Ibuxal plus

Patient Information Leaflet

Ibuxal Plus, 200 mg + 500 mg, coated tablets
Ibuprofenum + Paracetamolum
Please read this leaflet carefully before taking this 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
a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If any side effects occur, including side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Table of contents

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

1. What Ibuxal Plus is and what it is used for

This medicine is called Ibuxal Plus. Ibuxal Plus contains two active substances (the components responsible for the effect of the medicine): ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs work by reducing pain, swelling, and fever.
Paracetamol is a pain-relieving medicine that reduces pain and fever through a different mechanism than ibuprofen.
Ibuxal Plus is used for the short-term treatment of mild to moderate pain associated with migraine, headache, back pain, menstrual pain, toothache, muscle pain, symptoms of cold and flu, sore throat, and fever.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important information before taking Ibuxal Plus

When not to take Ibuxal Plus:

• if the patient is taking any other medicines containing paracetamol,
• if the patient is taking any other painkillers, including ibuprofen, acetylsalicylic acid in high doses (more than 75 mg per day), or other medicines from the group of non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors,
• if the patient is allergic to ibuprofen, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has allergy to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if there is currently or has previously been peptic ulcer or gastrointestinal bleeding (in the stomach or duodenum),
• if the patient has blood clotting disorders,
• if the patient has heart, liver or kidney failure,
• during the last three months of pregnancy,
• in individuals under 18 years of age.

Warnings and precautions
Before using Ibuxal Plus, consult a doctor or pharmacist if the patient:

• has an infection – see section "Infections" below,
• is elderly,
• has asthma or a history of asthma,
• has impaired function of the kidneys, heart, liver, or intestinal disorders,
• has systemic lupus erythematosus (SLE) – an autoimmune disease affecting connective tissue, causing joint pain, skin lesions and organ dysfunction; or other mixed connective tissue diseases,
• has gastrointestinal disorders or chronic inflammatory bowel diseases (e.g. ulcerative colitis, Crohn's disease),
• is a woman in the first 6 months of pregnancy or who is breastfeeding,
• is a woman who plans to become pregnant.

During treatment with Ibuxal Plus, inform a doctor immediately if:

• the patient has severe medical conditions, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (abnormality in blood and body fluids) have been reported in patients taking regular doses of paracetamol over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

Taking anti-inflammatory and 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. Before starting Ibuxal Plus, discuss with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina (chest pain), history of heart attack or coronary bypass surgery, peripheral arterial disease (poor circulation in feet and legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack, TIA),
• the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or smokes tobacco.

Infections
Ibuxal Plus may mask symptoms of infection such as fever and pain. Therefore, Ibuxal Plus 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, seek immediate medical advice.

Skin reactions
Serious skin reactions have been reported with the use of Ibuxal Plus. If any skin rash, mucosal lesions, blisters or other signs of allergy occur, stop taking this medicine immediately and seek medical help, as these may be early signs of a very serious skin reaction. See section 4.

Ibuxal Plus and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Do not take Ibuxal Plus:

• with other medicines containing paracetamol,
• with other NSAIDs, such as aspirin, ibuprofen.

Ibuxal Plus may affect certain other medicines or other medicines may affect its action, for example:

• corticosteroids in tablet form,
• antibiotics (e.g. chloramphenicol or quinolones),
• antibiotic (e.g. flucloxacillin), due to a serious disorder of blood and body fluids (called metabolic acidosis), which requires urgent treatment (see section 2),
• antiemetic medicines (e.g. metoclopramide, domperidone),
• anticoagulant medicines (i.e. blood thinners and those preventing blood clots, e.g. acetylsalicylic acid/aspirin, warfarin, ticlopidine),
• cardiac stimulants (e.g. glycosides),
• medicines used in patients with high cholesterol levels (e.g. cholestyramine),
• diuretics (facilitating excretion of excess water),
• medicines used to treat high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan),
• immunosuppressive medicines (e.g. methotrexate, cyclosporine, tacrolimus),
• medicines used in the treatment of phobias or depression (e.g. lithium or SSRIs – selective serotonin reuptake inhibitors),
• mifepristone (a medicine used to terminate pregnancy),
• medicines used in the treatment of HIV (e.g. zidovudine).

Some other medicines may also affect the action of Ibuxal Plus or their effects may be altered by this medicine. Always consult a doctor or pharmacist before using Ibuxal Plus together with other medicines.

Taking Ibuxal Plus with food and drink
To reduce the likelihood of adverse effects, Ibuxal Plus should be taken during meals.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Do not take Ibuxal Plus during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. Ibuxal Plus may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour.

Do not use Ibuxal Plus during the first six months of pregnancy unless the doctor considers it 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, Ibuxal Plus may cause kidney problems 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.

Ibuxal Plus may make it more difficult to become pregnant. Ibuprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible after stopping the medicine. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and using machines
Ibuxal Plus may cause dizziness, drowsiness, fatigue and visual disturbances in some people. These effects should be considered in situations requiring full psycho-physical performance, such as driving. Exercise caution when driving or operating machinery until it is known how Ibuxal Plus affects the patient.

Ibuxal Plus 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 Ibuxal Plus

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.
This medicine is for oral use and for short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Ibuxal Plus should not be used for longer than 3 days. If symptoms worsen or do not improve, contact a doctor.
Adults: take 1 tablet with food or water, up to 3 times daily. Maintain at least a 6-hour interval between doses.
If symptoms do not subside after taking one tablet, a maximum of 2 tablets may be taken up to 3 times daily. Do not take more than six tablets within 24 hours (corresponding to 3000 mg paracetamol, 1200 mg ibuprofen per day).
Use in children and adolescents
Do not use in children under 18 years of age.
Taking more than the recommended dose of Ibuxal Plus
If more than the recommended dose of Ibuxal Plus has been taken, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital for advice on possible health risks and actions to take. Symptoms of overdose may include nausea, abdominal pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4), diarrhoea, headache, tinnitus, confusion, and nystagmus. There may also be restlessness, drowsiness, disorientation, or coma. Seizures may occur in some patients. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in urine, low blood potassium levels, feeling cold, and respiratory disturbances. In addition, prothrombin time/INR may be prolonged, probably due to impaired blood clotting factor function. Acute kidney failure and liver damage may occur. Asthma may worsen in patients with asthma. In addition, low blood pressure and breathing difficulties may occur.
If more than the recommended dose of Ibuxal Plus has been taken, contact a doctor immediately, even if the patient feels well, because there is a risk of delayed, serious liver damage.
Missed dose of Ibuxal Plus
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as remembered, and the next dose may be taken no sooner than 6 hours later.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
YOU MUST STOP TAKING THE MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY IF THE FOLLOWING OCCUR:

• heartburn, indigestion,
• symptoms of gastrointestinal bleeding (severe abdominal pain, vomiting blood or vomiting material with dark particles resembling coffee grounds, blood in stool, black tarry stools),
• symptoms of meningitis such as neck stiffness, headache, malaise, fever or confusion,
• symptoms of a severe allergic reaction (swelling of the face, tongue or throat, difficulty breathing, worsening of asthma),
• Severe skin reactions with blistering, such as erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis,
• A severe skin reaction called DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophil count (a type of white blood cell).
• Severe skin reactions known as AGEP (acute generalized exanthematous pustulosis). A widespread, red, peeling rash with subcutaneous papules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment. If any of these symptoms occur, you must stop taking Ibuxal Plus and contact your doctor immediately. See also section 2.

Other possible adverse effects
Common (may occur in up to 1 in 10 people):

• abdominal pain or discomfort, nausea or vomiting, diarrhoea,
• increased liver enzyme activity (AlAT, GGTP), creatinine and urea in blood (detected in blood tests).

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

• headache and dizziness,
• flatulence and constipation,
• exacerbation of colitis and Crohn's disease,
• indigestion, heartburn or nausea (gastritis),
• pancreatitis with severe upper abdominal pain radiating to the back and vomiting,
• skin rashes, itching and facial swelling,
• increased liver enzyme activity (AspAT), increased ALP and CPK activity (detected in blood tests),
• decreased red blood cell count or increased platelet count (blood cells involved in blood clotting).

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

• decreased blood cell count (manifesting as sore throat, mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruising and nosebleeds),
• visual disturbances, tinnitus, sensation of spinning,
• disorientation, depression, hallucinations,
• numbness, itching and skin tingling, optic neuritis and somnolence,
• fatigue, general malaise,
• high blood pressure, fluid retention,
• liver problems (manifesting as yellowing of the skin and whites of the eyes),
• kidney problems (manifesting as increased or decreased urine output, leg swelling),
• heart problems (manifesting as shortness of breath, oedema),
• excessive sweating,
• purpura,
• increased skin sensitivity to sunlight.

Frequency not known (cannot be estimated from available data)

• a serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Use of medicines such as Ibuxal Plus may be associated with a slightly increased risk of
myocardial infarction (heart attack) or stroke (see section 2).
Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 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 Ibuxal Plus

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Ibuxal Plus contains

• The active substances are ibuprofen and paracetamol.
• The other ingredients are: Tablet core: corn starch, povidone K-30, sodium croscarmellose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, glycerol dibehenate. Tablet coating: Opadry White AMB II (polyvinyl alcohol – partially hydrolysed, talc, titanium dioxide (E 171), glycerol monooctanoate monocaprate, sodium lauryl sulphate).

What Ibuxal Plus looks like and contents of the pack
Ibuxal Plus are white to almost white, oval, biconvex film-coated tablets with dimensions (21 mm x 10.5 mm) ± 0.5 mm, marked on one side with a double-circle symbol.
The film-coated tablets are packed in blisters.
White PVC/PVDC/Aluminium blister containing the appropriate number of film-coated tablets
or
White PVC/PVDC/Aluminium child-resistant blister containing the appropriate number of film-coated tablets.
Pushing the tablet out of the child-resistant blister may require additional effort.
The cardboard box contains 1 blister (10 tablets) or 2 blisters (20 tablets) and a patient leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]

Manufacturer
ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče
Slovenia
Tel.: +386 1 300 42 90
Fax: +386 1 300 42 91
email: [email protected]
or
TERAPIA S.A.
124 Fabricii Street
400 632 Cluj-Napoca
Romania
Tel.: +40 (264) 501 500
Fax: +40 (264) 415 097
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Malta Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500 mg film-coated tablets
Bulgaria BlokMAX Duo 200 mg/500 mg film-coated tablets
БлокМАКС Дуо 200 mg/500 mg филмирани таблетки
Greece Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500 mg filmtabletta
Poland Ibuxal Plus
Romania PADUDEN DUO 200 mg/500 mg comprimate filmate
United Kingdom (Northern Ireland) Ibuprofen/Paracetamol 200 mg/500 mg film-coated tablets