IBUPROFEN DERMOGEN 400 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

For use in adults and adolescents from 12 years of age (> 40 kg body weight) 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. What Ibuprofen Dermogen is and what it is used for

• 2. What you need to know before you take 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 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 400 mg film-coated tablets]:

• – the symptomatic treatment of mild to moderate pain and/or fever.

• – the symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), and in painful swelling and inflammation after soft tissue injuries.

2. what you need to know before you take - 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 400 mg film-coated tablets]:

• – If the patient is a child younger than 12 years or an adolescent below 40 kg body weight

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.

• have an infection – please see heading “Infections” below.

Infections

Ibuprofen Dermogen may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen Dermogen may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

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

Serious skin reactions have been reported in association with Ibuprofen Dermogen treatment. You should stop taking Ibuprofen Dermogen and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

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 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 400 mg film-coated tablets]:

Pain and/or fever

Adults and adolescents from 12 years of age (> 40 kg body weight):

Initial dose should be of 400 mg ibuprofen. If necessary, additional doses of 400 mg ibuprofen can be taken. The respective dosing interval should be chosen in line with the observed symptoms and the maximum recommended daily dose. It should not be below 6 hours. A total dose of 1200 mg ibuprofen should not be exceeded in any 24-hour period.

Rheumatic diseases

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

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.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

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 400 mg film-coated tablets]:

Ibuprofen Dermogen 400 mg film-coated tablets is contraindicated in children younger than 12 years of age and in adolescents below 40 kg body weight.

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.

If you have taken more Ibuprofen Dermogen than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

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.
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen Dermogen if you develop these symptoms and seek medical attention immediately. See also section 2.

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 Yellow Card

Scheme at Website:

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 400 mg film-coated tablets:

Do not store above 30°C

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- the active substance is ibuprofen.

Each film-coated tablet contains 400 mg ibuprofen.

• – The other ingredients are:

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.

White, oblong, biconvex film-coated tablets.

Ibuprofen Dermogen 400 mg film-coated tablets is available in blisters in packs of 20, 30, and 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dermogen Farma, S.A.

C/ Aragoneses, 15 Pohgono

Ind. Alcobendas

28108 Alcobendas (Madrid),

Spain

Manufacturer

Rovi Pharma Industrial Services, S.A.

Via Complutense, 140, Alcala de Henares,

28805 Madrid

Spain

Farmalider, S.A

C/Aragoneses, 2

Alcobendas 28108

Madrid Spain

Toll Manufacturing Services S.L.

C/ Aragoneses N° 2,

28108 Alcobendas

Madrid, Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in January 2020