Ibuprofen Zentiva Generics

Package leaflet: Information for the patient

IBUPROFENE ZENTIVA GENERICS 400 mg film-coated tablets, 600 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What IBUPROFENE ZENTIVA GENERICS is and what it is used for
2. What you need to know before taking IBUPROFENE ZENTIVA GENERICS
3. How to take IBUPROFENE ZENTIVA GENERICS
4. Possible side effects
5. How to store IBUPROFENE ZENTIVA GENERICS
6. Contents of the pack and other information

1. What IBUPROFENE ZENTIVA GENERICS is and what it is used for

IBUPROFENE ZENTIVA GENERICS contains ibuprofen, a medicine belonging to a class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by reducing pain, fever, and inflammation.
IBUPROFENE ZENTIVA GENERICS is used for the symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), and painful swelling and inflammation following soft tissue injuries.
Additionally, IBUPROFENE ZENTIVA GENERICS 400 mg is intended for the symptomatic treatment of mild to moderate pain such as migraine, dental pain, menstrual pain, and/or fever.
IBUPROFENE ZENTIVA GENERICS 400 mg is indicated in adults and adolescents weighing 40 kg or more (12 years and older).
IBUPROFENE ZENTIVA GENERICS 600 mg is indicated in adults and adolescents weighing 50 kg or more (15 years and older).

2. What you need to know before taking IBUPROFENE ZENTIVA GENERICS

Do not take IBUPROFENE ZENTIVA GENERICS

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you have experienced allergic reactions such as asthma, excessive nasal discharge, itchy skin rashes, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other painkillers or anti-inflammatory drugs (NSAIDs).
• If you suffer from a stomach or small intestine (duodenum) ulcer or bleeding, or if you have had two or more such episodes in the past.
• If you have ever had gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
• If you suffer from unexplained blood disorders.
• If you suffer from severe heart, liver, or kidney failure.
• If you suffer from severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).
• If you have active bleeding (including in the brain).
• If you are a woman in the last 3 months of pregnancy.

Do not use IBUPROFENE ZENTIVA GENERICS 400 mg in adolescents weighing less than 40 kg or
in children under 12 years of age.
Do not use IBUPROFENE ZENTIVA GENERICS 600 mg in adolescents weighing less than 50 kg or
in children and adolescents under 15 years of age.
Warnings and precautions
You should discuss your treatment with your doctor or pharmacist before taking
IBUPROFENE ZENTIVA GENERICS:

• If you have kidney, liver, or heart problems.
• If you suffer from bronchial asthma.
• If you suffer from allergies, hay fever, nasal polyps, or chronic obstructive respiratory disorders due to an increased risk of allergic reactions.
• If you have inherited a disease of the red blood pigment haemoglobin (porphyria).
• If you have systemic lupus erythematosus (an immune system disorder) or mixed connective tissue disease (risk of aseptic meningitis).
• If you have an inflammatory ulcerative disease of the digestive tract such as Crohn's disease or ulcerative colitis.
• If you have disorders in blood cell formation.
• If you have problems with the normal blood clotting mechanism.
• If you have recently undergone major surgery.
• If you are in the first six months of pregnancy.
• If you are breastfeeding.
• In case of infection, see the section "Infections" below.
• With ibuprofen, signs of an allergic reaction to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. Immediately stop treatment with IBUPROFENE ZENTIVA GENERICS and contact your doctor or emergency medical services immediately if you notice any of these signs.

Infections
IBUPROFENE ZENTIVA GENERICS may mask symptoms of infections such as fever and pain.
Therefore, IBUPROFENE ZENTIVA GENERICS could delay appropriate treatment of the infection,
which might 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, seek immediate medical advice.
Elderly
If you are elderly, you are more likely to experience side effects, particularly bleeding and perforation of the digestive tract, which can be fatal.
Effects on the heart and brain
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight
increase in the risk of heart attack or stroke, particularly when used at high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking IBUPROFENE ZENTIVA
GENERICS if:

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

Ulcers, perforation, and bleeding in the stomach or intestine
If you have previously had a stomach or intestinal ulcer, especially if it was complicated by
perforation or accompanied by bleeding, you should be alert to any unusual abdominal symptoms and
report them immediately to your doctor, particularly if these symptoms occur at the beginning of
treatment. This is because the risk of gastrointestinal bleeding or ulceration is higher in such cases,
especially in elderly patients. If gastrointestinal bleeding or ulceration occurs, treatment must be
stopped.
Bleeding, ulceration, or perforation of the stomach or intestine can occur without any warning signs,
even in patients who have never had such problems before. It could 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 certain other medicines are taken simultaneously with
ibuprofen (see Other medicines and IBUPROFENE ZENTIVA GENERICS below).
Adverse effects can be minimized by using the lowest effective dose for the shortest duration
necessary to control symptoms.
Skin reactions
Serious skin reactions have been reported in association with treatment with IBUPROFENE
ZENTIVA GENERICS, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson
syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms
(DRESS), and generalized acute exanthematous pustulosis (GEP). Stop using IBUPROFENE
ZENTIVA GENERICS and contact your doctor immediately if you notice any symptoms related to
these serious skin reactions described in section 4.
Avoid using this medicine during chickenpox.
Effects on the kidneys
Ibuprofen may cause kidney function problems even in patients who have not previously had kidney
problems. This may cause swelling of the legs and may also lead to heart failure or hypertension in
predisposed individuals.
Ibuprofen may cause kidney damage especially in patients who already have kidney, heart, or liver
problems, or who are taking diuretics or ACE inhibitors, as well as in the elderly. However, stopping
ibuprofen usually leads to recovery.
Other precautions
Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed.
Immediately stop treatment at the first signs of hypersensitivity after taking IBUPROFENE
ZENTIVA GENERICS and inform your doctor immediately.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation) and prolong bleeding time.
Patients with blood clotting disorders should therefore be closely monitored.
Prolonged use of any type of painkiller for headache may worsen headaches. If this occurs or is
suspected, stop taking ibuprofen and consult your doctor. Medication-overuse headache (MOH)
should be suspected in patients who have frequent or daily headaches despite (or because of) regular
use of headache medications.
IBUPROFENE ZENTIVA GENERICS may reduce the chance of becoming pregnant. You should
inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
Children and adolescents
Do not administer IBUPROFENE ZENTIVA GENERICS 400 mg to adolescents weighing less than
40 kg or to children under 12 years of age.
Do not administer IBUPROFENE ZENTIVA GENERICS 600 mg to adolescents weighing less than
50 kg or to children and adolescents under 15 years of age.
There is a risk of kidney failure in dehydrated adolescents.
Other medicines and IBUPROFENE ZENTIVA GENERICS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Ibuprofen may affect or be affected by certain drugs. For example:

• other NSAIDs including COX-2 inhibitors, as this may increase the risk of gastrointestinal ulcers and bleeding
• medicines that are anticoagulants (i.e., thin the blood/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• methotrexate (used for the treatment of cancer and autoimmune diseases)
• digoxin (for the treatment of various heart conditions), as the effect of digoxin may be enhanced
• phenytoin (used to prevent epileptic seizures), as the effect of phenytoin may be enhanced
• lithium (used to treat depression and mania), as the effect of lithium may be enhanced
• diuretics (medicines to increase urination), as the effect of diuretics may be weakened
• potassium-sparing diuretics, as they may cause hyperkalaemia
• medicines that reduce blood pressure (ACE inhibitors, e.g., captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• colestyramine (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, citalopram, as they may increase the risk of gastrointestinal bleeding
• cyclosporine, tacrolimus (for immunosuppression after organ transplantation), as kidney damage may occur
• zidovudine or ritonavir (used for the treatment of HIV patients)
• mifepristone, as NSAIDs may reduce the effect of mifepristone
• probenecid or sulfinpyrazone (for the treatment of gout), as excretion of ibuprofen may be delayed
• quinolone antibiotics, as the risk of seizures may be increased
• sulfonylureas (for the treatment of type 2 diabetes), as blood sugar levels may be altered
• glucocorticoids (used against inflammations), as they may increase the risk of gastrointestinal ulcers or bleeding
• bisphosphonates (used in osteoporosis, Paget's disease, and to reduce high calcium levels in the blood)
• oxpentifylline (pentoxifylline) used in the treatment of circulatory disorders of the arteries in the legs or arms
• baclofen (a muscle relaxant), due to the high toxicity of baclofen
• the herbal medicine Ginkgo biloba (there is a possibility you may bleed more easily if taken together with ibuprofen)
• voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), as the effect of ibuprofen may increase. A dose reduction of
  ibuprofen should be considered, particularly when high doses of ibuprofen are used with voriconazole or
  fluconazole.
  Other medicines may also affect or be affected by treatment with IBUPROFENE ZENTIVA GENERICS. Therefore, always consult your doctor or pharmacist before using IBUPROFENE ZENTIVA GENERICS with other medicines.
  IBUPROFENE ZENTIVA GENERICS with alcohol
  Avoid alcohol as it may increase the side effects of IBUPROFENE ZENTIVA GENERICS, particularly those affecting the stomach, intestine, or central nervous system.
  Pregnancy, breastfeeding, and fertility
  If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
  Pregnancy and breastfeeding
  Do not take IBUPROFENE ZENTIVA GENERICS if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the newborn. It may affect your and your baby's tendency to bleed and may cause labour to start later or last longer than expected. You should not take IBUPROFENE ZENTIVA GENERICS during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, IBUPROFENE ZENTIVA GENERICS may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
  If you have taken this medicine during pregnancy, discuss it immediately with your doctor/midwife so that appropriate monitoring can be considered.
  Ibuprofen appears in breast milk in very small amounts and usually it is not necessary to stop breastfeeding during short-term treatment. However, if longer-term treatment is prescribed, early weaning should be considered.
  Fertility
  IBUPROFENE ZENTIVA GENERICS may make it more difficult for women to become pregnant. You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
  Driving and using machines
  Since undesirable effects on the central nervous system such as fatigue and dizziness may occur with higher doses of ibuprofen, reaction ability and the capacity to actively participate in road traffic and operate machinery may be impaired in isolated cases. This is particularly true when combined with alcohol.
  IBUPROFENE ZENTIVA GENERICS contains sodium
  This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take IBUPROFENE ZENTIVA GENERICS

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any 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, seek immediate medical advice if symptoms (such as fever and pain) persist or worsen (see section 2).
Your doctor will determine the duration of treatment.
In rheumatic diseases, the use of IBUPROFENE ZENTIVA GENERICS may be required for a longer period.

IBUPROFENE ZENTIVA GENERICS 400 mg is contraindicated in adolescents weighing less than 40 kg or in children under 12 years of age.
IBUPROFENE ZENTIVA GENERICS 600 mg is contraindicated in adolescents weighing less than 50 kg or in children and adolescents under 15 years of age.
The dose of ibuprofen depends on the patient's age and body weight. The maximum single daily dose for adults should not exceed 800 mg of ibuprofen.

Rheumatic diseases
Adults:
The recommended dose is 1,200 mg – 1,800 mg of ibuprofen per day in divided doses. Lower doses may be prescribed by your doctor. Due to the nature and severity of your condition, your doctor may temporarily increase your dose up to a maximum of 2,400 mg per day, taken in 3 or 4 divided doses.

Adolescents weighing at least 40 kg (12 years of age):
The recommended dose should be adjusted according to body weight: from 20 mg/kg to a maximum of 40 mg/kg body weight per day (temporarily up to a maximum of 2,400 mg per day), divided into 3–4 doses. Your doctor will advise you accordingly.

Adolescents weighing at least 50 kg (15 years of age):
The recommended dose should be adjusted according to body weight: from 20 mg/kg to a maximum of 40 mg/kg body weight per day (temporarily up to a maximum of 2,400 mg per day), divided into 3–4 doses. Your doctor will advise you accordingly.

Mild to moderate pain and fever
Adults and adolescents weighing ≥ 40 kg (12 years and older):
1 tablet of IBUPROFENE ZENTIVA GENERICS 400 mg as a single dose or 3 times daily with an interval of at least 6 hours. For migraine, the dosage should be: 1 tablet taken as a single dose, and if necessary, 1 tablet with intervals of at least 6 hours. The maximum daily dose should not exceed 3 tablets of IBUPROFENE ZENTIVA GENERICS 400 mg (1,200 mg of ibuprofen).

Menstrual pain
Adults and adolescents weighing ≥ 40 kg (12 years and older):
1 tablet of IBUPROFENE ZENTIVA GENERICS 400 mg 1–3 times daily, with an interval of at least 6 hours as needed. The maximum daily dose should not exceed 3 tablets of IBUPROFENE ZENTIVA GENERICS 400 mg (1,200 mg of ibuprofen).

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

Hepatic or renal impairment
If you suffer from reduced liver or kidney function, always consult your doctor before using IBUPROFENE ZENTIVA GENERICS. Your doctor will advise you accordingly.

Method of administration
Swallow the tablet with a glass of water, preferably after a meal. If you have a sensitive stomach, it is recommended to take this medicine with food.

If you take more IBUPROFENE ZENTIVA GENERICS than you should
If you have taken more IBUPROFENE ZENTIVA GENERICS than you should have, or if children have taken this medicine by mistake, contact your doctor or the nearest hospital immediately for advice on the risk and actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (which may be blood-streaked), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and involuntary tremulous eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may experience seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma may worsen in asthmatic patients. Low blood pressure and reduced breathing may also occur.

If you forget to take IBUPROFENE ZENTIVA GENERICS
Do not take a double dose to make up for a forgotten dose.
If you have any further questions 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 gets 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, gastrointestinal perforation, or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly. After administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Less frequently, inflammation of the stomach lining (gastritis) has been observed.
Medicines such as IBUPROFENE ZENTIVA GENERICS may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. Fluid retention (oedema), hypertension, and heart failure have been reported with NSAIDs.
The following side effects are important and, if they occur, require immediate action. You must stop taking IBUPROFENE ZENTIVA GENERICS and consult your doctor immediately if any of the following symptoms occur:
Common (may affect up to 1 in 10 people):

• Black, tarry stools or blood-stained vomit (gastrointestinal ulcer with bleeding).

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

• Visual disturbances.
• Hypersensitivity reactions such as skin rashes, itching, purpura, exanthema, asthma attacks (sometimes with low blood pressure).

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

• Loss of vision.

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

• 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 accumulation of fluid in the lungs leading to difficulty breathing.
• Sudden allergic reaction with shortness of breath, wheezing, and drop in blood pressure.
• -Flat, red, non-elevated, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). This may worsen further, with blisters enlarging and spreading, and parts of the skin may detach (Lyell's syndrome). Severe infections with destruction (necrosis) of the skin, subcutaneous tissue, and muscles may also occur.

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

• A widespread red, scaly rash with subcutaneous nodules and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Discontinue use of IBUPROFENE ZENTIVA GENERICS if these symptoms develop and seek immediate medical advice. See also section 2.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other possible side effects with IBUPROFENE ZENTIVA GENERICS are:
Very common (may affect more than 1 in 10 people):

• Gastrointestinal disorders such as diarrhoea, malaise, vomiting, flatulence, constipation.

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

• Gastrointestinal ulcer with or without perforation.
• Intestinal inflammation and worsening of inflammation of the colon (colitis) and gastrointestinal tract (Crohn's disease), and complications of colonic diverticula (perforation or fistula).
• Microscopic gastrointestinal bleeding which may lead to anaemia.
• Ulcers and inflammation of the mouth (ulcerative stomatitis).
• Headache, drowsiness, dizziness, vertigo, fatigue, restlessness, insomnia, and irritability.

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

• Inflammation of the stomach lining.
• Kidney problems including development of oedema, kidney inflammation, and renal failure.
• Rhinorrhoea.
• Breathing difficulties (bronchospasm).
• Various skin rashes.

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

• Depression, confusion, hallucinations.
• Drug-induced lupus erythematosus syndrome.
• Increased blood urea nitrogen, increased serum transaminases and alkaline phosphatase.
• Decreased haemoglobin and haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, and increased serum uric acid levels.

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

• Palpitations, heart failure, myocardial infarction, or hypertension.
• Disorders of blood cell formation (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). Early signs or symptoms may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe 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 use), or liver failure.
• Inflammation of the meninges without bacterial infection (aseptic meningitis).
• Kidney tissue damage.
• Hair loss.
• Psychotic reactions.
• Inflammation of blood vessels.

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

• Tingling in the hands and feet.
• Anxiety.
• Hearing impairment.
• General feeling of malaise.
• Optic neuritis, which may cause vision problems.
• Skin becomes sensitive to light.
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).

IBUPROFENE ZENTIVA GENERICS may cause a reduction in the number of white blood cells, reducing your resistance to infections. Seek immediate medical advice if you develop an infection with symptoms such as fever and severe deterioration in general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about the type of medicine you are taking.
During treatment with ibuprofen, cases of aseptic meningitis (presenting with neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease.
Reporting of side effects
If you experience any side effects, 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 https://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 ZENTIVA GENERICS

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What IBUPROFENE ZENTIVA GENERICS contains
The active substance is ibuprofen.
Each tablet contains 400 mg or 600 mg of ibuprofen.
The other components are:
Granular core: microcrystalline cellulose; sodium croscarmellose; hypromellose; stearic acid; anhydrous colloidal silica; magnesium stearate;
Coating for IBUPROFENE ZENTIVA GENERICS 400 mg film-coated tablet:
hypromellose; macrogol; talc; titanium dioxide (E171);
Coating for IBUPROFENE ZENTIVA GENERICS 600 mg film-coated tablet:
hypromellose; macrogol; talc; titanium dioxide (E171);

Description of the appearance of IBUPROFENE ZENTIVA GENERICS and package contents
IBUPROFENE ZENTIVA GENERICS 400 mg film-coated tablet: round film-coated tablets, white to off-white, with a diameter of 12 mm ± 1.0 mm.
IBUPROFENE ZENTIVA GENERICS 600 mg film-coated tablet: oblong film-coated tablets, white to off-white (17 x 10 ± 1.0 mm).

Pack sizes:
IBUPROFENE ZENTIVA GENERICS 400 mg: Film-coated tablets in PVC/Al blisters are packaged in packs of 20, 30 and 60.
Film-coated tablets in PVC/Glassin blisters (child-resistant laminate) are packaged in packs of 10, 20, 50 and 100.
IBUPROFENE ZENTIVA GENERICS 600 mg: Film-coated tablets in PVC/Al blisters are packaged in packs of 20, 30 and 60.
Film-coated tablets in PVC/Glassin blisters (child-resistant laminate) are packaged in packs of 10, 20, 50 and 100.
The secondary packaging is a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer
S.C. Zentiva S.A.
B-dul Theodor Pallady nr.50, sector 3
Bucurest
032266 – Romania
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Praha 10
Czech Republic

This medicinal product is authorized in the European Economic Area countries under the
following names:
Portugal: Zentidol
Germany: Ibu-Zentiva 400 mg Filmtabletten
Ibu-Zentiva 600 mg Filmtabletten
Ibu-Zentiva 800 mg Filmtabletten
France: Ibuprofene Zentiva LAB
Italy: IBUPROFENE ZENTIVA GENERICS