Acetylsalicylic acid Panpharma

Package leaflet: Information for the patient

ACETYLSALICYLIC ACID PANPHARMA 500 mg/2.5 ml powder and solvent for

injection solution
ACETYLSALICYLIC ACID PANPHARMA 1 g/5 ml powder and solvent for injection
solution
lysine acetylsalicylate
Please read all of this leaflet carefully before you are given this medicine because
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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACIDO ACETILSALICILICO PANPHARMA is and what it is used for

ACIDO ACETILSALICILICO PANPHARMA contains the active substance "lysine acetylsalicylate" and belongs to a class of medicines called "Other analgesics and antipyretics, salicylic acid and derivatives". ACIDO ACETILSALICILICO PANPHARMA works by reducing inflammation and pain.
ACIDO ACETILSALICILICO PANPHARMA is indicated for:
Treatment of acute pain caused by:

• inflammation of muscles and bones;
• pain due to tumours;
• pain following trauma;
• pain after surgical procedures.

2. What you should know before taking ACETYLSALICYLIC ACID PANPHARMA

Do not take ACETYLSALICYLIC ACID PANPHARMA

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any medicine belonging to a group called “non-steroidal anti-inflammatory drugs” (NSAIDs), or to any component contained therein.
• If you have previously suffered from a condition called asthma or nasal polyps associated with asthma shortly after taking a medicine belonging to a group called “acetylsalicylates” or shortly after taking medicines with similar activity, especially if belonging to a group called “non-steroidal anti-inflammatory drugs”.
• If you are in the third trimester of pregnancy (beyond 24 weeks of gestation) (see section “Pregnancy, breastfeeding and fertility”).
• If you have previously had or currently suffer from a lesion of the stomach or first part of the intestine wall (active, chronic or recurrent gastrointestinal ulcer), or have previously experienced gastrointestinal bleeding or perforation after treatment with acetylsalicylic acid or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation, fever and pain.
• If you suffer from any condition causing blood loss.
• If you are a person at risk of bleeding (haemorrhagic 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 heart problems (severe, uncontrolled heart failure).
• If you are taking a medicine called “methotrexate” at doses > 15 mg/week, together with other medicines containing “acetylsalicylic acid” (see “Other medicines and ACETYLSALICYLIC ACID PANPHARMA”).
• If you are taking oral medicines that affect blood coagulation (oral anticoagulants) together with medicines containing “acetylsalicylic acid” and in patients who have had gastro-duodenal ulcers (see “Other medicines and ACETYLSALICYLIC ACID PANPHARMA”).
• If you suffer from a condition called “mastocytosis”, where the use of medicines based on “acetylsalicylic acid” may cause severe allergic reactions including circulatory shock with sudden sensation of warmth (flushing), drop in blood pressure (hypotension), increased heart rate (tachycardia) and vomiting. Do not use this medicine if you suffer from allergies (hypersensitivity) to salicylates, if you are taking medicines that increase urine production (intensive diuretic therapy), if you suffer from severe blood loss (haemorrhagic diathesis), or if you are taking medicines used to reduce blood coagulation.

The use of this medicine is contraindicated in children and adolescents under
16 years of age.
Warnings and precautions
Take this medicine exactly as directed by your doctor or
pharmacist.
Contact your doctor or pharmacist before taking ACETYLSALICYLIC ACID
PANPHARMA:

• ACETYLSALICYLIC ACID PANPHARMA contains acetylsalicylic acid; if you are taking other medicines, check whether acetylsalicylic acid is present in other medicines you are taking. If it is, to avoid any risk of overdose, combination should be avoided;
• if you experience headache while taking pain medicines (analgesics) for a prolonged period and at high doses, do not increase the dose and contact your doctor;
• if you regularly use pain medicines (analgesics), particularly a combination of multiple analgesic medicines, as this may cause kidney problems, even severe ones;
• if you have a deficiency of a substance in the blood called G6PD (glucose-6-phosphate dehydrogenase), which may cause a particular inherited disease affecting red blood cells, since acetylsalicylic acid could lead to red blood cell breakdown (haemolysis) (see “Possible side effects”);
• if you have previously had stomach or intestinal lesions (gastric or duodenal ulcer), or gastrointestinal bleeding 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: an asthma attack in some people may be linked to an allergic reaction to non-steroidal anti-inflammatory drugs or to acetylsalicylic acid; in this case, ACETYLSALICYLIC ACID PANPHARMA is contraindicated (see “Do not take ACETYLSALICYLIC ACID PANPHARMA”);
• if you have heavy menstrual periods or bleeding between periods (metrorrhagia or menorrhagia), as there is a risk of increasing the volume and duration of menstrual periods;
• if gastrointestinal bleeding or lesions (ulcers)/perforations of the stomach or intestine occur. These effects, which increase with dose, may occur at any time during treatment, even if you have never previously suffered from these disorders, especially if you are elderly, have low body weight, and are on

treatment with medicines that make the blood thinner (anticoagulants or
platelet aggregation inhibitors) (see “Other medicines and ACETYLSALICYLIC
ACID PANPHARMA”) or if you have previously suffered from gastrointestinal
ulcer, particularly if complicated by bleeding or perforation. In case of
gastrointestinal bleeding, discontinue treatment immediately;

• if you are scheduled for surgery, even minor surgery (e.g. tooth extraction), since the use of ACETYLSALICYLIC ACID PANPHARMA increases the risk of bleeding. Your doctor will decide on a case-by-case basis whether to interrupt treatment before surgery. If you are taking high doses of ACETYLSALICYLIC ACID PANPHARMA for rheumatic diseases (anti-inflammatory doses), your doctor will monitor you, particularly important in children, especially at the beginning of treatment, for possible signs of overdose. If you experience tinnitus, hearing difficulties or dizziness, your treatment regimen must be reassessed by your doctor. Acetylsalicylic acid may interfere with uric acid elimination: high doses may increase uric acid excretion (uricosuric effect), while very low doses may reduce its excretion; therefore, the medicine is not recommended in people suffering from severe joint inflammation (gout). The use of ACETYLSALICYLIC ACID PANPHARMA is not recommended during breastfeeding (see “Pregnancy, breastfeeding and fertility”). If you are over 70 years old, especially if you are taking other medicines, you should use this medicine only after consulting your doctor. Your doctor will prescribe ACETYLSALICYLIC ACID PANPHARMA cautiously if you have mild or moderate liver problems (mild and moderate hepatic insufficiency), and if you are taking certain medicines, for example for diabetes, for stomach acidity, certain medicines to lower blood pressure and for inflammation (antidiabetics, antiacids, diuretics, glucocorticoids) (see “Other medicines and ACETYLSALICYLIC ACID PANPHARMA”). If you have reduced blood flow to the kidney (renal hypoperfusion), other kidney diseases or reduced heart function (heart failure), your doctor will prescribe ACETYLSALICYLIC ACID PANPHARMA with caution or use another medicine (ACETYLSALICYLIC ACID PANPHARMA interferes with the synthesis of prostaglandins and their important intermediates). Injectable ACETYLSALICYLIC ACID PANPHARMA cannot be considered a simple pain-relieving medicine (analgesic) and must be used under strict medical supervision. Furthermore, after the acute painful episode has passed, it is advisable to switch to oral formulations of the medicine (non-parenteral use), which, although causing qualitatively the same side effects, result in fewer severe reactions.
  Avoid using ACETYLSALICYLIC ACID PANPHARMA in combination with
  levotiroxine (a medicine used to treat thyroid disorders) (see “Other medicines and ACETYLSALICYLIC ACID PANPHARMA”). ACETYLSALICYLIC ACID PANPHARMA may lead to an increase in thyroid hormone levels in the blood; therefore, your doctor will monitor your thyroid hormone levels.
  If you take ACETYLSALICYLIC ACID PANPHARMA with nicorandil (a medicine used to prevent or relieve chest pain due to heart problems), the risk of gastrointestinal ulcer, perforation and bleeding may increase (see “Other medicines and ACETYLSALICYLIC ACID PANPHARMA”).
  In patients receiving the varicella vaccine, the use of acetylsalicylic acid should be avoided for 6 weeks following vaccination.
  Children and adolescents
  ACETYLSALICYLIC ACID PANPHARMA is contraindicated in children and adolescents under 16 years of age.
  In children and adolescents affected by viral diseases (particularly chickenpox and influenza) who had taken acetylsalicylic acid, a very rare and life-threatening condition has been observed, mainly associated with damage to the nervous system and liver (Reye's syndrome). Therefore, acetylsalicylic acid should be administered to children and adolescents in this situation only on medical advice, and only when other treatments have failed. If, during treatment with acetylsalicylic acid, the child or adolescent develops persistent vomiting, disturbances of consciousness or abnormal behaviour, the doctor will discontinue treatment.
  In children under 1 month of age, acetylsalicylic acid may be administered only in specific situations and on medical prescription.
  Other medicines and ACETYLSALICYLIC ACID PANPHARMA
  Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
  The effects of ACETYLSALICYLIC ACID PANPHARMA may be influenced by or may influence the following medicines.

• Abciximab, acetylsalicylic acid, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost tromethamine, ticlopidine and tirofiban, since these medicines thin the blood (platelet aggregation inhibitors). Concurrent use of different medicines acting on blood platelets increases the risk of bleeding, as does their combination with

heparin or similar substances, medicines called oral anticoagulants, or with other medicines called thrombolytics used to prevent blood clots. If you use these medicines together with ACETYLSALICYLIC ACID PANPHARMA, your doctor will monitor you.
Contraindicated combinations (see “Do not take ACETYLSALICYLIC ACID
PANPHARMA ”):

• Methotrexate (used to affect the body's immune system and in certain tumours) at doses greater than 15 mg per week with medicines containing “acetylsalicylic acid” at active doses for controlling inflammation, pain and fever, since this increases methotrexate toxicity, particularly haematological toxicity (toxicity to blood cells).
• Medicines used to make the blood thinner (oral anticoagulants) with medicines containing acetylsalicylic acid at active doses for controlling inflammation, pain and fever, in patients who have suffered from severe stomach lesions and a part of the intestine called “gastro-duodenal ulcers”, because this increases the risk of severe blood loss (haemorrhage). Combinations not recommended:
• Oral medicines to make the blood thinner (oral anticoagulants, ticlopidine) with medicines containing acetylsalicylic acid (antipyretics) and in patients who suffer or have suffered from a disease characterised by severe stomach lesions and a part of the intestine called (gastro-duodenal ulcer), because this increases the risk of blood loss (haemorrhage).
• Other non-steroidal anti-inflammatory drugs (NSAIDs), at anti-inflammatory doses or at analgesic or antipyretic doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and bleeding.
• Low molecular weight heparins (and related molecules) and unfractionated heparins (medicines to make the blood thinner) at therapeutic doses in elderly patients (> 64 years), regardless of heparin dose, and for anti-inflammatory doses of acetylsalicylic acid or for analgesic or antipyretic doses of acetylsalicylic acid: increased risk of bleeding (inhibition of platelet aggregation and damage to the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory medicine or another analgesic or antipyretic should be administered.
• A medicine called clopidogrel used to treat cardiovascular diseases with ACETYLSALICYLIC ACID PANPHARMA because it increases the risk of blood loss (haemorrhage). If concomitant administration cannot be avoided, the patient should be monitored by the doctor.
• Medicines that reduce the amount of a substance called “uric acid” in

the blood (Uricosurics: “benzbromarone” and “probenecid”): because when
administered with ACETYLSALICYLIC ACID PANPHARMA they reduce their
effectiveness and cause a decrease in acetylsalicylic acid excretion and an
increase in plasma levels.

• Glucocorticoids (except hydrocortisone), used to treat inflammation with acetylsalicylic acid used at doses for treating pain and fever, as they increase the risk of blood loss (haemorrhage).
• Pemetrexed (used in the treatment of certain types of cancer), may increase the risk of pemetrexed toxicity. Your doctor will monitor your clinical condition.
• Levotiroxine (used to treat thyroid disorders): ACETYLSALICYLIC ACID PANPHARMA may alter the amount of thyroid hormones in the blood; therefore, your doctor will monitor your thyroid hormone levels.
• 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 (serious disturbances of the brain and liver, especially in children) have occurred following the use of salicylates during varicella infection.
• Medicines for depression called “selective serotonin reuptake inhibitors” (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) because they increase the risk of blood loss (haemorrhage), particularly of the upper digestive tract. Therefore, if possible, concomitant use should be avoided. Combinations requiring precautions for use:
• Medicines to increase urine production (diuretics), medicines used to lower blood pressure and belonging to the class called ACE inhibitors or angiotensin II receptor antagonists, when administered together with ACETYLSALICYLIC ACID PANPHARMA, may result in reduced kidney function (acute renal failure), especially in dehydrated patients, or a decrease in blood pressure-lowering capacity (antihypertensive effect).
• Methotrexate (used to affect the body's immune system and in certain tumours) at doses less than or equal to 15 mg per week because when administered with ACETYLSALICYLIC ACID PANPHARMA it may cause an increase in methotrexate toxicity, particularly haematological toxicity (toxicity in the blood). Blood cell counts must be monitored weekly during the first weeks of concomitant administration. Your doctor will monitor carefully both patients with

kidney problems (renal insufficiency, even mild), and elderly patients.

• Methotrexate (used to affect the body's immune system and in certain tumours) at doses greater than 15 mg when administered together with ACETYLSALICYLIC ACID PANPHARMA (for blood coagulation reduction) may cause an increase in methotrexate toxicity, particularly haematological toxicity. Blood cell counts must be monitored weekly during the first weeks of concomitant administration. Concomitant use of methotrexate and ACETYLSALICYLIC ACID PANPHARMA requires monitoring in both patients with kidney problems (renal insufficiency, even mild) and elderly patients.

• Clopidogrel (used for reduced heart circulation problems called “acute coronary syndrome”) because when administered together with ACETYLSALICYLIC ACID PANPHARMA it may increase the risk of blood loss (haemorrhage). In this case, your doctor will monitor you closely. Medicines for the stomach and intestine belonging to the class of “gastrointestinal protectants”, “antacids” and adsorbents, including charcoal, as they reduce gastrointestinal absorption of ACETYLSALICYLIC ACID PANPHARMA. It is recommended, if possible, to take gastrointestinal protectants and antacids at least 2 hours apart from ACETYLSALICYLIC ACID PANPHARMA.

• Low molecular weight heparins (and related molecules) and unfractionated heparins, at preventive doses in patients under 65 years of age: co-administration of these medicines increases the risk of bleeding. Therefore, in patients under 65 years of age, co-administration of preventive-dose heparins (or related molecules) and acetylsalicylic acid, regardless of dose, must be carefully monitored.

• Low molecular weight heparins (and related molecules) and unfractionated heparins at therapeutic doses or in elderly patients (> 64 years), regardless of heparin dose, and for doses of acetylsalicylic acid used for platelet aggregation inhibition: increased risk of bleeding (inhibition of platelet aggregation and damage to stomach and intestinal mucosa by acetylsalicylic acid).

• Medicines used to prevent blood clot formation (thrombolytics) because they increase the risk of bleeding.

• Medicines that reduce blood coagulation taken orally (oral anticoagulants) with doses of ACETYLSALICYLIC ACID PANPHARMA used to thin the blood, because they increase the risk of bleeding, especially if you have previously suffered from gastrointestinal ulcer.

• Other non-steroidal anti-inflammatory drugs (NSAIDs) with ACETYLSALICYLIC ACID PANPHARMA at doses used to thin the blood,
  because they increase the risk of severe stomach lesions and blood loss (gastrointestinal ulcers and bleeding).

• Acetazolamide (used to treat high blood pressure): if taken concomitantly with ACETYLSALICYLIC ACID PANPHARMA, there is a risk of vomiting, tachycardia (fast heartbeat), hyperpnoea (rapid and deep breathing), mental confusion, fatigue, lethargy (extreme drowsiness), drowsiness, confusion, hyperchloremic metabolic acidosis (a condition characterised by increased acid levels in the blood).

• Medicines associated with bleeding risk: because combination with ACETYLSALICYLIC ACID PANPHARMA may have an additive effect on platelet aggregation (resulting in increased bleeding risk). In such cases, your doctor will perform regular clinical monitoring.

• Valproic acid (used to treat epilepsy): ACETYLSALICYLIC ACID PANPHARMA when used with valproic acid-based medicines may lead to increased blood levels of valproic acid. Therefore, your doctor will monitor valproate levels in your blood.

• Tenofovir (used in the treatment of certain viral infections): the use of ACETYLSALICYLIC ACID PANPHARMA with tenofovir may increase the likelihood of kidney problems (renal failure). Therefore, your doctor will monitor your kidney function.

• Insulin and sulfonylureas (medicines that lower blood sugar): combination with ACETYLSALICYLIC ACID PANPHARMA increases the risk of hypoglycaemia (low blood sugar levels).

• Nicorandil (medicine used to prevent or relieve chest pain due to heart problems): because if taken concomitantly with ACETYLSALICYLIC ACID PANPHARMA it may increase the risk of gastrointestinal ulcer, perforation and bleeding (see “Warnings and precautions”). ACETYLSALICYLIC ACID PANPHARMA may interact with:

• Medicines used after transplants such as: “cyclosporine” and “tacrolimus”; and other medicines that reduce transplant rejection.

• Ibuprofen (used for inflammation): because ibuprofen may interfere with the clot-preventing effects of low-dose acetylsalicylic acid (platelet aggregation).

• Metamizole, a medicine used for pain, because when taken concomitantly with acetylsalicylic acid it may reduce its effect on platelet aggregation. Therefore, your doctor will prescribe metamizole

cautiously if you are taking low doses of acetylsalicylic acid for heart protection (cardioprotection).
ACETYLSALICYLIC ACID PANPHARMA and alcohol
Alcohol may increase the risk of stomach and intestinal damage and alter blood coagulation tests (prolonged bleeding time) when taken together with acetylsalicylic acid. Therefore, alcoholic beverages should be consumed with caution by patients during and within 36 hours after taking acetylsalicylic acid.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
This medicine is contraindicated in the third trimester of pregnancy (beyond 24 weeks of gestation) (see “Do not take ACETYLSALICYLIC ACID PANPHARMA”).
ACETYLSALICYLIC ACID PANPHARMA may negatively affect pregnancy and/or fetal development.
Epidemiological studies suggest an increased risk of miscarriage, heart malformation and abdominal wall defect (gastroschisis) after using a medicine with the same mechanism of action as ACETYLSALICYLIC ACID PANPHARMA (inhibitor of prostaglandin synthesis) in early pregnancy. The risk increases with dose and duration of treatment.
Do not use ACETYLSALICYLIC ACID PANPHARMA during the first 24 weeks of pregnancy unless your doctor considers its use strictly necessary.
If you are a woman planning pregnancy or during the first 24 weeks of pregnancy, your doctor will keep the dose and duration of treatment as low as possible.
Beyond 24 weeks of pregnancy, all medicines acting like ACETYLSALICYLIC ACID PANPHARMA (inhibitors of prostaglandin synthesis) may expose the fetus to:

• heart and lung problems (with premature closure of the ductus arteriosus and pulmonary hypertension);
• kidney problems (renal dysfunction, which may progress to renal failure with oligo-anhydramnios);
• at the end of pregnancy, you and the newborn may experience:
• prolonged bleeding time, which may occur even after administration of very low doses of acetylsalicylic acid.
• inhibition of uterine contractions resulting in delayed or prolonged labour. Breastfeeding Acetylsalicylic acid passes into breast milk. Do not use ACETYLSALICYLIC ACID PANPHARMA during breastfeeding to avoid undesirable effects in the infant (see “Special warnings”). Fertility Administration of ACETYLSALICYLIC ACID PANPHARMA should be suspended if you have fertility problems or are undergoing fertility investigations. ACETYLSALICYLIC ACID PANPHARMA may cause reduced fertility in women through an effect on ovulation. This effect is reversible upon discontinuation of the medicine.

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

3. How to take ACETYLSALICYLIC ACID PANPHARMA

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is:
1 to 4 vials per day, or as prescribed by the doctor, administered into a vein (intravenous) or into a muscle (intramuscular).
ACETYLSALICYLIC ACID PANPHARMA 500 mg: administered deeply into a muscle every 6–8 hours.
ACETYLSALICYLIC ACID PANPHARMA 1 g: in cases of severe and resistant pain, administered into a vein every 6–12 hours.
Elderly patients
If you are elderly, your doctor will consider whether a dose reduction and/or less frequent administration than indicated above (for adults) is necessary.
If you take more ACETYLSALICYLIC ACID PANPHARMA than you should
In case of accidental ingestion/overdose of ACETYLSALICYLIC ACID PANPHARMA, contact your doctor immediately or go to the nearest hospital.
For acetylsalicylic acid, toxic doses range between 200 mg/kg and 300 mg/kg when taken orally.
In children, overdose may be fatal starting from a single dose of 100 mg/kg.
Exercise particular caution regarding overdose if you are elderly or if an excessive dose is taken by a young child (either during treatment or, more frequently, due to accidental poisoning).
Overdose with this type of medicine, especially in young children, may lead to severe lowering of blood sugar levels (hypoglycaemia) and potentially fatal poisoning.
Short- and long-term overdose of acetylsalicylic acid may result in life-threatening accumulation of fluid in the lungs (non-cardiogenic pulmonary oedema).
Symptoms of overdose

• Moderate intoxication: tinnitus, sensation of hearing loss, headache (cephalalgia), dizziness, vertigo, confusion, and nausea are signs of overdose and may be controlled by reducing the dose.
• Severe intoxication: fever, rapid breathing (hyperventilation), changes in blood acidity (ketosis, respiratory alkalosis, metabolic acidosis), coma, cardiovascular collapse, breathing difficulties (respiratory failure), severe reduction in blood sugar (severe hypoglycaemia).

If you forget to take ACETYLSALICYLIC ACID PANPHARMA
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult 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 of adverse events cannot be determined from
the available data. Therefore, the frequency is listed as "not known".

• Bleeding, potentially fatal (the risk depends on the amount of medicine taken):
  • in the urine and from the genital area,
  • from the nose (epistaxis),
  • from the gums,
  • inside the head (intracranial haemorrhage), which may lead to death, especially if you are elderly,
  • in the stomach and intestines (gastrointestinal haemorrhage, occult or overt – haematemesis, melena), leading to iron-deficiency anaemia,
  • bruising,
  • red spots on the skin due to bleeding (purpura). The risk of bleeding may persist for 4–8 days after stopping acetylsalicylic acid. This may increase the risk of bleeding (haemorrhage) if you are scheduled for surgery.
• Decrease in the number of platelets in the blood (thrombocytopenia).
• Breakdown of red blood cells in the blood (haemolytic anaemia) in people with deficiency of a substance in the blood called glucose-6-phosphate dehydrogenase (G6PD), which may cause a hereditary disease affecting red blood cells.
• Decrease, sometimes severe, in blood cells (pancytopenia, bicytopenia, aplastic anaemia, bone marrow failure, agranulocytosis, neutropenia, leucopenia).
• Allergic reactions (hypersensitivity, anaphylactic reactions, asthma, angioedema).
• Bronchospasm (contraction of bronchial muscles) and asthma (inflammation and narrowing of the airways).
• Headache, dizziness and vertigo, which may occur with high doses and prolonged treatment. If you experience these symptoms, contact your doctor immediately to evaluate whether treatment should be discontinued.
• Ringing in the ears (tinnitus) and hearing loss, which may occur with high doses and prolonged treatment. If you experience these symptoms, contact your doctor immediately to evaluate whether treatment should be discontinued.
• Abdominal pain.
• Indigestion (dyspepsia).
• Bleeding in 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 intestinal bleeding (erosive gastritis and duodenitis); ulcers in the stomach and/or intestines; inflammation (colitis) and perforation of the gastrointestinal tract. These reactions may or may not be associated with bleeding and may occur at any dose of acetylsalicylic acid, in patients with or without predictive risk factors and who have or have not previously had serious stomach or intestinal diseases.
• Inflammation of the pancreas (acute pancreatitis) as a hypersensitivity reaction to acetylsalicylic acid.
• Liver disorders and inflammation (chronic hepatitis), with abnormal liver blood tests (increased liver enzymes).
• Urticaria and other skin irritations that always appear in the same location (fixed eruptions).
• Reye's syndrome, a serious illness affecting mainly children, occurring with fever, influenza, varicella, and damage to the nervous system and liver (see "Warnings and precautions").
• Pain and local skin reaction at the site of administration (this is an injection).
• Allergic-type heart artery disorders (Kounis syndrome) in case of an allergic reaction to acetylsalicylic acid.
• Kidney disorders (renal failure).
• Accumulation of fluid in the lungs (non-cardiogenic pulmonary oedema) with prolonged use of the medicine, which may also occur in case of an allergic reaction to acetylsalicylic acid.
• Potentially fatal bleeding (severe blood loss, potentially life-threatening) and inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura).
• Presence of blood in semen (haemospermia).
• Swelling due to fluid retention (oedema) with administration of high doses.

Reporting of side effects
If you experience any side effect, including those not listed in
this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
http://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 ACETYLSALICYLIC ACID PANPHARMA

Do not store above 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 no longer required. This will help protect the environment.

6. Package contents and other information

What ACIDO ACETILSALICILICO PANPHARMA contains
ACIDO ACETILSALICILICO PANPHARMA 500 mg

• The active substance is lysine acetylsalicylate. One vial contains 900 mg of lysine acetylsalicylate (equivalent to 500 mg of acetylsalicylic acid).
• The other component is: gelatin.
• One solvent vial of 2.5 ml contains: water for injections.

ACIDO ACETILSALICILICO PANPHARMA 1000 mg

• The active substance is lysine acetylsalicylate. One vial contains 1800 mg of lysine acetylsalicylate (equivalent to 1000 mg of acetylsalicylic acid).
• The other component is: gelatin.
• One solvent vial of 5 ml contains: water for injections.

Description of the appearance of ACIDO ACETILSALICILICO PANPHARMA and contents of the pack
ACIDO ACETILSALICILICO PANPHARMA is presented as a powder and solvent for injectable solution:

• Box containing 6 powder vials (0.9 g) + 6 solvent vials of 2.5 ml
• Box containing 6 powder vials (1.8 g) + 6 solvent vials of 5 ml

Marketing Authorization Holder
Panmedica, 406 Bureaux de la Colline 92213 Saint-Cloud Cedex
Manufacturer
Delpharm Dijon – 6, Boulevard de l’Europe, 21800 Quétigny (France)
Panpharma – Zone d’activitè du Prè-Chenot, 56380 Beignon (France)
07.12.2023

The following information is intended exclusively for physicians or healthcare professionals:

The product may be diluted in physiological saline, glucose, isotonic electrolyte, dextran, Ringer's, or Darrow's solutions and administered by intravenous infusion.
In preanesthesia and premedication prior to endoscopic or arteriographic procedures, the product may be combined with atropine (two vials of 500 mg or one vial of 1000 mg, plus 0.25 mg of atropine, administered simultaneously by intravenous injection).

Patient Information Leaflet

ACETYLSALICYLIC ACID PANPHARMA 1000 mg effervescent powder for oral solution

lysine acetylsalicylate
Please read this leaflet carefully before taking this medicine because
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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACIDO ACETILSALICILICO PANPHARMA is and what it is used for

ACIDO ACETILSALICILICO PANPHARMA contains the active substance "lysine acetylsalicylate" and belongs to a class of medicines called "Other analgesics and antipyretics, salicylic acid and derivatives". ACIDO ACETILSALICILICO PANPHARMA works by reducing inflammation and pain.
ACIDO ACETILSALICILICO PANPHARMA is indicated for:

• pain of any type and severity;
• disorders affecting joints, tendons, muscles, and bones (acute rheumatic arthritis) and its complications;
• joint diseases (degenerative arthropathies);
• muscle pains (myalgia).

2. What you should know before taking ACETYLSALICYLIC ACID PANPHARMA

Do not take ACETYLSALICYLIC ACID PANPHARMA

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any medicine belonging to a class called "non-steroidal anti-inflammatory drugs" (NSAIDs) or to any component contained therein.
• If you have suffered from a condition called asthma or nasal polyps associated with asthma shortly after taking a medicine belonging to a class called "acetylsalicylates" or shortly after taking medicines with similar activity, especially if belonging to a class called "non-steroidal anti-inflammatory drugs".
• If you are in the third trimester of pregnancy (beyond 24 weeks of gestation) (see section "Pregnancy, breastfeeding and fertility").
• If you have had or currently have a lesion of the stomach or intestinal wall (active, chronic or recurrent gastrointestinal ulcer), or if you have previously experienced gastrointestinal bleeding or perforation after treatment with acetylsalicylic acid or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation, fever and pain.
• If you suffer from any disease causing blood loss (haemorrhagic disease).
• If you are at risk of bleeding (haemorrhagic risk).
• If you have severe liver problems (severe hepatic insufficiency).
• If you have severe kidney problems (severe renal insufficiency).
• If you have heart problems (severe uncontrolled heart failure).
• If you are taking a medicine called "methotrexate" at doses > 15 mg/week, together with other medicines containing "acetylsalicylic acid" (see "Other medicines and ACETYLSALICYLIC ACID PANPHARMA").
• If you are taking oral medicines that affect blood coagulation (oral anticoagulants) together with medicines containing "acetylsalicylic acid", in patients who have had stomach or intestinal ulcers (gastro-duodenal ulcers; see "Other medicines and ACETYLSALICYLIC ACID PANPHARMA").
• If you suffer from a disease called "mastocytosis", where the use of medicines based on "acetylsalicylic acid" may cause severe allergic reactions, including shock with sudden sensation of warmth (hot flushes), low blood pressure (hypotension), increased heart rate (tachycardia) and vomiting. Do not use this medicine if you have allergies (hypersensitivity) to salicylates, if you are taking medicines that increase urine production (intensive diuretic therapy), if you have a predisposition to bleeding (haemorrhagic diathesis), or if you are taking blood-thinning medicines.

The use of this medicine is contraindicated in children and adolescents under
16 years of age.
Warnings and precautions
Take this medicine exactly as prescribed by your doctor or
pharmacist.
Contact your doctor or pharmacist before taking ACETYLSALICYLIC ACID
PANPHARMA:

• ACETYLSALICYLIC ACID PANPHARMA 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 painkillers (analgesics) for a prolonged period and at high doses, do not increase the dose and contact your doctor;
• if you regularly use painkillers (analgesics), particularly a combination of multiple analgesic medicines, as this may cause kidney problems, even severe ones;
• if you have a deficiency of a substance in the blood called G6PD (glucose-6-phosphate dehydrogenase), which may cause a particular inherited disease affecting red blood cells, since acetylsalicylic acid could lead to rupture of red blood cells (haemolysis) (see "Possible side effects");
• if you have had stomach or intestinal lesions (gastric or duodenal ulcer), or gastrointestinal bleeding, or stomach inflammation (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: an asthma attack in some people may be related to an allergic reaction to non-steroidal anti-inflammatory drugs or acetylsalicylic acid; in this case, ACETYLSALICYLIC ACID PANPHARMA is contraindicated (see "Do not take ACETYLSALICYLIC ACID PANPHARMA");
• if you suffer from asthma or are predisposed to it, you may experience breathing difficulties (bronchospasm crisis) and possibly shock and other allergic phenomena;
• if you have heavy menstrual periods or bleeding between periods (metrorrhagia or menorrhagia), as there is a risk of increasing the volume and duration of menstrual periods;
• if gastrointestinal bleeding or lesions (ulcers)/perforations of the stomach or intestine occur. These effects, which increase with dose, may occur at any time during treatment, even if you have never suffered from these disorders, especially if you are elderly, have low body weight, or are being treated with medicines that make the blood thinner (anticoagulants or platelet aggregation inhibitors) (see "Other medicines and ACETYLSALICYLIC ACID PANPHARMA") or if you have previously suffered from gastrointestinal ulcer, particularly if complicated by bleeding or perforation. In case of gastrointestinal bleeding, discontinue treatment immediately;
• if you are scheduled for surgery, even minor (e.g. tooth extraction), since the use of ACETYLSALICYLIC ACID PANPHARMA increases the risk of bleeding. Your doctor will decide on a case-by-case basis whether to interrupt treatment before surgery. If you are taking high doses of ACETYLSALICYLIC ACID PANPHARMA for rheumatic diseases (anti-inflammatory doses), your doctor will monitor you, especially important in children, particularly at the beginning of treatment, for possible signs of overdose. In case of tinnitus, hearing difficulties or dizziness, the treatment regimen must be reassessed by your doctor. Acetylsalicylic acid may interfere with uric acid excretion: high doses may increase uric acid excretion (uricosuric effect) while very low doses may reduce its excretion; therefore, the medicine is not recommended in people suffering from severe joint inflammation (gout). The use of ACETYLSALICYLIC ACID PANPHARMA is not recommended during breastfeeding (see "Pregnancy, breastfeeding and fertility"). If you are over 70 years old, especially if you are taking other medicines, you should use this medicine only after consulting your doctor. If during treatment you experience prolonged vomiting and profound drowsiness, your doctor will ask you to stop administration. If you experience tinnitus, hearing difficulties or dizziness, your doctor must review the treatment regimen. Avoid using ACETYLSALICYLIC ACID PANPHARMA in combination with levothyroxine (used to treat thyroid disorders) (see "Other medicines and ACETYLSALICYLIC ACID PANPHARMA"). ACETYLSALICYLIC ACID PANPHARMA may lead to an increase in thyroid hormone levels in the blood; therefore, your doctor will monitor your thyroid hormone levels.

If you take ACETYLSALICYLIC ACID PANPHARMA with nicorandil (a medicine
used to prevent or relieve chest pain due to heart problems),
the risk of gastrointestinal ulcer, perforation and bleeding may increase
(see "Other medicines and ACETYLSALICYLIC ACID PANPHARMA").
In patients receiving the varicella vaccine, the use of acetylsalicylic acid
should be avoided for 6 weeks following vaccination.
Children and adolescents
ACETYLSALICYLIC ACID PANPHARMA is contraindicated in children and adolescents
under 16 years of age.
In children and adolescents affected by viral diseases (particularly chickenpox and influenza) who had taken acetylsalicylic acid, a very rare and life-threatening condition has been observed, mainly associated with damage to the nervous system and liver (Reye's syndrome). Therefore, acetylsalicylic acid should be administered to children and adolescents in this situation only on medical advice and only when other treatments have failed.
If during treatment with acetylsalicylic acid the child or adolescent develops persistent vomiting, disturbances of consciousness or abnormal behaviour, the doctor will discontinue treatment.
The doctor will monitor treated children, especially at the beginning of therapy.
In children under 1 month of age, acetylsalicylic acid may be administered only in specific situations and on medical prescription.
The 1 g oral solution powder sachets are not suitable for use in children weighing less than 50 kg.
Other medicines and ACETYLSALICYLIC ACID PANPHARMA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
The effects of ACETYLSALICYLIC ACID PANPHARMA may be influenced by or may influence the following medicines.

• Abciximab, acetylsalicylic acid, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost trometamol, ticlopidine and tirofiban, since these medicines thin the blood (platelet aggregation inhibitors). The concomitant use of different medicines that act by making the blood thinner (heparin or similar substances, medicines called oral anticoagulants or thrombolytics, used to prevent blood clots) increases the risk of bleeding. If you use these medicines together with ACETYLSALICYLIC ACID PANPHARMA, your doctor will monitor you.

Contraindicated combinations (see “Do not take ACETYLSALICYLIC ACID
PANPHARMA”):

• Methotrexate (used to affect the immune system and in some tumours) at doses greater than 15 mg per week with medicines containing acetylsalicylic acid at doses active for controlling inflammation, pain and fever, since it increases methotrexate toxicity, particularly haematological toxicity (blood cell toxicity).

• Medicines used to make the blood thinner (oral anticoagulants) with medicines containing acetylsalicylic acid at doses active for controlling inflammation, pain and fever, and in patients who have suffered from severe stomach lesions and a part of the intestine called "gastro-duodenal ulcers", because it increases the risk of severe blood loss (haemorrhage). Combinations not recommended:

• Oral medicines to make the blood thinner (oral anticoagulants, ticlopidine) with medicines containing acetylsalicylic acid (antipyretics) and in patients who suffer or have suffered from a disease characterised by severe stomach lesions and a part of the intestine called gastro-duodenal ulcer because it increases the risk of blood loss (haemorrhage).

• Other non-steroidal anti-inflammatory drugs (NSAIDs), at anti-inflammatory doses or at analgesic or antipyretic (pain and fever) doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and bleeding.

• Low molecular weight heparins (and related molecules) and unfractionated heparins (medicines to make the blood thinner) at therapeutic doses in elderly patients (> 64 years), regardless of heparin dose, and for anti-inflammatory doses of acetylsalicylic acid or for analgesic or antipyretic doses of acetylsalicylic acid: increased risk of bleeding (inhibition of platelet aggregation and damage to the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory medicine or another analgesic or antipyretic should be administered.

• A medicine called clopidogrel used to treat cardiovascular diseases with ACETYLSALICYLIC ACID PANPHARMA because it increases the risk of blood loss (haemorrhage). If concomitant administration cannot be avoided, the patient must be monitored by the doctor.

• Medicines that reduce the amount of a substance called "uric acid" in the blood (uricosurics: "benzbromarone" and "probenecid"): because if
  administered with ACETYLSALICYLIC ACID PANPHARMA they reduce
  their effectiveness and cause a decrease in acetylsalicylic acid excretion and an increase in plasma levels.

• Glucocorticoids (except hydrocortisone), used to treat inflammation, with acetylsalicylic acid used at doses for treating pain and fever, as the combination increases the risk of blood loss (haemorrhage).

• Pemetrexed (used for the treatment of certain types of cancer): ACETYLSALICYLIC ACID PANPHARMA may increase the risk of pemetrexed toxicity. Your doctor will monitor your clinical condition.

• Levothyroxine (used to treat thyroid disorders): ACETYLSALICYLIC ACID PANPHARMA may alter the amount of thyroid hormones in the blood; therefore, your doctor will monitor your thyroid hormone levels.

• 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 (serious brain and liver disorders, especially in children) have occurred following the use of salicylates during varicella infection.

• Medicines for depression called "selective serotonin reuptake inhibitors" (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) because they increase the risk of bleeding (haemorrhage), particularly in the upper digestive tract. Therefore, if possible, concomitant use should be avoided. Combinations requiring precautions for use:

• Medicines to increase urine production (diuretics), medicines used to lower blood pressure belonging to the classes called ACE inhibitors and angiotensin II receptor antagonists, if administered together with ACETYLSALICYLIC ACID PANPHARMA, since a reduction in kidney function (acute renal failure) may occur, especially in dehydrated patients, or a decrease in blood pressure lowering capacity (antihypertensive effect).

• Methotrexate (used to affect the immune system and in some tumours) at doses less than or equal to 15 mg per week because if administered with ACETYLSALICYLIC ACID PANPHARMA it may cause an increase in methotrexate toxicity, particularly haematological toxicity. Blood cell count must be monitored weekly during the first weeks of concomitant administration. Your doctor will carefully monitor both
  patients with kidney problems (renal insufficiency even mild) and elderly patients.

• Methotrexate (used to affect the immune system and in some tumours) at doses greater than 15 mg if administered together with ACETYLSALICYLIC ACID PANPHARMA (to thin the blood) may cause an increase in methotrexate toxicity, particularly haematological toxicity. Your doctor will perform blood tests (blood cell count) weekly during the first weeks of concomitant administration. Your doctor will carefully monitor both patients with kidney problems (renal insufficiency even mild) and elderly patients.

• Clopidogrel (used for problems with reduced heart circulation called "acute coronary syndrome") because if administered together with ACETYLSALICYLIC ACID PANPHARMA it may increase the risk of blood loss (haemorrhage). In this case, your doctor will monitor you closely.

• Medicines for the stomach and intestine belonging to the class of "gastrointestinal protectants", "antacids" and adsorbents, including charcoal: since they reduce the gastrointestinal absorption of ACETYLSALICYLIC ACID PANPHARMA. It is recommended, if possible, to take gastrointestinal protectants and antacids at least 2 hours apart from ACETYLSALICYLIC ACID PANPHARMA.

• Low molecular weight heparins (and related molecules) and unfractionated heparins, at prophylactic doses in patients under 65 years of age: the co-administration of these medicines increases the risk of bleeding. Therefore, in patients under 65 years of age, co-administration of prophylactic-dose heparins (or related molecules) and acetylsalicylic acid, regardless of dose, must be carefully monitored.

• Low molecular weight heparins (and related molecules) and unfractionated heparins at therapeutic doses or in elderly patients (> 64 years), regardless of heparin dose, and for doses of acetylsalicylic acid used for platelet aggregation inhibition: increased risk of bleeding (inhibition of platelet aggregation and damage to stomach and intestinal mucosa by acetylsalicylic acid).

• Medicines used to prevent blood clot formation (thrombolytics) since they increase the risk of bleeding.

• Medicines that reduce blood coagulation taken orally (oral anticoagulants) with doses of ACETYLSALICYLIC ACID PANPHARMA used to thin the blood, since they increase the risk of
  bleeding, especially if you have previously suffered from gastrointestinal ulcer.

• Other non-steroidal anti-inflammatory medicines (NSAIDs) with ACETYLSALICYLIC ACID PANPHARMA at doses used to thin the blood, since it increases the risk of severe stomach lesions and bleeding (gastrointestinal ulcers and bleeding).

• Acetazolamide (used to treat high blood pressure): if taken concomitantly with ACETYLSALICYLIC ACID PANPHARMA, there is a risk of vomiting, tachycardia (fast heartbeat), hyperpnoea (rapid and deep breathing), mental confusion, fatigue, lethargy (extreme drowsiness), drowsiness, confusion, hyperchloraemic metabolic acidosis (a condition characterised by increased acid levels in the blood).

• Medicines associated with a risk of bleeding: because the combination with ACETYLSALICYLIC ACID PANPHARMA may have an additive effect on platelet aggregation (resulting in increased risk of bleeding). In such cases, your doctor will perform regular clinical monitoring.

• Valproic acid (used to treat epilepsy): ACETYLSALICYLIC ACID PANPHARMA if used with valproic acid-based medicines may lead to an increase in valproic acid levels in the blood. Therefore, your doctor will monitor valproate levels in your blood.

• Tenofovir (used in the treatment of certain viral infections): the use of ACETYLSALICYLIC ACID PANPHARMA with tenofovir may increase the likelihood of kidney problems (renal failure). Therefore, your doctor will monitor your kidney function.

• Insulin and sulfonylureas (medicines that reduce blood sugar): the combination with ACETYLSALICYLIC ACID PANPHARMA increases the risk of hypoglycaemia (low blood sugar levels).

• Nicorandil (medicine used to prevent or relieve chest pain due to heart problems): because if taken concomitantly with ACETYLSALICYLIC ACID PANPHARMA it may increase the risk of gastrointestinal ulcer, perforation and bleeding (see "Warnings and precautions"). ACETYLSALICYLIC ACID PANPHARMA may interact with:

• Medicines used after transplants such as: "cyclosporine" and "tacrolimus" and other medicines that reduce transplant rejection.

• Ibuprofen (used for inflammation): because ibuprofen may interfere with the clot-preventing effects of low-dose acetylsalicylic acid (platelet aggregation).

• Metamizole, a medicine used for pain, since when taken concomitantly with acetylsalicylic acid it may reduce its effect on platelet aggregation. Therefore, your doctor will prescribe metamizole cautiously if you are taking low doses of acetylsalicylic acid for heart protection (cardioprotection).

ACETYLSALICYLIC ACID PANPHARMA and alcohol
Alcohol may increase the risk of stomach and intestinal damage and alter blood coagulation tests (prolonged bleeding time) when taken together with acetylsalicylic acid. Therefore, alcoholic beverages should be consumed with caution by patients during and within 36 hours after taking acetylsalicylic acid.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine is contraindicated in the third trimester of pregnancy (beyond 24 weeks of gestation) (see "Do not take ACETYLSALICYLIC ACID PANPHARMA").
ACETYLSALICYLIC ACID PANPHARMA may negatively affect pregnancy and/or foetal development.
Do not use ACETYLSALICYLIC ACID PANPHARMA during the first 24 weeks of pregnancy unless your doctor considers its use strictly necessary.
If you are a woman trying to conceive or during the first 24 weeks of pregnancy, your doctor will keep the dose and duration of treatment as low as possible.
Beyond 24 weeks of pregnancy, all medicines acting like ACETYLSALICYLIC ACID PANPHARMA (prostaglandin synthesis inhibitors) may expose the foetus to:

• Heart and lung problems (with premature closure of the ductus arteriosus and pulmonary hypertension).
• Kidney problems (renal dysfunction, which may progress to renal failure with oligo-hydramnios). At the end of pregnancy, you and the newborn may present:
• prolonged bleeding time, which may occur even after administration of very low doses of acetylsalicylic acid,
• inhibition of uterine contractions resulting in delayed or prolonged labour. Breastfeeding Acetylsalicylic acid passes into breast milk. Do not use ACETYLSALICYLIC ACID PANPHARMA during breastfeeding to avoid adverse effects in the infant (see "Special warnings"). Fertility Administration of ACETYLSALICYLIC ACID PANPHARMA should be discontinued if you have fertility problems or are undergoing fertility investigations. ACETYLSALICYLIC ACID PANPHARMA may cause a reduction in female fertility through an effect on ovulation. This effect is reversible upon discontinuation of the medicine.

Driving and using machines
No effects on the ability to drive or use machines are known.
ACETYLSALICYLIC ACID PANPHARMA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him
before taking this medicine.

3. How to take ACETYLSALICYLIC ACID PANPHARMA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is:
1000 mg sachets: 1 sachet to be dissolved in a glass of water, 2–3 times daily.
Your doctor may decide to adjust the recommended dose if considered necessary.
Elderly patients
If you are elderly, your doctor will evaluate whether a dose reduction and/or less frequent administration compared to the above recommendations (for adults) is appropriate.
Pour the contents of the sachet into a glass, add water, stir for a few seconds, and drink.
ACETYLSALICYLIC ACID PANPHARMA sachets should be taken with food, especially if your doctor has prescribed ACETYLSALICYLIC ACID PANPHARMA at high doses or for prolonged periods.
If you take more ACETYLSALICYLIC ACID PANPHARMA than you should
In case of accidental ingestion or overdose of ACETYLSALICYLIC ACID PANPHARMA, contact your doctor immediately or go to the nearest hospital.
For acetylsalicylic acid, oral toxic doses range between 200 mg/kg and 300 mg/kg.
In children, overdose may be fatal starting from a single dose of 100 mg/kg.
Pay particular attention to overdose if you are elderly or if an excessive dose is taken by a young child (either during treatment or, more frequently, due to accidental poisoning).
Overdose with this type of medicine, particularly in young children, may lead to severe lowering of blood sugar (hypoglycaemia) and potentially fatal poisoning.
Overdose of acetylsalicylic acid, both in the short and long term, may result in life-threatening accumulation of fluid in the lungs (non-cardiogenic pulmonary edema).
Symptoms of overdose

• Moderate intoxication: tinnitus, hearing loss, headache (cephalalgia), dizziness, vertigo, confusion, and nausea are signs of overdose and may be managed by reducing the dose.
• Severe intoxication: fever, rapid breathing (hyperventilation), changes in blood acidity (ketosis, respiratory alkalosis, metabolic acidosis), coma, cardiovascular collapse, breathing difficulties (respiratory failure), severe lowering of blood sugar (severe hypoglycaemia).

If you forget to take ACETYLSALICYLIC ACID PANPHARMA
Do not take a double dose to make up for the missed dose.
If you have any questions 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 everyone will experience them.
The frequency of adverse events cannot be determined from
available data. Therefore, the frequency is classified as "not known".

• Bleeding, potentially fatal (the risk depends on the amount of medicine taken):
  • in urine and from genital organs,
  • from the nose (epistaxis),
  • from the gums,
  • inside the head (intracranial hemorrhage), which may be fatal, especially in the elderly,
  • in the stomach and intestines (gastrointestinal hemorrhage, occult or overt – hematemesis, melena), leading to iron deficiency anemia,
  • bruising.
• Red spots on the skin due to bleeding (purpura).
• Abnormal blood coagulation tests (prolonged bleeding time). The risk of bleeding may persist for 4–8 days after stopping acetylsalicylic acid administration. This may increase the risk of bleeding (hemorrhage) if you undergo surgery.
• Decrease in the number of platelets in the blood (thrombocytopenia).
• Breakdown of red blood cells in the blood (hemolytic anemia) in people with deficiency of a substance in the blood called glucose-6-phosphate dehydrogenase (G6PD), which may cause a specific inherited disease affecting red blood cells.
• Decrease, sometimes severe, in blood cells (pancytopenia, bicytopenia, aplastic anemia, bone marrow failure, agranulocytosis, neutropenia, leucopenia).
• Allergic reactions (hypersensitivity, anaphylactic reactions, asthma, angioedema).
• Bronchospasm (contraction of bronchial muscles) and asthma (inflammation and narrowing of the airways).
• Headache, dizziness, and vertigo, which may occur with high doses and prolonged treatment. If you experience these symptoms, contact your doctor immediately to evaluate discontinuation of treatment.
• Ringing in the ears (tinnitus) and hearing loss, which may occur with high doses and prolonged treatment. If you experience these symptoms, contact your doctor immediately to evaluate discontinuation of treatment.
• Abdominal pain.
• Difficulty digesting (dyspepsia).
• Bleeding of the stomach and intestines (gastrointestinal hemorrhage); nausea; inflammation and lesions of the esophageal mucosa (esophagitis and esophageal ulcers); inflammation of the stomach and duodenum, with abdominal pain and intestinal bleeding (erosive gastritis and duodenitis); lesions (ulcers) in the stomach and/or intestines; inflammation (colitis) and perforation of the gastrointestinal tract.

These reactions may occur with or without bleeding;
they may occur at any dose of acetylsalicylic acid, and in
patients with or without predictive risk factors, and whether or not they have previously suffered from severe stomach or intestinal diseases.

• Inflammation of the pancreas (acute pancreatitis) as an allergic reaction (hypersensitivity) to acetylsalicylic acid.
• Liver disorders and inflammation (chronic hepatitis), with increased liver blood tests (elevated liver enzymes).
• Urticaria and other skin irritations that always appear in the same location (fixed eruptions).
• Reye's syndrome, a serious illness affecting mainly children, occurring with fever, influenza, chickenpox, and causing damage to the nervous system and liver (see "Warnings and precautions").
• Allergic-related heart artery disorders (Kounis syndrome) in case of an allergic reaction to acetylsalicylic acid.
• Kidney disorders (renal failure).
• Fluid accumulation in the lungs (non-cardiogenic pulmonary edema) with prolonged use of the medicine, which may also occur in case of allergy to acetylsalicylic acid.
• Potentially fatal hemorrhage (severe blood loss, potentially life-threatening) and inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura).
• Presence of blood in semen (haemospermia).
• Swelling due to fluid retention (edema) with administration of high doses.

Reporting of side effects
If you experience any side effect, including those not listed in
this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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 ACETYLSALICYLIC ACID PANPHARMA

Store in the original packaging at a temperature not exceeding 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 carton 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 no longer required. This will help protect the environment.

6. Package contents and other information

What ACIDO ACETILSALICILICO PANPHARMA 1000 mg effervescent powder for
oral solution contains

• The active substance is lysine acetylsalicylate. Each sachet contains 1800 mg lysine acetylsalicylate (equivalent to 1000 mg acetylsalicylic acid).
• The excipients are: glycine, tangerine flavour (lactose, maltodextrins, gum arabic, E320) and ammonium glycyrrhizinate.

Description of the appearance of ACIDO ACETILSALICILICO PANPHARMA 1000 mg
effervescent powder for oral solution and contents of the pack

ACIDO ACETILSALICILICO PANPHARMA is available as 1000 mg effervescent powder for oral solution in packs of 10 or 20 sachets.

Marketing Authorization Holder
Panmedica, 406 Bureaux de la Colline 92213 Saint-Cloud Cedex
Manufacturer
Sanofi Winthrop Industrie – 196, Rue du Marechal Juin - Amilly (France)
07.12.2023