Package leaflet: Information for the user

Algidrin

20 mg/ml Oral suspension, Children
Ibuprofen (Lysine)
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days of treatment.

Contents of this leaflet:

What ALGIDRIN is and what it is used for
What you need to know before taking ALGIDRIN
How to take ALGIDRIN
Possible side effects
How to store ALGIDRIN
Contents of the pack and other information

1. What ALGIDRIN 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 lysinate), reduces fever and relieves pain and inflammation. It is indicated in children over 3 months of age for the symptomatic treatment of fever, and mild to moderate pain.

2. What you should know before taking ALGIDRIN

Do not take ALGIDRIN:

if you are allergic (hypersensitive) to ibuprofen or any other NSAID, acetylsalicylic acid, or to any of the other ingredients of this medicine (listed in section 6). Signs indicating allergy include: skin rashes with itching, 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 experienced gastric or duodenal ulcer, gastrointestinal bleeding, or perforation of the gastrointestinal tract.
if you are vomiting blood.
if you have black stools or bloody diarrhoea.
if you suffer from bleeding disorders or coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to take anticoagulant medicines simultaneously, your doctor will perform a blood coagulation 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 the third trimester of pregnancy.

Warnings and precautions
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop taking ALGIDRIN immediately and contact your doctor or emergency medical 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 respiratory disorder.
Your doctor may carry out regular checks if you have kidney or liver disease, are over 60 years old, or need to take the medicine for a long period (1 to 2 weeks). Your doctor will inform you how often these checks should be performed.
If you have had or develop a stomach or duodenal ulcer, bleeding or perforation, presenting with severe 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 such cases, your doctor may consider combining the treatment with stomach-protective medicines.
If you are also taking medicines that affect blood coagulation, such as oral anticoagulants or platelet aggregation inhibitors like acetylsalicilic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, for example corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If you suffer from Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines such as ibuprofen may worsen these conditions.
If you are being treated with diuretics (medicines that help you urinate), because your doctor needs to monitor kidney function.
If you suffer from systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various vital organs, the nervous system, blood vessels, skin and joints), as there is an increased risk of aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria).
If you suffer from acute intermittent porphyria (a metabolic disorder affecting the blood that can cause symptoms such as reddish urine, blood in the urine or liver disease), to evaluate whether treatment with ibuprofen is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of this medicine.
This medicine may cause allergic reactions.
Your doctor will perform more stringent checks if you receive ibuprofen after undergoing major surgery.
It is advised not to take this medicine if you have chickenpox.
Talk to your pharmacist or doctor if you have an infection – see the section "Infections" below. It is important to use the lowest dose capable of relieving/controlling pain and not to take this medicine longer than necessary to control symptoms.

Infections
ALGIDRIN may mask signs of infection such as fever and pain. Therefore, ALGIDRIN may delay appropriate treatment of infection, which could lead to an increased 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 your infection symptoms persist or worsen, consult a doctor immediately.

Cardiovascular precautions
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
Inform your doctor or pharmacist about this treatment before taking this medicine if:

you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulatory problems in the legs or feet due to narrowing or blockage of arteries), or any type of stroke (including 'mini-stroke' or transient ischaemic attack, TIA).
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 may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

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

Children and adolescents
This medicine must 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 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 when strictly necessary. In such cases, the dose and duration should be limited to the minimum possible (see section “Pregnancy, breastfeeding and fertility”).
Administration of this medicine is contraindicated during the third trimester.
Women of childbearing age should be aware that medicines such as ibuprofen may reduce fertility.

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

Other non-steroidal anti-inflammatory drugs such as aspirin, as they may increase the risk of gastrointestinal ulcer or bleeding.
Antiplatelet agents (which prevent clot formation in blood vessels) such as ticlopidine.
Anticoagulant medicines (e.g. to treat coagulation problems/prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine).
Cholestyramine (a medicine used to reduce cholesterol levels in the blood).
Selective serotonin reuptake inhibitors (used for depression).
Lithium (used to treat depression). Your doctor may adjust the dose of this medicine.
Methotrexate (used to treat cancer and other inflammatory diseases). Your doctor may adjust the dose of this medicine.
Mifepristone (abortion-inducing agent).
Digoxin and cardiac glycosides (used to treat heart failure).
Hydantoins such as phenytoin (used to treat epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone (anti-inflammatory and immunosuppressive medicines).
Diuretics (medicines used to increase urine elimination), as they may increase the risk of renal toxicity.
Pentoxifylline (for treatment of intermittent claudication).
Probenecid (used in patients with gout or together with penicillin for infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes), as they may cause hypoglycaemia.
Tacrolimus or cyclosporine (used in organ transplantation to prevent rejection).
Zidovudine (a medicine used to treat AIDS virus).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor blockers such as losartan).
Thrombolytics (medicines that dissolve clots).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts (from the ginkgo biloba tree).
CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also affect or be affected by treatment with ALGIDRIN. Therefore, it is necessary to consult your doctor or pharmacist before taking ALGIDRIN with other medicines.
Taking ibuprofen may affect the following laboratory tests:

Bleeding time (may be prolonged for 1 day after stopping treatment).
Blood sugar levels (may be reduced).
Creatinine clearance (may be reduced).
Haematocrit and haemoglobin levels (may be reduced).
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may be increased).
Liver function tests (increased transaminase levels). Inform your doctor if you are undergoing clinical tests and if you are currently taking or have recently taken ibuprofen.

ALGIDRIN with food, drinks and alcohol
It is recommended to take this medicine with milk or food, or immediately after eating, to reduce the possibility of stomach problems. Do not consume alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding and fertility
The use of this medicine is not recommended in women who are trying to become pregnant. 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.
Do not take this medicine during the third trimester as it may harm the foetus or cause problems during delivery. It may cause kidney and heart problems in the foetus. It may affect your and your baby's tendency to bleed and delay or prolong labour more than expected. You should not take this medicine during the first 6 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 for the shortest possible time should be used. From week 20 of pregnancy onwards, this medicine may cause kidney problems in the foetus if taken for more than a few days, resulting in reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or 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.
Long-term use of this medicine is not recommended during breastfeeding, as small amounts of ibuprofen may pass into breast milk.

Driving and using machines
If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take a single dose of the medicine or for a short period, no special precautions are necessary.
Ibuprofen may slow reaction times, which should be taken into account when performing activities requiring greater attention, such as driving or operating machinery.
This is even more important when combined with alcohol.

ALGIDRIN contains Allura Red AC (E-129) and may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

ALGIDRIN contains maltitol (E-965). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 25 mg of sorbitol (E-420) per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before you (or your child) take this medicine.

ALGIDRIN contains methyl p-hydroxybenzoate (E-218), ethyl p-hydroxybenzoate (E-214) and propyl p-hydroxybenzoate (E-216). These may cause allergic reactions (including delayed reactions).

3. How to take ALGIDRIN

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.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If an infection is suspected, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
This medicine is an oral suspension intended for children over 3 months of age. It may be administered directly or diluted with water.
Children: the dose of ibuprofen to be administered depends on the child's age and body weight.
In general, for children aged between 3 months and 12 years, the recommended daily dose is 20 to 30 mg of ibuprofen per kg of body weight, divided into three or four individual doses. The interval between doses depends on how symptoms develop, but must not be less than 4 hours.
This medicine is not recommended for children weighing less than 5 kg.
The following dosing schedule is recommended:

DOSAGE FOR CHILDREN
Age/weight	Frequency	Dose	Maximum daily dose
From 3 to 6 months From about 5 to 7.6 kg	3 times a day	50 mg (2.5 ml)/dose	150 mg (7.5 ml)
From 6 to 12 months From about 7.7 to 9 kg	3 to 4 times a day	50 mg (2.5 ml)/dose	150-200 mg (7.5-10 ml)
From 1 to 3 years From about 10 to 15 kg	3 to 4 times a day	100 mg (5 ml)/dose	300-400 mg (15-20 ml)
From 4 to 6 years From about 16 to 20 kg	3 to 4 times a day	150 mg (7.5 ml)/dose	450-600 mg (22.5-30 ml)
From 7 to 9 years From about 21 to 29 kg	3 to 4 times a day	200 mg (10 ml)/dose	600-800 mg (30-40 ml)
From 10 to 12 years From about 30 to 40 kg	3 to 4 times a day	300 mg (15 ml)/dose	900-1200 mg (45-60 ml)

Adolescents (from 12 years of age):
The recommended dose is 10 - 20 ml (equivalent to 200-400 mg of ibuprofen) every 4-6 hours,
if necessary, without exceeding 1200 mg of ibuprofen within a 24-hour period.
Patients with renal and/or hepatic disease:
If you suffer from renal and/or hepatic disease, your doctor may prescribe a lower dose than
indicated. In this case, take exactly the prescribed dose.
Consult your doctor if symptoms persist or worsen during treatment. If you think the effect of
this medicine is too strong or too weak, inform your doctor or pharmacist.
Method of administration
The package contains an oral graduated syringe for accurate dosing.

Shake the bottle before use.
Remove the cap and insert the tip of the syringe into the hole of the perforated cap.
Invert the bottle, pull the plunger of the syringe until the liquid reaches the mark indicating the required number of ml. Return the bottle to its upright position and remove the syringe.
Administer directly using the syringe.
The syringe should be washed and thoroughly dried after each dose. In patients with gastric problems, the medicine should be taken during meals.

Adults: consult your doctor or pharmacist for other formulations of the medicine more
suitable for use in adults.
If you take more ALGIDRIN than you should
If you have taken more ALGIDRIN than you should have, or if a child has accidentally taken
the medicine, contact a doctor or the nearest hospital immediately for advice on the risk and
necessary actions. Symptoms of overdose usually appear 4 to 6 hours after ibuprofen intake.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with blood
streaks), gastrointestinal bleeding, diarrhoea, headache, tinnitus, confusion, involuntary eye
movements, and lack of muscular coordination. Agitation, drowsiness, disorientation, or coma
may also occur. At high doses, drowsiness, chest pain, palpitations, loss of consciousness,
seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels,
feeling cold, and breathing difficulties may be reported. Additionally, low blood pressure and
reduced breathing may occur.
If you forget to take ALGIDRIN
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, take it as soon as possible. However, if it is almost time for the
next dose, skip the missed dose and take the next dose at the usual scheduled time. If you
have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects of this medicine are more common in people over 65 years of age.
The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the maximum recommended dose.
The frequencies listed 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, diarrhoea, flatulence, dyspepsia (digestive disturbance affecting secretion or gastrointestinal motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness, feeling of instability, and fatigue have also been observed.
Uncommon adverse effects (may affect up to 1 in 100 people): development of gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or prickling sensation (pins and needles) in the skin, urticaria, purpura (purple spots on the skin), skin reactions to light, hypersensitivity, paraesthesia (numbness, tingling, etc., more frequently in hands, feet, arms or legs), drowsiness, insomnia, anxiety, hearing disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with mouth ulcer formation, gastrointestinal perforations, hepatitis (liver inflammation), liver dysfunction and jaundice (yellowing of the skin and eyes), asthma, bronchospasm and dyspnoea (difficulty breathing). Tubulo-interstitial nephritis (a kidney disorder), nephrotic syndrome (characterized by protein in urine and body swelling), and renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea levels.
Rare adverse effects (may affect up to 1 in 1,000 people): disorientation or confusion, depression, vertigo, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, oedema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction [in cases 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, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of ibuprofen-induced aseptic meningitis, patients had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Observed symptoms of aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever and disorientation. Other adverse effects include decreased platelets, decreased white blood cells (which may present as frequent infections with fever, chills or sore throat), decreased red blood cells (may present as breathlessness and pallor), neutropenia (low neutrophil count) and agranulocytosis (severe reduction in neutrophils), aplastic anaemia (inability of the bone marrow to produce various types of blood cells), and haemolytic anaemia (premature destruction of red blood cells). Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, and unexplained nosebleeds or skin bleeding.
Very rare adverse effects (may affect up to 1 in 10,000 people): pancreatitis, very severe blistering 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 mucous membranes and painful lesions with necrosis and skin peeling), erythema multiforme (skin lesion). Severe skin infections and complications of soft tissues during chickenpox may exceptionally occur. Hepatic failure (severe liver dysfunction), heart failure, myocardial infarction, hypertension. Increased infection-related inflammation has been observed with the use of NSAIDs. If signs of infection or worsening of infection occur during ibuprofen use, consult a doctor immediately.
Frequency not known (cannot be estimated from available data): exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea). Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin 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 skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular exanthema). Discontinue use of 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 a doctor immediately:
Allergic reactions such as skin rash, facial swelling, wheezing or shortness of breath.
Vomiting blood or material that looks like coffee grounds.
Blood in stools or bloody diarrhoea.
Severe stomach pain.
Blisters or peeling 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 limbs or fluid accumulation in arms and legs.
Flat, non-elevated reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These severe 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 appear at the beginning of treatment (generalized pustular exanthema).

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 ALGIDRIN

Keep this medicine out of the sight and reach of children. Do not store above 30 °C. After opening the package, use within 12 months. 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 ALGIDRIN contains:

The active substance is ibuprofen (lysine). Each ml of oral suspension contains 20 mg of ibuprofen (provided by 34 mg of ibuprofen lysinate).
The other components are: purified water, microcrystalline cellulose, sodium carboxymethylcellulose, sorbitol (E-420), maltitol (E-965), beta-cyclodextrin, sodium saccharin, sucralose (E-955), mixed berry flavour, Allura Red AC (E-129), methylparaben (E-218), ethylparaben (E-214) and propylparaben (E-216).

Description of the appearance of ALGIDRIN and the contents of the pack
ALGIDRIN is a red oral suspension with a mixed berry flavour and taste.
The pack contains a 100 ml, 120 ml or 200 ml amber-coloured polyethylene terephthalate (PET) bottle, with a white polyethylene cap equipped with a child-resistant safety mechanism, and a translucent polyethylene plunger, together with a 5 ml graduated oral dosing syringe.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dicofarm S.p.A. - Via del Casale della Marcigliana, 29 - 00138 Rome, Italy
Manufacturer
LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. (FARDI)
Calle Grassot, 16 - 08025 - Barcelona (Spain)
More detailed information on this medicinal product is available on the AIFA website:
https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home