Spididol analgesico

Package leaflet: Information for the patient

SPIDIDOL ANALGESIC 200 mg/ml oral drops solution

Ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What SPIDIDOL ANALGESIC is and what it is used for

This medicinal product contains the active ingredient ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving pain (analgesic effect) and reducing symptoms of inflammation (anti-inflammatory effect).
SPIDIDOL ANALGESIC is indicated:

• for the treatment of pain of various origin and nature, such as headache, toothache, nerve pain (neuralgia), bone, joint and muscle pain (osteo-articular and muscular pain), menstrual pain;
• as an adjunct in the treatment of symptoms of fever and influenza.

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

2. What you should know before taking SPIDIDOL ANALGESIC

Do not take SPIDIDOL ANALGESIC

• if you are allergic to ibuprofen, to other similar anti-inflammatory medicines (e.g. acetylsalicylic acid) or to any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking anti-inflammatory medicines (NSAIDs) or acetylsalicylic acid, you experienced swelling of the face due to fluid accumulation, especially around the mouth and eyes (angioedema), severe breathing difficulties (bronchospasm), breathing problems (asthma), skin irritation (urticaria), or inflammation of the nasal mucosa (rhinitis);
• if the patient is a child under 12 years of age;
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if you suffer from stomach or intestinal problems associated with lesions (active or severe gastroduodenal ulcer) or other stomach disorders (gastropathies);
• if you have previously experienced stomach or intestinal disorders associated with bleeding (gastrointestinal haemorrhage, perforation related to previous NSAID treatment, or history of bleeding, recurrent peptic ulcer with two or more distinct episodes of proven ulceration or bleeding);
• if you currently have other types of bleeding, such as cerebrovascular haemorrhage or ulcerative colitis;
• if you suffer from bleeding disorders (haemorrhagic diathesis);
• if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from severe heart disorders (severe heart failure);
• if you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.

Warnings and precautions
Talk to your doctor or pharmacist before taking SPIDIDOL ANALGESIC if:

• you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes); avoid taking SPIDIDOL ANALGESIC, as in these cases the risk of ulcers and bleeding may increase;
• you are taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents like aspirin (see section “Other medicines and SPIDIDOL ANALGESIC”);
• you have previously suffered from intestinal disorders (ulcerative colitis, Crohn’s disease);
• you suffer from heart disorders (mild to moderate congestive heart failure);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease (a condition affecting the skin, joints and kidneys);
• you have lost a significant amount of fluids. Ibuprofen may cause fluid and salt retention (sodium and potassium), even in patients who have never had kidney problems. This may lead to fluid accumulation (oedema), reduced heart function (heart failure), or increased blood pressure (hypertension) in predisposed patients;
• you have previously experienced breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs);
• you suffer from blood clotting disorders;
• you intend to become pregnant, as the use of SPIDIDOL ANALGESIC may impair female fertility; the use of SPIDIDOL ANALGESIC should be discontinued in women with fertility problems or undergoing fertility investigations;
• you suffer from asthma or allergic diseases, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), or inflammation of the nasal mucosa (sinusitis), as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema);
• you have an infection, as SPIDIDOL ANALGESIC may mask its symptoms;
• you suffer from heart problems, including heart failure, angina (chest pain), or have a history of heart attack, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke;
• you suffer from hypertension, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker;
• you are elderly, as the risk of bleeding, ulcers, and perforations is higher than in other patients;
• you have an infection (see section “Infections” below).

Use particular caution with SPIDIDOL ANALGESIC:
Serious skin reactions have been reported during treatment with ibuprofen, 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).
Stop using SPIDIDOL ANALGESIC and contact your doctor immediately if you notice any of the symptoms
related to these serious skin reactions described in section 4.
Adverse effects can be minimized by using the lowest recommended dose and only for the shortest duration
necessary to control your symptoms.
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of
heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or
treatment duration.
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 taking SPIDIDOL
ANALGESIC and contact your doctor or emergency medical services if you notice any of these signs.
If you have reduced kidney function, or heart or liver impairment, you may be more prone to kidney problems.
Additionally, habitual concomitant use of multiple analgesics may further increase this risk. In such cases,
the initial dose should be as low as possible and the treatment duration as short as possible.
In general, if you use pain medicines for a long period (even of different types), this may lead to serious and
persistent kidney problems.
Regular monitoring of liver function, kidney function, and blood cell counts is required during prolonged
treatment with SPIDIDOL ANALGESIC. Your doctor may ask you to have blood tests during treatment.
Your doctor should be informed if you are taking SPIDIDOL ANALGESIC for a prolonged period and suffer
from systemic lupus erythematosus, as kidney function should be monitored in this case.
Gastrointestinal bleeding and/or intestinal bleeding (gastrointestinal haemorrhage, ulceration, and perforation)
have occurred during treatment with anti-inflammatory medicines (NSAIDs). These effects can be fatal and
may occur at any time during treatment, with or without warning symptoms, even if you have not previously
suffered from serious stomach or intestinal disorders.
In particular, if you are elderly or have previously had ulcers, especially if the ulcer was associated with
bleeding or perforation, the risk of bleeding, ulceration, or perforation is higher with high doses of anti-inflammatory
medicines; therefore, in these cases, treatment should be started with the lowest available dose and for the
shortest possible duration. Your doctor may prescribe medicines that protect 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 have previously had stomach or intestinal diseases related to medication use, and especially if you are
elderly, inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly during the
initial stages of treatment. In case of gastrointestinal bleeding or ulcer formation, discontinue treatment with
this medicine.
Analgesic, antipyretic (fever-reducing), and anti-inflammatory medicines (NSAIDs) may cause allergic
reactions, potentially severe (anaphylactoid reactions), even if you have never taken this type of medicine
before. Allergic reactions may manifest as facial swelling due to fluid accumulation, especially around the
mouth and eyes (angioedema), severe breathing difficulties (bronchospasm), breathing problems (asthma),
skin irritation (urticaria), or inflammation of the nasal mucosa (rhinitis).
If you have previously experienced allergic reactions after taking anti-inflammatory medicines (NSAIDs) or
acetylsalicylic acid, you are at higher risk of developing such a reaction again.
If you experience an allergic reaction after taking SPIDIDOL ANALGESIC, stop treatment immediately at
the first symptoms and consult your doctor.
Severe allergic reactions (e.g. anaphylactic shock) have been observed rarely.
In rare cases, symptoms of aseptic meningitis, an inflammation of the brain characterized by fever, headache,
and neck stiffness, have been observed in patients treated with ibuprofen.
If you experience vision disturbances, stop treatment with this medicine and consult an ophthalmologist.
Regular ophthalmological check-ups are recommended in case of prolonged treatment.
Adolescents
This medicine should be administered with caution in dehydrated adolescents due to an increased risk of
kidney problems (see section 3 “Use in adolescents aged 12 to 18 years”).
Infections
SPIDIDOL ANALGESIC may mask symptoms of infections such as fever and pain. Therefore, SPIDIDOL
ANALGESIC may delay appropriate treatment of the infection, increasing the risk of complications. This has
been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this
medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Therefore, use ibuprofen therapy with caution in case of infection.
Other medicines and SPIDIDOL ANALGESIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SPIDIDOL ANALGESIC may affect or be affected by other medicines. For example:

• anti-inflammatory medicines (e.g. acetylsalicylic acid), as the risk of adverse effects may increase;
• medicines used to reduce inflammation and treat allergies (corticosteroids); SPIDIDOL ANALGESIC may increase the risk of stomach or intestinal ulcers or bleeding;
• medicines with anticoagulant effects (i.e. substances that thin the blood to prevent clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine); SPIDIDOL ANALGESIC may enhance the effect of these medicines; additionally, SPIDIDOL ANALGESIC taken concomitantly with antiplatelet agents may increase the risk of gastrointestinal bleeding;
• medicines used to treat certain mental disorders (selective serotonin reuptake inhibitor antidepressants); SPIDIDOL ANALGESIC may increase the risk of gastrointestinal bleeding; monitoring of coagulation status is recommended during treatment with these medicines;
• medicines used to lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). SPIDIDOL ANALGESIC may alter the effect of the medicines you are taking. Additionally, if you have kidney problems, especially if you are elderly and dehydrated, SPIDIDOL ANALGESIC may worsen your condition when taken with ACE inhibitors or angiotensin II antagonists; in such cases, you should maintain adequate fluid intake, and your doctor may periodically monitor your kidney function after starting treatment and during follow-up;
• medicines containing lithium and phenytoin used for mental disorders; SPIDIDOL ANALGESIC may reduce the elimination of these medicines. During treatment with these medicines, your doctor may ask you to undergo blood tests;
• medicines used to treat heart conditions such as digoxin; SPIDIDOL ANALGESIC may increase their plasma levels;
• non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors. SPIDIDOL ANALGESIC should be used cautiously in combination with other NSAIDs, as it may increase the risk of adverse gastrointestinal reactions;
• medicines containing methotrexate, used for uncontrolled proliferation of blood cells (leukaemia), chronic inflammatory skin diseases (psoriasis), and chronic inflammatory joint diseases associated with skin involvement (psoriatic arthritis). SPIDIDOL ANALGESIC may increase methotrexate plasma levels and the risk of toxicity;
• medicines containing zidovudine used to treat Human Immunodeficiency Virus (HIV) infection. SPIDIDOL ANALGESIC may increase the risk of bleeding in joints or muscles in HIV-positive haemophiliac patients; after 1-2 weeks of starting treatment with these medicines, your doctor may perform blood tests;
• medicines containing tacrolimus and cyclosporine used to prevent rejection in patients receiving liver, kidney, or heart transplants. SPIDIDOL ANALGESIC may increase the risk of renal toxicity;
• medicines used to lower blood sugar levels, hypoglycaemics, and insulin. Dose adjustment may be necessary. Monitoring of blood glucose levels is recommended during concomitant treatment;
• medicines containing cyclosporine used to reduce immune system activity in autoimmune diseases. SPIDIDOL ANALGESIC may increase the risk of renal toxicity;
• CYP2C9 inhibitors may slow down the elimination of ibuprofen (a CYP2C9 substrate), leading to increased exposure to ibuprofen. Consideration should be given to reducing the dose of ibuprofen when co-administered with strong CYP2C9 inhibitors, especially when high doses of SPIDIDOL ANALGESIC are administered with voriconazole or fluconazole. Medicines used to terminate pregnancy containing mifepristone. Dose adjustment of SPIDIDOL ANALGESIC may be necessary. Additionally, the efficacy of mifepristone may theoretically be reduced;
• medicines used to treat bacterial infections, such as quinolone antibiotics. SPIDIDOL ANALGESIC may increase the risk of seizures;
• medicines used to treat bacterial infections, such as aminoglycosides. SPIDIDOL ANALGESIC may reduce their elimination;
• products containing ginkgo biloba. SPIDIDOL ANALGESIC may enhance the risk of bleeding;
• medicines containing moclobemide used to treat depression, which increase the effect of SPIDIDOL ANALGESIC;
• medicines containing probenecid used to treat gout, which may slow down the excretion of SPIDIDOL ANALGESIC, potentially increasing its plasma concentrations;
• medicines used to treat certain heart diseases (cardiac glycosides): concomitant use with SPIDIDOL ANALGESIC may worsen heart failure and reduce the elimination of glycosides, increasing their plasma levels;
• medicines containing colestyramine, used to lower blood lipids: simultaneous administration with SPIDIDOL ANALGESIC may reduce gastrointestinal absorption of SPIDIDOL ANALGESIC and reduce its effectiveness;
• medicines containing ritonavir used to treat Human Immunodeficiency Virus (HIV) infection, which may increase plasma levels of SPIDIDOL ANALGESIC when administered together;
• medicines containing baclofen used to relax muscles: concomitant use with SPIDIDOL ANALGESIC increases toxicity;
• medicines used to treat bone diseases (bisphosphonate-containing medicines) and medicines used to treat leg ulcers containing oxpentifylline, which, if taken simultaneously with SPIDIDOL ANALGESIC, may increase gastrointestinal adverse effects and the risk of bleeding and ulceration.

SPIDIDOL ANALGESIC may 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 up to one day after discontinuation of therapy);
• tests to assess blood sugar concentrations (levels may decrease);
• tests to assess kidney function through creatinine, potassium, and nitrogen levels (levels may increase);
• tests to assess blood composition and haemoglobin (values may decrease);
• tests to assess liver function through transaminase levels (values may increase).

Some other medicines may also influence or be influenced by treatment with SPIDIDOL ANALGESIC. Therefore, always consult your doctor or pharmacist before using SPIDIDOL ANALGESIC with other medicines.
Ibuprofen and alcohol
Alcohol consumption should be avoided during the use of SPIDIDOL ANALGESIC, as it may intensify possible adverse effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Before starting treatment, ensure you are not pregnant; discontinue treatment if you become pregnant.
Do not take SPIDIDOL ANALGESIC during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. NSAIDs may cause kidney and heart problems in the fetus. They may affect the bleeding tendency in both mother and child and delay or prolong labour beyond the expected duration. You should not take SPIDIDOL ANALGESIC during the first six months of pregnancy unless absolutely necessary and under your doctor’s advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose and duration should be used. If taken for more than a few days from the 20th week of pregnancy onwards, NSAIDs may cause kidney problems in the fetus, reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Avoid taking SPIDIDOL ANALGESIC and consult your doctor if you are breastfeeding, as the medicine may pass into breast milk in small amounts at therapeutic doses and during short-term treatment. In case of long-term treatment, your doctor may consider early weaning.
Fertility
The use of SPIDIDOL ANALGESIC may alter fertility in women. Discontinue treatment with this medicine if you intend to become pregnant, if you have fertility problems, or if you are undergoing fertility investigations.
Driving and using machines
This medicine may cause drowsiness, dizziness, headache, or depression, which may impair your ability to drive or operate machinery. If this occurs, avoid driving or operating machinery.
SPIDIDOL ANALGESIC oral drops contain parahydroxybenzoates and sodium
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
SPIDIDOL ANALGESIC oral drops contain less than 1 mmol (23 mg) of sodium per ml of product, i.e. essentially “sodium-free”.

3. How to take SPIDIDOL ANALGESIC

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use
Follow these instructions for correct use of the medicine.
You may dilute the dose in water or other non-alcoholic beverages, or take it with a little sugar.
The bottle has a child-resistant cap. To open, press down on the cap while turning it counterclockwise until the bottle opens (Fig.1).
Place the bottle vertically with the opening facing downward and wait a few seconds until the liquid starts to flow (Fig.2). If the liquid does not flow, tap the bottom of the bottle with your finger 3–4 times.

Fig. 1

Fig. 2

Use in adults and children aged 12 years and older
The recommended dose is 1–2 ml (30–60 drops) 2–3 times daily.
The maximum recommended dose is 6 ml per day (1200 mg).
Do not exceed the recommended doses. In particular, if you are an elderly person, take the lowest recommended dose.
Use in patients with impaired renal, hepatic or cardiac function
If you have impaired renal, hepatic or cardiac function, always consult your doctor, as a dose reduction may be necessary.
SPIDIDOL ANALGESICO must not be used in cases of severe renal, hepatic or cardiac insufficiency (see section “Do not take SPIDIDOL ANALGESICO”).
Take the medicine with food.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms.
If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Use in children and adolescents
SPIDIDOL ANALGESICO is contraindicated in children under 12 years of age.
In adolescents aged 12 to 18 years
If treatment is required for longer than 3 days, or if your health condition worsens, consult your doctor.
If you take more SPIDIDOL ANALGESICO than you should
If you have taken more SPIDIDOL ANALGESICO than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately. Bring the medicine packaging and this leaflet with you to allow for appropriate medical advice regarding the risk and necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), diarrhoea (with blood), gastrointestinal bleeding (see also section 4), headache, tinnitus, confusion, uncontrolled eye movements and double vision. Agitation, drowsiness, disorientation or coma may also occur. Occasionally, patients may experience seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low blood potassium levels, feeling cold and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma exacerbation is possible.
Moreover, low blood pressure and reduced breathing may occur.
In cases of severe poisoning, disturbances in kidney function, low blood pressure, decreased level of consciousness and coma may occur.
Other possible effects include: abdominal pain, deep drowsiness with reduced response to normal stimuli (lethargy), loss of muscle coordination (ataxia), severe muscle problems (rhabdomyolysis), epileptic seizures, excitement, fainting, decreased or increased or altered heart rate (bradycardia, tachycardia).
Rarely, temporary interruption of breathing (apnoea) or reduced activity of the central nervous system (central nervous system depression) may occur.
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
If you have any doubts about the use of SPIDIDOL ANALGESICO, consult your doctor or pharmacist.
If you forget to take SPIDIDOL ANALGESICO
Do not take a double dose to make up for the 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 ibuprofen and consult your doctor immediately if you notice any of the following symptoms:

• flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or 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, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption).

The following side effects may occur:
Very common (may affect more than 1 in 10 people)

• difficulty digesting (dyspepsia);
• diarrhoea.

Common (may affect up to 1 in 10 people)

• stomach pain or discomfort, nausea, flatulence;
• headache (cephalalgia), dizziness;
• skin disease, skin rash;
• malaise, fatigue.

Uncommon (may affect up to 1 in 100 people)

• development of stomach or intestinal lesions (peptic ulcers or bleeding), sometimes fatal, particularly in elderly patients;
• vomiting;
• presence of blood in the stools (melena);
• inflammation of the stomach (gastritis);
• itching, skin irritation (urticaria), serious skin condition associated with bleeding (purpura);
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty breathing and swallowing (angioedema);
• hypersensitivity;
• difficulty breathing (asthma, worsening of asthma, bronchospasm, dyspnoea, apnoea);
• rhinitis;
• insomnia, anxiety;
• impaired kidney function, nephrotic syndrome and various forms of toxic nephropathy;
• paraesthesia (sensory disturbances in legs, arms or other body parts);
• impaired hearing, tinnitus, vertigo;
• visual disturbances;
• photosensitivity reactions.

Rare (may affect up to 1 in 1,000 people)

• development of stomach or intestinal lesions (gastrointestinal perforation);
• constipation;
• presence of blood in vomit (haematemesis);
• inflammation of the mouth associated with lesions (ulcerative stomatitis);
• worsening of certain chronic inflammatory bowel diseases (colitis and Crohn's disease);
• hearing disorders;
• blurred vision;
• inflammation of the optic nerve (toxic optic neuropathy);
• changes in platelet, white blood cell (leucopenia) and red blood cell counts (thrombocytopenia, agranulocytosis, neutropenia, aplastic anaemia, haemolytic anaemia, inhibition of platelet aggregation);
• increased concentration of nitrogenous waste products in the blood (hyperazotaemia);
• presence of blood in the urine (haematuria);
• liver problems;
• abnormal liver function tests: elevated transaminases, increased alkaline phosphatase, reduced haemoglobin, reduced haematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid;
• severe allergic reaction (anaphylaxis);
• infection of the membranes surrounding the brain without bacterial growth in culture (aseptic meningitis);
• depression, confusion, hallucinations;
• lupus erythematosus syndrome;
• inflammation of the optic nerve (optic neuritis).

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

• severe skin disorders (exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis);
• kidney problems (interstitial nephritis, papillary necrosis, acute renal failure);
• liver disease (hepatic failure);
• increased heart rate (tachycardia);
• awareness of your own heartbeat (palpitations), fluid accumulation in the lungs (acute pulmonary oedema);
• facial, tongue, laryngeal oedema, oedema of the airways;
• inflammation of the pancreas (pancreatitis).

Not known (frequency cannot be estimated from available data)

• sensation of heaviness in the stomach;
• stomach burning (gastric pyrosis), stomach pain (epigastric pain);
• decrease in red blood cell count (anaemia);
• loss of appetite and body weight (anorexia);
• swelling of a body part due to fluid accumulation (oedema);
• heart problems (heart failure, myocardial infarction, stroke);
• increased blood pressure (hypertension);
• blood circulation problems (thrombosis);
• decreased blood pressure (hypotension);
• drowsiness;
• swelling at the point where the optic nerve connects to the eye (papilloedema);
• worsening of skin rashes;
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells);
• unexpected and exaggerated skin reactions to sunlight (photosensitivity reaction);
• inflammation of the liver (hepatitis), liver damage, jaundice;
• abnormal kidney function tests;
• severe clinical reaction triggered in a sensitized individual upon contact with a specific allergen (anaphylactic shock);
• burning and pain in the throat (sore throat);
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using SPIDIDOL ANALGESICO 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 effect, including those 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/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store SPIDIDOL ANALGESIC

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

6. Package contents and other information

What SPIDIDOL ANALGESIC contains

• The active substance is ibuprofen. Each ml of solution contains 200 mg of ibuprofen.
• The other components are: l-arginine, sodium saccharin, mint flavour, raspberry flavour, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

Description of the appearance of SPIDIDOL ANALGESIC and package contents
Pack containing one 12.5 ml bottle.
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

Patient Information Leaflet: Information for the patient

SPIDIDOL ANALGESIC 200 mg tablets

Ibuprofen
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What SPIDIDOL ANALGESIC is and what it is 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 symptoms of inflammation (anti-inflammatory action).
SPIDIDOL ANALGESIC is indicated

• for the treatment of pain of various origin and nature, for example headache, toothache, nerve pain (neuralgia), bone, joint and muscle pain (musculoskeletal and muscular pain), menstrual pain;
• as an adjunct in the treatment of symptoms of fever and influenza.

Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms.

2. What you should know before taking SPIDIDOL ANALGESIC

Do not take SPIDIDOL ANALGESIC

• if you are allergic to ibuprofen, to other similar anti-inflammatory medicines (e.g. acetylsalicylic acid), or to any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking anti-inflammatory medicines (NSAIDs) or acetylsalicylic acid, you experienced facial swelling due to fluid accumulation, especially around the mouth and eyes (angioedema), severe breathing difficulty (bronchospasm), breathing problems (asthma), skin irritation (urticaria), or inflammation of the nasal mucosa (rhinitis);
• if the patient is a child under 12 years of age;
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if you suffer from stomach or intestinal problems associated with lesions (active or severe gastroduodenal ulcer), or other stomach disorders (gastropathies);
• if you have previously experienced stomach or intestinal disorders associated with bleeding (gastrointestinal haemorrhage, perforation related to previous NSAID treatment, or history of bleeding, recurrent peptic ulcer with two or more distinct episodes of proven ulceration or bleeding);
• if you currently have other bleeding conditions such as cerebrovascular haemorrhage or ulcerative colitis;
• if you suffer from bleeding disorders (haemorrhagic diathesis);
• if you have severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from severe heart problems (severe heart failure);
• if you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.

Warnings and precautions
Talk to your doctor or pharmacist before taking SPIDIDOL ANALGESIC if:

• you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes); avoid taking SPIDIDOL ANALGESIC as this may increase the risk of ulcers and bleeding (see section “Other medicines and SPIDIDOL ANALGESIC”);
• you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin (see section “Other medicines and SPIDIDOL ANALGESIC”);
• 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 systemic lupus erythematosus or mixed connective tissue disease (a condition affecting the skin, joints, and kidneys);
• you have lost a significant amount of fluids. Ibuprofen may cause fluid and salt retention (sodium and potassium), even in patients who have never had kidney problems. This may lead to fluid accumulation (oedema), reduced heart function (heart failure), or increased blood pressure (hypertension) in predisposed patients;
• you have previously experienced breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs);
• you suffer from blood clotting disorders;
• you plan to become pregnant, as the use of SPIDIDOL ANALGESIC may impair female fertility; SPIDIDOL ANALGESIC should be discontinued in women with fertility problems or undergoing fertility investigations;
• you suffer from asthma or allergic diseases, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), or inflammation of the nasal mucosa (sinusitis), as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema);
• you have an infection, as SPIDIDOL ANALGESIC may mask its symptoms;
• you suffer from heart problems, including heart failure, angina (chest pain), or have a history of heart attack, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke;
• you suffer from hypertension, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker;
• you are elderly, as the risk of bleeding (haemorrhage), lesions (ulcers), and perforations is higher than in other patients;
• you have an infection (see section “Infections” below).

Take particular care with SPIDIDOL ANALGESIC:
Serious skin reactions have been reported during treatment with ibuprofen, 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). Stop using SPIDIDOL ANALGESIC and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
The side effects of the medicine can be minimized by using the lowest recommended dose and only for the shortest duration necessary to control your symptoms.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
Signs of an allergic reaction to this medicine, including breathing problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop SPIDIDOL ANALGESIC immediately and contact your doctor or emergency medical services if you notice any of these signs.
If you have reduced kidney function, or heart or liver dysfunction, you may be more prone to kidney problems. Moreover, habitual concurrent use of multiple painkillers may further increase this risk. In such cases, the initial dose should be as low as possible and the treatment period kept as short as possible.
In general, if you use pain medicines for a long period (even of different types), they may lead to serious and persistent kidney problems.
Regular monitoring of liver function, kidney function, and blood cell counts is required during prolonged administration of SPIDIDOL ANALGESIC. Your doctor may ask you to undergo blood tests during treatment.
Your doctor must be informed if you are taking SPIDIDOL ANALGESIC for a prolonged period and suffer from systemic lupus erythematosus, as kidney function needs to be monitored in this case.
Gastrointestinal bleeding and/or intestinal bleeding (gastrointestinal haemorrhage, ulceration, and perforation) have occurred during treatment with anti-inflammatory medicines (NSAIDs). These effects can be fatal and may occur at any time during treatment, with or without warning symptoms, even in patients who have not previously suffered from serious stomach or intestinal disorders.
In particular, if you are elderly or have previously had ulcers, especially if the ulcer was associated with bleeding or perforation, the risk of bleeding, ulceration, or perforation is higher with high doses of anti-inflammatory medicines; therefore, in these cases, treatment should be started with the lowest available dose and for the shortest possible duration. Your doctor may prescribe medicines that protect 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 have previously had stomach or intestinal diseases related to medicine use, and particularly if you are elderly, inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly during the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, discontinue treatment with this medicine.
Painkillers, antipyretics (fever-reducing medicines), and anti-inflammatory medicines (NSAIDs) may cause allergic reactions, potentially severe (anaphylactoid reactions), even if you have never taken this type of medicine before.
Allergic reactions may present as facial swelling due to fluid accumulation, especially around the mouth and eyes (angioedema), severe breathing difficulty (bronchospasm), breathing problems (asthma), skin irritation (urticaria), or inflammation of the nasal mucosa (rhinitis).
If you have previously experienced allergic reactions after taking anti-inflammatory medicines (NSAIDs) or acetylsalicylic acid, you are at higher risk of developing such a reaction again. If an allergic reaction occurs after taking SPIDIDOL ANALGESIC, stop treatment at the first sign and consult your doctor.
Severe allergic reactions (e.g. anaphylactic shock) have been observed rarely.
In rare cases, symptoms of aseptic meningitis, an inflammation of the brain characterized by fever, headache, and neck stiffness, have been observed in patients treated with ibuprofen.
If you experience vision disturbances, stop treatment with this medicine and consult an ophthalmologist.
Periodic ophthalmological examinations are recommended during prolonged treatment.

Infections
SPIDIDOL ANALGESIC may mask symptoms of infections such as fever and pain. Therefore, SPIDIDOL ANALGESIC may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms persist or worsen, consult your doctor immediately.

Adolescents
This medicine should be administered with caution in dehydrated adolescents due to an increased risk of kidney problems (see section 3 “Use in adolescents aged 12 to 18 years”).

Other medicines and SPIDIDOL ANALGESIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SPIDIDOL ANALGESIC may affect or be affected by other medicines. For example:

• anti-inflammatory medicines (e.g. acetylsalicylic acid), as the risk of side effects may increase;
• medicines used to reduce inflammation and treat allergies (corticosteroids); SPIDIDOL ANALGESIC may increase the risk of stomach or intestinal ulcers or bleeding;
• medicines with anticoagulant effects (i.e. substances that thin the blood to prevent clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine); SPIDIDOL ANALGESIC may enhance the effect of these medicines; furthermore, SPIDIDOL ANALGESIC, when taken with antiplatelet agents, may increase the risk of stomach or intestinal bleeding;
• medicines used to treat certain mental disorders (selective serotonin reuptake inhibitor antidepressants); SPIDIDOL ANALGESIC may increase the risk of stomach or intestinal bleeding; monitoring of coagulation status is recommended during treatment with these medicines;
• medicines used to lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). SPIDIDOL ANALGESIC may alter the effect of the medicines you are taking. Additionally, if you have kidney problems, especially if you are elderly or dehydrated, SPIDIDOL ANALGESIC may worsen your condition when taken with ACE inhibitors or angiotensin II antagonists; in such cases, adequate fluid intake is necessary, and your doctor may periodically monitor your kidney function after starting treatment and during follow-up periods;
• medicines containing lithium and phenytoin. SPIDIDOL ANALGESIC may reduce the elimination of these medicines. During treatment with these medicines, your doctor may ask you to undergo blood tests;
• medicines used to treat heart conditions such as digoxin; SPIDIDOL ANALGESIC may increase their plasma levels;
• non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors. SPIDIDOL ANALGESIC should be used cautiously in combination with other NSAIDs, as it may increase the risk of gastrointestinal adverse reactions;
• medicines containing methotrexate used for uncontrolled proliferation of blood cells (leukaemia), chronic inflammatory skin diseases (psoriasis), and chronic inflammatory joint diseases associated with skin conditions (psoriatic arthritis). SPIDIDOL ANALGESIC may increase methotrexate plasma levels and the risk of toxicity;
• medicines containing zidovudine used to treat Human Immunodeficiency Virus (HIV) infection. SPIDIDOL ANALGESIC may increase the risk of bleeding in joints or muscles in HIV-positive haemophiliacs; your doctor may perform blood tests 1-2 weeks after starting treatment;
• medicines containing tacrolimus and cyclosporine used to prevent rejection in patients receiving liver, kidney, or heart transplants. SPIDIDOL ANALGESIC may increase the risk of renal toxicity;
• medicines used to lower blood sugar levels, hypoglycaemics, and insulin. Dosage adjustment may be necessary. In case of simultaneous treatment, blood glucose levels will be monitored;
• medicines containing cyclosporine used to reduce immune system activity in autoimmune diseases. SPIDIDOL ANALGESIC may increase the risk of renal toxicity;
• CYP2C9 inhibitors, which may slow down the elimination of ibuprofen (a CYP2C9 substrate), leading to increased exposure to ibuprofen. A reduction in the dose of ibuprofen should be considered when co-administered with strong CYP2C9 inhibitors, particularly when high doses of SPIDIDOL ANALGESIC are administered with voriconazole or fluconazole;
• medicines used for medical termination of pregnancy, containing mifepristone. Adjustment of the SPIDIDOL ANALGESIC dose may be necessary. Additionally, the effectiveness of mifepristone may theoretically be reduced;
• medicines used to treat bacterial infections, such as quinolone antibiotics. SPIDIDOL ANALGESIC may increase the risk of seizures;
• medicines used to treat bacterial infections, such as aminoglycosides. SPIDIDOL ANALGESIC may reduce their elimination;
• products containing ginkgo biloba. SPIDIDOL ANALGESIC may enhance the risk of bleeding;
• medicines containing moclobemide used to treat depression, which increase the effect of SPIDIDOL ANALGESIC;
• medicines containing probenecid used to treat gout, which may slow down the excretion of SPIDIDOL ANALGESIC, potentially increasing its plasma concentrations;
• medicines used to treat certain heart conditions (cardiac glycosides): concomitant use with SPIDIDOL ANALGESIC may worsen heart failure, reduce glycoside elimination, and increase their plasma levels;
• medicines containing cholestyramine, used to lower blood lipids: simultaneous administration of SPIDIDOL ANALGESIC may reduce its gastrointestinal absorption and reduce its efficacy;
• medicines containing ritonavir used to treat Human Immunodeficiency Virus (HIV) infection, which may increase plasma levels of SPIDIDOL ANALGESIC when administered together;
• medicines containing baclofen used to relax muscles: concomitant use with SPIDIDOL ANALGESIC increases its toxicity;
• medicines used to treat bone diseases (bisphosphonate-containing medicines) and medicines used to treat leg ulcers containing oxpentifylline, which, when taken simultaneously with SPIDIDOL ANALGESIC, may increase gastrointestinal side effects and the risk of bleeding and ulceration.

SPIDIDOL ANALGESIC may 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 up to one day after discontinuation of therapy);
• tests to assess blood sugar concentrations (levels may decrease);
• tests to assess kidney function through creatinine, potassium, and nitrogen levels (levels may increase);
• tests to assess blood composition and haemoglobin (values may decrease);
• tests to assess liver function through transaminase levels (values may increase).

Other medicines may also affect or be affected by treatment with SPIDIDOL ANALGESIC. Therefore, always consult your doctor or pharmacist before using SPIDIDOL ANALGESIC with other medicines.

Ibuprofen and alcohol
Avoid alcohol consumption during use of SPIDIDOL ANALGESIC as it may intensify possible side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Before starting treatment, ensure you are not pregnant; discontinue treatment if you become pregnant.
Do not take SPIDIDOL ANALGESIC during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. NSAIDs may cause kidney and heart problems in the fetus. They may affect bleeding tendencies in both mother and child and delay or prolong labour. You should not take SPIDIDOL ANALGESIC during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose and shortest duration should be used. If taken for more than a few days from the 20th week of pregnancy onwards, NSAIDs may cause kidney problems in the fetus, reducing amniotic fluid levels surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
Avoid taking SPIDIDOL ANALGESIC and consult your doctor if you are breastfeeding, as the medicine may pass into breast milk in small amounts at therapeutic doses and during short-term treatment.
In case of long-term treatment, your doctor may consider early weaning.

Fertility
The use of SPIDIDOL ANALGESIC may affect fertility in women. Discontinue treatment with this medicine if you plan to become pregnant, if you have fertility problems, or if you are undergoing fertility investigations.

Driving and using machines
This medicine may cause drowsiness, dizziness, headache, or depression, which may impair your ability to drive or operate machinery. If this occurs, avoid driving and using machinery.

SPIDIDOL ANALGESIC 200 mg tablets contain sodium
SPIDIDOL ANALGESIC tablets contain 41.3 mg of sodium (the main component of table salt) per tablet. This corresponds to 2% of the maximum daily recommended dietary intake for an adult. This should be considered in individuals with impaired kidney function or those on a low-sodium diet.

3. How to take SPIDIDOL ANALGESIC

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

Use in adults and children from 12 years of age
The recommended dose is 1–2 tablets 2–3 times daily.
The maximum recommended dose is 6 tablets per day.
Do not exceed the recommended doses. In particular, if you are elderly, take the lowest indicated dose.

Use in patients with impaired renal, hepatic or cardiac function
If you have 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 ANALGESIC is contraindicated (see section “Do not take SPIDIDOL ANALGESIC”).

Take the medicine with food.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, consult your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

Use in children and adolescents
SPIDIDOL ANALGESIC is contraindicated in children under 12 years of age.

In adolescents from 12 to 18 years of age
If treatment is required for longer than 3 days, or if your health condition worsens, consult your doctor.

If you take more SPIDIDOL ANALGESIC than you should
If you have taken more SPIDIDOL ANALGESIC than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately. Take the medicine packaging and this patient information leaflet with you to allow assessment of risk and to receive advice on necessary actions.

Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), diarrhoea (with blood), gastrointestinal bleeding (see also section 4), headache, tinnitus, confusion, uncontrolled eye movements and double vision. Agitation, drowsiness, disorientation or coma may also occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness may occur, as well as blood in the urine, low blood potassium levels, feeling cold and breathing difficulties. In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma exacerbation is possible.

Furthermore, low blood pressure and reduced breathing may occur.
In cases of severe poisoning, renal function impairment, low blood pressure, decreased level of consciousness and coma may also occur.

Other possible symptoms include: abdominal pain, deep sleep with reduced response to normal stimuli (lethargy), loss of muscle coordination (ataxia), severe muscle problems (rhabdomyolysis), epileptic seizures, excitement, fainting, and decreased, increased or irregular heart rate (bradycardia, tachycardia).

Rarely, temporary interruption of breathing (apnoea) and reduced activity of the central nervous system (central nervous system depression) may occur.

In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.

Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.

If you have any doubts about the use of SPIDIDOL ANALGESIC, consult your doctor or pharmacist.

If you forget to take SPIDIDOL ANALGESIC
Do not take a double dose to make up for the 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 everyone experiences them.
Stop taking ibuprofen and contact your doctor immediately if you notice any of the following symptoms:

• flat, reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or 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, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized acute 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)

• stomach pain or discomfort, nausea, flatulence;
• headache (cephalalgia), dizziness;
• skin disease, skin rash;
• malaise, fatigue.

Uncommon (may affect up to 1 in 100 people)

• development of stomach or intestinal lesions (peptic ulcers or bleeding), sometimes fatal, particularly in elderly patients;
• vomiting;
• presence of blood in stools (melena);
• inflammation of the stomach (gastritis);
• itching, skin irritation (urticaria), serious skin condition associated with bleeding (purpura);
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema);
• hypersensitivity;
• difficulty in breathing (asthma, worsening of asthma, bronchospasm, dyspnoea, apnoea);
• rhinitis;
• insomnia, anxiety;
• impaired kidney function, nephrotic syndrome and various forms of toxic nephropathy;
• paraesthesia (altered sensation in legs, arms or other parts of the body);
• impaired hearing, tinnitus, vertigo;
• visual disturbances;
• photosensitivity reactions.

Rare (may affect up to 1 in 1,000 people)

• development of stomach or intestinal lesions (gastrointestinal perforation);
• constipation;
• presence of blood in vomit (haematemesis);
• inflammation of the mouth associated with lesions (ulcerative stomatitis);
• worsening of certain chronic inflammatory bowel diseases (colitis and Crohn's disease);
• hearing disturbances;
• blurred vision;
• inflammation of the optic nerve (toxic optic neuropathy);
• changes in platelet, white blood cell (leucopenia) and red blood cell levels (thrombocytopenia, agranulocytosis, neutropenia, aplastic anaemia, haemolytic anaemia, inhibition of platelet aggregation);
• increased concentration of nitrogenous substances in the blood (hyperazotemia);
• presence of blood in urine (haematuria);
• liver problems;
• abnormal liver function tests, increased transaminases, increased alkaline phosphatase, reduced haemoglobin, reduced haematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid;
• severe allergic reaction (anaphylaxis);
• infection of the membranes surrounding the brain without bacterial growth in culture (aseptic meningitis);
• depression, confusion, hallucinations;
• lupus erythematosus syndrome;
• inflammation of the optic nerve (optic neuritis).

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

• severe skin disorders (exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis);
• kidney problems (interstitial nephritis, papillary necrosis, acute renal failure);
• liver disease (hepatic failure);
• increased heart rate (tachycardia);
• awareness of your own heartbeat (palpitations), fluid accumulation in the lungs (acute pulmonary oedema);
• oedema of the face, tongue, larynx, swelling of the airways;
• inflammation of the pancreas (pancreatitis).

Not known (frequency cannot be estimated from available data)

• sensation of heaviness in the stomach;
• burning sensation in the stomach (gastric pyrosis), stomach pain (epigastric pain), decrease in red blood cell count (anaemia);
• loss of appetite and body weight (anorexia);
• swelling of a part of the body due to fluid accumulation (oedema);
• heart problems (heart failure, myocardial infarction, stroke);
• increased blood pressure (hypertension);
• blood circulation problems (thrombosis);
• decreased blood pressure (hypotension);
• drowsiness;
• swelling at the point where the optic nerve connects to the eye (papilloedema);
• worsening of skin rashes;
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells);
• unexpected and exaggerated skin reactions upon exposure to sunlight (photosensitivity reaction);
• inflammation of the liver (hepatitis), liver damage, jaundice;
• abnormal kidney function tests;
• severe clinical reaction occurring in a sensitized individual upon contact with a specific allergen (anaphylactic shock);
• burning and pain in the throat (throat irritation);
• widespread, red, scaly rash, with pustules under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using SPIDIDOL ANALGESICO 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 those not listed in this leaflet, please speak to your
doctor or pharmacist. You can also report side effects directly via 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 ANALGESIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store protected from heat and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SPIDIDOL ANALGESIC contains

• The active substance is ibuprofen arginine salt. Each tablet contains 200 mg of ibuprofen.
• The other components are: l-arginine, sodium bicarbonate, magnesium stearate, crospovidone.

Description of the appearance of SPIDIDOL ANALGESIC and pack contents
Pack of 12 tablets in blister
Marketing Authorization 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

Patient Information Leaflet

SPIDIDOL ANALGESIC 200 mg effervescent tablets, oral solution granules

Ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What SPIDIDOL ANALGESIC is and what it is used for

This medicinal product contains the active substance ibuprofen, belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by relieving pain (analgesic effect) and reducing symptoms of inflammation (anti-inflammatory effect).
SPIDIDOL ANALGESIC is indicated

• for the treatment of pain of various origin and nature, for example headache, toothache, nerve pain (neuralgia), bone, joint and muscle pain (osteo-articular and muscular pain), menstrual pain;
• as an adjunct in the treatment of symptoms of fever and influenza.

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

2. What you should know before taking SPIDIDOL ANALGESIC

Do not take SPIDIDOL ANALGESIC

• if you are allergic to ibuprofen, to other similar anti-inflammatory medicines (e.g. acetylsalicylic acid) or to any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking anti-inflammatory medicines (NSAIDs) or acetylsalicylic acid, you experienced swelling of the face due to fluid accumulation, especially around the mouth and eyes (angioedema), severe breathing difficulty (bronchospasm), breathing problems (asthma), skin irritation (urticaria), or inflammation of the nasal mucosa (rhinitis);
• if the patient is a child under 12 years of age;
• if you are in the third trimester of pregnancy (See section “Pregnancy, breastfeeding and fertility”);
• if you suffer from stomach or intestinal problems associated with lesions (active or severe gastroduodenal ulcer) or other stomach disorders (gastropathies);
• if you have previously suffered from stomach or intestinal disorders associated with bleeding (gastrointestinal haemorrhage, perforation related to previous NSAID treatment, or history of bleeding, recurrent peptic ulcer, with two or more distinct episodes of proven ulceration or bleeding);
• if you currently have other types of bleeding, such as cerebrovascular haemorrhage or ulcerative colitis;
• if you suffer from bleeding disorders (haemorrhagic diathesis);
• if you suffer from severe liver or kidney problems (severe hepatic or renal insufficiency);
• if you suffer from severe heart problems (severe heart failure);
• if you have phenylketonuria, a condition in which levels of certain substances in urine and blood are altered. This warning applies only to the oral granules for solution, as they contain aspartame;
• if you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.

Warnings and precautions
Talk to your doctor or pharmacist before taking SPIDIDOL ANALGESIC if:

• you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes); avoid taking SPIDIDOL ANALGESIC as the risk of ulcers and bleeding may increase (see section “Other medicines and SPIDIDOL ANALGESIC”);
• you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents like aspirin (See section “Other medicines and SPIDIDOL ANALGESIC”);
• you have previously suffered from intestinal disorders (ulcerative colitis, Crohn’s disease);
• you suffer from heart disorders (mild to moderate congestive heart failure);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease (a disease affecting skin, joints and kidneys);
• you have lost a significant amount of fluids. Ibuprofen may cause fluid and electrolyte retention (sodium and potassium), even in patients who have never had kidney problems. This may lead to fluid accumulation (oedema), reduced heart function (heart failure), or increased blood pressure (hypertension) in predisposed patients;
• you have previously experienced breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs);
• you suffer from blood clotting disorders;
• you plan to become pregnant, as the use of SPIDIDOL ANALGESIC may impair female fertility; use of SPIDIDOL ANALGESIC should be discontinued in women with fertility problems or undergoing fertility investigations;
• you suffer from asthma or allergic diseases, chronic runny nose (chronic rhinitis), nasal polyps (nasal polyposis), or inflammation of the nasal mucosa (sinusitis), as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema);
• you have an infection, as SPIDIDOL ANALGESIC may mask its symptoms;
• you suffer from heart problems, including heart failure, angina (chest pain), or have a history of heart attack, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke;
• you suffer from hypertension, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker;
• you are elderly, as the risk of bleeding (haemorrhage), lesions (ulcers), and perforations is increased compared to other patients;
• you have an infection (see section “Infections” below).

Take special care with SPIDIDOL ANALGESIC:
Serious skin reactions have been reported with ibuprofen treatment, 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).
Stop using SPIDIDOL ANALGESIC and contact your doctor immediately if you notice any of the
symptoms related to these serious skin reactions described in section 4.
The unwanted effects of the medicine can be minimized if you use the lowest recommended dose and only
for the time necessary to control your symptoms.
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of
heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or
treatment duration.
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. Stop SPIDIDOL ANALGESIC immediately
and contact your doctor or emergency medical services if you notice any of these signs.
If you have reduced kidney function, or heart or liver dysfunction, you may be more prone to kidney
problems.
Moreover, habitual use of various painkillers may further increase this risk. In such cases, the initial dose
should be as low as possible and the treatment period as short as possible.
In general, if you use pain medicines for a long period (even of different types), this may lead to serious and
persistent kidney problems.
During prolonged administration of SPIDIDOL ANALGESIC, regular monitoring of liver function, kidney
function, and blood cell counts is required. Your doctor may ask you to undergo blood tests during treatment.
Your doctor must be informed if you take SPIDIDOL ANALGESIC for a prolonged period and suffer from
systemic lupus erythematosus, as kidney function needs to be monitored in this case.
Gastrointestinal bleeding and/or intestinal bleeding (gastrointestinal haemorrhage, ulceration and
perforation) have occurred during treatment with anti-inflammatory medicines (NSAIDs). These effects can
be fatal and may occur at any time during treatment, with or without symptoms, and even if you have never
previously suffered from serious stomach or intestinal disorders.
In particular, if you are elderly or have previously suffered from ulcers, especially if the ulcer was associated
with bleeding or perforation, the risk of bleeding, ulcer or perforation is higher with high doses of
anti-inflammatory medicines; therefore, in these cases, treatment should be started with the lowest available
dose and the treatment period should be as short as possible. Your doctor may prescribe medicines that
protect 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 have had stomach or intestinal diseases related to drug use, and particularly if you are elderly, you
should report any unusual intestinal symptoms (especially bleeding) to your doctor, particularly during the
initial stages of treatment. In case of bleeding or formation of ulcers in the stomach and/or intestine, discontinue
treatment with this medicine.
Analgesic, antipyretic (fever-reducing), and anti-inflammatory medicines (NSAIDs) may cause allergic
reactions, potentially severe (anaphylactoid reactions), even if you have never taken this type of medicine
before. Allergic reactions may manifest as facial swelling due to fluid accumulation, especially around the
mouth and eyes (angioedema), severe breathing difficulty (bronchospasm), breathing problems (asthma),
skin irritation (urticaria), or inflammation of the nasal mucosa (rhinitis).
If in the past, after taking anti-inflammatory medicines (NSAIDs) or acetylsalicylic acid, you experienced
allergic reactions, you are at higher risk of developing such a reaction again.
If you experience an allergic reaction after taking SPIDIDOL ANALGESIC, stop treatment immediately at
the first symptoms and consult your doctor.
Severe allergic reactions (e.g. anaphylactic shock) have been observed rarely.
In rare cases, symptoms of aseptic meningitis, an inflammation of the brain characterized by fever, headache,
and neck stiffness, have been observed in patients treated with ibuprofen.

Infections
SPIDIDOL ANALGESIC may mask symptoms of infections such as fever and pain. Therefore, SPIDIDOL
ANALGESIC may delay appropriate treatment of the infection, potentially increasing the risk of
complications. This has been observed in bacterial pneumonia and bacterial skin infections related to
chickenpox. If you take this medicine while having an infection and the symptoms of infection persist or
worsen, contact your doctor immediately.
If you experience vision disturbances, stop treatment with this medicine and consult an ophthalmologist.
Regular ophthalmological examinations are recommended in case of prolonged treatment.

Adolescents
This medicine should be administered with caution in dehydrated adolescents, as there is an increased risk of
kidney problems (see section 3 “Use in adolescents aged 12 to 18 years”).

Other medicines and SPIDIDOL ANALGESIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SPIDIDOL ANALGESIC may affect or be affected by other medicines. For example:

• anti-inflammatory medicines (e.g. acetylsalicylic acid), as the risk of adverse effects may increase;
• medicines used to reduce inflammation and treat allergies (corticosteroids); SPIDIDOL ANALGESIC may increase the risk of stomach or intestinal ulcers or bleeding;
• medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine); SPIDIDOL ANALGESIC may enhance the effect of these medicines; furthermore, SPIDIDOL ANALGESIC, when taken concomitantly with antiplatelet agents, may increase the risk of stomach or intestinal bleeding;
• medicines used to treat certain mental disorders (selective serotonin reuptake inhibitor antidepressants); SPIDIDOL ANALGESIC may increase the risk of stomach or intestinal bleeding; monitoring of coagulation status is recommended during treatment with these medicines;
• medicines used to lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan); SPIDIDOL ANALGESIC may alter the effect of the medicines you are taking. Additionally, if you have kidney problems, especially if you are elderly or dehydrated, SPIDIDOL ANALGESIC may worsen your condition when taken with ACE inhibitors or angiotensin II antagonists; in such cases, you should maintain adequate fluid intake, and your doctor may periodically monitor your kidney function after starting treatment and during subsequent periods;
• medicines based on lithium and phenytoin used for mental disorders; SPIDIDOL ANALGESIC may reduce the elimination of these medicines; during treatment with these medicines, your doctor may ask you to undergo blood tests;
• medicines used to treat heart problems such as digoxin; SPIDIDOL ANALGESIC may increase their plasma levels;
• non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors; SPIDIDOL ANALGESIC should be used with caution in combination with other NSAIDs, as it may increase the risk of adverse gastrointestinal reactions;
• medicines based on methotrexate, used for uncontrolled proliferation of blood cells (leukaemia), chronic inflammatory skin diseases (psoriasis), and chronic inflammatory joint diseases associated with skin conditions (psoriatic arthritis); SPIDIDOL ANALGESIC may increase methotrexate plasma levels and increase the risk of toxicity;
• medicines based on zidovudine used to treat Human Immunodeficiency Virus (HIV) infection; SPIDIDOL ANALGESIC may increase the risk of bleeding in joints or muscles in HIV-positive haemophiliac patients; after 1-2 weeks of starting treatment with these medicines, your doctor may ask you to undergo blood tests;
• medicines based on tacrolimus and cyclosporine used to prevent rejection in patients receiving liver, kidney, or heart transplants; SPIDIDOL ANALGESIC may increase the risk of renal toxicity;
• medicines used to lower blood sugar levels, hypoglycaemics and insulin; dosage adjustment may be necessary; in case of simultaneous treatment, blood glucose levels will be monitored;
• medicines based on cyclosporine used to reduce immune system activity in autoimmune diseases; SPIDIDOL ANALGESIC may increase the risk of renal toxicity;
• CYP2C9 inhibitors may slow the elimination of ibuprofen (a CYP2C9 substrate), leading to increased exposure to ibuprofen. Consideration should be given to reducing the dose of ibuprofen when co-administered with strong CYP2C9 inhibitors, particularly when high doses of SPIDIDOL ANALGESIC are administered with voriconazole or fluconazole;
• medicines used to terminate pregnancy, based on mifepristone; dosage adjustment of SPIDIDOL ANALGESIC may be necessary. Additionally, the efficacy of mifepristone may theoretically be reduced;
• medicines used to treat bacterial infections, such as quinolone antibiotics; SPIDIDOL ANALGESIC may increase the risk of seizures;
• medicines used to treat bacterial infections, such as aminoglycosides; SPIDIDOL ANALGESIC may reduce their elimination;
• products containing ginkgo biloba; SPIDIDOL ANALGESIC may enhance the risk of bleeding;
• medicines based on moclobemide used to treat depression; they increase the effect of SPIDIDOL ANALGESIC;
• medicines based on probenecid used to treat gout; they may slow the excretion of SPIDIDOL ANALGESIC, potentially increasing its plasma concentrations;
• medicines used to treat certain heart diseases (cardiac glycosides); concomitant use with SPIDIDOL ANALGESIC may worsen heart failure and reduce the elimination of glycosides, increasing their plasma levels;
• medicines based on colestyramine used to lower blood lipids; simultaneous administration of SPIDIDOL ANALGESIC may reduce the gastrointestinal absorption of SPIDIDOL ANALGESIC, reducing its efficacy;
• medicines based on ritonavir used to treat Human Immunodeficiency Virus (HIV) infection; they may increase plasma levels of SPIDIDOL ANALGESIC when administered together;
• medicines based on baclofen used to relax muscles; concomitant use with SPIDIDOL ANALGESIC increases toxicity;
• medicines to treat bone diseases (bisphosphonate-based medicines) and medicines to treat leg ulcers based on oxpentifylline; if taken simultaneously with SPIDIDOL ANALGESIC, they may increase gastrointestinal adverse effects and the risk of bleeding and ulceration.

SPIDIDOL ANALGESIC may 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 up to one day after treatment discontinuation);
• tests to assess blood sugar concentrations (concentrations may decrease);
• tests to assess kidney function through creatinine, potassium, and nitrogen levels (levels may increase);
• tests to assess blood composition and haemoglobin (values may decrease);
• tests to assess liver function through transaminase levels (values may increase).

Other medicines may also affect or be affected by treatment with SPIDIDOL ANALGESIC. Therefore, always consult your doctor or pharmacist before using SPIDIDOL ANALGESIC with other medicines.

Ibuprofen and alcohol
Avoid alcohol consumption during use of SPIDIDOL ANALGESIC, as it may intensify possible adverse effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Before starting treatment, ensure you are not pregnant, and discontinue treatment if you become pregnant.
Do not take SPIDIDOL ANALGESIC during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. NSAIDs may cause kidney and heart problems in the fetus. They may affect the bleeding tendency in both mother and child and delay or prolong labour beyond expected duration. You should not take SPIDIDOL ANALGESIC during the first six months of pregnancy unless absolutely necessary and under your doctor’s advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose and treatment duration should be used. If taken for more than a few days from the 20th week of pregnancy onwards, NSAIDs may cause kidney problems in the fetus, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If prolonged treatment is required, your doctor may recommend additional monitoring.

Breastfeeding
Avoid taking SPIDIDOL ANALGESIC and consult your doctor if you are breastfeeding, as the medicine may pass into breast milk in small amounts at therapeutic doses and during short-term treatment. In case of long-term treatment, your doctor may consider early weaning.

Fertility
Use of SPIDIDOL ANALGESIC may alter fertility in women. Discontinue treatment with this medicine if you plan to become pregnant, if you have fertility problems, or if you are undergoing fertility investigations.

Driving and using machines
This medicine may cause drowsiness, dizziness, headache, or depression, which may impair your ability to drive or use machinery. If this occurs, avoid driving and using machinery.

SPIDIDOL ANALGESIC 200 mg oral granules for solution contains sucrose, aspartame, sulfites, and sodium
SPIDIDOL ANALGESIC contains sucrose. This should be considered in patients with diabetes mellitus.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
SPIDIDOL ANALGESIC contains 20 mg of aspartame per sachet, equivalent to 20 mg/3 g.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation because the body cannot eliminate it properly.
This medicine contains 30.05 mg of sodium (main component of table salt) per sachet. This corresponds to 1.5% of the maximum recommended daily dietary intake for an adult. This should be considered in patients with reduced kidney function or those on a low-sodium diet.
SPIDIDOL ANALGESIC contains sulfites, which rarely may cause severe hypersensitivity reactions and bronchospasm.

SPIDIDOL ANALGESIC 200 mg effervescent tablets contain sodium
SPIDIDOL ANALGESIC contains 454.75 mg of sodium per tablet. Talk to your doctor or pharmacist if you need one or more tablets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take SPIDIDOL ANALGESIC

Take this medicine exactly as stated 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 children aged 12 years and older
The recommended dose is 1–2 tablets or sachets 2–3 times daily.
The maximum recommended dose is 6 tablets or sachets per day.
Do not exceed the recommended doses. In particular, if you are elderly, take the lowest recommended dose.

Use in patients with impaired renal, hepatic, or cardiac function
If you have impaired renal, hepatic, or cardiac function, consult your doctor, as a dose reduction may be necessary. SPIDIDOL ANALGESIC is contraindicated in cases of severe renal, hepatic, or cardiac insufficiency (see section “Do not take SPIDIDOL ANALGESIC”).

Take the medicine with food.
Dissolve SPIDIDOL ANALGESIC in a glass of plain water (50–100 ml) and take it immediately after preparing the solution.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

Use in children and adolescents
SPIDIDOL ANALGESIC is contraindicated in children under 12 years of age.
In adolescents aged 12 to 18 years:
If treatment is required for longer than 3 days or if your health condition worsens, consult your doctor.

If you take more SPIDIDOL ANALGESIC than you should
If you have taken more SPIDIDOL ANALGESIC than recommended, or if your child has accidentally ingested this medicine, contact a doctor or the nearest hospital immediately. Bring the medicine packaging and this leaflet with you to allow healthcare professionals to assess the risk and provide appropriate advice on necessary actions.

Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), diarrhoea (with blood), gastrointestinal bleeding (see also section 4), headache, tinnitus, confusion, uncontrolled eye movements, and double vision. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma exacerbation is possible.

Moreover, low blood pressure and reduced respiration may occur.
In cases of severe poisoning, disturbances in kidney function, low blood pressure, decreased level of consciousness, and coma may develop.
Other possible effects include abdominal pain, deep drowsiness with reduced response to normal stimuli (lethargy), loss of muscle coordination (ataxia), severe muscle problems (rhabdomyolysis), epileptic seizures, excitement, fainting, and decreased, increased, or irregular heart rate (bradycardia, tachycardia).

Rarely, temporary cessation of breathing (apnoea) and reduced activity of the central nervous system (central nervous system depression) may occur.
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.

Symptoms of overdose may appear within 4–6 hours after ibuprofen intake.

If you have any doubts about the use of SPIDIDOL ANALGESIC, consult your doctor or pharmacist.

If you forget to take SPIDIDOL ANALGESIC
Do not take a double dose to make up for the 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 will experience them.
Stop taking ibuprofen and consult your doctor immediately if you notice any of the following symptoms:

• Red, flat spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or 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, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized acute exanthematous pustulosis).

The following side effects may occur:
Very common (may affect more than 1 in 10 people)

• Indigestion (dyspepsia);
• Diarrhea.

Common (may affect up to 1 in 10 people)

• Abdominal pain or discomfort, nausea, flatulence;
• Headache (cephalalgia), dizziness;
• Skin disease, skin rash;
• Malaise, fatigue.

Uncommon (may affect up to 1 in 100 people)

• Formation of stomach or intestinal lesions (peptic ulcers or hemorrhages), sometimes fatal, particularly in elderly patients;
• Vomiting;
• Presence of blood in stools (melena);
• Inflammation of the stomach (gastritis);
• Itching, skin irritation (urticaria), serious skin disorder associated with bleeding (purpura);
• Swelling of the face, lips, mouth, tongue or throat, which may cause breathing or swallowing difficulties (angioedema);
• Hypersensitivity;
• Breathing difficulties (asthma, worsening of asthma, bronchospasm, dyspnea, apnea);
• Rhinitis;
• Insomnia, anxiety;
• Impaired kidney function, nephrotic syndrome and toxic nephropathy in various forms;
• Paresthesia (sensory disturbances in legs, arms or other body parts);
• Hearing impairment, tinnitus, vertigo;
• Visual disturbances;
• Photosensitivity reactions.

Rare (may affect up to 1 in 1,000 people)

• Formation of stomach or intestinal lesions (gastrointestinal perforation);
• Constipation;
• Presence of blood in vomit (haematemesis);
• Inflammation of the mouth associated with lesions (ulcerative stomatitis);
• Worsening of certain chronic inflammatory bowel diseases (colitis and Crohn's disease);
• Hearing disorders;
• Blurred vision;
• Inflammation of the optic nerve (toxic optic neuropathy);
• Changes in platelet levels, white blood cells (leucopenia), and red blood cells (thrombocytopenia, agranulocytosis, neutropenia, aplastic anaemia), haemolytic anaemia, inhibition of platelet aggregation;
• Increased concentration of nitrogenous substances in the blood (hyperazotemia);
• Presence of blood in urine (haematuria);
• Liver problems;
• Abnormal liver function tests (increased transaminases, increased alkaline phosphatase, reduced haemoglobin, reduced haematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid);
• Severe allergic reaction (anaphylaxis);
• Infection of the membranes covering the brain without bacterial growth in culture (aseptic meningitis);
• Depression, confusion, hallucinations;
• Erythematous lupus syndrome;
• Inflammation of the optic nerve (optic neuritis).

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

• Severe skin disorders (exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis);
• Kidney problems (interstitial nephritis, papillary necrosis, acute renal failure);
• Liver disease (hepatic failure);
• Increased heart rate (tachycardia);
• Awareness of one's own heartbeat (palpitations), fluid accumulation in the lungs (acute pulmonary edema);
• Facial, tongue, laryngeal edema, edema of the airways;
• Inflammation of the pancreas (pancreatitis).

Not known (frequency cannot be estimated from available data)

• Feeling of heaviness in the stomach;
• Burning sensation in the stomach (gastric pyrosis), stomach pain (epigastric pain);
• Decrease in red blood cell count (anaemia);
• Decreased appetite and body weight (anorexia);
• Swelling of a body part due to fluid accumulation (edema); heart problems (heart failure, myocardial infarction, stroke);
• Increased blood pressure (hypertension);
• Blood circulation problems (thrombosis);
• Decreased blood pressure (hypotension);
• Drowsiness;
• Swelling at the point where the optic nerve connects to the eye (papilledema);
• Worsening of skin rashes;
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell);
• Unexpected and exaggerated skin reactions to sunlight exposure (photosensitivity reaction);
• Inflammation of the liver (hepatitis), liver damage, jaundice;
• Abnormal kidney function tests;
• Severe clinical reaction triggered in a sensitized individual upon contact with a specific allergen (anaphylactic shock);
• Burning and pain in the throat (throat irritation);
• A widespread, red, scaly rash with pustules under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using SPIDIDOL ANALGESICO 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 effect, including those 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/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SPIDIDOL ANALGESIC

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

6. Package contents and other information

What SPIDIDOL ANALGESIC contains
SPIDIDOL ANALGESIC 200 mg effervescent tablets

• The active substance is ibuprofen arginine salt. Each tablet contains 200 mg of ibuprofen.
• The other components are: l-Arginine, sodium bicarbonate, sodium saccharin, mint flavour, sodium bitartrate, gum arabic.

SPIDIDOL ANALGESIC 200 mg granules for oral solution

• The active substance is ibuprofen arginine salt. Each sachet contains 200 mg of ibuprofen.
• The other components are: l-Arginine, sodium bicarbonate, sodium saccharin, aspartame, mint flavour (containing sulphites), sucrose.

Description of the appearance of SPIDIDOL ANALGESIC and package contents
SPIDIDOL ANALGESIC 200 mg effervescent tablets
Pack size: 12 effervescent tablets.
SPIDIDOL ANALGESIC 200 mg granules for oral solution
Pack size: 12 sachets.
Marketing Authorization 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