IBUPROFENE 400 mg Soft Capsules

Зміст інструкції

1. Ibuprofene Aurobindo Pharma 400 mg soft capsules
   1. What is Ibuprofene Aurobindo Pharma and what is it used for
   2. What you need to know before taking Ibuprofene Aurobindo Pharma
   3. How to take Ibuprofene Aurobindo Pharma
   4. Possible side effects
   5. How to store Ibuprofene Aurobindo Pharma
   6. Package contents and other information

Ibuprofene Aurobindo Pharma 400 mg soft capsules

Generic medicine

[For medicines with packs of 30, 36 and 50 capsules in Pvc/Pvdc-Al blisters:]

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. [For medicines with packs of 10, 12, 14 and 20 capsules in Pvc/Pvdc-Al blisters:]Read this leaflet carefully before taking this medicine as it contains important information for you.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 worsen 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

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

1. What is Ibuprofene Aurobindo Pharma and what is it 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 modifying the body's response to pain and fever.
Ibuprofene Aurobindo Pharma is indicated in adults and adolescents starting from 40 kg of body weight
(aged 12 years or older), for the symptomatic treatment of short-term pain from mild to
moderate such as headache, flu-like symptoms, toothache, muscle pain, painful periods and fever.
Ibuprofene Aurobindo Pharma is also indicated in adults for the treatment of mild to moderate
pain during migraine, with or without aura.

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

Do not take Ibuprofene Aurobindo Pharma

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction, such as asthma, difficulty breathing, swelling of the face, tongue or throat, urticaria, runny and itchy nose, caused by acetylsalicylic acid (ASA) or other NSAIDs.
• If you have (or have had two or more episodes of) stomach or intestinal ulcers or bleeding.
• If you have had a gastrointestinal perforation or bleeding while using NSAIDs.
• If you suffer from cerebrovascular bleeding or other active bleeding.
• If you suffer from disorders of unknown origin of blood formation.
• If you have severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).
• If you suffer from severe liver, kidney or heart failure.
• If you are in the last 3 months of pregnancy.

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

• if you have recently undergone major surgery;
• if you suffer from or have suffered from asthma or an allergic disease, because shortness of breath may occur;
• if you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, because there is an increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), angioedema or urticaria;
• if you have suffered from gastrointestinal ulcers (see also the section ‘Do not take Ibuprofene 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 disease that affects the skin, joints and kidneys);
• if you suffer from certain hereditary diseases of blood formation (e.g. acute intermittent porphyria);
• if you suffer from blood coagulation disorders;
• if you are taking other NSAIDs. Concomitant use with other NSAIDs, including specific cyclo-oxygenase-2 inhibitors, increases the risk of adverse reactions (see the section ‘Other medicines and Ibuprofene Aurobindo Pharma’ below) and should be avoided;
• if you have chickenpox, it is advisable to avoid using Ibuprofene 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

• Ibuprofene Aurobindo Pharma can mask the symptoms of infections such as fever and pain. Therefore, it is possible that Ibuprofene Aurobindo Pharma may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, see your doctor immediately.

Start treatment with the lowest available dose if you have ever had gastrointestinal ulcers, if you are elderly or
require concomitant administration of low-dose acetylsalicylic acid or other medicines that
may increase the risk of gastrointestinal problems (see ‘Other medicines and Ibuprofene Aurobindo Pharma’
below). Your doctor may also add a therapy with medicines that protect the gastric mucosa (e.g.
misoprostol or proton pump inhibitors). Tell your doctor if you experience unusual stomach symptoms, in
particular signs of bleeding such as vomiting blood or black stools like tar (see also section 4, ‘Possible
side effects’).
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a small increased risk of
myocardial infarction or stroke, especially when administered at high doses. Do not exceed the
recommended dose or duration of treatment (see section 3).
You should talk to your doctor or pharmacist before taking Ibuprofene Aurobindo
Pharma if:

• you suffer from heart problems, including heart failure, angina (chest pain), or if you have a history of heart attack, bypass surgery, peripheral artery disease (problems with 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”);
• you suffer from high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker. Very rare reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of ibuprofen. Patients are at higher risk of such reactions during the first month of therapy. Stop taking Ibuprofene Aurobindo Pharma and see your doctor or pharmacist if you notice a rash, mucous membrane lesions or any other signs of allergic reactions (see section 4).

Adverse effects can be minimized by using the lowest effective dose for the shortest possible time. Elderly patients have an increased risk of adverse effects.

Skin reactions
Serious skin reactions have been reported in association with treatment with Ibuprofene Aurobindo Pharma.
Stop taking Ibuprofene Aurobindo Pharma and consult your doctor immediately if
you develop a rash, mucous membrane lesions, blisters or other signs of allergy, as these may
be the first signs of a very serious skin reaction. See section 4.
In general, the regular use of pain relievers (even of different types) can lead to serious and
persistent kidney problems. This risk may increase during exercise associated with salt loss and
dehydration. Therefore, this should be avoided.
Prolonged use of any type of pain reliever for headache can worsen it. If such a situation is
present or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of
medication-overuse headache should be suspected in patients who have frequent or
daily headaches despite (or because of) the regular use of headache medications.
Regular monitoring of the liver, kidney function and blood cell count is required with prolonged administration of Ibuprofene Aurobindo Pharma. Your doctor may ask you to
undergo blood tests during treatment.

Children and adolescents
There is a risk of kidney failure in dehydrated children and adolescents.
Ibuprofene 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 Ibuprofene Aurobindo Pharma
Ibuprofene Aurobindo Pharma can affect or be affected by other medicines. For example:

• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Some other medicines can also affect or be affected by treatment with Ibuprofene
Aurobindo Pharma. Therefore, you should always ask your doctor or pharmacist for advice before using
Ibuprofene Aurobindo Pharma with other medicines. In particular, tell them if you are taking:

• Acetylsalicylic acid, or other NSAIDs (anti-inflammatory and analgesic drugs), as this may increase the risk of ulcers or gastrointestinal 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 ulcers or gastrointestinal bleeding.
• Phenytoin (for epilepsy), as the effect of phenytoin may be increased.
• Selective serotonin reuptake inhibitors (medicines used for depression), as they may increase the risk of gastrointestinal bleeding.
• Lithium (a medicine for manic-depressive illness and depression), as the effect of lithium may be increased
• Probenecid and sulfinpyrazone (medicines for treating gout), as the excretion of ibuprofen may be delayed.
• Moclobemide (used to treat depression).
• Potassium-sparing diuretics, as this may lead to hyperkalaemia (high levels of potassium in the blood).
• Methotrexate (a medicine for cancer and rheumatism), as the effect of methotrexate may be increased.
• Tacrolimus and cyclosporine (immunosuppressant drugs), as kidney damage may occur.
• Zidovudine or ritonavir (used for the treatment of patients with HIV): as the use of ibuprofen may cause an increased risk of bleeding in a joint or bleeding leading to swelling in HIV-positive patients with hemophilia.
• Sulfonylureas (antidiabetic drugs), interactions are possible.
• Quinolone antibiotics, as the risk of seizures may increase.
• Mifepristone (a medicine prescribed to terminate a pregnancy), as ibuprofen may reduce the effect of this medicine.
• Bisphosphonates (medicines prescribed to treat osteoporosis), as these may increase the risk of ulcers and gastrointestinal bleeding.
• Oxipentifylline (pentoxifylline) (a medicine prescribed to increase blood flow to arms and legs), as this may increase the risk of gastrointestinal bleeding.
• Baclofen, a muscle relaxant, as baclofen toxicity may increase.
• Herbal medicines based on Ginkgo biloba (there is a possibility of bleeding more easily if you are taking them 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 ibuprofen at high doses is used with voriconazole or fluconazole.
• Cholestyramine (used in the treatment of high cholesterol).

Ibuprofene Aurobindo Pharma with alcohol
Alcohol consumption should be avoided while using Ibuprofene Aurobindo Pharma, as it may
intensify possible side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Avoid using this medicine in 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 newborn or complications during childbirth.
If you have taken this medicine during pregnancy, tell your midwife or gynecologist immediately,
so that appropriate monitoring can be carried out if necessary.

Breastfeeding
Small amounts of ibuprofen can pass into breast milk. However, as no harmful effects on babies are known to date, it is usually not necessary to stop breastfeeding while using ibuprofen at
the recommended dose for fever and pain.

Fertility
This product belongs to a group of medicines (NSAIDs) that may impair fertility in women.
This effect is reversible after stopping treatment. Tell your doctor if you are planning a
pregnancy or have difficulty getting pregnant.

Driving and using machines
For short-term use at normal dosage, this medicine does not impair or impairs negligibly the
ability to drive vehicles or use machines. If side effects such as fatigue, dizziness, drowsiness and visual disturbances occur, you should not drive vehicles or use machines. Alcohol
consumption increases the risk of these effects.

Ibuprofene Aurobindo Pharma contains sorbitol
Ibuprofene 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 a
diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot
metabolize fructose, talk to your doctor before taking or receiving this medicine.

3. How to take Ibuprofene Aurobindo Pharma

[For medicines with packs of30, 36 and 50 capsules in Pvc/Pvdc-Al blisters:]
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

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

Dosage
Mild to moderate pain and/or fever

Adults and adolescents weighing 40 kg or more (aged 12 years or older)
The recommended single dose is 1 capsule of 400 mg, which can be taken, if necessary, up to 3 times a
day every 6-8 hours. Do not take more than 3 capsules (1200 mg of ibuprofen) within 24 hours.
Elderly patients, with an increased risk of side effects, should use the lowest possible dose for the
shortest time necessary to relieve symptoms.
Do not exceed the recommended doses or the duration of treatment (3 days in adolescents, and 3 days in case of
fever and 5 days in case of 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 one 400 mg capsule as soon as possible, at the beginning of the attack.
If you do not find relief after the first dose, a second dose should not be taken during the same
attack. However, the attack can be managed with another treatment that is not a non-steroidal
anti-inflammatory drug or acetylsalicylic acid.
If the pain returns, a second dose can be taken, provided that an interval of at least 8 hours is maintained
between the 2 doses. Do not take more than 3 capsules (1200 mg of ibuprofen) within 24 hours.
You should talk to your doctor if you do not feel better, or if you feel worse after 3 days.

Method of administration
The capsules of Ibuprofene Aurobindo Pharma 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 pain, headache, vomiting, diarrhea, ringing in the ears, vomiting of
blood and blood in the stool may occur. More serious poisoning can lead to dizziness, drowsiness, excitement,
disorientation, low blood pressure, reduced breathing (respiratory depression), bluish discoloration of the skin and
mucous membranes (cyanosis), loss of consciousness, convulsions and coma. In case of
severe poisoning, prolonged bleeding time, acute kidney failure, liver damage and worsening of asthma in asthmatic
subjects 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 previous instructions on how to take the medicine and do not take more than
recommended.
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects can be minimised by taking the lowest dose for the shortest time necessary to relieve symptoms. Elderly people using this product have a higher risk
of developing problems associated with side effects.
Medicines like Ibuprofene Aurobindo Pharma may be associated with a small increase in the
risk of a heart attack (“myocardial infarction”) or stroke (see section 2, ‘Warnings and
precautions’).

If you think you have any of the following side effects or symptoms, stop taking this
medicine and seek immediate medical attention:

• 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), such as:
• difficulty breathing or unexplained wheezing,
• dizziness or a fast heartbeat,
• a drop in blood pressure causing shock,
• swelling of the face, tongue and throat;
• life-threatening skin rashes with blistering and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or severe skin reactions that start with red, painful areas, then with large blisters and finally detachment of layers of the skin. This is accompanied by fever and chills, muscle pain and general malaise (toxic epidermal necrolysis) (very rare: may affect up to 1 in 10,000);
• a widespread red and scaly skin rash with bumps under the skin and blisters mainly located on skin folds, trunk and upper limbs accompanied by fever at the beginning

of treatment (acute generalised exanthematous pustulosis). See also section 2 (not known: the
frequency cannot be estimated from the available data);

• a severe skin condition that can affect the mouth and other parts of the body with symptoms including red patches, often itchy, similar to a measles rash, starting on the limbs and sometimes on the face and the rest of the body. The spots may swell or may progress to form raised, red spots with a pale centre. Affected patients may have fever, sore throat, headache and/or diarrhoea (very rare: may affect up to 1 in 10,000);
• severe shedding or peeling of the skin (very rare: may affect up to 1 in
• 10,000);
• inflammation of the pancreas with severe upper abdominal pain, often with nausea and vomiting (very rare: may affect up to 1 in 10,000);
• nausea, vomiting, loss of appetite, feeling generally unwell, 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);
• heart disorder with shortness of breath and swelling of the feet or legs due to fluid retention (heart failure) (not known: the frequency cannot be estimated from the available data);
• aseptic meningitis (infection around the brain or spinal cord, with symptoms including fever, nausea, vomiting, headache, stiff neck and confusion to the point of not being fully aware of the environment) (very rare: may affect up to 1 in
• 10,000);
• heart attack (“myocardial infarction”, very rare: may affect up to 1 in 10,000) or stroke (frequency not known: cannot be estimated from the available data);
• severe kidney damage (papillary necrosis), particularly with long-term use (rare: may affect up to 1 in 1,000);
• worsening of inflammation related to an infection (e.g. development of the “flesh-eating bacteria” syndrome) particularly with the use of other NSAIDs (very rare: may affect up to 1 in 10,000);
• problems with the production of blood cells - early signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding (very rare: may affect up to 1 in 10,000);
• a severe 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: the frequency cannot be estimated from the 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, feeling giddy, fatigue, restlessness, difficulty sleeping, irritability.
• hidden blood loss which can lead to a condition where there is a reduced number of red blood cells (symptoms include fatigue, headache, shortness of breath on exertion, dizziness and paleness), 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 low blood pressure);
• runny or blocked nose, sneezing, pressure or pain in the face, difficulty breathing;
• inflammation of the stomach (symptoms include pain, nausea, vomiting, vomiting blood, blood in bowel movements);
• fluid retention in the body tissues, especially in patients with high blood pressure or kidney problems;
• visual disturbances

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

• a disease that affects the skin, joints and kidneys (systemic lupus erythematosus);
• depression, confusion, hallucinations, mental illnesses with strange or disturbing thoughts or moods;
• ringing, buzzing, whistling, sounds or other noises that persist in the ears;
• increased blood urea, serum transaminases and alkaline phosphatase, decreased values of haemoglobin and haematocrit, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid, all detected with a blood test;
• loss of vision.

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

• fast or irregular heartbeat (palpitations);
• fluid retention in the body tissues;
• high blood pressure;
• inflammation of the food pipe, narrowing of the intestine;
• loss or thinning of hair;
• in the case of chickenpox, serious skin infections with complications of the soft tissues may occur;
• menstrual cycle disorders.

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

• skin sensitivity to light.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 that is reported on the packaging and on the blister after “EXP”. The date
of expiry refers to the last day of that month.
Store at a temperature below 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help to protect the environment.

6. Package contents and other information

What Ibuprofene Aurobindo Pharma 400 mg soft capsules contain

• The active ingredient is ibuprofen. Each capsule contains 400 mg of ibuprofen.
• The other ingredients are: Capsule content: Macrogol 600, potassium hydroxide. Capsule shell: Gelatin, liquid sorbitol. Printing ink: Printing ink ingredients (black): Black iron oxide (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’, with “I400” printed with edible black ink, containing a clear, colorless to pale yellow viscous liquid.
Ibuprofene Aurobindo Pharma is packaged 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 Member States of the European Economic Area with the following
names:
Belgium: Ibuprofen AB 400 mg soft capsules
Czech Republic: Ibuprofen Aurovitas
France: Ibuprofene Arrow Conseil 400 mg, soft capsules
Italy: Ibuprofene Aurobindo Pharma
Netherlands: Ibuprofen Liquid Caps Auro 400 mg, capsules, soft
Poland: Ibuprofen Aurovitas Max
Portugal: Ibuprofeno Generis
Romania: Auroprofen 400 mg soft capsules