Ibuprofen zentiva

Package leaflet: Information for the patient

Ibuprofen Zentiva, 200 mg, coated tablets
Ibuprofenum
Please read this leaflet carefully before taking the medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your doctor 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 side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days in the case of fever or migraine headache, or after 5 days for pain, or if you feel worse, you should consult a doctor.

Contents of the leaflet

1. What Ibuprofen Zentiva is and what it is used for
2. What you need to know 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 Ibuprofen Zentiva is and what it is used for

Ibuprofen Zentiva belongs to a group of medicines called 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 pain in muscles and joints,
• toothache,
• painful menstruation.

Ibuprofen Zentiva is also used for acute pain and fever associated with colds.
Children aged 6–12 years (weighing 20–40 kg) may be treated with Ibuprofen Zentiva 200 mg for acute pain and fever associated with colds.
Ibuprofen Zentiva 200 mg is recommended for use in adults, adolescents, and children weighing at least 20 kg (over 6 years of age).

2. 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 had hypersensitivity reactions such as asthma, rhinitis, itchy skin rash, or swelling of the lips, face, tongue, or throat after taking

medicines containing 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 treatment with NSAIDs.
• if the patient has blood clotting disorders or other blood formation disorders.
• if the patient has severe heart, liver, or kidney failure.
• if the patient is significantly dehydrated (due to vomiting, diarrhea, or insufficient 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 to take Ibuprofen Zentiva, consult your doctor or pharmacist if:

• the patient has impaired kidney or liver function.
• the patient has asthma.
• the patient has hay fever, nasal polyps, or chronic obstructive respiratory diseases, due to an increased risk of allergic reactions.
• the patient is also taking medicines that may increase the risk of ulcers or gastrointestinal bleeding (see below, section "Ibuprofen Zentiva with other medicines").
• the patient has heart conditions such as heart failure, angina (chest pain), a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the arms, legs, or feet due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack).
• the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.
• the patient has systemic lupus erythematosus (an autoimmune disorder) or mixed connective tissue disease (risk of aseptic meningitis).
• the patient has gastrointestinal ulcerative diseases such as Crohn's disease or ulcerative colitis.
• the patient has problems with normal blood clotting mechanisms.
• the patient has recently undergone major surgery.
• the patient is in the first six months of pregnancy.
• the patient is breastfeeding (see section "Pregnancy, breastfeeding and fertility").
• the patient has an infection – see section "Infections" below.

Allergic reactions to ibuprofen have been reported during treatment, 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, particularly 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 can be life-threatening.

The risk of gastrointestinal bleeding, ulceration, or perforation 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 further 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 individuals, should pay attention to any unusual gastrointestinal symptoms and report them immediately to a doctor. Treatment should be discontinued if gastrointestinal bleeding or ulceration occurs during ibuprofen therapy.

Effects on the heart and brain

Taking anti-inflammatory and/or pain-relieving 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 greater with higher doses and prolonged use.

Skin reactions

Severe skin reactions have been reported with the use of ibuprofen, 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).

If the patient experiences any symptoms related to these severe skin reactions described in section 4, Ibuprofen Zentiva should be stopped immediately and medical help should be sought.

Effects on the kidneys

Ibuprofen may cause kidney function impairment, even in patients who previously had no kidney disease. This may lead to swelling of the legs and may even contribute to 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 is taking this medicine during an ongoing infection and symptoms persist or worsen, they should consult a doctor immediately.

Other warnings

Long-term use of any pain-relieving medicine for headache may worsen headache. If frequent or daily headaches occur despite (or because of) regular use of pain medication, consult a doctor before taking another painkiller. 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 200 mg in children weighing less than 20 kg (under 6 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 a fever, consult a doctor if:

• the child has not taken any fluids or has lost a significant amount of fluid due to persistent vomiting or diarrhea.
• 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 you are currently taking, have recently taken, or 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/preventing blood clots, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, 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 cancer and autoimmune disease treatment), as ibuprofen may enhance the effect of this medicine.
• digoxin (used in treating various heart conditions), as its effect may be intensified.
• phenytoin (used to prevent epileptic seizures), as ibuprofen may enhance its effect.
• lithium (used in treating depression and mania), as ibuprofen may enhance its effect.
• potassium-sparing diuretics, as this may lead to hyperkalemia (increased potassium levels in blood).
• cholestyramine (used in treating high cholesterol), as the effect of ibuprofen may be reduced. Medicinal products should be taken at least one hour apart.
• aminoglycosides (antibiotics effective against certain bacteria), as ibuprofen may reduce their 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 treating 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 treating HIV-infected patients), as concomitant use may increase the risk of joint bleeding or bleeding leading to swelling in HIV-positive patients with hemophilia.
• ritonavir (used in treating HIV-infected patients), as ritonavir may increase ibuprofen levels.
• mifepristone, as ibuprofen may reduce its effectiveness.
• probenecid or sulfinpyrazone (used in treating gout), as ibuprofen excretion may be delayed.
• quinolone antibiotics, as the risk of seizures may be increased.
• sulfonylureas (used in treating type 2 diabetes), as their effect may be enhanced.
• corticosteroids (used in inflammatory conditions), as they may increase the risk of gastrointestinal ulcers or bleeding.
• bisphosphonates (used in osteoporosis, Paget's disease, and to reduce elevated blood calcium), as they may increase the risk of ulcers or bleeding.
• oxpentifylline (pentoxifylline) (used in treating circulatory disorders in arteries of hands or legs), as it may increase the risk of gastrointestinal ulcers or bleeding.
• baclofen (a muscle relaxant), as its toxicity may be increased.
• CYP2C9 inhibitors, as concomitant administration of ibuprofen with CYP2C9 inhibitors (e.g., 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. Alcohol should be avoided, as it may worsen the undesirable effects of this medicine, particularly 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 taking this medicine.

Pregnancy

Do not take 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 labor. Ibuprofen Zentiva should not be used during the first six months of pregnancy unless a doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 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 is required for longer than a few days, 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 make it more difficult to become pregnant. Inform your doctor if you are planning to conceive or have difficulty conceiving.

This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after stopping the medicine.

Driving and using machines

Ibuprofen generally does not affect the ability to drive or operate machinery. However, since undesirable 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 concurrently.

Ibuprofen Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., the medicine is considered "sodium-free".

3. How to take Ibuprofen Zentiva

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your 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 if 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 200 mg in children weighing less than 20 kg or under 6 years of age.

Higher than recommended doses may pose a serious risk. Do not use 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.

Children weighing 20–29 kg (aged 6–9 years):
Maximum daily dose: 600 mg (3 tablets of 200 mg).
One 200 mg tablet, 1 to 3 times daily as needed. Leave at least 4 to 6 hours between doses.

Children weighing 30–40 kg (aged 10–12 years):
Maximum daily dose: 800 mg (4 tablets of 200 mg).
One 200 mg tablet, 1 to 4 times daily, with at least 4 to 6 hours between doses.

Adults and adolescents weighing 40 kg or more (aged over 12 years):
Maximum daily dose: 1200 mg.
The dose should be taken as follows:
200 mg tablets: One to two tablets as a single dose or 3 to 4 times daily. Leave at least 4 to 6 hours between doses. The maximum daily dose should not exceed 6 tablets.
A single dose higher than 400 mg does not provide better pain relief.

Migraine headache
Adults and adolescents weighing 40 kg or more (aged over 12 years):
Maximum daily dose: 1200 mg.
The dose should be taken as follows:
Two 200 mg tablets as needed, 1 to 3 times daily. Leave 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 weighing 40 kg or more (aged over 12 years):
Maximum daily dose: 1200 mg.
The dose should be taken as follows:
One to two 200 mg tablets at the first signs of menstruation, 1 to 3 times daily. Leave 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 susceptible to adverse effects, especially gastrointestinal bleeding and perforation, which may be fatal. Your doctor will provide appropriate advice.

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

If more Ibuprofen Zentiva has been taken 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, ringing in the ears, confusion and nystagmus. After large doses, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. Additionally, low blood pressure may occur.

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

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects are more likely with high doses and long-term treatment.
Stop taking Ibuprofen Zentiva and contact your doctor immediately if any of the following side effects 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 reactions such as toxic epidermal necrolysis and/or erythema multiforme (very rare side effect). Additionally, severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell). Frequency unknown (frequency cannot be estimated from available data).

• Red, scaly rash with subcutaneous nodules and blisters, mainly 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, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, mouth, throat, nose, genital or eye ulcers. These severe skin reactions 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 possible side effects 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 people):

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

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

• 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 people):

• Depression, confusion, hallucinations.
• Systemic lupus erythematosus.
• Increased blood urea nitrogen and other liver enzymes, decreased haemoglobin and haematocrit, inhibition of platelet aggregation and 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, heart attack or high blood pressure.
• Blood cell formation disorders (with symptoms such as: fever, sore throat, superficial mouth 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.
• Meningitis (non-bacterial).
• Kidney tissue damage.
• Hair loss (alopecia).
• Psychotic reactions.
• Vasculitis (inflammation of blood vessels).
• Ibuprofen may mask signs of infection, worsening of infection or infection complications. If a patient takes this medicine during an infection and symptoms persist or worsen, medical advice should be sought immediately.

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

• Tingling in hands and feet.
• Restlessness.
• Hearing impairment.
• 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 reduce white blood cell count, and resistance to infections may be reduced. If a patient develops an infection with symptoms such as fever and significant deterioration in general condition, or fever with local infection symptoms such as sore throat or mouth ulcers or problems with urination, immediate medical attention is required. 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 taking this medicine.
Cases of meningitis (characterized by neck stiffness, headache, nausea, vomiting, fever or disorientation) have been observed during ibuprofen treatment in patients with pre-existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue disease.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Side effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Ibuprofen Zentiva

Keep this medicine out of the 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 specified month.
Medicines must not be disposed of via sewage or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Zentiva contains
The active substance is ibuprofen.
Each tablet contains 200 mg of ibuprofen.
The other ingredients are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose 2910/5, stearic acid, anhydrous colloidal silicon dioxide, magnesium stearate.
Tablet coating: hypromellose 2910/5, macrogol 300, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

What Ibuprofen Zentiva looks like and contents of the pack
Light yellow to beige, round coated tablets with a diameter of 9 mm.
The tablets are packed in PVC/Aluminium blisters.
Pack sizes:
10, 12, 20, 24, 50, 100 film-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 marketing authorisation holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00