FROBEFLU 330 mg/200 mg Effervescent Tablet

Зміст інструкції

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

FROBEFLU

330 mg + 200 mg effervescent tablets

acetylsalicylic acid / ascorbic acid

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after three days of use at the maximum dose or after 5 days of use.

Contents of this leaflet:

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

1. What is FROBEFLU and what is it 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 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 febrile and painful conditions such as
flu-like illnesses, colds, headache, toothache, rheumatic and muscular pains, menstrual pains, 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.

2. What you need to know before taking FROBEFLU

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 that belong to the group of salicylates or non-steroidal anti-inflammatory drugs;
• if you have had stomach or intestinal bleeding in the past, or lesions in the stomach, 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 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 with consequent breathing difficulties), especially if you also have other respiratory problems (nasal polyps and angioedema);
• if you are under 16 years of age;
• if you are affected by the varicella virus or influenza, 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 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 association 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 their direct supervision.
Side effects can be minimized by using the lowest effective dose for the shortest possible duration necessary to control the symptoms (see section 3 “How to take FROBEFLU”).
Surgery
Do not take this medicine before undergoing a surgical operation, as it may interfere with blood clotting during surgery (even minor surgery, such as tooth extractions) and therefore cause bleeding. The surgeon should be informed of the possible effects on coagulation if you have used acetylsalicylic acid or another NSAID.
If prolonged vomiting and deep 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 may 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 (worsened);
• 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 (hemorrhage) (see section “Other medicines and FROBEFLU);
• if you suffer or have suffered from kidney stones;
• if you suffer from blood 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 the tissues) have been reported in association with NSAID therapy. The risk is higher 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 section “Other medicines and FROBEFLU”).

It is advisable to consult your doctor if you experience:

• gastric and intestinal disorders;
• reduced kidney function (reduction of kidney function from mild to moderate);
• 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.

During treatment with all non-steroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported at any time, 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, especially if complicated by bleeding or perforation (see section 4 “Possible side effects”). People who habitually consume large amounts of alcohol are more exposed to the risk of bleeding.
In these cases, treatment should be started at the lowest available dose and the possibility of using gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered. The use of gastroprotective agents should also be considered if you are taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see “Other medicines and FROBEFLU”).

If you experience gastrointestinal bleeding or ulceration while taking FROBEFLU, stop treatment immediately and do not resume it without first consulting your doctor.
Very rarely, serious skin reactions, some of which have been 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 rash, mucous membrane lesions or any other signs of hypersensitivity.
Acetylsalicylic acid and other NSAIDs can cause allergic reactions including asthma attacks, runny nose, angioedema (swelling of the skin, face and mucous membranes) or urticaria (small spots on the skin accompanied by itching).
In subjects with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more frequent and severe.
Acetylsalicylic acid modifies uricemia (level of uric acid in the blood).
Menorrhagia or metrorrhagia: concomitant administration 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 section “Do not take FROBEFLU”) especially if they have infections caused by viruses, such as influenza A, influenza B and varicella. In this case there is a risk of a very rare and life-threatening disease, Reye's syndrome, which requires immediate medical intervention and manifests with persistent vomiting and damage to the central nervous system (stupor, generalized convulsions 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 these patients should start treatment with the lowest available dose and the possibility of using gastroprotective 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 only take this medicine after consulting a doctor.

Other medicines and FROBEFLU
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take FROBEFLU together with these medicines (see “Do not take FROBEFLU”):

• Methotrexate (used in some cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin (anticoagulant).

Take FROBEFLU with caution together with the following medicines:

• medicines for blood coagulation disorders (anticoagulants) and heparin;
• methotrexate, a medicine used to treat some cancers, because acetylsalicylic acid makes it more toxic (at doses less than 15 mg/week);
• medicines used for inflammation (corticosteroids), to thin the blood (antiplatelet agents) or for anxiety and depression (selective serotonin reuptake inhibitors) as you may experience bleeding in the stomach and intestines;
• other non-steroidal anti-inflammatory drugs, because they may increase side effects;
• anagrelide, a drug used to decrease high levels of platelets in the blood and which may therefore increase the risk of bleeding;
• antidiabetics: medicines that lower blood sugar levels, such as oral hypoglycemic agents (sulfonylureas);
• diuretics (medicines to increase urine output) and antihypertensives: such as spironolactone, furosemide and preparations used against gout;
• valproic acid: acetylsalicylic acid reduces the binding of valproic acid to serum albumin, increasing its plasma concentrations;
• pemetrexed a medicine used in the treatment of tumors;
• metamizole (a substance used to reduce pain and fever) may decrease the effect of acetylsalicylic acid on platelet aggregation (blood cells that attach and form a blood clot), if taken simultaneously. Therefore, this combination should be used with caution in patients taking aspirin at low doses for cardioprotection;
• alkalinizing agents of the urine (e.g. antacids, citrates): reduce the absorption of the medicine;
• digoxin and lithium: acetylsalicylic acid reduces the excretion by the kidneys of digoxin and lithium with consequent increase of their plasma concentrations;
• carbonic anhydrase inhibitors (acetazolamide): reduced elimination of acetazolamide which may cause severe acidosis and increased toxicity to the central nervous system;
• phenytoin: increased effect of phenytoin;
• metoclopramide and domperidone: increased effect of acetylsalicylic acid due to increased absorption rate;
• uricosurics (e.g. probenecid, benzbromarone and sulfinpyrazone): decrease of the uricosuric effect;
• varicella vaccine: it is recommended not to administer salicylates to patients who have received the varicella vaccine for a period of six weeks after vaccination. Cases of Reye's syndrome have occurred following the use of salicylates during varicella infection;
• zafirlukast, a drug used in asthma whose concentration in the blood may increase;
• alcohol: increased risk of intestinal bleeding.

Stop treatment with this medicine a few days before undergoing diagnostic tests, because vitamin C may interfere, especially at high doses, with the results, particularly for glucose research in urine with non-specific means.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you need to continue or start treatment with FROBEFLU during pregnancy as directed by your
doctor, use FROBEFLU as recommended by your doctor and do not use doses higher than those recommended.
Pregnancy – third trimester
Do not take FROBEFLU at doses greater than 100 mg per day if you are in the last 3 months of
pregnancy, as it may harm the fetus or cause problems during labor. It can cause
problems with the kidneys and heart of the fetus. It may affect your and your baby's tendency to
bleeding and delay or prolong labor more than expected.
If you take FROBEFLU at low doses (up to 100 mg per day inclusive), close
obstetric monitoring is necessary as recommended by your doctor.
Pregnancy – first and second trimester
You should not take FROBEFLU in the first 6 months of pregnancy unless absolutely necessary
and under the advice of your doctor. Where treatment is needed in this period or during attempts to
conceive, the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy, FROBEFLU can cause kidney problems in the fetus if taken for more
than a few days, reducing the levels of amniotic fluid surrounding the baby
(oligohydramnios) or causing the narrowing of a blood vessel (ductus arteriosus) in the
baby's heart. Where treatment is needed for more than a few days, your doctor may advise
additional monitoring.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts: FROBEFLU should not be
taken during breastfeeding.
Fertility
If acetylsalicylic acid is used by a woman who is trying to conceive, the dose and duration of
treatment should be kept as low as possible.

Driving and operating machinery
This medicine, especially when taken at high doses, can cause headache or dizziness. If
this happens, avoid driving vehicles or using machinery.

FROBEFLU contains sodium
The maximum recommended daily dose of this medicine contains 2908 mg of sodium (present
in table salt). This is equivalent to 145% of the maximum recommended daily intake of sodium.
Talk to your doctor or pharmacist if you need 1 or more tablets a day for a prolonged
period, especially if you have been advised to follow a low-sodium diet.

FROBEFLU contains sodium benzoate
This medicine contains 48 mg of sodium benzoate per tablet.

3. How to take FROBEFLU

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose to reduce fever and relieve mild to moderate pain is 1 tablet every 4-6 hours, as needed.
The recommended dose for rheumatic, muscular and nerve pain is 1-2 tablets, 2 or 3 times a day.
Do not exceed the recommended doses without consulting your doctor.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after three days of use at the maximum dose or after 5 days of continuous use of FROBEFLU.
Dissolve the tablets in a glass of water.
Take this medicine on a full stomach.

Elderly
It is recommended to take the lowest possible dosage.

If you take more FROBEFLU than you should
In case of accidental ingestion/intake of an excessive dose of FROBEFLU, immediately inform your doctor or go to the nearest hospital.
Salicylate toxicity (a dosage greater than 100 mg/kg/day for 2 consecutive days may induce toxicity) may be the consequence of chronic intake of excessive doses or acute overdose, potentially life-threatening and including accidental ingestion in children.
Moderate poisoning: ringing in the ears, a sensation of reduced hearing acuity, headache, dizziness are the distinctive signs of an excessive dose of the medicine and can be controlled by reducing the dosage.
Severe poisoning: symptoms include fever, hyperventilation (breathing too deeply), ketosis (acetone), respiratory alkalosis (alteration of acid-base balance following changes in respiration), metabolic acidosis (accumulation of acidic molecules in the body), coma, cardiovascular collapse, respiratory failure, severe hypoglycemia (decreased glucose concentration in the blood).
In these cases, supportive measures are taken to limit the absorption of the drug in the gastrointestinal tract through:

• gastric lavage (forced emptying of the stomach);
• administration of activated charcoal (substance that absorbs the excess drug on its surface);
• control of acid-base balance;
• alkaline diuresis (alkalinize the urine);
• compensate for dehydration (excessive fluid loss) with adequate fluid administration;
• supportive symptomatic treatment.

If you forget to take FROBEFLU
If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• stomach disorders (heartburn, epigastric pain), gastritis, constipation, nausea, vomiting, diarrhoea, excessive gas in the intestine (flatulence), digestive disorders (dyspepsia), abdominal pain, erosion of the oral mucosa (ulcerative stomatitis), worsening of pre-existing gastrointestinal diseases (colitis, Crohn's disease, peptic ulcer even perforated)
• gastrointestinal bleeding, sometimes fatal, which may manifest with vomiting or melena (black stools due to the presence of blood) or be occult and cause iron deficiency anaemia (reduction of red blood cells due to iron deficiency). Such bleeding is more frequent with increasing dosage and in elderly patients. Gastritis (inflammation of the lining of the stomach) has been observed less frequently
• heart disorders (edema, hypertension, heart failure)
• blistering skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis)
• bleeding syndromes such as nosebleeds (epistaxis), gum bleeding, reduced platelets in the blood (thrombocytopenia), purpura (small skin hemorrhages). This effect persists for 4-8 days after discontinuation of acetylsalicylic acid
• high doses of Vitamin C (> 1 g) may 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, bronchial obstruction (bronchospasm), angioedema (swelling of large areas of the face and oral mucosa which may also affect the respiratory and gastrointestinal tract), acute and non-acute asthma, nasal 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 suspend treatment or reduce the dosage
• decreased blood flow to the kidneys and worsening of kidney disorders (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
• 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 labour.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 FROBEFLU

Keep this medicine out of the sight and reach of children.
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.
Store in a tightly closed container and at a temperature not exceeding 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FROBEFLU contains
The active ingredients are acetylsalicylic acid and ascorbic acid. Each effervescent tablet contains
330 mg of acetylsalicylic acid and 200 mg of ascorbic acid.
The other ingredients are: sodium bicarbonate, anhydrous citric acid, glycine, sodium benzoate (E211).

Description of the appearance of FROBEFLU and contents of the pack
Pack of 10 or 20 effervescent tablets

Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(Netherlands)

Manufacturer
E-Pharma Trento S.p.A., Via Provina 2, Frazione Ravina, 38123 – Trento (TN)
Special Product’s Line S.p.A., via Fratta Rotonda vado Largo, 1, 03012 Anagni (FR)