IBUXAL 200 mg/500 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: Information for the user
2. Ibuxal Plus, 200 mg + 500 mg, coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ibuxal Plus and what is it used for
4. Important information before taking Ibuxal Plus
   1. When not to take Ibuxal Plus:
   2. Warnings and precautions
   3. Ibuxal Plus and other medicines
   4. Taking Ibuxal Plus with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Ibuxal Plus contains sodium
5. How to take Ibuxal Plus
   1. Use in children and adolescents
   2. Taking a higher dose of Ibuxal Plus than recommended
   3. Missing a dose of Ibuxal Plus
6. Possible side effects
   1. STOP TAKINGthe medicine and consult a doctor if you experience:
   2. Other possible side effects
   3. Reporting side effects
7. How to store Ibuxal Plus
8. Contents of the packaging and other information
   1. What Ibuxal Plus contains
   2. What Ibuxal Plus looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   7. Date of last revision of the leaflet: 10.03.2025

Leaflet accompanying the packaging: Information for the user

Ibuxal Plus, 200 mg + 500 mg, coated tablets

Ibuprofen+ Paracetamol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Ibuxal Plus and what is it 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 packaging and other information

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

The medicine is called Ibuxal Plus. Ibuxal Plus contains two active substances (which make the medicine work). These are ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
The action of NSAIDs is to reduce pain, reduce swelling, and lower high body temperature.
Paracetamol is a pain reliever that, acting differently than ibuprofen, relieves pain and fever.
Ibuxal Plus is used for short-term treatment of mild to moderate pain associated with migraine, headache, back pain, menstrual pain, toothache, muscle pain, treatment of cold and flu symptoms, sore throat, and fever.
If after 3 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Ibuxal Plus

When not to take Ibuxal Plus:

• if you are taking any other medicines containing paracetamol,
• if you are taking any other pain relievers, including ibuprofen, acetylsalicylic acid in large doses(more than 75 mg per day) or other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors,
• if you are allergic to ibuprofen, paracetamolor any of the other ingredients of this medicine (listed in section 6),
• if you have an allergy to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if you currently have or have had ulcers or bleeding in the stomach or duodenum(small intestine),
• if you have blood clotting problems(blood clotting disorders),
• if you have heart, liver, or kidney failure,
• in the last three months of pregnancy,
• in people under 18 years of age.

Warnings and precautions

Before taking Ibuxal Plus, you should discuss it with your doctor or pharmacist if you:

• have an infection- see "Infections" below,
• are elderly,
• have asthmaor have had asthma in the past,
• have kidney, heart, liverproblems or gastrointestinal problems,
• have systemic lupus erythematosus (SLE)- an autoimmune disease affecting connective tissue, causing joint pain, skin changes, and disorders of some organs; or other mixed connective tissue diseases,
• have gastrointestinal or chronic inflammatory bowel diseases(e.g., ulcerative colitis, Crohn's disease),
• are breastfeeding or in the first 6 months of pregnancyor planning to become pregnant.

While taking Ibuxal Plus, you should immediately inform your doctor if:

• you have severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when you are also taking flucloxacillin (an antibiotic). There have been reports of a severe condition called metabolic acidosis (a blood and fluid disorder) in patients taking paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Taking anti-inflammatory and pain relievers, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.
Before starting to take Ibuxal Plus, you should discuss it with your doctor or pharmacist if:

• you have heart diseases, such as heart failure, angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, have peripheral artery disease (poor circulation in the feet and legs due to narrowing or blockage of arteries) or have had any stroke (including mini-stroke or transient ischemic attack, TIA),
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Infections
Ibuxal Plus may mask the symptoms of an infection, such as fever and pain. Therefore, Ibuxal Plus may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you are taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, you should immediately consult a doctor.
Skin reactions
Serious skin reactions have been reported with the use of Ibuxal Plus. If you experience any skin rash, changes in the mucous membranes, blisters, or other signs of an allergic reaction, you should stop taking this medicine immediately and seek medical attention, as these may be the first signs of a very serious skin reaction. See section 4.

Ibuxal Plus and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Ibuxal Plus:

• with other medicines containing paracetamol,
• with other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen.

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

• corticosteroidsin tablets,
• antibiotics(e.g., chloramphenicol or quinolones),
• antibiotic(e.g., flucloxacillin), due to a serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2),
• 2),
• anti-emetic medicines(e.g., metoclopramide, domperidone),
• blood-thinning medicines (i.e., thinning the blood and preventing blood clots, e.g., acetylsalicylic acid/aspirin, warfarin, ticlopidine),
• heart stimulants(e.g., glycosides),
• medicines used in patients with high cholesterol(e.g., cholestyramine),
• diuretic medicines(facilitating the removal 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 to treat phobias or depression(e.g., lithium or SSRI - selective serotonin reuptake inhibitors),
• mifepristone(a medicine that causes abortion),
• medicines used to treat HIV(e.g., zidovudine).

Some other medicines may also affect the action of Ibuxal Plus or their action may change under the influence of this medicine. You should always consult your doctor or pharmacist before taking Ibuxal Plus with other medicines.

Taking Ibuxal Plus with food and drink

To reduce the likelihood of side effects, Ibuxal Plus should be taken with food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Do not take Ibuxal Plus if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems during delivery. Ibuxal Plus may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in you and your baby and cause delayed or prolonged labor.
In the first 6 months of pregnancy, you should not take Ibuxal Plus unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to become pregnant, you should use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Ibuxal Plus may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your 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 you are planning to become pregnant or are having trouble becoming pregnant, you should inform your doctor.

Driving and using machines

Ibuxal Plus may cause dizziness, drowsiness, fatigue, and vision disturbances in some people. This should be taken into account in situations where full physical and mental fitness is required, e.g., when driving a vehicle. You should exercise caution when driving vehicles and operating machines until you are sure how Ibuxal Plus affects you.

Ibuxal Plus contains sodium

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

3. How to take Ibuxal Plus

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The medicine is for oral use and should only be used for short-term use.
You should use the smallest effective dose for the shortest duration necessary to relieve the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should immediately consult a doctor (see section 2).
Ibuxal Plus should not be used for more than 3 days.If the symptoms worsen or do not improve, you should contact your doctor.
Adults:you should take 1 tablet with food or water, up to 3 times a day. You should maintain at least a 6-hour interval between doses.
If the symptoms do not improve after taking one tablet, you can take a maximum of 2 tablets up to 3 times a day. Do not take more than six tablets in 24 hours(which corresponds to 3000 mg of paracetamol, 1200 mg of ibuprofen per day).

Use in children and adolescents

Do not use in children under 18 years of age.

Taking a higher dose of Ibuxal Plus than recommended

If you have taken more than the recommended dose of Ibuxal Plus or if a child has accidentally taken the medicine, you should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what actions to take in this situation. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, and nystagmus. You may also experience agitation, drowsiness, disorientation, or coma. Seizures have also been reported. After taking a large dose, there have been reports of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and respiratory disorders. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of blood clotting factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma is possible in patients with asthma. Additionally, low blood pressure and breathing difficulties may occur.
If you have taken more than the recommended dose of Ibuxal Plus, you should immediately contact your doctor, even if you feel well, as there is a risk of delayed serious liver damage.

Missing a dose of Ibuxal Plus

You should not take a double dose to make up for a missed dose. If you miss a dose, you should take it as soon as you remember, and the next dose can be taken no earlier than 6 hours later.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TAKINGthe medicine and consult a doctor if you experience:

• heartburn, indigestion,
• symptoms of gastrointestinal bleeding(severe stomach pain, vomiting blood or coffee grounds, blood in the stool, black tarry stools),
• symptoms of meningitissuch as stiff neck, headache, malaise, fever, or disorientation,
• symptoms of a severe allergic reaction(swelling of the face, tongue, or throat, difficulty breathing, worsening of asthma),
• Severe skin reactions with blisters, such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis,
• A severe skin reaction called DRESS syndromemay occur. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• Severe skin reactions called AGEP (acute generalized exanthematous pustulosis). A red, peeling, widespread rash with bumps under the skin and blisters, mainly located in skin folds, torso, and upper limbs, accompanied by fever at the beginning of treatment. If you experience these symptoms, you should stop taking Ibuxal Plus and seek medical attention immediately. See also section 2.

Other possible side effects

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

• stomach pain or malaise, nausea or vomiting, diarrhea,
• increased activity of liver enzymes (ALT, GGTP), creatinine, and urea in the blood (detected in blood tests).

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

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

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

• decreased blood cell count (manifested by sore throat, mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, and bruising),
• vision disturbances, ringing in the ears, feeling of spinning,
• disorientation, depression, hallucinations,
• numbness, itching, and tingling of the skin, optic neuritis, and drowsiness,
• fatigue, general malaise,
• high blood pressure, water retention,
• liver problems (manifested by yellowing of the skin and whites of the eyes),
• kidney problems (manifested by increased or decreased urine output, swelling of the legs),
• heart problems (manifested by shortness of breath, swelling),
• excessive sweating,
• purpura,
• increased sensitivity of the skin to sunlight.

Frequency not known(cannot be estimated from the available data)

• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Taking such medicines as Ibuxal Plus may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke (see section 2).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuxal Plus

The medicine should be stored 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 month.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuxal Plus contains

• The active substances of the medicine are ibuprofen and paracetamol.
• The other ingredients are: Tablet core: corn starch, povidone K-30, sodium croscarmellose, microcrystalline cellulose, anhydrous colloidal silica, glycerol dibehenate. Tablet coating: Opadry White AMB II (partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monokaprylokapronian, sodium lauryl sulfate).

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 with a double circle on one side.
The tablets are packaged in blisters.
A blister pack of white PVC/PVDC/Aluminum foil containing the appropriate number of film-coated tablets or
A child-resistant blister pack of white PVC/PVDC/Aluminum foil containing the appropriate number of film-coated tablets.
Pushing the tablet out of a child-resistant blister pack may require extra effort.
A carton contains 1 blister (10 tablets) or 2 blisters (20 tablets) and a patient leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
email: [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
email: [email protected]

This medicine is authorized 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 δισκίο
Hungary
Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500 mg filmtabletta
Poland
Ibuxal Plus
Romania
PADUDEN DUO 200 mg/500 mg comprimate filmate
United Kingdom Ibuprofen/Paracetamol 200 mg/500 mg film-coated tablets
(Northern Ireland)

Date of last revision of the leaflet: 10.03.2025