IBUPROFEN SAN*24FC TAB 200MG

Ibuprofene Sandoz 200 mg film-coated tablets
Generic medicine

What it is and what it is used for
This medicine contains the active ingredient ibuprofen, belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) which reduce pain (analgesic action) and lower fever.

Ibuprofene Sandoz is indicated for the treatment of various types of pain: menstrual pain, headache, toothache, pain in one or more nerves (neuralgia), bone, joint, and muscle pain (osteoarticular and muscular pain).

The medicine is also indicated as an additional therapy in the treatment of fever and flu symptoms.

Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

What you need to know before taking the medicine
Do not take Ibuprofene Sandoz
- if you are allergic to the active ingredient, or to 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), fever (antipyretics) such as non-steroidal anti-inflammatory drugs (NSAIDs), especially when the allergy is associated with swelling of the nasal mucosa (nasal polyposis), angioedema and asthma, and presents with an asthmatic reaction (bronchospasm), urticaria, or severe rhinitis (acute rhinitis) (see section Warnings and precautions);
- if you suffer from severe liver or kidney problems;
- if you suffer from severe heart conditions (severe heart failure);
- if you have had stomach and/or intestinal bleeding (haemorrhage) or perforation after previous treatments with other medicines;
- if you suffer or have suffered from recurrent bleeding or ulcers (two or more distinct episodes of proven ulceration or bleeding);
- if you have had a severe ulcer in the stomach or the first part of the intestine;
- if you have an ongoing ulcer;
- if you have bleeding in the brain (cerebrovascular haemorrhage) or other types of bleeding;
- if you have an alteration in blood cell production, the cause of which is unknown;
- if you are in the last 3 months of pregnancy (See section Pregnancy and breastfeeding);
- if the patient is a child under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Ibuprofene Sandoz.

What you need to know before taking Ibuprofene Sandoz

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 Ibuprofene Sandoz immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.
Pay particular attention with Ibuprofene Sandoz:
Skin reactions
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop using Ibuprofene Sandoz and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially when given in high doses. Do not exceed the recommended dose or duration of treatment.
Do not take this medicine if you are already taking other medicines (See section Other medicines and Ibuprofene Sandoz).

You should discuss therapy with your doctor or pharmacist before taking Ibuprofene Sandoz 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);
- high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker;
- if you have an infection - see section Infections below.

Take this medicine with caution:
- if you suffer or have suffered in the past from bowel disorders (ulcerative colitis, Crohn's disease);
- if you suffer from heart problems (mild to moderate heart failure, congestive heart failure, confirmed ischemic heart disease, heart decompensation). In this case, your doctor must subject you to frequent checks, especially if you take the medicine for prolonged periods of time;
- if you have hepatic porphyria;
- if you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
- if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (e.g. aspirin) and other NSAIDs, corticosteroids administered orally, by injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section Other medicines and Ibuprofene Sandoz);
- if you have liver, kidney, or heart problems unless you have a severe form of liver, kidney or heart failure, because in these latter cases you must not take Ibuprofene Sandoz (see section 2 Do not take Ibuprofene Sandoz);
- if you have reduced kidney function or if you suffer from liver problems (hepatic dysfunction). In these cases, your doctor must subject you to frequent checks, especially if you take the medicine for prolonged periods of time;
- if you suffer from breathing disorders (asthma), if you have seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps) other allergic diseases or if in the past you have experienced breathing difficulties (bronchospasm), also following the use of other medicines similar to Ibuprofene Sandoz (aspirin or other NSAIDs);
- if the patient is a child or adolescent with dehydration problems, because in this case the medicine can cause kidney problems;
- if you are using medicines that increase urine production (diuretics) or other medicines that may affect kidney function;
- if you have reduced body fluid volume (e.g. before or after major surgery);
- if you are about to undergo or have undergone major surgery;
- if you have stomach or intestinal problems, unless you have one or more conditions for which you must not take Ibuprofene Sandoz (see section Do not take Ibuprofene Sandoz);
- if you are a woman and are planning a pregnancy;
- if you are a woman and have fertility problems or are undergoing fertility investigations, because you should stop treatment with Ibuprofene Sandoz;
- if you have an autoimmune disease e.g. Lupus erythematosus or connective tissue diseases.

In these cases, your doctor will keep you under strict control and will periodically re-evaluate the need for treatment with Ibuprofene Sandoz. In addition, your doctor may ask you to undergo periodic examinations (such as monitoring kidney function) to assess your condition during treatment with Ibuprofene Sandoz.

Infections
Ibuprofene Sandoz can mask the symptoms of infections such as fever and pain. Therefore, it is possible that Ibuprofene Sandoz 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 infection symptoms persist or worsen, consult your doctor immediately.

Stop treatment and inform your doctor if, during treatment with Ibuprofene Sandoz, you develop:
• gastrointestinal bleeding or ulceration
• mucosal lesions or any other sign of an allergic reaction
• fluid retention and swelling due to fluid accumulation (edema)
• signs and symptoms of liver problems or if liver function parameters are not normal (visible from blood tests)
• unusual stomach and intestinal symptoms especially at the beginning of treatment with Ibuprofene Sandoz
• fever, sore throat, superficial mouth ulcers, flu-like symptoms, profound fatigue, unexplained bruising and bleeding because you may have a reduction in white blood cells (agranulocytosis)
• stiffness in the neck, headache, nausea, vomiting, fever, disorientation because you may be suffering from aseptic meningitis. Patients with autoimmune diseases (Systemic Lupus Erythematosus, connective tissue disease) appear to be more predisposed to developing aseptic meningitis
• symptoms of an infection (e.g. headache, fever) or if you notice the worsening of an infection as Ibuprofene Sandoz can mask the signs and symptoms of the infection.

In these cases, your doctor will assess whether to continue or discontinue treatment with Ibuprofene Sandoz.

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

Other important information:
- During treatment with NSAIDs, including ibuprofen, gastrointestinal bleeding, ulceration or perforation may occur, which can also cause death, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. You should take the lowest effective dose of ibuprofen to reduce the risk of gastrointestinal toxicity and your doctor may prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
- Side effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 How to take Ibuprofene Sandoz).
- Avoid the use of ibuprofen during treatment with other NSAIDs administered orally, by injection and rectally, including selective cyclooxygenase-2 inhibitors, because it increases the possibility of you having side effects.

Cases of aseptic meningitis have been reported during treatment with ibuprofen, although they are more likely in patients with Lupus erythematosus or connective tissue diseases.

During treatment with this medicine, eye problems (ocular alterations) may occur. Therefore, in case of prolonged treatments, it is recommended to undergo periodic eye (ophthalmological) check-ups.

Children and adolescents
Ibuprofene Sandoz is contraindicated in children under 12 years of age.

Elderly patients
Elderly patients are more likely to experience adverse reactions, especially stomach or intestinal bleeding and perforation which are generally more severe and can be fatal.
If you are elderly, you should take the lowest dose of Ibuprofene Sandoz. As a precaution, your doctor may have you undergo a kidney function check and prescribe medicines that protect the gastrointestinal mucosa such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach and intestinal symptoms, especially at the beginning of treatment with this medicine.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms.
Side effects depend on the dose and may vary from patient to patient.

Stop treatment with Ibuprofene Sandoz and consult your doctor immediately if you notice any of the following symptoms:
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome;
• reddish, non-elevated, target-shaped or circular spots on the trunk, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin 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 enlarged lymph nodes (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);

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 may occur, which can even 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, dark stools with blood (melena) and vomiting with blood (hematemesis) due to bleeding from the stomach, esophagus, and duodenum have been reported after administration of Ibuprofene Sandoz.

Medicines such as Ibuprofene Sandoz may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke (see section Warnings and precautions).

The following side effects may occur, which generally resolve with discontinuation of treatment:

Common side effects (may affect up to 1 in 10 people)
- difficulty digesting (dyspepsia)
- abdominal pain
- nausea
- vomiting

Uncommon side effects (may affect up to 1 in 100 people)
- allergic reactions including skin rash, hives, itching, and asthmatic attacks
- headache
- dizziness
- insomnia
- agitation
- irritability
- fatigue
- skin rash

Rare side effects (may affect up to 1 in 1,000 people)
- ringing and buzzing in the ears (tinnitus)
- hearing impairment
- stomach or first part of the intestine ulcer (peptic ulcer)
- perforation or bleeding from the stomach and/or intestine
- inflammation of the oral mucosa with ulceration (ulcerative stomatitis)
- inflammation of the stomach (gastritis)
- 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 uric acid concentration in the blood

Very rare side effects (may affect up to 1 in 10,000 people)
- worsening of infection-related inflammations (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)
- severe allergic reaction (anaphylactic reaction)
- swelling due to fluid accumulation (angioedema)
- aseptic meningitis (infection of the meninges, membranes of the brain)
- alterations in liver function tests
- liver problems, e.g., liver inflammation (hepatitis) and yellowing of the skin, mucous membranes, and eyes (jaundice)
- liver damage, particularly in long-term therapy
- skin and mucous membrane reactions, including severe ones (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Not known (frequency cannot be estimated from the available data)
- mental alterations (psychotic reactions)
- depression
- vision disorders
- irregular heartbeat (palpitations)
- swelling (edema)
- heart failure
- heart attack
- high blood pressure (hypertension)
- inflammation of the esophagus (esophagitis)
- inflammation of the pancreas (pancreatitis)
- intestinal strictures (diaphragmatic intestinal stenoses)
- gas emission (flatulence)
- diarrhea
- constipation
- edema formation, particularly in patients with high blood pressure or kidney problems (renal insufficiency, nephrotic syndrome, interstitial nephritis) which may be accompanied by acute renal failure
- skin becomes sensitive to light
- a widespread, red, and scaly rash, with pustules forming under the skin and blisters located mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swelling of lymph nodes, and an increase in eosinophils (a type of white blood cell).
Other side effects reported include: bronchospasm or dyspnea, apnea, epigastric pain, heartburn, rhinitis, anxiety, confusional state, hallucinations, paresthesia, drowsiness, optic neuritis, optic neuropathy, vertigo, photosensitivity reactions, malaise.
Stop using Ibuprofene Sandoz if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.