SPIDIDOL 400 MG FILM-COATED TABLETS 24 TABLETS IN AL/PE/PA BLISTER

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


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 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 fever and influenza , in addition to other medicines.

Contact your doctor if you notice no improvement or if you notice worsening of your symptoms.


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 section 6);
- if you have suffered in the past from stomach and intestinal disorders associated with bleeding (gastrointestinal bleeding or perforation related to previous treatment with anti-inflammatory drugs (NSAIDs) or history of recurrent peptic ulcer/haemorrhage, with two or more distinct episodes of proven 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 bleeding in your stomach or intestines (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 liver and kidney failure);
- 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 swelling of the face due to fluid accumulation, especially around the mouth and eyes (angioedema), severe difficulty breathing (bronchospasm), breathing problems (asthma), skin irritation (hives), inflammation of the nasal mucosa (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 section "Pregnancy, breastfeeding and fertility");
- before or after heart surgery;
- if you have phenylketonuria, a condition in which the levels of certain substances in your urine and blood are altered. This warning applies only to the granules for oral solution as they contain aspartame.


Warnings and precautions
Talk to your doctor or pharmacist before taking SPIDIDOL if you have an infection (see section "Infections").

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

Take this medicine with caution if:
- you are already taking other anti-inflammatory medicines (including selective COX-2 inhibitors, see the section "Other medicines and SPIDIDOL");
- 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 the section "Other medicines and SPIDIDOL");
- have suffered from high blood pressure (hypertension) since, in association with NSAID therapy, you may have problems eliminating fluids (water retention) and experience swelling due to fluid accumulation (edema);
- have suffered from intestinal disorders in the past (ulcerative colitis, Crohn's disease);
- suffer from heart problems (mild to moderate congestive heart failure);
- have suffered from breathing problems (bronchospasm), especially if following medication use. Bronchospasm may be worsened in patients who have or have had bronchial asthma or allergic diseases. In these cases, especially with prolonged treatments, your doctor may recommend periodic tests;
- suffer from blood clotting disorders or impaired heart, liver, or kidney function; in these cases, especially with prolonged treatment, periodic tests may be necessary. Hypersensitivity to SPIDIDOL can cause liver problems (hepatotoxic reactions);
- suffer from lupus erythematosus, a chronic autoimmune disease that can affect multiple organs and tissues and causes facial lesions and pain, or suffer from other skin diseases (collagen diseases). In this case, you should consult your doctor before taking SPIDIDOL. The risk of developing skin disorders may increase;
- intends to become pregnant, as the use of SPIDIDOL may compromise 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-relieving drugs such as ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking SPIDIDOL 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.

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

Gastrointestinal risks
At any time, with or without warning symptoms or a previous history of serious gastrointestinal disease, bleeding from the stomach and intestines (gastrointestinal hemorrhage), the formation of serious lesions (ulceration and perforation), which can be fatal, may occur.
If you have a history of ulcers, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased doses of NSAIDs. Your doctor will suggest taking specific medications to protect your stomach, such as misoprostol or proton pump inhibitors, especially if you take other medications (e.g., aspirin or medications 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). Doses higher than 1000 mg per day may result in prolonged bleeding time.
If you experience gastrointestinal bleeding or ulceration, stop treatment with SPIDIDOL and contact your doctor or the nearest hospital.

Vision problems
If you experience any vision problems, stop taking this medicine and contact your eye doctor.

Elderly patients
If you are elderly, the risk of side effects is greater, especially bleeding and perforation of the stomach and intestines (gastrointestinal events), which can be fatal. The risk of gastrointestinal bleeding, ulceration, or perforation is higher with higher doses of NSAIDs.
Therefore, start treatment with the lowest available dose and take SPIDIDOL for the shortest possible duration to control your symptoms. Your doctor may prescribe stomach-protective medications (misoprostol or proton pump inhibitors), especially if you take other medications (e.g., aspirin or medications 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, bleeding time may be prolonged.
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 given with caution to dehydrated adolescents because there is an increased risk of kidney problems (see section 3 "Use in adolescents aged 12 to 18 years").

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

Infections
SPIDIDOL may mask the symptoms of infections, such as fever and pain. Therefore, 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 persist or worsen, contact your doctor immediately. Therefore, if you have an infection, use ibuprofen therapy with caution.

NSAIDs may cause an increase in liver function test results.
You should avoid drinking 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 must be initiated by specialized medical personnel, in line with the symptoms.
Ibuprofen acid may cause a prolongation of bleeding time because it reversibly inhibits platelet aggregation.
Pay particular attention in the above cases, keeping in mind that any risk is more likely when using this medicine at high doses and during prolonged therapy.


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

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 vesicles, 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 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 start of treatment (acute generalized exanthematous pustulosis).

The following side effects may occur:

Very common (may affect more than 1 in 10 people)
- difficulty in digestion (dyspepsia);
- diarrhea.

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

Uncommon (may affect up to 1 in 100 people)
- formation of lesions in the stomach or intestine (peptic ulcers or hemorrhages) which are sometimes fatal, especially in the elderly;
- vomit;
- presence of blood in the stool (melena);
- inflammation of the stomach (gastritis);
- inflammation of the mouth (stomatitis);
- confusion;
- drowsiness;
- itching, skin irritation (hives, rash), serious skin problem associated with bleeding (purpura);
- swelling of the face, lips, mouth, tongue or throat which may cause difficulty breathing or 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 intestine (gastrointestinal perforation);
- constipation;
- presence of blood in vomit (hematemesis);
- inflammation of the mouth associated with the presence of lesions (ulcerative stomatitis);
- worsening of some chronic inflammatory bowel diseases (colitis and Crohn's disease);
- hearing problems, perception of ringing in the ear (tinnitus);
- vision disorders (blurred vision, amblyopia and color vision disorders);
- alteration of platelet, white blood cell and red blood cell levels (thrombocytopenia, agranulocytosis, aplastic anemia, hemolytic anemia, granulocytopenia);
- presence of blood in the urine (hematuria);
- difficulty passing urine (dysuria);
- liver problems (hepatotoxicity);
- alteration of liver function tests (elevated transaminases);
- alteration of diagnostic tests (increased alkaline phosphatase, decreased hematocrit, prolonged bleeding time, decreased blood calcium*, increased uric acid*);
- severe allergic reaction (anaphylaxis);
- cerebrovascular accident*.
* NSAID class effect

Very rare (may affect up to 1 in 10,000 people)
- weakening of sensory and orientation functions (clouding of the senses);
- 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);
- alteration of diagnostic tests (decrease in the level of hemoglobin in the blood).

Not known (the frequency of which 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);
- decrease in blood pressure (hypotension);
- depression and mental problems (psychotic reaction);
- infection of the membranes surrounding the brain without bacterial growth in culture (aseptic meningitis);
- a swelling affecting the connection point between the optic nerve and the eye (papilloedema);
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome): 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).
- worsening of skin rashes;
- unexpected and exaggerated skin reactions to sun exposure (photosensitivity reaction);
- anemia;
- muscle stiffness;
- increased levels of uric acid in the blood (uricemia);
- poor elimination of sodium and fluids which manifests itself with swelling (edema);
- menstrual cycle disorders;
- inflammation of the liver (hepatitis), liver damage, jaundice;
- alteration of kidney function tests;
- serious clinical reaction that occurs in a subject sensitized to contact with a specific allergen (anaphylactic shock);
- burning and sore throat (throat irritation);
- a widespread, red, scaly rash with pustules under the skin and blisters, mainly located in the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using SPIDIDOL if you develop these symptoms and contact your doctor immediately. See also section 2;
- chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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.