ALGOFEN "200 MG COATED TABLETS" 12 TABLETS"

Name
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) which work by reducing pain and inflammation.

This medicine is used to treat pain of various origins 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 section 6);
- if you are allergic to acetylsalicylic acid or other medicines used to reduce pain (analgesics) and fever (antipyretics) or to non-steroidal anti-inflammatory drugs (NSAIDs), in particular when the allergy is associated with swelling of the nasal mucosa (nasal polyposis) or asthma, and presents with an asthmatic reaction (bronchospasm), urticaria or severe cold (acute rhinitis) (see section "Warnings and precautions");
- if you have suffered from ulcers or bleeding in the stomach or intestines after taking other medicines;
- if you suffer from ulcers or bleeding in the stomach or small intestine (duodenum);
- if you have suffered from two or more episodes of this type in the past;
- if you have a disorder in the production of blood cells, the cause of which is not known;
- if you have bleeding in the brain (cerebrovascular haemorrhage) or other types of bleeding;
- if you suffer from a disease that may lead to an increased tendency to bleed;
- if you have severe liver or kidney problems;
- if he is very dehydrated (this condition may be due to vomiting, diarrhoea or insufficient fluid intake);
- if you are in the last three months of pregnancy (see section "Pregnancy, breast-feeding and fertility");
- if you suffer from severe heart problems (severe heart failure);
- in children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before using ALGOFEN.

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

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

Serious 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 serious skin reactions described in section 4.

You should discuss your treatment with your doctor or pharmacist before taking ALGOFEN if:
- have heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including 'mini-stroke' or 'TIA', transient ischaemic attack);
- have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker;
- suffer from asthma (difficulty breathing) or other allergies;
- have seasonal colds on an allergic basis (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps);
- have chronic obstructive pulmonary disease or chronic respiratory tract infections;
- have liver or kidney problems, unless you have a severe form of liver or kidney failure because in these cases you should not take ALGOFEN (see section 2 "Do not use ALGOFEN"). If you are in any doubt, ask your doctor;
- has hepatic porphyria;
- are using medicines that increase urine production (diuretics) or other medicines that may affect the way your kidneys work;
- has reduced body fluid volume (for example before or after major surgery);
- is due to undergo or has undergone major surgery;
- are taking other NSAID medicines, including the specific type of NSAIDs called COX-2 inhibitors. In this case, taking ALGOFEN should be avoided;
- are taking other medicines used against inflammation belonging to the corticosteroid family, or medicines used to prevent blood clotting (such as warfarin), or aspirin, or medicines against depression called selective serotonin reuptake inhibitors or SSRIs;
- suffer from chronic inflammatory bowel diseases such as inflammation of the colon 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 may 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 section "Do not use ALGOFEN");
- is in the first six months of pregnancy (see "Pregnancy, breastfeeding and fertility");
- the patient is a teenager with dehydration problems, because in this case the medicine can cause kidney problems;
- have an autoimmune disease e.g. lupus erythematosus or connective tissue disease;
- have an infection (see section "Infections" 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 treatment. Do not exceed the recommended doses or duration of treatment indicated.

Elderly people
Older people may be more susceptible to side effects, especially 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 gastric or intestinal ulcer, particularly if it was complicated by perforation or accompanied by bleeding, you should pay attention to any unusual symptoms in the abdomen and report them to your doctor immediately, especially if these symptoms occur at the start 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 stopped.

Bleeding, ulceration, or perforation in the stomach or intestines may 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 certain other medicines are taken at the same time as ibuprofen (see "Other medicines and ALGOFEN").

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

Infections
ALGOFEN may hide the symptoms of infections such as fever and pain. It is therefore possible that ALGOFEN may delay adequate 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 get worse, contact your doctor immediately.

ALGOFEN may decrease the chances of becoming pregnant. Tell your doctor if you are planning to become pregnant or have fertility problems (see "Pregnancy, breast-feeding and fertility").

Children and adolescents
This medicine should not be used in children under 12 years of age (see section 2 "Do not use ALGOFEN").
In dehydrated adolescents there is a risk of impaired renal 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 may vary from patient to patient.

Stop using ibuprofen and see your doctor immediately if you notice any of the following symptoms:
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and 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 skin rash, high body temperature and swollen lymph nodes and increased eosinophils (a type of white blood cell) (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

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

Fluid retention (oedema), high blood pressure and heart problems (heart failure) have been reported in association with NSAIDs.

The most commonly observed adverse events are stomach and/or intestinal. Ulcers of the stomach or upper intestine (peptic ulcer), perforation or bleeding from the stomach and/or intestine may occur, which may be fatal, particularly in the elderly.
In particular, the risk of bleeding from the stomach and/or intestine depends on the dose and duration of treatment.

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

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

Common side effects (may affect up to 1 in 10 people):
- skin rash;
- headache, drowsiness, dizziness, vertigo, fatigue, agitation, insomnia, irritability;
- gastric and duodenal ulcers, sometimes with bleeding and perforation, occult blood loss which may lead to anemia, black tarry stools, vomiting blood, mouth ulcers, inflammation of the colon, worsening of inflammatory bowel disease, inflammation of the intestinal wall;
- vision problems.

Uncommon side effects (may affect up to 1 in 100 people):
- allergic reactions including skin rash, hives, itching and asthma attacks;
- skin irritation associated with bleeding (purpura);
- skin sensitivity to light;
- alteration of sensitivity in some parts of the body (paraesthesia);
- difficulty breathing (bronchospasm);
- sneezing, stuffy or runny nose (rhinitis);
- inflammation of the stomach (gastritis);
- liver problems, inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice);
- formation of edema particularly in patients with high blood pressure or kidney problems (renal 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);
- ringing and buzzing in the ears (tinnitus);
- hearing impairment;
- worsening of inflammation of the colon (colitis);
- worsening of a chronic inflammatory disease of the digestive system (Crohn's disease);
- kidney failure;
- damage to kidney tissue (papillary necrosis) (particularly in long-term therapy);
- increased concentration of uric acid in the blood;
- 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 changes (psychotic reactions);
- increased blood urea nitrogen, transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolongation of bleeding time, decreased serum calcium, increased serum uric acid, all observed with a blood test;
- decreased vision.

Very rare side effects (may affect up to 1 in 10,000 people):
- worsening of inflammation 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);
- changes in tests to evaluate liver function;
- 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);
- rapid or irregular heartbeat (palpitations);
- inflammation of the esophagus, narrowing of the intestine;
- serious skin infections, with soft tissue complications, may occur if you have chickenpox;
- fluid build-up 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 with unknown frequency (frequency cannot be estimated from the available data):
- a widespread, red, scaly rash with pustules under the skin and vesicles located mainly in the skin folds, trunk and upper limbs accompanied by fever at the start 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 may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.