SPIDIDOL <400 MG Tabletki powlekane

Treść ulotki

1. SPIDIDOL 400 mg granules for oral solution cola-lemon flavour
   1. What is SPIDIDOL and what is it used for
   2. What you need to know before taking SPIDIDOL
   3. How to take SPIDIDOL
   4. Possible side effects
   5. How to store SPIDIDOL
   6. Contents of the pack and other information
2. SPIDIDOL 400 mg film-coated tablets, 400 mg oral granules apricot flavour
   1. What is SPIDIDOL and what is it used for
   2. What you need to know before taking SPIDIDOL
   3. How to take SPIDIDOL
   4. Possible side effects
   5. How to store SPIDIDOL
   6. Contents of the pack and other information

SPIDIDOL 400 mg granules for oral solution cola-lemon flavour

Ibuprofen arginine salt

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

• 1. What SPIDIDOL is and what it is used for
• 2. What you need to know before you take SPIDIDOL
• 3. How to take SPIDIDOL
• 4. Possible side effects
• 5. How to store SPIDIDOL
• 6. Contents of the pack and other information

1. What is SPIDIDOL and what is it used for

This medicine contains the active ingredient ibuprofen, belonging to a group of medicines known
as non-steroidal anti-inflammatory drugs (NSAIDs) which 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:

• Treatment of pain: headache, toothache, menstrual pain, neuralgia, osteoarticular (bone) and muscular pain.
• Treatment of feverish and flu-like states,in addition to other medicines.

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

2. What you need to know before taking SPIDIDOL

Do not take SPIDIDOL

• if you are allergic to ibuprofen, to other similar medicines or to any of the other components of this medicine (listed in paragraph 6);
• if you have previously suffered from stomach and intestinal disorders associated with bleeding (gastrointestinal hemorrhage or perforation related to previous treatments with anti-inflammatory medicines (NSAIDs) or a history of recurrent peptic hemorrhage/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 bleeding in the stomach or intestines (gastrointestinal bleeding);
• if you have ongoing 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 bleeding disorders (hemorrhagic 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 (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 urine and blood are altered.

Warnings and precautions
Consult your doctor or pharmacist before taking SPIDIDOL if you have an infection (see paragraph
“Infections” below).
Pay particular attention 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 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 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) as, in association with NSAID therapy, you may have problems eliminating fluids (fluid retention) and experience swelling due to fluid accumulation (edema);
• you have previously suffered from intestinal disorders (ulcerative colitis, Crohn's disease);
• you suffer from heart disorders (congestive heart failure from mild to moderate);
• you have suffered from breathing problems (bronchospasm) especially following the use of medicines. In patients who suffer or have suffered from bronchial asthma or allergic diseases, bronchospasm may worsen. In these cases, especially for prolonged treatments, your doctor may suggest periodic analyses;
• you suffer from blood clotting disorders or a decrease in the functioning of the heart, liver or kidneys; in these cases, especially for prolonged treatments, periodic analyses 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 lesions on the face 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;
• you are planning a pregnancy, as the use of SPIDIDOL may impair female fertility; the use of SPIDIDOL should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Risks of Stroke and Heart Attack
Anti-inflammatory/pain relievers may be associated with a modest increase in the risk of
heart attack or stroke, especially if administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss the 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 transient ischemic attack (TIA));
• 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 (angioedema) and chest pain, have been reported with ibuprofen.
Immediately stop SPIDIDOL 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 events,
bleeding in the stomach and intestines (gastrointestinal hemorrhage), formation of serious lesions (ulceration and perforation), which can be fatal, have been reported.
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 may suggest taking specific medicines to
protect your 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), in particular
at the beginning of treatment with SPIDIDOL, inform your doctor of any gastrointestinal symptoms you experience (especially bleeding). At doses higher than 1000 mg per day, a
prolongation of bleeding time may occur.
If you should experience bleeding or a gastrointestinal ulcer, discontinue treatment with
SPIDIDOL and consult your doctor or the nearest hospital.

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

Elderly Patients
If you are an elderly person, the risk of adverse 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 useful to control the symptoms. Your doctor may indicate medicines that perform
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), in particular
at the beginning of treatment with SPIDIDOL, inform your doctor
of any gastrointestinal symptoms you experience (especially bleeding). At doses higher than 1000
mg per day, a prolongation of bleeding time may occur.
If you should experience bleeding or a gastrointestinal ulcer, discontinue treatment with
SPIDIDOL and consult your doctor or the nearest hospital.

Children and Adolescents
This medicine should be administered with caution in dehydrated adolescents because there is a
greater risk of kidney problems (see paragraph 3 “Use in adolescents aged between 12 and 18 years”).
Use caution when starting treatment with ibuprofen 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 skin infections
related to varicella. 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 with caution.
NSAIDs can cause an increase in liver function test results.
You should avoid consuming alcohol as it may 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.
Acidic ibuprofen can 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

using this medicine at high doses and in prolonged therapies.

Other medicines and SPIDIDOL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Taking SPIDIDOL, like other similar medicines (non-steroidal anti-inflammatory drugs,
analgesics, antipyretics), can cause allergic-type reactions (hypersensitivity), even serious ones (see the
paragraph “Possible side effects”). Do not use SPIDIDOL if you are taking other anti-inflammatory medicines
(e.g. analgesics, antipyretics and other NSAIDs, such as acetylsalicylic acid/Aspirin),
because the risk of side effects may increase. If you take products based on acetylsalicylic acid
(Aspirin) for heart problems, do not take SPIDIDOL at the same time as it may
reduce the cardioprotective effect.
SPIDIDOL can influence or be influenced by other medicines. For example:

• medicines used to reduce inflammation and for the treatment of allergies (oral corticosteroids); SPIDIDOL may increase the risk of ulcers or bleeding in the stomach or intestine;
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine); SPIDIDOL may increase the effect of these medicines, your doctor may therefore ask you to undergo appropriate tests to assess whether to modify your therapy. SPIDIDOL may also increase the risk of bleeding in the stomach or intestine when taken concurrently with antiplatelet agents;
• medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan). SPIDIDOL may alter the effect of the medicines you are taking. Also, if you have kidney problems, especially if you are elderly or dehydrated, SPIDIDOL may worsen your condition if you are taking ACE inhibitors or angiotensin II antagonists; in these cases, it is necessary that you take an adequate amount of fluids, in addition, the doctor may periodically check the correct functioning of your kidneys after the start of treatment;
• medicines used for the treatment of depression and anxiety disorders (selective serotonin reuptake inhibitors) SPIDIDOL may increase the risk of bleeding in the stomach or intestine;
• medicines used for mental disorders based on lithium and phenytoin;
• medicines used for the treatment of heart problems such as digoxin;
• non-steroidal anti-inflammatory drugs (NSAIDs) including selective COX-2 inhibitors. SPIDIDOL should be used with caution in association with other NSAIDs because it may increase the risk of adverse reactions in the gastrointestinal tract;
• medicines based on methotrexate, used for the uncontrolled proliferation of blood cells (leukemia), for chronic inflammatory skin diseases (psoriasis) and for chronic inflammatory joint diseases associated with those affecting the skin (psoriatic arthritis). SPIDIDOL may increase plasma levels of methotrexate;
• medicines based on zidovudine used for the treatment of infection with the Human Immunodeficiency Virus (HIV). SPIDIDOL may increase the risk of bleeding into the joints or muscles of patients with HIV (+);
• medicines based on tacrolimus and cyclosporine used to prevent rejection in patients receiving liver, kidney or heart transplants. SPIDIDOL may increase the risk of renal toxicity;
• medicines used to lower blood sugar levels, hypoglycemic agents and insulin. It may be necessary to adjust the dosage;
• medicines based on cyclosporine used to reduce the activity of the immune system in autoimmune diseases. SPIDIDOL may increase the risk of renal toxicity;
• medicines with an antifungal effect, based on voriconazole and fluconazole. It may be necessary to adjust the dosage of SPIDIDOL;
• medicines used for the interruption of pregnancy, based on mifepristone. It may be necessary to adjust the dosage of SPIDIDOL. Furthermore, the effectiveness of mifepristone may theoretically be reduced;
• medicines used for the treatment of bacterial infections, such as quinolone antibiotics. SPIDIDOL may lead to an increased risk of seizures;
• medicines used for the treatment of bacterial infections, such as aminoglycosides. SPIDIDOL may decrease their elimination;
• products containing ginkgo biloba. SPIDIDOL may potentiate the risk of bleeding;
• medicines containing bisphosphonates, drugs for the treatment of bone diseases, and pentoxifylline, a vasodilator drug, may potentiate gastrointestinal side effects and the risk of bleeding and ulcer.
• medicines based on baclofen, a muscle relaxant used for severe muscle and nervous system pathologies: high toxicity of baclofen.

SPIDIDOL can affect the results of the following diagnostic tests:

• tests to assess the time required to stop blood loss after bleeding (bleeding time may be prolonged for up to one day after stopping therapy)
• tests to assess blood sugar concentrations (concentrations may decrease)
• to assess kidney function, through the dosage of creatinine, potassium levels and nitrogen (levels may increase)
• tests to assess blood composition and hemoglobin (values may decrease)
• tests to assess liver function through the dosage of transaminases (values may increase).

Even some other medicines can influence or be influenced by treatment with SPIDIDOL.
Therefore, always consult your doctor or pharmacist before using SPIDIDOL with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Before starting treatment, make sure you are not pregnant, stop it if you find out you are.
Do not take SPIDIDOL if you are in the last 3 months of pregnancy as it may harm the fetus
or cause problems during childbirth. NSAIDs can cause problems with the kidneys and heart of the fetus.
It may affect the tendency of the mother and child to bleed and delay or
prolong labor more than expected. You should not take SPIDIDOL in the first 6 months of
pregnancy unless absolutely necessary and under the advice of your doctor.
If treatment is necessary during this period or during attempts to conceive, it should
be used at the lowest possible dose and duration. If taken for more than a few
days from the twentieth week of pregnancy onwards, NSAIDs can cause kidney problems in
the fetus, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or
causing the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If
treatment is necessary for more than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Avoid taking SPIDIDOL during breastfeeding.

Fertility
Do not take SPIDIDOL if you have fertility problems.

Driving and operating machinery
This medicine can cause drowsiness, dizziness, headache and depression that can
impair the ability to drive vehicles and operate machinery. If these effects occur,
avoid driving vehicles and operating machinery.

SPIDIDOL granules for oral solution contains aspartame, sucrose and sodium

• This medicine contains 60 mg of aspartame per sachet equivalent to 60 mg/3 g. Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the body is unable to dispose of it correctly (see paragraph “Do not take Spididol”).
• This medicine contains sucrose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains 56.98 mg of sodium (main component of table salt) per sachet. This is equivalent to 2.85% of the maximum recommended daily intake with the diet of an adult. To be taken into consideration in people with reduced kidney function or who are following a low-sodium diet.

3. How to take SPIDIDOL

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults and adolescents (from 12 years)
The recommended dose is 1 sachet, 2-3 times a day.
Do not exceed the maximum recommended dose of 1200 mg per day (3 sachets).
Dissolve the contents of one sachet in a glass of water (50-100 ml) and take it immediately after dissolving. Take the solution with a full stomach.

Use in adolescents aged between 12 and 18 years
Consult your doctor if treatment for more than 3 days is necessary or if a worsening of symptoms occurs.

Use in elderly people
If you are an elderly person, adhere to the minimum dosages indicated above. However, always consult your doctor because a dose reduction may be necessary.

Use in people with impaired renal, hepatic or cardiac function
If you are a person with impaired renal, hepatic or cardiac function, always consult your doctor because a dose reduction may be necessary. In cases of severe renal, hepatic or cardiac insufficiency, the USE of SPIDIDOL is contraindicated (see paragraph “Do not take SPIDIDOL”).
Do not exceed the recommended dose or the duration of treatment.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms.
If you have an infection, consult your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see paragraph 2).

If you take more SPIDIDOL than you should
If you have taken more SPIDIDOL than you should or if your child has mistakenly taken this medicine, always contact a doctor or the nearest hospital and bring with you the packaging of the medicine and the undertaking.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), diarrhea (with blood), gastrointestinal bleeding (see also paragraph 4), headache, ringing in the ears, confusion, uncontrolled eye movements and double vision. Agitation, drowsiness, disorientation or coma may also occur.
Occasionally patients develop convulsions. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in the urine, low potassium levels in the blood, feeling cold and breathing problems have been reported. In addition, the prothrombin time/INR may be prolonged, probably due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage may occur. In asthmatic subjects, an exacerbation of asthma is possible.
In addition, low blood pressure and reduced breathing may occur. In case of severe poisoning, disturbances in renal function, low blood pressure, decreased state of consciousness and coma may also occur.
You may also experience: stomach pain, a state of deep sleep with reduced response to normal stimuli (lethargy), loss of muscle coordination (ataxia), severe muscle disorders (rhabdomyolysis), epileptic seizures, a state of excitement, fainting, decrease or increase or alteration of the heartbeat (bradycardia, tachycardia).
Rarely, temporary interruption of breathing (apnea), reduction of the activity of the central nervous system (Central Nervous System depression) may occur.
In case of severe poisoning, metabolic acidosis (increased acids in the blood) may occur.
Symptoms of an overdose may appear within 4-6 hours of taking ibuprofen.
If you have any doubts about the use of SPIDIDOL, consult your doctor or pharmacist.

If you forget to take SPIDIDOL
Do not take a double dose to make up for a missed dose.
If you have any doubts, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using ibuprofene 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, mouth, throat, nose, genitals and eye ulcers. These serious 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 swollen lymph nodes (DRESS syndrome).
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The following side effects may occur:

Very common(may affect more than 1 in 10 people)

• difficulty digesting food (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 sores in the stomach or intestine (peptic ulcers or bleeding), sometimes fatal, particularly 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, rash), serious skin problem associated with bleeding (purpura);
• swelling of the face, lips, mouth, tongue or throat which may 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 sores in the stomach or intestine (gastrointestinal perforation);
• constipation;
• blood in vomit (hematemesis);
• inflammation of the mouth associated with the presence of sores (ulcerative stomatitis);
• worsening of certain chronic inflammatory bowel diseases (colitis and Crohn's disease);
• hearing disorders, ringing in the ears (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 urinating (dysuria);
• liver problems (hepatotoxicity);
• alteration of liver function tests (elevated transaminases);
• alteration of diagnostic tests (increased alkaline phosphatase, reduced haematocrit, prolonged bleeding time, decreased blood calcium*, increased uric acid*);
• severe allergic reaction (anaphylaxis);
• stroke*.

Very rare(may affect up to 1 in 10,000 people)

• weakening of sensory and orientation functions (obnubilation 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);
• alteration of diagnostic tests (decrease in blood haemoglobin level).

Not known(frequency cannot be estimated from 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);
• a swelling that affects the point of connection between the optic nerve and the eye (papilloedema);
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells);
• worsening of skin rashes;
• unexpected and exaggerated skin manifestations upon exposure to sunlight (photosensitivity reaction);
• anaemia;
• muscle stiffness;
• increased levels of uric acid in the blood (uricemia);
• poor elimination of sodium and fluids, which manifests with swelling (edema);
• menstrual cycle disorders;
• inflammation of the liver (hepatitis), liver damage, jaundice;
• alteration of kidney function tests;
• severe clinical reaction triggered in a subject sensitized to 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 the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized 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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store SPIDIDOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SPIDIDOL contains

• The active ingredient is ibuprofen arginine salt, corresponding to 400 mg of ibuprofen.
• The other ingredients are: l-Arginine, sodium bicarbonate, sodium saccharin, aspartame, cola-lemon flavour, sucrose.

Description of the appearance of SPIDIDOL and contents of the pack
SPIDIDOL 400 mg granules for oral solution cola-lemon flavour
Pack of 12 sachets of 400 mg.

Marketing Authorisation Holder
ZAMBON ITALIA s.r.l - Via Lillo del Duca, 10 - 20091 Bresso (MI)

Manufacturer
ZAMBON S.p.A. - via della Chimica 9 – 36100 - Vicenza

SPIDIDOL 400 mg film-coated tablets, 400 mg oral granules apricot flavour

Ibuprofen arginine salt

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

• 1. What SPIDIDOL is and what it is used for
• 2. What you need to know before you take SPIDIDOL
• 3. How to take SPIDIDOL
• 4. Possible side effects
• 5. How to store SPIDIDOL
• 6. Contents of the pack and other information

1. What is SPIDIDOL and what is it used for

This medicine contains the active ingredient ibuprofen, belonging to a group of medicines known
as non-steroidal anti-inflammatory drugs (NSAIDs) which 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 feverish and flu-like states,in addition to other medicines.

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

2. What you need to know before taking SPIDIDOL

Do not take SPIDIDOL

• if you are allergic to ibuprofen, other similar medicines or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously suffered from stomach and intestinal disorders associated with bleeding (gastrointestinal haemorrhage or perforation related to previous treatments with anti-inflammatory medicines (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 bleeding in the stomach or intestines (gastrointestinal bleeding);
• if you have ongoing 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 failure);
• if you suffer from bleeding disorders (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 (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 section “Pregnancy, breastfeeding and fertility”);
• before or after heart surgery;
• if you have phenylketonuria, a condition in which the levels of certain substances in urine and blood are altered. This warning applies 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 section
“Infections”).
Take particular care with SPIDIDOL:
Severe skin reactions have been reported in association with ibuprofen treatment, including
exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP). Stop using SPIDIDOL and contact your doctor immediately if you notice
any of the symptoms related to these severe 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 section “Other medicines and SPIDIDOL”);
• you are taking other medicines that may 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 section “Other medicines and SPIDIDOL”);
• you have suffered from high blood pressure (hypertension) as, in association with NSAID therapy, you may have problems eliminating fluids (fluid retention) and experience swelling due to accumulation of these fluids (edema);
• you have previously suffered from intestinal disorders (ulcerative colitis, Crohn's disease);
• you suffer from heart disorders (congestive heart failure from mild to moderate);
• you have suffered from breathing problems (bronchospasm) especially following the use of medicines. In patients who suffer from or have suffered from bronchial asthma or allergic diseases, bronchospasm may worsen. In these cases, especially for prolonged treatments, your doctor may suggest you undergo periodic tests;
• you suffer from blood clotting disorders or decreased function of the heart, liver or kidneys; 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 lesions on the face and pain, or suffer from other skin diseases (collagen diseases). In this case, you should consult your doctor before taking SPIDIDOL. The risk of skin disorders may increase;
• you are planning to become pregnant, as the use of SPIDIDOL may impair female fertility; the use of SPIDIDOL should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Risks of Stroke and Heart Attack
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a modest
increase in the risk of heart attack or stroke, especially if administered at high doses. Do not
exceed the recommended dose or duration of treatment.
You should discuss the 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 blockage 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 region (angioedema) and chest pain have been reported with ibuprofen.
Immediately stop SPIDIDOL and contact your doctor or emergency health service immediately if you notice any of these signs.

Gastrointestinal Risks
At any time, with or without warning symptoms or a previous history of severe gastrointestinal
diseases, bleeding from the stomach and intestines (gastrointestinal haemorrhage), formation of severe
lesions (ulceration and perforation) can occur, which may be fatal.
If you have had an ulcer in the past, the risk of gastrointestinal bleeding, ulceration or perforation
is higher with increased doses of NSAIDs. Your doctor may suggest you take specific medicines to
protect your 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 from or have suffered from stomach or intestinal problems (gastrointestinal toxicity), in particular
at the beginning of treatment with SPIDIDOL, tell your doctor about any gastrointestinal symptoms
you experience (especially bleeding). At doses higher than 1000 mg per day, a prolongation of bleeding time may occur.
If you experience bleeding or a gastrointestinal ulcer, stop treatment with
SPIDIDOL and consult your doctor or the nearest hospital.

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

Elderly Patients
If you are an elderly person, the risk of adverse 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
period possible useful to control the symptoms. Your doctor may recommend medicines that have a
protective effect 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 from or have suffered from stomach or intestinal problems (gastrointestinal
toxicity), particularly at the beginning of treatment with SPIDIDOL, tell your doctor
about any gastrointestinal symptoms you experience (especially bleeding). At doses higher than 1000
mg per day, bleeding time may be prolonged.
If you experience bleeding or a gastrointestinal ulcer, stop treatment with
SPIDIDOL and consult your doctor or the nearest hospital.

Children and Adolescents
This medicine should be administered with caution in dehydrated adolescents because there is a
greater risk of kidney problems (see section 3 “Use in adolescents aged between
12 and 18 years”).
Use caution when starting treatment with ibuprofen if you suffer from severe dehydration.

Infections
SPIDIDOL can mask the symptoms of infections such as fever and pain. Therefore, it is 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 skin infections
bacterial related to varicella. 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 consuming alcohol as it may 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 can 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

using this medicine at high doses and in prolonged therapies.

Other medicines and SPIDIDOL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Taking SPIDIDOL, like other medicines similar to it (non-steroidal anti-inflammatory drugs,
analgesics, antipyretics), can cause allergic (hypersensitivity) reactions, even serious ones (see the
paragraph “Possible side effects”). Do not use SPIDIDOL if you are taking other anti-inflammatory
medicines (e.g. analgesics, antipyretics and other NSAIDs, such as acetylsalicylic acid/Aspirin),
because the risk of side effects may increase. If you take products based on acetylsalicylic acid
(Aspirin) for heart problems, do not take SPIDIDOL at the same time, as the cardioprotective effect may be
reduced.
SPIDIDOL can influence or be influenced by other medicines. For example:

• medicines used to reduce inflammation and for the treatment of allergies (oral corticosteroids); SPIDIDOL may increase the risk of ulcers or bleeding in the stomach or intestines;
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine); SPIDIDOL may increase the effect of these medicines, your doctor may therefore ask you to undergo appropriate tests to assess whether to modify your therapy. SPIDIDOL may also increase the risk of bleeding in the stomach or intestines when taken concurrently with antiplatelet agents;
• medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). SPIDIDOL may alter the effect of the medicines you are taking. Furthermore, if you have kidney problems, especially if you are elderly or dehydrated, SPIDIDOL may worsen your condition if you are taking ACE inhibitors or angiotensin II antagonists; in these cases it is necessary for you to take an adequate amount of fluids, and the doctor may periodically check the proper functioning of your kidneys after starting treatment;
• medicines used for the treatment of depression and anxiety disorders (selective serotonin reuptake inhibitors) SPIDIDOL may increase the risk of bleeding in the stomach or intestines;
• medicines used for mental disorders based on lithium and phenytoin;
• medicines used for the treatment of heart problems such as digoxin;
• non-steroidal anti-inflammatory drugs (NSAIDs) including selective COX-2 inhibitors. SPIDIDOL should be used with caution in association with other NSAIDs because it may increase the risk of adverse reactions in the gastrointestinal tract;
• medicines, based on methotrexate, used for the uncontrolled proliferation of blood cells (leukemia), for chronic inflammatory skin diseases (psoriasis) and for chronic inflammatory joint diseases associated with those affecting the skin (psoriatic arthritis). SPIDIDOL may increase plasma levels of methotrexate;
• medicines based on zidovudine used for the treatment of infection with the Human Immunodeficiency Virus (HIV). SPIDIDOL may increase the risk of bleeding in the joints or muscles of HIV (+) hemophilic patients;
• medicines based on tacrolimus and cyclosporine used to prevent rejection in patients receiving liver, kidney or heart transplants. SPIDIDOL may increase the risk of renal toxicity;
• medicines used to lower blood sugar levels, hypoglycemic agents and insulin. It may be necessary to adjust the dosage;
• medicines based on cyclosporine used to reduce the activity of the immune system in autoimmune diseases. SPIDIDOL may increase the risk of renal toxicity;
• medicines with an antifungal effect, based on voriconazole and fluconazole. It may be necessary to adjust the dosage of SPIDIDOL;
• medicines used for the interruption of pregnancy, based on mifepristone. It may be necessary to adjust the dosage of SPIDIDOL. Furthermore, the effectiveness of mifepristone may theoretically be reduced;
• medicines used for the treatment of bacterial infections, such as quinolone antibiotics. SPIDIDOL may lead to an increased risk of seizures;
• medicines used for the treatment of bacterial infections, such as aminoglycosides. SPIDIDOL may decrease their elimination;
• products containing ginkgo biloba. SPIDIDOL may potentiate the risk of bleeding;
• medicines containing bisphosphonates, drugs for the treatment of bone diseases, and pentoxifylline, a vasodilator drug: may potentiate gastrointestinal side effects and the risk of bleeding and ulcer;
• medicines based on baclofen, a muscle relaxant used for severe muscle and nervous system pathologies: high toxicity of baclofen.

SPIDIDOL can influence the results of the following diagnostic tests:

• tests to assess the time required to stop blood loss after bleeding (bleeding time may be prolonged up to one day after stopping therapy)
• tests to assess blood sugar levels (levels may decrease)
• to assess kidney function, through the dosage of creatinine, potassium levels and nitrogen (levels may increase)
• tests to assess blood composition and hemoglobin (values may decrease)
• tests to assess liver function through the dosage of transaminases (values may increase).

Some other medicines may also influence or be influenced by treatment with SPIDIDOL.
Therefore, always consult your doctor or pharmacist before using SPIDIDOL with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Before starting treatment, make sure you are not pregnant, stop it if you find out you are.
Do not take SPIDIDOL if you are in the last 3 months of pregnancy as it may harm the fetus
or cause problems during childbirth. NSAIDs can cause problems with the kidneys and heart of the fetus.
It may affect the tendency of the mother and child to bleed and delay or
prolong labor more than expected. You should not take SPIDIDOL in the first 6 months of
pregnancy unless absolutely necessary, and under the advice of your doctor.
If treatment is necessary during this period or during attempts to conceive, it should
be used at the lowest possible dose and duration. If taken for more than a few
days from the twentieth week of pregnancy onwards, NSAIDs can cause kidney problems in
the fetus, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or
causing the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If
treatment is necessary for more than a few days, the doctor may advise additional monitoring.

Breastfeeding
Avoid taking SPIDIDOL during breastfeeding.

Fertility
Do not take SPIDIDOL if you have fertility problems.

Driving and operating machinery
This medicine can cause drowsiness, dizziness, headache and depression that can
impair the ability to drive vehicles and operate machinery. If these effects occur,
avoid driving vehicles and operating machinery.

SPIDIDOL 400 mg coated tablets contains sucrose and sodium

• This medicine contains sucrose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains 82.98 mg of sodium (main component of table salt) per tablet. This is equivalent to 4.15% of the recommended maximum daily intake with the diet of an adult. This should be taken into consideration in people with impaired renal function or who are following a low-sodium diet.

SPIDIDOL 400 mg granules for oral solution contains aspartame, sucrose and sodium

• This medicine contains 60 mg of aspartame per sachet equivalent to 60 mg/3 g. Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the body cannot dispose of it properly (see paragraph “Do not take Spididol”).
• This medicine contains sucrose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains 56.98 mg of sodium (main component of table salt) per sachet. This is equivalent to 2.85% of the recommended maximum daily intake with the diet of an adult. This should be taken into consideration in people with impaired renal function or who are following a low-sodium diet.

3. How to take SPIDIDOL

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults and adolescents (from 12 years of age)
The recommended dose is 1 tablet or 1 sachet, 2-3 times a day.
Do not exceed the recommended maximum dose of 1200 mg per day (3 tablets/sachets).
Take the tablets with a little water. If you suffer from stomach problems, take the tablets with a full stomach.
Granules: dissolve the contents of one sachet in a glass of water (50-100 ml) and take it immediately after dissolving. Take the solution with a full stomach.

Use in adolescents aged between 12 and 18 years
Consult your doctor if treatment for more than 3 days is necessary or if symptoms worsen.

Use in elderly people
If you are an elderly person, adhere to the minimum dosages indicated above. However, always consult your doctor as a dose reduction may be necessary.

Use in people with impaired renal, hepatic or cardiac function
If you are a person with impaired renal, hepatic or cardiac function, always consult your doctor as a dose reduction may be necessary. In cases of severe renal, hepatic or cardiac insufficiency, the use of SPIDIDOL is contraindicated (see section “Do not take SPIDIDOL”).
Do not exceed the recommended dose or the duration of treatment.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms.
If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

If you take more SPIDIDOL than you should
If you have taken more SPIDIDOL than you should or if your child has taken this medicine by mistake, always contact a doctor or the nearest hospital and bring with you the packaging of the medicine and the undertaking.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), diarrhea (with blood), gastrointestinal bleeding (see also section 4), headache, ringing in the ears, confusion, involuntary eye movements and double vision. Agitation, drowsiness, disorientation or coma may also occur.
Occasionally patients develop convulsions. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in the urine, low potassium levels in the blood, feeling cold and breathing problems have been reported. In addition, the prothrombin/INR time may be prolonged, probably due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage may occur. In asthmatic subjects, an exacerbation of asthma is possible.
Furthermore, a drop in blood pressure and reduced breathing may occur. In case of severe poisoning, disturbances in renal function, low blood pressure, decreased state of consciousness and coma may also occur.
You may also experience: stomach pain, a state of deep sleep with reduced response to normal stimuli (lethargy), loss of muscle coordination (ataxia), severe muscle disorders (rhabdomyolysis), epileptic seizures, a state of excitement, fainting, decrease or increase or alteration of heartbeats (bradycardia, tachycardia).
Rarely, temporary interruption of breathing (apnea), reduction of the activity of the central nervous system (depression of the Central Nervous System) may occur.
In case of severe poisoning, metabolic acidosis (increased acids in the blood) may occur.
Symptoms of an overdose may appear within 4-6 hours of taking ibuprofen.
If you have any doubts about the use of SPIDIDOL, consult your doctor or pharmacist.

If you forget to take SPIDIDOL
Do not take a double dose to make up for a missed dose.
If you have any doubts, consult your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using ibuprofene and consult your doctor immediately if you notice any of the following
symptoms:

• reddish, non-raised patches, target-shaped or circular on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These serious 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 swollen 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 following side effects may occur:

Very common(may affect more than 1 in 10 people)

• difficulty digesting food (dyspepsia);
• diarrhoea.

Common(may affect up to 1 in 10 people)

• stomach or abdominal pain, heartburn, nausea, flatulence;
• headache, dizziness;
• skin disease, rash.

Uncommon(may affect up to 1 in 100 people)

• formation of sores in the stomach or intestine (peptic ulcers or bleeding), 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, rash), serious skin problem associated with bleeding (purpura);
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty 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 holes in the stomach or intestine (gastrointestinal perforation);
• constipation;
• blood in the vomit (hematemesis);
• inflammation of the mouth associated with the presence of sores (ulcerative stomatitis);
• worsening of certain chronic inflammatory bowel diseases (colitis and Crohn's disease);
• hearing disorders, ringing in the ears (tinnitus);
• vision disorders (blurred vision, amblyopia and difficulty distinguishing colors);
• alteration of platelet, white blood cell and red blood cell levels (thrombocytopenia, agranulocytosis, aplastic anemia, hemolytic anemia, granulocytopenia);
• blood in the urine (hematuria);
• difficulty urinating (dysuria);
• liver problems (hepatotoxicity);
• alteration of liver function tests (elevated transaminases);
• alteration of diagnostic tests (increased alkaline phosphatase, reduced hematocrit, prolonged bleeding time, decreased blood calcium*, increased uric acid*);
• severe allergic reaction (anaphylaxis);
• stroke*.

Very rare(may affect up to 1 in 10,000 people)

• weakening of sensory and orientation functions (obnubilation of consciousness);
• severe skin disorders (exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, allergic vasculitis);
• kidney problems (interstitial nephritis, papillary necrosis, kidney failure, including acute form);
• alteration of diagnostic tests (decrease in blood hemoglobin levels).

Not known(frequency cannot be estimated from 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);
• a swelling affecting the point of connection 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. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• worsening of skin rashes;
• unexpected and exaggerated skin manifestations upon exposure to the sun (photosensitivity reaction);
• anemia;
• muscle stiffness;
• increased levels of uric acid in the blood (uricemia);
• poor elimination of sodium and fluids which manifests with swelling (edema);
• menstrual cycle disorders;
• inflammation of the liver (hepatitis), liver damage, jaundice;
• alteration of kidney function tests;
• a serious clinical reaction triggered in a subject sensitized to 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 the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized 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, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store SPIDIDOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The
expiry date refers to the last day of that month.
Store the tablets at a temperature not exceeding 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SPIDIDOL contains
SPIDIDOL 400 mg granules for oral solution apricot flavour

• The active ingredient is ibuprofen arginine salt, corresponding to 400 mg of ibuprofen.
• The other ingredients are: l-Arginine, sodium bicarbonate, sodium saccharin, aspartame, apricot flavour, sucrose.

SPIDIDOL 400 mg film-coated tablets

• The active ingredient is ibuprofen arginine salt, corresponding to 400 mg of ibuprofen.
• The other ingredients are: l-Arginine, sodium bicarbonate, crospovidone, magnesium stearate, hydroxypropylmethylcellulose, sucrose, titanium dioxide, polyethylene glycol.

Description of the appearance of SPIDIDOL and contents of the pack
SPIDIDOL 400 mg granules for oral solution apricot flavour
Pack of 12 sachets of 400 mg.
SPIDIDOL 400 mg film-coated tablets
Pack of 3, 6, 12, 20, 24 and 30 tablets of 400 mg.

Marketing Authorisation Holder
ZAMBON ITALIA s.r.l - Via Lillo del Duca, 10 - 20091 Bresso (MI)

Manufacturer
ZAMBON S.p.A. - via della Chimica 9 – 36100 - Vicenza