ACIDO 500 mg /2.5 Ml Proszek I Rozpuszczalnik Do Roztworu Do Wstrzykiwań

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1. ACETIC ACID SALICYLIC PANPHARMA 500 mg/2.5 ml powder and solvent for
2. ACETIC ACID SALICYLIC PANPHARMA 1 g/5 ml powder and solvent for solution
   1. What is ACIDO ACETILSALICILICO PANPHARMA and what is it used for
   2. What you need to know before taking ACIDO ACETILSALICILICO PANPHARMA
   3. How to take ACIDO ACETILSALICILICO PANPHARMA
   4. Possible side effects
   5. How to store ACIDO ACETILSALICILICO PANPHARMA
   6. Package contents and other information
3. ACIDO ACETILSALICILICO PANPHARMA 1000 mg powder for oral solution
   1. What ACIDO ACETILSALICILICO PANPHARMA is and what it is used for
   2. What you need to know before taking ACIDO ACETILSALICILICO PANPHARMA
   3. How to take ACIDO ACETILSALICILICO PANPHARMA
   4. Possible side effects
   5. How to store ACIDO ACETILSALICILICO PANPHARMA
   6. Contents of the pack and other information

ACETIC ACID SALICYLIC PANPHARMA 500 mg/2.5 ml powder and solvent for

injectable solution

ACETIC ACID SALICYLIC PANPHARMA 1 g/5 ml powder and solvent for solution

injectable
lysine acetylsalicylate

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it could 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 ACETIC ACID SALICYLIC PANPHARMA is and what it is used for
• 2. What you need to know before you take ACETIC ACID SALICYLIC PANPHARMA
• 3. How to take ACETIC ACID SALICYLIC PANPHARMA
• 4. Possible side effects
• 5. How to store ACETIC ACID SALICYLIC PANPHARMA
• 6. Contents of the pack and other information

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

ACIDO ACETILSALICILICO PANPHARMA contains the active ingredient “acetylsalicylate of
lysine” 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 PANPHARMAis indicated for:
Treatment of acute pain caused by:

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

2. What you need to know before taking ACIDO ACETILSALICILICO PANPHARMA

Do not take ACIDO ACETILSALICILICO PANPHARMA

• If you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any medicine belonging to a category called “non-steroidal anti-inflammatory drugs” (NSAIDs), or to any component contained in them.
• If you have suffered from a disease called asthma or nasal polyps associated with asthma immediately after taking a medicine belonging to a category called “acetylsalicylates” or immediately after taking medicines with similar activity, especially if belonging to a category called “non-steroidal anti-inflammatory drugs”.
• 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, an injury to the wall of the stomach or the first part of the intestine (active, chronic or recurrent gastrointestinal ulcer), or if you have had bleeding or perforation of the stomach in the past after treatment with acetylsalicylic acid or with other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation, fever and pain.
• If you suffer from any disease that causes 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 heart failure, uncontrolled).
• If you are using a medicine called “methotrexate” used at doses > 15 mg/week, with other medicines that contain “acetylsalicylic acid” (see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”).
• If you are taking oral medicines that act on blood coagulation (oral anticoagulants) with medicines that contain “acetylsalicylic acid” and in patients who have had gastro-duodenal ulcers (see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”).
• If you suffer from a disease called “mastocytosis”, where the use of medicines based on “acetylsalicylic acid” can cause severe allergic reactions including circulatory shock with a sudden sensation of heat (hot flashes), low 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 that are used to reduce blood clotting.

The use of this medicine is contraindicated in children and adolescents under the age of 16.

Warnings and precautions
Take this medicine following exactly the instructions of your doctor or
pharmacist.
Consult your doctor or pharmacist before taking ACIDO ACETILSALICILICO
PANPHARMA:

• ACIDO ACETILSALICILICO PANPHARMA contains acetylsalicylic acid, if you are taking other medicines, check that acetylsalicylic acid is not present in the other medicines you are taking. If it is contained, to avoid any risk of overdose, the association 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 ones;
• 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, which affects red blood cells, as acetylsalicylic acid may lead to rupture of red blood cells (hemolysis) (see “Possible side effects”);
• if you have had injuries to 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: 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, ACIDO ACETILSALICILICO PANPHARMA is contraindicated (see “Do not take ACIDO ACETILSALICILICO PANPHARMA”);
• if you have heavy menstrual bleeding 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 suffered from these disorders, especially if you are elderly, if you have a low body weight, and if you are in

treatment with medicines that make the blood more fluid (anticoagulants or
platelet aggregation inhibitors) (see “Other medicines and ACIDO
ACETILSALICILICO PANPHARMA”) or if you have suffered in the past from a
gastrointestinal ulcer, particularly if complicated by bleeding or perforation. In
case of bleeding from the stomach or intestine (gastrointestinal bleeding), stop
treatment immediately;

• if you are to undergo surgery, even minor (e.g. tooth extraction), as the use of ACIDO ACETILSALICILICO PANPHARMA increases the risk of bleeding. The doctor will decide on a case-by-case basis whether to stop treatment before the operation. If you are taking high doses of ACIDO ACETILSALICILICO PANPHARMA for rheumatic diseases (anti-inflammatory doses), the doctor will subject you to checks, particularly important in children, especially at the beginning of treatment, for the possible onset of overdose disorders. In case of ringing in the ears, hearing difficulties or dizziness, the treatment methods must be re-evaluated by the 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 a severe inflammation of the joints (gout). The use of ACIDO ACETILSALICILICO PANPHARMA 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. The doctor will prescribe ACIDO ACETILSALICILICO PANPHARMA with caution if you have mild or moderate liver problems (mild and moderate hepatic insufficiency), and if you are using some medicines, for example to treat diabetes, for heartburn, some medicines to lower blood pressure and for inflammation (antidiabetics, antacids, diuretics, glucocorticoids) (see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”). If you have reduced blood flow to the kidney (renal hypoperfusion), other kidney diseases or reduced heart function (heart failure), the doctor will prescribe ACIDO ACETILSALICILICO PANPHARMA with caution or use another medicine (ACIDO ACETILSALICILICO PANPHARMA interferes with the synthesis of prostaglandins and their important intermediates). ACIDO ACETILSALICILICO PANPHARMA injectable cannot be considered a simple pain reliever (analgesic) and must be used under strict medical supervision. Furthermore, once the acute pain episode is over, it is prudent to switch to using the medicinal preparations for oral use (non-parenteral use), which, while causing qualitatively the same side effects, give fewer serious reactions.

Avoid using ACIDO ACETILSALICILICO PANPHARMA in combination with
levothyroxine (a medicine used to treat thyroid disorders)
(see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”). ACIDO
ACETILSALICILICO PANPHARMA can lead to an increase in the amount in
the blood of thyroid hormones, so the doctor will subject you to checks of the thyroid
hormones.
If you are taking ACIDO ACETILSALICILICO PANPHARMA with Nicorandil (a medicine
used to prevent or relieve chest pain due to heart problems)
may increase the risk of ulcer, perforation and gastrointestinal bleeding
(see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”).
In patients receiving the varicella vaccine, the use of acetylsalicylic acid
should be avoided for the 6 weeks following vaccination.

Children and adolescents
ACIDO ACETILSALICILICO PANPHARMA is contraindicated in children and
adolescents under the age of 16.
In children and adolescents with diseases caused by viruses (especially
varicella and influenza) who had taken acetylsalicylic acid, a
very rare and life-threatening disease has been observed, associated mainly with
damage to the nervous system and liver (Reye's syndrome). Consequently, acetyl
salicylic acid must be administered to children and adolescents in this
situation following the doctor's advice, only when other treatments
have failed. If, during treatment with acetylsalicylic acid, the child or
adolescent experiences persistent vomiting, loss of consciousness and an
abnormal behavior, the doctor will interrupt the treatment.
In children under 1 month of age, acetylsalicylic acid can only be administered
in specific situations and on the doctor's prescription.

Other medicines and ACIDO ACETILSALICILICO PANPHARMA
Inform your doctor or pharmacist if you are taking, have recently taken or
may take any other medicine.
The effects of ACIDO ACETILSALICILICO PANPHARMA 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 thin the blood (platelet aggregation inhibitors). The simultaneous use of different medicines that act 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
are using these medicines together with ACIDO ACETILSALICILICO PANPHARMA, the
doctor will subject you to checks.

Contraindicated associations (see “Do not takeACIDO ACETILSALICILICO
PANPHARMA ”):

• 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, particularly hematological toxicity (toxicity to blood cells).
• Medicines used to make the blood more fluid (oral anticoagulants) with medicines containing acetylsalicylic acid at active doses for the control of inflammation, pain and fever, in patients who have suffered from severe injuries to the stomach and a part of the intestine called “gastro-duodenal ulcers” because it increases the risk of severe blood loss (hemorrhage). Associations not recommended:
• Medicines to be taken by mouth to make the blood more fluid (oral anticoagulants, ticlopidine) with medicines containing acetylsalicylic acid (antipyretics) and in patients who suffer from or have suffered from a disease characterized by severe injuries to the stomach and a part of the intestine called (gastro-duodenal ulcer) because it increases the risk of blood loss (hemorrhage).
• Other non-steroidal anti-inflammatory drugs (NSAIDs), at anti-inflammatory doses or analgesic or antipyretic doses of acetylsalicylic acid: increased risk of ulcers and gastrointestinal bleeding.
• Low molecular weight heparins (and related molecules) and unfractionated heparins (medicines to make the blood more fluid) at therapeutic doses in elderly patients (> 64 years), regardless of the dose of heparin, 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 lesion of the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory or analgesic or antipyretic medicine must be administered.
• A medicine called Clopidogrel used to treat cardiovascular diseases with ACIDO ACETILSALICILICO PANPHARMA because it increases the risk of blood loss (hemorrhage). 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 if
administered with ACIDO ACETILSALICILICO PANPHARMA they decrease their
effectiveness and produce a decrease in the excretion of acetylsalicylic acid
and an increase in plasma levels.

• Glucocorticoids (with the exception of hydrocortisone), used for the treatment of inflammation with acetylsalicylic acid used at doses for the treatment of pain and fever, as they increase the risk of blood loss (hemorrhage).
• Pemetrexed (used for the therapy of some types of tumor), may increase the risk of pemetrexed toxicity. The doctor will monitor your clinical condition.
• Levothyroxine (used for the treatment of thyroid disorders): ACIDO ACETILSALICILICO PANPHARMA may change the amount of thyroid hormones in the blood, therefore the 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 (severe brain and liver disorders, especially in children) have occurred following the use of salicylates during varicella infection.
• Medicines against depression called “selective serotonin reuptake inhibitors” (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina) because they increase the risk of blood loss (hemorrhage), in particular of the upper digestive tract. Therefore, if possible, concomitant use should be avoided. Associations that require precautions for use:
• Medicines to increase urine production (diuretics), medicines used to lower blood pressure and belonging to the class called ACE inhibitors of angiotensin II receptor antagonists if administered together with ACIDO ACETILSALICILICO PANPHARMA may cause a reduction in kidney function (acute renal failure), especially in dehydrated patients, or a decrease in the ability to lower blood pressure (antihypertensive effect).
• Methotrexate (used to influence the body's defense system and in some tumors) at dosages less than or equal to 15 mg per week because if administered with ACIDO ACETILSALICILICO PANPHARMA it may determine an increase in the toxicity of methotrexate, in particular hematological toxicity. Blood cell count must be checked weekly during the first weeks of concomitant administration. The doctor will carefully monitor both patients with

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

• Methotrexate (used to influence the body's defense system and in some tumors) at doses greater than 15 mg if administered together with ACIDO ACETILSALICILICO PANPHARMA (for the reduction of blood coagulation) may determine an increase in the toxicity of methotrexate, in particular toxicity to the blood (hematological). Blood cell count must be checked weekly during the first weeks of simultaneous administration. A simultaneous intake of methotrexate and ACIDO ACETILSALICILICO PANPHARMA requires monitoring in both patients with kidney problems (even mild renal insufficiency), and in elderly patients.
• Clopidogrel (used for problems of reduced circulation to the heart called “acute coronary syndrome”) because if administered together with ACIDO ACETILSALICILICO PANPHARMA it may increase the risk of having blood loss (hemorrhage). In this case the doctor will monitor you carefully. Medicines for the stomach and intestines belonging to the class of “gastrointestinal topics”, “antacids” and adsorbents, including charcoal, because they decrease the gastrointestinal absorption of ACIDO ACETILSALICILICO PANPHARMA. It is recommended, if possible, to take gastrointestinal topics and antacids at least 2 hours apart from ACIDO ACETILSALICILICO 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 drugs increases the risk of bleeding. Therefore, in patients under 65 years of age, the co-administration of prophylactic doses of heparin (or related molecules), and acetylsalicylic acid, regardless of the 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 the dose of heparin, and for doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increased risk of bleeding (inhibition of platelet aggregation and lesion of the stomach and intestinal mucosa by acetylsalicylic acid).
• Medicines used to prevent the formation of blood clots (thrombolytics) because they increase the risk of bleeding.
• Medicines that reduce blood coagulation taken by mouth (oral anticoagulants) with doses of ACIDO ACETILSALICILICO PANPHARMA used to thin the blood because they increase the risk of bleeding, especially if you have already suffered from a gastrointestinal ulcer.
• Other non-steroidal anti-inflammatory drugs (NSAIDs) with ACIDO

ACETILSALICILICO PANPHARMA at the doses used to thin the blood,
because it increases the risk of severe injuries and blood loss at the level of
the stomach (ulcers and gastrointestinal bleeding).

• Acetazolamide (used to treat high blood pressure): if taken in conjunction with ACIDO ACETILSALICILICO PANPHARMA, there is a risk of vomiting, tachycardia (fast heartbeat), hyperpnea (rapid and deep breathing), mental confusion, fatigue, lethargy (extreme drowsiness), drowsiness, confusion, hyperchloremic metabolic acidosis (a condition characterized by an increase in the amount of acid in the blood).
• Drugs that are associated with a risk of bleeding: because the association with ACIDO ACETILSALICILICO PANPHARMA 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.
• Valproic acid (used for the treatment of epilepsy): ACIDO ACETILSALICILICO PANPHARMA if used with valproic acid-based drugs may lead to an increase in the amount of valproic acid in the blood. Therefore the doctor will subject you to checks of the levels of valproate in the blood.
• Tenofovir (used in the treatment of some viral infections): the use of ACIDO ACETILSALICILICO PANPHARMA with tenofovir may increase the probability of kidney problems (renal failure). Therefore the doctor will subject you to checks of kidney function.
• Insulin and sulfonylureas (medicines that lower blood sugar): the association with ACIDO ACETILSALICILICO PANPHARMA increases the risk of hypoglycemia (low blood sugar).
• Nicorandil (medicine used to prevent or alleviate chest pain due to heart problems): because if taken in conjunction with ACIDO ACETILSALICILICO PANPHARMA it may increase the risk of ulcer, perforation and gastrointestinal bleeding (see “Warnings and precautions”). ACIDO ACETILSALICILICO PANPHARMA may interact with:
• Medicines used after transplants such as: “cyclosporine” and “tacrolimus”; and other medicines that reduce rejection after transplants.
• Ibuprofen (used for inflammation): because it is possible that ibuprofen interferes with the blood-clotting prevention effects of low-dose acetylsalicylic acid (platelet aggregation).
• Metamizole, a medicine used against pain, because when taken in conjunction with acetylsalicylic acid it may reduce its effect on platelet aggregation. Therefore, the doctor will prescribe metamizole

with caution if you are taking low doses of acetylsalicylic acid for heart protection
(cardioprotection).

ACIDO ACETILSALICILICO PANPHARMA with alcohol
Alcohol may increase the risk of injury to the stomach and intestines and alter
tests for blood coagulation (prolongation of 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.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect 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 (after 24
weeks of gestation) (see ”Do not take ACIDO ACETILSALICILICO
PANPHARMA”).
ACIDO ACETILSALICILICO PANPHARMA may negatively affect pregnancy
and/or the fetal development of the child.
Results of epidemiological studies suggest an increased risk of abortion, heart malformation and having a defect in the abdominal wall (gastroschisis)
after the use of a medicine that has the same mode of action as ACIDO
ACETILSALICILICO PANPHARMA (inhibitor of prostaglandin synthesis), in the
early stages of pregnancy. The risk increases with the dose and duration of therapy.
Do not use ACIDO ACETILSALICILICO PANPHARMA during the first 24 weeks of
pregnancy, unless the doctor considers the use of ACIDO ACETILSALICILICO
PANPHARMA strictly necessary.
If you are a woman trying to conceive or during the first 24 weeks of
pregnancy, the doctor will keep the dose and duration of treatment as low as
possible.
After 24 weeks of pregnancy, all medicines that act like ACIDO
ACETILSALICILICO PANPHARMA (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);
• problems with the kidneys (renal dysfunction, which can progress to renal failure with oligo-hydramnios);
• 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. BreastfeedingAcetylsalicylic acid passes into breast milk. Do not use ACIDO ACETILSALICILICO PANPHARMA during breastfeeding to avoid adverse effects on the child (see “Special warnings”). FertilityThe administration of ACIDO ACETILSALICILICO PANPHARMA should be discontinued if you have fertility problems or are undergoing fertility investigations. ACIDO ACETILSALICILICO PANPHARMA may cause a reduction in fertility in women through an effect on ovulation. This effect is reversible once the use of the medicine is stopped.

Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery are known.

3. How to take ACIDO ACETILSALICILICO PANPHARMA

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

Adults
The recommended dose is:
from 1 to 4 vials per day, or as prescribed by your doctor, into a vein (intravenous route) or
into a muscle (intramuscular).
ACIDO ACETILSALICILICO PANPHARMA 500 mg: administered deep into a
muscle every 6-8 hours.
ACIDO ACETILSALICILICO PANPHARMA 1 g: in cases of severe and resistant pain, into a
vein every 6-12 hours.

Elderly patients
If you are elderly, your doctor will assess a possible reduction in the dose and administrations
compared to what is indicated above (adults).

If you take more ACIDO ACETILSALICILICO PANPHARMA than you should
In case of accidental ingestion/intake of an excessive dose of ACIDO
ACETILSALICILICO PANPHARMA, 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).
Overdose with this type of medicine, especially in small children, can
lead to a severe decrease in blood sugar levels (hypoglycemia) and
to potentially fatal poisoning.
With overdose of acetylsalicylic acid in the short and long term, an excess of fluids in the lungs (non-cardiogenic pulmonary edema) may occur
life-threatening.

Symptoms of overdose

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

If you forget to take ACIDO ACETILSALICILICO PANPHARMA
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, potentially fatal (the risk depends on the amount of medicine taken):
• in the urine and from the genitals,
• from the nose (epistaxis),
• from the gums,
• from inside the head (intracranial hemorrhage) which can lead to death, especially if you are elderly,
• of the stomach and intestines (occult or overt gastrointestinal hemorrhage - hematemesis, melena) resulting in iron deficiency anemia,
• 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 cause an increased risk of bleeding (hemorrhage) if you are to undergo surgery.
• Decreased number of platelets in the blood (thrombocytopenia).
• Rupture of red blood cells in the blood (hemolytic anemia) in people with a deficiency of a substance in the blood called glucose-6-phosphate dehydrogenase (G6PD), which can cause a particular hereditary disease affecting red blood cells.
• Decrease, even severe, in the number of blood cells (pancytopenia, bicytopenia, aplastic anemia, bone marrow failure, agranulocytosis, neutropenia, leukopenia).
• Allergic reactions (hypersensitivity, anaphylactic reactions, asthma, angioedema).
• Bronchospasm (contraction of the bronchial muscles) and asthma (inflammation and contraction of the bronchi).
• Headache, dizziness and lightheadedness, which can occur with high doses and long-term treatment. If you experience these symptoms, consult your doctor immediately to evaluate stopping treatment.
• Sounds in the ear (tinnitus) and deafness, which can occur with high doses and long-term treatment. If you experience these symptoms, consult your doctor immediately to evaluate stopping treatment.
• Abdominal pain.
• Difficulty digesting (dyspepsia).
• Bleeding of the stomach and intestines (gastrointestinal hemorrhage); nausea, inflammation and lesions of the esophagus mucosa (esophagitis and esophageal 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 may or may not be associated with bleeding and may occur with any dose of acetylsalicylic acid and in patients with or without predictive disorders and who have had or not had severe diseases of the stomach and intestines.
• Inflammation of the pancreas (acute pancreatitis) as a 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 manifest always in the same point (fixed eruptions).
• Reye's syndrome, a serious illness that mainly affects children and manifests with fever, flu, chickenpox, damage to the nervous system and liver (see “Warnings and precautions”).
• Pain and local skin reaction at the injection site (if it is an injection).
• Heart artery disorders of an allergic nature (Kounis syndrome) in the case of an allergic reaction to acetylsalicylic acid.
• Kidney disorders (renal failure).
• Increased fluid in the lungs (non-cardiogenic pulmonary edema) with prolonged use of the medicine, which can also occur in case of an allergic reaction to acetylsalicylic acid.
• Potentially fatal bleeding (severe blood loss, potentially life-threatening) and inflammation of the blood vessels (vasculitis including Schönlein-Henoch purpura).
• Presence of blood in the semen (hematospermia).
• Swelling due to fluid accumulation (edema) with high dose administration.

Reporting of side effects
If you experience any side effects, including those not listed in
this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store ACIDO ACETILSALICILICO PANPHARMA

Do not store at a temperature above 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package
after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to eliminate medicines that you no longer use. This will help to
protect the environment.

6. Package contents and other information

What ACIDO ACETILSALICILICO PANPHARMA contains
ACIDO ACETILSALICILICO PANPHARMA 500 mg

• The active ingredient is lysine acetylsalicylate. One vial contains 900 mg of lysine acetylsalicylate (corresponding to 500 mg of acetylsalicylic acid).
• The other ingredients are: glycocolla.
• One 2.5 ml solvent vial contains: water for injections. ACIDO ACETILSALICILICO PANPHARMA 1000 mg
• The active ingredient is lysine acetylsalicylate. One vial contains 1800 mg of lysine acetylsalicylate (corresponding to 1000 mg of acetylsalicylic acid).
• The other ingredients are: glycocolla.
• One 5 ml solvent vial contains: water for injections.

Description of the appearance of ACIDO ACETILSALICILICO PANPHARMA and package contents
ACIDO ACETILSALICILICO PANPHARMA is presented in powder and solvent
form for injectable solution:

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

Marketing authorisation 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 doctors or
healthcare professionals:
The product can be diluted in physiological, glucosated, isoeletrolyte,
dextran, Ringer's and Darrow solutions and administered by fleboclisis.
In preanaesthesiaand in premedicationduring endoscopic and
arteriographic examinations, the product can be associated with atropine (two 500 mg
vials or one 1000 mg vial and 0.25 mg of atropine injected simultaneously
intravenously).

ACIDO ACETILSALICILICO PANPHARMA 1000 mg powder for oral solution

lysine acetylsalicylate

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 pass it on to others, even if their symptoms are the same as yours, as it could 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 ACIDO ACETILSALICILICO PANPHARMA is and what it is used for
• 2. What you need to know before you take ACIDO ACETILSALICILICO PANPHARMA
• 3. How to take ACIDO ACETILSALICILICO PANPHARMA
• 4. Possible side effects
• 5. How to store ACIDO ACETILSALICILICO 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 ingredient “acetilsalicilato di
lisina” 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:

• pains of any nature and severity;
• joint, tendon, muscle, bone disorders (acute rheumatic arthritis) and its complications;
• joint diseases (degenerative arthropathies);
• muscle pain (myalgia).

2. What you need to know before taking ACIDO ACETILSALICILICO PANPHARMA

Do not take ACIDO ACETILSALICILICO PANPHARMA

• If you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any medicine belonging to a category called “non-steroidal anti-inflammatory drugs” (NSAIDs) or to any component contained in them.
• If you have suffered from a disease called asthma or nasal polyps associated with asthma immediately after taking a medicine belonging to a category called “acetylsalicylates” or immediately after taking medicines with similar activity, especially if belonging to a category called “non-steroidal anti-inflammatory drugs”.
• 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, an injury to the wall of the stomach or the first part of the intestine (active, chronic or recurrent gastrointestinal ulcer), or if you have had in the past a hemorrhage or perforation of the stomach after treatment with acetylsalicylic acid or with other drugs called non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation, fever and pain.
• If you suffer from any disease that causes blood loss (bleeding disorder).
• If you are a person at risk of bleeding (hemorrhagic 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 heart failure, uncontrolled).
• If you are using a medicine called “methotrexate” used at doses > 15 mg/week, with other medicines that contain “acetylsalicylic acid” (see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”).
• If you are taking orally medicines that act on blood coagulation (oral anticoagulants) with medicines that contain “acetylsalicylic acid”, in patients who have had ulcers in the stomach and intestines (gastro-duodenal ulcers; see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”).
• If you suffer from a disease called “mastocytosis”, where the use of medicines based on “acetylsalicylic acid” can cause severe allergic reactions, which include shock with a sudden feeling of heat (hot flashes), lowering of blood pressure (hypotension), increased heart rate (tachycardia) and vomiting. Do not use this medicine if you suffer from allergies (hypersensitivity) to salicylates, if you take medicines that increase urine production (intensive diuretic therapy), if you suffer from a predisposition to bleeding (hemorrhagic diathesis) or if you take medicines that thin the blood.

The use of this medicine is contraindicated in children and adolescents under the age of 16.

Warnings and precautions
Take this medicine following exactly the instructions of your doctor or
pharmacist.
Consult your doctor or pharmacist before taking ACIDO ACETILSALICILICO
PANPHARMA:

• ACIDO ACETILSALICILICO 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 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 more than one analgesic medicine, because you may have kidney problems, even serious ones;
• 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 acetylsalicylic acid may lead to red blood cell breakdown (hemolysis) (see “Possible side effects”);
• if you have had injuries to 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: 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, ACIDO ACETILSALICILICO PANPHARMA is contraindicated (see “Do not take ACIDO ACETILSALICILICO PANPHARMA”);
• if you suffer from asthma or are predisposed to it, you may have difficulty breathing (bronchospasm) 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 bleeding or injuries (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 suffered from these disorders, especially if you are elderly, if you have a low body weight and if you are being treated with medicines that thin the blood (anticoagulants or antiplatelet agents) (see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”) 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 (e.g. tooth extraction), as the use of ACIDO ACETILSALICILICO PANPHARMA increases the risk of bleeding. The doctor will decide on a case-by-case basis whether to interrupt treatment before the operation. If you are taking high doses of ACIDO ACETILSALICILICO PANPHARMA for rheumatic diseases (anti-inflammatory doses), the doctor will subject you to checks, particularly important in children, especially at the beginning of treatment, for the possible onset of overdose disorders. In case of ringing in the ears, hearing difficulties or dizziness, the treatment modalities must be re-evaluated by the doctor. Acetylsalicylic acid can interfere with the elimination of uric acid: high doses can increase the elimination of uric acid (uricosuric effect) while very low doses can reduce its elimination; therefore the medicine is not recommended for people suffering from a severe inflammation of the joints (gout). The use of ACIDO ACETILSALICILICO PANPHARMA 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 use this medicine only after consulting your doctor. If during treatment you should experience prolonged vomiting and deep drowsiness, the doctor will ask you to stop taking it. If you experience ringing in the ears, difficulty hearing or dizziness, the doctor must review the treatment modalities. Avoid using ACIDO ACETILSALICILICO PANPHARMA in combination with levothyroxine (used for the treatment of thyroid disorders) (see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”). ACIDO ACETILSALICILICO PANPHARMA can lead to an increase in the amount of thyroid hormones in the blood, so the doctor will subject you to checks of thyroid hormones.

If you take ACIDO ACETILSALICILICO PANPHARMA with Nicorandil (a medicine
used to prevent or relieve chest pain due to heart problems)
may increase the risk of gastric ulcer, perforation and bleeding
(see “Other medicines and ACIDO ACETILSALICILICO PANPHARMA”).
In patients receiving the varicella vaccine, the use of acetylsalicylic acid
should be avoided for the 6 weeks following vaccination.

Children and adolescents
ACIDO ACETILSALICILICO PANPHARMA is contraindicated in children and
adolescents under the age of 16.
In children and adolescents with diseases caused by viruses (in particular
varicella and influenza) who have taken acetylsalicylic acid, a very rare and life-threatening disease has been observed, associated mainly with damage to
the nervous system and liver (Reye's syndrome). Consequently, acetylsalicylic
acid must be administered to children and adolescents in this
situation following the advice of the doctor, only when other treatments
have failed.
If the child or adolescent develops persistent vomiting, loss of consciousness and abnormal behavior
during treatment with acetylsalicylic acid, the doctor will stop the treatment.
The doctor will monitor children treated, especially at the beginning of therapy.
In infants under 1 month of age, acetylsalicylic acid can only be administered
in specific situations and on the doctor's prescription.
The powder for oral solution sachets of 1 g are not suitable for use in children
weighing less than 50 kg.

Other medicines and ACIDO ACETILSALICILICO PANPHARMA
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
The effects of ACIDO ACETILSALICILICO PANPHARMA can be influenced by or
influence the following medicines.

• Abciximab, acetylsalicylic acid, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost trometamol, ticlopidine and tirofiban, as these medicines thin the blood (platelet aggregation inhibitors). The simultaneous use of different medicines that make the blood more fluid (heparin or similar substances, medicines called oral anticoagulants or with other medicines called thrombolytics, used to prevent blood clots) increases the risk of bleeding. If you are using these medicines together with ACIDO ACETILSALICILICO PANPHARMA, your doctor will subject you to checks.

Contraindicated associations (see “Do not take ACIDO ACETILSALICILICO

PANPHARMA”):

• 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, particularly toxicity to blood cells (hematology).
• Medicines used to make the blood more fluid (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 part of the intestine called "gastro-duodenal ulcers" because it increases the risk of severe blood loss (hemorrhage). Not recommended associations:
• Medicines to be taken by mouth to make the blood more fluid (oral anticoagulants, ticlopidine) with medicines containing acetylsalicylic acid (antipyretics) and in patients who suffer from or have suffered from a disease characterized by serious injuries to the stomach and part of the intestine called a gastro-duodenal ulcer because it increases the risk of blood loss (hemorrhage).
• Other non-steroidal anti-inflammatory drugs (NSAIDs), at anti-inflammatory doses or at analgesic or antipyretic doses (against pain and fever) of acetylsalicylic acid: increased risk of ulcers and gastrointestinal bleeding.
• Low molecular weight heparins (and similar molecules) and unfractionated heparins (medicines to make the blood more fluid) at therapeutic doses in elderly patients (> 64 years), regardless of the dose of heparin, 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 lesion of the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory medicine or another analgesic or antipyretic must be administered.
• A medicine called Clopidogrel used to treat cardiovascular diseases with ACIDO ACETILSALICILICO PANPHARMA because it increases the risk of blood loss (hemorrhage). 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 ACIDO ACETILSALICILICO PANPHARMA they decrease the
their effectiveness and produce a decrease in the excretion of acetylsalicylic
acid and an increase in plasma levels.

• Glucocorticoids (with the exception of hydrocortisone), used for the treatment of inflammation, with acetylsalicylic acid used at doses for the treatment of pain and fever, as the association increases the risk of blood loss (hemorrhage).
• Pemetrexed (used for the therapy of some types of tumor): ACIDO ACETILSALICILICO PANPHARMA may increase the risk of pemetrexed toxicity. The doctor will check your clinical condition.
• Levothyroxine (used for the treatment of thyroid disorders): ACIDO ACETILSALICILICO PANPHARMA may change 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 disorders of the brain and liver, especially in children) have occurred following the use of salicylates during varicella infection.
• Medicines against depression called "selective serotonin reuptake inhibitors" (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina) because they increase the risk of blood loss (hemorrhage), in particular of the upper digestive tract. Therefore, if possible, concomitant use should be avoided. Associations that require precautions for use:
• Medicines to increase urine production (diuretics), medicines used to lower blood pressure and belonging to the classes called ACE inhibitors and angiotensin II receptor antagonists, if administered together with ACIDO ACETILSALICILICO PANPHARMA, as a reduction in kidney function (acute renal failure) may occur, especially in dehydrated patients, or a decrease in the ability to lower blood pressure (antihypertensive effect).
• Methotrexate (used to influence the body's defense system and in some tumors) at dosages less than or equal to 15 mg per week because if administered with ACIDO ACETILSALICILICO PANPHARMA it may determine an increase in the toxicity of methotrexate, in particular toxicity in the blood (hematological). The blood cell count must be checked weekly during the first weeks of concomitant administration. The doctor will carefully monitor both

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

• Methotrexate (used to influence the body's defense system and in some tumors) at doses greater than 15 mg if administered together with ACIDO ACETILSALICILICO PANPHARMA (to thin the blood) may determine an increase in the toxicity of methotrexate, in particular toxicity in the blood (hematological). The doctor will have you undergo blood tests (blood cell count) weekly during the first weeks of simultaneous administration. The doctor will carefully monitor both patients with kidney problems (even mild renal insufficiency) and elderly patients.
• Clopidogrel (used for problems of reduced circulation to the heart called "acute coronary syndrome") because if administered together with ACIDO ACETILSALICILICO PANPHARMA it may increase the risk of having blood loss (hemorrhage). In this case the doctor will monitor you carefully.
• Medicines for the stomach and intestines belonging to the class of "gastrointestinal topics", "antacids" and adsorbents, including charcoal: because they decrease the gastrointestinal absorption of ACIDO ACETILSALICILICO PANPHARMA. It is recommended, if possible, to take gastrointestinal topics and antacids at least 2 hours away from ACIDO ACETILSALICILICO PANPHARMA.
• Low molecular weight heparins (and similar molecules) and unfractionated heparins, at prophylactic doses in patients under 65 years of age: the co-administration of these drugs increases the risk of bleeding. Therefore, in patients under 65 years of age, the co-administration of prophylactic doses of heparin (or similar molecules) and acetylsalicylic acid, regardless of the dose, must be carefully monitored.
• Low molecular weight heparins (and similar molecules) and unfractionated heparins at therapeutic doses or in elderly patients (> 64 years), regardless of the dose of heparin, and for doses of acetylsalicylic acid used for inhibition of platelet aggregation: increased risk of bleeding (inhibition of platelet aggregation and lesion of the stomach and intestinal mucosa by acetylsalicylic acid).
• Medicines used to prevent the formation of blood clots (thrombolytics) because they increase the risk of bleeding.
• Medicines that decrease blood coagulation taken by mouth (oral anticoagulants) with doses of ACIDO ACETILSALICILICO PANPHARMA used to thin the blood, because they increase the risk of

bleeding, especially if you have already suffered from a gastrointestinal
ulcer.

• Other non-steroidal anti-inflammatory drugs (NSAIDs) with ACIDO ACETILSALICILICO PANPHARMA at the doses used to thin the blood, because it increases the risk of serious injuries and blood loss at the level of the stomach (ulcers and gastrointestinal bleeding).
• Acetazolamide (used to treat high blood pressure): if taken in conjunction with ACIDO ACETILSALICILICO PANPHARMA, there is a risk of vomiting, tachycardia (fast heartbeat), hyperpnea (rapid and deep breathing), mental confusion, fatigue, lethargy (extreme sleepiness), drowsiness, confusion, hyperchloremic metabolic acidosis (a condition characterized by an increase in the amount of acid in the blood).
• Drugs that are associated with a risk of bleeding: because the association with ACIDO ACETILSALICILICO PANPHARMA 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.
• Valproic acid (used for the treatment of epilepsy): ACIDO ACETILSALICILICO PANPHARMA if used with valproic acid-based drugs may lead to an increase in the amount of valproic acid in the blood. Therefore, the doctor will subject you to checks of valproate levels in the blood.
• Tenofovir (used in the treatment of some viral infections): the use of ACIDO ACETILSALICILICO PANPHARMA with tenofovir may increase the probability of kidney problems (renal failure). Therefore, the doctor will subject you to checks of kidney function.
• Insulin and sulfonylureas (medicines that reduce blood sugar): the association with ACIDO ACETILSALICILICO PANPHARMA increases the risk of hypoglycemia (low blood sugar).
• Nicorandil (medicine used to prevent or alleviate chest pain due to heart problems): because if taken in conjunction with ACIDO ACETILSALICILICO PANPHARMA it may increase the risk of ulcer, perforation and gastrointestinal bleeding (see "Warnings and precautions"). ACIDO ACETILSALICILICO PANPHARMA may interact with:
• Medicines used after transplants such as: "cyclosporine" and "tacrolimus" and other medicines that reduce rejection after transplants.
• Ibuprofen (used for inflammation): because it is possible that ibuprofen interferes with the blood-clotting prevention effects of low-dose acetylsalicylic acid (platelet aggregation).
• Metamizole, a medicine used against pain, because, when taken in conjunction with acetylsalicylic acid, it may reduce its effect on platelet aggregation. Therefore, the doctor will prescribe metamizole with caution if you are taking low doses of acetylsalicylic acid for heart protection (cardioprotection).

ACIDO ACETILSALICILICO PANPHARMA with alcohol
Alcohol may increase the risk of injury to the stomach and intestines and alter
tests for blood coagulation (prolongation of 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.

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

Pregnancy
This medicine is contraindicated in the third trimester of pregnancy (over 24
weeks of gestation) (see ”Do not take ACIDO ACETILSALICILICO
PANPHARMA”).
ACIDO ACETILSALICILICO PANPHARMA may negatively affect pregnancy
and/or the development of the baby.
Do not use ACIDO ACETILSALICILICO PANPHARMA during the first 24 weeks of
pregnancy, unless your doctor considers the use of ACIDO ACETILSALICILICO
PANPHARMA strictly necessary.
If you are a woman planning 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 ACIDO
ACETILSALICILICO PANPHARMA (prostaglandin synthesis inhibitors) can
expose the fetus to:

• Problems for the heart and lungs (with premature closure of the ductus arteriosus and pulmonary hypertension).
• Kidney problems (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 may also occur after the administration of very low doses of acetylsalicylic acid,
• blockage of uterine contractions resulting in delayed or prolonged labor. BreastfeedingAcetylsalicylic acid passes into breast milk. Do not use ACIDO ACETILSALICILICO PANPHARMA during breastfeeding to avoid adverse effects on the baby (see “Special warnings”). FertilityThe administration of ACIDO ACETILSALICILICO PANPHARMA should be stopped if you have fertility problems or are undergoing fertility investigations. ACIDO ACETILSALICILICO PANPHARMA may cause a decrease in fertility in women through an effect on ovulation. This effect is reversible once use of the medicine is stopped.

Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery have been reported.

ACIDO ACETILSALICILICO PANPHARMA contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them
before taking this medicine.

3. How to take ACIDO ACETILSALICILICO PANPHARMA

Take this medicine following exactly the instructions of your doctor or
pharmacist. If you have 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 a
day.
The doctor may decide to modify the recommended dose if he/she deems it
necessary.

Elderly patients
If you are elderly, your doctor will assess a possible reduction of the dose and administrations compared to what is indicated above (adults).
Pour the contents of the sachet into a glass, add water, stir for a few
seconds and drink.
The intake of ACIDO ACETILSALICILICO PANPHARMA sachets must be taken with a
full stomach, particularly if your doctor has prescribed ACIDO
ACETILSALICILICO PANPHARMA at high doses and for a prolonged period.

If you take more ACIDO ACETILSALICILICO PANPHARMA than you should
In case of accidental ingestion/intake of an excessive dose of ACIDO
ACETILSALICILICO PANPHARMA, immediately inform your doctor or go to the nearest
hospital.
For acetylsalicylic acid, toxic doses are between 200 mg/kg and 300 mg/kg
if taken orally.
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).
Overdose with this type of medicine, especially in young children, can
lead to a severe decrease in blood sugar levels (hypoglycemia) and
potentially fatal poisoning.
With an overdose of acetylsalicylic acid in the short and long term, an
excess of fluid in the lungs (non-cardiogenic pulmonary edema) may occur
which is life-threatening.

Symptoms of overdose

• Moderate poisoning: ringing in the ears, sensation of hearing loss, headache, dizziness, vertigo, confusion and nausea are indicative of overdose and can be controlled by a dose reduction.
• Severe poisoning: fever, rapid breathing (hyperventilation), change in blood acidity (ketosis, respiratory alkalosis, metabolic acidosis), coma, cardiovascular collapse, breathing difficulties (respiratory failure), severe reduction in blood sugar (severe hypoglycemia).

If you forget to take ACIDO ACETILSALICILICO PANPHARMA
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not 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, potentially fatal (the risk depends on the amount of medicine taken):
• in the urine and from the genitals,
• from the nose (epistaxis),
• from the gums,
• from inside the head (intracranial hemorrhage) which can lead to death, especially if elderly,
• of the stomach and intestines (occult or overt gastrointestinal hemorrhage - hematemesis, melena) resulting in iron deficiency anemia,
• bruising.
• Red spots on the skin due to bleeding (purpura).
• Alteration of blood coagulation tests (prolongation of bleeding time). The risk of bleeding may persist for 4-8 days after stopping acetylsalicylic acid. This may cause an increased risk of bleeding (hemorrhage) if you are to undergo surgery.
• Decreased number of platelets in the blood (thrombocytopenia).
• Breakage of red blood cells in the blood (hemolytic anemia) in people with a deficiency of a substance present in the blood called glucose-6-phosphate dehydrogenase (G6PD), which can cause a particular hereditary disease affecting red blood cells.
• Decrease, even severe, in the number of blood cells (pancytopenia, bicytopenia, aplastic anemia, bone marrow failure, agranulocytosis, neutropenia, leukopenia).
• Allergic reactions (hypersensitivity, anaphylactic reactions, asthma, angioedema).
• Bronchospasm (contraction of the bronchial muscles) and asthma (inflammation and contraction of the bronchi).
• Headache, dizziness, and lightheadedness, which can occur with high doses and long-term treatment. If you experience these symptoms, consult your doctor immediately to evaluate stopping treatment.
• Sounds in the ear (tinnitus) and deafness, which can occur with high doses and long-term treatment. If you experience these symptoms, consult your doctor immediately to evaluate stopping treatment.
• Abdominal pain.
• Difficulty digesting (dyspepsia).
• Bleeding of the stomach and intestines (gastrointestinal hemorrhage); nausea, inflammation and lesions of the esophagus mucosa (esophagitis and esophageal 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 tract

gastrointestinal. These reactions may be associated or not with bleeding;
furthermore, they may occur with any dose of acetylsalicylic acid and in
patients with or without predictive disorders and who have or have not had serious
diseases of the stomach and intestines.

• Inflammation of the pancreas (acute pancreatitis) as an allergic reaction (hypersensitivity) to acetylsalicylic acid.
• Disorders and inflammation of the liver (chronic hepatitis), with increased blood tests affecting the liver (increased liver enzymes).
• Hives and other skin irritations that appear always in the same place (fixed eruptions).
• Reye's syndrome, a serious illness that primarily affects children and manifests with fever, flu, chickenpox, damage to the nervous system and liver (see “Warnings and precautions”).
• Disorders of the heart arteries of an allergic nature (Kounis syndrome) in the event of an allergic reaction to acetylsalicylic acid.
• Kidney disorders (renal failure).
• Fluid buildup in the lungs (non-cardiogenic pulmonary edema) with prolonged use of the medicine, which can also occur in case of allergy 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 the semen (hematospermia).
• Swelling due to fluid accumulation (edema) with high-dose administration.

Reporting of side effects
If you experience any side effects, including those not listed in
this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store ACIDO ACETILSALICILICO PANPHARMA

Store in the original packaging at a temperature not exceeding 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package
after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to eliminate medicines that you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What ACIDO ACETILSALICILICO PANPHARMA 1000 mg powder for
oral solution contains

• The active ingredient is lysine acetylsalicylate. Each sachet contains lysine acetylsalicylate 1800 mg (equivalent to 1000 mg of acetylsalicylic acid).
• The excipients are: glycocol, mandarin aroma (lactose, maltodextrins, gum arabic, E320) and ammonium glycyrrhizate.

Description of the appearance of ACIDO ACETILSALICILICO PANPHARMA 1000 mg
powder for oral solution and contents of the pack
ACIDO ACETILSALICILICO PANPHARMA is presented in the form of 1000 mg powder for
oral solution in a box containing 10 sachets or 20 sachets.

Marketing Authorisation 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