Product Information for the Patient

Inyesprin 900 mg Powder for Injection and Infusion

Acetylsalicylic acid lysine

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Inyesprin and how is it used

2. What you need to know before Inyesprin is administered

3. How to take Inyesprin

4. Possible adverse effects

5. Storage of Inyesprin

6. Contents of the package and additional information

Aspirinbelongs to a group of medications, derived from salicylic acid, used for the treatment of pain and fever.

Aspirin is indicated for:

• Rheumatic pains, neuralgic pains, post-traumatic pains, post-operative pains, postpartum pains, and neoplastic pains.
• Prevention and treatment of thromboembolic disease.
• Fever of any cause.

Do not use this medication

• If you are allergic to acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, or tartrazine (food coloring), or to any of the other components of this medication (listed in section 6).
• If you are under 16 years old, unless specifically prescribed by a doctor, as the use of acetylsalicylic acid is associated with the development of Reye's syndrome, a rare but serious disease.
• If you have an active, chronic, or recurrent peptic ulcer.
• If you have asthma and/or nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid, acetylsalicylates, or similar substances, especially nonsteroidal anti-inflammatory drugs.
• If you have any bleeding disorder.
• If you are at risk of bleeding.
• If you have hemophilia or other coagulation disorders.
• If you have severe kidney and/or liver disease (severe renal and/or hepatic insufficiency).
• If you have severe heart disease (uncontrolled severe heart failure).
• If you have a history of gastric or duodenal ulcer and are taking anticoagulant medications and are prescribed acetylsalicylic acid to treat inflammation, pain, or fever.
• If you are taking 15 mg or more of methotrexate per week, a medication used to treat certain cancers, rheumatoid arthritis, and/or psoriasis, and are prescribed acetylsalicylic acid to treat inflammation, pain, or fever.
• If you are more than 24 weeks pregnant (see "Pregnancy" section).

If you are unsure whether to start taking this medication, consult your doctor.

Adverse reactions and precautionsConsult your doctor or pharmacist before starting to useAspirin:

• If you have a type of anemia caused by a genetic disorder due to a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).
• If you have kidney and/or liver insufficiency.
• If you have asthma, as the onset of an asthma attack in some patients may be related to an allergy to nonsteroidal anti-inflammatory drugs or acetylsalicylic acid, and in this case, this medication would be contraindicated (see "Do not use this medication" section).
• If you have heavy uterine bleeding, any menstrual alteration, or if you are using an intrauterine device (IUD).

• If you have a history of gastric or duodenal ulcer, gastrointestinal bleeding, or gastritis.
• Bleeding, ulcers, or perforation may occur at any time during treatment, even without previous symptoms or history. The risk of this occurring is higher in older patients, individuals with low body weight, or patients taking anticoagulant medications. In the event of gastrointestinal bleeding, treatment should be immediately discontinued.

• If you have or have had rhinitis or urticaria.
• If you have hypertension (elevated blood pressure).

• Before any surgical interventions (e.g., tooth extraction), inform your doctor or dentist that you are using this medication, as there is a risk of bleeding and it is recommended to discontinue its administration one week before the intervention.
• If you are prone to gout, note that low-dose acetylsalicylic acid reduces the excretion of uric acid in the urine and may trigger a gout attack.
• Reye's syndrome is a rare but potentially fatal disease that has been observed in children and adolescents with signs of viral infection (particularly chickenpox and flu-like episodes) taking acetylsalicylic acid. Consequently, acetylsalicylic acid should only be administered to children and adolescents in this situation following medical advice, when other measures have failed. In the event of persistent vomiting, altered consciousness, or abnormal behavior, treatment should be discontinued.
• The continued use of pain medications may cause headaches. If this occurs, consult your doctor.
• The habitual use of pain medications, especially when used in combination, may cause permanent kidney damage, with a risk of renal insufficiency.
• When using this medication with other medications, it should be ruled out that acetylsalicylic acid is part of the composition of these medications, in order to avoid any risk of overdose.
• If you start experiencing ringing in the ears, hearing loss, or dizziness during treatment, you should immediately consult your doctor, as these may be signs of overdose. In children, the doctor will perform blood tests, especially at the beginning of treatment.
• Consult your doctor again if the pain persists for more than 10 days, fever for more than 3 days, or worsens or new symptoms appear.
• If you are taking medications that may increase the risk of bleeding (corticosteroids, anti-inflammatory drugs, a type of antidepressant called selective serotonin reuptake inhibitors, antiplatelet agents, or anticoagulants). In these cases, consult your doctor, who will decide whether you can use Aspirin with these medications. Discontinue treatment and immediately see your doctor if your stools become black and viscous, you vomit blood, your blood pressure drops, you experience cold sweats, abdominal pain, or dizziness.
• This medication should not be used intravenously in children.
• This medication should not be used during breastfeeding (see "Breastfeeding" section).

Interference with diagnostic tests

Inform your doctor that you are using Aspirin, as it may alter the results of any diagnostic tests.

Children and adolescents

This medication should not be used intravenously in children.

Reye's syndrome is a rare but potentially fatal disease that has been observed in children and adolescents with signs of viral infection (particularly chickenpox and flu-like episodes) taking acetylsalicylic acid. Consequently, acetylsalicylic acid should only be administered to children and adolescents in this situation following medical advice, when other measures have failed. In the event of persistent vomiting, altered consciousness, or abnormal behavior, treatment should be discontinued.

In children under 1 month, the administration of acetylsalicylic acid is only justified in certain situations and under medical prescription.

In children, it is recommended to monitor salicylate levels, especially at the beginning of treatment.

Use in elderly patients

Caution is recommended in elderly patients, especially those with kidney insufficiency or low albumin levels in the blood, as there is a risk of elevated toxicity.

Other medications and Aspirin

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Certain medications may interact with Aspirin, in which case it may be necessary to change the dose or discontinue treatment with one of the medications.

It is essential to inform your doctor if you are undergoing any of the following treatments:

• Treatment with medications containing methotrexate (used to treat cancer, rheumatoid arthritis, and/or psoriasis).
• Treatment with medications for blood circulation (oral anticoagulants, heparins, clopidogrel, ticlopidine, thrombolytics).
• Treatment with other medications that reduce pain and inflammation (nonsteroidal anti-inflammatory drugs such as indomethacin, fenoprofen, naproxen, flurbiprofen, ibuprofen, diclofenac, and piroxicam).
• Treatment with corticosteroids.
• Treatment with pemetrexed (used to treat certain types of cancer).
• Treatment with certain medications used to treat gout (benzbromarone, probenecid, sulfinpyrazone).
• Treatment with certain medications used to lower blood pressure (diuretics, angiotensin-converting enzyme inhibitors, angiotensin II antagonists).
• Treatment with medications for the stomach, such as topical gastrointestinals, antacids, and activated charcoal.
• Treatment with a type of antidepressant called selective serotonin reuptake inhibitors.
• Treatment with cimetidine and ranitidine (used to treat stomach acid).
• Treatment with medications used to treat epilepsy (phenytoin and valproic acid).
• Treatment with medications used to lower blood sugar levels (oral hypoglycemics or insulin).
• Treatment with antibiotics such as vancomycin or sulfonamides.
• Treatment with zidovudine (used to treat HIV infection).
• Treatment with digoxin (heart medication).
• Treatment with lithium (for depression).
• Treatment with barbiturates (used for sleep problems, such as sedatives and anticonvulsants).
• Treatment with other medications with antiplatelet properties, such as tirofiban, epithelbatide, epoprostenol, abciximab, acetylsalicylic acid, iloprost, and iloprost trometamol.

Use of Aspirin with alcohol

You should not consume alcohol during treatment with Aspirin, as the use of acetylsalicylic acid in patients who regularly consume alcohol (three or more alcoholic beverages per day) may cause gastric bleeding.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

During the first and second trimesters of pregnancy, Aspirin should not be administered unless it is strictly necessary and the doctor considers it necessary.

The use of Aspirin is contraindicated from 24 weeks of pregnancy (third trimester).

Breastfeeding

Aspirin is not recommended during breastfeeding due to its excretion in breast milk.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been observed.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of treatment with Inyesprin.

The administration can be performed by deep intramuscular injection, direct intravenous injection, dissolving the contents of the vial in 5 ml of injectable water, or in perfusion in neutral solutions.

It is recommended to avoid mixing this medication with other injectable specialties in the same syringe.

The recommended dose is:

Adults:it is recommended to administer one vial1 to3 times a day. Maximum 4 vials/day.

NChildren::the recommended dose is20 to50 mg/Kg/day.

This medication should not be used by intravenous injection in children.

Remember to take your medication.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you use more Inyesprin than you should

If you have used more Inyesprin than you should, consult your doctor or pharmacist immediately.

The symptoms of moderate poisoning are: buzzing in the ears, hearing disturbances, headache, and dizziness.

In case of severe poisoning, the following may appear: fever, increased respiratory rate, metabolic disturbances in the blood, coma, cardiovascular collapse, respiratory insufficiency, and a very marked decrease in blood sugar levels.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 0420. Also, inform your doctor immediately. Bring this leaflet with you.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The frequency of adverse reactions cannot be estimated based on available data.

Blood and lymphatic system disorders

Bleeding syndromes (nosebleeds, gum bleeding,appearance of purple spots on the skin, etc.) with an increase in bleeding time. The risk of bleeding may persist for 4-8 days after stopping acetylsalicylic acid, which may increase the risk of bleeding during surgery. It may also cause gastrointestinal and intracranial bleeding.

Immune system disorders

Hypersensitivity reactions, anaphylactic reactions (generalized allergic reaction, potentially severe), asthma, angioedema (severe allergic reaction with sudden onset of swelling, skin rash, and difficulty breathing).

Nervous system disorders

Headache, dizziness, sensation of hearing loss,ringing in the ears, which are usually indicative of an overdose.

Intracranial hemorrhage.

Gastrointestinal disorders

Abdominal pain

Occult or overt gastrointestinal bleeding (vomiting or stools with blood) leading to iron deficiency anemia. The risk of bleeding depends on the dose. Gastric ulcers and perforations.

Hepatobiliary disorders

Elevation of liver enzymes (indicators of liver function), liver damage.

Skin and subcutaneous tissue disorders

Urticaria, skin reactions.

General disorders and administration site conditions

Reye's syndrome (see “Warnings and precautions”),pain and local skin reactions at the injection site.

If you notice the appearance of:

• Abdominal discomfort, gastric or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unexpected changes in urine quantity or appearance.
• Swelling of the face, feet, or legs.

Stop taking the medication and consult your doctor immediately, as they may indicate the onset of adverse effects that require urgent medical attention.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and vial after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Inyesprin

• The active ingredient is lysine acetylsalicylate. Each vial contains 900 mg of lysine acetylsalicylate (equivalent to 500 mg of acetylsalicylic acid).

After reconstitution with 5 ml of injectable water, each ml of the solution contains 180 mg of lysine acetylsalicylate.

• The other components are glycine.

Appearance of the product and contents of the package

Inyesprin 900 mg powder for injectable solution is presented in the form of white or light yellow powder in containers containing 100 vials.

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Last review date of this leaflet: September 2021.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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This information is intended solely for Healthcare Professionals:

Please consult the Technical Dossier (TD) of the product for additional information.

Instructions for use and handling

Inyesprin must be prepared for administration by or under the direct supervision of a pharmacist who is familiar with its properties and safe handling requirements.

Preparation of the Inyesprin solution

Extemporaneously dissolve the contents of the vial in 5 ml of injectable water. Administration can be made by IM deep injection, IV direct injection, or IV infusion with the help of a diluent (sodium chloride solution, glucose, or sorbitol).

It is recommended to avoid mixing this medication with other injectable specialties in the same syringe.

The elimination of unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations.

Please refer to the TD for administration instructions for Inyesprin.