulcers or bleeding).
• if you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• if you are in the last trimester of pregnancy.
• if you are a child under 12 years of age or an adolescent with a body weight below 40 kg.

Warnings and precautions

Before starting treatment with Ibuprofen Dermogen, discuss it with your doctor or pharmacist.
Side effects can be minimized by taking the smallest effective dose for the shortest necessary time.
Taking anti-inflammatory and pain-relieving medicines like ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.
Before starting treatment with Ibuprofen Dermogen, discuss it with your doctor or pharmacist:

• if you have heart disease, including heart failure, angina, or a history of heart attack, coronary artery bypass grafting, peripheral arterial disease (circulatory problems in the legs or feet due to narrowed or blocked arteries), or any stroke (including mini-stroke or transient ischemic attack "TIA").
• if you have high blood pressure, diabetes, high cholesterol, heart disease, or a history of stroke in your family, or if you smoke.
• if you have systemic lupus erythematosus (SLE) or connective tissue disease (autoimmune diseases affecting connective tissue)
• if you have certain inherited blood disorders (e.g. acute intermittent porphyria).
• if you have liver or kidney function disorders
• if you have undergone major surgery
• if you have an allergy (hypersensitivity) to other substances
• if you have hay fever, nasal polyps, or chronic obstructive respiratory diseases, as there is a greater risk of allergic reactions. They can take the form of an asthma attack (asthma caused by painkillers), Quincke's edema, or hives
• if you have an infection - see below, section entitled "Infections".

Infections
Ibuprofen Dermogen may mask the symptoms of an infection, such as fever and pain. As a result, Ibuprofen Dermogen may delay the use of appropriate infection treatment, and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you are taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, you should consult your doctor immediately.
Gastrointestinal safety
It is recommended to avoid taking Ibuprofen Dermogen at the same time as other nonsteroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors.
Elderly:
Older adults are more likely to experience side effects related to NSAID use. In particular, gastrointestinal bleeding and perforation can occur, which in some cases can be life-threatening.
Gastrointestinal bleeding, ulcers, and perforation:
There have been reports of gastrointestinal bleeding, ulcers, and perforation associated with all NSAIDs. Such events can occur at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulcers, or perforation increases with the dose of NSAIDs and in patients with a history of ulcers, especially if complicated by bleeding or perforation (see section 2: "When not to take Ibuprofen Dermogen").
As with other NSAIDs, elderly patients are at a higher risk of gastrointestinal side effects. For these patients, treatment should be started with the lowest available dose. For these patients, as well as those requiring concomitant use of low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal side effects, it is recommended to consider combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors).
If a patient has ever experienced gastrointestinal side effects, especially if they are elderly, the patient should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.
Caution is recommended if the patient is taking other medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents (e.g. acetylsalicylic acid) (see section 2: "Ibuprofen Dermogen and other medicines").
In case of gastrointestinal bleeding or ulcers during treatment with Ibuprofen Dermogen, treatment should be discontinued and a doctor consulted.
NSAIDs should be used with caution in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), as they may worsen the disease (see section 4).
Skin reactions
Severe skin reactions have been reported with Ibuprofen Dermogen. If a skin rash, mucosal lesions, blisters, or other signs of hypersensitivity occur, the patient should stop taking Ibuprofen Dermogen and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
It is recommended to avoid taking Ibuprofen Dermogen in case of chickenpox.
Other notes
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. After the first symptoms of a hypersensitivity reaction to Ibuprofen Dermogen, treatment should be discontinued and a doctor consulted immediately.
Ibuprofen may temporarily inhibit platelet aggregation. Patients with coagulation disorders should be closely monitored.
During long-term treatment with Ibuprofen Dermogen, regular monitoring of liver function, kidney function, and blood morphology is necessary.
During treatment with Ibuprofen Dermogen, the patient should inform their doctor or dentist before undergoing any surgical procedure.
Long-term use of all painkillers for headaches can lead to their worsening. If this occurs or is suspected, the patient should consult their 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.
In general, habitual use of painkillers, especially multiple pain-relieving substances in combination, can lead to permanent kidney damage and an increased risk of kidney failure (analgesic nephropathy). This risk can increase with physical exertion associated with salt and dehydration loss. Therefore, it should be avoided.
The risk of kidney failure is higher in dehydrated patients, the elderly, and those taking diuretics and ACE inhibitors.
Ibuprofen may mask the symptoms of an infection.
Patients reporting eye disorders during ibuprofen treatment should discontinue treatment and undergo an ophthalmological examination.

Ibuprofen Dermogen and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Ibuprofen Dermogen may affect other medicines, and other medicines may affect the action of this medicine. For example:

• Anticoagulants (i.e. blood thinners or anticoagulants, e.g. acetylsalicylic acid, warfarin, ticlopidine)
• Blood pressure-lowering medicines (ACE inhibitors, e.g. captopril, beta-blockers, e.g. atenolol, or angiotensin II receptor antagonists, e.g. losartan)

Ibuprofen Dermogen may also affect other medicines, and other medicines may affect the action of this medicine. Before taking Ibuprofen Dermogen with other medicines, always consult your doctor or pharmacist.
In particular, inform 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 corticosteroids, as they may increase the risk of stomach ulcers and duodenal ulcers and bleeding, due to additive action.
• Diuretics and blood pressure-lowering medicines (hypotensive), as NSAIDs may weaken the effect of these medicines and may increase the risk of kidney disease. Additionally, the use of potassium-sparing diuretics may lead to an increase in potassium levels in the blood. Therefore, monitoring of potassium levels in the blood is recommended.
• Ibuprofen Dermogen may weaken the effect of ACE inhibitors (used to treat heart failure and high blood pressure). Additionally, if these medicines are taken together, there is a greater risk of kidney function disorders.
• Digoxin (used to treat heart failure), phenytoin (used to treat epilepsy), or lithium (used to treat depression), as ibuprofen may increase the levels of these medicines in the blood. Monitoring of lithium levels in the blood is recommended. Monitoring of digoxin and phenytoin levels in the blood is recommended.
• Methotrexate (used to treat certain cancers and rheumatism), as it may increase its effect.
• Anticoagulants (blood thinners). NSAIDs may enhance the effect of these medicines.
• Antiplatelet agents, e.g. acetylsalicylic acid, and certain antidepressants (selective serotonin reuptake inhibitors, SSRIs), may increase the risk of gastrointestinal bleeding.
• Medicines containing probenecid and sulfinpyrazone (used to treat gout) may delay the excretion 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 these medicines are taken together, it is recommended to monitor blood glucose levels.
• Quinolone antibiotics, 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 levels in the blood. It is recommended to consider reducing the dose of ibuprofen, especially if ibuprofen is administered in high doses with voriconazole or fluconazole.
• Zidovudine (an antiviral medicine used to treat HIV infections) due to an increased risk of bleeding into the joints and bruising in HIV-positive patients with hemophilia.
• Aminoglycosides (a type of antibiotic). NSAIDs may inhibit the excretion of aminoglycosides.
• Ginkgo biloba (a herbal preparation) may increase the risk of bleeding.

Taking Ibuprofen Dermogen with alcohol

Patients who consume alcohol are more likely to experience side effects, such as gastrointestinal disorders and central nervous system disorders.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you become pregnant while taking Ibuprofen Dermogen, inform your doctor.
In the first and second trimester of pregnancy, the doctor will prescribe ibuprofen only if it is absolutely necessary. In such cases, the lowest dose should be used and the duration of treatment should be as short as possible.
In the last three months of pregnancy, THIS MEDICINE SHOULD NOT BE TAKEN, as ibuprofen may have a very serious, potentially life-threatening effect on the baby's heart and kidneys, even after a single dose.
Breastfeeding
The medicine passes into breast milk, but it can be used during breastfeeding if the recommended dose is used and for as short a time as possible.
Fertility
Ibuprofen may make it more difficult to become pregnant. Inform your doctor if you plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

Ibuprofen has no or negligible influence on the ability to drive and use machines. However, as with other NSAIDs, when taking high doses of the medicinal product, side effects related to the central nervous system, such as drowsiness and dizziness, may occur. In individual cases, reaction time and the ability to actively participate in traffic and operate machinery may be impaired. This is especially important when consuming alcohol.

Ibuprofen Dermogen contains lactose

If you have been told that you have an 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. If you are not sure, ask your doctor or pharmacist.
The dose should be adjusted according to the patient's age or body weight.
Use the smallest effective dose for the shortest necessary time to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Recommended dose:
Pain and/or fever
Adults and adolescents over 12 years of age (with a body weight of ≥ 40 kg):
Initial dose: 400 mg of ibuprofen. If necessary, additional doses of 400 mg of ibuprofen can be taken. The intervals between doses should be determined based on the observed symptoms and the maximum recommended daily dose. The interval between doses should not be less than 6 hours. Do not exceed a total dose of 1200 mg of ibuprofen per day.
Rheumatic diseases
Adults
Recommended dose is 1200–1800 mg per day in divided doses. In some patients, a maintenance dose of 600–1200 mg per day may be sufficient. In severe or acute conditions, it may be beneficial 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 Single dose Maximum daily dose

1200–2400 mg
of ibuprofen
(3–6 tablets)
Adolescents from 15 to 17 years old
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.
Side effects can be minimized by taking the lowest effective dose for the shortest necessary time to relieve symptoms (see section 4.4).
Special patient groups
Elderly patients:
No dose adjustment is necessary. Due to the possible side effect profile, it is recommended to closely monitor elderly patients.
Kidney failure:
400–800 mg
of ibuprofen
(1–2 tablets)
Adults
No dose adjustment is necessary for patients with mild and moderate kidney function disorders (patients with severe kidney function disorders, see section 2: "When not to take Ibuprofen Dermogen").
Liver failure:
No dose adjustment is necessary for patients with mild and moderate liver function disorders (patients with severe liver function disorders, see section 2: "When not to take Ibuprofen Dermogen").

Children and adolescents

The use of Ibuprofen Dermogen 400 mg coated tablets is contraindicated in children under 12 years of age and adolescents with a body weight below 40 kg.
Method of administration
Ibuprofen Dermogen is intended for oral use. The tablets should be swallowed whole with a glass of water.
It is recommended that patients with sensitive stomachs take Ibuprofen Dermogen with food.
Duration of treatment
The duration of treatment is determined by the doctor.
In rheumatic diseases, treatment with Ibuprofen Dermogen may be required for a longer period.

Overdose of Ibuprofen Dermogen

In case of suspected overdose of Ibuprofen Dermogen, contact a doctor immediately.
Symptoms may include headache, dizziness, sleepiness, and loss of consciousness (also myoclonic seizure in children), as well as abdominal pain, nausea, vomiting, gastrointestinal bleeding, liver function disorders, and kidney function disorders. Additionally, decreased blood pressure, slowed breathing (respiratory depression), and blue discoloration of the skin and mucous membranes (cyanosis) may occur.
If you have taken more than the recommended dose of Ibuprofen Dermogen or if a child has accidentally taken the medicine, you should always consult a doctor or go to the nearest hospital to get advice on the possible risk to your health and the actions to be taken in such a case.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, rapid heartbeat, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred, as well as blood in the urine, feeling cold, and breathing difficulties.
There is no specific antidote in case of ibuprofen overdose.

Missed dose of 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.
In the case of the following side effects, it should be remembered that they are largely dose-dependent, and their severity varies from patient to patient.
The most common side effects are related to the gastrointestinal tract. Stomach and/or duodenal ulcers, perforation, or bleeding may occur, sometimes leading to death, especially in elderly patients (see section 2: "Warnings and precautions"). After taking the medicine, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, and mouth ulcers have been reported. Less frequently, gastritis has been observed. The risk of gastrointestinal bleeding depends in particular on the dose and duration of treatment.
With the use of NSAIDs, cases of fluid retention (edema), high blood pressure, and heart failure have been reported.
Medicines like Ibuprofen Dermogen may be associated with a slightly increased risk of heart attack or stroke.
Very common side effects (may affect more than 1 in 10 people):

• Gastrointestinal disorders, such as heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding, which in rare cases may lead to anemia. If you experience relatively severe abdominal pain, bloody vomiting, or black and/or tarry stools, you should stop taking Ibuprofen Dermogen and consult your doctor immediately.

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

• Central nervous system disorders, such as dizziness, headache, insomnia, restlessness, irritability, or fatigue.
• Stomach or duodenal ulcers, potentially with bleeding and perforation (a hole in the wall of the gastrointestinal tract). Mouth ulcers, worsening of ulcerative colitis or Crohn's disease (inflammatory bowel disease).

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

• Vision disorders.
• Fluid retention (edema), especially in patients with high blood pressure or kidney failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure. Therefore, regular monitoring of kidney function is recommended.
• Gastritis.
• Allergic reactions with skin rash and itching, as well as asthma attacks (possibly with a drop in blood pressure). If any of these symptoms occur, consult your doctor immediately.

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

• Ringing or buzzing in the ears (tinnitus).
• Hearing disorders (hearing loss).
• Kidney tissue damage (renal papillary necrosis), elevated uric acid levels in the blood, elevated urea levels in the blood.

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

• Blood disorders, such as a decrease in the number of red blood cells or hemoglobin level (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anemia, or hemolytic anemia). The first symptoms may be fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and bleeding from the skin. During long-term treatment, regular blood morphology tests should be performed.
• Severe generalized allergic reactions (hypersensitivity). They can take the form of facial swelling, tongue and throat swelling with narrowing of the airways, respiratory failure, rapid heartbeat, decreased blood pressure, and life-threatening shock. If any of these symptoms occur, consult your doctor immediately.
• Low blood sugar levels (hypoglycemia).
• Low sodium levels in the blood (hyponatremia).
• Rapid heartbeat (tachycardia), heart failure, heart attack.
• High blood pressure (hypertension).
• Vasculitis.

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

• Rhinitis (nasal inflammation).
• Paresthesia (tingling and numbness) and optic neuritis.
• Kidney function disorders.
• Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• A red scaly rash with thickening of the skin and blisters, usually located in skin folds, on the trunk, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking Ibuprofen Dermogen and seek medical attention immediately. See also section 2.
• The skin becomes sensitive to light.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the representative of the marketing authorization holder.
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 stated on the carton after "EXP". The expiry date refers to the last day of that month.
Ibuprofen Dermogen, 400 mg, coated tablets:
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 (6mPas), sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, maize starch, colloidal anhydrous silica, and magnesium stearate
Coating
Hypromellose 2910 (6mPas), titanium dioxide (E 171), talc, and propylene glycol

What Ibuprofen Dermogen looks like and contents of the pack

Coated tablet.
White, oblong, biconvex coated tablets with a break line on both sides. The break line is not intended for breaking the tablet.
Ibuprofen Dermogen, 400 mg, coated tablets are available in blisters (Aluminum/PVC/PVDC) of 20, 30, and 60 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Poland
Ibuprofen Dermogen
Date of last revision of the leaflet: 12/2020