Laboratory polfa łódź ibuprofen max: detailed information

Package leaflet: Information for the user

Laboratoria PolfaLodz Ibuprofen MAX, 400 mg, film-coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because 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 consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
If symptoms do not improve after 3 days or if you feel worse, consult a doctor.

Contents of the leaflet

What Laboratoria PolfaLodz Ibuprofen MAX is and what it is used for
Important information before taking Laboratoria PolfaLodz Ibuprofen MAX
How to take Laboratoria PolfaLodz Ibuprofen MAX
Possible side effects
How to store Laboratoria PolfaLodz Ibuprofen MAX
Contents of the pack and other information

1. What Laboratoria PolfaLodz Ibuprofen MAX is and what it is used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have therapeutic effects including anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) properties.
Laboratoria PolfaLodz Ibuprofen MAX is indicated for the following conditions:
mild to moderate pain of various origins (e.g. headache, including tension headache and migraine, toothache, neuralgia, muscular, joint and bone pain, pain associated with influenza and common cold),
fever of various causes (e.g. during influenza, common cold or other infectious diseases),
painful menstruation.

2. Important information before using Laboratoria PolfaŁódź Ibuprofen MAX

When not to use Laboratoria PolfaŁódź Ibuprofen MAX
if the patient is allergic to ibuprofen or any of the other ingredients of this medicine
(listed in section 6),
if the patient is allergic to medicines from the NSAID group, including acetylsalicylic acid, or to other
substances; history of aspirin-induced asthma, angioedema
(skin and mucous membrane disorders characterised by swelling), bronchospasm, rhinitis (nasal congestion) or urticaria associated with the use of acetylsalicylic acid or other
NSAIDs,
if the patient has severe renal and/or hepatic insufficiency,
in case of active or past history of gastric or duodenal ulcer,
perforation or bleeding, including bleeding after use of NSAIDs,
in severe heart failure (NYHA class IV),
if the patient has severe hypertension,
if the patient has cerebral haemorrhage or any other active bleeding,
if the patient has unexplained blood disorders,
if the patient has severe dehydration (caused by vomiting, diarrhoea or
inadequate fluid intake),
in case of haemorrhagic diathesis (tendency to bleed, e.g. in the skin, mucous membranes, nose, gastrointestinal tract) and concomitant use of anticoagulants,
when taking other NSAIDs, including COX-2 inhibitors,
during the last three months of pregnancy,
in children and adolescents weighing less than 40 kg (under 12 years of age).

Warnings and precautions
Before starting use of Laboratoria PolfaŁódź Ibuprofen MAX, discuss this with your
doctor or pharmacist.
Exercise particular caution:
in patients with impaired liver and/or kidney or cardiovascular function; in patients with kidney dysfunction, effective doses should be as low as possible, with simultaneous monitoring of kidney function,
in patients with bronchial asthma or allergies – taking the medicine may cause bronchospasm,
in patients who have experienced hay fever, nasal polyps and chronic obstructive respiratory diseases due to increased risk of allergic reactions; allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma),
in patients with systemic lupus erythematosus or mixed connective tissue disease,

increased risk of aseptic meningitis, during chickenpox – use of Laboratoria PolfaŁódź Ibuprofen MAX is not recommended, in patients with inherited blood disorders (acute intermittent porphyria), in patients with gastrointestinal disease history (ulcerative colitis, Crohn's disease) – symptoms may worsen, in patients with cardiac arrhythmias, hypertension, myocardial infarction or heart failure in history – fluid retention may occur due to worsening kidney function, in patients concurrently taking anticoagulants or with blood clotting disorders
ibuprofen may prolong bleeding time, in patients with impaired red blood cell formation, in diabetic patients, immediately after major surgery.

Children and adolescents
In dehydrated children and adolescents, there is a risk of kidney dysfunction.
In patients over 65 years of age, the risk of adverse effects is higher than in younger patients.
With prolonged use of the medicine, especially in patients with a history of gastrointestinal disorders, particularly in those over 65 years of age, there is a risk of gastrointestinal bleeding, ulceration or perforation. If any unusual gastrointestinal symptoms occur, especially at the beginning of treatment, the medicine should be discontinued immediately and a doctor should be consulted.
Exercise caution when using Laboratoria PolfaŁódź Ibuprofen MAX in patients concurrently taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants like warfarin (acenocoumarol) or antiplatelet agents like acetylsalicylic acid.
Concurrent, prolonged use of various analgesics may lead to kidney damage with risk of renal failure.
During prolonged treatment with Laboratoria PolfaŁódź Ibuprofen MAX, regular monitoring of liver function, kidney function and blood morphology is required.

Skin reactions
Severe skin reactions associated with the use of Laboratoria PolfaŁódź Ibuprofen MAX have been reported. If any skin rash, mucosal changes, blisters or other allergic symptoms appear, discontinue use of Laboratoria PolfaŁódź Ibuprofen MAX immediately and seek medical help without delay, as these may be the first signs of a very serious skin reaction. See section 4.
Severe and acute hypersensitivity reactions (e.g. anaphylactic shock) are very rare. If the first symptoms of severe hypersensitivity occur after administration of Laboratoria PolfaŁódź Ibuprofen MAX, treatment should be discontinued and a doctor should be consulted immediately.

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs, NSAIDs) which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of therapy.
Taking anti-inflammatory/analgesic 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 using Laboratoria PolfaŁódź Ibuprofen MAX, the patient should discuss treatment with a doctor or pharmacist if:

the patient has heart diseases such as heart failure, angina pectoris (chest pain), previous heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA),
the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker,
the patient has an infection – see below, section titled "Infections".

Infections
Laboratoria PolfaŁódź Ibuprofen MAX may mask symptoms of infection such as fever and pain.
Therefore, Laboratoria PolfaŁódź Ibuprofen MAX may delay appropriate treatment of infection, thereby increasing 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 ongoing infection and symptoms persist or worsen, medical advice should be sought immediately.
With prolonged use of analgesics, headache may occur, which should not be treated by increasing the dose of the medicine. Discontinue use and consult a doctor if headaches occur frequently despite taking Laboratoria PolfaŁódź Ibuprofen MAX.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
Laboratoria PolfaŁódź Ibuprofen MAX, as an over-the-counter product, is recommended for short-term use only, although use on a doctor's recommendation is not excluded.
If new symptoms occur or the above-mentioned symptoms worsen, contact a doctor or pharmacist.

Laboratoria PolfaŁódź Ibuprofen MAX and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Laboratoria PolfaŁódź Ibuprofen MAX may affect the action of other medicines or other medicines may affect the action of Laboratoria PolfaŁódź Ibuprofen MAX.
Laboratoria PolfaŁódź Ibuprofen MAX should be used cautiously in combination with:

acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors, or glucocorticosteroids; concomitant use of these medicines with ibuprofen may increase the risk of gastrointestinal adverse effects,
antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan) and diuretics: ibuprofen (like other NSAIDs) may reduce the effectiveness of these medicines,
potassium-sparing diuretics: risk of increased blood potassium levels,
anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine): limited clinical data suggest NSAIDs may enhance the effect of medicines reducing blood coagulation,
lithium: evidence suggests potential increase in serum lithium levels during concomitant use of ibuprofen (similarly to other NSAIDs),
methotrexate: risk of increased methotrexate plasma concentration during concomitant use of ibuprofen (similarly to other NSAIDs),
phenytoin: risk of increased phenytoin plasma concentration during concomitant use of ibuprofen (similarly to other NSAIDs),
cardiac glycosides (e.g. digoxin): due to possible potentiation of digoxin effects,
serotonin reuptake inhibitors (SSRIs): due to increased risk of gastrointestinal bleeding,
aminoglycosides: ibuprofen may slow down elimination of aminoglycosides from the body, enhancing their toxic effects,
tacrolimus, cyclosporine: risk of kidney damage,
cholestyramine: cholestyramine administered simultaneously with ibuprofen reduces its absorption – a minimum interval of 2 hours should be observed,
probenecid or sulfinpyrazone: due to possible delayed elimination of ibuprofen,
quinolone antibiotics: due to increased risk of seizures,
sulfonylurea derivatives: due to possible interaction,
zidovudine: evidence suggests increased risk of joint haemorrhage and haematoma in haemophilic, HIV-positive patients taking zidovudine and ibuprofen concurrently,
with mifepristone – NSAIDs should not be used within 8–12 days after mifepristone administration, as they may reduce the effectiveness of mifepristone.

Some other medicines may also influence or be influenced by treatment with Laboratoria PolfaŁódź Ibuprofen MAX. Therefore, always consult a doctor or pharmacist before using Laboratoria PolfaŁódź Ibuprofen MAX with other medicines.

Laboratoria PolfaŁódź Ibuprofen MAX with food, drink and alcohol
Tablets should be swallowed whole with water.
In patients with gastrointestinal complaints, it is recommended to take Laboratoria PolfaŁódź Ibuprofen MAX during meals.
Alcohol consumption should be avoided, as it may intensify adverse effects of Laboratoria PolfaŁódź Ibuprofen MAX, particularly on the gastrointestinal tract and central nervous system.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Laboratoria PolfaŁódź Ibuprofen MAX must not be taken during the last three months of pregnancy, as it may harm the unborn child or adversely affect delivery.
Use of ibuprofen during the last three months of pregnancy may lead to kidney and heart problems in the unborn child. It may also cause bleeding tendency in both mother and child and lead to delayed or prolonged labour.
This medicine should not be used during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment with ibuprofen is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. Use of Laboratoria PolfaŁódź Ibuprofen MAX after 20 weeks of pregnancy for longer than a few days may cause kidney problems in the unborn child and subsequently lead to low levels of amniotic fluid (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.
This medicine passes into breast milk, but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.
This medicine belongs to a group of medicines (NSAIDs) which may impair fertility in women. Use of this medicine is not recommended in women trying to conceive. This effect is reversible and resolves after discontinuation of therapy.

Driving and operating machinery
Generally, ibuprofen has no effect or only negligible effect on the ability to drive and operate machinery. However, due to the possibility of adverse effects such as fatigue, drowsiness, dizziness (reported as common) and visual disturbances (reported as uncommon) during use of high doses, ability to drive and operate machinery may be impaired in individual cases. This effect may be intensified by concomitant alcohol consumption.

Laboratoria PolfaŁódź Ibuprofen MAX contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Laboratoria PolfaŁódź Ibuprofen MAX contains carmine red (E 124) and azorubine (E 122) – the medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 dose, meaning the medicine is considered "sodium-free".

3. How to use Laboratoria PolfaŁódź IBUPROFEN MAX

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults and adolescents (aged 12 years and older) with body weight of 40 kg or more:
The initial dose of ibuprofen is 400 mg (1 tablet). If necessary, an additional dose of 400 mg ibuprofen (1 tablet) may be taken. The interval between doses should be determined according to symptom severity, while respecting the maximum recommended daily dose. The interval should not be less than 6 hours. Do not exceed a total daily dose of 1200 mg ibuprofen (3 tablets) within 24 hours.

Dosage for migraine headache: 400 mg (1 tablet) as a single dose, and if necessary, 400 mg (1 tablet) every 4 to 6 hours. The maximum daily dose of ibuprofen should not exceed 1200 mg (3 tablets). The use of this medicine should be limited to a maximum of two or three days per week.

Method of administration
Oral administration.
Tablets should be swallowed whole with water.
In patients with gastrointestinal disorders, it is recommended to take Laboratoria PolfaŁódź IBUPROFEN MAX during meals.

Do not use this medicine in patients weighing less than 40 kg.
Do not use this medicine in patients under 12 years of age.

Patients aged 65 years and older
Elderly patients should always consult a doctor before starting treatment with Laboratoria PolfaŁódź IBUPROFEN MAX due to an increased risk of adverse effects. The doctor will advise on appropriate use of the medicine.

Liver and kidney function disorders
If the patient suffers from impaired kidney or liver function, always consult a doctor before using Laboratoria PolfaŁódź IBUPROFEN MAX. The doctor will advise on appropriate use of the medicine.

If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Use of a higher than recommended dose of Laboratoria PolfaŁódź IBUPROFEN MAX
If you take more than the recommended dose, contact a doctor or pharmacist immediately.
If you have taken more than the recommended dose of Laboratoria PolfaŁódź IBUPROFEN MAX, or if a child has accidentally ingested the medicine, seek medical advice immediately from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on appropriate actions.

Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur.
Tinnitus, headache, diarrhea, and gastrointestinal bleeding may also occur.
In more severe cases of overdose, transient agitation, disorientation, coma, renal failure, and liver damage may occur.
In patients with asthma, the condition may worsen.

Missed dose of Laboratoria PolfaŁódź IBUPROFEN MAX
Do not take a double dose to make up for a missed dose.

Stopping Laboratoria PolfaŁódź IBUPROFEN MAX
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Treatment with NSAIDs has been associated with reports of oedema, hypertension and heart failure.

Taking medicines containing ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and prolonged use of the medicine.

Adverse effects occurring not very frequently (in less than 1 in 100 people):

rash,
dyspepsia, abdominal pain, nausea,
headache,
visual disturbances,
urticaria and itching.

Adverse effects occurring rarely (less frequently than in 1 in 1000 people):

diarrhoea, flatulence, constipation, vomiting, gastritis,
depression, disorientation, hallucinations, insomnia,
dizziness, restlessness, irritability and fatigue,
toxic amblyopia,
tinnitus,
decreased haemoglobin and haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium concentration, increased serum uric acid concentration.

Adverse effects occurring very rarely (less frequently than in 1 in 10,000 people):

blood count abnormalities (anaemia, leukopenia – reduced number of white blood cells, thrombocytopenia – reduced number of platelets, pancytopenia – deficiency of all normal blood cells: red cells, white cells and platelets, agranulocytosis – absence of a type of white blood cells called granulocytes),
liver function disorders, particularly during long-term use,
erythema multiforme, Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction), toxic epidermal necrolysis,
melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Peptic ulcer of the stomach and/or duodenum, gastrointestinal bleeding and perforation, particularly in patients over 65 years of age,
aseptic meningitis,
oedema, dysuria (discomfort during urination), decreased urine output, renal failure, renal papillary necrosis, increased serum urea concentration, increased plasma sodium concentration (sodium retention),
severe hypersensitivity reactions such as facial, tongue and laryngeal swelling, dyspnoea, tachycardia (rapid heartbeat), hypotension (sudden drop in blood pressure), shock; exacerbation of asthma and bronchospasm,
in patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms associated with aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, disorientation have been observed during ibuprofen treatment,
oedema, hypertension, heart failure associated with the use of NSAIDs at high doses,
hypertension.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy and increased eosinophil count (a type of white blood cells).
red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, discontinue use of Laboratoria PolfaLodz Ibuprofen MAX immediately and seek medical help without delay. See also section 2.
skin becomes sensitive to light.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Laboratoria PolfaLodz IBUPROFEN MAX

Do not store above 25°C.
Store in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the blister and carton.
The expiry date (EXP) refers to the last day of the stated month.
Do not use this medicine if the blister is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Laboratoria PolfaŁódź Ibuprofen MAX contains

The active substance is ibuprofen (Ibuprofenum). Each coated tablet contains: 400 mg of ibuprofen.
Other components (excipients) are:
Tablet core: microcrystalline cellulose, lactose monohydrate, maize starch, sodium croscarmellose, povidone K30, talc, dimethicone, colloidal anhydrous silica.
Tablet coating Opadry 03F240028 Pink: talc, hypromellose, macrogol 6000, carmine red (E 124), titanium dioxide (E 171), azorubine (E 122).

What Laboratoria PolfaŁódź Ibuprofen MAX looks like and contents of the pack
Coated tablet
Shiny purple, biconvex, round coated tablets, with the imprint „R-06” on one side, packed in blisters and placed in a cardboard box. Each blister contains 10 tablets.
Pack sizes:
10 tablets – 1 blister containing 10 tablets
20 tablets – 2 blisters containing 10 tablets each
30 tablets – 3 blisters containing 10 tablets each
40 tablets – 4 blisters containing 10 tablets each
50 tablets – 5 blisters containing 10 tablets each
60 tablets – 6 blisters containing 10 tablets each
Not all pack sizes may be marketed.

Marketing Authorisation Holder
URGO Sp. z o.o.
Al. Jerozolimskie 142 B
02-305 Warsaw
tel: 22 616 33 48

Importer
Wörwag Pharma Operations Spółka z ograniczoną odpowiedzialnością
ul. gen. Mariana Langiewicza 58
95-050 Konstantynów Łódzki