Ibuprofen Livsane: detailed information

Package leaflet: Information for the user

Ibuprofene Aurobindo Italia 200 mg film-coated tablets

Ibuprofene Aurobindo Italia 400 mg film-coated tablets
Generic medicine (only for the 400 mg dosage)
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if symptoms worsen
after 3 days in adolescents
after 3 days for migraine headache and fever, and after 4 days for pain and menstrual pain in adults.

Contents of this leaflet:

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

1. What Ibuprofene Aurobindo Italia is and what it is used for

Ibuprofene Aurobindo Italia belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which work by reducing pain and fever.
Ibuprofene Aurobindo Italia is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, including migraine headache, toothache, menstrual pain, and/or fever.

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

Do not take Ibuprofene Aurobindo 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 a stomach or small intestine (duodenum) ulcer or bleeding related to previous use of painkillers and anti-inflammatory medicines (NSAIDs)
if you currently have stomach or intestinal bleeding or perforation, or have had two or more such episodes 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 severely 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 blood cell formation.

Ibuprofene Aurobindo Italia is contraindicated in children under 12 years of age.
Warnings and precautions
Talk to your doctor before taking Ibuprofene Aurobindo Italia:

if you have systemic lupus erythematosus (SLE) or other connective tissue disorders
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 affecting 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 an increased risk of airway narrowing and breathing difficulties (bronchospasm)
if you have liver, kidney, heart problems, or high blood pressure
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 gastrointestinal bleeding
If you have recently had a gastric or intestinal ulcer, especially if complicated by perforation or accompanied by bleeding, you should pay attention to any unusual abdominal symptoms and report them immediately to your doctor, especially if these symptoms occur at the beginning of treatment. This is because the risk of gastrointestinal bleeding or ulceration is higher in such cases, particularly 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 previously experienced these problems. These events can also be fatal.
The risk of ulcers, perforation, or gastrointestinal bleeding 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 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 severe 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.
Avoid using this medicine if you have chickenpox.
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 (7 days in adults or 3 days in children and adolescents).
Discuss your treatment with your doctor or pharmacist before taking ibuprofen 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 in 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 cause heart failure or high blood pressure in predisposed individuals.
Ibuprofen may cause kidney damage, particularly in patients who already have kidney, heart, or liver problems, those taking diuretics or ACE inhibitors, and in the elderly. However, discontinuation of ibuprofen generally leads to recovery of kidney function.
Aseptic meningitis (inflammation of brain membranes without bacterial infection)
Cases of meningitis (presenting with neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed during ibuprofen treatment. 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 chronic conditions.
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 Italia and contact 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 medicines.
Regular use of painkillers may cause permanent kidney damage, with a risk of kidney failure.
Ibuprofen may mask symptoms or signs of infection (fever, pain, swelling) and temporarily prolong bleeding time.
Ibuprofen may reduce the likelihood of becoming pregnant. Inform your doctor if you are planning a pregnancy or if you have difficulty conceiving.
Children and adolescents
Do not use in children under 12 years of age.
Ibuprofene Aurobindo Italia may cause kidney problems in dehydrated adolescents.
Other medicines and Ibuprofene Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ibuprofene Aurobindo Italia 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 such as warfarin or heparin, as their effect may be enhanced
platelet aggregation inhibitors (anticoagulants) 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 reduce 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 ibuprofen elimination 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 high blood calcium levels)
oxpentifylline [(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
Gingko biloba (there is a possibility you may bleed more easily if taking it with ibuprofen)
voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), as the effect of ibuprofen may be increased. A reduction in ibuprofen dose should be considered, especially when high doses of ibuprofen are taken with voriconazole or fluconazole.
Other medicines may also influence or be influenced by treatment with Ibuprofene Aurobindo Italia. Therefore, always consult your doctor or pharmacist before using Ibuprofene Aurobindo Italia with other medicines.

Ibuprofene Aurobindo 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, think 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 problems to the heart, lungs, and kidneys of the unborn baby. If used at the end of pregnancy, it may cause bleeding tendencies in both mother and baby and weaken 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.
This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.
Ibuprofen passes into breast milk in very small amounts and it is generally not necessary to stop breastfeeding during short-term treatment. However, if prolonged treatment is prescribed, early weaning should be considered.
Driving and using machines
Ibuprofen generally does not have adverse effects on the ability to drive or operate machinery. However, at high doses, adverse effects such as fatigue, drowsiness, dizziness (reported as common), and visual disturbances (reported as uncommon) may occur, and in isolated cases, the ability to drive or operate machinery may be impaired. The effect is enhanced by concomitant alcohol intake.
Ibuprofene Aurobindo Italia contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per 200 mg/400 mg tablet, and is therefore essentially “sodium-free”.

3. How to take Ibuprofene Aurobindo 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.
For short-term use only.
The dose of ibuprofen depends on the patient's age and body weight. The recommended dose is:
Fever and mild to moderate pain
Adults and adolescents weighing ≥ 40 kg (12 years of age or older):
1-2 tablets administered as a single dose or 3-4 times daily at 6-hour intervals as needed.
½-1 tablet administered as a single dose or 3-4 times daily at 6-hour intervals as needed.
The maximum daily dose must not exceed 6 tablets (1200 mg).
The maximum daily dose must not exceed 3 tablets (1200 mg).
Migraine headache
Adults and adolescents weighing ≥ 40 kg (12 years of age or older):
2 tablets administered as a single dose, if necessary 2 tablets at 6-hour intervals.
1 tablet administered as a single dose, if necessary 1 tablet at 6-hour intervals.
The maximum daily dose must not exceed 6 tablets (1200 mg).
The maximum daily dose must not exceed 3 tablets (1200 mg).
Menstrual pain
Adults and adolescents weighing ≥ 40 kg (12 years of age or older):
1-2 tablets 1-3 times daily at 4-6 hour intervals, as needed. The maximum daily dose must not exceed 6 tablets (1200 mg).
½-1 tablet 1-3 times daily at 4-6 hour intervals, as needed. The maximum daily dose must not exceed 3 tablets (1200 mg).
The tablets should be swallowed with a glass of water during or after meals. Patients with stomach problems are advised to take ibuprofen during meals. To facilitate swallowing or to adjust doses, the tablets may be divided into two equal halves.
If you are an adult and your condition has not improved within 3 days (or within 4 days for pain and menstrual pain), or if your headache or fever worsens, consult your doctor.
If a child or adolescent requires this medicine for more than 3 days, or if symptoms worsen, consult a doctor.
Use in children
Ibuprofene Aurobindo Italia must not be given to children under 12 years of age.
Elderly
If you are elderly, you should always consult your doctor before taking ibuprofen, as you may be more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation, which can be fatal. Your doctor will advise you accordingly.
Renal or hepatic impairment
If you have impaired renal or hepatic function, always consult your doctor before taking Ibuprofene Aurobindo Italia. Your doctor will advise you accordingly.
If you take more Ibuprofene Aurobindo Italia than you should
If you take more ibuprofen than you should, or if a child takes the medicine by mistake, always contact a doctor or the nearest emergency department for advice on the risk and actions to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), or more rarely diarrhea. Headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, and nystagmus may also occur, as well as worsening of asthma in asthmatic patients. In more severe cases of overdose, drowsiness, agitation, disorientation, chest pain, palpitations, loss of consciousness, seizures (particularly in children), dizziness, weakness, dizziness, blood in the urine, low blood pressure, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR, acute renal failure, liver damage, reduced breathing, cyanosis, cold sensation, and breathing difficulties may occur.
If you forget to take Ibuprofene Aurobindo Italia
Do not take a double dose to make up for a forgotten 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 will experience them.
The following side effects largely depend 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 intestines, sometimes fatal, may occur, particularly in elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melena, haematemesis, ulcerative stomatitis, and worsening of colitis or Crohn's disease have been reported following administration.
Less frequently, inflammation of the stomach lining (gastritis) has been reported.
Medicines such as ibuprofen 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 list of side effects below includes all adverse reactions observed during treatment with ibuprofen, including those in patients with rheumatic conditions undergoing long-term therapy with high doses. The frequencies indicated, which extend beyond very rare reports, refer to short-term use of daily doses up to a maximum of 1,200 mg of ibuprofen for oral dosage forms and up to 1,800 mg for suppositories.
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 available data

The following side effects are important and require immediate attention if they occur. Stop taking ibuprofen 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, wheezing 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 this 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, exanthema, 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 causing breathing difficulties, high blood pressure, fluid retention and weight gain

Other possible side effects with Ibuprofene Aurobindo 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 values, inhibition of platelet aggregation and prolonged bleeding time, decreased calcium and increased serum uric acid
Kidney tissue damage

Very rare:

Palpitations, heart failure or heart attack
Disorders in blood cell formation (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 (jaundice), liver dysfunction, liver damage (particularly with long-term therapy), or liver failure
Hair loss
Inflammation of the membrane covering the brain in the absence of bacterial infection (aseptic meningitis)

Not known:

Tingling in the 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 Italia may reduce 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 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 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 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 Italia contains

The active substance is ibuprofen. Each film-coated tablet contains 200 mg of ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
The other components are: Tablet core: maize starch, pregelatinized starch (maize starch), anhydrous colloidal silica, sodium croscarmellose, talc, stearic acid. Film coating: talc (E553b), polyvinyl alcohol, macrogol 3350 (E1521), titanium dioxide (E171).

Description of the appearance of Ibuprofene Aurobindo Italia and package contents
Film-coated tablet.
Ibuprofene Aurobindo Italia 200 mg film-coated tablets
White to almost white, round (diameter 9.8 mm), film-coated tablets with a score line on one side and smooth on the other side. The tablets can be divided into two equal doses.
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 tablets can be divided into two equal doses.
Ibuprofene Aurobindo Italia film-coated tablets are available in blister packs.
Pack sizes:
Blister packs:
200 mg: 10, 20, 24, 56, 60 and 84 film-coated tablets.
400 mg: 10, 20, 24, 50, 56, 84 and 100 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)
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia
BBG 3000 Malta
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road, Ruislip
HA4 6QD United Kingdom
Generis Farmacêutica, S.A.
Rua João de Deus, 19
Amadora
2700-487 Portugal

This medicinal product is authorized in the European Economic Area Member States under the following names:
Belgium: Ibuprofen Aurobindo 200 mg/400 mg filmomhulde tabletten
Germany: Ibuprofen PUREN akut 400 mg Filmtabletten
Italy: Ibuprofene Aurobindo Italia
Portugal: Ibuprofeno Mer
Romania: Ibuprofen Aurobindo 200 mg/400 mg comprimate filmate
Netherlands: Ibuprofen Sanias 200 mg/400 mg, filmomhulde tabletten
United Kingdom: Ibuprofen 200 mg/400 mg film-coated tablets