CARDIRENE 160 mg Proszek Doustny

Treść ulotki

1. Cardirene 75 mg powder for oral solution, 100 mg powder for oral solution, 160 mg powder for oral solution, 300 mg powder for oral solution
   1. What Cardirene is and what it is used for
   2. What you need to know before taking Cardirene
   3. How to take Cardirene
   4. Possible side effects
   5. How to store Cardirene
   6. Contents of the pack and other information

Cardirene 75 mg powder for oral solution, 100 mg powder for oral solution, 160 mg powder for oral solution, 300 mg powder for oral solution

acetylsalicylic acid lysine salt

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cardirene is and what it is used for

Cardirene contains the active ingredient acetylsalicylic acid D,L-lysine (analogous to acetylsalicylic acid
or acetylsalicylates) and belongs to the category of medicines called "Antithrombotics,
Antiplatelet agents".
Cardirene works by preventing the formation of blood clots (thrombi), blocking
the aggregation of certain blood cells called "platelets".

Cardirene is indicated for:

• 1. the prevention of problems caused by the formation of blood clots and the stiffening of the arteries (major atherothrombotic events):
• after heart attack (myocardial),
• after damage to the blood vessels in the brain (cerebral stroke) or temporary disturbances of blood circulation (transient ischemic attacks - TIA),
• in people who suffer from chest pain at rest (unstable angina pectoris),
• in people who suffer from chest pain under exertion (chronic stable angina pectoris);
• 2. the prevention of the re-closure of by-passes (aortocoronary by-pass) and in a particular method that dilates the arteries that carry blood to the heart (percutaneous transluminal coronary angioplasty - PTCA);
• 3. the prevention of problems with the heart and circulation (cardiovascular events) in people with stiffening and alterations of the arteries (established atherosclerotic disease), in

a particular inflammation of the blood vessels (Kawasaki syndrome), in people
on hemodialysis and in the prevention of blood clot formation (thrombosis)
during the technique used in surgery for the circulation of blood outside the
body (extracorporeal circulation).
The 100 mg dosage only is indicated for:

• 4. the prevention of problems with the heart and circulation (cardiovascular events) in people at high risk for these disorders.

2. What you need to know before taking Cardirene

Do not take Cardirene

• if you are allergic to acetylsalicylic acid of D,L-lysine or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have suffered from asthma or nasal polyps associated with asthma immediately after taking a medicine containing substances similar to the active ingredient of Cardirene (acetylsalicylates) or substances with similar activity, especially non-steroidal anti-inflammatory drugs, or if you have had allergic reactions (bronchospasm, anaphylactic reactions) to substances similar to the active ingredient of Cardirene (salicylates);
• if you are in the third trimester of pregnancy (over 24 weeks of gestation) (see section "Pregnancy, breastfeeding and fertility");
• if you have suffered from or are suffering from a lesion of the stomach wall or the first part of the intestine (active, chronic or recurrent gastrointestinal ulcer) or have had gastric bleeding or perforation in the past after treatment with acetylsalicylic acid or with other drugs called non-steroidal anti-inflammatory drugs (NSAIDs).
• if you suffer from any disease that causes blood loss (bleeding disorder);
• if you are a person at risk of bleeding (bleeding risk);
• if you suffer from severe liver problems (severe hepatic insufficiency);
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you suffer from severe heart problems (severe heart failure), not controlled;
• if you are taking a medicine called “methotrexate”, used to treat tumors, at doses higher than 15 mg/week (see “Other medicines and Cardirene”);
• if you are taking oral medicines that act on blood coagulation (oral anticoagulants);
• if you suffer from a disease called “mastocytosis”, where the use of medicines based on “acetylsalicylic acid” can cause severe allergic reactions, including shock with a sudden feeling of heat (hot flashes), low blood pressure (hypotension), increased heart rate (tachycardia) and vomiting;
• if you are a child or adolescent under the age of 16.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cardirene:

• Cardirene contains acetylsalicylic acid, if you are taking other medicines; check that they do not contain acetylsalicylic acid. If they do, to avoid any risk of overdose, the combination should be avoided;
• if you experience headache while taking medicines for pain (analgesics) for a prolonged period of time and at high doses; do not increase the dosage and contact your doctor;
• if you regularly use medicines for pain (analgesics), especially the combination

of multiple analgesic medicines, because you may have kidney problems, even serious (persistent kidney damage, with risk of renal failure);

• if you have a deficiency of a substance present in the blood called G6PD (glucose-6-phosphate dehydrogenase) which can cause a particular hereditary disease, affecting red blood cells, as there is a risk of red blood cell breakdown (hemolysis) (see “Possible side effects”);
• if you have suffered from lesions of the stomach or intestine (gastric or duodenal ulcer), or bleeding in the stomach or intestine, or inflammation of the stomach (gastritis);
• if you have kidney problems (mild or moderate renal insufficiency);
• if you have liver problems (mild or moderate hepatic insufficiency);
• if you suffer from asthma: the occurrence of an asthma attack, in some people, may be linked to an allergic reaction to non-steroidal anti-inflammatory drugs or acetylsalicylic acid; in this case Cardirene is contraindicated (see “Do not take Cardirene”);
• if you have heavy menstrual periods or bleeding between periods (menorrhagia or metrorrhagia), as there is a risk of increasing the volume and duration of menstrual periods;
• if bleeding or lesions (ulcers)/perforations of the stomach or intestine occur. These effects, which increase with the dose, can occur at any time during treatment, even if you have never had similar disorders, especially if you are elderly, have a low body weight, and are being treated with medicines that make the blood more fluid (anticoagulants or antiplatelet agents) (see “Other medicines and Cardirene”) or if you have suffered in the past from a gastrointestinal ulcer, particularly if complicated by bleeding or perforation. If bleeding from the stomach or intestine (gastrointestinal bleeding) occurs, stop treatment immediately;
• if you are to undergo surgery, even minor surgery (e.g. tooth extraction), as the use of Cardirene increases the risk of bleeding. Your doctor will decide on a case-by-case basis whether to stop treatment before the surgery.

If you take high doses of Cardirene for rheumatic diseases (anti-inflammatory doses), your doctor will perform some checks, particularly important in children, especially at the beginning of treatment.
If you experience ringing in the ears, hearing difficulties or dizziness, tell your doctor.
Acetylsalicylic acid can interfere with the elimination of uric acid: high doses can increase the excretion of uric acid (uricosuric effect) while very low doses can reduce its excretion; therefore, the medicine is not recommended in people who suffer from severe joint inflammation (gout).
The use of Cardirene is not recommended during breastfeeding (see “Pregnancy, breastfeeding and fertility”).
If you are over 70 years of age, especially if you are taking other medicines, you should only use this medicine after consulting your doctor.
Your doctor will prescribe Cardirene with caution if you have mild or moderate liver problems (mild and moderate hepatic insufficiency), and if you are using certain medicines, for example to treat diabetes, for heartburn, to lower blood pressure and for inflammation (antidiabetics, antacids, diuretics, glucocorticoids) (see “Other medicines and Cardirene”).
Your doctor will prescribe Cardirene with caution if you are a woman who is using a device that is inserted into the uterus to prevent pregnancy (intrauterine device, such as a coil).
Alcohol can increase the risk of lesions of the stomach and intestine and alter tests for blood coagulation (prolonged bleeding time) when taken together with acetylsalicylic acid. Therefore, alcoholic beverages should be taken with caution by patients during and within 36 hours after taking acetylsalicylic acid.
If you are taking Nicorandil (a medicine used to prevent or relieve chest pain due to heart problems) together with salicylates, it may increase the risk of ulcer, perforation and gastrointestinal bleeding (see “Other medicines and Cardirene”).
Avoid using Cardirene in combination with levothyroxine (a medicine used to treat thyroid disorders) and with other medicines containing acetylsalicylic acid (see “Other medicines and Cardirene”). Cardirene may lead to an increase in the amount of thyroid hormones in the blood, so your doctor will perform checks on your thyroid hormones.

In patients receiving the varicella vaccine, the use of acetylsalicylic acid should be avoided for the 6 weeks following vaccination.

Doses of acetylsalicylic acid equal to or greater than 500 mg per day
The medicine, by blocking the production of an enzyme (cyclooxygenase) with a consequent reduction in the production of prostaglandins (hormones), can cause a reduction in fertility in women through an effect on ovulation. This effect is reversible once the use of the medicine is stopped. Keep this in mind especially if you have fertility problems or are undergoing fertility investigations.

Children and adolescents
The use of this medicine is contraindicated in children and adolescents under the age of 16.
In children and adolescents with diseases caused by viruses (especially chickenpox and influenza) who have taken acetylsalicylic acid, a very rare and life-threatening disease, associated mainly with damage to the nervous system and liver (Reye's syndrome) may occur. Consequently, acetylsalicylic acid should be administered to children and adolescents in this situation following the advice of a doctor, only when other treatments have failed.
If, during treatment with acetylsalicylic acid, the child or adolescent experiences persistent vomiting, loss of consciousness and abnormal behavior, the treatment should be stopped.
In infants under 1 month of age, acetylsalicylic acid can only be administered in specific situations and on the prescription of a doctor.

Other medicines and Cardirene
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
The effects of Cardirene may be influenced by or influence the following medicines.

• Abciximab, acetylsalicylic acid, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost trometamol, ticlopidine and tirofiban, as these medicines prevent blood platelet aggregation. The concurrent use of different medicines that act on blood platelets increases the risk of bleeding, as does their combination with heparin or similar substances, or oral anticoagulants, or with other medicines called thrombolytics (used to prevent blood clots). If you are using these medicines together with Cardirene, your doctor will subject you to checks.

Contraindicated associations (see “Do not take Cardirene”):

• Methotrexate (used to influence the body's defense system and in some tumors), at doses greater than 15 mg per week with medicines containing acetylsalicylic acid at active doses for the control of inflammation, pain and fever, as it increases the toxicity of methotrexate, in particular the toxicity to blood cells (hematological).
• Medicines used to make the blood more fluid taken by mouth (oral anticoagulants), with medicines containing acetylsalicylic acid at active doses for the control of inflammation, pain and fever and in patients who have suffered from serious injuries to the stomach and a part of the intestine called “gastro-duodenal ulcer”, as it increases the risk of bleeding (hemorrhage).

Associations not recommended:

• Medicines that make the blood more fluid taken by mouth (oral anticoagulants) with medicines containing acetylsalicylic acid at active doses for the control of pain or fever, even if you have never had injuries to the stomach and intestine, as they increase the risk of bleeding (hemorrhage).
• Medicines that make the blood more fluid taken by mouth (oral anticoagulants) with acetylsalicylic acid, used at active doses to prevent blood platelet aggregation and if you have suffered from injuries to the stomach and intestine, as it increases the risk of bleeding.
• Other non-steroidal anti-inflammatory drugs (NSAIDs), with acetylsalicylic acid, used at active doses for the treatment of inflammation, for pain or fever, as it increases the risk of injury and bleeding to the stomach and intestine (ulcers and gastrointestinal bleeding).
• Heparins (and similar substances), used to keep the blood fluid, with therapeutic doses of acetylsalicylic acid if you are elderly (age greater than or equal to 65 years), regardless of the dose of heparin, and with active doses of acetylsalicylic acid for the treatment of inflammation, for pain or fever, as it increases the risk of bleeding. In these cases, your doctor will prescribe you another anti-inflammatory medicine or another analgesic or antipyretic.
• Clopidogrel (used to treat heart and circulation diseases), as it increases the risk of bleeding. If concomitant administration cannot be avoided, your doctor will subject you to checks.
• Medicines that reduce the amount of a substance called “uric acid” in the blood (uricosurics: “benzbromarone” and “probenecid”): because if administered with Cardirene they decrease their effectiveness and produce a decrease in the excretion of acetylsalicylic acid and an increase in plasma levels.
• Ticlopidine, used to prevent blood platelet aggregation, as it increases the risk of bleeding. If concomitant administration cannot be avoided, your doctor will subject you to checks.
• Glucocorticoids (except hydrocortisone therapy), medicines used for the treatment of inflammation, with acetylsalicylic acid used at active anti-inflammatory doses, as it increases the risk of bleeding.
• Pemetrexed, used against some types of tumors, if you have mild or moderate kidney problems,

with acetylsalicylic acid, used at active anti-inflammatory doses, as it increases the risk of
pemetrexed toxicity.

• Levothyroxine (used for the treatment of thyroid disorders): Cardirene may lead to an increase in the amount of thyroid hormones in the blood, so your doctor will subject you to checks of thyroid hormones.
• Varicella vaccine: it is recommended not to administer salicylates to patients who have received the varicella vaccination for a period of six weeks after vaccination. Cases of Reye's syndrome (serious brain and liver disorders, especially in children) have occurred following the use of salicylates during varicella infection.
• Medicines called "Selective Serotonin Reuptake Inhibitors" (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), used for the treatment of depression, as they increase the risk of bleeding, in particular of the upper digestive tract. Therefore, if possible, concomitant use should be avoided.
• Pentoxifylline, used to prevent the formation of blood clots (thrombi), as it increases the risk of bleeding.

Associations that require precautions for use:

• Medicines to increase urine production (diuretics), medicines to treat high blood pressure (angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists) with acetylsalicylic acid at active doses for the treatment of inflammation, for pain or fever, as kidney problems (acute renal failure) may occur, especially in dehydrated patients. Furthermore, a reduction in the blood pressure lowering effect (antihypertensive) may occur.
• Methotrexate, used to influence the body's defense system and in some tumors, at dosages equal to or less than 15 mg/week with acetylsalicylic acid at active doses for the treatment of inflammation, for pain or fever, as it increases the toxicity of methotrexate, in particular the toxicity to blood cells. Your doctor will subject you to checks, especially in the first weeks of treatment and in particular if you have kidney problems (even mild) or are elderly.
• Methotrexate, used to influence the body's defense system and in some tumors, at doses greater than 15 mg with acetylsalicylic acid at active doses to prevent blood platelet aggregation, as it increases the toxicity of methotrexate, in particular the toxicity to blood cells. Your doctor will subject you to checks, especially in the first weeks of treatment and in particular if you have kidney problems (even mild) or are elderly.
• Clopidogrel (used for problems of reduced circulation to the heart called “acute coronary syndrome”), used to treat heart and circulation diseases, as it increases the risk of bleeding. Your doctor will subject you to checks.
• Medicines for the stomach and intestines (gastrointestinal topicals, antacids and adsorbents including charcoal) as they decrease the gastrointestinal absorption of Cardirene. If possible, take gastrointestinal topicals and antacids at least 2 hours away from Cardirene.
• Pemetrexed, used against some types of tumors, even if you have normal kidney function, as it increases the risk of pemetrexed toxicity with anti-inflammatory doses of acetylsalicylic acid. Your doctor will check your kidney function.
• Heparins (and similar medicines), at active doses to keep the blood fluid for preventive purposes if you are under the age of 65, as the co-administration of medicines that act on blood coagulation increases the risk of bleeding. If you need to take heparins at the same time as Cardirene, your doctor will subject you to checks.
• Heparins (and similar substances) at therapeutic doses or if you are elderly ( 65 years). regardless of the dose of heparin, and for doses of acetylsalicylic acid used to prevent blood platelet aggregation, as it increases the risk of

bleeding.

• Medicines used to prevent the formation of blood clots (thrombolytics), as they increase the risk of bleeding.
• Medicines that make the blood more fluid taken by mouth (oral anticoagulants) with acetylsalicylic acid at the doses used to prevent blood platelet aggregation, as they increase the risk of bleeding, especially if you have suffered from a gastrointestinal ulcer.
• Other non-steroidal anti-inflammatory drugs (NSAIDs) with acetylsalicylic acid at the doses used to prevent blood platelet aggregation, as it increases the risk of injury and bleeding to the stomach and intestine.
• Glucocorticoids (except hydrocortisone), medicines used for the treatment of inflammation, with acetylsalicylic acid at the doses for the treatment of pain and fever, as it increases the risk of bleeding; after stopping glucocorticoids, an overdose of acetylsalicylic acid may occur.
• Acetazolamide, a medicine used to treat high blood pressure, taken in conjunction with salicylates as there is a greater risk of metabolic acidosis, a condition characterized by an increase in the amount of acids in the blood.
• Ibuprofen (used for inflammation): because ibuprofen may interfere with the blood clot prevention effects of low-dose acetylsalicylic acid (platelet aggregation).
• Metamizole, a medicine used against pain, as when taken in conjunction with acetylsalicylic acid it may reduce its effect on platelet aggregation. Therefore, your doctor will prescribe metamizole with caution if you are taking low doses of acetylsalicylic acid for heart protection (cardioprotection).
• Drugs that are associated with a risk of bleeding: because the association with Cardirene may have an additive effect on platelet aggregation (resulting in an increased risk of bleeding). In this case, the doctor will perform a regular clinical check.
• Insulin and sulfonylureas (medicines that lower blood sugar): the association with Cardirene increases the effect of insulin and sulfonylureas.
• Nicorandil (a medicine used to prevent or relieve chest pain due to heart problems): because if taken in conjunction with salicylates it may increase the risk of ulcer, perforation and gastrointestinal bleeding (see “Warnings and precautions”).
• Valproic acid (used for the treatment of epilepsy): Cardirene, if used with valproic acid-based drugs, may lead to an increase in the amount of valproic acid in the blood. Therefore, your doctor will check your blood levels of valproate.
• Tenofovir (used in the treatment of some infections caused by viruses): the use of Cardirene with Tenofovir may increase the likelihood of kidney problems (renal failure). Therefore, your doctor will check your kidney function.

Cardirene with alcohol
Alcohol taken together with acetylsalicylic acid may increase the risk of injury to the
stomach and intestine and alter tests for blood coagulation (prolongation
of bleeding time). Therefore, alcoholic beverages should be taken with
caution by patients during and within 36 hours after taking acetylsalicylic acid.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Administration in the last three months of pregnancy (after 24 weeks of gestation) is
contraindicated.
During other periods of pregnancy, take Cardirene, for long-term treatments, only if your doctor
has told you to do so, because acetylsalicylic acid can cause:
bleeding in both you and the fetus,
delayed labor,
heart problems (premature closure of the ductus arteriosus) in the newborn.
Cardirene can negatively affect pregnancy and/or the development of the newborn.
The use of Cardirene in the early stages of pregnancy may increase the risk of abortion, altered
formation of the abdominal wall (gastroschisis) and heart malformations. Therefore, do not use
Cardirene during the first 24 weeks of pregnancy, unless your doctor considers the use of
Cardirene strictly necessary.
If you are trying to conceive or during the first 24 weeks of pregnancy, your doctor will
maintain the dose and duration of treatment as low as possible.
After 24 weeks of pregnancy, all medicines that act like Cardirene (inhibitors of
prostaglandin synthesis) can expose the fetus to:

• problems with the heart and lungs (with premature closure of the ductus arteriosus and pulmonary hypertension);
• kidney problems, even serious (renal dysfunction, which can progress to renal failure with oligo-hydroamnios).

At the end of pregnancy, you and the newborn may experience:

• prolongation of bleeding time, which can also occur after the administration of very low doses of acetylsalicylic acid,
• blockage of uterine contractions resulting in delayed or prolonged labor.

Breastfeeding
Acetylsalicylic acid passes into breast milk. Do not use Cardirene during breastfeeding due to
the possible risk of increased acidity in the blood (acidosis) and bleeding (hemorrhagic syndrome) in the infant.

Fertility
For dosages greater than or equal to 500 mg/day, Cardirene may cause a reduction in fertility
in women through an effect on ovulation. This effect is reversible once use of the medicine is stopped.
Keep this in mind especially if you have fertility problems or are undergoing fertility investigations.

Driving and using machines
No effects of Cardirene on the ability to drive vehicles or use machines are known.

Cardirene powder for oral solution contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Cardirene

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is: 1 sachet per day to be dissolved in a glass of water.
Start treatment with Cardirene 160 mg or Cardirene 300 mg, as prescribed by your
doctor, immediately after the onset of the first symptoms and continue for at least 5 weeks.
It is possible to continue therapy with Cardirene 75 mg or with Cardirene 100 mg.
If you have had a heart attack or have chest pain at rest (unstable angina), your doctor will
start treatment as soon as possible.
If you are at high risk of heart and blood circulation problems (cardiovascular events),
your doctor will prescribe a dosage of 100 mg.
Use Cardirene only if it has been prescribed by your doctor.

If you take more Cardirene than you should
In case of accidental ingestion/intake of an excessive dose of Cardirene, immediately inform your
doctor or go to the nearest hospital.
For acetylsalicylic acid, toxic doses are between 200 mg/kg and 300 mg/kg by
oral route.
In children, an overdose can be fatal starting from a dosage of 100 mg/kg in
a single intake.
Pay particular attention to overdose if you are elderly or if an excessive dose is
taken by a small child (both during therapy or, more frequently, due to
accidental poisoning).
Overdosage with this type of medicine, especially in small children, can lead to
a severe decrease in blood sugar levels (hypoglycemia) and potentially fatal poisoning. With an overdose of acetylsalicylic acid, an increase
in fluid in the lungs (non-cardiogenic pulmonary edema) can occur, which is life-threatening.
If you follow the recommended dosage, an overdose is unlikely.

Symptoms of overdose

• Moderate poisoning: ringing in the ears, feeling of hearing loss, headache, dizziness, vertigo, confusion and nausea are signs of overdose and can be controlled by reducing the dosage.
• Severe poisoning: fever, rapid breathing (hyperventilation), changes in blood acidity (respiratory alkalosis, ketosis, metabolic acidosis), coma, cardiovascular collapse, difficulty breathing (respiratory failure), severe decrease in blood sugar levels (hypoglycemia).

If you forget to take Cardirene
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 everyone will experience them.
The frequency with which adverse events occur cannot be defined based on the available data, therefore the frequency is defined as "not known".

• Bleeding, (haemorrhagic syndromes, even potentially fatal: nosebleeds (epistaxis); gum bleeding; bleeding in the urine and from the genitals; bleeding inside the head (intracranial haemorrhage) which can lead to death, especially if you are elderly; bleeding from the stomach and intestines, with blood in vomit or stool (occult or overt gastrointestinal haemorrhage, haematemesis, melena, etc.) resulting in iron deficiency anaemia; bruises, red spots on the skin (purpura); prolonged bleeding time. The risk of bleeding may persist for 4-8 days after stopping acetylsalicylic acid. This may cause an increased risk of bleeding (haemorrhage) if you are to undergo surgery.
• Decrease in the number of blood platelets (thrombocytopenia).
• Breakage of red blood cells (haemolytic anaemia) in people with G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency), a particular hereditary disease that affects red blood cells.
• Severe decrease in the number of blood cells (pancytopenia, bilineage cytopenia, aplastic anaemia, bone marrow failure, agranulocytosis, neutropenia, leucopenia).
• Allergic reactions (anaphylactic reactions, asthma, angioedema, oedema)
• Bronchospasm
• Headache, dizziness and lightheadedness, which may occur with high doses and long-term treatment. If you experience these symptoms, consult your doctor immediately who will assess whether to discontinue treatment.
• Ringing in the ears (tinnitus) and deafness, which may occur with high doses and long-term treatment. If you experience these symptoms, consult your doctor immediately who will assess whether to discontinue treatment.
• Abdominal pain.
• Difficulty digesting food (dyspepsia).
• Bleeding from the stomach and intestines (gastrointestinal haemorrhage); nausea, inflammation and lesions of the oesophageal mucosa (oesophagitis and oesophageal ulcers); inflammation of the stomach and duodenum, with abdominal pain and bleeding from the intestine (erosive gastritis and duodenitis); lesions (ulcers) in the stomach and/or intestine; inflammation (colitis) and perforation of the gastrointestinal tract. These reactions can occur with any dose of acetylsalicylic acid and in patients with or without disorders that allow prediction, who have or have not suffered from serious gastrointestinal events.
• Inflammation of the pancreas (acute pancreatitis) as an allergic (hypersensitivity) reaction to acetylsalicylic acid.
• Disorders and inflammation of the liver (chronic hepatitis), with increased blood tests affecting the liver (increased liver enzymes).
• Urticaria, and other skin irritations that appear always in the same place (fixed drug eruptions).
• Kidney problems (renal failure).
• Reye's syndrome, a serious disease that mainly affects children and manifests with fever, flu, chickenpox, damage to the nervous system and liver (see "Warnings and precautions").
• Acetylsalicylic acid may prolong labour and delay delivery.
• Increased fluid in the lungs (non-cardiogenic pulmonary oedema) with prolonged use of the medicine, which can also occur in case of an allergic reaction to acetylsalicylic acid.
• Inflammation of blood vessels (vasculitis including Schönlein-Henoch purpura).
• Heart artery disorders of allergic nature (Kounis syndrome) in case of an allergic reaction to acetylsalicylic acid.
• Presence of blood in semen (haematospermia).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly
through the national reporting system at 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 Cardirene

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Store in the original container.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. 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 Cardirene contains
Cardirene 75 mg
The active ingredient is acetylsalicylic acid lysine salt. One sachet contains 135 mg of
acetylsalicylic acid lysine salt (corresponding to 75 mg of acetylsalicylic acid).
The other ingredients are: glycine, mandarin aroma (mandarin essential oil,
citrus juice and lactose), ammonium glycyrrhizate.

Cardirene 100 mg
The active ingredient is acetylsalicylic acid lysine salt. One sachet contains 180 mg of
acetylsalicylic acid lysine salt (corresponding to 100 mg of acetylsalicylic acid).
The other ingredients are: glycine, mandarin aroma (mandarin essential oil,
citrus juice and lactose), ammonium glycyrrhizate.

Cardirene 160 mg
The active ingredient is acetylsalicylic acid lysine salt. One sachet contains 288 mg of
acetylsalicylic acid lysine salt (corresponding to 160 mg of acetylsalicylic acid).
The other ingredients are: glycine, mandarin aroma (mandarin essential oil,
citrus juice and lactose), ammonium glycyrrhizate.

Cardirene 300 mg
The active ingredient is acetylsalicylic acid lysine salt. One sachet contains 540 mg of
acetylsalicylic acid lysine salt (corresponding to 300 mg of acetylsalicylic acid).
The other ingredients are: glycine, mandarin aroma (mandarin essential oil,
citrus juice and lactose), ammonium glycyrrhizate.

Description of the appearance of Cardirene and contents of the pack
Cardirene is presented in the form of powder for oral solution in a box containing 30 sachets.

Marketing Authorisation Holder
Sanofi S.p.A. Viale L. Bodio, 37/B - Milan

Manufacturer
Sanofi Winthrop Industrie - 196, rue du Marechal Juin - Amilly (France)