Package leaflet: Information for the user

Ibuprofene Aurobindo Pharma Italia 400 mg film-coated tablets, 600 mg film-coated tablets

Generic medicine
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, ask 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, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ibuprofene Aurobindo Pharma Italia is and what it is used for
What you need to know before taking Ibuprofene Aurobindo Pharma Italia
How to take Ibuprofene Aurobindo Pharma Italia
Possible side effects
How to store Ibuprofene Aurobindo Pharma Italia
Contents of the pack and other information

1. What Ibuprofen Aurobindo Pharma Italia is and what it is used for

Ibuprofen Aurobindo Pharma Italia belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) that reduce pain, inflammation, and fever.
Ibuprofen Aurobindo Pharma Italia 400 mg film-coated tablets
Ibuprofen is used for the symptomatic treatment of:
Mild to moderate pain, including headache
Menstrual pain
Fever.
Additionally, Ibuprofen Aurobindo Pharma Italia is used for the symptomatic treatment of pain and inflammation in disorders caused by arthritis (e.g. rheumatoid arthritis), degenerative conditions of arthritis (e.g. osteoarthritis), and pain due to swelling and inflammation following soft tissue injuries.
Ibuprofen Aurobindo Pharma Italia 600 mg film-coated tablets
Ibuprofen is used for the symptomatic treatment of mild to moderate pain, such as headache, including migraine headache, menstrual pain, and/or fever.
Additionally, Ibuprofen Aurobindo Pharma Italia is used for the treatment of pain and inflammation in disorders caused by arthritis (e.g. rheumatoid arthritis), degenerative conditions of arthritis (e.g. osteoarthritis), and pain due to swelling and inflammation following soft tissue injuries.

2. What you need to know before taking Ibuprofene Aurobindo Pharma Italia

Do not take Ibuprofene Aurobindo Pharma Italia:

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 skin rash, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other painkillers or anti-inflammatory medicines (NSAIDs)
if you have previously suffered from stomach or intestinal ulcers or bleeding related to the use of painkillers or 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 episodes of such conditions in the past

if you have severe liver, kidney, or heart problems
if you are in the last 3 months of pregnancy
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-origin disease causing abnormal red blood cell formation.

Ibuprofene Aurobindo Pharma Italia 400 mg film-coated tablets
Ibuprofene Aurobindo Pharma Italia is contraindicated in children weighing less than 20 kg and under 6 years of age.
Ibuprofene Aurobindo Pharma Italia 600 mg film-coated tablets
Ibuprofene Aurobindo Pharma Italia is contraindicated in children and adolescents under 15 years of age.

Warnings and precautions
Talk to your doctor before taking ibuprofen:

if you have systemic lupus erythematosus (SLE) or other autoimmune diseases
if you have a hereditary disorder of the blood pigment haemoglobin (porphyria)
if you have chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers), 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 have allergies, hay fever, asthma, chronic swelling of the nasal mucosa, sinuses, and adenoids, or chronic obstructive respiratory diseases, as there is a higher risk of airway constriction and breathing difficulties (bronchospasm)
if you have liver, kidney, or heart problems
if you have recently undergone surgery
if you are in the first six months of pregnancy
if you are breastfeeding.

Elderly
Elderly patients may be more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation, which can be fatal.
Ulcers, perforations, and bleeding in the stomach or intestine
If you have previously had a gastric 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 stopped.
Bleeding, ulceration, or perforation in the stomach or intestine may occur without warning signs, even in patients who have never previously experienced such problems. These events can also be fatal.
The risk of ulcers, perforation, or bleeding in the stomach or intestine generally increases with higher doses of ibuprofen. The risk is further increased if ibuprofen is taken together with certain other medicines (see below “Other medicines and Ibuprofene Aurobindo Pharma Italia”).
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Skin reactions
You must stop taking ibuprofen at the first sign of skin rash, mucosal lesions, or other signs of allergy, as these may be the initial symptoms of a serious skin reaction (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome), which may occasionally be fatal. The highest risk for such reactions occurs during the first month of treatment.
If you have chickenpox, it is advisable to avoid using this medicine.
Effects on the heart and brain
Anti-inflammatory/painkillers 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 your treatment with your doctor or pharmacist before taking Ibuprofene Aurobindo Pharma Italia if:

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

Effects on the kidneys
Ibuprofen may cause kidney function problems even in patients who have never previously had kidney issues. These effects may lead to leg swelling and may also result in heart failure or high blood pressure in predisposed individuals.
Ibuprofen can cause kidney damage, particularly in patients who have previously had 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 of kidney function.
Aseptic meningitis (inflammation of the brain membranes without bacterial infection)
During treatment with ibuprofen, rare cases of meningitis (presenting with neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed. Although more likely to occur in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disorders, it has also been reported in patients without pre-existing long-term illness.
Other precautions
Very rare cases of severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed.
Immediately discontinue treatment at the first signs of hypersensitivity reaction after taking Ibuprofene Aurobindo Pharma Italia and inform your doctor immediately.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with blood clotting disorders should be closely monitored.
Prolonged use of any type of painkiller for headache may worsen it. If this occurs or is suspected, discontinue ibuprofen and consult your doctor.
The diagnosis of medication-overuse headache (MOH) should be considered in patients who have frequent or daily headaches despite (or because of) regular use of headache medications.
Headaches may occur during long-term use of high doses of painkillers and should not be treated with high doses of this medicine.
Habitual use of painkillers may cause permanent kidney damage, with risk of kidney failure.
Ibuprofen may mask symptoms or signs of infection (fever, pain, swelling) and temporarily prolong bleeding time.
Ibuprofene Aurobindo Pharma Italia may reduce the likelihood of becoming pregnant. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Children and adolescents
Ibuprofene Aurobindo Pharma Italia 400 mg film-coated tablets
Ibuprofene Aurobindo Pharma Italia is contraindicated in children weighing less than 20 kg and under 6 years of age.
Ibuprofene Aurobindo Pharma Italia 600 mg film-coated tablets
Ibuprofene Aurobindo Pharma Italia is contraindicated in children and adolescents under 15 years of age.
Ibuprofen may cause kidney problems in dehydrated children and adolescents.

Other medicines and Ibuprofene Aurobindo Pharma Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ibuprofen may affect or be affected by other medicines.
For example:

other NSAIDs including COX-2 inhibitors, as they may increase the risk of gastrointestinal ulcers and bleeding
anticoagulant medicines (anticoagulants) such as warfarin or heparin, as their effect may be increased
platelet aggregation inhibitors (antiplatelets) such as ticlopidine or clopidogrel
methotrexate (used in the treatment of cancer and autoimmune diseases)
digoxin (for the treatment of various heart conditions), as the effect of digoxin may be increased
phenytoin (used to prevent epileptic seizures), as the effect of phenytoin may be increased
lithium (used to treat depression and mania), as the effect of lithium may be increased
diuretics, as their effect may be reduced
potassium-sparing medicines, as this may lead to hyperkalaemia
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
cholestyramine (used in the treatment of high cholesterol)
aminoglycosides (medicines against certain types of bacteria), as NSAIDs may reduce aminoglycoside excretion
SSRIs (medicines for depression) such as paroxetine, sertraline, and citalopram, as they may increase the risk of stomach and intestinal bleeding
cyclosporine, tacrolimus (for immunosuppression after organ transplantation), as kidney damage may occur
zidovudine or ritonavir (used in the treatment of HIV-positive patients)
mifepristone, as NSAIDs may reduce the effect of mifepristone
probenecid or sulfinpyrazone (for the treatment of gout), as elimination of ibuprofen may be delayed
quinolone antibiotics, as they may increase the risk of seizures
sulfonylureas (for the treatment of type 2 diabetes), as they may alter blood sugar levels
glucocorticoids (used against inflammation), as the risk of stomach or intestinal ulcers or bleeding may be increased
bisphosphonates (used in osteoporosis, Paget's disease, and to reduce elevated calcium levels in the blood)
oxpentifilline [(pentoxifylline), used in the treatment of circulatory disorders of the arteries in the legs or arms]
baclofen (a muscle relaxant), due to its high toxicity
voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), as the effect of ibuprofen may be increased. A reduction in the dose of ibuprofen should be considered, especially when high doses of ibuprofen are taken with voriconazole or fluconazole.

Other medicines may also affect or be affected by treatment with Ibuprofene Aurobindo Pharma Italia. Therefore, always consult your doctor or pharmacist before using Ibuprofene Aurobindo Pharma Italia with other medicines.

Ibuprofene Aurobindo Pharma Italia and alcohol
Avoid drinking alcohol, as it may increase the adverse effects of ibuprofen, particularly those affecting the stomach, intestine, or central nervous system.

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.
Ibuprofen must not be taken during the last 3 months of pregnancy because it may cause serious heart, lung, and kidney problems in the unborn baby. If used at the end of pregnancy, it may cause bleeding tendencies in both mother and child and weaken the strength of uterine contractions, thereby delaying the onset of labour.
You should use ibuprofen during the first 6 months of pregnancy only after consulting your doctor and exclusively if strictly necessary.
Ibuprofen may make it more difficult to become pregnant. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Ibuprofen passes into breast milk in very small amounts and it is generally not necessary to stop breastfeeding during short-term treatments. However, if prolonged treatment is prescribed, early weaning should be considered.

Driving and using machines
Ibuprofen generally has no adverse effects on the ability to drive vehicles or operate machinery. However, since undesirable effects such as fatigue, drowsiness, dizziness (reported as common), and visual disturbances (reported as uncommon) may occur at high doses, in isolated cases the ability to drive or operate machinery may be impaired. This effect is enhanced by concomitant alcohol intake.

Ibuprofene Aurobindo Pharma Italia contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per 400 mg/600 mg tablet and is therefore essentially “sodium-free”.

3. How to take Ibuprofene Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Your doctor will decide the duration of treatment.
In rheumatic diseases, the use of ibuprofen may be prolonged.

Ibuprofene Aurobindo Pharma Italia 400 mg film-coated tablets
The dose of ibuprofen depends on the patient's age and weight. The maximum dose in adults must not
exceed 800 mg of ibuprofen per day (2 tablets).
The recommended dose is:

Fever and mild to moderate pain
Adults and adolescents weighing ≥ 40 kg (12 years or older):
½–1 tablet administered as a single dose or 3–4 times daily at 6-hour intervals.
The maximum daily dose must not exceed 3 tablets (1200 mg).

Children weighing ≥ 20 kg (aged 6–11 years):
Other medicines may be more suitable for this age group. Your doctor will advise accordingly.

Children weighing 20–29 kg (aged 6–9 years):
½ tablet administered 1–3 times daily at 6-hour intervals.
The maximum number of tablets must not exceed 1½ tablets per day.

Children weighing 30–39 kg (aged 10–11 years):
½ tablet administered 1–4 times daily at 6-hour intervals.
The maximum number of tablets must not exceed 2 tablets per day.

Migraine headache
Adults and adolescents weighing ≥ 40 kg (12 years or older):
1 tablet administered as a single dose; if needed, 1 tablet at 6-hour intervals.
The maximum daily dose must not exceed 3 tablets (1200 mg).

Menstrual pain
Adults and adolescents weighing > 40 kg (12 years or older):
½–1 tablet 1–3 times daily at 6-hour intervals, as needed.
The maximum daily dose must not exceed 3 tablets (1200 mg).

Rheumatic pain
Adults:
The recommended dose is 3–4½ tablets three times daily (1200 mg – 1800 mg). Your doctor will prescribe the lowest dose.
Due to the severity of your condition, your doctor may increase the dose up to a maximum of 6 tablets
per day (2400 mg), administered in 3 or 4 divided doses.

Adolescents over 12 years of age (> 40 kg):
The recommended daily dose ranges from 20 mg/kg up to a maximum of 40 mg/kg, administered in
3 or 4 divided doses. Your doctor will advise accordingly.

The tablet should be swallowed with a glass of water during or after meals. To facilitate swallowing or adjust dosing, tablets may be divided into two equal halves.

Ibuprofene Aurobindo Pharma Italia 600 mg film-coated tablets
The dose of ibuprofen depends on the patient's age and weight. The maximum dose in adults must not
exceed 800 mg of ibuprofen per day.

Rheumatic pain
Adults:
The recommended dose is 400 mg–600 mg three times daily. Your doctor will prescribe the lowest dose.
Depending on the nature and severity of your condition, your doctor may increase the dose up to
a maximum of 2400 mg per day, administered in 3 or 4 divided doses.

Adolescents aged 15 to 17 years:
The recommended daily dose ranges from 20 mg/kg up to a maximum of 40 mg/kg, administered in
3 or 4 divided doses. Your doctor will advise accordingly.

The tablet should be swallowed with a glass of water during or after meals. To facilitate swallowing or adjust dosing, tablets may be divided into two equal halves.

Elderly
If you are elderly, you are more likely to experience adverse effects, particularly gastrointestinal bleeding and perforation, which can be fatal. Your doctor will advise accordingly.

Renal or hepatic impairment
If you have impaired kidney or liver function, your doctor will advise accordingly.

If you take more Ibuprofene Aurobindo Pharma Italia than you should
If you take more ibuprofen than you should, or if a child takes the medicine by accident, contact a doctor or the nearest emergency department immediately for advice on the risk and actions to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), or less commonly, diarrhoea. Other symptoms may include headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, eye tremors, and worsening of asthma in asthmatic patients. In more severe cases of overdose, drowsiness, agitation, disorientation, chest pain, palpitations, coma, convulsions (particularly in children), dizziness, weakness, vertigo, blood in urine, low blood pressure, hyperkalaemia, metabolic acidosis, prolonged prothrombin time/INR, acute renal failure, liver damage, reduced breathing, cyanosis, feeling cold, and respiratory problems may occur.

If you forget to take Ibuprofene Aurobindo Pharma Italia
If you miss a dose, take it as soon as possible unless it is less than 4 hours before your next dose.
Do not take a double dose to make up for the missed dose.
If you have any questions 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 everyone gets them.
The following side effects depend largely on the dose and may vary from patient to patient.
The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or bleeding of the stomach or intestine, sometimes fatal, may occur, particularly in elderly patients. After taking the medicine, nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melena, haematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported.
Less frequently, inflammation of the stomach lining (gastritis) has been reported.
Medicines such as Ibuprofene Aurobindo Pharma Italia may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Fluid retention (oedema), high blood pressure and heart failure have been reported in association with NSAIDs.
The side effects are listed according to how often they occur, using the following convention:
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 they occur.
Stop treatment with Ibuprofene Aurobindo Pharma Italia and contact your doctor immediately if you experience any of the following symptoms:

Common:

Black stools or blood in vomit (gastrointestinal ulcer with bleeding)

Very 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, laboured breathing and drop in blood pressure
Severe skin rash with blisters on the skin, particularly on legs, arms, hands and feet, which may spread to the face and lips (erythema multiforme, Stevens-Johnson syndrome). This condition may worsen, with enlargement and spreading of blisters and possible detachment of the skin (Lyell's syndrome). A severe skin infection with destruction (necrosis) of the skin, subcutaneous tissue and muscle (necrotising fasciitis) may also occur.

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

Very common:

Heartburn, abdominal pain, indigestion

Uncommon:

Blurred vision
Hypersensitivity reactions such as skin rashes, itching, purpura, exanthema and asthma attacks (sometimes accompanied by low blood pressure)
Photosensitivity (increased sensitivity to light)

Rare:

Loss of vision

Very rare:

Sudden accumulation of fluid in the lungs leading to breathing difficulties, high blood pressure, fluid retention and weight gain

Other possible side effects with Ibuprofene Aurobindo Pharma Italia include:

Very common:

Gastrointestinal disorders such as diarrhoea, nausea, vomiting, flatulence, constipation

Common:

Gastrointestinal ulcer with or without perforation
Inflammation of the intestine and worsening of inflammation of the colon (colitis) and gastrointestinal tract (Crohn's disease), and complications of colonic diverticula (perforation or fistula)
Micro-bleeding of the intestine, which may cause anaemia
Ulcers and inflammation of the mouth (ulcerative stomatitis)
Headache, drowsiness, dizziness, vertigo, fatigue, restlessness, insomnia and irritability

Uncommon:

Inflammation of the stomach lining
Kidney problems, including development of oedema, kidney inflammation and renal failure
Excessive nasal discharge
Breathing difficulties (bronchospasm)

Rare:

Depression, confusion, hallucinations
Systemic lupus erythematosus
Increased blood urea nitrogen, serum transaminases and alkaline phosphatase, decreased haemoglobin and haematocrit, inhibition of platelet aggregation and prolonged bleeding time, decreased blood calcium and increased blood uric acid
Kidney tissue damage

Very rare:

Palpitations, heart failure, heart attack or high blood pressure
Blood cell formation disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). Initial symptoms or signs include: fever, sore throat, mouth ulcers, flu-like symptoms, fatigue, nosebleeds and skin bleeding
Ringing or buzzing in the ears
Inflammation of the oesophagus or pancreas
Intestinal narrowing
Acute inflammation of the liver, yellowing of the skin or whites of the eyes, liver dysfunction, liver damage or liver failure
Liver damage, particularly with long-term therapy, or liver failure
Hair loss
Inflammation of the meninges in the absence of bacterial infection (aseptic meningitis)

Not known:

Tingling in hands and feet
Anxiety
Impaired hearing
General feeling of malaise
Inflammation of the optic nerve which may cause vision problems

A serious skin reaction known as DRESS may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
Ibuprofene Aurobindo Pharma Italia may cause a reduction in the number of white blood cells and decrease your resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general health, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary problems, contact your doctor immediately. A blood test will be performed to determine whether there is a reduction in white blood cells (agranulocytosis). It is important to inform your doctor about the medicine you are taking.

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 the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofene Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 Aurobindo Pharma Italia contains

The active substance is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.
The other components are:
Tablet core: maize starch, pregelatinized starch (maize starch), anhydrous colloidal silica, croscarmellose sodium, talc, stearic acid.
Film coating: talc (E553b), polyvinyl alcohol, macrogol 3350 (E1521), titanium dioxide (E171).

Description of the appearance of Ibuprofene Aurobindo Pharma Italia and contents of the pack
Film-coated tablet.
Ibuprofene Aurobindo Italia 400 mg film-coated tablets
White to almost white, round, film-coated tablets, with a score line on one side and smooth on the other side. The tablet can be divided into two equal doses.
Ibuprofene Aurobindo Italia 600 mg film-coated tablets
White to almost white, oval, film-coated tablets, with a score line on one side and smooth on the other side. The tablet can be divided into two equal doses.
Ibuprofene Aurobindo Pharma Italia film-coated tablets are available in blister packs.
Pack sizes: 20, 30 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l., via San Giuseppe, 102 - 21047 Saronno (VA), Italy
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia
BBG 3000 Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
Amadora
2700-487 Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: IBUPROFENO AUROVITAS
Italy: Ibuprofene Aurobindo Pharma Italia