Ibuprofen zentiva

Package leaflet: Information for the patient

Ibuprofen Zentiva, 400 mg, film-coated tablets
Ibuprofenum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If, after 3 days of treatment for fever or migraine headache, or after 5 days for pain, there is no improvement or if your condition worsens, you should consult a doctor.

Table of contents of the leaflet

1. What is Ibuprofen Zentiva and what is it used for
2. Important information before taking Ibuprofen Zentiva
3. How to take Ibuprofen Zentiva
4. Possible side effects
5. How to store Ibuprofen Zentiva
6. Contents of the pack and other information

1. What is Ibuprofen Zentiva and what is it used for

Ibuprofen Zentiva belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
These medicines have analgesic, antipyretic, and anti-inflammatory properties.
Adults and adolescents (aged 12–18 years, weighing at least 40 kg): Ibuprofen Zentiva is used for short-term, symptomatic treatment of mild to moderate pain such as:

• headache (including migraine headache),
• back pain and muscle and joint pain,
• toothache,
• painful menstruation.

Ibuprofen Zentiva is also used for acute pain and fever associated with the common cold.
Ibuprofen Zentiva 400 mg is recommended for use in adults and adolescents weighing at least 40 kg (above 12 years of age).

2. Important information before taking Ibuprofen Zentiva

When not to take Ibuprofen Zentiva

• if the patient has hypersensitivity to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever experienced hypersensitivity reactions such as asthma, rhinitis, itchy skin rash, or swelling of the lips, face, tongue or throat after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• if the patient currently has or has previously had recurrent ulcers or gastrointestinal bleeding (in the stomach or small intestine (duodenum)) with two or more such episodes in the past.
• if the patient has experienced gastrointestinal bleeding or perforation related to previous NSAID therapy.
• if the patient has blood clotting disorders or disorders of blood cell formation.
• if the patient has severe heart, liver or kidney failure.
• if the patient is significantly dehydrated (due to vomiting, diarrhoea or inadequate fluid intake).
• if the patient has any active bleeding (including in the brain).
• if the patient is in the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility"). Warnings and precautions Before starting treatment with Ibuprofen Zentiva, discuss with your doctor or pharmacist:
• if the patient has impaired kidney or liver function.
• if the patient has asthma.
• if the patient has hay fever, nasal polyps or chronic obstructive respiratory diseases, due to an increased risk of allergic reactions.
• if the patient is also taking medicines that may increase the risk of ulceration or bleeding (see below, section "Ibuprofen Zentiva with other medicines").
• if the patient has heart diseases such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in hands, legs or feet due to narrowed or blocked arteries), or if the patient has had any stroke (including mini-stroke or transient ischaemic attack).
• if the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.
• if the patient has systemic lupus erythematosus (an autoimmune disorder) or mixed connective tissue disease (risk of aseptic meningitis).
• if the patient has gastrointestinal ulcerative diseases such as Crohn's disease or ulcerative colitis.
• if the patient has problems with normal blood clotting mechanisms.
• if the patient has recently undergone major surgery.
• if the patient is in the first six months of pregnancy.
• if the patient is breastfeeding (see section "Pregnancy, breastfeeding and fertility").
• if the patient has an infection - see section "Infections" below.

During treatment with ibuprofen, allergic reactions have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If the patient experiences any of these symptoms, they should immediately stop taking Ibuprofen Zentiva and contact a doctor or emergency services.

Elderly patients
Elderly patients should be aware of an increased risk of adverse effects, especially gastrointestinal bleeding and perforation, which may be life-threatening.

Ulcers, perforation and bleeding in the stomach or intestines
Bleeding, ulceration or perforation of the stomach or intestines may occur without warning symptoms, even in patients who have never previously experienced such problems. These events may be life-threatening.
The risk of gastrointestinal bleeding, ulceration or perforation substantially increases with higher doses of ibuprofen. The risk is also greater in elderly patients; more information on this is provided in the section "Elderly patients" in "How to take Ibuprofen Zentiva". The risk is also increased when taking certain other medicines concomitantly with ibuprofen (see section "Ibuprofen Zentiva with other medicines").
Patients who have previously had gastrointestinal problems, especially elderly patients, should pay attention to any unusual gastrointestinal symptoms and report them to their doctor immediately. Treatment should be discontinued if gastrointestinal bleeding or ulceration occurs during ibuprofen therapy.

Effects on the heart and brain
Taking anti-inflammatory and/or analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment. The risk is more likely with higher doses and prolonged treatment.

Skin reactions
Severe skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Treatment with Ibuprofen Zentiva should be stopped and medical advice sought immediately if any symptoms related to severe skin reactions described in section 4 occur.

Effects on the kidneys
Ibuprofen may cause kidney dysfunction, even in patients who have not previously had kidney disease. This may lead to leg swelling and even heart failure or high blood pressure in predisposed individuals.
Ibuprofen may cause kidney damage particularly in patients who already have kidney, heart or liver disease, or who are taking diuretics, ACE inhibitors, or in elderly patients. However, discontinuation of ibuprofen usually leads to recovery.

Infections
Ibuprofen Zentiva may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen Zentiva may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and symptoms persist or worsen, they should consult a doctor immediately.

Other warnings
Long-term use of any analgesic for headache may worsen its effectiveness. If frequent or daily headaches occur despite (or because of) regular use of headache medication, consult a doctor before taking another analgesic. Treatment should be discontinued if medication-overuse headache (MOH) is diagnosed.
Do not take Ibuprofen Zentiva if the patient is planning pregnancy. Consult a doctor first. See also section "Pregnancy, breastfeeding and fertility".

Children and adolescents
Do not use Ibuprofen Zentiva 400 mg in children weighing less than 40 kg (under 12 years of age).
Consult a doctor before using this medicine if:

• the child is seriously ill or has abdominal pain, stiff neck or back pain.
• the child has severe ear, throat or tracheal diseases.

If the child has fever, consult a doctor if:

• the child has not taken any fluids or has lost a large amount of fluid due to persistent vomiting or diarrhoea.
• there is no improvement in pain or fever after the first day of treatment.
• new symptoms appear, or abdominal pain or gastrointestinal problems worsen or persist for a prolonged period.

Ibuprofen Zentiva with other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, and any medicines you plan to take. Ibuprofen Zentiva may affect the action of other medicines or other medicines may affect the action of Ibuprofen Zentiva. For example:

• anticoagulant medicines (such as blood thinners/anti-thrombotic agents, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).
• other NSAIDs or acetylsalicylic acid, as these may increase the risk of gastrointestinal ulcers or bleeding.
• methotrexate (used in the treatment of cancer and autoimmune diseases), as ibuprofen may enhance the effect of this medicine.
• digoxin (used in the treatment of various heart conditions), as the effect of digoxin may be enhanced.
• phenytoin (used to prevent epileptic seizures), as ibuprofen may enhance its effect.
• lithium (used in the treatment of depression and mania), as ibuprofen may enhance its effect.
• potassium-sparing diuretics, as this may lead to hyperkalaemia (increased potassium levels in blood).
• cholestyramine (used to treat high cholesterol), as the effect of ibuprofen may be reduced. Medicinal products should be taken at least one hour apart.
• aminoglycosides (antibiotics against certain types of bacteria), as ibuprofen may reduce aminoglycoside elimination; concomitant use may increase the risk of toxicity.
• SSRIs (antidepressants), such as paroxetine, sertraline, citalopram, as they may increase the risk of gastrointestinal bleeding.
• moclobemide (RIMA - used in the treatment of depression or social phobia), as the effect of ibuprofen may be enhanced.
• cyclosporine, tacrolimus (used to suppress immunity after organ transplantation), as kidney damage may occur.
• zidovudine (used in the treatment of HIV-infected patients), as use of this medicine may increase the risk of joint bleeding or bleeding leading to swelling in patients with haemophilia HIV (+).
• ritonavir (used in the treatment of HIV-infected patients), as ritonavir may increase ibuprofen levels.
• mifepristone, as ibuprofen may weaken its effect.
• probenecid or sulfinpyrazone (used in the treatment of gout), as ibuprofen excretion may be delayed.
• quinolone antibiotics, as the risk of seizures may be increased.
• sulfonylurea derivatives (used in the treatment of type 2 diabetes), as the effect of these medicines may be enhanced.
• corticosteroids (used in inflammatory conditions), as these may increase the risk of gastrointestinal ulcers or bleeding.
• bisphosphonates (used in osteoporosis, Paget's disease and to reduce elevated blood calcium levels), as they may increase the risk of ulcers or bleeding.
• oxpentifylline (pentoxifylline) (used in the treatment of circulatory disorders in the arteries of the legs or arms), as it may increase the risk of gastrointestinal ulcers or bleeding.
• baclofen (a muscle relaxant), as baclofen toxicity may be increased.
• CYP2C9 inhibitors, as concomitant administration of ibuprofen with CYP2C9 inhibitors (voriconazole, fluconazole) may increase exposure to ibuprofen (a CYP2C9 substrate).

Ibuprofen Zentiva with food, drink and alcohol
If the patient has a sensitive stomach, it is recommended to take this medicine with food. Avoid alcohol, as it may worsen the undesirable effects of this medicine, especially those affecting the stomach, intestines or brain.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Do not use Ibuprofen Zentiva during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Ibuprofen Zentiva should not be used during the first six months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Ibuprofen Zentiva may cause kidney function disturbances in the unborn child if taken for longer than a few days. This 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 for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk, but it is unlikely to affect the breastfed infant when used for short-term treatment. However, if longer-term treatment is recommended, early weaning should be considered.

Fertility
Ibuprofen Zentiva may impair fertility. Inform your doctor if you are planning pregnancy or have difficulty conceiving.
This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the medicine.

Driving and operating machinery
Ibuprofen generally does not affect the ability to drive or operate machinery. However, since adverse effects such as fatigue and dizziness may occur with high doses of the medicine, the ability to drive or operate machinery may be impaired. This is particularly important when alcohol is consumed simultaneously.

Ibuprofen Zentiva contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Ibuprofen Zentiva

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

How to take Ibuprofen Zentiva
Swallow the tablet whole with a glass of water. Do not crush, chew or suck the tablet to avoid irritation of the stomach or throat. If the patient has a sensitive stomach, it is recommended to take this medicine with food.

How much Ibuprofen Zentiva to take
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If the patient has an infection, seek medical advice immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults: If there is no improvement or symptoms worsen after 3 days for fever or migraine headache, or after 5 days for pain, consult a doctor.

Children and adolescents: If this medicine needs to be used for longer than 3 days or if symptoms worsen, consult a doctor.

The dose of ibuprofen for children and adolescents depends on the patient's age and body weight.

Do not use Ibuprofen Zentiva 400 mg in adolescents with body weight below 40 kg or under 12 years of age.

Higher than recommended doses may pose serious risks. Do not take different types of painkillers simultaneously without medical advice.

Mild to moderate pain and acute pain and fever associated with colds
For dosing in children, use Ibuprofen Zentiva 200 mg.

Adults and adolescents with body weight of 40 kg or more (aged over 12 years):
Maximum daily dose: 1200 mg.

The dose should be taken as follows:
400 mg tablets: One tablet as a single dose or up to three times daily. Allow at least 4 to 6 hours between doses. The maximum daily dose should not exceed 3 tablets.

A single dose higher than 400 mg does not provide better pain relief.

Migraine headache
Adults and adolescents with body weight of 40 kg or more (aged over 12 years):
Maximum daily dose: 1200 mg.

The dose should be taken as follows:
One 400 mg tablet as needed, 1 to 3 times daily. Allow at least 4 to 6 hours between doses.

A single dose higher than 400 mg does not provide better pain relief.

Menstrual pain
Adults and adolescents with body weight of 40 kg or more (aged over 12 years):
Maximum daily dose: 1200 mg.

The dose should be taken as follows:
One 400 mg tablet at the first signs of menstruation, 1 to 3 times daily. Allow at least 4 to 6 hours between doses.

A single dose higher than 400 mg does not provide better pain relief.

Elderly patients
If the patient is elderly, always consult a doctor before taking Ibuprofen Zentiva. Elderly patients are more likely to experience adverse effects, especially gastrointestinal bleeding and perforation, which can be fatal. A doctor will provide appropriate advice.

Liver or kidney function disorders
If the patient has impaired liver or kidney function, always consult a doctor before using Ibuprofen Zentiva.

Taking more Ibuprofen Zentiva than recommended
If the patient has taken more than the recommended dose of Ibuprofen Zentiva or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital for advice on possible health risks and what actions to take.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion and nystagmus. After large doses, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, feeling cold and breathing difficulties may occur. Low blood pressure may also occur.

If you miss a dose of Ibuprofen Zentiva
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are more likely with high doses and prolonged treatment.
Stop taking Ibuprofen Zentiva and contact your doctor immediately if any of the following adverse reactions occur:

• Angioedema (may affect up to 1 in 10,000 people) with symptoms such as:
  • swelling of the face, tongue or throat
  • difficulty swallowing
  • rash and difficulty breathing.
• Black, tarry stools or vomiting blood (may affect up to 1 in 10 people).
• Severe skin and mucous membrane disorders, such as epidermal necrolysis and (or) erythema multiforme (very rare adverse reaction). Additionally, severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophils (a type of white blood cell). Frequency unknown (frequency cannot be estimated from available data).
• Red, scaly rash with subcutaneous nodules and blisters, usually located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Frequency unknown (frequency cannot be estimated from available data).
• Blurred vision or other eye problems such as light sensitivity, loss of vision (may affect up to 1 in 1,000 people).
• Red, flat, non-elevated, target-like or round spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose,

genital organs and eyes. These severe skin rashes may be preceded by fever and
flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] (may affect up to 1
in 10,000 people).

Other adverse reactions that may occur are listed below by frequency of occurrence:
Very common (may affect more than 1 in 10 people):

• Heartburn, abdominal pain, indigestion.
• Gastrointestinal disturbances such as diarrhoea, malaise, vomiting, flatulence, constipation.

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

• Gastrointestinal ulcer with or without perforation.
• Inflammation of the intestine and exacerbation of inflammatory bowel disease (colitis) and gastrointestinal tract (Crohn's disease), and complications of colonic diverticula (perforation or fistula).
• Microscopic gastrointestinal bleeding which may lead to anaemia.
• Oral ulcers and inflammatory conditions of the mouth.
• Headache, drowsiness, vertigo, fatigue, restlessness, insomnia and irritability.

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

• Gastritis (inflammation of the stomach lining).
• Kidney disorders, including development of oedema, nephritis and renal failure.
• Rhinitis, asthma.
• Rash, increased skin sensitivity to sunlight.
• Hypersensitivity reactions such as urticaria (hives), itching.

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

• Depression, confusion, hallucinations.
• Systemic lupus erythematosus.
• Increased blood urea nitrogen levels and other liver enzymes, decreased haemoglobin and haematocrit values, inhibition of platelet aggregation and prolonged bleeding time, decreased serum calcium concentration and increased serum uric acid concentration.

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

• Palpitations, heart failure or myocardial infarction or high blood pressure.
• Blood cell formation disorders (with symptoms such as: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding).
• Tinnitus (ringing or buzzing in the ears).
• Oesophagitis or pancreatitis.
• Intestinal stricture.
• Liver damage causing yellowing of the skin or whites of the eyes (jaundice) and fluid retention in the body.
• Meningitis (without bacterial infection).
• Kidney tissue damage.
• Alopecia (hair loss).
• Psychotic reactions.
• Vasculitis (inflammation of blood vessels). Ibuprofen may mask symptoms of infection, worsening of infection or complications of infection. If a patient takes this medicine during an infection and symptoms persist or worsen, immediate consultation with a doctor is necessary.

Frequency not known (frequency cannot be estimated from available data):

• Tingling in hands and feet.
• Restlessness.
• Impaired hearing.
• General malaise.
• Optic neuritis, which may cause visual disturbances.
• Low neutrophil count (a type of white blood cell).
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Use of medicines such as Ibuprofen Zentiva may slightly increase the risk of heart attack
or stroke. Fluid retention (oedema), high blood pressure and heart failure have been reported with the use of NSAIDs.
Ibuprofen Zentiva may cause a decrease in white blood cell count, and resistance to infections may
be reduced. If a patient develops an infection with symptoms such as fever and serious worsening
of general condition or fever with signs of local infection, such as sore throat or mouth ulcers or
problems with urination, medical advice should be sought immediately. A blood test
will be performed to check for possible reduction in white blood cell count (agranulocytosis). It is important to
inform the doctor about the use of this medicine.
During treatment with ibuprofen, a few cases of meningitis (manifesting as neck stiffness, headache, nausea, vomiting, fever or confusion) have been observed in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus or mixed connective tissue disease.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder in Poland.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Ibuprofen Zentiva

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Zentiva contains
The active substance is ibuprofen.
Each tablet contains 400 mg of ibuprofen.
The other ingredients are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose 2910/5, stearic acid, colloidal anhydrous silica, magnesium stearate.
Tablet coating: hypromellose 2910/5, macrogol 300, talc, titanium dioxide (E 171).
What Ibuprofen Zentiva looks like and contents of the pack
White to almost white, round coated tablets with a diameter of 12 mm.
The tablets are packed in PVC/Aluminium blisters.
Pack sizes:
10, 12, 20, 24, 30, 36, 40, 48, 50, 100, 250 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer
Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
S.C. Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3,
032266 Bucharest
Romania
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information about the medicinal product, please contact the representative of the responsible entity in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00