Inflanor Plus

Leaflet attached to the packaging: Information for the user

Inflanor Plus, 500 mg + 200 mg coated tablets

paracetamol + ibuprofen

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 this patient leaflet or as directed 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 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 after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Inflanor Plus contains two active substances. These are ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
The action of NSAIDs is to reduce pain, swelling, and fever.
Paracetamol is a pain reliever that, acting differently than ibuprofen, reduces pain and fever.
Inflanor Plus is used for 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.
To reduce rheumatic pain and pain in mild forms of arthritis, Inflanor Plus should only be used on the advice or recommendation of a doctor. This medicine is particularly
suitable in cases of pain that has not been reduced by ibuprofen or paracetamol alone.
Inflanor Plus is intended for adult patients.

2. Important information before taking Inflanor Plus

When not to take Inflanor Plus

• 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 taking any other medicines containing paracetamol;
• if the patient is taking any other pain relievers such as ibuprofen, acetylsalicylic acid (aspirin) in high doses (above 75 mg per day) or other NSAIDs, including cyclooxygenase-2 (COX-2) inhibitors;
• if the patient has ever had an allergic reaction, such as bronchospasm (tightening of the lung muscles, which can cause shortness of breath), asthma, rhinitis, itching, and nasal congestion,

hives (itching rash) or angioedema (swelling under the skin) while taking acetylsalicylic acid or other NSAIDs;

• if the patient currently or in the past has had recurrent ulcers or bleeding in the stomach or duodenum (part of the small intestine), (at least two separate episodes of confirmed bleeding or ulcers);
• if the patient currently or in the past has had ulcers, perforation, or bleeding in the stomach or duodenum caused by NSAID treatment;
• in patients with blood coagulation disorders;
• in patients with severe heart, liver, or kidney failure;
• in the last 3 months of pregnancy.

Warnings and precautions

Before taking Inflanor Plus, the patient should discuss it with their doctor or pharmacist if:
the patient has an infection — see below, "Infections";
the patient is elderly;
the patient has or has had asthma;
there is kidney, heart, liver, or bowel dysfunction;
the patient has systemic lupus erythematosus (SLE) — an autoimmune disease affecting connective tissue, causing joint pain, skin changes, and dysfunction of other organs or mixed connective tissue disease;
the patient has gastrointestinal or chronic inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease);
the patient is pregnant or breastfeeding;
the patient is planning to become pregnant.

Infections

Inflanor Plus may mask the symptoms of infection, such as fever and pain. Therefore, Inflanor Plus may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

Skin reactions

Severe skin reactions have been reported with the use of Inflanor Plus. If the patient experiences any skin rash, mucosal lesions, blisters, or other signs of allergy, they should stop taking Inflanor Plus and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
Pain relievers and/or anti-inflammatory drugs, such as ibuprofen, may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before taking Inflanor Plus, the patient should discuss the treatment with their doctor or pharmacist if they have:
heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or any stroke (including mini-stroke or transient ischemic attack, TIA);
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if they smoke.

Children and adolescents

This medicine is not intended for use in children and adolescents under 18 years of age.

Inflanor Plus 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.
Inflanor Plus should not be taken:
with other medicines containing paracetamol,
with other NSAIDs such as acetylsalicylic acid (in doses above 75 mg per day), ibuprofen, or other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors.
Inflanor Plus may affect the action of other medicines. For example:
corticosteroids,
antibiotics (e.g., chloramphenicol or quinolones),
antiemetics (e.g., metoclopramide, domperidone),
anticoagulants (used to thin blood and prevent clotting, such as acetylsalicylic acid, warfarin, ticlopidine),
heart stimulants (e.g., glycosides),
cholesterol-lowering medicines (e.g., cholestyramine),
diuretics (which facilitate water excretion),
high blood pressure medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, e.g., losartan),
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 used for medical termination of pregnancy),
medicines used to treat HIV (e.g., zidovudine),
flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires emergency treatment and may occur especially in patients with severe kidney dysfunction, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Inflanor Plus should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney or heart problems in the unborn baby. It may increase the risk of bleeding in the patient and the baby and cause delayed or prolonged labor. During the first 6 months of pregnancy, Inflanor Plus should not be taken unless the doctor considers it 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 the 20th week of pregnancy, Inflanor Plus may cause kidney dysfunction in the unborn baby if taken for more than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Only small amounts of paracetamol and ibuprofen and their metabolites pass into breast milk. This medicine can be taken during breastfeeding if used in the recommended dose and for the shortest possible time.
Inflanor Plus may make it harder to become pregnant. Ibuprofen belongs to a group of medicines that can affect female fertility. This effect is temporary and reverses after stopping the medicine. The patient should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

After taking an NSAID, possible side effects such as dizziness, drowsiness, fatigue, and vision disturbances may occur. The patient should not drive or operate machinery if they experience any of these side effects.

Inflanor Plus contains sodium

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

3. How to take Inflanor Plus

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
This medicine is for oral use and short-term use only.
The patient should take the smallest effective dose for the shortest time necessary to relieve symptoms.
If the symptoms (such as fever and pain) persist or worsen during an infection, the patient should consult their doctor immediately (see section 2).

Adults

Recommended doseis 1 tablet 1 to 3 times a day. The patient should maintain an interval of at least 6 hours between doses.
If symptoms do not improve after taking one tablet, the patient can take a maximum of 2 tablets, not more than three times a day. Due to the presence of paracetamol, a single dose of 2 tablets is intended only for patients with a body weight of 60 kg or more.
The patient should not take more than 6 tablets in 24 hours (which corresponds to 1200 mg of ibuprofen and 3000 mg of paracetamol per day).
Method of administration
The tablets should be taken with a glass of water.
To reduce the likelihood of side effects, Inflanor Plus should be taken with food.
The patient should not take Inflanor Plus for more than 3 days. If symptoms worsen or persist, the patient should consult their doctor.
If the patient has liver or kidney disease, or is elderly, the doctor will determine the appropriate dose, which will be the lowest possible. The patient should not take this medicine if they have severe kidney or liver failure.

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Inflanor Plus than recommended

If the patient has taken a higher dose of Inflanor Plus than recommended, or if the medicine has been accidentally taken by a child, they should always contact their doctor or the nearest hospital for information on possible health risks and advice on what to do.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and nystagmus. After taking large doses, the following have been observed: drowsiness, chest pain, palpitations (rapid heartbeat), loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing problems.
In case of an overdose of this medicine, the patient should contact their doctor, even if they feel well. This is because too much paracetamol can cause delayed, severe liver damage.

Missing a dose of Inflanor Plus

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.
If the patient has further questions on the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Inflanor Plus can cause side effects, although not everybody gets them.

STOP TAKING AND CONTACT A DOCTOR IF THE FOLLOWING SYMPTOMS OCCUR:

heartburn, indigestion (uncommon side effects; may affect up to 1 in 100 people);
symptoms of gastrointestinal bleeding (severe abdominal pain, vomiting blood or coffee grounds, blood in the stool, black tarry stools), (uncommon side effect; may affect up to 1 in 100 people);
symptoms of meningitis such as stiff neck, headache, nausea, or vomiting, fever, or feeling disoriented (very rare side effect; may affect up to 1 in 10,000 people);
symptoms of a severe allergic reaction (face, tongue, or throat swelling, difficulty breathing, worsening of asthma), (very rare side effect; may affect up to 1 in 10,000 people);
severe skin reactions, such as blisters — also see below.
A severe skin reaction known as DRESS syndrome (frequency not known). DRESS symptoms include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell).
A red, scaly, widespread rash with thickening of the skin and blisters, usually in skin folds on the torso and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency not known). If such symptoms occur, the patient should stop taking Inflanor Plus and seek medical attention immediately. See also section 2.

Other possible side effects

Common:may affect up to 1 in 10 people
abdominal pain or discomfort, nausea, or vomiting, diarrhea,
increased liver enzyme activity (ALT, GGT), increased creatinine and urea levels (in blood tests),
excessive sweating.
Uncommon:may affect up to 1 in 100 people
headache and dizziness,
gas and constipation,
mouth ulcers, worsening of ulcerative colitis or Crohn's disease, gastritis or pancreatitis,
skin rashes, facial swelling, itching,
increased activity of certain liver enzymes (AST, ALP) and creatine phosphokinase,
decreased hemoglobin level (a protein in red blood cells) or increased platelet count (blood clotting cells) (in blood tests).
Rare:may affect up to 1 in 10,000 people
reduced blood cell count (manifested as 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,
fatigue, general malaise,
severe skin reactions, such as blisters,
skin becomes sensitive to light,
red or purple spots on the skin that do not fade under pressure and are caused by bleeding under the skin (petechiae),
high blood pressure, fluid retention,
liver dysfunction (manifested as yellowing of the skin and whites of the eyes),
kidney dysfunction (manifested as increased or decreased urine output, swelling of the legs),
heart failure (manifested as shortness of breath, swelling),
tingling, numbness, or itching (tingling and pins and needles),
optic neuritis,
drowsiness.
The use of medicines like Inflanor Plus 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, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 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, more information can be gathered on the safety of this medicine.

5. How to store Inflanor Plus

This medicine should be stored 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 that month.
There are no special storage instructions for this medicine.
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. This will help protect the environment.

6. Contents of the packaging and other information

What Inflanor Plus contains

• The active substances of Inflanor Plus are paracetamol and ibuprofen. One coated tablet contains 500 mg of paracetamol and 200 mg of ibuprofen.
• The other ingredients are: sodium carmellose; hydroxypropylcellulose; microcrystalline cellulose; silicon dioxide; stearic acid; magnesium stearate.

Coating: methacrylic acid - ethyl acrylate copolymer (1:1); talc; titanium dioxide (E 171); glycerol monocaprylocaprate; polyvinyl alcohol; titanium dioxide (E 171); black iron oxide (E172).

What Inflanor Plus looks like and contents of the pack

Gray coated tablet with a sheen, oval, with "200 M 500" embossed on one side. The size of the coated tablet is: length: 18.9-19.4 mm, width: 8.9-9.3 mm, thickness: 6.3-7.3 mm.
Inflanor Plus is packaged in white blisters of PVC/PVDC/Aluminum in a cardboard box.
Pack sizes: 10, 20 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland

To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: +48 22 375 92 00

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

Czech Republic, Slovakia:
Paracetamol/Ibuprofen Zentiva
Poland, Romania:
Inflanor Plus
Date of last revision of the leaflet:December 2024