Name
FROBEFLU 330 mg + 200 mg effervescent tablets
Acetylsalicylic acid/ascorbic acid


What is it and what is it for?
FROBEFLU contains the active ingredients acetylsalicylic acid and ascorbic acid. Acetylsalicylic acid belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), used to treat mild pain and inflammation. Ascorbic acid is a vitamin also called vitamin C.
FROBEFLU is used to treat symptoms of feverish and painful conditions such as flu, colds, headaches, toothaches, rheumatic and muscle pain, menstrual pain, and nerve pain (neuralgia).

Contact your doctor if you do not feel better or if you feel worse after three days of use at the maximum dose or after 5 days of use.


What you need to know before taking the medicine
Do not take FROBEFLU
- if you are allergic to acetylsalicylic acid, ascorbic acid or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to medicines belonging to the group of salicylates or non-steroidal anti-inflammatory drugs;
- if you have had stomach or intestinal bleeding or stomach injuries in the past, due to previous treatments;
- if you have lesions in the stomach or duodenum (ulcer) or suffer from other diseases affecting the stomach (gastropathies);
- if you have a predisposition to blood loss, for example if you suffer from blood clotting disorders (haemophilia, hypoprothrombinemia and vitamin K deficiency);
- if you suffer from severe heart problems (severe heart failure);
- if you suffer from severe kidney or liver problems (renal or hepatic insufficiency);
- if you suffer from bronchial asthma (narrowing of the lower airways resulting in breathing difficulties), particularly if you also have other breathing problems (nasal polyposis and angioedema);
- if you are under 16 years of age;
- if you have chickenpox or influenza virus, because it can cause serious complications (Reye's syndrome), especially in children and adolescents (see section "Children and adolescents");
- in doses greater than 100 mg per day during the third trimester of pregnancy (see the section "Pregnancy, breastfeeding and fertility");
- if you are breastfeeding;
- if you have a deficiency of a particular enzyme, glucose-6-phosphate dehydrogenase, which causes blood problems;
- if you are taking methotrexate (at doses of 15 mg/week or more) or walfarin (see "Other medicines and FROBEFLU").


Warnings and precautions
Talk to your doctor or pharmacist before taking FROBEFLU.

Avoid taking FROBEFLU in combination with other NSAIDs (non-steroidal anti-inflammatory drugs), including selective COX-2 inhibitors, such as celecoxib, valdecoxib, lumiracoxib, etc. (see "Other medicines and FROBEFLU").

Avoid using high doses and/or for a long time without first consulting your doctor and without his direct supervision.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 3 "How to take FROBEFLU").

Surgery
Do not take this medicine before undergoing surgery, as it can hinder blood clotting during surgery (even minor ones, such as tooth extractions) and thus cause bleeding. You should inform your surgeon about the possible effects on blood clotting if you have used acetylsalicylic acid or another NSAID.

If prolonged vomiting and profound drowsiness occur during treatment, stop taking it.

Use particular caution in the following cases:
- if you are elderly and have kidney problems or have low levels of a blood protein, albumin, because the medicine could be toxic in this case;
- if you suffer from chronic or recurrent gastric or intestinal disorders (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (aggravated);
- if you are taking medicines used to improve blood clotting (anticoagulants or antiplatelet agents), medicines for anxiety and depression (selective serotonin reuptake inhibitors) or medicines for inflammation (corticosteroids), because there is a risk of blood loss (haemorrhages) (see the section "Other medicines and FROBEFLU");
- if you suffer or have suffered from kidney stones;
- if you suffer from blood problems such as haemochromatosis, thalassemia or sideroblastic anaemia;
- if you suffer from high blood pressure or heart problems (heart failure), as fluid retention (a tendency to retain fluid in the body) and edema (accumulation of fluid in the tissues) have been reported in association with NSAID therapy. The risk is greater in patients treated with diuretics;
- if you take medicines used to increase urine production (spironolactone, furosemide) and medicines to treat gout, unless otherwise indicated by your doctor, because their effect is reduced by this medicine (see the section "Other medicines and FROBEFLU").

It is advisable to consult your doctor if you have:
- gastric and intestinal disorders;
- reduced kidney function (mild to moderate reduction in kidney function);
- any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in early treatment;
- if you are in the first or second trimester of pregnancy (see "Pregnancy, breastfeeding and fertility");
- if you are diabetic, as salicylates may increase the hypoglycaemic effect of sulfonylureas.

Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all nonsteroidal anti-inflammatory drugs (NSAIDs), at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration, or perforation is greater with high doses of NSAIDs in patients who have had ulcers in the past, particularly if complicated by bleeding or perforation (see section 4 "Possible side effects"). People who drink large amounts of alcohol are at increased risk of bleeding.

In these cases, treatment should be initiated at the lowest available dose, and the possibility of using concomitant gastroprotective agents (e.g., misoprostol or proton pump inhibitors) should be considered. The use of gastroprotective agents should also be considered if low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events are being taken (see "Other medicines and FROBEFLU").

If gastrointestinal bleeding or ulceration occurs while taking FROBEFLU, stop treatment immediately and do not restart without first consulting your doctor.

Serious skin reactions, some of them fatal (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported very rarely with the use of NSAIDs (see section 4). The onset of reactions occurs in most cases within the first month of treatment. Stop taking FROBEFLU and talk to your doctor or pharmacist if you notice a skin rash, mucosal lesions, or any other sign of hypersensitivity.

Acetylsalicylic acid and other NSAIDs can cause allergic reactions including asthma attacks, runny nose, angioedema (swelling of the skin, face and its mucous membranes) or urticaria (small itchy spots on the skin).
In subjects with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria, reactions may be more frequent and severe.

Acetylsalicylic acid changes uricemia (the level of uric acid in the blood).

Metrorrhagia or menorrhagia: taking acetylsalicylic acid at the same time may increase the risk of greater intensity and duration of bleeding.

Children and adolescents
This medicine is contraindicated in children and adolescents under 16 years of age (see the section "Do not take FROBEFLU"), especially if they have infections caused by viruses, such as influenza A, influenza B, and chickenpox. In this case, there is a risk of a very rare and life-threatening disease, Reye's syndrome, which requires immediate medical attention and manifests itself with persistent vomiting and central nervous system damage (numbness, generalized convulsions, and coma), liver damage, and low blood sugar levels (hypoglycemia).

Elderly people
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 3 "How to take FROBEFLU"). The risk is higher with increased doses of NSAIDs, therefore these patients should start treatment with the lowest available dose and the possibility of using concomitant gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
People over 70 years of age, especially if they are undergoing other treatments, should take this medicine only after consulting their doctor.


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

The following side effects may occur:
- stomach problems (heartburn, epigastralgia), gastritis, constipation, nausea, vomiting, diarrhea, excessive intestinal gas (flatulence), digestive disorders (dyspepsia), abdominal pain, erosion of the oral mucosa (ulcerative stomatitis), worsening of previous gastrointestinal diseases (colitis, Crohn's disease, peptic ulcer, even perforated);
- gastrointestinal bleeding, sometimes fatal, which may manifest as vomiting or melena (black stools due to the presence of blood) or be occult and cause iron deficiency anemia (reduction in red blood cells due to iron deficiency). Such bleeding is more frequent with increasing dosage and in elderly patients. Gastritis (inflammation of the mucosa lining the stomach) has been observed less frequently;
- heart disorders (edema, hypertension, heart failure);
- bullous skin reactions (Steven Johnson Syndrome, toxic epidermal necrolysis);
- bleeding syndromes such as nosebleeds (epistaxis), gum bleeding, decreased blood platelet count (thrombocytopenia), and purpura (small subcutaneous hemorrhages). This effect persists for 4-8 days after stopping acetylsalicylic acid administration;
- high doses of Vitamin C (> 1 g) may increase white blood cell breakdown (hemolysis) in patients with G6PD-dehydrogenase deficiency;
- allergic reactions such as skin rashes, swelling of the larynx due to fluid accumulation, obstruction of the bronchi (bronchospasm), Quincke's edema (swelling of large areas of the face and mucous membranes of the mouth that may also affect the respiratory and gastrointestinal systems), acute and non-acute asthma, nose problems (nasal polyps), runny nose (rhinorrhea), sudden swelling of the skin and mucous membranes (angioedema);
- ringing in the ears (tinnitus) and hearing loss, which may occur at high doses. In this case, you should temporarily discontinue treatment or reduce the dosage;
- decreased blood flow to the kidneys and worsening of kidney problems (acute renal failure) in people who already suffer from these problems;
- high doses of Vitamin C (> 1 g) may promote the formation of stones (oxalate and uric acid stones) in some people;
- serious rare disease that can be fatal (Reye's syndrome);
- headache, dizziness;
- rhinitis (runny nose), dyspnea (difficulty breathing);
- bronchospasm (abnormal contraction of the smooth muscles of the bronchi or bronchioles), asthma attacks;
- delayed delivery.

Reporting of side effects
If you experience any side effects, including any 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/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.