ALGIDRIN 20 MG/ML ORAL SUSPENSION FOR CHILDREN 1 PET BOTTLE OF 120 ML WITH 5 ML SYRINGE FOR ORAL ADMINISTRATION

Name
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 nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen, the active ingredient of this medicine, in soluble saline 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 to 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 rash, 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 he vomits blood;
- if you have black stools or bloody diarrhea;
- if you suffer from bleeding or clotting disorders or are taking anticoagulants (medicines used to "liquefy" the blood).
If you need to take anticoagulant drugs at the same time, your doctor will perform a blood clotting test;
- if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
- if you suffer from severe heart failure;
- if you are in your third trimester of pregnancy.


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

Talk to your doctor or pharmacist before taking this medicine: - if you have oedema (fluid retention);
- if you suffer or have suffered from heart problems or have high blood pressure;
- if you suffer from asthma or any other breathing disorder;
- your doctor may carry out regular checks if you suffer from kidney or liver disease, are over 60 years of age or need to take the medicine for a long time (1 to 2 weeks).
Your doctor will tell you how often these checks should be done;
- if you have had or develop an ulcer, bleeding or perforation in the stomach or duodenum, presenting with severe or persistent abdominal pain and/or black stools, or even without warning symptoms.

This risk is greater 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 association with stomach-protective drugs:
- if you are also taking medicines that alter blood clotting, such as oral anticoagulants or antiplatelet drugs, such as acetylsalicylic acid. You should 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 usually produces bloody diarrhoea) or ulcerative colitis, as medicines such as ibuprofen can make these diseases worse;
- if you are being treated with diuretics (drugs that help you urinate) because your doctor needs to monitor your 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 affecting the blood and which may 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 higher doses of this medicine;
- this medicine may cause allergic reactions;
- your doctor will carry out more stringent checks if you receive ibuprofen after having undergone major surgery;
- it is recommended not to take this medicine if you have chickenpox;
- talk to your pharmacist or doctor if you have an infection – see “Infections” section below.

It is important to use the lowest dose that relieves/controls your pain and not to take this medicine for longer than necessary to control your symptoms.

Infections
ALGIDRIN may hide the signs of infection such as fever and pain. It is therefore possible that ALGIDRIN may delay the appropriate treatment of the infection, which may 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 symptoms of the infection persist or get worse, consult a doctor immediately.

Cardiovascular precautions
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of suffering from heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.

You should tell your doctor or pharmacist before taking this medicine:
- if you have heart problems, including heart failure, angina (chest pain) or have had a heart attack, bypass surgery, peripheral artery disease (circulation 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 ischaemic 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 drug can also cause fluid retention, especially in patients who have 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 serious 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 medicinal products such as ibuprofen is associated with an increased risk of congenital abnormalities/spontaneous abortion, administration during the first and second trimester of pregnancy is not recommended, unless clearly necessary. In these cases, the dose and duration should be limited to the minimum possible (see section "Pregnancy, breast-feeding and fertility").

Administration of this medicine is contraindicated during the third trimester.

Patients of childbearing potential should take into account that drugs such as ibuprofen are associated with a decrease in the ability to conceive.


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 lower than the maximum recommended dose.

The frequencies given below refer to short-term use at maximum daily doses of up to 1200 mg of oral ibuprofen:
- Common side effects (may affect up to 1 in 10 people): gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disturbance of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness, feeling unsteady and tiredness have also been observed.

- Uncommon side effects (may affect up to 1 in 100 people): appearance of gastritis, duodenal ulcers, gastric ulcers, redness of the skin, itching or a sensation of pins and needles in the skin, hives, purpura (purple marks on the skin), skin reactions to light, hypersensitivity, paraesthesia (sensation of numbness, tingling, etc. more frequently in the hands, feet, arms or legs), drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), 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 dyspnoea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and swelling of the body) and renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

- Rare side effects (may affect up to 1 in 1,000 people): disorientation or confusion, depression, dizziness, tinnitus (thumping or ringing in the ear), hearing impairment, reversible toxic amblyopia, liver damage, oedema (swelling caused by fluid build-up in the tissues), optic neuritis, anaphylactic reaction [in case of severe general hypersensitivity, signs may include swelling of the face, tongue and larynx, dyspnoea (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, the patients had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The observed symptoms of aseptic meningitis were stiff neck, headache, nausea, vomiting, fever and disorientation. Other adverse effects are low platelets, low white blood cells (which may present as frequent infections with fever, chills or sore throat), low red blood cells (which may present as difficulty breathing and paleness), neutropenia (low neutrophils) and agranulocytosis (large low neutrophils), aplastic anaemia (inability of the bone marrow to produce different types of cells), haemolytic anaemia (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 of unknown cause.

- Very rare side effects (may affect up to 1 in 10,000 people): pancreatitis, very severe bullous reactions including Stevens-Johnson syndrome (disseminated 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). Serious skin infections and soft tissue complications during chickenpox may appear exceptionally. Liver failure (severe liver dysfunction), heart failure, myocardial infarction, hypertension. Increased inflammation related to infection has been observed in conjunction with the use of NSAIDs. If you experience signs or worsening of infection while using ibuprofen, seek medical advice 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 usually produces bloody diarrhoea).
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell). A red, scaly rash with bumps 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 ALGIDRIN if you develop these symptoms and seek medical advice immediately. See also section 2.

If any of the following side effects occur, stop treatment and consult your doctor immediately :
- allergic reactions such as skin 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 the stool or bloody diarrhea;
- severe stomach pain;
- blisters or scaly skin over a large area;
- severe or persistent headache;
- yellowing of the skin (jaundice);
- signs of severe hypersensitivity (allergy) (see above in this section);
- swelling of the limbs or accumulation of fluid in the arms and legs;
- reddish, non-raised, 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).

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.