SPIDIDOLPOCKET*12SACHETS 200MG

SPIDIDOLPOCKET 200 mg oral suspension in sachet
Ibuprofen

What it is and what it is used for
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by modifying the body's response to pain, inflammation and high body temperature.

SPIDIDOLPOCKET is used for the short-term treatment of mild to moderate pain such as headache, toothache, menstrual pain, feverish states and cold and flu symptoms.

In addition, on medical advice, SPIDIDOLPOCKET is also used to relieve post-operative pain.

SPIDIDOLPOCKET 200 mg is recommended for adults, adolescents and children weighing 20 kg or more (aged 6 years or older).

What you need to know before taking the medicine
Do not take SPIDIDOLPOCKET
- if you are allergic to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in paragraph 6);
- if you have experienced shortness of breath, asthma, runny nose, swelling of the face, tongue or throat or hives after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have ever had gastrointestinal bleeding or perforation related to previous NSAID therapy;
- if you have an active or recurrent stomach or duodenal ulcer or bleeding, or if you have had this problem repeatedly (two or more proven episodes of ulceration or bleeding) in the past;
- if you suffer from severe liver, kidney or heart failure;
- if you suffer from bleeding in the brain (cerebrovascular bleeding) or other active bleeding;
- if you are severely dehydrated (due to vomiting, diarrhoea or insufficient fluid intake);
- if you suffer from unknown origin blood formation disorders, such as thrombocytopenia;
- if you are a woman in the third trimester of pregnancy (see Pregnancy, breastfeeding and fertility).

Warnings and precautions
Talk to your doctor or pharmacist before taking SPIDIDOLPOCKET if:
- you suffer from certain hereditary blood formation diseases (e.g. acute intermittent porphyria);
- you have ever suffered from high blood pressure and/or heart failure;
- you suffer from certain skin diseases (systemic lupus erythematosus [SLE] or mixed connective tissue disease);
- you suffer or have suffered from bowel diseases (ulcerative colitis or Crohn's disease), as they may worsen (see paragraph 4 Possible side effects);
- you have reduced kidney function;
- you have liver problems;
- you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), blood thinners (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression) or antiplatelet agents (e.g. acetylsalicylic acid);
- you are taking other NSAIDs (including cyclooxygenase 2 [COX-2] inhibitors, such as celecoxib or etoricoxib), as concomitant intake should be avoided;
- you have heart problems, including heart failure and angina pectoris (chest pain), or if you have a history of heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or transient ischemic attack, TIA);
- you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
- you have recently undergone major surgery;
- you are dehydrated, as there is an increased risk of kidney problems;
- you have blood clotting problems;
- you have an infection - see Infections section below.

Side effects can be limited by using the lowest effective dose for the shortest period of time.

Prolonged use of any type of analgesic for headaches can worsen it. If this is the case, ask your doctor for advice and stop treatment with SPIDIDOLPOCKET.

In general, regular intake of (different types of) analgesics can cause serious and permanent kidney problems. This risk may be increased under physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

If you suffer or have suffered from asthma or allergic diseases, shortness of breath may occur.

If you suffer from hay fever, nasal polyps or chronic obstructive respiratory diseases, there is an increased risk of allergic reactions that can manifest as asthma attacks (so-called analgesic asthma), Quincke's oedema or urticaria.
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed.
As soon as the first signs of a severe hypersensitivity reaction appear after taking SPIDIDOLPOCKET, stop treatment immediately. Based on the symptoms presented, a qualified doctor must initiate the necessary medical procedures.

Infections
SPIDIDOLPOCKET can mask the symptoms of infections such as fever and pain. It is therefore possible that SPIDIDOLPOCKET may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

Skin reactions
Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop using SPIDIDOLPOCKET and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in paragraph 4.
During chickenpox, it is advisable to avoid the use of SPIDIDOLPOCKET.

The use of anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if taken in high doses. Do not exceed the recommended dose or the maximum duration of treatment.

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

Potentially fatal gastrointestinal bleeding, ulceration or perforation have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a prior history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, discontinue taking this medicine immediately. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation (see paragraph 2 Do not take SPIDIDOLPOCKET), and in the elderly. These patients should start treatment with the lowest available dose. For these patients, as well as for patients requiring concomitant use of low doses of acetylsalicylic acid or other drugs that may increase gastrointestinal risk, combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.

If any of the above conditions apply to you, consult your doctor before using SPIDIDOLPOCKET.

In case of prolonged use of SPIDIDOLPOCKET, periodic checks of liver values, kidney function and blood count are necessary.

Elderly
Elderly people taking NSAIDs are at greater risk of side effects, particularly those related to the stomach and intestines. For more information, see paragraph 4 Possible side effects.

If you have a history of gastrointestinal toxicity, especially if you are elderly, report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment.

Children and adolescents
There is a risk of kidney impairment in dehydrated children and adolescents.
SPIDIDOLPOCKET 200 mg is not suitable for children weighing less than 20 kg or under 6 years of age due to the high amount of active ingredient contained in each sachet.

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

Side effects can be limited by using the lowest dose for the minimum time necessary to relieve symptoms. You may experience one of the known side effects of NSAIDs. If this occurs, or if you have any doubts, stop taking this medicine and consult your doctor as soon as possible.

Elderly people using this medicine are at greater risk of developing problems associated with side effects.

It should be noted that the following side effects are mainly dose-dependent and vary from patient to patient.

Stop taking this medicine and seek immediate medical attention if you experience:
- signs of intestinal bleeding such as: severe abdominal pain, dark, tar-like stools, vomiting blood or dark, coffee-ground-like particles;
- signs of very rare but severe allergic reactions, such as wheezing or unexplained shortness of breath, swelling of the face, tongue or throat, difficulty breathing, accelerated heart rate, drop in blood pressure resulting in shock. These can also occur on the first intake of this medicine. If any of these symptoms occur, call your doctor immediately;
- severe skin reactions, such as rashes covering the entire body, exfoliation, blistering or peeling of the skin (e.g. Steven-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell's syndrome);
- vision problems/changes;
- non-raised, target-shaped or circular reddish patches on the trunk, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These serious rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
- widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome);
- widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Talk to your doctor if you experience any of the following side effects, if they worsen or if you notice any effect not listed.

Common (may affect up to 1 in 10 people):
- stomach problems, such as heartburn, stomach ache, nausea, vomiting, flatulence (gas in the intestine), diarrhoea, constipation and slight blood loss in the stomach and/or intestine which, in exceptional cases, can cause anaemia.

Uncommon (may affect up to 1 in 100 people):
- inflammation of the stomach, worsening of colitis and Crohn's disease;
- central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability or fatigue;
- gastrointestinal ulcers that can bleed or open;
- ulcers in the mouth and/or swelling and irritation of the mouth;
- hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with a drop in blood pressure). In this case, the doctor must be informed immediately and SPIDIDOLPOCKET must be stopped;
- various skin rashes.

Rare (may affect up to 1 in 1,000 people):
- tinnitus (perception of sounds in the ears);
- inflammation of the bladder;
- inflammation of the nasal mucosa;
- dry eyes;
- more frequent urination, blood in the urine;
- redness and peeling of the skin, skin reactions to sunlight;
- higher uric acid concentrations in the blood, higher urea concentrations in the blood;
- low red blood cell count;
- flank and/or abdominal pain, blood in the urine and fever which may be signs of kidney damage (papillary necrosis).

Very rare (may affect up to 1 in 10,000 people):
- inflammation of the oesophagus or pancreas, intestinal obstruction;
- in exceptional cases, during a chickenpox infection, severe skin infections and soft tissue complications may occur;
- reduced urine excretion and swelling (particularly in patients with high blood pressure or reduced kidney function) and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) which can lead to acute kidney failure. If any of the above symptoms occur or if you feel generally unwell, stop taking SPIDIDOLPOCKET and consult your doctor immediately, as these could be the first signs of kidney damage or kidney failure;
- problems in the production of blood cells (the first signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, unexplained or unusual bruising). In these cases, therapy must be stopped immediately and a doctor consulted. No treatment with painkillers or fever-reducing medicines (antipyretic drugs) should be undertaken;
- psychotic reactions and depression;
- worsening of an inflammation due to an infection (e.g. necrotizing fasciitis). If signs of an infection appear or worsen during the use of SPIDIDOLPOCKET, consult a doctor immediately;
- swelling, high blood pressure, palpitations, heart failure, heart attack;
- liver problems or liver inflammation. Liver failure or damage, particularly with long-term use, manifests as yellowing of the skin and eyes or pale stools and dark urine;
- very rarely, during treatment with ibuprofen, symptoms of aseptic meningitis have been observed with neck stiffness, headache, nausea, vomiting, fever or blurred consciousness. Patients suffering from autoimmune disorders (SLE and mixed connective tissue disease) appear to be predisposed. If such symptoms appear, contact a doctor immediately;
- jaundice (yellowing of the skin and/or whites of the eyes), severe liver damage;
- decrease in the amount of pigment that carries oxygen in the blood, haemoglobin;
- inflammation of blood vessels;
- hair loss (alopecia).

Not known (frequency cannot be estimated from the available data):
- hearing impairment;
- fluid retention (too much water in the body), loss of appetite;
- asthma, narrowing of the larynx, excessive contraction of the smooth muscles of the bronchi, as occurs in asthma, or blockage of breathing, difficulty breathing or wheezing;
- a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell);
- a widespread, red and scaly rash, with the formation of pustules under the skin and blisters mainly located on the skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using SPIDIDOLPOCKET if you develop these symptoms and contact your doctor immediately. See also paragraph 2;
- chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines like this may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.