Ibuprofen Aurobindo Pharma: detailed information

Package leaflet: Information for the user

Ibuprofene Aurobindo Pharma 400 mg soft capsules

Generic medicine
[For medicines with packs of 30, 36 and 50 capsules in Pvc/Pvdc-Al blisters:]
Please read all of 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. [For medicines with packs of 10, 12, 14 and 20 capsules in Pvc/Pvdc-Al blisters:] Please read all of this leaflet carefully before taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days in adolescents, or after 3 days in case of fever or migraine and 5 days in case of pain in adults.

Contents of this leaflet

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

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

Ibuprofene Aurobindo Pharma contains the active substance ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by altering the body's response to pain and fever.
Ibuprofene Aurobindo Pharma is indicated in adults and adolescents weighing at least 40 kg (aged 12 years and older) for the short-term symptomatic treatment of mild to moderate pain such as headache, flu-like symptoms, toothache, muscle pain, menstrual pain, and fever.
Ibuprofene Aurobindo Pharma is also indicated in adults for the treatment of mild to moderate pain associated with migraine, with or without aura.

2. What you need to know before taking Ibuprofen Aurobindo Pharma

Do not take Ibuprofen Aurobindo Pharma

If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
If you have experienced an allergic reaction, such as asthma, difficulty breathing, swelling of the face, tongue or throat, hives, runny nose and itching, caused by acetylsalicylic acid (ASA) or other NSAIDs.
If you have (or have had two or more episodes of) stomach or intestinal ulcer or bleeding.
If you have had gastrointestinal perforation or bleeding while using NSAIDs.
If you suffer from cerebrovascular bleeding or other active bleeding.
If you have blood disorders of unknown origin.
If you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
If you suffer from severe liver, kidney or heart failure.
If you are in the last three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen Aurobindo Pharma:

if you have recently undergone major surgery;
if you suffer or have suffered from asthma or an allergic condition, as shortness of breath may occur;
if you suffer from hay fever, nasal polyps or chronic obstructive pulmonary disease, because the risk of allergic reactions increases. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema or urticaria;
if you have had gastrointestinal ulcers (see also section 'Do not take Ibuprofen Aurobindo Pharma');
if you have a history of gastrointestinal diseases (such as ulcerative colitis, Crohn's disease);
if you suffer from systemic lupus erythematosus or mixed connective tissue disease (a condition affecting the skin, joints and kidneys);
if you suffer from certain inherited blood disorders (e.g. acute intermittent porphyria);
if you have blood clotting disorders;
if you are taking other NSAIDs. Concomitant use with other NSAIDs, including specific cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see section 'Other medicines and Ibuprofen Aurobindo Pharma' below) and should be avoided;
if you have chickenpox, it is advisable to avoid using Ibuprofen Aurobindo Pharma;
if you are elderly;
if you suffer from kidney or liver problems;
if you have an infection – please see the section 'Infections' below.

Infections

Ibuprofen Aurobindo Pharma may mask symptoms of infections such as fever and pain. Therefore, Ibuprofen Aurobindo Pharma may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.

Start treatment with the lowest available dose if you have ever had gastrointestinal ulcers, if you are elderly, or if you require concomitant administration of low-dose acetylsalicylic acid or other medicines that may increase gastrointestinal risk (see 'Other medicines and Ibuprofen Aurobindo Pharma' below). Your doctor may also add therapy with medicines that protect the gastric mucosa (e.g. misoprostol or proton pump inhibitors). Inform your doctor if unusual stomach symptoms occur, particularly signs of bleeding such as vomiting blood or black, tarry stools (see also section 4, 'Possible side effects').
Non-steroidal anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when administered at high doses. Do not exceed the recommended dose or duration of treatment (see section 3).
You should discuss treatment with your doctor or pharmacist before taking Ibuprofen Aurobindo Pharma if:

you suffer from heart problems, including heart failure, angina (chest pain), or have a history of heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowing or blockage of arteries), or any type of stroke (including "mini-stroke" or transient ischaemic attack, "TIA");
you suffer from hypertension, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker. Very rare cases of potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with ibuprofen use. Patients are at higher risk of such reactions during the first month of treatment. Stop taking Ibuprofen Aurobindo Pharma and consult your doctor or pharmacist if you notice a skin rash, mucosal lesions or any other signs of allergic reactions (see section 4).

Side effects can be minimised by using the lowest effective dose for the shortest possible time. Elderly patients have an increased risk of side effects.
Skin reactions
Serious skin reactions have been reported with treatment using Ibuprofen Aurobindo Pharma. Discontinue use of Ibuprofen Aurobindo Pharma and consult your doctor immediately if a skin rash, mucosal lesions, blisters or other signs of allergy appear, as these may be early signs of a serious skin reaction. See section 4.
Regular use of analgesics (even of different types) may lead to serious and persistent kidney problems. This risk may increase during physical exercise associated with loss of salts and dehydration. Therefore, such use should be avoided.
Prolonged use of any type of analgesic for headache may worsen the headache. If this occurs or is suspected, medical advice should be sought and treatment discontinued. Medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medicines.
Regular monitoring of liver function, kidney function and blood cell counts is required during prolonged administration of Ibuprofen Aurobindo Pharma. Your doctor may require you to have blood tests during treatment.
Children and adolescents
There is a risk of kidney failure in dehydrated children and adolescents.
Ibuprofen Aurobindo Pharma is not indicated for use in adolescents weighing less than 40 kg and in children under 12 years of age.
Other medicines and Ibuprofen Aurobindo Pharma
Ibuprofen Aurobindo Pharma may affect or be affected by other medicines. For example:

medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine);
medicines that reduce hypertension (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Other medicines may also affect or be affected by treatment with Ibuprofen Aurobindo Pharma. Therefore, you should always consult your doctor or pharmacist before using Ibuprofen Aurobindo Pharma with other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, inform them if you are taking:

Acetylsalicylic acid or other NSAIDs (anti-inflammatory and analgesic medicines), as this may increase the risk of gastrointestinal ulcers or bleeding.
Digoxin (for heart failure), as the effect of digoxin may be increased.
Glucocorticoids (medicines containing cortisone or cortisone-like substances), as this may increase the risk of gastrointestinal ulcers or bleeding.
Phenytoin (for epilepsy), as the effect of phenytoin may be increased.
Selective serotonin reuptake inhibitors (medicines used for depression), as these may increase the risk of gastrointestinal bleeding.
Lithium (a medicine for bipolar disorder and depression), as the effect of lithium may be increased.
Probenecid and sulfinpyrazone (medicines for treating gout), as ibuprofen excretion may be delayed.
Moclobemide (used to treat depression).
Potassium-sparing diuretics, as this may lead to hyperkalaemia (high potassium levels in the blood).
Methotrexate (a medicine for cancer and rheumatic diseases), as the effect of methotrexate may be increased.
Tacrolimus and cyclosporine (immunosuppressive medicines), as kidney damage may occur.
Zidovudine or ritonavir (used to treat HIV patients): as ibuprofen use may increase the risk of bleeding into a joint or bleeding causing swelling in HIV-positive patients with haemophilia.
Sulfonylureas (antidiabetic medicines), possible interactions may occur.
Quinolone antibiotics, as the risk of seizures may increase.
Mifepristone (a medicine prescribed to terminate pregnancy), as ibuprofen may reduce the effect of this medicine.
Bisphosphonates (medicines prescribed for osteoporosis), as these may increase the risk of gastrointestinal ulcers and bleeding.
Oxypentifylline (pentoxifylline) (a medicine prescribed to improve blood flow in arms and legs), as this may increase the risk of gastrointestinal bleeding.
Baclofen, a muscle relaxant, as baclofen toxicity may increase.
Herbal medicines containing Ginkgo biloba (there is a possibility you may bleed more easily if taking them 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-dose ibuprofen is used with voriconazole or fluconazole.
Cholestyramine (used in the treatment of high cholesterol).

Ibuprofen Aurobindo Pharma with alcohol
Alcohol consumption should be avoided during use of Ibuprofen Aurobindo Pharma, as it may intensify possible side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Avoid using this medicine during the first six months of pregnancy unless your doctor advises otherwise.
If you are in the last three months of pregnancy, do not use this medicine, as it may cause problems for the unborn child or complications during delivery.
If you have taken this medicine during pregnancy, speak immediately with your midwife or gynaecologist so that appropriate monitoring can be carried out if necessary.
Breastfeeding
Small amounts of ibuprofen may pass into breast milk. However, since harmful effects on infants are not currently known, breastfeeding usually does not need to be interrupted during short-term use of ibuprofen at the recommended dose for fever and pain.
Fertility
This product belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible after discontinuation of treatment. Inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
Driving and using machines
For short-term use at normal dosage, this medicine does not affect or affects negligibly the ability to drive or use machines. If side effects such as fatigue, dizziness, drowsiness or visual disturbances occur, you must not drive or operate machinery. Alcohol consumption increases the risk of such effects.
Ibuprofen Aurobindo Pharma contains sorbitol
Ibuprofen Aurobindo Pharma contains 79.20 mg of sorbitol per capsule.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolise fructose, speak with your doctor before taking or receiving this medicine.

3. How to take Ibuprofene Aurobindo Pharma

[For medicines with pack sizes of 30, 36 and 50 capsules in Pvc/Pvdc-Al blisters:]
Take this medicine exactly as directed by your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
[For medicines with pack sizes of 10, 12, 14 and 20 capsules in Pvc/Pvdc-Al blisters:]
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have
an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen
(see section 2).

Dosage
Mild to moderate pain and/or fever
Adults and adolescents weighing 40 kg or more (aged 12 years and above)
The recommended single dose is 1 capsule of 400 mg, which may be taken, if necessary, up to 3 times daily every 6–8 hours. Do not take more than 3 capsules (1200 mg of ibuprofen) within 24 hours.
Elderly patients, who are at increased risk of side effects, should use the lowest possible dose for the shortest time needed to relieve symptoms.
Do not exceed the recommended doses or duration of treatment (3 days in adolescents, and 3 days for fever and 5 days for pain in adults).
Ibuprofene Aurobindo Pharma is not intended for use in adolescents weighing less than 40 kg and in children under 12 years of age.

In case of migraine attack
Adults
Take 1 capsule of 400 mg as soon as possible at the onset of the attack.
If you do not obtain relief after the first dose, a second dose must not be taken during the same attack. However, the attack may be managed with another treatment that is not a non-steroidal anti-inflammatory drug or acetylsalicylic acid.
If pain recurs, a second dose may be taken, provided that at least an 8-hour interval is maintained between the two doses. Do not take more than 3 capsules (1200 mg of ibuprofen) within 24 hours.
You should speak with your doctor if you do not feel better, or if you feel worse after 3 days.

Method of administration
Ibuprofene Aurobindo Pharma capsules must be swallowed whole with plenty of water. Do not chew the capsules.

If you take more Ibuprofene Aurobindo Pharma than you should
Nausea, stomach ache, headache, vomiting, diarrhoea, tinnitus, vomiting of blood and blood in the faeces may occur. More severe poisoning may lead to dizziness, drowsiness, agitation, disorientation, low blood pressure, reduced breathing (respiratory depression), bluish discoloration of the skin and mucous membranes (cyanosis), loss of consciousness, seizures and coma. In case of severe poisoning, prolonged bleeding time, acute kidney failure, liver damage and worsening of asthma in asthmatic patients may occur.
In case of overdose, consult your doctor immediately, even if you feel well.

If you forget to take Ibuprofene Aurobindo Pharma
Simply refer to the instructions above regarding how to take the medicine and do not take more than recommended.
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by taking the lowest effective dose for the shortest duration needed to relieve symptoms. Elderly patients using this product have a higher risk of developing problems associated with side effects.
Medicines such as Ibuprofen Aurobindo Pharma may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (see section 2, "Warnings and precautions").
If you think you are experiencing any of the following side effects or symptoms, stop taking this medicine and seek immediate medical help:

gastric or intestinal ulcers, sometimes with bleeding and perforation, vomiting blood, or black, tarry stools (common: may affect up to 1 in 10 people);
kidney problems with blood in the urine which may be associated with kidney failure (uncommon: may affect up to 1 in 100 people);
severe allergic reactions (very rare: may affect up to 1 in 10,000 people), such as:
unexplained difficulty breathing or wheezing,
dizziness or rapid heartbeat,
drop in blood pressure causing shock,
swelling of the face, tongue, and throat;
potentially life-threatening skin rashes, with severe blistering and bleeding of the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome) or severe skin reactions starting with painful red areas, followed by large blisters and eventually detachment of skin layers. This is accompanied by fever, chills, muscle pain, and general malaise (toxic epidermal necrolysis) (very rare: may affect up to 1 in 10,000 people);
a widespread red, scaly rash with subcutaneous lumps and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalised exanthematous pustulosis). See also section 2 (not known: frequency cannot be determined from available data);
severe skin condition affecting the mouth and other body parts, with symptoms including red spots, often itchy, resembling measles rash, starting on limbs and sometimes on the face and rest of the body. The spots may swell or progress to raised, red lesions with a pale center. Affected patients may have fever, sore throat, headache, and/or diarrhoea (very rare: may affect up to 1 in 10,000 people);
severe peeling or shedding of the skin (very rare: may affect up to 1 in 10,000 people);
inflammation of the pancreas with severe epigastric pain, often with nausea and vomiting (very rare: may affect up to 1 in 10,000 people);
nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, pale stools, dark urine, which may be signs of hepatitis or liver failure (very rare: may affect up to 1 in 10,000 people);
heart problems with shortness of breath and swelling of the feet or legs due to fluid retention (heart failure) (not known: frequency cannot be determined from available data);
aseptic meningitis (infection around the brain or spinal cord, with symptoms including fever, nausea, vomiting, headache, neck stiffness, and mental confusion leading to disorientation) (very rare: may affect up to 1 in 10,000 people);
heart attack ("myocardial infarction", very rare: may affect up to 1 in 10,000 people) or stroke (frequency not known: cannot be determined from available data);
severe kidney damage (papillary necrosis), particularly with long-term use (rare: may affect up to 1 in 1,000 people);
worsening of inflammation related to an infection (e.g. development of "flesh-eating" bacterial syndrome), particularly when using other NSAIDs (very rare: may affect up to 1 in 10,000 people);
problems in blood cell production – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, bleeding from nose and skin (very rare: may affect up to 1 in 10,000 people);
a serious skin reaction known as DRESS syndrome may occur. DRESS syndrome includes: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of blood cell) (not known: frequency cannot be determined from available data).

Other side effects:
Very common (may affect more than 1 in 10 people):

nausea, heartburn, flatulence, diarrhoea, constipation, vomiting, abdominal pain.

Common (may affect up to 1 in 10 people):

headache, drowsiness, dizziness, spinning sensation, fatigue, restlessness, inability to sleep, irritability.
occult blood loss which may lead to a condition with reduced red blood cells (symptoms include fatigue, headache, shortness of breath during physical activity, dizziness, and pallor), mouth ulcers and cold sores, inflammation of the colon (symptoms include diarrhoea, usually with blood and mucus, stomach pain, fever), worsening of inflammatory bowel disease, inflammation of the intestinal wall.

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

urticaria, itching, unusual bleeding or bruising under the skin, skin rash, asthma attacks (sometimes with hypotension);
runny or blocked nose, sneezing, facial pressure or pain, difficulty breathing;
inflammation of the stomach (symptoms include pain, nausea, vomiting, vomiting blood, blood in bowel movements);
fluid accumulation in body tissues, especially in patients with high blood pressure or kidney problems;
visual disturbances.

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

a disease affecting the skin, joints, and kidneys (lupus erythematosus syndrome);
depression, confusion, hallucinations, mental disorders with strange or disturbing thoughts or moods;
ringing, buzzing, hissing, or other persistent noises in the ears;
increased blood urea nitrogen, increased serum transaminases and alkaline phosphatase, decreased haemoglobin and haematocrit, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid, all detectable by blood tests;
loss of vision.

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

fast or irregular heartbeat (palpitations);
fluid accumulation in body tissues;
high blood pressure;
inflammation of the digestive tract, narrowing of the intestine;
unusual hair loss or thinning;
in case of chickenpox, severe skin infections with soft tissue complications may occur;
menstrual cycle disorders.

Not known (frequency cannot be determined from available data):

skin sensitivity to light.

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 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 Aurobindo Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the date stated on the packaging and blister after "EXP". The expiration date refers to the last day of that month.
Store below 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. This will help protect the environment.

6. Package contents and other information

What Ibuprofene Aurobindo Pharma 400 mg soft capsules contains

The active substance is ibuprofen. Each capsule contains 400 mg of ibuprofen.
The other components are: Capsule contents: Macrogol 600, potassium hydroxide. Capsule shell: Gelatin, liquid sorbitol. Printing ink: Components of the printing ink (black): Iron oxide black (E172)

Propylene glycol (E1520)
Hypromellose 2910 (6 cP)
Description of the appearance of Ibuprofene Aurobindo Pharma 400 mg soft capsules and package contents
Clear, transparent, oval-shaped soft gelatin capsules, size '12', printed with “I400” in edible black ink, containing a clear, colourless to pale yellow viscous liquid.
Ibuprofene Aurobindo Pharma is available in blister packs of 10, 12, 14, 20, 30, 36 and 50 capsules.
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)
Italy
Manufacturer
APL Swift Services (Malta) Ltd., HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Arrow Génériques, 26 Avenue Tony Garnier, 69007 Lyon, France
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Ibuprofen AB 400 mg zachte capsules/capsules molles/Weichkapseln
Czech Republic: Ibuprofen Aurovitas
France: Ibuprofene Arrow Conseil 400 mg, capsule molle
Italy: Ibuprofene Aurobindo Pharma
Netherlands: Ibuprofen Liquid Caps Auro 400 mg, capsules, zacht
Poland: Ibuprofen Aurovitas Max
Portugal: Ibuprofeno Generis
Romania: Auroprofen 400 mg capsule moi