Package leaflet: Information for the patient

IBUPROFENE PENSA PHARMA 400 mg granules for oral solution

Ibuprofen
Equivalent medicine
Contents of this leaflet:

What IBUPROFENE PENSA PHARMA is and what it is used for
What you need to know before taking IBUPROFENE PENSA PHARMA
How to take IBUPROFENE PENSA PHARMA
Possible side effects
How to store IBUPROFENE PENSA PHARMA
Contents of the pack and other information

1. What IBUPROFENE PENSA PHARMA is and what it is used for

IBUPROFENE PENSA PHARMA contains the active substance ibuprofen, belonging to a group of
medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by relieving pain
(analgesic effect) and reducing body temperature in feverish conditions (antipyretic effect).
IBUPROFENE PENSA PHARMA is indicated in adults and adolescents over 12 years of age:

for the treatment of pain of various origin and nature, for example headache, toothache, nerve pain (neuralgia), bone, joint and muscle pain (osteo-articular and muscular pain), menstrual pain;
as an adjunct in the treatment of symptoms of fever and influenza.

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

2. What you need to know before taking IBUPROFENE PENSA PHARMA

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 reduce fever), NSAIDs (non-steroidal anti-inflammatory drugs, medicines used to treat inflammation), or to 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 have stomach or intestinal problems due to lesions (active or severe gastroduodenal ulcer), or if you suffer from other stomach disorders (gastropathies);
if you have previously experienced stomach or intestinal disorders associated with bleeding (gastrointestinal haemorrhage, perforation related to previous active treatments or history of recurrent peptic ulcer/bleeding, with two or more distinct episodes of proven ulceration or bleeding);
if you have severe liver or kidney problems (severe hepatic or renal insufficiency);
if you have severe heart problems (severe heart failure);
if you have phenylketonuria (a congenital metabolic disorder of the amino acid phenylalanine) (see section “IBUPROFENE PENSA PHARMA contains sucrose, potassium and aspartame”);
if you are severely dehydrated (due to vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions
Talk to your doctor or pharmacist before taking IBUPROFENE PENSA PHARMA.
The risk of unwanted 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:

you are elderly, as this may increase the risk of adverse reactions to NSAIDs, bleeding (haemorrhages) and perforations of the stomach and/or intestine, which can be fatal;
you notice the appearance of skin irritation (cutaneous rash) or lesions of the mucosa. 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 planning pregnancy, have fertility problems, or are undergoing fertility investigations, as you should discontinue treatment with IBUPROFENE 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), as they may increase the risk of bleeding and ulceration (see section “Other medicines and IBUPROFENE PENSA PHARMA”);
you have previously had an ulcer, 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 medicines (NSAIDs). These effects can be fatal and may occur at any time during treatment, with or without symptoms, especially if you are elderly or have previously suffered from stomach disorders associated with lesions (ulcer). In this case, you should start with the lowest dosage of IBUPROFENE PENSA PHARMA. As a precaution, your doctor may prescribe medicines that protect 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 in the stomach and/or intestine, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (serotonin reuptake inhibitors), or antiplatelet agents (e.g. aspirin). See also section “Other medicines and IBUPROFENE PENSA PHARMA”. If bleeding or ulceration occurs in the stomach and/or intestine, stop treatment with this medicine;
you have previously suffered from intestinal disorders (ulcerative colitis, Crohn’s disease);
you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis) or inflammation of the nasal mucosa (sinusitis), or have a history of allergies, as you may experience breathing difficulties (bronchospasm), skin redness with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines for joint or muscle pain, fever or inflammation (NSAIDs);
you have experienced bronchospasm after taking aspirin or other NSAIDs;
you suffer or have suffered from heart problems (heart failure) and high blood pressure, as fluid retention, hypertension and oedema have been reported in association with NSAID treatment (see section “Other medicines and IBUPROFENE PENSA PHARMA”). Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment. You should discuss treatment with your doctor or pharmacist before taking IBUPROFENE PENSA PHARMA if you have:
heart problems including heart attack, angina (chest pain) or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked 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.

In addition, talk to your doctor or pharmacist:

if you are severely dehydrated;
if you have kidney disorders (reduced kidney function);
if you suffer from heart disease (heart failure);
if you suffer from liver disease (hepatic dysfunction);
if you suffer from an autoimmune disease that can affect various organs and tissues of the body (systemic lupus erythematosus), or from a connective tissue disease present in many parts of the body, such as bones and cartilage, as in rare cases, 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 may be more likely to develop permanent kidney damage and kidney disease. This risk is more likely with prolonged treatment. Your doctor will therefore prescribe tests to monitor your kidney function;
if you have blood clotting disorders or are taking medicines with anticoagulant effects (see section “Other medicines and IBUPROFENE PENSA PHARMA”);
if you have an infection – see section “Infections” below.

Infections
IBUPROFENE PENSA PHARMA may mask symptoms of infections such as fever and pain. Therefore, IBUPROFENE PENSA PHARMA may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Alcohol consumption may intensify the unwanted effects of NSAIDs, especially those affecting the gastrointestinal tract or 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 kidney disorders, even severe ones (such as renal papillary necrosis, analgesic nephropathy and renal failure); therefore, your doctor will monitor your kidney function.
Medicines such as IBUPROFENE PENSA PHARMA may be associated with ocular disturbances. This risk is more likely with prolonged treatment. Therefore, your doctor may prescribe periodic eye examinations.

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

Other medicines and IBUPROFENE PENSA PHARMA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take this medicine with caution and consult your doctor if you are taking the following medicines:

medicines used to reduce inflammation and certain immune system disorders (corticosteroids);
medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, warfarin or heparin);
acetylsalicylic acid (aspirin), selective cyclooxygenase-2 (COX-2) inhibitors (an enzyme involved in inflammatory processes), medicines used to treat inflammation or other non-steroidal anti-inflammatory drugs (NSAIDs), as they may increase possible unwanted effects on the stomach and intestine;
medicines used to treat depression such as selective serotonin reuptake inhibitors;
medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol and angiotensin II antagonists such as losartan);
lithium (a medicine used to treat mental illnesses);
methotrexate (a medicine used to treat cancer or rheumatoid arthritis);
moclobemide, a medicine used to treat depression;
sulfonylureas (medicines used to treat diabetes), as IBUPROFENE PENSA PHARMA may enhance the effect of these medicines;
aminoglycosides (antibiotic medicines);
phenytoin (a medicine used to treat epilepsy);
ritonavir (a medicine used to treat AIDS);
probenecid (a medicine used to treat gout), as IBUPROFENE PENSA PHARMA may reduce the elimination of these medicines;
cardiac glycosides (medicines used to treat certain heart conditions). Medicines such as IBUPROFENE PENSA PHARMA may worsen heart disease;
colestyramine (a medicine used to lower blood lipids);
cyclosporine and tacrolimus (medicines used in organ transplantation), as medicines such as IBUPROFENE PENSA PHARMA may increase the risk of kidney damage;
herbal extracts such as Ginkgo biloba, as when taken together with medicines such as IBUPROFENE PENSA PHARMA, they may increase the risk of gastrointestinal bleeding;
mifepristone (a medicine used in women to induce abortion);
quinolone antibiotics (medicines used to treat infections), as when taken together with medicines such as IBUPROFENE PENSA PHARMA, there may be an increased risk of developing seizures;
zidovudine and ritonavir (medicines used to treat AIDS), as when taken together with medicines such as IBUPROFENE PENSA PHARMA, they may increase the risk of blood toxicity;
CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
bisphosphonates, medicines used to treat osteoporosis;
oxpentifylline, a medicine used for blood vessel problems;
baclofen, a medicine used to relax muscles;
moclobemide, a medicine used to treat depression.

Other medicines may also influence or be influenced by treatment with IBUPROFENE PENSA PHARMA. Therefore, always consult your doctor or pharmacist before taking IBUPROFENE PENSA PHARMA with other medicines.

IBUPROFENE PENSA PHARMA with alcohol
Avoid concomitant use of IBUPROFENE PENSA PHARMA with alcohol (see “Warnings and precautions”).
This combination may intensify the unwanted effects of NSAIDs, especially those affecting the gastrointestinal tract or nervous system.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Do not take IBUPROFENE PENSA PHARMA during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect your and your baby’s tendency to bleed and cause delayed or prolonged labour.

You should not take IBUPROFENE PENSA PHARMA during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, IBUPROFENE PENSA PHARMA may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
This medicine should not be used during breastfeeding.

Fertility
Avoid taking this medicine if you have fertility problems and are trying to become pregnant.

Driving and using machines
This medicine does not affect the ability to drive or use machinery. However, if during treatment with this medicine you experience drowsiness, dizziness or depression, avoid driving and using machinery.

IBUPROFENE PENSA PHARMA contains sodium, sucrose, potassium and aspartame
This medicine contains 45 mg of sodium (a main component of table salt) per sachet. This should be taken into account if you are on a low-sodium diet or have reduced kidney function.
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 90 mg of potassium (2.3 mmol) per sachet. This should be taken into account in patients with reduced kidney function or those on a low-potassium diet.
This medicine contains 20 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take IBUPROFENE PENSA PHARMA

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults and adolescents over 12 years of age is 1-2 sachets, 2-3 times daily.
Dissolve the contents of one sachet in a glass of water, stirring with a teaspoon until fully dissolved, and drink the solution immediately.
IBUPROFENE PENSA PHARMA may be taken on an empty stomach. However, if you have stomach problems, it is preferable to take the medicine with food.
Do not take more than 3 sachets per day, especially if you are elderly.
Consult your doctor if in adolescents aged between 12 and 18 years, this medicine requires use beyond 3 days or if symptoms worsen.
IBUPROFENE PENSA PHARMA is contraindicated in children under 12 years of age.

Elderly patients
If you are elderly, your doctor will decide the most appropriate dose for you, possibly reducing the doses indicated above.

Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will determine the most appropriate dose for you, possibly reducing the doses indicated above. If you have severe kidney or liver problems, you must not take this medicine (see "Do not take IBUPROFENE PENSA PHARMA").
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. Use the minimum effective dose, particularly in elderly patients and in patients with liver or kidney disease (hepatic insufficiency or renal insufficiency). If you have an infection, contact your doctor immediately if symptoms (e.g., fever and pain) persist or worsen (see section 2).

If you take more IBUPROFENE PENSA PHARMA than you should
If you have taken more IBUPROFENE PENSA PHARMA than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and what actions to take.
Symptoms of overdose may include nausea, abdominal pain, stomach ache, vomiting (possibly with blood), headache, ringing in the ears (tinnitus), confusion, and uncontrolled eye movements (nystagmus). At high doses, drowsiness, deep sleep with reduced response to normal stimuli (lethargy), chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Rarely, it may cause: lowering of body temperature (hypothermia), kidney-related effects, bleeding of the stomach and intestines, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression) and reduced respiratory activity (respiratory depression).
In addition, disorientation, excited state, fainting, and cardiovascular toxicity including low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia) may occur.
If you take significantly high doses of ibuprofen, severe damage to the kidneys and liver may occur.
In cases of severe poisoning, increased levels of acid in the blood (metabolic acidosis) may develop.
Most patients who have ingested significant amounts of ibuprofen will show symptoms within 4-6 hours.

Treatment
There is no specific antidote for ibuprofen overdose. Therefore, symptomatic and supportive treatment is indicated in case of overdose.
If you have any questions about the use of IBUPROFENE PENSA PHARMA, consult your doctor or pharmacist.

If you forget to take IBUPROFENE PENSA PHARMA
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking IBUPROFENE PENSA PHARMA and contact your doctor immediately
if you experience any of the following conditions:

Stomach or intestinal wall damage (peptic ulcers), sudden and severe pain in the upper abdomen or stomach (gastrointestinal perforation), or bleeding from the stomach or intestines (gastrointestinal haemorrhage), sometimes fatal, particularly in the elderly. Gastrointestinal perforation with ibuprofen use has been observed rarely.
Skin rashes (exanthema), skin eruptions 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). These conditions occur with uncommon frequency. Very rarely, a severe allergic reaction may occur, characterised by increased heart rate (tachycardia) and anaphylaxis, swelling of the face, tongue, larynx, and 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 may occur during varicella infection.
Flat, reddish, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include widespread rash, high fever, swollen lymph nodes, and increased eosinophils (a type of white blood cells).
Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear early in treatment (generalised exanthematous pustulosis).
Drug-induced lupus erythematosus syndrome (a disease affecting connective tissue causing joint or muscle pain, skin changes, and problems in 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
Sensory disturbances (paraesthesia), drowsiness
Inflammation of the nasal mucosa (rhinitis)
Vision disorders
Impaired hearing, ringing in the ears (tinnitus), vertigo
Liver function abnormalities, yellowing 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 renal failure (kidney function abnormalities)

Rare side effects (may affect up to 1 in 1,000 people)

Decrease in white blood cell count (leucopenia), 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
Vision disturbances, for example due to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy
Increased non-protein nitrogen in the blood (hyperazotaemia)
Swelling in a part of the body due to fluid accumulation (oedema)
Increased levels of liver enzymes (transaminases and alkaline phosphatase), increased blood uric acid levels
Reduced haemoglobin, haematocrit (percentage of blood volume occupied by red blood cells), and blood calcium levels
Prolonged bleeding time

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

Inflammation of the pancreas (pancreatitis)
Sensation of heart pounding (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), increased fluid around the lungs (acute pulmonary oedema), high blood pressure (hypertension)
Reduced liver function (hepatic failure)

Other side effects (frequency not known, frequency cannot be estimated from available data)

Feeling of heaviness in the stomach, nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty passing stools (constipation), indigestion (dyspepsia), stomach pain, pain or burning in the upper stomach (gastric pyrosis), inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), abdominal pain, vomiting blood (haematemesis) or black stools (melena), worsening of colon inflammation (colitis) and Crohn's disease.
Widespread, red, scaly rash with pustules under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalised exanthematous pustulosis). Stop using IBUPROFENE PENSA PHARMA if you develop these symptoms and contact your doctor immediately. See also section 2.

Medicines such as IBUPROFENE PENSA PHARMA may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IBUPROFENE PENSA PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IBUPROFENE PENSA PHARMA contains
IBUPROFENE PENSA PHARMA 400 mg granules for oral solution

The active substance is ibuprofen sodium dihydrate. Each sachet contains 512 mg of ibuprofen sodium dihydrate (equivalent to 400 mg of ibuprofen).
The other components are: sucrose, potassium bicarbonate, orange flavour, acesulfame potassium, aspartame (E951).

Description of the appearance of IBUPROFENE PENSA PHARMA and package contents
IBUPROFENE PENSA PHARMA is presented as granules for oral solution in sachets. A pack contains 12 sachets.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy
Manufacturer
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via Grignano, 43
24041 - Brembate (BG)

Ibuprofen Pensa Pharma