SPIDIDOL*OS GRA 12SACH 400MG AL

SPIDIDOL 400 mg film-coated tablets
SPIDIDOL 400 mg granules for oral solution apricot flavour
Ibuprofen arginine salt

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 act by relieving pain (analgesic action) and reducing the symptoms of inflammation (anti-inflammatory action).

SPIDIDOL is indicated for the treatment of pain or inflammatory conditions in the following cases:
- Pain treatment: headache, toothache, menstrual pain, neuralgia, osteoarticular (bone) and muscle pain.
- Treatment of febrile and flu-like conditions, in addition to other medicines.

Consult your doctor if you do not notice any improvement or if your symptoms worsen.

What you need to know before taking the medicine
Do not take SPIDIDOL
- if you are allergic to ibuprofen, other similar medicines or any of the other ingredients of this medicine (listed in paragraph 6);
- if you have previously suffered from stomach and intestinal disorders associated with bleeding (gastrointestinal bleeding or perforation related to previous treatments with anti-inflammatory drugs (NSAIDs) or a history of recurrent peptic haemorrhage/ulcer, with two or more distinct episodes of demonstrated ulceration or bleeding);
- if you suffer from stomach and intestinal disorders associated with the presence of lesions and bleeding (active and recurrent peptic ulcer);
- if you suffer from stomach or intestinal bleeding (gastrointestinal bleeding);
- if you have other bleeding such as cerebrovascular bleeding;
- if you suffer from ulcerative colitis or Crohn's disease;
- if you suffer from severe liver or kidney problems (severe hepatic and renal insufficiency);
- if you suffer from haemorrhages (haemorrhagic diathesis);
- if you suffer from severe heart problems (severe heart failure);
- if in the past, after taking acetylsalicylic acid or other anti-inflammatory medicines (NSAIDs), you have experienced facial swelling due to fluid accumulation, especially around the mouth and eyes (angioedema), severe respiratory difficulty (bronchospasm), breathing problems (asthma), skin irritation (urticaria), inflammation of the nasal mucous membranes (rhinitis) or nasal polyps;
- if you suffer from systemic lupus erythematosus or other skin diseases (collagen diseases);
- if you are in the third trimester of pregnancy (See paragraph Pregnancy, breastfeeding and fertility);
- before or after heart surgery;
- if you suffer from phenylketonuria, a condition in which the levels of certain substances in the urine and blood are altered. This warning refers only to the granules for oral solution as it contains aspartame.

Warnings and precautions
Consult your doctor or pharmacist before taking SPIDIDOL if you have an infection (see paragraph Infections).

Take special care with SPIDIDOL:
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 SPIDIDOL and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

Take this medicine with caution if:
- you are already taking other anti-inflammatory medicines (including selective COX-2 inhibitors, see paragraph Other medicines and SPIDIDOL);
- you are taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (See paragraph Other medicines and SPIDIDOL);
- you have suffered from high blood pressure (hypertension) because, in association with NSAID therapy, you may have problems eliminating fluids (fluid retention) and experience swelling due to the accumulation of fluids (edema);
- you have previously suffered from intestinal disorders (ulcerative colitis, Crohn's disease);
- you suffer from heart problems (mild to moderate congestive heart failure);
- you have suffered from breathing problems (bronchospasm) especially if due to the use of medicines. In patients who suffer or have suffered from bronchial asthma or allergic diseases, bronchospasm could worsen. In these cases, especially for prolonged treatments, your doctor may suggest periodic tests;
- you suffer from coagulation disorders or a decrease in heart, liver or kidney function; in these cases, especially for prolonged treatments, periodic tests may be necessary. Hypersensitivity to SPIDIDOL can cause liver problems (hepatotoxic reactions);
- you suffer from lupus erythematosus, a chronic autoimmune disease that can affect various organs and tissues and causes facial lesions and pain, or you suffer from other skin diseases (collagen diseases). In this case, you must consult your doctor before taking SPIDIDOL. The risk of developing skin disorders may increase;
- you intend to become pregnant, as the use of SPIDIDOL may impair female fertility; the use of SPIDIDOL must be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Risks of Stroke and Heart Attack
Anti-inflammatory/pain relief drugs such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your therapy with your doctor or pharmacist before taking SPIDIDOL 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, a family history of heart disease or stroke, or if you are a smoker.

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 SPIDIDOL immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Gastrointestinal risks
At any time, with or without warning symptoms or a previous history of serious gastrointestinal diseases, stomach and intestinal bleeding (gastrointestinal haemorrhage), severe lesion formation (ulceration and perforation), which can be fatal, may occur. If you have previously suffered from an ulcer, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. Your doctor will suggest taking specific medicines to protect the stomach such as misoprostol or proton pump inhibitors, especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems).
If you suffer or have suffered from stomach or intestinal problems (gastrointestinal toxicity), especially at the beginning of treatment with SPIDIDOL, tell your doctor about any gastrointestinal symptoms you experience (especially bleeding). At doses greater than 1000 mg per day, a prolongation of bleeding time may occur.
If you experience gastrointestinal bleeding or ulceration, stop treatment with SPIDIDOL and contact your doctor or the nearest hospital.

Vision problems
If you experience vision problems, stop treatment with this medicine and consult an ophthalmologist.

Elderly patients
If you are an elderly person, the risk of side effects is greater, especially bleeding and perforations in the stomach and intestines (gastrointestinal events) which can be fatal. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs.
Therefore, start treatment with the lowest available dose and take SPIDIDOL for the shortest possible period to control symptoms. Your doctor may indicate medicines that have a protective action on the stomach (misoprostol or proton pump inhibitors), especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems). If you suffer or have suffered from stomach or intestinal problems (gastrointestinal toxicity), especially at the beginning of treatment with SPIDIDOL, tell your doctor about any gastrointestinal symptoms you experience (especially bleeding). At doses greater than 1000 mg per day, a prolongation of bleeding time may occur.
If you experience gastrointestinal bleeding or ulceration, stop treatment with SPIDIDOL and contact your doctor or the nearest hospital.

Children and adolescents
This medicine should be administered with caution in dehydrated adolescents because there is an increased risk of kidney problems (see paragraph 3 Use in adolescents aged 12 to 18 years).

Use caution when starting ibuprofen treatment if you suffer from severe dehydration.

Infections
SPIDIDOL can mask the symptoms of infections such as fever and pain. It is therefore possible that SPIDIDOL 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 worsen, consult your doctor immediately.
Therefore, in case of infection, use ibuprofen therapy with caution.

NSAIDs can cause an increase in liver function test results.
You should avoid alcohol because it can increase the side effects of NSAIDs, especially those affecting the gastrointestinal tract or the central nervous system.
If you experience a hypersensitivity reaction after taking ibuprofen, stop treatment immediately.
Medically assisted measures should be initiated by specialised medical personnel, in line with the symptomatology.
Ibuprofen acid can cause a prolongation of bleeding time because it reversibly inhibits platelet aggregation.

Pay particular attention in the aforementioned cases, bearing in mind that any risk is more likely when using this medicine at high doses and in prolonged therapies.

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

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 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 generalised exanthematous pustulosis).

The following side effects may occur:

Very common (may affect more than 1 in 10 people)
- indigestion (dyspepsia);
- diarrhoea.

Common (may affect up to 1 in 10 people)
- abdominal pain or discomfort, heartburn, nausea, flatulence;
- headache, dizziness;
- skin disease, rash.

Uncommon (may affect up to 1 in 100 people)
- formation of lesions in the stomach or intestines (peptic ulcers or haemorrhages) sometimes fatal, especially in the elderly;
- vomiting;
- blood in the stools (melena);
- inflammation of the stomach (gastritis);
- inflammation of the mouth (stomatitis);
- confusion;
- drowsiness;
- itching, skin irritation (urticaria, exanthema), severe skin problem associated with bleeding (purpura);
- swelling of the face, lips, mouth, tongue or throat that can cause difficulty in breathing and swallowing (angioedema);
- allergic reactions;
- difficulty breathing (asthma, worsening of asthma, bronchospasm, dyspnea).

Rare (may affect up to 1 in 1,000 people)
- formation of lesions in the stomach or intestines (gastrointestinal perforation);
- constipation;
- blood in vomit (haematemesis);
- inflammation of the mouth associated with the presence of lesions (ulcerative stomatitis);
- worsening of certain chronic inflammatory bowel diseases (colitis and Crohn's disease);
- hearing disorders, perception of ringing in the ear (tinnitus);
- vision disorders (blurred vision, amblyopia and difficulty distinguishing colours);
- alteration of platelet, white blood cell and red blood cell levels (thrombocytopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia, granulocytopenia);
- blood in the urine (haematuria);
- difficulty passing urine (dysuria);
- liver problems (hepatotoxicity);
- altered liver function tests (elevated transaminases);
- altered diagnostic tests (increased alkaline phosphatase, reduced haematocrit, prolonged bleeding time, decreased blood calcium*, increased uric acid*);
- severe allergic reaction (anaphylaxis);
- cerebrovascular accident*.
* Effect of the NSAID class

Very rare (may affect up to 1 in 10,000 people)
- weakening of sensory and orientation functions (clouding of consciousness);
- severe skin disorders (exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, allergic vasculitis);
- kidney problems (interstitial nephritis, papillary necrosis, renal failure, including acute form);
- altered diagnostic tests (decrease in haemoglobin level in the blood).

Not known (frequency cannot be estimated from the available data)
- decreased appetite and body weight (anorexia);
- swelling of a part of the body due to fluid accumulation (edema);
- fever;
- heart problems (heart failure);
- increased blood pressure (hypertension);
- blood circulation problems (thrombosis);
- decreased blood pressure (hypotension);
- depression and mental problems (psychotic reaction);
- infection of the membranes surrounding the brain without bacterial growth in culture (aseptic meningitis);
- swelling affecting the connection point between the optic nerve and the eye (papilledema);
- drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);
- worsening of skin rashes;
- unexpected and exaggerated skin manifestations on exposure to the sun (photosensitivity reaction);
- anaemia;
- muscle stiffness;
- increased uric acid levels in the blood (hyperuricemia);
- poor elimination of sodium and fluids manifested by swelling (edema);
- menstrual cycle disorders;
- liver inflammation (hepatitis), liver damage, jaundice;
- altered kidney function test;
- severe clinical reaction triggered in a sensitised subject on contact with a specific allergen (anaphylactic shock);
- burning and pain in the throat (throat irritation);
- a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on skin folds, on the trunk and on the upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using SPIDIDOL if you develop these symptoms and contact your doctor immediately.
See also paragraph 2;
- 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, 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.