Apap intense

Package leaflet: Information for the user

APAP intense
200 mg + 500 mg coated tablets
Ibuprofen + Paracetamol
Please read the entire 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 for future reference.
• 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, or if you feel worse, consult your doctor.

Table of contents

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

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

APAP intense contains two active substances (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 relieving pain, reducing swelling, and lowering fever.
Paracetamol is a painkiller which, acting differently than ibuprofen, relieves pain and fever.
This medicine is particularly suitable for achieving a stronger pain-relieving effect than when using ibuprofen or paracetamol alone.
APAP intense is used for the short-term treatment of mild to moderate pain associated with migraine, headache, backache, menstrual pain, toothache, rheumatic pain, muscle pain, mild forms of arthritis, symptoms of cold and flu, sore throat, or fever.
APAP intense is intended for adults aged 18 years and older.
If there is no improvement or if you feel worse after 3 days of treatment, you should contact your 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 painkillers such as ibuprofen, acetylsalicylic acid (aspirin) at high doses (above 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 is allergic to acetylsalicylic acid or other painkillers from the group of NSAIDs,
• if there is currently or has previously been a peptic ulcer or gastrointestinal bleeding (stomach or duodenum),
• in patients with blood clotting disorders (coagulation disorders),
• in patients with heart, liver or kidney failure,
• during the last 3 months of pregnancy.

Warnings and precautions
Before starting to take APAP intense, consult your doctor or pharmacist if:

• the patient is elderly,
• the patient has or has had asthma,
• there is impaired function of the kidneys, heart, liver or intestines,
• systemic lupus erythematosus (SLE) is present - an autoimmune disease affecting connective tissue, causing joint pain, skin changes and organ dysfunction, or other mixed connective tissue diseases,
• gastrointestinal disorders or chronic inflammatory bowel diseases are present (e.g. ulcerative colitis, Crohn's disease),
• the patient is in the first 6 months of pregnancy or during breastfeeding,
• the patient plans to become pregnant,
• the patient has an infection - see below, section titled "Infections".

While using APAP intense, contact your doctor immediately if:

• The patient has severe illnesses, including severe kidney impairment 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). In these situations, severe metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients taking paracetamol at standard doses 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.
Skin reactions
Severe skin reactions associated with the use of APAP intense have been reported.
If any skin rash, mucosal lesions, blisters or other signs of allergy appear, stop taking the medicine immediately and seek urgent medical help, as these may be the first signs of a very serious skin reaction. See section 4.
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Infections
APAP intense may mask symptoms of infection such as fever and pain. Therefore, APAP intense 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 infection and symptoms persist or worsen, consult a doctor immediately.
Before using APAP intense, the patient should discuss treatment with a doctor or pharmacist if:

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

APAP intense and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Do not take APAP intense:

• with other medicines containing paracetamol,
• with other medicines from the NSAID group such as acetylsalicylic acid, ibuprofen.

Exercise particular caution, as some medicines may interact with APAP intense, for example:

• corticosteroids in tablet form,
• antibiotics (e.g. chloramphenicol or quinolones),
• antiemetics (e.g. metoclopramide, domperidone),
• cardiac stimulants (e.g. cardiac glycosides),
• cholesterol-lowering medicines (e.g. cholestyramine),
• diuretics (facilitating excretion of excess water),
• immunosuppressants (e.g. methotrexate, cyclosporine, tacrolimus),
• medicines used in the treatment of mania or depression (e.g. lithium or selective serotonin reuptake inhibitors, SSRIs),
• mifepristone (a medicine used to terminate pregnancy),
• medicines used in the treatment of HIV (e.g. zidovudine).

Inform your doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid abnormalities (called metabolic acidosis), which requires urgent 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:

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

Some other medicines may also be affected by or affect treatment with APAP intense; therefore, always consult a doctor or pharmacist before using APAP intense with other medicines.
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Taking APAP intense with food and drink
To reduce the likelihood of adverse effects, APAP intense should be taken during meals.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or 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 APAP intense 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 tendency to bleed in both the mother and the child and may delay or prolong labour. APAP intense should not be used during the first 6 months of pregnancy unless the doctor considers its use absolutely necessary.
If treatment is necessary 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, APAP intense 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 for longer than a few days is required, the doctor may recommend additional monitoring.
APAP intense may cause difficulties in becoming pregnant.
This product belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible after stopping the medicine. Inform your doctor if a woman plans to become pregnant or has difficulty becoming pregnant.
Driving and operating machinery
APAP intense may cause dizziness, concentration disturbances and drowsiness.
If such symptoms occur, do not drive or operate vehicles or machinery.

3. How to use the medicine APAP intense

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults: the recommended dose is 1 tablet, taken with food and swallowed with water, no more frequently than 3 times a day.
There should be at least a 6-hour interval between doses.
If symptoms do not improve after taking one tablet, up to two tablets may be taken, no more frequently than three times a day.
Do not take more than six tablets within 24 hours (equivalent 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.
This medicine is intended for short-term oral use.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. Do not use APAP intense for longer than 3 days. If symptoms persist or worsen, consult a doctor. If symptoms of infection (such as fever and pain) persist or intensify, seek immediate medical advice (see section 2).
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Taking more than the recommended dose of APAP intense
If more than the recommended dose of APAP intense is taken, or if the medicine is accidentally ingested by a child, always consult a doctor or go to the nearest hospital for information on potential risks and further management.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), headache, tinnitus, confusion, and nystagmus. Following large doses, cases have been reported of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties.
If an excessive dose of this medicine is taken, contact a doctor immediately, even if the patient feels well, due to the risk of delayed, serious liver damage following an overdose of paracetamol.
Missed dose of APAP intense
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as possible, and the next dose should not be taken earlier than 6 hours after the previous one.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
YOU SHOULD DISCONTINUE TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY IF THE FOLLOWING OCCUR:

• heartburn, indigestion,
• symptoms of gastrointestinal bleeding (severe abdominal pain, vomiting blood or material that looks like coffee grounds, blood in stool, black tarry stools),
• symptoms of meningitis such as neck stiffness, 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 unknown). Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).

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

• abdominal pain or discomfort, nausea or vomiting, diarrhoea,
• increased liver enzyme activity (seen in blood tests).

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

• headache and dizziness, flatulence and constipation, rash, facial swelling,
• decreased number of red blood cells or increased number of platelets (blood cells involved in blood clotting).

Very rare (may occur in less than 1 in 10,000 people)

• decreased number of blood cells (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,
• fatigue, general malaise,
• severe skin reactions, including blistering,

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• high blood pressure, fluid retention,
• liver function abnormalities (manifesting as yellowing of the skin and whites of the eyes),
• kidney function abnormalities (manifesting as increased or decreased urination, swelling of the legs),
• heart failure (manifesting as shortness of breath, swelling).

Frequency not known (cannot be estimated from available data)

• Red, scaly rash with subcutaneous nodules and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever early in therapy (acute generalized exanthematous pustulosis). If such symptoms occur, the medicine should be discontinued immediately and medical help sought without delay. See also section 2.
• Skin becomes sensitive to light.
• Serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Use of medicines such as APAP intense may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke (see section 2).
Reporting of adverse reactions
If any adverse reactions occur, inform your doctor or pharmacist.
This includes any side effects not listed in this leaflet. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store APAP intense

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister after the symbol "EXP". The expiry date refers to the last day of the specified month.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

6. Contents of the pack and other information

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

What APAP intense looks like and contents of the pack
APAP intense 200 mg + 500 mg, coated tablets are white to almost white, oval-shaped coated tablets measuring 19.7 mm x 9.2 mm.
Blister packs made of PVC/PVDC/Aluminium in cardboard cartons containing 4, 6, 8, 10, 12, 16, 20, 24 or 32 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław, Poland

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland – APAP intense

For further information about this medicinal product, please contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35, 02-822 Warsaw, Poland
Tel.: +48 (22) 543 60 00

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