IBUPROFEN ZENTIVA

Package leaflet: Information for the user

Ibuprofen Zentiva, 400 mg, modified-release tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains important
information for you.
This medicine should always be taken exactly as described in this patient leaflet or as advised by your
doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Adults: If there is no improvement after 3 days in case of fever or migraine headache, or after 5 days in case of pain, or if you feel worse, consult your doctor.
• Adolescents: If there is no improvement after 3 days or if you feel worse, consult your 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 analgesics (painkillers), antipyretics (fever-reducing agents), and non-steroidal anti-inflammatory drugs (NSAIDs).
It contains the active substance ibuprofen, which relieves pain, reduces inflammation, and lowers fever. Ibuprofen works by inhibiting the production of certain substances (prostaglandins) that contribute to pain, fever, and inflammation in the body.
Ibuprofen Zentiva is intended for short-term symptomatic relief of mild to moderate pain, such as headache (including migraine), back pain, toothache, menstrual pain, muscle and joint pain, and postoperative pain.
Ibuprofen Zentiva is used for acute painful conditions and fever associated with colds and influenza.
Ibuprofen Zentiva is a modified-release tablet with dual-layer technology containing 400 mg of ibuprofen (170 mg immediate-release and 230 mg prolonged-release). The first layer dissolves quickly and is absorbed into the bloodstream, allowing rapid delivery to the site of pain.
The second layer is designed for slow release of the medicine over a longer period, particularly to maintain effective blood concentrations of ibuprofen for an extended duration and to provide 8-hour symptom relief.
This medicine is intended for use in adults and adolescents with body weight above 40 kg (aged 12 years and above).

2. Important information before taking Ibuprofen Zentiva

When not to take Ibuprofen Zentiva

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had hypersensitivity reactions such as asthma, rhinitis, swelling of various body parts, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• if the patient has previously experienced gastrointestinal bleeding (from the stomach or intestines) or perforation caused by taking non-steroidal anti-inflammatory drugs (NSAIDs).
• if the patient currently has ulcers or bleeding in the stomach or small intestine (duodenum), or has had two or more episodes of gastric or duodenal ulcers, or gastrointestinal bleeding in the past.
• if the patient has severe heart failure.
• if the patient has severe impairment of kidney or liver function.
• if the patient has hematopoietic disorders (blood formation disorders) or coagulation disorders.
• if the patient is in the last 3 months of pregnancy.
• if the patient is significantly dehydrated (e.g. due to vomiting, diarrhoea, or inadequate fluid intake).

Warnings and precautions
Before starting to take Ibuprofen Zentiva, discuss with your doctor or pharmacist:

• if the patient has ever had gastric or duodenal ulcers, bloody stools, or black tarry stools (do not take this medicine if there have been recurrent ulcers or gastrointestinal bleeding in the past).
• if the patient has chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), as the patient's condition may worsen after taking this medicine.
• in case of mild or moderate impairment of liver or kidney function.
• in case of dehydration in adolescents, as there is a risk of kidney function disorders.
• if the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in arms, legs or feet due to narrowed or blocked arteries), or if the patient has had any stroke (including mini-stroke or transient ischaemic attack "TIA").
• 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 asthma or allergic conditions due to increased risk of breathlessness.
• if the patient has hay fever, sinusitis, nasal polyps, or chronic respiratory diseases, due to increased risk of allergic reactions; allergic reactions most commonly manifest as asthma attack, urticaria, or swelling of various body parts.
• if the patient has an immune system disorder (systemic lupus erythematosus) or another connective tissue disease, as there is a risk of aseptic meningitis (inflammation of the meninges without presence of microorganisms).
• if the patient has an infection – see section "Infections" below.
• if the patient has chickenpox, do not take this medicine.

Talk to your doctor if any of the above warnings apply to the patient's condition.
The risk of adverse effects increases with higher doses of the medicinal product and in elderly patients. Therefore, treatment should be initiated at the lowest possible dose and continued for the shortest duration necessary to relieve symptoms.
If abdominal pain, tarry stools, vomiting (nausea), diarrhoea or other digestive disturbances occur, or any signs of allergy appear, discontinue use and consult a doctor.
Allergic reactions to ibuprofen have been reported during treatment, including difficulty breathing, 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.
In patients with high blood pressure and/or heart failure, Ibuprofen Zentiva may cause fluid retention and oedema.
Anti-inflammatory/pain-relieving medicines (with anti-inflammatory and analgesic effects), such as ibuprofen, may cause a small increase in the risk of cardiovascular (heart-related) or cerebrovascular (brain blood vessel-related) events, especially when high doses are taken. Therefore, do not exceed the recommended dose or duration of treatment.
Serious skin adverse reactions
Serious 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 generalised exanthematous pustulosis (AGEP). Discontinue use of Ibuprofen Zentiva and seek immediate medical advice if any of the symptoms associated with serious skin reactions described in section 4 occur.
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 ongoing infection and infection symptoms persist or worsen, seek immediate medical advice.
Other warnings
Prolonged use of any painkiller for headache may worsen it. If such a situation is suspected, consult a doctor and discontinue treatment. Medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of analgesics.
Children and adolescents
This medicine should not be used in adolescents with body weight below 40 kg or in children under 12 years of age.
Ibuprofen Zentiva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Ibuprofen Zentiva may affect the action of other medicines, or other medicines may affect the action of Ibuprofen Zentiva.
Avoid taking Ibuprofen Zentiva if the patient is currently taking another painkiller from the group of non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), or any other painkillers, including those containing acetylsalicylic acid (if taken as a painkiller).
Ibuprofen Zentiva prolonged-release tablets should not be combined with immediate-release ibuprofen products. There is a difference in dosing intervals (8 hours for Ibuprofen Zentiva modified-release tablets compared to 4–6 hours for immediate-release ibuprofen).
Ibuprofen Zentiva may affect the action of other medicines, or other medicines may affect the action of Ibuprofen Zentiva. Such medicines include:

• anticoagulants/antiplatelet agents (i.e. blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines for lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• corticosteroids such as prednisolone or dexamethasone
• diuretics (water pills)
• cardiac glycosides (medicines used in heart disease treatment, e.g. digoxin)
• antidepressant medicines (lithium or so-called selective serotonin reuptake inhibitors)
• methotrexate (used in cancer treatment)
• certain medicines used to suppress immune system function (medicines containing cyclosporine or tacrolimus)
• antiepileptic medicines (phenytoin)
• medicines containing mifepristone (abortion pill)
• AIDS medicines containing zidovudine
• quinolone and aminoglycoside antibiotics
• Ginkgo biloba
• voriconazole or fluconazole (a type of antifungal medicines) (CYP2C9 inhibitors). Ibuprofen Zentiva may affect the action of other medicines, or other medicines may affect the action of Ibuprofen Zentiva. Therefore, always consult your doctor or pharmacist before taking Ibuprofen Zentiva together with other medicines.

Ibuprofen Zentiva with food, drink and alcohol
Consumption of alcoholic beverages is not recommended during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist 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 delivery complications. It may cause kidney and heart function disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.
During the first 6 months of pregnancy, do not use Ibuprofen Zentiva unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. Taking Ibuprofen Zentiva for longer than a few days beyond the 20th week of pregnancy may result in impaired kidney function in the unborn child, 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 required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen pass into breast milk. It is not necessary to interrupt breastfeeding with short-term use of the recommended dose of the medicine.
Fertility
Ibuprofen Zentiva may make it more difficult to become pregnant. Inform your doctor if you are planning to become pregnant or are experiencing difficulty conceiving.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may impair fertility in women. This effect is reversible after stopping the medicine.
Driving and using machines
Ibuprofen has no effect or negligible effect on the ability to drive and operate machinery when used on a single or short-term basis.
Ibuprofen Zentiva contains sodium
This 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 this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Ibuprofen Zentiva is intended for short-term use only.
The dosing intervals for Ibuprofen Zentiva, which is a modified-release ibuprofen product, differ from those of immediate-release ibuprofen products. Ibuprofen Zentiva releases the active substance over a longer period, and the minimum interval between two doses must be 8 hours. It should not be combined with immediate-release ibuprofen products, for which the minimum dosing interval is 4–6 hours.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Recommended dose
Adults and adolescents with body weight of 40 kg (aged 12 years and above)
The initial dose is one tablet, followed by one tablet every 8 hours if needed.
There must be at least an 8-hour interval between doses.
Do not exceed the maximum daily dose of 3 tablets (1,200 mg ibuprofen) within 24 hours.

Elderly patients
If the patient is elderly, always consult a doctor before taking Ibuprofen Zentiva. Elderly patients are more susceptible to adverse effects, particularly gastrointestinal bleeding, ulcers, and perforation, which may be fatal. The 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. This medicine is contraindicated in patients with severe liver or kidney impairment.

Method of administration
Swallow the tablet whole with a glass of water or another liquid. The tablet may be taken with or without food.
Do not crush, chew, or suck the tablet, to avoid irritation of the stomach or throat and to ensure the modified-release tablet delivers the active ingredient as intended.
Patients with a sensitive stomach are advised to take Ibuprofen Zentiva with a small amount of food.

Duration of treatment
If adolescents require this medicinal product for longer than 3 days or if symptoms worsen, consult a doctor.
If adults require this medicinal product for longer than 3 days for fever or migraine pain, or longer than 5 days for pain treatment, or if symptoms worsen, consult a doctor.

Taking more Ibuprofen Zentiva than recommended
If a patient takes more than the recommended dose of Ibuprofen Zentiva, or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, abdominal pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus, or less commonly, diarrhoea.
With large doses, gastrointestinal bleeding (from stomach and intestines), restlessness, visual disturbances, low blood pressure, kidney failure, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.

If you forget to take Ibuprofen Zentiva
Do not take a double dose to make up for a missed dose.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Elderly people are at significantly higher risk of experiencing adverse effects.
The frequency of adverse effects is minimized by taking the lowest possible dose for the shortest possible duration.
Some adverse effects require immediate medical intervention.
You must stop taking Ibuprofen Zentiva and contact your doctor immediately if any of the following symptoms occur:

• Severe allergic reaction with swelling of the face, tongue, or throat (angioedema), or rapidly developing generalized allergic reaction with breathlessness, rapid heartbeat, drop in blood pressure, or shock (anaphylactic reaction) (very rare – may affect up to 1 in 10,000 people)
• Symptoms of aseptic meningitis (inflammation of the membranes surrounding the brain without pus), such as neck stiffness, headache, nausea, vomiting, fever, or confusion (very rare – may affect up to 1 in 10,000 people)
• Symptoms of gastrointestinal bleeding, such as severe upper abdominal pain, passing blood in stool (faeces/defecation), passing black tarry stools, or vomiting blood or dark particles resembling coffee grounds (very rare – may affect up to 1 in 10,000 people)
• Red, non-itchy, flat or raised circular patches on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, 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) (very rare – may affect up to 1 in 10,000 people)
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome) (frequency unknown – frequency cannot be estimated from available data)
• Red, scaly widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency unknown – frequency cannot be estimated from available data).

If any of these symptoms occur, stop taking Ibuprofen Zentiva immediately and seek medical help right away. See section 2.
Other adverse effects that may occur during treatment with this medicine are listed below, grouped by frequency of occurrence:
Not common (may affect up to 1 in 100 people):

• Allergic reactions associated with urticaria (hives), itching, and various skin rashes;
• Headache;
• Abdominal pain, nausea, dyspepsia.

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

• Diarrhoea, bloating, constipation, and vomiting.

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

• Blood cell formation disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis);
• Asthma;
• Peptic ulcer, mouth ulcers, gastritis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• Liver function disorders;
• Heart failure, fluid retention (oedema due to fluid accumulation in tissues), increased blood pressure;
• Severe kidney failure, reduced urine production, increased serum urea concentration, renal papillary necrosis (severe kidney tissue damage).

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

• Bronchospasm (narrowing of the airways), shortness of breath
• Increased skin sensitivity to light
• Hearing impairment
• Kidney failure
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome

Medicines such as Ibuprofen Zentiva may cause a small increase in the risk of cardiovascular or cerebrovascular events (related to blood vessels in the brain).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
"EXP". The expiry date refers to the last day of the stated month.
This medicinal product does not require any special storage temperature conditions.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Zentiva contains

• The active substance is ibuprofen. Each modified-release tablet contains 400 mg of ibuprofen.
• The other ingredients are:
  Tablet core:
  Immediate-release layer: hydroxypropylcellulose; silicified microcrystalline cellulose (composed of: microcrystalline cellulose, colloidal anhydrous silica); sodium croscarmellose; iron(III) oxide red (E 172); colloidal anhydrous silica; glycerol dibehenate; sodium stearyl fumarate.
  Prolonged-release layer: hydroxypropylcellulose; hypromellose; colloidal anhydrous silica; silicified microcrystalline cellulose (composed of: microcrystalline cellulose, colloidal anhydrous silica); glycerol dibehenate; sodium stearyl fumarate.
  Tablet coating: hypromellose, macrogol 300 (E 1521), talc (E 553b).

What Ibuprofen Zentiva looks like and contents of the pack
Pinkish-white to pinkish-yellow, two-layer, elongated coated tablet with dimensions of approximately 17.9 x 7.6 mm and thickness of approximately 6.9 mm.
The tablets are packed in transparent PVC/aluminum blisters in a cardboard carton.
Pack sizes:
Ibuprofen Zentiva 400 mg: 14, 28 modified-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
ul. Żmigrodzka 242 E
51-131 Wrocław, Poland

Manufacturer
Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Product information
Tel.: (22) 742 00 22
E-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names: