ALGIDRIN*ORAL SOLUTION 120ML 20MG/ML+SYR

Algidrin 20 mg/ml Oral Suspension, Children
Ibuprofen (Lysine)

What it is and what it is used for
ALGIDRIN belongs to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen, the active ingredient in this medicine, in soluble salt form, ibuprofen (lysine), reduces fever and relieves pain and inflammation. It is indicated in children over 3 months of age for the symptomatic treatment of fever, mild or moderate pain.

What you need to know before taking the medicine
Do not take ALGIDRIN:
- if you are allergic (hypersensitive) to ibuprofen or any other NSAID, acetylsalicylic acid, or any of the other ingredients of this medicine (listed in section 6). Reactions indicating allergy are: itchy skin rashes, swelling of the face, lips or tongue, runny nose, shortness of breath, and asthma;
- if you suffer from severe liver or kidney disease;
- if you have previously suffered from gastric or duodenal ulcer or bleeding or perforation of the gastrointestinal tract;
- if you vomit blood;
- if you have black stools or diarrhea with blood;
- if you suffer from bleeding or coagulation disorders or are taking anticoagulants (medicines used to thin the blood).
If it is necessary to take anticoagulants at the same time, the doctor will perform a blood coagulation test;
- if you suffer from severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
- if you suffer from severe heart failure;
- if you are in the third trimester of pregnancy.

Warnings and precautions
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 ALGIDRIN immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Speak to your doctor or pharmacist before taking this medicine:
- if you have edema (fluid retention);
- if you suffer or have suffered from heart problems or have high blood pressure;
- if you suffer from asthma or any other respiratory disorder;
- the doctor may perform regular checks if you suffer from kidney or liver disease, are over 60 years old, or need to take the medicine for a long period (1 to 2 weeks).
The doctor will tell you the frequency of these checks;
- if you have had or develop an ulcer, bleeding or perforation in the stomach or duodenum, experiencing intense or persistent abdominal pain and/or black stools, or even without warning symptoms.

This risk is higher at high doses and with prolonged treatment, in patients with a history of peptic ulcer and in elderly patients. In these cases, the doctor will consider the combination with stomach protective drugs:
- if you are also taking medicines that alter blood coagulation, such as oral anticoagulants or antiplatelet agents, such as acetylsalicylic acid. You must also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants;
- if you suffer from Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that generally produces bloody diarrhea) or ulcerative colitis, since drugs such as ibuprofen can exacerbate these diseases;
- if you are being treated with diuretics (drugs that help you urinate) because the doctor must monitor kidney function;
- if you suffer from systemic lupus erythematosus (a chronic disease that affects the immune system and can affect several vital organs, the nervous system, blood vessels, skin and joints), as there is an increased risk of aseptic meningitis (inflammation of the meninges which are membranes that protect the brain and spinal cord, not caused by bacteria);
- if you suffer from acute intermittent porphyria (a metabolic disease that affects the blood and can cause symptoms such as red urine, blood in the urine, or liver disease), to assess whether treatment with ibuprofen is appropriate;
- if you suffer from headaches after prolonged treatment, you should not take larger doses of this medicine;
- this medicine can cause allergic reactions;
- the doctor will perform stricter checks if you receive ibuprofen after undergoing major surgical treatment;
- it is not advisable to take this medicine if you have chickenpox;
- talk to your pharmacist or doctor if you have an infection - see the Infections section below.

It is important to use the lowest dose capable of relieving/controlling pain and not to take this medicine for longer than necessary to control symptoms.

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

Cardiovascular precautions
Anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially if used at high doses. Do not exceed the recommended dose or duration of treatment.

You should tell your doctor or pharmacist about your treatment before taking this medicine:
- if you have heart problems, including heart failure, angina (chest pain) or have had a heart attack, bypass surgery, peripheral arterial disease (circulatory problems in the legs or feet due to narrowing or blockage of the arteries) or any other type of stroke (including mini-stroke or transient ischemic attack, TIA);
- if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

This type of medicine can also cause fluid retention, especially in patients suffering from heart failure and/or high blood pressure (hypertension).

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 ALGIDRIN and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and adolescents
This medicine should not be given to children under 3 months of age. There is a risk of kidney damage in dehydrated children and adolescents.

Precautions during pregnancy and in women of childbearing age
Since the administration of medicines such as ibuprofen is associated with an increased risk of congenital abnormalities/spontaneous abortion, administration during the first and second trimesters of pregnancy is not recommended, except in strictly necessary cases. In these cases, the dose and duration should be limited to the minimum possible (see the Pregnancy, breastfeeding and fertility section).

The administration of this medicine is contraindicated during the third trimester.

Patients of childbearing age should be aware that drugs such as ibuprofen are associated with a decrease in conception capacity.

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

The side effects of this medicine are more common in people over 65 years of age.

The incidence of adverse effects caused is lower with short treatments and when the daily dose is below the maximum recommended dose.

The frequencies indicated below refer to short-term use at maximum daily doses up to 1200 mg of oral ibuprofen:
- Common adverse effects (may affect up to 1 in 10 people): gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, stomach acidity, abdominal pain, blood in stools, vomiting with blood, headache, dizziness, feeling of instability, and fatigue have also been observed.

- Uncommon adverse effects (may affect up to 1 in 100 people): onset of gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or sensation of pins and needles in the skin, urticaria, purpura (purple marks on the skin), skin reactions to light, hypersensitivity, paresthesia (sensation of numbness, tingling, etc. more frequently in the hands, feet, arms or legs), drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (nasal mucous membrane inflammation), inflammation of the oral mucosa with formation of mouth ulcers, gastrointestinal perforations, hepatitis (inflammation of the liver), liver dysfunction and jaundice (yellowing of the skin and eyes), asthma, bronchospasm and dyspnea (difficulty breathing). Interstitial tubule nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling) and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with an increase in urea.

- Rare adverse effects (may affect up to 1 in 1,000 people): disorientation or confusion, depression, vertigo, tinnitus (ringing or sounds in the ear), hearing disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in the tissues), optic neuritis, anaphylactic reaction [in case of severe general hypersensitivity, signs may include swelling of the face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock)], aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where ibuprofen-induced aseptic meningitis has been reported, patients suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Observed symptoms of aseptic meningitis were stiff neck, headache, nausea, vomiting, fever and disorientation. Other adverse effects are a decrease in platelets, a decrease in white blood cells (which may present as frequent infections with fever, chills or sore throat), a decrease in red blood cells (may present as shortness of breath and pallor), neutropenia (decrease in neutrophils) and agranulocytosis (large decrease in neutrophils), aplastic anemia (inability of the bone marrow to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme tiredness, and nose and skin bleeding with unknown cause.

- Very rare adverse effects (may affect up to 1 in 10,000 people): pancreatitis, very severe bullous reactions including Stevens-Johnson syndrome (widespread sores affecting the skin and two or more mucous membranes and purple lesions, usually on the trunk) and toxic epidermal necrolysis (sores on the mucous membranes and painful lesions with necrosis and peeling of the skin), erythema multiforme (skin lesion). Severe skin infections and soft tissue complications during chickenpox may appear exceptionally. Hepatic failure (severe liver dysfunction), heart failure, myocardial infarction, hypertension. Increased infection-related inflammation has been observed in coincidence with NSAID use. In case of signs or worsening of infection during ibuprofen use, consult a doctor immediately.

- Frequency not known (cannot be estimated from the available data): exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that generally produces bloody diarrhea).
Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: rash, fever, inflammation of the lymph nodes, and an increase in eosinophils (a type of white blood cell). A red, scaly rash with bumps under the skin and blisters localized mainly on the skin folds, trunk, and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using ALGIDRIN if these symptoms develop and consult a doctor immediately. See also section 2.

If you experience any of the following adverse effects, stop treatment and consult your doctor immediately:
- allergic reactions such as rash, swelling of the face, wheezing in the chest or shortness of breath;
- vomit containing blood or similar in appearance to coffee grounds;
- blood in stools or bloody diarrhea;
- intense stomach pain;
- blisters or scaly skin over a large area;
- intense or persistent headache;
- yellowing of the skin (jaundice);
- signs of severe hypersensitivity (allergy) (see above in this section);
- swelling of the limbs or fluid accumulation in the arms and legs;
- reddish, non-raised spots, target-shaped or circular on the trunk, often with central blisters, skin peeling, 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 rash, elevated body temperature, and enlarged 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).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.