EUSPIFLU 400 mg/240 mg Effervescent Tablet

Зміст інструкції

1. Euspiflu 400 mg + 240 mg effervescent tablets
   1. What is Euspiflu and what is it used for
   2. What you need to know before you take Euspiflu
   3. How to take Euspiflu
   4. Possible side effects
   5. How to store Euspiflu
   6. Contents of the pack and other information

Euspiflu 400 mg + 240 mg effervescent tablets

Acetylsalicylic acid / ascorbic acid

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always 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.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What is Euspiflu and what is it used for

Euspiflu contains two active ingredients, acetylsalicylic acid and ascorbic acid (vitamin C), it belongs to the
group of analgesic (pain-relieving) and antipyretic (fever-reducing) medicines.
Euspiflu is used in adults for the symptomatic treatment of febrile and painful conditions (flu-like illnesses,
common cold, headache, toothache, rheumatic and muscle pains, menstrual pains,
neuralgia).

2. What you need to know before you take Euspiflu

Do not take Euspiflu

• 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 another salicylate (the group of substances to which acetylsalicylic acid belongs) or to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have an active gastro-duodenal ulcer and other gastropathies (stomach diseases);
• if you are at risk of bleeding, especially if you have haemophilia, or other blood coagulation disorders (such as a decrease in protein that is part of the blood coagulation chain (hypoprothrombinemia), and vitamin K deficiency, which activates some coagulation proteins);
• if you have or have had impaired kidney function (renal insufficiency) or severe liver function (hepatic insufficiency);
• if you suffer from bronchial asthma, particularly if associated with the formation of (growths in the nose (nasal polyps) and swelling of the skin and mucous membranes (angioedema);
• during the third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• in children and adolescents under 16 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Euspiflu.
Pay particular attention with Euspiflu and tell your doctor:

• if you are elderly with impaired kidney function or if you have decreased levels of albumin in the blood, because an increased risk of toxicity may occur;
• if you are over 70 years old, especially if you are being treated with other therapies;
• if you have a deficiency of the glucose-6-phosphate dehydrogenase enzyme because haemolysis (rupture of red blood cells in the blood) may occur;
• if you are taking anticoagulant drugs (i.e., that slow down or stop the blood clotting process), because an increased risk of bleeding may occur (see section “Other medicines and Euspiflu”);
• if you are taking corticosteroids (steroidal anti-inflammatory drugs), because an increased risk of gastrointestinal bleeding may occur (see section “Other medicines and Euspiflu”;
• if you suffer from or have suffered from nephrolithiasis (kidney stones);
• if you have a disease characterized by abnormal accumulation of iron in organs and tissues (haemochromatosis), a hereditary disease characterized by anaemia (thalassaemia) or sideroblastic anaemia;
• if you are taking diuretics, medicines used to increase urine production and elimination, such as spironolactone and furosemide, or medicines used to treat gout (see section “Other medicines and Euspiflu”
• if you are to undergo surgery, because acetylsalicylic acid administered before the operation may interfere with blood clotting processes during the operation (intraoperative haemostasis);

After 3 days of using the maximum dose or after 5 - 7 days of use without appreciable results,
consult your doctor.
Talk to your doctor before taking Euspiflu if a high-dose and/or long-term use of this medicine is necessary.
If prolonged vomiting and deep drowsiness occur during treatment, immediately
stop taking Euspiflu and consult your doctor.

Children and adolescents
Euspiflu should not be used in children and adolescents under 16 years of age.
In adolescents over 16 years of age in case of viral infections, such as influenza or varicella,
consult your doctor before administering this medicine.

Other medicines and Euspiflu
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor or pharmacist if you are taking:

• anticoagulants (such as coumarin derivatives and heparin) used to slow down or stop the blood clotting process, because acetylsalicylic acid may potentiate their activity, especially with long-term therapy;
• methotrexate, a medicine used for the therapy of autoimmune diseases and neoplasms, because acetylsalicylic acid may potentiate its side effects;
• corticosteroids (steroidal anti-inflammatory drugs), because acetylsalicylic acid may increase the risk of gastrointestinal bleeding;
• other non-steroidal anti-inflammatory drugs (NSAIDs), because acetylsalicylic acid may increase their side effects;
• oral hypoglycaemic agents (sulphonylureas), used for the treatment of type II (or adult-onset) diabetes mellitus because acetylsalicylic acid may potentiate their effect;
• diuretics (used to increase urine production and elimination), such as spironolactone and furosemide, or antigout drugs (used for the treatment of gout), because acetylsalicylic acid may decrease their activity.

Laboratory tests and Euspiflu
Talk to your doctor before taking Euspiflu if you are to undergo a diagnostic test, because ascorbic
acid may interfere with the results of some tests, in particular the search for glucose in the urine, and may
therefore be necessary to suspend the intake of vitamin C a few days before undergoing the diagnostic tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
If you continue or start treatment with Euspiflu during pregnancy, follow your doctor's instructions,
use Euspiflu as recommended by your doctor and do not use a dose higher than the recommended one.
Euspiflu should not be taken in the last trimester of pregnancy.

Last three months of pregnancy
Do not take acetylsalicylic acid at a dose higher than 100 mg per day in the last 3 months of pregnancy,
as it could harm the foetus or cause problems during delivery. It can cause kidney and
heart problems in the foetus. It can affect the mother's and baby's tendency to bleed and delay or prolong
labour.
If you are taking acetylsalicylic acid at low doses (up to 100 mg per day), you need strict
obstetric monitoring as recommended by your doctor.

First six months of pregnancy
You should not take Euspiflu during the first 6 months of pregnancy unless absolutely
necessary and recommended by your doctor. If treatment is necessary during this period or while
trying to become pregnant, you should use the lowest dose for the shortest possible time. If taken for more than
a few days from the 20th week of pregnancy, Euspiflu may cause kidney problems in the foetus
reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) and causing the
narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is
necessary for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
During breastfeeding, you should avoid taking high doses of acetylsalicylic acid.

Driving and using machines
No effects on the ability to drive and use machines are known.

Euspiflu contains sodium
This medicine contains 19.5 mmol (or 448.5 mg) of sodium per effervescent tablet.
Talk to your doctor or pharmacist if you need one or more effervescent tablets a day for a
prolonged period, especially if you have been told to follow a low-sodium diet.

3. How to take Euspiflu

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Elderly, adults and adolescents over 16 years of age

• As an antipyretic and analgesic for mild or moderate pain: 1 tablet, repeating the dose if necessary, at intervals of up to 4 - 6 hours, depending on the intensity of the symptoms.
• As an analgesic for rheumatic pain, muscle pain and neuralgia: 1 or 2 tablets, repeating the dose if necessary, at intervals of up to 2 - 3 times a day.

Caution: do not exceed the recommended doses without consulting your doctor.
In particular, elderly patients should adhere to the minimum dosages indicated above.
Euspiflu should only be used for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any change in your symptoms.

Method of administration:
Take the tablets with a full stomach.
Dissolve the effervescent tablets in a glass of water.

If you take more Euspiflu than you should
In case of accidental ingestion of an excessive dose of Euspiflu, immediately notify your doctor or go to the nearest hospital.

If you forget to take Euspiflu
Do not take a double dose to make up for the missed tablet.

If you stop taking Euspiflu
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Euspiflu the following may occur:

• reduction of platelets (thrombocytopenia).
• gastric disorders such as a burning sensation (pyrosis) or pain (epigastralgia), constipation, or nausea,
• bleeding (haemorrhage) and gastrointestinal ulcers.
• allergic reactions of a dermatological type (such as skin redness, itching, etc.), and of a respiratory type such as narrowing of the bronchi (bronchospasm), swelling in the region located just below the vocal cords before the trachea (laryngeal oedema),
• acute asthma attacks, increased nasal secretion (rhinorrhoea), sudden and transient swelling of the skin or mucous membranes (angioedema), and nasal polyps. Furthermore, at higher dosages the following may occur:
• decrease in hearing and a sensation of ringing in the ear (tinnitus).
• headache
• gastro-intestinal disorders of a laxative type. In such situations the doctor should contact the doctor, reduce the dosage or temporarily suspend treatment. In patients with reduced kidney function, acetylsalicylic acid can induce acute renal failure (see paragraph 2 “Do not take Euspiflu”).

These side effects are generally transient. However, when they occur it is advisable to consult
your doctor or pharmacist.

Reporting of side effects
If you experience any side effects, including 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 Euspiflu

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Keep the tube tightly closed and in a dry place.
Do not use this medicine after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Euspiflu contains

• The active ingredients are acetylsalicylic acid and ascorbic acid. Each effervescent tablet contains 400 mg of acetylsalicylic acid and 240 mg of ascorbic acid.
• The other ingredients are: sodium bicarbonate, citric acid, sodium carbonate.

Description of the appearance of Euspiflu and contents of the pack
Euspiflu is available in the form of effervescent tablets for oral use, contained in a tube.
Pack of 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. - Via P. Paleocapa, 7
20121 Milano

Manufacturer
E-Pharma Trento S.p.A. Via Provina, 2 Ravina (TN) Italy