SPIDIDOLPOCKET 200 MG ORAL SUSPENSION IN SACHET 12 SACHETS IN PET/ALU/PET/PE

Name
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 nonsteroidal anti-inflammatory drugs (NSAIDs). These medicines work by changing 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 cramps, fever, and cold and flu symptoms.

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

SPIDIDOLPOCKET 200 mg is recommended for adults, adolescents and children with a body weight of 20 kg or more (aged 6 years and over).


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 section 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 ulcer or bleeding in your stomach or duodenum or if you have had this problem repeatedly (two or more episodes of proven 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 blood formation disorders of unknown origin, such as thrombocytopenia;
- if you are a woman in the third trimester of pregnancy (see "Pregnancy, breast-feeding and fertility").


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

Undesirable effects may be limited by using the lowest effective dose for the shortest period of time.

Prolonged use of any type of painkiller for headaches may make them worse. If this happens to you, ask your doctor for advice and stop taking SPIDIDOLPOCKET.

In general, the habitual intake of (different types of) painkillers 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 pulmonary disease, there is an increased risk of allergic reactions which may manifest as asthma attacks (so-called analgesic asthma), Quincke's edema 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, a qualified doctor will have to start the necessary medical procedures.

Infections
SPIDIDOLPOCKET may hide 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 get worse, 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 section 4.
During chickenpox it is advisable to avoid the use of SPIDIDOLPOCKET.

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

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

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. If GI bleeding or ulceration occurs, discontinue taking this medicine immediately. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 2 "Do not take SPIDIDOLPOCKET"), and in the elderly. These patients should start treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, as well as for patients who require concomitant use of low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk.

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, renal function and blood count are necessary.

Elderly people
Elderly people taking NSAIDs are at increased risk of side effects, especially those related to the stomach and intestines. For more information, see section 4 "Possible side effects".

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

Children and adolescents
There is a risk of renal 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 quantity 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 shortest time necessary to relieve symptoms. You may experience one of the known side effects of NSAIDs. If this happens, or if you are in any doubt, stop taking this medicine and consult your doctor as soon as possible.

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

It should be taken into account that the following undesirable effects are mainly dose-dependent and vary from patient to patient.

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

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

Common (may affect up to 1 in 10 people):
- stomach problems, such as heartburn, stomach pain, nausea, vomiting, flatulence (air in the intestine), diarrhoea, constipation and slight loss of blood in the stomach and/or intestine which, in exceptional cases, may 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 tiredness;
- gastrointestinal ulcers that may bleed or open;
- mouth ulcers 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 the intake of 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;
- need to urinate more often, presence of blood in the urine;
- redness and peeling of the skin, skin reactions to sunlight;
- higher concentrations of uric acid in the blood, higher concentrations of urea in the blood;
- low red blood cell count;
- pain in the sides and/or abdomen, presence of 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 esophagus or pancreas, intestinal blockage;
- in exceptional cases, during a chickenpox infection, serious skin infections and soft tissue complications may occur;
- reduced urine output and swelling (especially in patients with high blood pressure or reduced kidney function) and cloudy urine (nephrotic syndrome), inflammatory disease of the kidneys (interstitial nephritis) which may lead to acute kidney failure. If you experience any of the symptoms mentioned above or if you feel generally unwell, stop taking SPIDIDOLPOCKET and consult your doctor immediately, as these may be the first signs of kidney damage or kidney failure;
- problems with the production of blood cells (the first signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, nose and skin bleeding, unexplained or unusual bruising). In these cases, you should stop treatment immediately and consult a doctor. You should not take any treatment with painkillers or medicines that reduce fever (antipyretic drugs);
- psychotic reactions and depression;
- worsening of an inflammation due to an infection (e.g. necrotizing fasciitis). If signs of an infection develop or worsen during the use of SPIDIDOLPOCKET, consult a doctor immediately;
- swelling, high blood pressure, palpitations, heart failure, heart attack;
- liver problems or inflammation of the liver. Liver failure or damage, especially with long-term use, may manifest as yellowing of the skin and eyes or pale stools and dark urine;
- very rarely, symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or blurred consciousness have been observed during treatment with ibuprofen. Patients with autoimmune disorders (SLE and mixed connective tissue disease) seem to be predisposed. If such symptoms occur, contact a doctor immediately;
- jaundice (yellowing of the skin and/or whites of the eyes), severe liver damage;
- decrease in the amount of the oxygen-carrying pigment in the blood, hemoglobin;
- 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), decreased 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 serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);
- a widespread, red, scaly rash with pustules under the skin and blisters mainly located in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using SPIDIDOLPOCKET 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.

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.