Package leaflet: Information for the patient

IBUPROFENE PENSA GENERICS 400 mg film-coated tablets
Ibuprofen
For use in adults and adolescents weighing at least 40 kg (from 12 years of age and above)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

IBUPROFENE PENSA GENERICS contains the active substance ibuprofen. Ibuprofen belongs to the group of NSAIDs (non-steroidal anti-inflammatory drugs). IBUPROFENE PENSA GENERICS relieves pain and has an anti-inflammatory effect.
In adults and adolescents aged 12 years and above (≥ 40 kg body weight), IBUPROFENE PENSA GENERICS is used for:

Symptomatic treatment of mild to moderate pain.
Symptomatic treatment of primary dysmenorrhoea.

2. What you should know before taking IBUPROFENE PENSA GENERICS

Do not take IBUPROFENE PENSA GENERICS

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include swelling of the eyelids, lips, tongue or throat.
if you have ever had an allergic reaction (such as bronchospasm (tightening of the lung muscles which can cause asthma and breathlessness), asthma attacks, runny nose, nasal congestion, skin reactions or sudden swelling) after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
if you have an undiagnosed blood disorder.
if you suffer from or have a history of active ulcerative colitis, Crohn's disease, recurrent gastric/duodenal ulcers (peptic ulcers), or bleeding (at least two separate episodes of ulcers confirmed or

bleeding).

if you have a history of gastrointestinal bleeding or perforation associated with previous NSAID therapy.
if you have active bleeding (including in the brain).
if you suffer from severe liver, kidney or heart failure.
if you are severely dehydrated (e.g. due to vomiting, diarrhoea or insufficient fluid intake).
if you suffer from congenital disorders of porphyrin metabolism (e.g. acute intermittent porphyria).
if you suffer from chronic alcoholism (14 to 20 drinks/week or more).
if you are a child or adolescent weighing less than 40 kg or a child under 12 years of age.
if you are in the last three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking IBUPROFENE PENSA GENERICS.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration
necessary to control symptoms.
You should discuss treatment with your doctor or pharmacist before taking IBUPROFENE PENSA
GENERICS if:

you suffer from uncontrolled hypertension.
you suffer from congestive heart failure.
you have established ischaemic heart disease.
you suffer from peripheral arterial disease and/or cerebrovascular disease.
you suffer from systemic lupus erythematosus (SLE, sometimes known as lupus) or connective tissue disease (autoimmune diseases affecting connective tissue).
you have impaired liver or kidney function.
you have recently undergone major surgery.
you are sensitive (allergic) to other substances.
you suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders, as you are at increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), rapid swelling (Quincke's oedema) or urticaria.
you are a child.
you have an infection – see the section "Infections" below.

Effects on the gastrointestinal tract
The combined use of IBUPROFENE PENSA GENERICS with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), must be avoided.
Gastrointestinal bleeding, ulcers and perforation:
Gastrointestinal bleeding, ulcers and perforations, sometimes life-threatening, have been reported with all NSAIDs. These events may occur at any time during therapy, with or without warning symptoms or previous history of serious gastrointestinal problems.
The risk of developing gastrointestinal bleeding, ulcers and perforations is higher with increasing doses of NSAIDs and is greater in patients who have previously had ulcers, especially with complications such as bleeding or perforation (see section 2 “Do not take IBUPROFENE PENSA GENERICS”) and in elderly patients. These patients should start treatment with the lowest available dose.
For these patients, as well as for those requiring additional treatment with low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal disorders, concomitant treatment with gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
If you have a history of gastrointestinal adverse effects, especially if you are elderly, contact a doctor if you experience unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of therapy.
Caution is advised if you are also taking other medicines that may increase the risk of ulcers or bleeding, e.g. 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 IBUPROFENE PENSA GENERICS”).
Treatment must be discontinued and a doctor consulted if you develop gastrointestinal bleeding or ulcers during treatment with IBUPROFENE PENSA GENERICS.
Effects on the cardiovascular system
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially 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
GENERICS if:

you have heart problems including heart failure and angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor blood circulation in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischaemic attack "TIA").
you have high blood pressure, diabetes or high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Renal effects
Caution should be exercised when starting ibuprofen treatment in patients with significant dehydration. There is a risk of kidney failure, particularly in dehydrated children, adolescents and elderly patients.
As with other NSAIDs, long-term administration of ibuprofen has caused renal papillary necrosis and other pathological changes in the kidneys. Renal toxicity has also been observed in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, consequently, in renal blood flow, which may lead to renal failure. Patients at greatest risk of this reaction include those with impaired kidney, heart or liver function, patients taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state.
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 GENERICS and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
During chickenpox infection, it is recommended to avoid the use of IBUPROFENE PENSA GENERICS.
Infections
IBUPROFENE PENSA GENERICS may mask signs of infection such as fever and pain. Therefore, IBUPROFENE PENSA GENERICS may delay appropriate treatment of the infection, potentially increasing 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, consult a doctor immediately.
Respiratory disorders and hypersensitivity reactions
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. At the first signs of a hypersensitivity reaction after taking/administering IBUPROFENE PENSA GENERICS, treatment must be stopped and a doctor consulted. Necessary medical measures, appropriate to the symptoms, must be carried out by healthcare professionals.
Haematological effects
Ibuprofen may temporarily inhibit blood platelet function (blood platelet aggregation). Patients with blood coagulation disorders should therefore be closely monitored.
Regular monitoring of liver function tests, kidney function tests and blood counts is required during prolonged use of IBUPROFENE PENSA GENERICS.
If IBUPROFENE PENSA GENERICS is taken before surgery, consult/inform your doctor or dentist.
SLE and mixed connective tissue disease
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increased risk of aseptic meningitis (see below and section 4.8).
Aseptic meningitis
Aseptic meningitis has been observed rarely in patients receiving ibuprofen therapy. Although it is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been reported in patients without underlying chronic illness.
When using NSAIDs, adverse reactions, particularly those affecting the gastrointestinal tract or central nervous system, may be increased with concomitant alcohol consumption.
Patients who develop eye disorders during treatment with ibuprofen should discontinue therapy and undergo ophthalmological examinations.
Signs of an allergic reaction to this medicine, including respiratory problems, swelling of the face and neck region (angioedema) and chest pain, have been reported with ibuprofen. Immediately stop taking Ibuprofene Pensa Generics and contact your doctor or emergency medical services if you notice any of these signs.
Elderly patients
Elderly patients have an increased risk of adverse effects with the use of non-steroidal anti-inflammatory drugs, particularly gastrointestinal bleeding and perforation, which in some cases may be life-threatening. For this reason, particularly careful medical monitoring is required in elderly patients.
Children and adolescents
There is a risk of kidney failure in dehydrated adolescents.
Other medicines and IBUPROFENE PENSA GENERICS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
IBUPROFENE PENSA GENERICS may affect or be affected by other medicines. For example:

Digoxin, phenytoin and lithium: concomitant use of IBUPROFENE PENSA GENERICS and digoxin (used to strengthen the heart), phenytoin (used to treat seizures/epilepsy) or lithium (used to treat, for example, depression) may increase blood concentrations of these medicines. Monitoring of lithium blood levels is necessary. Monitoring of digoxin and phenytoin blood levels is recommended.
Anticoagulants (e.g. blood thinners/prevention of clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine). NSAIDs may potentiate the effects of anticoagulants such as warfarin.
Diuretics (tablets that promote urination) and medicines for high blood pressure:
e.g. ACE inhibitors, beta-blockers and angiotensin II receptor antagonists. Combined administration of IBUPROFENE PENSA GENERICS and potassium-sparing diuretics (some types of diuretics) may lead to increased potassium levels in the blood. Therefore, monitoring of blood potassium levels is recommended.
Medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan): IBUPROFENE PENSA GENERICS may reduce the effect of ACE inhibitors (used to treat heart failure and high blood pressure). In addition, when used in combination, there is an increased risk of kidney dysfunction.
Cholestyramine (a medicine used to lower cholesterol levels) used in combination with IBUPROFENE PENSA GENERICS may reduce the absorption of IBUPROFENE PENSA GENERICS in the gastrointestinal tract. However, the clinical significance is unknown.
Other painkillers: concomitant use of IBUPROFENE PENSA GENERICS with other anti-inflammatory and pain-relieving NSAIDs, including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastrointestinal ulcers and bleeding.
Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
Methotrexate: administration of IBUPROFENE PENSA GENERICS within 24 hours before or after methotrexate (used to treat certain types of cancer or rheumatism) may lead to increased methotrexate concentrations and increased adverse effects.
Cyclosporine and tacrolimus may damage the kidneys.
Probenecid or sulfinpyrazone: medicines containing probenecid or sulfinpyrazone (used to treat gout) may delay the excretion of ibuprofen. This may cause accumulation of IBUPROFENE PENSA GENERICS in the body, increasing its adverse effects.
Sulfonylureas: during concomitant use of IBUPROFENE PENSA GENERICS and sulfonylureas (medicines used to treat diabetes), monitoring of blood sugar levels is recommended as a precaution.
Zidovudine: evidence suggests a higher risk of haemarthrosis (blood accumulation in joints) and bruising (haematoma) in HIV-positive haemophiliacs using zidovudine (an antiviral drug used to treat HIV infections) together with ibuprofen.
Quinolone antibiotics: the risk of seizures (fits) may increase when antibiotics called quinolones, such as ciprofloxacin, are taken

simultaneously with ibuprofen.

Aminoglycosides: concomitant use of IBUPROFENE PENSA GENERICS with aminoglycosides (a type of antibiotic) and NSAIDs may reduce aminoglycoside excretion.
Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections, as the effect of ibuprofen may increase. Consideration should be given to reducing the dose of ibuprofen, especially when high doses of ibuprofen are administered with voriconazole or fluconazole.
Ginkgo biloba (a herbal medicine) may increase the risk of bleeding with NSAIDs.
Mifepristone: concomitant use of mifepristone with other anti-inflammatory and pain-relieving NSAIDs (e.g. ibuprofen) may reduce the effect of mifepristone.
Medicines for treating inflammation (corticosteroids) due to increased risk of gastrointestinal ulcers or bleeding.

Other medicines may also affect or be affected by treatment with IBUPROFENE
PENSA GENERICS. Therefore, you should always consult your doctor or pharmacist before using
IBUPROFENE PENSA GENERICS with other medicines.
IBUPROFENE PENSA GENERICS with alcohol
Alcohol may enhance the adverse effects of IBUPROFENE PENSA GENERICS, particularly those affecting the central nervous system and gastrointestinal tract. You should possibly avoid alcoholic drinks during use of IBUPROFENE PENSA GENERICS.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take IBUPROFENE PENSA GENERICS during the last three months of pregnancy as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect your tendency and that of your baby to bleed and may cause delayed or prolonged labour. Do not take IBUPROFENE PENSA GENERICS 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 available dose should be used for the shortest possible time. If taken for more than a few days from week 20 of pregnancy onwards, IBUPROFENE PENSA GENERICS may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If longer-term treatment is needed, your doctor may recommend additional monitoring.
Epidemiological study data suggest an increased risk of miscarriage and heart defects and gastroschisis after use of a prostaglandin synthesis inhibitor early in pregnancy.
Breastfeeding
The use of IBUPROFENE PENSA GENERICS is not recommended in women who are breastfeeding.
Fertility
There is some evidence that substances which inhibit prostaglandin synthesis/cyclooxygenase may cause reduced female fertility through an effect on ovulation. This effect is reversible upon discontinuation of treatment.
Driving and using machines
Ibuprofen generally does not affect or affects only slightly the ability to drive vehicles and use machines. However, since at higher doses adverse effects on the central nervous system such as fatigue and dizziness may occur, the ability to react and the ability to drive attentively and use machines may be impaired in individual cases. This is particularly important when alcohol is consumed simultaneously.
IBUPROFENE PENSA GENERICS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
IBUPROFENE PENSA GENERICS 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 GENERICS

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you
have an infection, consult a doctor immediately if symptoms persist or worsen (see
section 2).
The recommended dose is:
Pain
Adults and adolescents weighing 40 kg or more (from 12 years of age onwards)
One whole 400 mg tablet as a single dose. If necessary, additional doses of
400 mg ibuprofen may be taken. The interval between doses should be determined according to the symptoms observed
and the maximum recommended daily dose. It should not be less than 6 hours. Do not take more than
1200 mg of ibuprofen in 24 hours.
Special populations
If you have severe liver or kidney disease, or if you are elderly, your doctor will determine the most appropriate dose, which will be the lowest possible.
Use in children and adolescents
IBUPROFENE PENSA GENERICS 400 mg film-coated tablets are not indicated for
adolescents weighing less than 40 kg or for children under 12 years of age.
Method of administration
IBUPROFENE PENSA GENERICS is for oral use.
Take the tablets with a glass of water.
The tablets must not be crushed, chewed, or sucked to avoid irritation of the stomach or
throat. The score line is not intended for breaking the tablet.
Patients with a sensitive stomach should take IBUPROFENE PENSA GENERICS with food.
Duration of treatment
Your doctor will decide the duration of treatment.
If you take more IBUPROFENE PENSA GENERICS than you should
If you take more IBUPROFENE PENSA GENERICS than you should, or if your child has taken this
medicine by mistake, contact a doctor or go to the nearest hospital for advice on the risk and guidance on actions to take.
Symptoms may include nausea, stomach ache, vomiting (possibly with blood), or more
rarely diarrhoea. In addition, headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion and uncontrolled eye movements, and worsening of asthma in asthmatics. At
high doses, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness,
seizures (especially in children), dizziness, weakness and vertigo, blood in the urine, low blood
pressure, increased potassium levels in the blood, prolonged prothrombin time/INR,
acute kidney failure, liver damage, respiratory depression, cyanosis, feeling cold and breathing
difficulties.
If you forget to take IBUPROFENE PENSA GENERICS
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The adverse event profile reported with ibuprofen is similar to that of other NSAIDs.

Gastrointestinal disorders: The most commonly observed adverse effects affect the digestive tract. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2: "Warnings and precautions"). Nausea, vomiting, diarrhoea, flatulence, constipation, digestive disturbances, abdominal pain, black stools, vomiting blood, mouth and throat ulcers (ulcerative stomatitis), and worsening of colitis and Crohn's disease (see section 2: "Warnings and precautions") have been reported after use. Less frequently, 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.

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

Infections and infestations: Rhinitis and aseptic meningitis (especially in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms such as neck stiffness, headache, nausea, vomiting, fever or confusion (see section 4.4) have been reported. Worsening of inflammation associated with infections coinciding with the use of NSAIDs has been reported. If signs of infection appear or worsen during ibuprofen use, patients are therefore advised to seek immediate medical advice.

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

Cardiac and vascular disorders: Oedema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increase in the risk of arterial thrombotic events such as myocardial infarction or stroke (see section 4.4).

Stop taking ibuprofen and consult your doctor immediately if you notice any of the following symptoms:

Flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome).
Widespread, red, scaly rash with lumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).

Other side effects that may occur:
Common (may affect up to 1 in 10 people):

Headache, dizziness
Gastrointestinal side effects (dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, black stools, stomach and intestinal bleeding, blood in vomit)
Rash
Tiredness

Uncommon (may affect up to 1 in 100 people):

Rhinitis
Hypersensitivity
Insomnia, anxiety
Paraesthesia
Somnolence
Visual disturbances, hearing damage
Vertigo
Tinnitus
Bronchospasm, asthma
Dyspnoea
Mouth ulcers
Stomach ulcer, intestinal ulcer, perforation of stomach ulcer, inflammation of the stomach lining
Hepatitis, jaundice, abnormal liver function
Pruritus, small bruises on the skin and mucous membranes
Photosensitivity
Nephrotoxicity in various forms, e.g. tubulointerstitial nephritis, nephrotic syndrome and renal failure

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

Aseptic meningitis
Leucopenia
Thrombocytopenia
Aplastic anaemia
Neutropenia
Agranulocytosis
Haemolytic anaemia
Anaphylactic reaction
Depression, confusion
Optic neuritis
Toxic optic neuropathy
Oedema

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

Heart failure, myocardial infarction
Hypertension
Pancreatitis, liver failure
Severe forms of skin reactions (e.g. erythema multiforme, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis)

Not known (frequency cannot be estimated from the available data):

Worsening of ulcers in the large intestine (colitis) and Crohn's disease (intestinal disease)
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Acute generalized exanthematous pustulosis (AGEP)
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 GENERICS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after 'Exp.'.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What IBUPROFENE PENSA GENERICS contains
The active substance is ibuprofen. Each film-coated tablet contains 400 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, titanium dioxide (E171), talc, propylene glycol.

Description of the appearance of IBUPROFENE PENSA GENERICS and package contents
White, oblong, biconvex film-coated tablets, engraved on both sides. The engraved line is not intended for breaking the tablet.
IBUPROFENE PENSA GENERICS 400 mg film-coated tablets are available in aluminum-PVC/PVDC blisters, in pack sizes of 20, 30 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 Milan
Italy

Manufacturers
ROVI PHARMA INDUSTRIAL SERVICES, S.A.
Vía Complutense, 140,
E-28805 Alcalá de Henares (Madrid), Spain
FARMALIDER S.A.
C/ Aragoneses, 2
28108 (Alcobendas-Madrid), Spain
TOLL MANUFACTURING SERVICES S.L.
C/ Aragoneses, 2
28108 Alcobendas (Madrid), Spain

This medicinal product is authorized in the European Economic Area member states under the following names:
Italy: Ibuprofene Pensa Generics
Portugal: Ibuprofeno Pensa
Spain: Ibuprofeno pensa pharma

Ibuprofen Pensagenerics