IBUPROFEN PEN*12SACH 400MG

IBUPROFEN PENSA PHARMA 400 mg granules for oral solution
Ibuprofen

Equivalent medicine

What it is and what it is used for
IBUPROFEN PENSA PHARMA contains the active ingredient ibuprofen, belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) which act by relieving pain (analgesic action) and lowering body temperature in febrile states (antipyretic action).

IBUPROFEN PENSA PHARMA is indicated in adults and adolescents over 12 years of age:
- for the treatment of pain of various origins and nature, e.g. headache, toothache, pain in one or more nerves (neuralgia), bone, joint and muscle pain (osteo-articular and muscular), menstrual pain;
- as an adjunct in the treatment of fever and flu symptoms.

Consult your doctor if you do not feel better or if you feel worse after three days.

What you need to know before taking the medicine
Do not take IBUPROFEN PENSA PHARMA
- if you are allergic to ibuprofen, acetylsalicylic acid, other analgesics (medicines used to relieve pain), antipyretics (medicines used to lower fever), NSAIDs (non-steroidal anti-inflammatory drugs, medicines used to treat inflammation) or any of the other ingredients of this medicine (listed in section 6);
- if you are under 12 years of age;
- if you are in the third trimester (7th-9th month) of pregnancy and/or if you are breastfeeding (See section Pregnancy, breastfeeding and fertility);
- if you suffer from even serious stomach and intestinal problems due to the presence of lesions (active or severe gastroduodenal ulcer), or if you suffer from other stomach disorders (gastropathies);
- if you have suffered in the past from stomach and intestinal disorders associated with bleeding (gastrointestinal haemorrhage, perforation related to previous active treatments or history of recurrent peptic haemorrhage/ulcer, with two or more distinct episodes of proven ulceration or bleeding);
- if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
- if you suffer from severe heart disorders (severe heart failure);
- If you suffer from phenylketonuria (a congenital error of amino acid metabolism, phenylalanine) (see section IBUPROFEN PENSA PHARMA contains sucrose, potassium and aspartame);
- If you are severely dehydrated (due to vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions
Consult your doctor or pharmacist before taking IBUPROFEN PENSA PHARMA.

The risk of side effects can be reduced by using the minimum effective dose for the shortest possible time.

Consult your doctor or pharmacist before taking IBUPROFEN PENSA PHARMA if:
- you are elderly because the risk of NSAID side effects, bleeding (haemorrhages) and stomach and/or intestinal perforations which can be fatal may increase;
- you notice the appearance of skin irritation (skin rash) or the formation of mucosal lesions. These symptoms can occur especially within the first month of treatment and some can be very serious, even fatal (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, see section Possible side effects). In this case, stop treatment with IBUPROFEN PENSA PHARMA;
- you are a woman planning a pregnancy, have fertility problems or are undergoing fertility investigations because you should stop treatment with IBUPROFEN PENSA PHARMA (see section Pregnancy, breastfeeding and fertility);
- you are taking other medicines (e.g. analgesics, antipyretics and other NSAIDs, such as acetylsalicylic acid, including selective COX-2 inhibitors) because they could lead to an increased risk of haemorrhage and ulceration (See section Other medicines and IBUPROFEN PENSA PHARMA);
- you have had an ulcer in the past, especially if complicated by bleeding or perforation (see section Do not take IBUPROFEN PENSA PHARMA), as the risk of bleeding, ulcer or perforation is higher with high doses of anti-inflammatory medicines (NSAIDs). These effects can be fatal and can occur at any time during treatment, with or without symptoms, especially if you are an elderly person and if you have suffered in the past from stomach disorders associated with lesions (ulcer). In this case you should start with the lowest dosage of IBUPROFEN PENSA PHARMA. As a precaution, your doctor may recommend medicines that have a protective action on the stomach (misoprostol or proton pump inhibitors), especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems);
- you are taking other medicines that increase the risk of ulcer or bleeding of the stomach and/or intestine, such as corticosteroids taken orally (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (serotonin inhibitors), or antiplatelet agents (e.g. aspirin). See also section Other medicines and IBUPROFEN PENSA PHARMA.
If bleeding or ulcer formation in the stomach and/or intestine occurs, discontinue treatment with this medicine - you have suffered from intestinal disorders in the past (ulcerative colitis, Crohn's disease);
- you suffer from asthma, runny nose (chronic rhinitis), presence of polyps in the nose (nasal polyposis) or inflammation of the nasal mucosa (sinusitis) or you suffer/have suffered from allergies because you could experience difficulty breathing (bronchospasm), skin redness with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after using other medicines used for the treatment of joint or muscle pain, fever or for the treatment of inflammation (NSAIDs);
- you have had bronchospasm after taking aspirin or other NSAIDs;
- you suffer or have suffered from heart disorders (heart failure) and high blood pressure because fluid retention, hypertension and oedema have been observed in association with NSAID treatment (See section Other medicines and IBUPROFEN PENSA PHARMA).

Anti-inflammatory/painkiller medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if administered at high doses. Do not exceed the recommended dose or duration of treatment. You should discuss therapy with your doctor or pharmacist before taking IBUPROFEN PENSA PHARMA if you have:
• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Also, consult your doctor or pharmacist:
• if you suffer from severe dehydration,
• if you have kidney disorders (reduced kidney function),
• if you suffer from a heart disease (heart failure),
• if you suffer from liver diseases (liver dysfunction),
• if you suffer from an autoimmune disease that can affect several organs and tissues of the body (systemic lupus erythematosus), or a connective tissue disease, present in many parts of the body, such as bones and cartilage, as in rare occasions symptoms of aseptic meningitis have been observed in patients treated with ibuprofen,
• if you are taking medicines to treat heart disease or high blood pressure (diuretics, ACE inhibitors - see section Other medicines and IBUPROFEN PENSA PHARMA), as you are more likely to experience permanent kidney damage and kidney disease. This risk is more likely with prolonged treatments. Your doctor will therefore prescribe tests to check kidney function,
• if you have blood clotting defects or if you are taking medicines that have an anticoagulant effect (See section Other medicines and IBUPROFEN PENSA PHARMA),
• if you have an infection - see section Infections below.

Infections
IBUPROFEN PENSA PHARMA may mask the symptoms of infections such as fever and pain. It is therefore possible that IBUPROFEN PENSA PHARMA may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Alcohol consumption can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal or nervous system. Avoid concomitant use of IBUPROFEN PENSA PHARMA with alcohol (see IBUPROFEN PENSA PHARMA with alcohol).
Medicines such as IBUPROFEN PENSA PHARMA may be associated with the appearance of even serious kidney diseases (such as renal papillary necrosis, analgesic nephropathy and kidney failure), so your doctor will monitor your kidney function;
Medicines such as IBUPROFEN PENSA PHARMA may be associated with ocular changes. This risk is more likely with prolonged treatments. Therefore, your doctor may prescribe periodic eye check-ups.

Skin reactions
Serious skin reactions have been reported in association with IBUPROFEN PENSA PHARMA treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP).
Stop using IBUPROFEN PENSA PHARMA and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Signs of an allergic reaction to this medicine have been reported with ibuprofen, including breathing problems, swelling of the face and neck area (angioedema) and chest pain. Stop IBUPROFEN PENSA PHARMA immediately and contact your doctor or emergency health service immediately if you notice any of these signs or if a rash, mucosal lesions, blisters or other signs of allergy appear, as these may be the first signs of a very serious skin reaction.
See section 4.

Children and adolescents
Do not give IBUPROFEN PENSA PHARMA to children under 12 years of age.
During treatment with IBUPROFEN PENSA PHARMA in dehydrated children and adolescents there is a risk of kidney failure.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop taking IBUPROFEN PENSA PHARMA and contact your doctor immediately if you experience any of the following conditions:
- Lesions of the stomach or intestinal wall (peptic ulcers), severe and sudden pain in the pit of the stomach or abdomen (gastrointestinal perforation) or bleeding from the stomach or intestine (gastrointestinal haemorrhage), sometimes fatal, particularly in the elderly. Gastrointestinal perforation with the use of ibuprofen has been observed rarely.
- Skin rashes (exanthema), skin eruption with redness (purpura), urticaria, itching, photosensitivity reactions, rapid swelling of subcutaneous and submucosal tissues (angioedema), severe asthma (sometimes with low blood pressure) and breathing difficulties (bronchospasm, dyspnoea, apnoea). Such conditions occur with uncommon frequency. Very rarely, a severe allergic reaction may also appear, characterized by an increase in heart rate (tachycardia) and anaphylaxis, swelling of the face, tongue, larynx, airways with breathing difficulties (bronchospasm, dyspnoea), skin lesions (including exfoliative and bullous dermatitis, Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme). In exceptional cases, severe skin infections and pathological complications of soft tissues can occur during chickenpox infection.
- Non-raised, target-shaped or circular reddish spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
- Drug reaction with eosinophilia (increase in the number of a type of white blood cells in the blood) and systemic symptoms (DRESS syndrome):
A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: widespread rash, high body temperature, enlarged lymph nodes and an increase in eosinophils (a type of white blood cell).
- Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
- Lupus erythematosus syndrome (disease affecting connective tissue causing joint or muscle pain, skin changes and problems with other organs). This condition occurs rarely.
- Inflammation of the meninges (aseptic meningitis). This condition occurs rarely.
- Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Common side effects (may affect up to 1 in 10 people)
- Dizziness
- Malaise, fatigue

Uncommon side effects (may affect up to 1 in 100 people)
- Increased stomach acidity (gastritis)
- Difficulty falling asleep (insomnia), anxiety
- Altered sensation (paraesthesia), drowsiness
- Inflammation of the nasal mucosa (rhinitis)
- Vision disturbances
- Impaired hearing, ringing in the ears (tinnitus), vertigo
- Altered liver function, yellowish discoloration of the eyes or skin (jaundice), inflammation of the liver (hepatitis)
- Impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis (kidney inflammation), nephrotic syndrome and kidney failure (altered kidney function)

Rare side effects (may affect up to 1 in 1,000 people)
- Decrease in the number of white blood cells (leukopenia), platelet count (thrombocytopenia), certain types of white blood cells (neutropenia, agranulocytosis), bone marrow problems (aplastic anaemia and haemolytic anaemia), inhibition of platelet aggregation
- Depression, confusion, hallucinations
- Altered vision due, for example, to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy
- Increased non-protein nitrogen in the blood (hyperazotemia)
- Swelling in a part of the body due to fluid accumulation (oedema)
- Increased levels of liver enzymes (transaminases and alkaline phosphatase), uric acid levels in the blood
- Prolonged bleeding time

Very rare side effects (may affect up to 1 in 10,000 people)
- inflammation of the pancreas (pancreatitis)
- feeling of heart in throat (palpitations), heart attack (myocardial infarction), reduced heart function (failure), increased fluid around the lungs (acute pulmonary oedema), high blood pressure (hypertension)
- reduced liver function (hepatic insufficiency)

Other side effects (frequency not known, frequency cannot be estimated from the available data)
- feeling of heaviness in the stomach, nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty in defecation (constipation), indigestion (dyspepsia), stomach pain, pain or burning in the pit of the stomach (heartburn), inflammation of the oral mucosa with ulcers (ulcerative stomatitis), abdominal pain, blood-containing vomit (haematemesis) or black stools (melena), worsening of colon inflammation (colitis) and Crohn's disease.
- widespread, red and scaly rash, with the formation of pustules under the skin and vesicles located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using IBUPROFEN PENSA PHARMA if you develop these symptoms and contact your doctor immediately.
See also section 2.

Medicines such as IBUPROFEN PENSA PHARMA may be associated with a modest increased risk of heart attack or stroke.