Ibuprofen Pensaitalia: detailed information

Package Leaflet: Information for the Patient

IBUPROFENE PENSA ITALIA 200 mg film-coated tablets

ibuprofen
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your pharmacist.
If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
You must consult a doctor if you do not feel better or if you feel worse:
after 3 days if treating fever, or after 4 days if treating pain.

Contents of this leaflet
1. What IBUPROFENE PENSA ITALIA is and what it is used for
2. What you need to know before taking IBUPROFENE PENSA ITALIA
3. How to take IBUPROFENE PENSA ITALIA
4. Possible side effects
5. How to store IBUPROFENE PENSA ITALIA
6. Contents of the pack and other information

1. What IBUPROFENE PENSA ITALIA is
IBUPROFENE PENSA ITALIA is indicated for use in adults and adolescents over 12 years of age.
IBUPROFENE PENSA ITALIA belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) that work by reducing pain, inflammation, and fever.
IBUPROFENE PENSA ITALIA is used to provide relief from mild to moderate pain, such as headache, toothache, menstrual pain, and pain associated with the common cold and fever (for less than 3 days).
Consult your doctor if you do not feel better or if you feel worse after 3 days when treating fever, or after 4 days when treating pain in adults.

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

Do not take IBUPROFENE PENSA ITALIA 200 mg film-coated tablets:

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
if you have had allergic reactions such as asthma, runny nose, itchy rash, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid or other pain and anti-inflammatory drugs (NSAIDs).
if you have previously suffered from stomach or small intestine (duodenum) ulcer or bleeding due to prior use of pain and anti-inflammatory medicines (NSAIDs)
if you currently have a stomach or small intestine (duodenum) ulcer or bleeding, or if you have had two or more such episodes in the past
if you suffer from severe liver, kidney, or heart problems (including coronary heart disease)
if you are significantly dehydrated (caused by vomiting, diarrhoea, or insufficient fluid intake)
if you have active bleeding (including in the brain)
if you suffer from an unknown condition causing abnormal blood cell formation
if you are in the last three months of pregnancy

Do not give IBUPROFENE PENSA ITALIA 200 mg film-coated tablets to children weighing less than 20 kg (or under approximately 6 years of age).
Warnings and precautions
Talk to your doctor before taking IBUPROFENE PENSA ITALIA 200 mg film-coated tablets

if you suffer from systemic lupus erythematosus (SLE) or other autoimmune diseases of the red blood pigment (porphyria)
if you suffer from chronic inflammatory bowel diseases such as ulcerative colitis (ulcers in the colon), Crohn's disease (inflammation affecting the digestive tract), or other stomach or intestinal disorders
if you have disorders in blood cell formation
if you have problems with normal blood clotting mechanisms
if you suffer from allergies, hay fever, asthma, chronic swelling of the nasal mucosa, paranasal sinuses, adenoids, or chronic obstructive respiratory disorders, as the risk of developing airway narrowing with breathing difficulties (bronchospasm) is higher
if you suffer from circulation problems in the arteries of the arms or legs
if you have liver, kidney, heart problems, or hypertension
if you have recently undergone major surgery
if you are in the first six months of pregnancy
if you are breastfeeding

Elderly
If you are elderly, you are more likely to experience side effects, particularly bleeding and perforation of the digestive tract, which can be fatal.
Ulcers, perforation, and bleeding in the stomach or intestine
If you have previously had a stomach or intestinal ulcer, especially if it was complicated by perforation or accompanied by bleeding, you should pay attention to any unusual abdominal symptoms and report them immediately to your doctor, particularly if these symptoms occur at the beginning of treatment. This is because the risk of gastrointestinal bleeding or ulceration is higher in such cases, especially in elderly patients.
If gastrointestinal bleeding or ulceration occurs, treatment must be discontinued.
Bleeding, ulceration, or perforation in the stomach or intestine may occur without warning signs, even in patients who have never had such problems before. This could also be fatal.
The risk of ulcers, perforations, or bleeding in the stomach or intestine generally increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken simultaneously with ibuprofen (see 'Other medicines and IBUPROFENE PENSA ITALIA 200 mg film-coated tablets', below).
In patients with a history of ulcers, particularly those complicated by bleeding or perforation, and in elderly patients, as well as in patients requiring additional treatment with low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal disorders, combination therapy with protective medicines (e.g., misoprostol or proton pump inhibitors) should be considered.
Caution is advised in patients who are also taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or platelet aggregation inhibitors like acetylsalicylic acid.
Treatment must be stopped if gastrointestinal bleeding or ulcers develop during treatment with IBUPROFENE PENSA ITALIA.
Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, 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 ITALIA 200 mg film-coated tablets and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Effects on heart and brain
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight increase in the 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 treatment with your doctor or pharmacist before taking IBUPROFENE PENSA ITALIA 200 mg film-coated tablets 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 legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
you have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.

Effects on kidneys
Ibuprofen may cause kidney function problems even in patients who have not previously had kidney issues. This may cause swelling of the legs and may also lead to heart failure or hypertension in predisposed individuals.
Ibuprofen may cause kidney damage, especially in patients who already have kidney, heart, or liver problems, or who are taking diuretics or ACE inhibitors, as well as in the elderly.
However, discontinuation of ibuprofen generally leads to recovery.
Aseptic meningitis (inflammation of the brain membranes without bacterial infection)
During treatment with ibuprofen, some cases of meningitis (presenting with neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed. Although it is probably more likely to occur in patients with existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue diseases, it has also been reported in patients without long-term existing conditions.
Other precautions
With long-term and high-dose use of painkillers, headaches may occur that should not be treated with high doses of this medicine.
Habitual use of painkillers may cause permanent kidney damage and risk of kidney failure.
Ibuprofen may mask symptoms or signs of infection (fever, pain, swelling) and temporarily prolong bleeding time.
During chickenpox (varicella), it is recommended to avoid using IBUPROFENE PENSA ITALIA 200 mg film-coated tablets.
IBUPROFENE PENSA ITALIA 200 mg film-coated tablets may reduce the chance of becoming pregnant. You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking IBUPROFENE PENSA ITALIA immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Children and adolescents
Do not use in children under 12 years of age.
Ibuprofen may cause kidney problems in dehydrated children and adolescents.
Other medicines and IBUPROFENE PENSA ITALIA 200 mg film-coated tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The side effects of IBUPROFENE PENSA ITALIA 200 mg film-coated tablets may increase if certain medicines are taken at the same time. Conversely, IBUPROFENE PENSA ITALIA 200 mg film-coated tablets may increase or decrease the effect of other medicines or increase their side effects if taken simultaneously.
IBUPROFENE PENSA ITALIA 200 mg film-coated tablets may affect or be affected by other medicines. For example:

other NSAIDs
medicines that are anticoagulants (e.g., blood thinners/prevent clotting, such as acetylsalicylic acid, warfarin, heparin, ticlopidine)
platelet aggregation inhibitors (against clotting) such as clopidogrel
methotrexate (used to treat cancer and autoimmune diseases)
digoxin (for the treatment of various heart conditions)
phenytoin (used to prevent epileptic seizures)
lithium (used to treat depression and mania)
diuretics (water tablets), including potassium-sparing diuretics
medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
colestyramine (used in the treatment of high cholesterol)
aminoglycosides (medicines against certain types of bacteria)
SSRIs (medicines for depression) such as paroxetine, sertraline, citalopram
moclobemide (RIMA - a medicine for the treatment of depressive illness or social phobia)
cyclosporine, tacrolimus (for immunosuppression after organ transplantation)
zidovudine or ritonavir (used for the treatment of HIV patients)
mifepristone
probenecid or sulfinpyrazone (for the treatment of gout)
quinolone antibiotics
sulfonylureas (for the treatment of type 2 diabetes)
corticosteroids (used against inflammations)
bisphosphonates (used in osteoporosis, Paget's disease, and to reduce high calcium levels in the blood)
oxpentifilline ((pentoxifylline) used in the treatment of circulatory disorders of the arteries in the arms or legs)
baclofen (a muscle relaxant)
herbal extracts such as Ginkgo Biloba

Consult your doctor before taking IBUPROFENE PENSA ITALIA 200 mg film-coated tablets if you are using any of the medicines listed above.
Other medicines may also affect or be affected by treatment with IBUPROFENE PENSA ITALIA 200 mg film-coated tablets. Therefore, you should always seek advice from your doctor or pharmacist before using IBUPROFENE PENSA ITALIA 200 mg film-coated tablets with other medicines.
IBUPROFENE PENSA ITALIA 200 mg film-coated tablets with food and drink
For maximum and faster effect, IBUPROFENE PENSA ITALIA should be taken on an empty stomach. Patients with a sensitive stomach are advised to take IBUPROFENE PENSA ITALIA with food. Take ibuprofen tablets with plenty of liquid.
Avoid alcohol, as it may enhance the side effects of IBUPROFENE PENSA ITALIA 200 mg film-coated tablets, especially those affecting the stomach, intestine, or brain.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take IBUPROFENE PENSA ITALIA if you are in the last three months of pregnancy, as it may harm the fetus or cause problems during childbirth. IBUPROFENE PENSA ITALIA may cause kidney and heart problems in the unborn child. It may affect your and your baby's tendency to bleed and may cause delayed or prolonged labour.
You should not take IBUPROFENE PENSA ITALIA during the first six months of pregnancy unless absolutely necessary and advised by your doctor. 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 the 20th week of pregnancy onwards, IBUPROFENE PENSA ITALIA may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Epidemiological study data suggest an increased risk of miscarriage and cardiac malformations and gastroschisis after use of a prostaglandin synthesis inhibitor early in pregnancy.
Breastfeeding
The use of IBUPROFENE PENSA ITALIA is not recommended in women who are breastfeeding.
Fertility
There is some evidence that substances that inhibit prostaglandin/cyclooxygenase synthesis may reduce female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment.
Driving and using machines
Patients' reactions may be affected during treatment with ibuprofen. Therefore, increased caution is recommended when driving vehicles or operating machinery.
This effect is enhanced by simultaneous alcohol consumption.
IBUPROFENE PENSA ITALIA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
IBUPROFENE PENSA ITALIA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially "sodium-free".

3. How to take IBUPROFENE PENSA ITALIA

Take this medicine exactly as stated in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The dose of ibuprofen depends on the patient's age and body weight. The appropriate dosing interval should be chosen according to the symptoms observed and the recommended maximum daily dose. In adults and adolescents, the maximum single daily dose of 400 mg of ibuprofen must not be exceeded.

The recommended dose is:
Adults and adolescents over 12 years of age (≥40 kg):
1-2 tablets administered as a single dose or up to 3 times daily, with an interval of 4 to 6 hours.
The maximum daily dose must not exceed 6 tablets (1200 mg).

Use in children and adolescents
The daily dose of ibuprofen is 20-30 mg/kg body weight, given in divided doses.
IBUPROFENE PENSA ITALIA 200 mg film-coated tablets must not be used in children under 12 years of age, as other ibuprofen formulations considered more suitable for this population are available.

The tablet should be swallowed with a glass of water.
To achieve the fastest possible maximum effect, IBUPROFENE PENSA ITALIA should be taken on an empty stomach.
Do not crush, chew, or suck the tablet to avoid irritation of the stomach or throat. If you have a sensitive stomach, it is recommended to take this medicine with food.

If you are an adult and your condition does not improve or worsens within 4 days of treatment for pain or within 3 days for fever, you must contact a doctor.

Elderly
If you are elderly, always consult your doctor before using IBUPROFENE PENSA ITALIA 200 mg film-coated tablets, as you may be more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation, which can be fatal. Your doctor will advise you accordingly.

Reduced renal or hepatic function
If you suffer from reduced renal or hepatic function, always consult your doctor before using IBUPROFENE PENSA ITALIA 200 mg film-coated tablets. Your doctor will advise you accordingly.

If you take more IBUPROFENE PENSA ITALIA 200 mg film-coated tablets than you should
If you have taken more IBUPROFENE PENSA ITALIA 200 mg film-coated tablets than recommended, or if a child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and what steps to take.
Symptoms of overdose may include nausea, stomach ache, diarrhoea, vomiting (which may be blood-streaked), headache, tinnitus, confusion, and eye movement tremors. Bleeding from the stomach or intestines may also occur.
At high doses and in more severe cases of overdose, symptoms may include drowsiness, chest pain, palpitations, loss of consciousness, excitement, disorientation, coma, convulsions (especially in children), weakness, dizziness, cramps (especially in children), blurred vision and visual disturbances, renal failure, blood in the urine, liver damage, low blood pressure, low blood potassium levels, feeling cold, breathing difficulties, bluish discoloration of the lips, tongue, and fingers, and increased tendency to bleed.
Asthma may also worsen in patients with asthma.

If you forget to take IBUPROFENE PENSA ITALIA 200 mg film-coated tablets
If you forget one or more doses, continue with the next dose as usual.
Do not take a double dose to make up for the forgotten dose.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects are more likely with higher doses and longer duration of treatment.
Adverse reactions reported for ibuprofen are similar to those of other NSAIDs.

Gastrointestinal disorders
The most commonly observed adverse reactions are gastrointestinal in nature. Nausea, dyspepsia, vomiting, haematemesis, flatulence, abdominal pain, diarrhoea, constipation, melena, ulcerative stomatitis, gastrointestinal bleeding, and exacerbation of colitis and Crohn's disease have been reported after use. Less frequently, gastritis, duodenal and gastric ulcers, and gastrointestinal perforation have been observed.

Immune system disorders
Hypersensitivity reactions have been reported following treatment with ibuprofen. These may include non-specific allergic reactions and anaphylaxis; respiratory tract reactivity including asthma, worsening asthma, bronchospasm or dyspnoea; or various skin disorders, including rashes of different types, pruritus, urticaria, purpura, angioedema and, very rarely, bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis) and erythema multiforme.

Infections and infestations
Exacerbation of infection-related inflammation has been described in association with the use of NSAIDs (e.g., development of necrotising fasciitis). Therefore, if signs of infection appear or worsen during ibuprofen use, patients are advised to seek immediate medical attention.

Skin and subcutaneous tissue disorders
In rare cases, severe skin infections and soft tissue complications may occur during chickenpox infection (see also "Infections and infestations").

Cardiovascular and cerebrovascular disorders
Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day) and with long-term treatment, may be associated with a modest increase in the risk of arterial thrombotic events (such as myocardial infarction or stroke) (see "Warnings and precautions"). Medicines such as IBUPROFENE PENSA ITALIA 200 mg film-coated tablets may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. Fluid retention (oedema), hypertension and heart failure have been reported in association with NSAIDs.

Side effects are listed according to their frequency of occurrence. The following convention has been used:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

The following side effects are important and require immediate action if experienced. You must stop taking IBUPROFENE PENSA ITALIA 200 mg film-coated tablets and consult your doctor immediately if you experience any of the following symptoms:

Common:

Black, tarry stools or blood-stained vomit (gastrointestinal ulcer with bleeding)

Rare:

Swelling of the face, tongue or throat (larynx) which may cause severe breathing difficulties (angioedema), rapid heartbeat, severe drop in blood pressure or potentially life-threatening shock
Sudden allergic reaction with shortness of breath, wheezing and drop in blood pressure

Very rare:

Severe skin rash with blisters on the skin, especially on legs, arms, hands and feet, which may also involve the face and lips. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Not known:

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
Red, scaly and widespread rash with swellings under the skin and localized blisters, mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using IBUPROFENE PENSA ITALIA 200 mg film-coated tablets if you develop these symptoms and seek immediate medical advice. See also section 2.

You must stop taking the medicine and contact your doctor as soon as possible if you experience any of the following side effects:

Common:

Skin rash

Rare:

Blurred vision or other eye problems such as sensitivity to light
Hypersensitivity reactions such as skin rash, pruritus, asthma attacks (sometimes with low blood pressure)
Photosensitivity (increased sensitivity to sunlight)

Other possible side effects with IBUPROFENE PENSA ITALIA include:

Common:

Gastrointestinal disorders such as diarrhoea, malaise, vomiting, flatulence, constipation
Heartburn, abdominal pain, indigestion
Microscopic gastrointestinal bleeding which may lead to anaemia
Headache, dizziness and fatigue

Uncommon:

Inflammation of the stomach lining
Kidney problems including development of oedema, kidney inflammation and renal failure
Rhinorrhoea
Difficulty breathing (bronchospasm)
Insomnia
Anxiety
Somnolence
Tinnitus or ringing in the ears
Altered hearing
Tingling in hands and feet
Vertigo
Gastrointestinal ulcer with or without perforation
Acute inflammation of the liver, yellowing of the skin or whites of the eyes (jaundice), liver dysfunction, liver damage
Mouth ulcers and inflammation

Rare:

Depression, confusion, hallucinations
Decreased haemoglobin and haematocrit levels, inhibition of platelet aggregation and prolonged bleeding time
Inflammation of the meninges without bacterial infection (aseptic meningitis)
Disorders of blood cell formation (with symptoms such as: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding)
Inflammation of the optic nerve which may cause vision problems
Toxic optic neuropathy

Very rare:

Heart failure, heart attack or hypertension
Pancreatitis
Liver failure

Not known:

Inflammation of the intestine and worsening of colonic inflammation (colitis) and gastrointestinal tract (Crohn's disease)
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

IBUPROFENE PENSA ITALIA 200 mg film-coated tablets may cause a reduction in the number of white blood cells, and your resistance to infections may be reduced. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, you must consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister
after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not dispose of any medicine 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 ITALIA contains

The active substance is ibuprofen. Each film-coated tablet contains 200 mg of ibuprofen.
The other ingredients are:
Tablet core: hypromellose, sodium croscarmellose, monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica and magnesium stearate.
Film coating: hypromellose, propylene glycol, talc and titanium dioxide (E171).

Description of the appearance of IBUPROFENE PENSA ITALIA and package contents
White, oblong, biconvex film-coated tablets, with a break line on one side and smooth on the opposite side.
IBUPROFENE PENSA ITALIA 200 mg film-coated tablets are available in aluminum – PVC/PVDC blisters containing 12, 20 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 – Milano
Italy

Manufacturers
Toll Manufacturing Services S.L.
C/Aragonesi, 2
28108 Alcobendas (Madrid)
Spain
Farmalider SA
C/ Aragonesi, 2
28108 (Alcobendas-Madrid)
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: IBUPROFENE PENSA ITALIA
Portugal: Ibuprofeno Pensavital