IBUPROFENE PEN "400 MG GRANULES FOR ORAL SOLUTION" 12 SACHETS"

Name
IBUPROFENE PENSA PHARMA 400 mg granules for oral solution
Ibuprofen

Equivalent medicine


What it is and what it is used for
IBUPROFENE 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 feverish states (antipyretic action).

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

Contact 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 IBUPROFENE 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 he is under 12 years old;
- if you are in the third trimester (7th-9th month) of pregnancy and/or if you are breast-feeding (See section "Pregnancy, breast-feeding and fertility");
- if you suffer from problems, even serious ones, of your stomach and intestines 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 bleeding, perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage, 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 problems (severe heart failure);
- If you suffer from phenylketonuria (an inborn error in the metabolism of an amino acid, phenylalanine) (see paragraph "IBUPROFENE PENSA PHARMA contains sucrose, potassium and aspartame");
- If you are severely dehydrated (due to vomiting, diarrhoea or not taking enough fluids).


Warnings and precautions
Talk to your doctor or pharmacist before taking IBUPROFENE PENSA PHARMA.

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

Talk to your doctor or pharmacist before taking IBUPROFENE PENSA PHARMA if:
- are elderly because they may increase the risk of developing adverse reactions to NSAIDs, bleeding (haemorrhages) and perforations of the stomach and/or intestine which can be fatal;
- notice the appearance of skin irritation (rash) or formation of mucosal lesions. These symptoms may occur especially within the first month of treatment and some may 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 IBUPROFENE PENSA PHARMA;
- you are a woman who is planning to become pregnant, has fertility problems or is undergoing investigation of fertility because you should stop treatment with IBUPROFENE PENSA PHARMA (see section "Pregnancy, breast-feeding and fertility");
- are taking other medicines (e.g. analgesics, antipyretics and other NSAIDs, such as acetylsalicylic acid, including selective COX-2 inhibitors) because they may lead to an increased risk of bleeding and ulceration (See the section "Other medicines and IBUPROFENE PENSA PHARMA");
- have had ulcers in the past, especially if complicated by bleeding or perforation (see section "Do not take IBUPROFENE PENSA PHARMA"), since the risk of bleeding, ulceration or perforation is higher with high doses of anti-inflammatory drugs (NSAIDs). These effects can be life-threatening and can occur at any time during treatment, with or without symptoms, especially if you are elderly and if you have suffered from stomach problems associated with lesions (ulcers) in the past. In this case, you should start with the lowest dose of IBUPROFENE PENSA PHARMA. As a precaution, your doctor may prescribe medicines that have a protective effect on the stomach (misoprostol or proton pump inhibitors), especially if you take other medicines (for example, aspirin or medicines that increase the risk of gastrointestinal problems);
- are taking other medicines that increase the risk of ulcers or bleeding in the stomach and/or intestines, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (serotonin inhibitors), or blood thinners (e.g. aspirin). See also the section "Other medicines and IBUPROFENE PENSA PHARMA".
If bleeding or ulcers occur in the stomach and/or intestines, stop taking this medicine - you have suffered from intestinal disorders in the past (ulcerative colitis, Crohn's disease);
- suffer from asthma, runny nose (chronic rhinitis), presence of polyps in the nose (nasal polyposis) or inflammation of the nasal mucosa (sinusitis) or suffer/have suffered from allergies because you may experience difficulty breathing (bronchospasm), redness of the skin with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after using other medicines used to treat joint or muscle pain, fever or to treat inflammation (NSAIDs);
- have had bronchospasm after taking aspirin or other NSAIDs;
- suffer or have suffered from heart problems (heart failure) and high blood pressure since fluid retention, hypertension and oedema have been reported in association with treatment with NSAIDs (See the section "Other medicines and IBUPROFENE PENSA PHARMA").

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when taken in high doses. Do not exceed the recommended dose or duration of treatment. You should discuss your treatment with your doctor or pharmacist before taking IBUPROFENE PENSA PHARMA if you have:
• heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including 'mini-stroke' or 'TIA', transient ischaemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Also, talk to your doctor or pharmacist:
• if you suffer from severe dehydration,
• if you have kidney problems (reduced kidney function),
• if you suffer from heart disease (heart failure),
• if you suffer from liver disease (liver dysfunction),
• if you suffer from an autoimmune disease that can affect various organs and tissues of the body (systemic lupus erythematosus), or a disease of the connective tissue, which is present in many parts of the body, such as bones and cartilage, as on 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 IBUPROFENE PENSA PHARMA"), as you are more likely to develop permanent kidney damage and kidney disease. This risk is more likely with prolonged treatments. Your doctor will therefore prescribe tests to check your kidney function,
• if you have blood clotting problems or if you are taking medicines that have an anticoagulant effect (See the section "Other medicines and IBUPROFENE PENSA PHARMA"),
• if you have an infection – see section “Infections” below.

Infections
IBUPROFENE PENSA PHARMA may hide the symptoms of infections such as fever and pain. It is therefore possible that IBUPROFENE PENSA PHARMA may delay adequate 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 get worse, contact your doctor immediately.

Alcohol consumption may intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or the nervous system. Avoid concomitant use of IBUPROFENE PENSA PHARMA with alcohol (see "IBUPROFENE PENSA PHARMA with alcohol").
Medicines such as IBUPROFENE PENSA PHARMA may be associated with the onset of even serious kidney disease (such as renal papillary necrosis, analgesic nephropathy and renal failure), therefore your doctor will monitor the function of your kidneys;
Medicines such as IBUPROFENE PENSA PHARMA may be associated with eye changes. This risk is more likely with prolonged treatments. Therefore, your doctor may prescribe periodic eye checks.

Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with IBUPROFENE PENSA PHARMA.
Stop using IBUPROFENE 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 (angioedema) and chest pain. Stop IBUPROFENE PENSA PHARMA immediately and contact your doctor or emergency services immediately if you notice any of these signs or if you develop a rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction.
See paragraph 4.

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


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

Stop taking IBUPROFENE PENSA PHARMA and contact your doctor immediately if you experience any of the following conditions:
- Lesions of the stomach or intestinal wall (peptic ulcers), sudden severe pain in the pit of the stomach or belly (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 rash with redness (purpura), hives, itching, photosensitivity reactions, rapid swelling of the tissues under the skin and under the mucous membranes (angioedema), severe asthma (sometimes with low blood pressure) and breathing difficulties (bronchospasm, dyspnoea, apnoea). These conditions occur uncommonly. Very rarely, a serious allergic reaction may also occur, characterised 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, serious skin infections and pathological complications of the soft tissues may occur during chickenpox infection.
- Non-raised, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
- Drug reaction with eosinophilia (increased number of a type of white blood cell in the blood) and systemic symptoms (DRESS syndrome):
A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: widespread rash, high body temperature, swollen lymph nodes, and increased eosinophils (a type of white blood cell).
- Widespread, red, 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 (a disease that affects the 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
- Changes in sensation (paraesthesia), drowsiness
- Inflammation of the nasal mucosa (rhinitis)
- Vision disturbances
- Impaired hearing, ringing in the ears (tinnitus), vertigo
- Changes in liver function, yellowing of the eyes or skin (jaundice), inflammation of the liver (hepatitis)
- Impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis (inflammation of the kidney), nephrotic syndrome and renal failure (changes in kidney function)

Rare side effects (may affect up to 1 in 1000 people)
- Decrease in the number of white blood cells (leukopenia), the number of platelets (thrombocytopenia), certain types of white blood cells (neutropenia, agranulocytosis), bone marrow problems (aplastic anaemia and haemolytic anaemia), inhibition of platelet aggregation
- Depression, confusion, hallucinations
- Changes in 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 (edema)
- Increased levels of liver enzymes (transaminases and alkaline phosphatase), uric acid levels in the blood
- Reduction of hemoglobin, hematocrit (percentage of blood volume occupied by red blood cells), calcium levels in the blood
- Prolongation of bleeding time

Very rare side effects (may affect up to 1 in 10,000 people)
- inflammation of the pancreas (pancreatitis)
- feeling of heart in the 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 (liver failure)

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 bowel movements (constipation), indigestion (dyspepsia), stomach pain, pain or burning in the pit of the stomach (heartburn), inflammation of the mucosa of the mouth with ulcers (ulcerative stomatitis), abdominal pain, vomiting containing blood (haematemesis) or black stools (melaena), worsening of inflammation of the colon (colitis) and Crohn's disease.
- widespread, red, scaly rash with pustules under the skin and blisters mainly located in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using IBUPROFENE PENSA PHARMA if you develop these symptoms and contact your doctor immediately.
See also paragraph 2.

Medicines such as IBUPROFENE PENSA PHARMA may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.