INYESPRIN 900 MG POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

2. What you need to know before you are given Inyesprin

Do not use this medicine

• If you are allergic to acetylsalicylic acid, non-steroidal anti-inflammatory drugs, or tartrazine (food coloring), or to any of the other components of this medicine (listed in section 6).
• If you are under 16 years old, unless explicitly prescribed by a doctor, as the use of lysine acetylsalicylate is related to the onset of Reye's syndrome, a very rare but serious disease.
• In case of active, chronic, or recurrent peptic ulcer.
• In case of asthma and/or nasal polyps associated with asthma that are induced or worsened by acetylsalicylic acid, acetylsalicylates, or substances with similar activity, especially non-steroidal anti-inflammatory drugs.
• If you have a hemorrhagic disease.
• If you are at risk of bleeding.
• In case of hemophilia or other blood 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 had gastroduodenal ulcer and are being treated with medications for blood circulation (oral anticoagulants) 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 pregnant for more than 24 weeks (see "Pregnancy").

If you are not sure if you should start taking this medicine, consult your doctor.

Warnings and precautionsConsult your doctor or pharmacist before starting to use Inyesprin:

• If you have a type of anemia due to a hereditary disease that occurs due to a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).
• In case of renal and/or hepatic insufficiency.
• If you have asthma, as the onset of an asthma attack in some patients may be related to an allergy to non-steroidal anti-inflammatory drugs or acetylsalicylic acid, and in this case, this medicine would be contraindicated (see "Do not use this medicine").
• In cases of abundant uterine bleeding, any menstrual alteration, as well as if you are using an intrauterine device (IUD).

• If you have a history of gastric or duodenal ulcer, gastrointestinal bleeding, or gastritis.
• Gastrointestinal bleeding, ulcer, or perforation may occur at any time during treatment, without necessarily having previous symptoms or history. The risk of this happening is higher in elderly patients, people with low body weight, or patients being treated with medications for blood circulation (anticoagulants or antiplatelet agents). In case of gastrointestinal bleeding, treatment should be interrupted immediately.

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

• Before possible surgical interventions (e.g., tooth extraction), you should inform your doctor or dentist that you are using this medicine, as there is a risk of bleeding and it is advisable to suspend its administration one week before the intervention.
• If you are prone to gout, you should be aware that acetylsalicylic acid at low doses reduces the elimination of uric acid in the urine and may trigger a gout attack.
• Reye's syndrome is a very rare, 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 case of persistent vomiting, disorders of consciousness, or abnormal behavior, treatment should be interrupted.
• Continuous use of pain medications can cause headaches; if this happens to you, consult your doctor.
• Regular use of pain medications, especially if a combination of these is used, can cause permanent kidney damage, with a risk of renal failure.
• In case of use 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 during treatment you start to have ringing in your ears, hear worse, or feel dizzy, you should consult your doctor immediately, as these could be signs of overdose. In the case of children, the doctor will perform blood tests, especially at the start of treatment.
• Consult your doctor again if the pain persists for more than 10 days, the fever for more than 3 days, or if it worsens or other symptoms appear.
• If you are being treated with medications that may increase the risk of bleeding (corticosteroids, anti-inflammatory drugs, a type of medication used to treat depression called selective serotonin reuptake inhibitors, antiplatelet agents, or anticoagulants). In these cases, you should consult your doctor, who will decide if you can use Inyesprin with these medications. Suspend treatment and go to the doctor immediately if your stools become black and viscous, you vomit blood, your blood pressure drops, you have cold sweats, abdominal pain, or you feel dizzy.
• This medicine should not be used intravenously in children.
• It is not recommended to use this medicine during breastfeeding (see "Breastfeeding").

Interference with diagnostic tests

If you are going to have any diagnostic tests, inform your doctor that you are using Inyesprin, as it may alter the results.

Children and adolescents

This medicine should not be used intravenously in children.

Reye's syndrome is a very rare, 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 case of persistent vomiting, disorders of consciousness, or abnormal behavior, treatment should be interrupted.

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 start of treatment.

Use in elderly patients

Caution is recommended in elderly patients, especially with renal insufficiency, or those with reduced albumin levels in the blood, as there is a risk of high toxicity.

Other medicines and Inyesprin

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Certain medicines may interact with Inyesprin; in these cases, it may be necessary to change the dose or interrupt treatment with one of the medicines.

It is important that you inform your doctor if you are undergoing any of the following treatments:

• Treatment with medicines containing methotrexate (used to treat cancer, rheumatoid arthritis, and/or psoriasis).
• Treatment with medicines for blood circulation (oral anticoagulants, heparins, clopidogrel, ticlopidine, thrombolytics).
• Treatment with other medicines that reduce pain and inflammation (non-steroidal 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 medicines used to treat gout (benzobromarone, probenecid, sulfinpyrazone).
• Treatment with certain medicines used to lower blood pressure (diuretics, angiotensin-converting enzyme inhibitors, angiotensin II antagonists).
• Treatment with medicines for the stomach such as gastrointestinal topics, antacids, and activated charcoal.
• Treatment with a type of medicine used to treat depression called selective serotonin reuptake inhibitors.
• Treatment with cimetidine and ranitidine (used for stomach acidity).
• Treatment with medicines used to treat epilepsy (phenytoin and valproic acid).
• Treatment with medicines used to lower blood sugar levels (oral hypoglycemics or insulin).
• Treatment with medicines used to treat infections (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, as sedatives, and anticonvulsants).
• Treatment with other medicines with antiplatelet properties such as tirofiban, eptifibatide, epoprostenol, abciximab, acetylsalicylic acid, iloprost, and iloprost tromethamine.

Using Inyesprin with alcohol

Do not drink alcohol during treatment with Inyesprin, as the use of acetylsalicylic acid in patients who habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor... - per day) may cause gastric bleeding.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

The use of Inyesprin is contraindicated from the 24th week of pregnancy (third trimester).

Breastfeeding

The use of Inyesprin is not recommended during breastfeeding because it is excreted in breast milk.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

3. How to use Inyesprin

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with Inyesprin.

Administration can be done by deep intramuscular route, direct intravenous route, dissolving the contents of the vial in 5 ml of water for injectables, or in perfusion in neutral solutions.

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

The recommended dose is:

Adults:it is recommended to administer one vial 1 to 3 times a day. Maximum 4 vials/day.

Children:the recommended dose is 20 to 50 mg/kg/day.

This medicine should not be used intravenously in children.

Remember to take your medicine.

If you think the action of this medicine is too strong or too weak, tell 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: ringing in the ears, hearing disorders, headache, and dizziness.

In case of severe poisoning, the following may appear: fever, increased respiratory rate, metabolic disorders in the blood, coma, cardiovascular collapse, respiratory failure, and a significant decrease in blood sugar levels.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20. Also, inform your doctor immediately. Bring this leaflet with you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Blood and lymphatic system disorders

Hemorrhagic 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 discontinuation of acetylsalicylic acid, which may cause an increased risk of bleeding in case of surgery. Gastrointestinal bleeding and intracranial bleeding may also occur.

Immune system disorders

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

Nervous system disorders

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

Intracranial bleeding.

Gastrointestinal disorders

Abdominal pain.

Gastrointestinal bleeding, occult or patent (vomiting or stools with blood), which can lead to iron deficiency anemia. The risk of bleeding depends on the dose. Stomach 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 or pain, gastrointestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Breathing difficulties.
• Unforeseen changes in the amount or appearance of urine.
• Swelling of the face, feet, or legs.

Stop taking the medicine and consult your doctor immediately, as these may indicate the onset of side effects that require urgent medical attention.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

Reporting of side effects

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

5. Storing Inyesprin

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

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

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Inyesprin Composition

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

After reconstitution with 5 ml of water for injectables, each ml of the solution contains 180 mg of lysine acetysalicylate.

• The other components are glycine.

Product Appearance and Container Content

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Medicamentos Internacionales Laboratories, S.A.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Date of the last revision of this prospectus: September 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended solely for Healthcare Professionals:

For additional information, please consult the Technical Data Sheet (TDS) of the product

Instructions for Use and Handling

Inyesprin should 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

Dissolve the contents of the vial extemporaneously in 5 ml of water for injectables. Administration can be done by deep IM, direct IV, or IV perfusion with the help of an excipient (sodium chloride solution, glucose, or sorbitol).

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

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

For instructions on the administration of Inyesprin, please refer to the TDS.