ACETYLSALICYLIC ACID AND ASCORBIC ACID COOP

Patient Information Leaflet

ACETYLSALICYLIC ACID AND ASCORBIC ACID COOP

330 mg + 200 mg effervescent tablets
Acetylsalicylic Acid and Ascorbic Acid
Please read all of 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 further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment (at the maximum dose) or after 5–7 days.

Contents of this leaflet:

1. What Acetylsalicylic Acid and Ascorbic Acid COOP is and what it is used for
2. What you need to know before taking/giving Acetylsalicylic Acid and Ascorbic Acid COOP to a child
3. How to take/give Acetylsalicylic Acid and Ascorbic Acid COOP to a child
4. Possible side effects
5. How to store Acetylsalicylic Acid and Ascorbic Acid COOP
6. Contents of the pack and other information

1. What Acido acetilsalicilico e Acido ascorbico COOP is and what it is used for

Acido acetilsalicilico e Acido ascorbico COOP contains the active substances acetylsalicylic acid and ascorbic acid, which act by reducing fever (antipyretic activity) and relieving pain (analgesic activity).
Acido acetilsalicilico e Acido ascorbico COOP is used in adults and adolescents over 16 years of age for:

• the treatment of fever associated with influenza, respiratory tract disorders, etc.
• the treatment of pain of various origin and nature (headache, nerve pain, muscle and joint pain, menstrual pain).

Consult a doctor if you/your child do not feel better or feel worse after 3 days of treatment (at the maximum dose) or 5-7 days.

2. What you need to know before taking Acido acetilsalicilico e Acido ascorbico COOP

Do not take Acido acetilsalicilico e Acido ascorbico COOP

• if you are allergic to acetylsalicylic acid or ascorbic acid or to any of the other ingredients of this medicine (listed in section 6)
• if you have had asthma or allergic reactions (e.g. bronchospasm, urticaria, rhinitis) triggered by taking acetylsalicylic acid or related medicines (especially non-steroidal anti-inflammatory drugs)
• if you suffer from stomach or intestinal diseases (e.g. gastroduodenal ulcer)
• if you have previously experienced gastrointestinal bleeding or perforation after taking medications
• if you have previously had two or more separate episodes of stomach ulcer or gastrointestinal bleeding
• if you have a bleeding disorder or are at risk of bleeding (haemorrhagic diathesis)
• if you suffer from severe impairment of liver or kidney function (severe hepatic or renal insufficiency)
• if you have low blood phosphate levels (hypophosphataemia)
• if you are beyond the fifth month of pregnancy (see section “Pregnancy and breastfeeding”)
• if you are under 16 years of age (see section “Children and adolescents”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido acetilsalicilico e Acido ascorbico COOP:

• if you are taking other medicines containing acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and Acido acetilsalicilico e Acido ascorbico COOP”)
• if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, a hereditary condition affecting red blood cells, because high doses of acetylsalicylic acid may cause haemolysis (destruction of red blood cells), if you suffer from long-standing or recurrent gastric disorders or if you have liver problems
• if you suffer from asthma or allergies, currently or in the past, as bronchospasm may occur. In this case, use of this medicine is not recommended
• acetylsalicylic acid alters the level of uric acid in the blood. This should be considered if you suffer from gout

Children and adolescents
Do not use Acido acetilsalicilico e Acido ascorbico COOP in children and adolescents under 16 years of age,
as there is a risk of developing Reye's syndrome (a rare but very serious illness mainly associated with
neurological and liver damage).

Other medicines and Acido acetilsalicilico e Acido ascorbico COOP
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines:

• medicines containing acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• oral anticoagulants (medicines used to thin the blood), such as coumarin derivatives and heparin;
• methotrexate (a medicine used for cancer or rheumatoid arthritis);
• corticosteroids (medicines used for inflammation);
• sulphonylureas (medicines used to lower blood glucose);
• diuretics (medicines used to treat fluid retention), such as spironolactone and furosemide;
• angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin II receptor antagonists (medicines used to lower high blood pressure or to treat heart diseases);
• medicines used to treat gout, such as probenecid and sulfinpyrazone.

Acido acetilsalicilico e Acido ascorbico COOP with food, drinks and alcohol
Take Acido acetilsalicilico e Acido ascorbico COOP with food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy

• Do not take Acido acetilsalicilico e Acido ascorbico COOP if you are beyond the fifth month of pregnancy (after 24 weeks of missed menstruation), i.e. from the beginning of the 6th month of
  pregnancy, because acetylsalicylic acid may cause serious problems to the baby and to the mother during delivery and after birth (risk of haemorrhage, delayed labour, kidney problems, cardiopulmonary toxicity).

• During the first 5 months of pregnancy, take Acido acetilsalicilico e Acido ascorbico COOP only after consulting your doctor. Doses and duration of treatment should be kept as low as possible.

• Avoid use if you suspect or are planning a pregnancy.

Breastfeeding
During breastfeeding, take Acido acetilsalicilico e Acido ascorbico COOP only after consulting your doctor.
Driving and using machines
Acido acetilsalicilico e Acido ascorbico COOP does not affect the ability to drive or operate machinery.
Acido acetilsalicilico e Acido ascorbico COOP contains sodium
This medicine contains approximately 485 mg of sodium per tablet. Your doctor will take this into account if you have impaired kidney function or are on a low-sodium diet.

3. How to take Acetylsalicylic Acid and Ascorbic Acid COOP

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.
Dissolve the tablet in half a glass of still (non-carbonated) water.

Adults and adolescents over 16 years of age
The recommended dose is 1–2 tablets at a time, repeated if necessary up to 3–4 times daily.
The maximum dose is 8 tablets per day (24 hours) (see "If you take more Acetylsalicylic Acid and Ascorbic Acid COOP than you should").

Elderly (65 years and older)
Take Acetylsalicylic Acid and Ascorbic Acid COOP only after consulting your doctor.

Use in children and adolescents
Do not use Acetylsalicylic Acid and Ascorbic Acid COOP in children and adolescents under 16 years of age.

Duration of treatment
Do not take Acetylsalicylic Acid and Ascorbic Acid COOP for more than 3 consecutive days (at the maximum dose) or for more than 5–7 consecutive days without consulting your doctor.

If you take more Acetylsalicylic Acid and Ascorbic Acid COOP than you should
In case of accidental ingestion/overdose of Acetylsalicylic Acid and Ascorbic Acid COOP, contact your doctor immediately or go to the nearest hospital.

Symptoms
If you accidentally take very high doses of Acetylsalicylic Acid and Ascorbic Acid, symptoms you may experience include:

• dizziness
• ringing in the ears (tinnitus)
• nausea, vomiting, and stomach disturbances (gastric disturbances)
• confusion
• numbness
• collapse
• seizures
• breathing or kidney problems
• bleeding

Treatment
Depending on the nature and severity of the symptoms, the doctor will provide appropriate supportive therapy.

If you forget to take Acetylsalicylic Acid and Ascorbic Acid COOP
Do not take a double dose to make up for the missed dose.

If you stop taking Acetylsalicylic Acid and Ascorbic Acid COOP
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You may experience the following side effects, for which there are insufficient data available to determine the frequency.

Effects related to the blood

• reduction in blood cell count (anaemia, thrombocytopenia, pancytopenia, agranulocytosis).

Effects related to the stomach and intestine

• indigestion
• abdominal pain
• nausea and vomiting
• inflammation of the stomach lining (gastritis)
• bleeding or perforation of the stomach or intestine

Effects related to hearing

• ringing in the ears (tinnitus)

Effects related to the immune system (the body's defence system)

• allergic reactions:
• urticaria (reddening of the skin accompanied by itching)
• bronchospasm (difficulty breathing)
• worsening of asthma
• angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
• anaphylactic shock (severe allergic reaction).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the Italian Medicines Agency - Website: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Acetylsalicylic acid and Ascorbic acid COOP

Store below 25°C.
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.
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 Acido acetilsalicilico e Acido ascorbico COOP contains

• The active substances are: Acido acetilsalicilico and Acido ascorbico (each tablet contains 330 mg of Acido acetilsalicilico and 200 mg of Acido ascorbico).
• The other components are: citric acid, glycocola, sodium bicarbonate and sodium benzoate (see section “Acido acetilsalicilico e Acido ascorbico contains sodium”).

Description of the appearance of Acido acetilsalicilico e Acido ascorbico COOP and contents of the pack
It is presented as white, flat effervescent tablets. The tablets are packaged in plastic bottles containing
20 effervescent tablets.
Marketing Authorization Holder
COOP ITALIA Società Cooperativa
Via del Lavoro, 6/8
40033 Casalecchio di Reno (BO)
Manufacturer
Zeta Farmaceutici S.p.A.
Via Galvani 10 - 36066 Sandrigo (VI)
or
Doppel Farmaceutici S.r.l.
Via Volturno 48, Quinto De Stampi – 20089 Rozzano (MI)