IBUPROFENE SAN "200 MG FILM-COATED TABLETS" BLISTER OF 24 TABLETS"

Name
Ibuprofen Sandoz 200 mg film-coated tablets
Equivalent medicine


What is it and what is it used for?
This medicine contains the active substance ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) that work by reducing pain (analgesic action) and lowering fever.

Ibuprofen 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 (osteo-articular and muscular).

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

Contact 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 Ibuprofen Sandoz
- if you are allergic to the active substance, 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), hives or a severe cold (acute rhinitis) (see section "Warnings and precautions");
- if you suffer from severe liver or kidney problems;
- if you suffer from severe heart problems (severe heart failure);
- if you have had bleeding (haemorrhage) from the stomach and/or intestine or perforation after previous treatments with other medicines;
- if you suffer or have suffered from bleeding or ulcers that occur repeatedly (two or more distinct episodes of proven ulceration or bleeding);
- if you have had a severe ulcer in your stomach or upper intestine;
- if you have an ongoing ulcer;
- if you have bleeding in the brain (cerebrovascular haemorrhage) or other types of bleeding;
- if you have a change in blood cell production, the cause of which is not known;
- 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
Talk to your doctor or pharmacist before taking Ibuprofene Sandoz.

What you need to know before taking Ibuprofen Sandoz

Signs of an allergic reaction to ibuprofen, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking Ibuprofen Sandoz immediately and contact your doctor or emergency services immediately if you notice any of these signs.
Take special care with Ibuprofen Sandoz:
Skin reactions
Serious skin reactions, including 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 in association with ibuprofen treatment. Stop using Ibuprofen Sandoz and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Anti-inflammatory/pain-relieving medications 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.
Do not take this medicine if you are already taking other medicines (See the section "Other medicines and Ibuprofen Sandoz").

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Sandoz if you 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 a "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 intestinal disorders (ulcerative colitis, Crohn's disease);
- if you suffer from heart problems (mild to moderate heart failure, congestive heart failure, known ischemic heart disease, heart failure). In this case, your doctor should monitor you frequently, 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, ulcers and perforations such as acetylsalicylic acid (e.g. aspirin) and other NSAIDs, corticosteroids given by mouth, injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section "Other medicines and Ibuprofen Sandoz");
- if you have liver, kidney or heart problems unless you have severe liver, kidney or heart failure because in these cases you should not take Ibuprofene Sandoz (see section 2 "Do not take Ibuprofene Sandoz");
- if you have reduced kidney function or liver problems (liver dysfunction). In these cases, your doctor should monitor you frequently, especially if you take the medicine for prolonged periods;
- if you suffer from breathing problems (asthma), if you have seasonal colds caused by allergies (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps), other allergic diseases or if you have had difficulty breathing (bronchospasm) in the past, even following the use of other medicines similar to Ibuprofen 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 the functioning of the kidneys;
- if you have low body fluid volume (for example before or after major surgery);
- if you are undergoing or have undergone major surgery;
- if you have stomach or intestinal problems, unless you have one or more conditions for which you should not take Ibuprofene Sandoz (see section "Do not take Ibuprofene Sandoz");
- if she is a woman and is planning a pregnancy;
- if you are a woman and have fertility problems or are undergoing investigations into fertility, because you should stop treatment with Ibuprofen Sandoz;
- if you have an autoimmune disease such as lupus erythematosus or connective tissue disease.

In these cases, your doctor will monitor you closely and periodically reassess the need for treatment with Ibuprofen Sandoz. Additionally, your doctor may perform periodic tests (such as monitoring your kidney function) to evaluate your condition while you're taking Ibuprofen Sandoz.

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

Stop treatment and inform your doctor if you develop:
• gastrointestinal bleeding or ulceration
• mucosal lesions or any other signs of allergic reaction
• fluid retention and swelling from fluid accumulation (edema)
• signs and symptoms of liver problems or if liver function parameters are abnormal (visible in blood tests)
• unusual symptoms in the stomach and intestines especially at the beginning of treatment with Ibuprofene Sandoz
• fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, unexplained bruising and bleeding because you may have a reduction in white blood cells (agranulocytosis)
• Neck tension, 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 a worsening of an infection as Ibuprofen Sandoz may hide the signs and symptoms of infection.

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

Serious skin reactions have been reported in association with treatment with Ibuprofen Sandoz. Stop taking Ibuprofen Sandoz and consult your doctor immediately if you develop a 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.

Other important information:
- Gastrointestinal bleeding, ulceration, or perforation, which can be fatal, may occur during treatment with NSAIDs, including ibuprofen. This 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 medications (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 Ibuprofen Sandoz").
- Avoid using ibuprofen during treatment with other NSAIDs administered by mouth, injection and rectally, including selective cyclooxygenase-2 inhibitors, because it increases the possibility of you experiencing 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.

Eye problems (ocular changes) may occur during treatment with this medicine. Therefore, if you are taking this medicine for a long time, it is recommended that you undergo regular eye (ophthalmological) check-ups.

Children and adolescents
Ibuprofen 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 usually more severe and can be fatal.
If you are elderly, you should take the lowest dose of Ibuprofen Sandoz. As a precaution, your doctor may check your kidney function and prescribe medications that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Tell your doctor about any unusual stomach and intestinal symptoms, especially when you first start taking this medicine.


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

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

Stop taking Ibuprofen Sandoz and consult your doctor immediately if you notice any of the following symptoms:
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• 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 (DRESS syndrome);
• widespread, red, 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 involve the stomach and/or intestines. Stomach or upper intestinal ulcers (peptic ulcers), perforation, or bleeding from the stomach and/or intestines may occur, which can even be fatal, especially 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, dark bloody stools (melena) and bloody vomiting (haematemesis) due to bleeding from the stomach, oesophagus and duodenum have been reported after administration of Ibuprofen Sandoz.

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

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

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

Uncommon side effects (may affect up to 1 in 100 people)
- allergic reactions including skin rash, hives, itching and asthma attacks
- heachache
- 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
- ulcer of the stomach or upper part of the intestine (peptic ulcer)
- perforation or bleeding from the stomach and/or intestines
- inflammation of the oral mucosa with ulceration (ulcerative stomatitis)
- inflammation of the stomach (gastritis)
- 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

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)
- severe allergic reaction (anaphylactic reaction)
- swelling due to fluid accumulation (angioedema)
- aseptic meningitis (infection of the meninges, membranes of the brain)
- changes in tests to evaluate liver function
- liver problems, e.g. inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice)
- liver damage, especially in long-term therapy
- skin and mucous membrane reactions, even severe ones (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Not known (frequency cannot be estimated from the available data)
- mental changes (psychotic reactions)
- depression
- vision problems
- irregular heartbeat (palpitations)
- swelling (edema)
- heart failure
- heart attack
- high blood pressure (hypertension)
- inflammation of the esophagus (esophagitis)
- inflammation of the pancreas (pancreatitis)
- narrowing of the intestine (diaphragmatic intestinal stenosis)
- gas emission (flatulence)
- diarrhea
- constipation (constipation)
- 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
- the skin becomes sensitive to light
- 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).

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

Reporting of side effects
If you experience 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.