FROBEFLU*20 effervescent tablets 330mg+200mg

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

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

Consult 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 salicylate or non-steroidal anti-inflammatory groups;
- if you have a history of stomach or intestinal bleeding or stomach lesions due to previous treatments;
- if you have stomach or duodenal lesions (ulcer) or suffer from other conditions affecting the stomach (gastropathies);
- if you have a predisposition to bleeding, for example if you suffer from blood coagulation disorders (hemophilia, 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 are affected by the chickenpox or flu virus, as it can cause serious complications (Reye's syndrome), especially in children and adolescents (see the 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 warfarin (see Other medicines and FROBEFLU).

Warnings and precautions
Consult 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 consulting your doctor first and without their direct supervision.
Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment 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 a surgical procedure (even minor, such as tooth extractions) and thus cause bleeding. You should inform the surgeon about the possible effects on coagulation if you have used acetylsalicylic acid or another NSAID.

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

Use particular caution in the following cases:
- if you are elderly and have kidney problems or 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 can 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 bleeding (hemorrhages) (see the section Other medicines and FROBEFLU);
- if you suffer or have suffered from kidney stones;
- if you suffer from blood-related problems such as hemochromatosis, thalassemia, or sideroblastic anemia;
- if you suffer from high blood pressure or have heart problems (heart failure), as fluid retention (tendency to retain fluids in the body) and edema (fluid accumulation in tissues) have been reported in association with NSAID therapy. The risk is greater in patients treated with diuretics;
- if you are taking medicines used to increase urine production (spironolactone, furosemide) and medicines for the treatment of 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 the early stages of treatment;
- if you are in the first or second trimester of pregnancy (see Pregnancy, breastfeeding, and fertility);
- if you are diabetic, as salicylates can increase the hypoglycemic effect of sulfonylureas.

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

In these cases, treatment should be started at the lowest available dose, and the possibility of concurrently using gastroprotective agents (e.g., misoprostol or proton pump inhibitors) should be considered. The use of gastroprotective agents should also be considered if low doses of 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 it without first consulting your doctor.

Very rarely, severe skin reactions, some of which fatal (exfoliative dermatitis, Stevens-Johnson Syndrome, toxic epidermal necrolysis) have been reported 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 spots on the skin accompanied by itching).
In individuals with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria, reactions may be more frequent and severe.

Acetylsalicylic acid modifies uric acid levels (uricemia).

Metrorrhagia or menorrhagia: concomitant intake of acetylsalicylic acid 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 viral infections, such as influenza A, influenza B, and chickenpox. In this case, there is a risk of a very rare and life-threatening condition, Reye's syndrome, which requires immediate medical intervention and manifests with persistent vomiting and central nervous system damage (lethargy, generalized seizures and coma), liver lesions, and low blood sugar levels (hypoglycemia).

Elderly
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 3 How to take FROBEFLU). The risk is higher with increased doses of NSAIDs, therefore such patients should start treatment with the lowest available dose, and the possibility of concurrently using gastroprotective agents (e.g., misoprostol or proton pump inhibitors) should be considered.
Individuals over 70 years of age, especially if 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 upset (heartburn, epigastric pain), gastritis, constipation, nausea, vomiting, diarrhea, excessive intestinal gas (flatulence), indigestion (dyspepsia), abdominal pain, erosion of the mouth lining (ulcerative stomatitis), worsening of pre-existing gastrointestinal diseases (colitis, Crohn's disease, peptic ulcer, even perforated);
- gastrointestinal bleeding, sometimes fatal, which may manifest as vomiting or melena (dark stools due to the presence of blood) or be occult and cause iron deficiency anemia (reduction of red blood cells due to iron deficiency). Such bleeding is more frequent with increasing dosage and in elderly patients. Less frequently, gastritis (inflammation of the stomach lining) has been observed;
- heart problems (edema, hypertension, heart failure);
- blistering skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis);
- hemorrhagic syndromes such as nosebleeds (epistaxis), gum bleeding, reduction of platelets in the blood (thrombocytopenia), purpura (small subcutaneous hemorrhages). This effect persists for 4-8 days after discontinuing acetylsalicylic acid;
- high doses of Vitamin C (> 1 g) can increase the breakdown of white blood cells (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 oral cavity that can also affect the respiratory and gastrointestinal systems), acute and non-acute asthma, nasal problems (nasal polyps), runny nose (rhinorrhea), sudden swelling of the skin and mucous membranes (angioedema);
- ringing in the ear (tinnitus) and decreased hearing, which may occur at high doses. In this case, you should temporarily stop 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) can promote the formation of stones (oxalate and uric acid stones) in some people;
- severe 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 labor.

Reporting of side effects
If you get 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.