IBUPROFENE 200 mg Film-Coated Tablets

Зміст інструкції

1. Ibuprofene Aurobindo Italia 200 mg film-coated tablets, 400 mg film-coated tablets
   1. What is Ibuprofene Aurobindo Italia and what is it used for?
   2. What you need to know before you take Ibuprofene Aurobindo Italia
   3. How to take Ibuprofene Aurobindo Italia
   4. Possible side effects
   5. How to store Ibuprofene Aurobindo Italia
   6. Contents of the pack and other information

Ibuprofene Aurobindo Italia 200 mg film-coated tablets, 400 mg film-coated tablets

Equivalent medicine (only for 400 mg dosage)

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse
• after 3 days in adolescents
• after 3 days with migraine headache and fever and after 4 days with pain and menstrual cramps in adults.

Contents of this leaflet:

• 1. What Ibuprofene Aurobindo Italia is and what it is used for
• 2. What you need to know before you take Ibuprofene Aurobindo Italia
• 3. How to take Ibuprofene Aurobindo Italia
• 4. Possible side effects
• 5. How to store Ibuprofene Aurobindo Italia
• 6. Contents of the pack and other information

1. What is Ibuprofene Aurobindo Italia and what is it 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 symptomatic treatment of short-term duration in case of mild to moderate pain, such as headache, including that caused by migraine, toothache, menstrual pain and/or fever.

2. What you need to know before you take 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 rash or swelling of the lips, face, tongue or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other pain relievers or anti-inflammatory drugs (NSAIDs)
• if you have suffered from an ulcer or bleeding of the stomach or duodenum in relation to previous use of pain relievers and anti-inflammatory drugs (NSAIDs)
• if you suffer from bleeding or perforation of the stomach or intestine or if you have suffered from two or more episodes of this type in the past
• if you suffer from severe problems with the liver, kidneys or heart
• if you are in the last 3 months of pregnancy
• if you suffer from severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake)
• if you have active bleeding (including in the brain)
• if you suffer from a disease of unknown origin that causes abnormal formation of blood cells.

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 suffer from systemic lupus erythematosus (SLE) or other mixed connective tissue diseases
• if you suffer from a hereditary disorder of the red blood pigment hemoglobin (porphyria)
• if you suffer from chronic inflammatory diseases of the intestine such as inflammation of the colon with ulcers (ulcerative colitis), inflammation of the digestive tract (Crohn's disease) or other diseases of the stomach and intestines
• if you suffer from disorders of blood cell formation
• if you suffer from problems with the normal mechanism of blood coagulation
• if you suffer from allergies, hay fever, asthma, chronic swelling of the nasal mucosa, sinuses and adenoids or chronic obstructive diseases of the respiratory tract, because there is a greater risk of narrowing of the airways, with difficulty breathing (bronchospasm)
• if you suffer from problems with the liver, kidneys, heart 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 bleeding and perforation of the digestive tract, which can be fatal.

Ulcers, perforations and bleeding in the stomach or intestine
If you have recently had a gastric or intestinal ulcer, especially if it has been complicated by perforation or accompanied by bleeding, you should pay attention to any unusual symptoms in the abdomen and immediately report them to your doctor, especially if these symptoms occur at the beginning of treatment. This is because the risk of bleeding or ulceration of the digestive tract is higher in this case, particularly in elderly patients. If bleeding or ulceration of the digestive tract occurs, treatment should be discontinued.
Bleeding, ulceration or perforation in the stomach or intestine can occur without any warning signs, even in patients who have never had these problems before. They 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 also increases if you are taking certain other medicines with ibuprofen (see below “Other medicines and Ibuprofene Aurobindo Italia”).
Adverse effects can be minimized by using the lowest effective dose, for the shortest period of time necessary to control the symptoms.

Skin reactions
You should stop taking ibuprofen at the first sign of rash, mucous membrane lesions or other signs of allergy because it may be the first sign of a serious skin reaction (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome), sometimes with fatal outcome. The greatest risk for these reactions is 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/pain relievers such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially if 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).
You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• you have heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including ‘mini-stroke’ or transient ischemic attack "TIA");
• high blood pressure, diabetes, high cholesterol or a family history of heart disease or stroke, or if you are a smoker.

Effects on the kidneys
Ibuprofen can cause kidney problems even in patients who have never suffered from kidney problems before. These effects can lead to swelling of the legs and can also determine heart failure or high blood pressure in predisposed individuals.
Ibuprofen can cause kidney damage, especially in patients who have already suffered from 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 membranes of the brain without bacterial infection)
During treatment with ibuprofen, some cases of meningitis have been observed (which presents with stiff neck, headache, nausea, vomiting, fever or disorientation). Although it is more likely to occur in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus or connective tissue diseases, it has been reported in patients without a long-term pre-existing disease.

Other precautions
Very rare cases of severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed.
Immediately stop treatment after the first signs of a hypersensitivity reaction after taking Ibuprofene Aurobindo Italia and immediately inform your doctor.
Ibuprofen can temporarily inhibit platelet function (platelet aggregation). Therefore, patients with blood coagulation disorders should be carefully monitored.
Prolonged use of any type of pain reliever for headache can worsen it. If this occurs or is suspected, stop taking 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.
Regular use of pain relievers can cause permanent damage to the kidneys, with a risk of kidney failure.
Ibuprofen can mask the symptoms or signs of an infection (fever, pain and swelling) and temporarily prolong bleeding time.
Ibuprofen may decrease the likelihood of becoming pregnant. Tell your doctor if you are planning a pregnancy or if you are having difficulty getting pregnant.

Children and adolescents
Do not use in children under 12 years of age.
Ibuprofene Aurobindo Italia can cause kidney problems in dehydrated adolescents.

Other medicines and Ibuprofene Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ibuprofene Aurobindo Italia can influence or be influenced by other medicines.
For example:

• other NSAIDs including COX-2 inhibitors, as they can increase the risk of ulcers and gastrointestinal bleeding
• anticoagulant medicines such as warfarin or heparin as their effect may be increased
• 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 diseases) as the effect of digoxin may be increased
• phenytoin (used in the prevention of 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 decreased
• potassium-sparing medicines, as this can lead to hyperkalemia
• 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 some types of bacteria) as NSAIDs can reduce the excretion of aminoglycosides
• SSRIs (medicines against depression) such as paroxetine, sertraline and citalopram as they can increase the risk of bleeding of the stomach and intestines
• 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 can reduce the effect of mifepristone
• probenecid or sulfinpyrazone (for the treatment of gout) as the elimination of ibuprofen may be delayed
• quinolone antibiotics as it may increase the risk of seizures
• sulfonylurea (for the treatment of type 2 diabetes) as it may alter blood sugar levels
• glucocorticoids (used against inflammation) as the risk of ulcers or bleeding of the stomach or intestine may be increased
• bisphosphonates (used in osteoporosis, Paget's disease and to reduce high calcium levels in the blood)
• oxpentifylline [(pentoxifylline) used in the treatment of circulatory diseases of the legs or arms]
• baclofen (a muscle relaxant) due to its high toxicity
• Gingko biloba (there is a possibility that you may bleed more easily if you are taking it with ibuprofen)
• 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 and fluconazole. Some 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 with alcohol
Avoid drinking alcohol as it can increase the side effects of ibuprofen, especially those affecting the stomach, intestines or central nervous system.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Ibuprofen should not be taken during the last 3 months of pregnancy as it can cause significant disturbances to the heart, lungs and kidneys of the fetus. If used at the end of pregnancy, it can cause a tendency to bleeding in both mother and child and weaken the strength of uterine contractions, thus delaying the onset of labor.
You should use ibuprofen during the first 6 months of pregnancy only after consulting your doctor and only if strictly necessary.
This medicine belongs to a group of medicines (NSAIDs) that can impair fertility in women. The effect is reversible by stopping the medicine.
Ibuprofen appears in breast milk in very small amounts and it is generally not necessary to stop breastfeeding during short-term treatments. However, if a prolonged treatment is prescribed, the possibility of 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, as adverse 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 vehicles or operate machinery may be impaired. The effect is enhanced by concomitant consumption of alcohol.

Ibuprofene Aurobindo Italia contains sodium.This medicine contains less than 1 mmol of sodium (23 mg) per 200 mg/400 mg tablet, therefore it is essentially “sodium-free”.

3. How to take Ibuprofene Aurobindo Italia

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time
necessary to control the symptoms.
Exclusively for short-term use.
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 or older):
1-2 tablets administered in a single dose or 3-4 times a day at intervals of 6 hours
as needed.
½-1 tablet administered in a single dose or 3-4 times a day at intervals of 6 hours as needed.
The maximum daily dose should not exceed 6 tablets (1200 mg).
The maximum daily dose should not exceed 3 tablets (1200 mg).

Migraine headache

Adults and adolescents weighing ≥ 40 kg (12 years or older):
2 tablets administered in a single dose, if necessary 2 tablets at intervals of 6 hours.
1 tablet administered in a single dose, if necessary 1 tablet at intervals of 6 hours.
The maximum daily dose should not exceed 6 tablets (1200 mg).
The maximum daily dose should not exceed 3 tablets (1200 mg).

Menstrual pains

Adults and adolescents weighing ≥ 40 kg (12 years or older):
1-2 tablets 1-3 times a day at intervals of 4-6 hours, as needed. The maximum daily dose should not
exceed 6 tablets (1200 mg).
½-1 tablet 1-3 times a day at intervals of 4-6 hours, as needed. The maximum daily dose should not
exceed 3 tablets (1200 mg).
The tablets should be swallowed with a glass of water during or after meals. It is recommended
for patients with stomach problems to take ibuprofen during meals. To facilitate
swallowing or to adjust the doses, the tablets can be divided into two equal halves.
If you are an adult and your condition has not improved within 3 days or has worsened, in case of migraine
headache or fever and within 4 days in case of pain and menstrual pains, consult your doctor.
If a child or adolescent needs this medicine for more than 3 days, or if the symptoms
worsen, a doctor should be consulted.

Use in children
Ibuprofene Aurobindo Italia should not be administered to children under 12 years of age.

Elderly
If you are elderly, you should always consult your doctor before using ibuprofen because you will be more
susceptible to undesirable effects, in particular bleeding and perforation of the digestive tract, which can
be fatal. Your doctor will advise you accordingly.

Impairment of renal or hepatic function
If you suffer from reduced 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 has taken the medicine by mistake, always consult
a doctor or the nearest emergency room for an opinion on the risk and advice on the actions
to be taken.
Symptoms of overdose may include nausea, stomach pain, vomiting (with presence of
blood) or more rarely diarrhea. Headache, bleeding in the stomach or
intestine, blurred vision, ringing in the ears, confusion and trembling eye movement and
worsening of asthma in asthmatic patients may also occur. In more severe cases of overdose, may occur
drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, convulsions
(especially in children), dizziness, weakness and lightheadedness, blood in the urine, low blood pressure,
hyperkalemia, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage, reduced breathing, cyanosis, feeling of cold and breathing problems.

If you forget to take Ibuprofene Aurobindo Italia
Do not take a double dose to make up for a missed 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.
With regard to the following side effects, it should be considered that they largely depend on the dose and vary from patient to patient.
The most commonly observed side effects are of a gastrointestinal nature. Peptic ulcers, perforation or bleeding of the stomach or intestine, sometimes fatal, may occur, particularly in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, melena, hematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported following intake.
Inflammation of the stomach lining (gastritis) has been reported less frequently.
Medicines such as ibuprofen may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Fluid retention (edema), high blood pressure and heart failure have been reported in association with NSAIDs.
The list of the following side effects includes all side effects encountered during treatment with ibuprofen, including those in patients with rheumatism undergoing long-term therapy with high doses. The frequencies indicated, which extend beyond very rare reports, refer to short-term use of daily doses of up to a maximum of 1,200 mg of ibuprofen for oral dosage forms and a maximum of 1,800 mg for suppositories.
Side effects are reported according to the frequency with which they occur. 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: the frequency cannot be estimated from available data

The following side effects are important and require immediate attention if they occur. Stop treatment with ibuprofen and seek medical advice immediately if you experience the following symptoms:

Common:

• black stools or presence of blood in vomit (ulcer of the digestive tract with bleeding)

Very rare:

• swelling of the face, tongue or throat (larynx), which can cause severe difficulty breathing (angioedema), increased heart rate, 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, especially on legs, arms, hands and feet, which may spread to the face and lips (erythema multiforme, Stevens-Johnson syndrome). This condition may also worsen, with widening and spreading of the blisters and possible detachment of the skin (Lyell's syndrome). A severe skin infection with destruction (necrosis) of the skin, subcutaneous tissue and muscle (necrotizing fasciitis) may also occur.

Stop treatment with the medicine and consult a doctor as soon as possible if you experience the following side effects:

Very common:

• heartburn, abdominal pain, indigestion

Uncommon:

• blurred vision
• hypersensitivity reactions, such as skin rashes, itching, urticaria, asthma attacks (sometimes accompanied by low blood pressure)
• photosensitivity (increased sensitivity to light)

Rare:

• loss of vision

Very rare:

• sudden leakage of fluid into the lungs with resulting difficulty breathing, high blood pressure, fluid retention and weight gain. Other possible side effects with Ibuprofene Aurobindo Italia are:

Very common:

• digestive disorders, such as diarrhea, nausea, vomiting, flatulence, constipation

Common:

• ulcer of the digestive tract with or without perforation
• inflammation of the intestine and worsening of inflammation of the colon (colitis) and digestive tract (Crohn's disease) and complications of diverticula of the large intestine (perforation or fistula)
• microsanguinamenti of the intestine, which can cause anemia
• ulcers and inflammation of the mouth (ulcerative stomatitis)
• headache, drowsiness, dizziness, lightheadedness, fatigue, agitation, insomnia and irritability

Uncommon:

• inflammation of the stomach lining
• kidney problems, including development of edema, kidney inflammation and kidney failure
• abundant secretion from the nasal passages
• difficulty breathing (bronchospasm)

Rare:

• depression, confusion, hallucinations
• systemic lupus erythematosus
• increased urea nitrogen in the blood, serum transaminases and alkaline phosphatase
• decrease in hemoglobin and hematocrit values, inhibition of platelet aggregation and prolongation of bleeding time, decrease in calcium and increase in uric acid in the serum
• damage to kidney tissue

Very rare:

• noticeable awareness of heartbeat, heart failure or heart attack
• blood cell formation disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). The first symptoms or signs include fever, sore throat, ulcers in the mouth, flu-like symptoms, fatigue, nosebleeds and skin bleeding
• ringing or whistling in the ears
• inflammation of the esophagus or pancreas
• narrowing of the intestine
• acute inflammation of the liver, yellowing of the skin or whites of the eyes, liver dysfunction, liver damage, especially with long-term therapy or liver failure
• hair loss
• inflammation of the brain membrane in the absence of bacterial infection (aseptic meningitis)

Not known:

• tingling of the hands and feet
• anxiety
• hearing impairment
• general feeling of discomfort
• inflammation of the optic nerve which can cause vision problems

A severe 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 cells).
Ibuprofene Aurobindo Italia may cause a reduction in the number of white blood cells and decrease its resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration of general health conditions or fever with symptoms of localized infection such as sore throat/pharynx/mouth or urinary problems, seek medical advice immediately. A blood test will be performed to determine any reduction in white blood cells (agranulocytosis). It is important to inform the doctor of the medicine you are taking.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 that is reported on the package after Exp. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofene Aurobindo Italia contains

• The active ingredient is ibuprofen. Each film-coated tablet contains 200 mg of ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
• The other ingredients are: Tablet core:corn starch, pregelatinized starch (corn 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 contents of the pack
Film-coated tablet.

Ibuprofene Aurobindo Italia 200 mg film-coated tablets
Tablets from white to almost white, round (diameter 9.8 mm), film-coated, 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
Tablets from white to almost white, round, film-coated, 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 is available in blister packs.

Packs:

Blisters:
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 Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following
names:
Belgium: Ibuprofen Aurobindo 200 mg/400 mg film-coated tablets
Germany: Ibuprofen PUREN akut 400 mg film-coated tablets
Italy: Ibuprofene Aurobindo Italia
Portugal: Ibuprofeno Mer
Romania: Ibuprofen Aurobindo 200 mg/400 mg film-coated tablets
Netherlands: Ibuprofen Sanias 200 mg/400 mg, film-coated tablets
United Kingdom: Ibuprofen 200 mg/400 mg film-coated tablets