APAP 200 mg/500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: Information for the user
2. APAP intense
3. 200 mg + 500 mg coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is APAP intense and what is it used for
5. Important information before using APAP intense
   1. When not to use APAP intense
   2. Warnings and precautions
   3. APAP intense and other medicines
   4. APAP intense should not be used with:
   5. Also, some other medicines may be affected by or have an effect on the treatment with APAP intense, so before using APAP intense with other medicines, the patient should always consult their doctor or pharmacist.
   6. Using APAP intense with food and drink
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
6. How to use APAP intense
   1. Use in children and adolescents
   2. Do not use in children and adolescents under 18 years of age.
   3. Taking a higher dose of APAP intense than recommended
   4. In case of taking too much of this medicine, the patient should contact their doctor, even if they feel well, due to the risk of delayed serious liver damage after taking an excessive dose of paracetamol.
   5. Missing a dose of APAP intense
7. Possible side effects
   1. THE PATIENT SHOULD STOP USING THE MEDICINE AND CONTACT THEIR DOCTOR IF THE FOLLOWING OCCUR:
   2. Other possible side effects
   3. Reporting side effects
8. How to store APAP intense
9. Contents of the packaging and other information
   1. What APAP intense contains
   2. What APAP intense looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: April 2025

Leaflet attached to the packaging: Information for the user

APAP intense

200 mg + 500 mg coated tablets

Ibuprofen + Paracetamol

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

• This medicine should always be used exactly as described in this patient leaflet or as directed by a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days of using the medicine, they should contact their doctor.

Table of contents of the leaflet

• 1. What is APAP intense and what is it used for
• 2. Important information before using APAP intense
• 3. How to use APAP intense
• 4. Possible side effects
• 5. How to store APAP intense
• 6. Contents of the packaging and other information

1. What is APAP intense and what is it used for

APAP intense contains two active substances (responsible for the medicine's effect), which are ibuprofen and paracetamol.
Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs).
The action of NSAIDs is to relieve pain, reduce swelling, and lower high body temperature.
Paracetamol is a pain reliever that, acting differently than ibuprofen, relieves pain and fever.
This medicine is particularly suitable for obtaining a stronger pain-relieving effect than when using ibuprofen or paracetamol alone.
APAP intense is used for the short-term treatment of mild or moderate pain associated with migraine, headache, back pain, menstrual pain, toothache, rheumatic pain, muscle pain, pain associated with mild forms of arthritis, treatment of cold and flu symptoms, sore throat, or fever.
APAP intense is intended for adults aged 18 and over.
If there is no improvement or the patient feels worse after 3 days of using the medicine, they should contact their doctor.
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2. Important information before using APAP intense

When not to use APAP intense

• if the patient is taking any medicines containing paracetamol,
• if the patient is taking any other pain relievers such as ibuprofen, acetylsalicylic acid (aspirin)in high doses (over 75 mg per day) or other NSAIDsincluding cyclooxygenase-2 (COX-2) inhibitors,
• if the patient is allergic to ibuprofen, paracetamolor any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to acetylsalicylic acid or other NSAIDs,
• if the patient currently has or has had ulcers or bleeding in the stomach or duodenum (small intestine),
• in patients with blood clotting disorders (coagulation),
• in patients with heart, liver, or kidney failure,
• in the last 3 months of pregnancy.

Warnings and precautions

Before starting to use APAP intense, the patient should discuss it with their doctor or pharmacist if:

• -the patient is elderly,
• -the patient has or has had asthma,
• -there is kidney, heart, liver, or gut disorder,
• -there is 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,
• -there are gastrointestinal disorders or chronic inflammatory bowel diseases(e.g., ulcerative colitis, Crohn's disease),
• -the patient is pregnant or breastfeedingor plans to become pregnant,
• -the patient plans to become pregnant,
• -the patient has an infection– see below, the section titled "Infections".

If the patient experiences any of the following while using APAP intense, they should immediately inform their doctor:

• If the patient has severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or if they are taking flucloxacillin (an antibiotic) along with paracetamol. In these situations, patients have reported a serious condition called metabolic acidosis (a blood and body fluid disorder), which requires emergency treatment. Symptoms of metabolic acidosis may include: severe breathing difficulties, rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Using pain relievers and anti-inflammatory drugs like ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose of the medicine or the duration of treatment.
Skin reactions
Severe skin reactions have been reported with the use of APAP intense.
If the following occur: any skin rash, mucosal lesions, blisters, or other signs of an allergic reaction, the patient should stop using the medicine and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
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Infections
APAP intense may mask the symptoms of an infection, such as fever and pain. As a result, APAP intense may delay the use of appropriate infection treatment, potentially leading to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine while an infection is present, and the infection symptoms persist or worsen, they should immediately consult their doctor.
Before using APAP intense, the patient should discuss treatment with their doctor or pharmacist if:

• -the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or suffers from peripheral artery disease (poor blood circulation in the legs due to narrowed or blocked arteries) or if they have had any stroke (including mini-stroke or transient ischemic attack, TIA);
• -the patient has high blood pressure, diabetes, high cholesterol levels, or if there is a history of heart disease or stroke in their family, or if the patient smokes.

APAP intense and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

APAP intense should not be used with:

• -other medicines containing paracetamol,
• -other NSAIDssuch as acetylsalicylic acid, ibuprofen.

Special caution is advised, as some medicines may interact with APAP intense, such as:

• -corticosteroidsin tablets,
• -antibiotics(e.g., chloramphenicol or quinolones),
• -anti-emetic medicines(e.g., metoclopramide, domperidone),
• -heart stimulants(e.g., glycosides),
• -cholesterol-lowering medicines(e.g., cholestyramine),
• -diuretics(which facilitate the removal of excess water),
• -immunosuppressants(e.g., methotrexate, cyclosporine, tacrolimus),
• -medicines used to treat mania or depression(e.g., lithium or selective serotonin reuptake inhibitors, SSRIs),
• -mifepristone(a medicine that causes abortion),
• -medicines used to treat HIV(e.g., zidovudine).

The patient should inform their doctor or pharmacist if they are taking:

• -flucloxacillin (an antibiotic) due to the serious risk of developing a blood and body fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

APAP intense may affect the action of other medicines or other medicines may affect the action of APAP intense. For example:

• -blood-thinning medicines(i.e., anticoagulants, such as acetylsalicylic acid, warfarin, ticlopidine);
• -blood pressure-lowering medicines(e.g., ACE inhibitors, such as captopril, beta blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Also, some other medicines may be affected by or have an effect on the treatment with APAP intense, so before using APAP intense with other medicines, the patient should always consult their doctor or pharmacist.

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Using APAP intense with food and drink

In order to reduce the likelihood of side effects, APAP intense should be taken during meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. APAP intense should not be used if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery.
APAP intense may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, APAP intense should not be used unless the doctor considers it absolutely necessary.
If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, APAP intense may cause kidney disorders in the unborn child if used for more than a few days. This may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
APAP intense may cause difficulty in becoming pregnant.
The product belongs to a group of medicines that may have a negative effect on female fertility. This effect is temporary after stopping the use of the medicine. The patient should inform their doctor if they plan to become pregnant or are having difficulty becoming pregnant.

Driving and using machines

APAP intense may cause dizziness, impaired concentration, and drowsiness.
If such symptoms occur, the patient should not drive vehicles or operate machinery.

3. How to use APAP intense

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Adults: the recommended doseis 1 tablet, taken with food and swallowed with water, not more than 3 times a day.
The patient should maintain an interval of at least 6 hoursbetween doses.
If symptoms do not improve after taking one tablet, the patient can take a maximum of two tablets, not more than three times a day.
Do not take more than six tablets in 24 hours(which corresponds to 1200 mg of ibuprofen and 3000 mg of paracetamol per day).

Use in children and adolescents

Do not use in children and adolescents under 18 years of age.

The medicine is intended for short-term oral use.
The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. APAP intense should not be used for more than 3 days.If symptoms persist or worsen, the patient should consult their doctor. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2).
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Taking a higher dose of APAP intense than recommended

In case of taking a higher dose of APAP intense than recommended, or if a child accidentally ingests the medicine, the patient should always consult their doctor or go to the nearest hospital to get information about the risk and guidance on what to do next.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. In connection with taking large doses of the medicine, reports have been made of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, presence of blood in the urine, feeling cold, and breathing difficulties.

In case of taking too much of this medicine, the patient should contact their doctor, even if they feel well, due to the risk of delayed serious liver damage after taking an excessive dose of paracetamol.

Missing a dose of APAP intense

The patient should not take a double dose to make up for a missed dose. If a dose is missed, the patient should take it as soon as possible, and the next dose should not be taken earlier than 6 hours later.

4. Possible side effects

Like all medicines, APAP intense can cause side effects, although not everybody gets them.

THE PATIENT SHOULD STOP USING THE MEDICINE AND CONTACT THEIR DOCTOR IF THE FOLLOWING OCCUR:

• -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, nausea or vomiting, fever, or feeling disoriented,
• -symptoms of a severe allergic reaction(swelling of the face, tongue, or throat, difficulty breathing, worsening of asthma),
• -severe skin reactions, known as DRESS syndrome (frequency not known). Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).

Other possible side effects

Common(may affect up to 1 in 10 people)

• -stomach pain or discomfort, nausea or vomiting, diarrhea,
• -increased liver enzyme activity (in blood tests).

Uncommon(may affect up to 1 in 100 people)

• -headache and dizziness, gas and constipation, rash, facial swelling,
• -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 as sore throat, mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruising, and nosebleeds),
• -vision disturbances, ringing in the ears, feeling of spinning,
• -disorientation, depression, hallucinations,
• -fatigue, general malaise,
• -severe skin reactions, including blistering,

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• -high blood pressure, water retention,
• -liver function disorders (manifested as yellowing of the skin and whites of the eyes),
• -kidney function disorders (manifested as increased or decreased urine output, swelling of the legs),
• -heart failure (manifested as shortness of breath, swelling).

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

• -A red, scaly rash with subcutaneous nodules and blisters, mainly in skin folds, on the torso and upper limbs, accompanied by fever in the early stages of therapy (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop using the medicine and seek medical attention immediately. See also section 2.
• -The skin becomes sensitive to light.
• -A serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Using medicines like APAP intense may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke (see section 2).

Reporting side effects

If the patient experiences any side effects, they should tell their doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 181C, 02-222 Warsaw
Phone: +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, more information can be collected on the safety of the medicine.

5. How to store APAP intense

This medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date, which is stated on the carton and blister pack after the symbol "EXP". The expiry date refers to the last day of the month.
There are no special storage precautions for the medicine.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. These measures help protect the environment.

6. Contents of the packaging and other information

What APAP intense contains

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• The active substances of the medicine are ibuprofen and paracetamol. One coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol.
• The other ingredients are: Tablet core: cornstarch, crospovidone (Type A), colloidal anhydrous silica, povidone K-30, starch, maize starch, talc, stearic acid. Coating: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171).

What APAP intense looks like and what the pack contains

APAP intense, 200 mg + 500 mg, coated tablets appear as white to almost white, oval, coated tablets with dimensions of 19.7 mm x 9.2 mm.
Blisters of PVC/PVDC/Aluminum in a cardboard box, containing 4, 6, 8, 10, 12, 16, 20, 24, or 32 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
Larissa Industrial Area, P.O. Box 3012
Larissa, 41 500
Greece

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

Poland – APAP intense
To obtain more detailed information on this medicine, the patient should contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa
phone: +48 (22) 543 60 00

Date of last revision of the leaflet: April 2025

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