ALGOFEN*12FILMTABS 200MG

ALGOFEN 200 mg coated tablets
Ibuprofen

What it is and what it is used for
ALGOFEN contains the active ingredient ibuprofen, which belongs to the class of medicines called Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs) that act by reducing pain and inflammation.

This medicine is used to treat various types of pain such as: headache, toothache, nerve pain (neuralgia), bone and joint pain (osteoarticular), muscle pain and menstrual pain.

Contact your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not use ALGOFEN
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- if you are allergic to acetylsalicylic acid or other medicines used to reduce pain (analgesics) and fever (antipyretics) or non-steroidal anti-inflammatory drugs (NSAIDs), particularly when the allergy is associated with swelling of the nasal mucous membrane (nasal polyposis) or asthma, and presents with an asthmatic reaction (bronchospasm), urticaria or severe rhinitis (acute rhinitis) (see Warnings and precautions section);
- if you have suffered from stomach or intestinal ulcers or bleeding after taking other medicines;
- if you suffer from stomach or small intestine (duodenum) ulcers or bleeding;
- if you have suffered two or more such episodes in the past;
- if you have an unknown disorder in blood cell production;
- if you have bleeding in the brain (cerebrovascular hemorrhage) or other types of bleeding;
- if you suffer from a disease that may lead to an increased bleeding tendency;
- if you have severe liver or kidney problems;
- if you are very dehydrated (this condition may be due to vomiting, diarrhea or insufficient fluid intake);
- if you are in the last three months of pregnancy (see Pregnancy, breastfeeding and fertility section);
- if you suffer from severe heart problems (severe heart failure);
- in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using ALGOFEN.

Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if taken in high doses. Do not exceed the recommended dose or duration of treatment.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck area (angioedema) and chest pain, have been reported with ibuprofen. Stop ALGOFEN immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using ALGOFEN and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

You should discuss your therapy with your doctor or pharmacist before taking ALGOFEN if:
- you have heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic attack);
- you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
- you suffer from asthma (difficulty breathing) or other allergies;
- you have seasonal allergic rhinitis, swelling of the nasal mucous membrane (e.g. nasal polyps);
- you have chronic obstructive pulmonary disease or chronic infections of the respiratory tract;
- you have liver or kidney problems, unless you have a severe form of liver or kidney insufficiency, in which case you should not take ALGOFEN (see paragraph 2 Do not use ALGOFEN). If in doubt, consult your doctor;
- you have hepatic porphyria;
- you are using medicines that increase urine production (diuretics) or other medicines that may affect kidney function;
- you have a reduced volume of body fluids (e.g. before or after major surgery);
- you need to undergo or have undergone major surgery;
- you are taking other NSAIDs, including the specific type of NSAIDs called COX-2 inhibitors. In this case, taking ALGOFEN should be avoided;
- you are taking other anti-inflammatory medicines belonging to the corticosteroid family, or medicines used to prevent blood clotting (such as warfarin), or aspirin or antidepressant drugs called selective serotonin reuptake inhibitors or SSRIs;
- you suffer from chronic inflammatory bowel diseases such as colon inflammation with ulcers (ulcerative colitis), inflammation of the digestive tract (Crohn's disease);
- you are elderly, because you may be more susceptible to side effects, which can also be serious or life-threatening (see Elderly and Ulcers, perforations and bleeding in the stomach or intestines);
- if you have stomach or intestinal problems, unless you have one or more conditions for which you should not take ALGOFEN (see Do not use ALGOFEN section);
- you are in the first six months of pregnancy (see Pregnancy, breastfeeding and fertility);
- the patient is an adolescent with dehydration problems, because in this case the medicine may cause kidney problems;
- you have an autoimmune disease e.g. Lupus erythematosus or connective tissue diseases;
- you have an infection (see Infections section below).

Effects on the heart and brain
Medicines containing ibuprofen, such as ALGOFEN, are associated with a slightly higher risk of heart attack (myocardial infarction) or stroke. The risk is higher if you take high doses of ibuprofen and long-term treatments. Do not exceed the recommended doses or the indicated duration of treatment.

Elderly
Elderly people may be more susceptible to side effects, particularly bleeding and perforation of the digestive tract, which can be fatal.
Ulcers, perforations and bleeding in the stomach or intestines
If you have had a stomach or intestinal ulcer, especially if it was complicated by perforation or accompanied by bleeding, you should pay attention to any unusual abdominal symptoms and report them immediately to your doctor, particularly if these symptoms occur at the beginning of treatment. In fact, the risk of bleeding or ulceration of the digestive tract is greater in this case, particularly in elderly patients. If bleeding or ulceration of the digestive tract occurs, treatment should be discontinued.

Bleeding, ulceration or perforation in the stomach or intestines can occur without any warning signs, even in patients who have never had these problems before. They can also be fatal.

The risk of ulcers, perforations or bleeding in the stomach or intestines generally increases with higher doses of ibuprofen. The risk also increases if some other medicines are taken simultaneously with ibuprofen (see Other medicines and ALGOFEN).

Skin reactions
Severe skin reactions have been reported in association with ALGOFEN treatment.
Stop taking ALGOFEN and consult your doctor immediately if you experience a rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very severe skin reaction. See paragraph 4.

Infections
ALGOFEN can mask the symptoms of infections such as fever and pain. Therefore, ALGOFEN may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

ALGOFEN may decrease the chances of becoming pregnant. Tell your doctor if you are planning a pregnancy or have fertility problems (see Pregnancy, breastfeeding and fertility).

Children and adolescents
This medicine should not be used in children under 12 years of age (see paragraph 2 Do not use ALGOFEN).
In dehydrated adolescents, there is a risk of impaired kidney function.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects depend on the dose and can vary from patient to patient.

Stop using ibuprofen and consult your doctor immediately if you notice any of the following symptoms:
• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread rash, high body temperature and swollen lymph nodes and increased eosinophils (a type of white blood cell) (DRESS syndrome);
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Medicines containing ibuprofen for long-term treatments may be associated with a slightly higher risk of heart attack (myocardial infarction) or stroke.

In association with NSAIDs, fluid retention (edema), high blood pressure and heart problems (heart failure) have been reported.

The most commonly observed adverse events affect the stomach and/or intestines. Stomach or first part of the intestine ulcers (peptic ulcer), perforation or bleeding from the stomach and/or intestines can occur, which can also be fatal, particularly in the elderly. In particular, the risk of bleeding from the stomach and/or intestines depends on the dose and duration of treatment.

In addition to the side effects listed below, after administration of ALGOFEN, the following have been reported: black stools (melena), presence of blood in vomit (digestive tract ulcer with bleeding).

Very common side effects (may affect more than 1 in 10 people):
- nausea, flatulence, diarrhea, constipation, vomiting;
- indigestion (dyspepsia);
- abdominal pain;
- heartburn.

Common side effects (may affect up to 1 in 10 people):
- rash;
- headache, drowsiness, dizziness, lightheadedness, fatigue, agitation, insomnia, irritability;
- gastric and duodenal ulcers, sometimes with bleeding and perforation, occult blood loss that can lead to anemia, tar-like black stools, bloody vomit, mouth ulcers, colon inflammation, worsening of inflammatory bowel disease, intestinal wall inflammation;
- vision disturbances.

Uncommon side effects (may affect up to 1 in 100 people):
- allergic reactions including skin rash, urticaria, itching and asthma attacks;
- skin irritation associated with bleeding (purpura);
- sensitivity of the skin to light;
- altered sensation in some parts of the body (paresthesia);
- difficulty breathing (bronchospasm);
- sneezing, stuffy nose or runny nose (rhinitis);
- stomach inflammation (gastritis);
- liver problems, liver inflammation (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice);
- edema formation particularly in patients with high blood pressure or kidney problems (kidney failure, nephrotic syndrome, interstitial nephritis) which may be accompanied by acute kidney failure.

Rare side effects (may affect up to 1 in 1,000 people):
- cerebrovascular accident (stroke, cerebral hemorrhage);
- whistling and ringing in the ears (tinnitus);
- hearing impairment;
- worsening of colon inflammation (colitis);
- worsening of a chronic inflammatory disease of the digestive system (Crohn's disease);
- kidney failure;
- kidney tissue damage (papillary necrosis) (especially in long-term therapy);
- increased blood uric acid concentration;
- aseptic meningitis (infection of the meninges, membranes of the brain);
- a disease affecting the skin, joints and kidneys (lupus erythematosus syndrome);
- depression, confusion, hallucinations, mental alterations (psychotic reactions);
- increased urea nitrogen, transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid, all observed with a blood test;
- decreased visual acuity.

Very rare side effects (may affect up to 1 in 10,000 people):
- worsening of infections associated with infection (e.g. development of necrotizing fasciitis);
- reduction in the number of platelets in the blood (thrombocytopenia);
- anemia;
- reduction in the number of white blood cells in the blood (leukopenia, agranulocytosis);
- reduction in the number of all cells present in the blood (pancytopenia);
- presence of blood in the urine (hematuria);
- severe allergic reaction (anaphylactic reaction);
- swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing (angioedema);
- alterations in liver function tests;
- acute hepatitis;
- liver damage, particularly in long-term therapy and liver failure;
- skin and mucous membrane reactions, including severe ones (erythema multiforme, exfoliative dermatitis, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis);
- fast or irregular heartbeat (palpitations);
- inflammation of the esophagus, narrowing of the intestine;
- severe skin infections, with soft tissue complications, may occur if you have chickenpox;
- fluid accumulation in the lungs, symptoms include shortness of breath, which can be very severe and usually worsens when lying down (pulmonary edema);
- swelling (edema);
- heart attack;
- high blood pressure (hypertension);
- heart failure;
- inflammation of the pancreas;
- unusual hair loss (alopecia);
- menstrual disorders.

Side effects of unknown frequency (frequency cannot be estimated from the available data):
- a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using ALGOFEN if you develop these symptoms and contact your doctor immediately. See also paragraph 2;
- muscle stiffness (musculoskeletal stiffness);
- chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.