Algo pirina for fever and pain

Package leaflet: Information for the patient

ALGOPIRINA FEVER AND PAIN

200 mg oral suspension in sachet, orange flavour
Ibuprofen
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, 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 your symptoms worsen after 3 days.

Contents of this leaflet:

1. What Algopirina Fever and Pain is and what it is used for
2. What you need to know before taking Algopirina Fever and Pain
3. How to take Algopirina Fever and Pain
4. Possible side effects
5. How to store Algopirina Fever and Pain
6. Contents of the pack and other information

1. What Algopirina Fever and Pain is and what it is used for

Algopirina Fever and Pain contains the active substance ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is indicated for the symptomatic treatment of fever, including post-vaccination fever, and mild to moderate pain (such as headache, toothache, sore throat, earache).

2. What you need to know before taking Algopirina Fever and Pain

Do not take Algopirina Fever and Pain if:

• you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• you have had or currently experience allergic reactions such as shortness of breath, runny nose (rhinitis), swelling of the face, lips, and throat (angioedema), or hives, especially if associated with nasal polyps and asthma, after taking other painkillers, antipyretics, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• you have an active lesion of the inner lining (mucosa) of the stomach or the first part of the intestine (active peptic ulcer);
• you have severe impairment of kidney or liver function;
• you suffer from severe heart problems (severe heart failure);
• you have experienced or currently have bleeding or perforation of the stomach and/or intestine (gastrointestinal haemorrhage) or perforation following previous treatment with NSAIDs;
• you have or have had gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of proven ulceration or bleeding);
• you are currently taking other non-steroidal anti-inflammatory drugs (NSAIDs), including those that selectively inhibit the action of an enzyme called COX-2 (see Other medicines and Algopirina Fever and Pain);
• you have cerebrovascular bleeding (brain bleeding) or other active bleeding;
• you suffer from severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake);
• you have unexplained blood disorders such as low platelet count;
• you are in the last trimester of pregnancy (see Pregnancy and breastfeeding).

Warnings and precautions
Take special care with Algopirina Fever and Pain.
Serious skin reactions have been reported in association with treatment with ibuprofen, 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 Algopirina Fever and Pain and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Consult your doctor or pharmacist before taking Algopirina Fever and Pain if:

• you have or have had allergies to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs), and if you suffer from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, severe respiratory or chest problems such as chronic obstructive pulmonary disease, or swelling of the face, lips, and throat (angioedema);

• you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) to reduce fever and/or treat inflammation, including those that selectively inhibit the action of an enzyme called COX-2;

• medicines that increase the risk of bleeding or ulcer formation, such as oral corticosteroids, medicines that prevent blood clotting (anticoagulants such as warfarin), antidepressants, or antiplatelet agents such as aspirin (see “Other medicines and Algopirina Fever and Pain”);

• you have had stomach or intestinal disorders (history of ulcers), especially if complicated by bleeding or perforation, as there may be an increased risk of gastrointestinal bleeding and perforation. In such cases, your doctor will advise starting treatment with the lowest available dose and possibly using concomitant medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see section “Other medicines and Algopirina Fever and Pain”). During treatment with all NSAIDs, at any time and with or without warning symptoms or previous history of serious gastrointestinal events, bleeding, ulceration, and perforation of the stomach or intestine may occur, which can be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Algopirina Fever and Pain and contact your doctor;

• you suffer from gastrointestinal diseases such as Crohn’s disease or ulcerative colitis; inform your doctor, as the use of NSAIDs may worsen these conditions (see section 4);

• you are taking medicines that may increase the risk of ulcers or bleeding, such as medicines used to treat inflammation and certain immune system disorders (oral corticosteroids), anticoagulants such as warfarin, medicines with antiplatelet effects such as aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and Algopirina Fever and Pain”);

• you have heart conditions (uncontrolled hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease) or have had reduced blood flow to the brain (stroke), or if you think the child may be at risk for these conditions (e.g., if they have high blood pressure, high blood sugar (diabetes), high blood fat levels, or smoke). Medicines such as Algopirina Fever and Pain may be associated with a slight increase in the risk of heart attack or stroke: the risk is more likely at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment;

• you have or have had high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (edema) have been reported with NSAID therapy;

• you have an infection – see section “Infections” below;

• you have chickenpox, as use of Algopirina Fever and Pain is not recommended in such cases.

Inform your doctor or pharmacist before taking medicines containing ibuprofen, acetylsalicylic acid, or other analgesics, antipyretics, or NSAIDs.
The use of Algopirina Fever and Pain requires adequate precautions, especially if:

• you have or have had asthma, as it may worsen breathing difficulties;
• you have coagulation disorders, as reduced clot formation may occur;
• you have kidney, heart disease, or hypertension: possible severe reduction in kidney function (especially in patients with impaired kidney or liver function, heart failure, or those taking diuretics), kidney toxicity (nephrotoxicity), or fluid retention may occur;
• you have liver disease, as possible liver toxicity may develop;
• you are dehydrated due to fever, vomiting, or diarrhoea; your doctor will advise rehydration both before and during treatment to avoid the risk of impaired kidney function.

Anti-inflammatory/pain-relief medicines such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially when administered at high doses.
Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Algopirina Fever and Pain if you have:

• heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or TIA, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

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 taking Algopirina Fever and Pain immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
During prolonged treatment with Algopirina Fever and Pain, pay particular attention and inform your doctor immediately if you experience:

• signs or symptoms of injury (ulceration) or bleeding of the stomach and intestine (e.g., black, foul-smelling stools, vomiting blood);
• signs and symptoms of liver damage (e.g., hepatitis with jaundice);
• signs and symptoms of kidney damage (e.g., increased urine production, blood in urine);
• visual disturbances such as blurred or reduced vision, partial or complete blindness (scotomas), altered colour perception: in this case, stop treatment immediately and consult an ophthalmologist;
• symptoms such as headache, disorientation, nausea, vomiting, neck stiffness, and fever, as these may indicate aseptic meningitis (more frequent in patients with systemic lupus erythematosus or other collagenoses).

Skin reactions
Serious skin reactions have been reported in association with treatment with ibuprofen.
Stop taking Algopirina Fever and Pain and consult your doctor immediately if you develop a skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.
Infections
Algopirina Fever and Pain may mask symptoms of infections such as fever and pain. Therefore, Algopirina Fever and Pain may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
To reduce the possible side effects listed above, the lowest effective dose should be used
for the shortest duration necessary to control symptoms.
Children and adolescents
Do not give this medicine to children under 12 years of age.
Other medicines and Algopirina Fever and Pain
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Algopirina Fever and Pain may affect or be affected by other medicines, especially inform your doctor if you are taking:

• other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors or acetylsalicylic acid). In such cases, these combinations should be avoided as they increase the risk of possible adverse effects;
• corticosteroids, medicines used to treat inflammation and certain immune system disorders: may increase the risk of gastrointestinal ulcers or bleeding (see “Warnings and precautions”);
• antibiotics known as quinolones: may increase the risk of seizures;
• anticoagulant medicines (i.e., substances that thin the blood to prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat depression such as selective serotonin reuptake inhibitors (SSRIs): increase the risk of gastrointestinal bleeding (see “Warnings and precautions”);
• antidiabetic medicines to treat high blood sugar (sulfonylureas): concomitant use may enhance the effect of these drugs;
• a medicine used to treat viral infections (ritonavir): increases NSAID blood concentration;
• medicines that modulate the immune response (cyclosporine and tacrolimus): increase the risk of kidney toxicity;
• a medicine used in the treatment of cancer and rheumatism (e.g., methotrexate);
• a medicine used for mental disorders (lithium): increases the risk of toxicity;
• a medicine used for medical termination of pregnancy (mifepristone): do not take NSAIDs within 8–10 days after taking mifepristone;
• a medicine used to treat gout (probenecid);
• zidovudine (a medicine used in the treatment of AIDS): increases the risk of haemarthrosis (blood accumulation in a joint cavity due to sprain, dislocation, or bone fracture) and haematoma formation in HIV-positive patients with haemophilia;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) and diuretics;
• potassium-sparing diuretics;
• CYP2C9 inhibitors (e.g., voriconazole, fluconazole), as concomitant administration of ibuprofen and CYP2C9 inhibitors may slow down ibuprofen elimination (CYP2C9 substrate), leading to increased ibuprofen exposure;
• zidovudine (a medicine used in the treatment of HIV/AIDS);
• medicines used to treat heart conditions (cardiac glycosides).

In some patients with kidney problems (e.g., dehydrated patients or elderly patients with impaired kidney function), concomitant administration of ACE inhibitors or angiotensin II antagonists with agents that inhibit the cyclooxygenase system (i.e., with the same mechanism as NSAIDs) may lead to further worsening of kidney function, including potentially severe kidney impairment, usually reversible.
These interactions should be considered in patients taking Algopirina Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be used with caution.
Patients starting this concomitant therapy should be adequately hydrated, and their kidney function should be closely monitored by the doctor.
All the interactions listed above are common to ibuprofen, acetylsalicylic acid, and other analgesics, antipyretics, and other non-steroidal anti-inflammatory drugs (NSAIDs).
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when both drugs are administered concomitantly.
However, only limited data are currently available, and uncertainties remain regarding their clinical relevance; therefore, definitive conclusions cannot be drawn for continuous ibuprofen use. Occasional use of ibuprofen appears not to have clinically relevant effects.
Algopirina Fever and Pain with food and drinks
The medicine can be taken with or without food.
Possible stomach-related side effects, if present, may be reduced by taking the medicine with food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
In such circumstances, consider the following:

• do not take Algopirina Fever and Pain during pregnancy, as the mechanism of action of ibuprofen (inhibition of prostaglandin synthesis) may negatively interfere with pregnancy and/or embryofetal development;
• do not take Algopirina Fever and Pain in the early stages of pregnancy, as epidemiological studies suggest an increased risk of miscarriage and cardiac malformations and gastroschisis (a defect in embryonic development of the abdominal wall leading to incomplete closure of abdominal muscles and skin, resulting in protrusion of internal organs) after use of a prostaglandin synthesis inhibitor. The absolute risk of cardiac malformations increased from less than 1% to about 1.5%. The risk is believed to increase with dose and duration of treatment. In animals, administration of prostaglandin synthesis inhibitors has shown increased pre- and post-implantation losses and embryofetal mortality. Furthermore, in animals treated with prostaglandin synthesis inhibitors during organogenesis, an increased incidence of various malformations, including cardiovascular ones, has been observed.

Do not take ibuprofen during the last 3 months of pregnancy, as it may harm the fetus or cause delivery complications. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour. You should not take ibuprofen 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, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
This medicine passes into breast milk in small amounts. It can be used during breastfeeding if taken at recommended doses and for short periods.
Fertility
Avoid taking this medicine if you are trying to conceive, as it may affect ovulation. This effect reverses upon discontinuation of treatment.
Driving and using machines
Algopirina Fever and Pain does not affect or affects negligibly the ability to drive or use machines when taken for short treatment periods.
Algopirina Fever and Pain contains:

• liquid maltitol: if your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
• sodium: this medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially “sodium-free”. Algopirina Fever and Pain does not contain sugar and is therefore suitable for patients who need to control sugar and calorie intake.

3. How to take Algopirina Fever and Pain

Take this medicine exactly as stated in this leaflet or as directed 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 you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
To reduce the risk of possible side effects, the lowest effective dose for the shortest time needed to control symptoms should be used (see section 4).
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Use in adults and adolescents over 12 years of age
The recommended dose is 1-2 sachets, up to 3-4 times daily.
The interval between doses should not be less than 4-6 hours.
Do not exceed 1200 mg (6 sachets) in 24 hours.

Use in children and adolescents
Algopirina Fever and Pain must not be taken by children under 12 years of age.

Method of administration
If you have stomach problems, you may take the medicine during meals.

If you take more Algopirina Fever and Pain than you should
If you have taken more Algopirina Fever and Pain than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately to obtain advice on the risk and actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements.
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low potassium levels in blood, feeling cold, and breathing difficulties have been reported.
Rarely, uncontrolled eye movements (nystagmus), increased levels of acid in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney problems, stomach and intestinal bleeding, coma, temporary interruption of breathing (apnea), diarrhea, reduced activity of the nervous system and respiratory depression may occur.
In addition, disorientation, excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia), and lethargy may occur.
In cases of severe poisoning, prolonged blood clotting time (prolonged prothrombin time (INR)) may occur. If you suffer from asthma, your symptoms may worsen.
If you take significantly excessive doses, severe kidney and liver damage may occur.
Symptoms of overdose may appear within 4-6 hours after taking ibuprofen.
Symptoms of overdose may occur in children who have ingested more than 400 mg/kg. The time required to reduce drug concentrations in the blood after excessive intake is 1.5-3 hours.

Treatment
There is no specific antidote for ibuprofen overdose. Therefore, symptomatic and supportive treatment is recommended in case of overdose.
In acute overdose, gastric emptying (induced vomiting or gastric lavage) is more effective the sooner it is performed; administration of alkaline substances and induction of diuresis may also be helpful. Taking a substance known as activated charcoal may help reduce drug absorption.
In case of accidental ingestion of an excessive dose of Algopirina Fever and Pain, contact your doctor immediately or go to the nearest hospital.

If you forget to take Algopirina Fever and Pain
Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, STOP treatment with Algopirina Fever and Pain and contact your doctor immediately:

• severe skin and mucous membrane reactions characterised by rashes, redness, itching and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• allergic reactions, even severe ones, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), breathing difficulties (bronchospasm or dyspnea), irregular heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, shock and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, stiff neck and fever (more frequent if the child has systemic lupus erythematosus or other collagen diseases);
• flat, non-elevated reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin eruptions 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 occur at the beginning of treatment (generalized pustular eruption).

Other side effects include:
Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, drowsiness and seizures;
• stomach pain, nausea and indigestion (dyspepsia);
• skin rashes.

Rare (may affect up to 1 in 1,000 people):

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, mood instability, disturbances in hearing and vision;
• cerebrovascular haemorrhage;
• dry eyes;
• awareness of heartbeat (palpitations);
• diarrhoea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia), skin reaction due to exposure to sunlight (photosensitivity dermatitis);
• serious kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine and increased urine production;
• decreased haematocrit levels.

Very rare (may affect up to 1 in 10,000 people):

• reduction in the number of blood cells (anaemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and bleeding;
• signs or symptoms of stomach or intestinal ulcers or bleeding, black and foul-smelling stools, vomiting blood;
• bleeding lesions in the mouth, heartburn (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, hepatic dysfunction, hepatitis, jaundice);
• serious kidney diseases (acute renal failure, papillary necrosis), particularly after long-term treatment, associated with increased blood urea concentration and swelling (oedema);
• decreased haemoglobin levels in the blood;
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of inflammation related to infections (e.g. necrotizing fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of infection appear or worsen, contact your doctor immediately to assess whether anti-infective/antibiotic therapy is needed.

Not known (frequency cannot be estimated from available data):

• irritability;
• fluid retention and loss of appetite;
• abnormal perception of sounds such as ringing, buzzing or humming (tinnitus);
• severe heart disease (heart failure) and swelling (oedema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, laryngeal obstruction, laboured breathing (bronchospasm), temporary cessation of breathing (apnoea) and difficulty breathing (dyspnoea);
• worsening of inflammatory bowel diseases (colitis and Crohn's disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the oesophagus (oesophagitis);
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells);
• a widespread, red, scaly rash with pustule formation under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Algopirina Fever and Pain if you develop these symptoms and contact your doctor immediately. See also section 2;
• skin becomes sensitive to light;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

The use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a
modest increase in the risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 Algopirina Fever and Pain

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label 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 Algopirina Fever and Pain contains
The active substance is ibuprofen.
Each sachet contains:
Ibuprofen 200 mg
The other ingredients are:
Monohydrate citric acid, sodium citrate, potassium acesulfame, xanthan gum, sodium benzoate,
orange flavour, liquid maltitol, glycerin, purified water.

Description of the appearance of Algopirina Fever and Pain and the contents of the pack
Single-dose sachets with a capacity of 10 ml, made of a polyester/aluminum/polyethylene laminate.
The carton contains the oral suspension in 6 or 12 sachets of 10 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM) Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) Italy

Package leaflet: information for the patient

ALGOPIRINA FEVER AND PAIN Children 100mg/5ml oral suspension, strawberry flavour, sugar-free

ALGOPIRINA FEVER AND PAIN Children 100mg/5ml oral suspension, orange flavour, sugar-free
Ibuprofen
Generic medicine

Please read this entire leaflet carefully before using this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If your child experiences any of the side effects listed in this leaflet, or any not listed, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not observe improvement or if symptoms worsen after:
  • 24 hours in infants aged 3 to 5 months;
  • 3 days in infants and children aged 6 months and older, and adolescents.

Contents of this leaflet:

1. What Algopirina Fever and Pain is and what it is used for
2. What you need to know before using Algopirina Fever and Pain
3. How to use Algopirina Fever and Pain
4. Possible side effects
5. How to store Algopirina Fever and Pain
6. Package contents and other information

1. What Algopirina Fever and Pain is and what it is used for

Algopirina Fever and Pain contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs) that act to reduce pain, fever, and inflammation.
Algopirina Fever and Pain is indicated in children from 3 months to 12 years of age for the symptomatic treatment of fever, including post-vaccination fever, and for mild to moderate pain (such as headache, toothache, sore throat, earache).

2. What you need to know before using Algopirina Fever and Pain

Do not use Algopirina Fever and Pain if:

• you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• you have experienced or currently experience allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips and throat (angioedema), or hives, particularly if associated with
  nasal polyps and asthma, after taking other painkillers, other antipyretics, acetylsalicylic acid,
  or other non-steroidal anti-inflammatory drugs (NSAIDs);
• you suffer from severe kidney or liver disease (renal or hepatic failure);
• you have severe heart problems (severe heart failure);
• you currently have or have previously had gastrointestinal bleeding and/or perforation (gastrointestinal hemorrhage) following previous treatment with NSAIDs;
• you currently have or have previously had gastric/duodenal ulcers (peptic ulcers) or recurrent bleeding (at least two separate episodes of ulceration or bleeding);
• you are currently taking other medicines from the same family as non-steroidal anti-inflammatory drugs (NSAIDs), including those that selectively inhibit the action of an enzyme called COX-2 (see section “Other medicines and Algopirina Fever and Pain”);
• you have any condition that increases the risk of bleeding;
• in case of unexplained blood disorders;
• you are severely dehydrated, for example, if you have experienced severe episodes of vomiting, diarrhea, or have been drinking very little;
• you are under 3 months of age or weigh less than 5.6 kg;
• you are in the third trimester of pregnancy (see Pregnancy and breastfeeding).

Warnings and precautions
Severe 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 Algopirina Fever and Pain and contact
your doctor immediately if you notice any of the symptoms related to these severe skin
reactions described in section 4.
Consult your doctor or pharmacist before using Algopirina Fever and Pain if:

• you currently have or have previously had allergies to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs), and if you suffer from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, or have severe respiratory or chest problems, e.g., chronic obstructive pulmonary disease, or swelling of the face, lips, and throat (angioedema);
• you are taking other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs), including those that selectively inhibit the action of an enzyme called COX-2 (see “Other medicines and Algopirina Fever and Pain”);
• you have had stomach or intestinal problems (history of ulcers), especially if complicated by bleeding or perforation, as there may be an increased risk of gastrointestinal bleeding and perforation. In such cases, your doctor may advise starting treatment with the lowest available dose and possibly using concomitant medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see section “Other medicines and Algopirina Fever and Pain”). During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, bleeding, ulceration, and perforation of the stomach or intestine may occur, which can be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.

If gastrointestinal bleeding or ulceration occurs, stop treatment with
Algopirina Fever and Pain and contact your doctor;

• you currently have or have previously had gastrointestinal diseases such as Crohn’s disease or ulcerative colitis, inform your doctor, as the use of NSAIDs could worsen these conditions (see section 4 “Possible side effects”);
• you are taking medicines that could increase the risk of ulcer or bleeding, such as medicines used to treat inflammation and certain immune system disorders (oral corticosteroids), anticoagulants such as warfarin, medicines with antiplatelet effects like aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs) (see section “Other medicines and Algopirina Fever and Pain”);
• you have heart disease (uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease) or have had reduced blood flow to the brain (stroke), or if you think the child may be at risk for these conditions (e.g., if they have high blood pressure, high blood sugar levels (diabetes), high blood lipid levels, or if they smoke). Medicines like Algopirina Fever and Pain may be associated with a slight increase in the risk of heart attack or stroke: the risk is higher at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• you currently have or have previously had high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (edema) have been reported during NSAID therapy;
• you have an infection – see section “Infections” below.
• you have chickenpox, as the use of Algopirina Fever and Pain is not recommended.

The use of Algopirina Fever and Pain requires adequate precautions, especially if the child:

• currently has or has previously had asthma, as it may worsen breathing difficulties;
• has coagulation disorders or hypertension;
• has kidney, heart, or liver disease;
• is taking medicines that increase urine production (diuretics), or has recently undergone major surgery resulting in fluid loss, as your doctor may recommend periodic blood and urine tests for the child;
• has recently undergone major surgery;
• has certain congenital disorders affecting blood formation (e.g., acute intermittent porphyria);
• is dehydrated due to fever, vomiting, or diarrhea; your doctor will advise rehydration both before and during treatment to avoid the risk of impaired kidney function.

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a modest
increase in the risk of heart attack or stroke, especially when administered at high doses.
Do not exceed the recommended dose or duration of treatment.
Discuss treatment with your doctor or pharmacist before using Algopirina Fever and Pain if
the child has:

• heart problems, including heart attack, angina (chest pain), or history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including 'mini-stroke' or "TIA", transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if they are a smoker.

Signs of an allergic reaction to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported.
Stop treatment with Algopirina Fever and Pain immediately and contact
your doctor or emergency medical services immediately if you notice any of these
signs.
During prolonged treatment with Algopirina Fever and Pain, pay particular
attention and inform your doctor immediately if the following occur:

• signs or symptoms of injury (ulceration) or bleeding in the stomach and intestine (e.g., black, foul-smelling stools, vomiting blood);
• signs and symptoms of liver damage (e.g., hepatitis and jaundice);
• signs and symptoms of kidney damage (e.g., increased urine production, blood in urine);
• visual disturbances such as blurred or reduced vision, partial or complete blindness (scotomas), or altered color perception: in this case, stop treatment immediately and consult an ophthalmologist; symptoms such as frequent or daily headaches despite regular use of headache medicines, as they may be caused by excessive use of these medicines;
• symptoms such as headache, disorientation, nausea, vomiting, neck stiffness, and fever, as these could be symptoms of aseptic meningitis (more common if the child has systemic lupus erythematosus or other collagen diseases).

Skin reactions
Severe skin reactions have been reported in association with ibuprofen treatment.
Stop taking Algopirina Fever and Pain and consult your doctor immediately if a skin rash, mucosal lesions, blisters, or other signs of allergy appear, as
they may be early signs of a serious skin reaction. See section 4.
Infections
Algopirina Fever and Pain may mask symptoms of infections such as fever and pain. Therefore,
Algopirina Fever and Pain could delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this
medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
To reduce the possible side effects listed above, the lowest effective dose should be used
for the shortest duration necessary to control symptoms.
Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Other medicines and Algopirina Fever and Pain
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicine.
Algopirina Fever and Pain may affect or be affected by other medicines, particularly
inform your doctor or pharmacist if the child is taking:

• other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors or acetylsalicylic acid). Such combinations should be avoided as they increase the risk of possible side effects;
• corticosteroids, medicines used to treat inflammation and certain immune system disorders: may increase the risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”);
• medicines used to treat bacterial infections (quinolone antibiotics): may increase the risk of seizures;
• anticoagulant medicines (i.e., substances that thin the blood and prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat depression such as selective serotonin reuptake inhibitors (SSRIs): increase the risk of gastrointestinal bleeding (see “Warnings and precautions”);
• a medicine used to treat seizures (phenytoin);
• antidiabetic medicines to treat high blood sugar levels (sulfonylureas): concomitant use may increase the effect of these drugs;
• a medicine used to treat viral infections (ritonavir): increases NSAID blood concentration;
• medicines that modulate immune response (tacrolimus and cyclosporine): increase the risk of kidney toxicity;
• a medicine used in the treatment of cancer and rheumatism (methotrexate);
• a medicine used for mental illness (lithium): increases the risk of toxicity;
• a medicine used for medical abortion (mifepristone): do not take NSAIDs in the 8–12 days following mifepristone intake;
• a medicine used to treat gout (probenecid and sulfinpyrazone);
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) and diuretics;
• potassium-sparing diuretics;
• CYP2C9 inhibitors (e.g., voriconazole, fluconazole), as concomitant administration of ibuprofen and CYP2C9 inhibitors may slow down ibuprofen elimination (a CYP2C9 substrate), leading to increased exposure to ibuprofen;
• medicines used to treat heart conditions (cardiac glycosides such as digoxin);
• zidovudine (a medicine used in the treatment of HIV/AIDS).

Algopirina Fever and Pain with food and drinks
The medicine can be taken with or without food.
Possible stomach-related side effects, if present, may be reduced by taking the
medicine with food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before taking this
medicine.
Pregnancy
It is unlikely that individuals under 12 years of age will become pregnant or breastfeed.
In such cases, keep in mind the following considerations:

• do not take Algopirina Fever and Pain if you are pregnant, as the mechanism of action of ibuprofen (inhibition of prostaglandin synthesis) may negatively interfere with pregnancy and/or embryofetal development;
• do not take Algopirina Fever and Pain during early pregnancy, as epidemiological studies suggest an increased risk of miscarriage and of heart malformations and gastroschisis (a defect in embryonic development of the abdominal wall leading to incomplete closure of abdominal muscles and skin, resulting in protrusion of internal organs) after use of a prostaglandin synthesis inhibitor. The absolute risk of heart malformations increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has shown a higher incidence of pre- and post-implantation losses and embryofetal mortality. Furthermore, in animals administered prostaglandin synthesis inhibitors during organ formation, an increased incidence of various malformations, including cardiovascular ones, has been observed.

Do not take ibuprofen during the last three months of pregnancy, as it may harm the fetus or
cause problems during childbirth. It may cause kidney and heart problems in the fetus. It could
affect your and your baby’s tendency to bleed and delay or prolong labor beyond expected. You should not take ibuprofen 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, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
This medicine passes into breast milk in small amounts. It may be used during
breastfeeding if taken at recommended doses and for short periods of time.
Fertility
Avoid taking this medicine if you are trying to conceive, as it may affect ovulation. This effect reverses upon discontinuation of treatment.
Algopirina Fever and Pain contains:

• liquid maltitol: if your doctor has diagnosed your child with intolerance to certain sugars, contact them before giving this medicine. It may have a mild laxative effect.
• 4.4 mg of sodium (main component of table salt) per 2.5 ml dose, equivalent to 0.23% of the maximum daily recommended dietary intake for an adult. Talk to your doctor or pharmacist if your child needs 2 or more 2.5 ml doses per day for a prolonged period, especially if they are on a low-sodium diet.
• potassium: this medicine contains 0.75 mg per 2.5 ml dose. This should be considered in cases of reduced kidney function or a low-potassium diet.

3. How to take Algopirina Fever and Pain

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The daily dose is based on the patient's weight and age.
To reduce the possible unwanted effects, use the lowest effective dose for the shortest time necessary to control symptoms (see section 4).

Use in children aged between 3 and 6 months
Limit administration to those weighing more than 5.6 kg.

Use in infants and children aged between 3 months and 12 years
Oral administration should be performed using the dosing syringe provided with the product.
The daily dose of 20–30 mg/kg body weight, taken 3 times a day at intervals of 6–8 hours, can be administered according to the following table (calculate the dose to be administered based on the weight and age of the child):

| Body weight | Age | Single dose in ml | Maximum number of doses/day | |-----------------|---------|------------------------|----------------------------------| | From 5.6 kg | 3 - 6 months | 2.5 ml | | | From 7 kg | 6 - 12 months | 2.5 ml | | | From 10 kg | 1 - 3 years | 5 ml | 3 in 24 hours | | From 15 kg | 4 - 6 years | 7.5 ml (5 ml + 2.5 ml) | | | From 20 kg | 7 - 9 years | 10 ml | | | From 28 to 43 kg| 10 - 12 years | 15 ml | |

The graduated scale on the syringe barrel clearly shows markings for different doses; in particular, the 2.5 ml mark corresponds to 50 mg of ibuprofen and the 5 ml mark corresponds to 100 mg of ibuprofen.

If the child suffers from stomach discomfort, administer Algopirina Fever and Pain preferably during meals.

In case of fever following vaccination, refer to the recommended daily dosage shown in the table above.

The product should be used for short-term treatment only.
Use the lowest effective dose for the shortest period needed to relieve symptoms. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

In infants and children over 6 months of age and in adolescents: if it is necessary to use the medicine for more than 3 days or if symptoms worsen, inform your doctor.

In infants aged between 3 and 5 months: consult your doctor if symptoms persist for longer than 24 hours or if they worsen.

Taking the medicine with food may reduce gastrointestinal discomfort.

Instructions for using the dosing syringe:
1- Unscrew the cap by pushing it downwards and turning it to the left.
2- Insert the tip of the syringe fully into the opening of the inner cap.
3- Shake well.
4- Invert the bottle, then, holding the syringe firmly, gently pull the plunger down to draw the suspension into the syringe up to the mark corresponding to the desired dose.
5- Return the bottle to an upright position and remove the syringe by gently rotating it.
6- Insert the tip of the syringe into the child's mouth and gently press the plunger to dispense the suspension.

After use, screw the cap back on to close the bottle and wash the syringe with warm water. Allow it to dry and store it out of sight and reach of children.

If you take more Algopirina Fever and Pain than you should
If you have taken more Algopirina Fever and Pain than recommended or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and actions to take.

Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements.

At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.

Rarely, uncontrolled eye movements (nystagmus), increased levels of acid in the blood (metabolic acidosis), lowering of body temperature (hypothermia), kidney problems, bleeding of the stomach and intestines, coma, temporary cessation of breathing (apnea), diarrhoea, reduced activity of the nervous system and respiratory depression may occur.

In addition, the following may occur: disorientation, excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia), lethargy.

In cases of severe poisoning, a prolonged blood clotting time (prolonged prothrombin time (INR)) may occur. If you suffer from asthma, your symptoms may worsen.

If significantly high doses are taken, serious damage to the kidneys and liver may occur.

Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.

Symptoms of overdose may occur in children who have ingested more than 400 mg/kg. The time required to reduce drug concentrations in the blood after excessive intake is 1.5–3 hours.

Treatment
There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore recommended.

In case of acute overdose, gastric emptying (induced vomiting or gastric lavage) is more effective the sooner it is performed; administration of alkaline substances and induction of diuresis may also be helpful. Taking a substance known as activated charcoal may help reduce drug absorption.

In case of accidental ingestion of an excessive dose of Algopirina Fever and Pain, contact your doctor immediately or go to the nearest hospital.

If you forget to take Algopirina Fever and Pain
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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.
If the child experiences any of the following side effects, STOP treatment with Algopirina Febbre e Dolore and contact a doctor immediately:

• severe skin and mucous membrane reactions characterized by rashes, redness, itching, and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis);
• allergic reactions, even severe ones, which may include: urticaria, itching, purpura, swelling of the face, mouth, and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), irregular heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, stiff neck, and fever (more frequent if the child has systemic lupus erythematosus or other collagenopathies);
• flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions 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 occur at the beginning of treatment (generalized acute exanthematous pustulosis).

Other side effects include:
Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, drowsiness, and convulsions;
• stomach pain, nausea, and difficulty digesting (dyspepsia);
• skin rashes;
• vision disturbances.

Rare (may affect up to 1 in 1,000 people):

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, mood instability, hearing disturbances;
• cerebrovascular haemorrhage;
• dry eyes;
• awareness of heartbeat (palpitations);
• diarrhoea, flatulence, dry mouth, constipation, and vomiting;
• hair loss (alopecia), skin becomes light-sensitive;
• severe kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine, and increased urine production;
• decreased haematocrit levels.

Very rare (may affect up to 1 in 10,000 people):

• reduction in blood cell counts (anaemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and bleeding;
• signs or symptoms of stomach or intestinal ulcers or bleeding, black and foul-smelling stools, vomiting blood;
• bleeding lesions in the mouth, stomach burning (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, hepatic dysfunction, hepatitis, jaundice);
• severe kidney diseases (acute renal failure, papillary necrosis), particularly following long-term treatment, associated with increased blood urea concentration and swelling (oedema);
• decreased haemoglobin levels in the blood;
• heart attack (myocardial infarction);
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of inflammation related to infections (e.g. necrotizing fasciitis);
• associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of infection appear or worsen, contact a doctor immediately to assess whether anti-infective/antibiotic therapy is needed.

Not known (frequency cannot be estimated from the available data):

• irritability;
• fluid retention and decreased appetite;
• abnormal perception of noises such as buzzing, ringing, or hissing (tinnitus);
• severe heart disease (heart failure) and swelling (oedema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, laryngeal obstruction, laboured breathing (bronchospasm), temporary cessation of breathing (apnoea), and difficulty breathing (dyspnoea);
• worsening of inflammatory bowel diseases (colitis and Crohn's disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the oesophagus (oesophagitis);
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin 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 affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using Algopirina Febbre e Dolore if these symptoms develop and contact a doctor immediately. See also section 2;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

The use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effects, 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 Algopirina Fever and Pain

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.".
The expiry date refers to the last day of that month.
The product must be used within 6 months after first opening.
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 Algopirina Febbre e Dolore contains
The active substance is ibuprofen.
Algopirina Febbre e Dolore Bambini 100mg/5ml oral suspension, strawberry flavour, sugar-free
Each ml of oral suspension contains:
Ibuprofen 20 mg
The other components are:
Monohydrate citric acid, sodium citrate, potassium acesulfame, xanthan gum, sodium benzoate,
strawberry flavour, maltitol syrup, glycerin, purified water.
Algopirina Febbre e Dolore Bambini 100mg/5ml oral suspension, orange flavour, sugar-free
Each ml of oral suspension contains:
Ibuprofen 20 mg
The other components are:
Monohydrate citric acid, sodium citrate, potassium acesulfame, xanthan gum, sodium benzoate,
orange flavour, maltitol syrup, glycerin, purified water.
Description of the appearance of Algopirina Febbre e Dolore and contents of the pack
The carton contains the oral suspension in a 150 ml amber-coloured bottle with child-resistant cap and a 5 ml dosing syringe.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM) - Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) - Italy