Package leaflet: Information for the patient

IBUPROFEN FORTE DOZ, 400 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, so 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 not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
If symptoms worsen or do not improve after 3 days, you should contact your doctor.

Contents of this leaflet

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

1. What Ibuprofen Forte DOZ is and what it is used for
The active substance in Ibuprofen Forte DOZ is ibuprofen.
Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) that have anti-inflammatory, analgesic and antipyretic effects.
Ibuprofen Forte DOZ is used for the treatment of:

mild to moderate pain of various origins: headache (including tension headache and migraine), toothache, muscular, joint and bone pain, pain associated with influenza and colds, neuralgia;
fever of various causes (including during influenza, colds or other infectious diseases);
painful menstruation.

This medicine is intended for short-term use only.

2. Important information before taking Ibuprofen Forte DOZ

When not to take Ibuprofen Forte DOZ

if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced allergic reactions after taking acetylsalicylic acid or other NSAIDs, such as rhinitis, urticaria, angioedema or asthma;
if you have or have had peptic ulcer or (and) duodenal ulcer, gastrointestinal perforation or bleeding (two or more episodes), including those associated with previous NSAID treatment;
in patients with severe hepatic or renal impairment;
in patients with severe heart failure;
if you have experienced cerebral haemorrhage or any other active bleeding;
in patients concurrently taking other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors), due to increased risk of adverse effects;
in women during the last three months of pregnancy;
in patients with bleeding disorders (tendency to bleed).

Warnings and precautions

if you have connective tissue disorders such as systemic lupus erythematosus or mixed connective tissue disease;
if you have or have previously had intestinal disease (ulcerative colitis, Crohn's disease);
if you have persistently high blood pressure and (or) heart function disorders;
if you have renal function impairment;
if you have hepatic function impairment;
immediately after major surgical procedures;
if you have blood coagulation disorders;
if you suffer from or have suffered from bronchial asthma or have a history of allergies, as bronchospasm may occur after taking the medicine;
alcohol consumption during ibuprofen treatment increases the risk of adverse effects;
if you are taking other medicines [corticosteroids (anti-inflammatory drugs), diuretics, cardiac medications, particularly anticoagulants or drugs preventing thrombus formation], you should consult your doctor before combining ibuprofen with these medicines;
there is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal. These reactions may occur without warning symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately;
patients with current or past gastrointestinal disorders, especially elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period;
concurrent, long-term use of various analgesics may lead to kidney damage or even renal failure (so-called analgesic nephropathy);
this medicine belongs to a group of medicines that may adversely affect fertility in women (non-steroidal anti-inflammatory drugs). This effect is reversible and resolves after discontinuation of treatment;
in case of chickenpox, use of the medicine should be avoided.

Skin reactions
Serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If you experience any of the symptoms related to these serious skin reactions described in section 4, discontinue Ibuprofen Forte DOZ immediately and seek medical help.
Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment. If symptoms persist, worsen or do not resolve after 3 days in case of fever or after 4 days in case of pain, or if new symptoms occur, contact your doctor.
Allergic reactions to this medicine, including breathing difficulties, facial and neck swelling (angioedema), chest pain, have been reported during ibuprofen use. If any of these symptoms occur, discontinue Ibuprofen Forte DOZ immediately and contact your doctor or emergency medical services without delay.
Before taking Ibuprofen Forte DOZ, you should discuss treatment with your doctor or pharmacist:

if you have heart conditions such as heart failure, angina (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or if you have had a stroke (including mini-stroke or transient ischemic attack - TIA);
if you have hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if you smoke;
if you have an infection - see below, section titled "Infections". Infections: Ibuprofen Forte DOZ may mask objective signs of infection, such as fever and pain. Therefore, Ibuprofen Forte DOZ 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 you take this medicine during an ongoing infection and infection symptoms persist or worsen, seek immediate medical advice.

Ibuprofen Forte DOZ and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription. Ibuprofen Forte DOZ may affect the action of other medicines, and other medicines may affect the action of Ibuprofen Forte DOZ.
For example:

anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as medicines containing atenolol, angiotensin II receptor antagonists, such as losartan). Other medicines may also interact with or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before taking Ibuprofen Forte DOZ with other medicines. Do not take Ibuprofen Forte DOZ with the following medicines:
acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
digoxin, used in heart failure,
medicines used for high blood pressure,
diuretics,
antiplatelet medicines,
anticoagulant medicines,
phenytoin, used in epilepsy treatment,
selective serotonin reuptake inhibitors, used in depression treatment,
lithium, used in psychiatric disorders,
probenecid and sulfinpyrazone, used in gout treatment,
potassium-sparing diuretics,
methotrexate, used in cancer treatment,
zidovudine, used in HIV (human immunodeficiency virus) infections,
corticosteroids, used in inflammatory conditions,
tacrolimus and cyclosporine, used in, e.g., atopic dermatitis treatment,
sulfonylurea derivatives, used in diabetes treatment,
quinolone antibiotics.

Taking Ibuprofen Forte DOZ with food and drink
Ibuprofen Forte DOZ should be taken with a large amount of water.
In patients with gastrointestinal disorders, it is recommended to take the medicine with food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Ibuprofen Forte DOZ is contraindicated during the last three months of pregnancy, as it may increase the risk of complications for both mother and child before and after delivery and may cause delivery complications. The medicine may cause kidney and heart disorders in the unborn child. It may affect bleeding tendency in both mother and child and may delay or prolong labour.
During the first six months of pregnancy, Ibuprofen Forte DOZ should not be used unless necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration.
Ibuprofen Forte DOZ taken for longer than a few days starting from the 20th week of pregnancy may cause kidney disorders in the unborn child, leading to low levels of amniotic fluid surrounding the child (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If you need to take the medicine for longer than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
No adverse effects have been reported in breastfed infants to date.
Breastfeeding need not be interrupted during short-term treatment with ibuprofen at recommended doses.
Fertility
This medicine belongs to a group of NSAIDs that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Driving and operating machinery
There is no data available on the effect of Ibuprofen Forte DOZ on the ability to drive or operate machinery.
Ibuprofen Forte DOZ contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
3. How to take Ibuprofen Forte DOZ
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Recommended doses:
Adults and adolescents over 12 years of age: initial dose is one tablet; if needed, another tablet may be taken after 4 hours. Do not take more than three tablets (1200 mg ibuprofen) in 24 hours. Maintain a 4-hour interval between doses.
Dose adjustment is not necessary in elderly patients.
Tablets should be taken after a meal and swallowed with water. In patients with gastrointestinal disorders, it is recommended to take the medicine with food.
Do not use in children under 12 years of age.
This medicine is intended for oral use only and short-term treatment. Use the lowest effective dose for the shortest possible time to relieve symptoms. Do not use the medicine for longer than 3 days without medical advice.
If symptoms persist or worsen, or if new symptoms occur, contact your doctor.
Taking more Ibuprofen Forte DOZ than recommended
Overdose is rare. If you have taken more than the recommended dose of Ibuprofen Forte DOZ or if a child accidentally ingests the medicine, always contact your doctor or go to the nearest hospital for advice on possible health risks and what actions to take. Your doctor may recommend gastric lavage. Activated charcoal may be administered orally within 1 hour of overdose.
Most patients may experience overdose symptoms: nausea, vomiting, epigastric pain, diarrhoea, tinnitus, headache, gastrointestinal bleeding.
Severe poisoning affects the nervous system and manifests as drowsiness; very rarely, agitation, disorientation or coma may occur. Seizures are very rare.
During severe poisoning, metabolic acidosis, blood coagulation disorders, acute renal failure or liver damage may also occur. Symptoms of metabolic acidosis may include nausea, stomach pain, vomiting (possibly with blood traces), headache, tinnitus, disorientation and nystagmus. After a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, cold sensation and breathing difficulties may occur. In patients with asthma, asthma symptoms may worsen. Additionally, low blood pressure and shallow breathing may occur.
Missing a dose of Ibuprofen Forte DOZ
Do not take a double dose to make up for a missed dose.
Stopping Ibuprofen Forte DOZ
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The use of medicines such as Ibuprofen Forte DOZ may be associated with a small increased risk
of heart attack (myocardial infarction) or stroke.
Ibuprofen Forte DOZ is generally well tolerated. In some patients using ibuprofen short-term
at over-the-counter doses, the following adverse effects have occurred:
Not common (occurring in more than 1 in 1,000 patients but less than 1 in 100 patients):
dyspepsia, abdominal pain, nausea, headache, urticaria, itching.
Rare (occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients):
diarrhoea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia, restlessness,
irritability or fatigue.
Very rare (occurring in less than 1 in 10,000 patients): exacerbation of ulcerative colitis and Crohn's disease
(chronic inflammatory bowel diseases), peptic ulcer of the stomach and/or duodenum, perforations
(gastrointestinal perforation) and gastrointestinal bleeding (symptoms include tarry stools,
bloody vomiting), sometimes fatal, particularly in elderly patients, acute renal failure, necrosis of parts of the kidneys with oedema, especially during prolonged use, liver function disorders, particularly during prolonged use, anaemia, reduction in white blood cell count (leukopenia), reduction in platelet count (thrombocytopenia), a disorder involving deficiency of red blood cells, white blood cells and platelets (pancytopenia), reduction in granulocytes (agranulocytosis) – initial symptoms of blood disorders include fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, severe fatigue, unexplained bleeding (e.g. bruising, petechiae, purpura, nosebleeds), swelling of the face, tongue and larynx, shortness of breath, rapid heartbeat (tachycardia), drop in blood pressure (hypotension), worsening of asthma symptoms and bronchospasm, palpitations, heart failure, myocardial infarction.
Additionally, severe skin reactions may occur (red, flat, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs and eyes). These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). If severe skin reactions occur, ibuprofen must be discontinued immediately and medical help must be sought.
Frequency not known:

skin becomes sensitive to light,
red scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, on the trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, Ibuprofen Forte DOZ must be discontinued immediately and medical help must be sought without delay. See also section 2.
chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

In patients with autoimmune diseases (in which the immune system attacks the body's own tissues, such as systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever and disorientation, have been reported during ibuprofen treatment.
Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include widespread skin rash, high fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell). If such symptoms occur, Ibuprofen Forte DOZ must be discontinued immediately and medical help must be sought without delay.
Other adverse effects may occur when ibuprofen is used for other indications or over prolonged periods.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen Forte DOZ
Keep out of sight and reach of children.
No special storage conditions required.
Do not use Ibuprofen Forte DOZ after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine Ibuprofen Forte DOZ contains

The active substance is ibuprofen (Ibuprofenum). Each coated tablet contains 400 mg of ibuprofen.
Other ingredients are povidone, pregelatinized starch, maize starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
Coating composition: Aqua Polish P white 010.28: hypromellose, macrogol, talc, titanium dioxide (E 171).

What the medicine Ibuprofen Forte DOZ looks like and contents of the pack
Ibuprofen Forte DOZ is a coated tablet.
The cardboard box contains:

5 tablets, 10 tablets or 20 tablets in PVC/Aluminium blisters;
60 tablets in a HDPE container with LDPE cap;
60 tablets in a HDPE container with PE screw cap and seal.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOZ S.A.
Al. Jerozolimskie 134
02-305 Warsaw
Telephone number: 800 110 110
Manufacturer:
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity