Inyesprin 900 mg powder for solution for injection and for infusion

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Inyesprin 900 mg powder for injectable solution and for infusion

lysine acetylsalicylate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Inyesprin is and what it is used for

Inyesprin belongs to a group of medicines, derivatives of salicylic acid, used for the treatment of pain and fever.

Inyesprin is indicated for:

• Rheumatic, neuralgic, post-traumatic, post-operative, post-partum, and neoplastic pain.
• the prevention and treatment of thromboembolic disease.
• fever of any cause.

2. What you need to know before Inyesprin is administered to you

Do not use this medicine

• If you are allergic to acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), or tartrazine (a food colouring), or to any of the other components of this medicine (listed in section 6).
• If you are under 16 years of age, unless specifically prescribed by a doctor, as the use of lysine acetylsalicylate has been associated with Reye's syndrome, a very rare but serious illness.
• If you have active, chronic, or recurrent peptic ulcer.
• If you have asthma and/or nasal polyps associated with asthma that are triggered or worsened by acetylsalicylic acid, acetylsalicylates, or substances with similar activity, especially non-steroidal anti-inflammatory drugs.
• If you have any bleeding disorder.
• If you are at risk of bleeding.
• If you have haemophilia 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 or currently have a gastroduodenal ulcer and are being treated with blood circulation medications (oral anticoagulants) and are prescribed acetylsalicylic acid for 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 for inflammation, pain, or fever.
• If you are more than 24 weeks pregnant (see section “Pregnancy”).

If you are unsure whether you should start taking this medicine, consult your doctor.

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

• If you have a type of anaemia caused by an inherited condition due to deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).
• If you have renal and/or hepatic insufficiency.
• If you have asthma, as asthma attacks in some patients may be related to an allergy to non-steroidal anti-inflammatory drugs or acetylsalicylic acid; in such cases, this medicine is contraindicated (see section “Do not use this medicine”).
• If you have heavy uterine bleeding, any menstrual disturbances, or are using an intrauterine device (IUD).
• If you have a history of gastric or duodenal ulcer, gastrointestinal bleeding, or gastritis.
• Gastrointestinal bleeding, ulceration, or perforation may occur at any time during treatment, even without warning symptoms or prior history. The risk is higher in elderly patients, those with low body weight, or patients taking blood circulation medications (anticoagulants or antiplatelet agents). If gastrointestinal bleeding occurs, treatment must be stopped immediately.
• If you have a history of rhinitis or urticaria.
• If you have hypertension (high blood pressure).
• Before any surgical procedures (e.g. dental extraction), inform your doctor or dentist that you are using this medicine, as there is a risk of bleeding and it is advisable to discontinue administration one week prior to the procedure.
• If you are prone to gout, note that low-dose acetylsalicylic acid reduces urinary excretion of uric acid and may trigger a gout attack.
• Reye's syndrome is a very rare but potentially fatal condition observed in children and adolescents with signs of viral infection (particularly chickenpox and flu-like episodes) who are taking acetylsalicylic acid. Therefore, acetylsalicylic acid should only be given to children and adolescents in such cases under medical advice, and only when other treatments have failed. If persistent vomiting, disturbances in consciousness, or abnormal behaviour occur, treatment must be stopped immediately.
• Prolonged use of pain-relieving medicines may cause headaches; if this occurs, consult your doctor.
• Regular use of pain-relieving medicines, especially in combination, may cause permanent kidney damage and risk of renal failure.
• When used concomitantly with other medicines, ensure that acetylsalicylic acid is not already included in their composition, to avoid the risk of overdose.
• If, during treatment, you develop tinnitus (ringing in the ears), hearing loss, or dizziness, consult your doctor immediately, as these may be signs of overdose. In children, the doctor may perform blood tests, especially at the beginning of treatment.
• Consult your doctor again if pain persists for more than 10 days, fever for more than 3 days, or if symptoms worsen or new symptoms appear.
• If you are taking medications that may increase the risk of bleeding (corticosteroids, NSAIDs, a type of antidepressant called selective serotonin reuptake inhibitors, antiplatelet agents, or anticoagulants). In such cases, consult your doctor, who will decide whether you can use Inyesprin alongside these medications. Discontinue treatment and seek immediate medical attention if you develop black, tarry stools, vomit blood, experience low blood pressure, cold sweats, abdominal pain, or dizziness.
• This medicine must not be administered intravenously in children.
• Use of this medicine during lactation is not recommended (see section “Breastfeeding”).

Interference with diagnostic tests

If you are due to undergo any diagnostic tests, inform your doctor that you are using Inyesprin, as it may alter test results.

Children and adolescents

This medicine must not be administered intravenously in children.

Reye's syndrome is a very rare but potentially fatal condition observed in children and adolescents with signs of viral infection (particularly chickenpox and flu-like episodes) who are taking acetylsalicylic acid. Therefore, acetylsalicylic acid should only be given to children and adolescents in such cases under medical advice, and only when other treatments have failed. If persistent vomiting, disturbances in consciousness, or abnormal behaviour occur, treatment must be stopped immediately.

In infants under 1 month of age, administration of acetylsalicylic acid is only justified in specific situations and under medical prescription.

In children, monitoring of salicylate levels in blood (salicylémia) is recommended, especially at the beginning of treatment.

Use in elderly patients

Caution is advised in elderly patients, particularly those with renal insufficiency or low blood albumin levels, due to increased risk of toxicity.

Other medicines and Inyesprin

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

Certain medicines may interact with Inyesprin. In such cases, it may be necessary to adjust the dose or discontinue 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 blood circulation medicines (oral anticoagulants, heparins, clopidogrel, ticlopidine, thrombolytics).
• Treatment with other pain- and inflammation-reducing medicines (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 for gout (benzbromarone, probenecid, sulfinpyrazone).
• Treatment with certain medicines used to lower blood pressure (diuretics, angiotensin-converting enzyme inhibitors, angiotensin II antagonists).
• Treatment with stomach medicines such as gastrointestinal protectants, antacids, and activated charcoal.
• Treatment with a type of antidepressant called selective serotonin reuptake inhibitors (SSRIs).
• Treatment with cimetidine and ranitidine (used for stomach acidity).
• Treatment with medicines used for epilepsy (phenytoin and valproic acid).
• Treatment with medicines used to lower blood sugar levels (oral hypoglycaemics 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 (a heart medicine).
• Treatment with lithium (for depression).
• Treatment with barbiturates (used for sleep disorders, as sedatives, and anticonvulsants).
• Treatment with other medicines with antiplatelet properties such as: tirofiban, eptifibatide, epoprostenol, abciximab, acetylsalicylic acid, iloprost, and iloprost tromethamine.

Use of Inyesprin with alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

Inyesprin should not be administered during the first and second trimesters of pregnancy unless strictly necessary and considered appropriate by your doctor.

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

Breastfeeding

The use of Inyesprin during breastfeeding is not recommended, as 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 instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of treatment with Inyesprin.

Administration may be performed by deep intramuscular injection, direct intravenous injection (by dissolving the contents of the vial in 5 ml of water for injections), or by infusion into neutral solutions.

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

Recommended dosage:

Adults: One vial is recommended 1 to 3 times daily. Maximum 4 vials/day.

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

This medicine must not be administered intravenously in children.

Remember to take your medicine as prescribed.

If you feel that the effect of this medicine 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, contact your doctor or pharmacist immediately.

Symptoms of moderate poisoning include: tinnitus, hearing disturbances, headache, and dizziness.

In cases of severe poisoning, the following may occur: fever, increased respiratory rate, metabolic disturbances in the blood, coma, cardiovascular collapse, respiratory failure, and a marked decrease in blood sugar levels.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20. Also, notify your doctor immediately. Take this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Disorders of the blood and lymphatic system

Haemorrhagic syndromes (nosebleeds, bleeding from the gums, appearance of purple spots on the skin, etc.) with prolonged bleeding time. The risk of bleeding may persist for 4–8 days after discontinuation of acetylsalicylic acid, which may increase the risk of bleeding in the event of surgery. Gastrointestinal and intracranial bleeding may also occur.

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, tinnitus, which are usually indicative of overdose.

Intracranial bleeding.

Gastrointestinal disorders

Abdominal pain.

Occult or overt gastrointestinal bleeding (vomiting blood or bloody stools), leading to iron-deficiency anaemia. 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 reactions

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

If you notice any of the following:

• Gastric discomfort or pain, gastric or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unexpected 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 adverse effects requiring urgent medical attention.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Inyesprin

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

Do not use this medicine after the expiry date stated on the packaging and on the vial after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inyesprin

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

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

• The other component is glycine.

Appearance of the product and contents of the pack

Inyesprin 900 mg powder for injectable solution is presented as a white or pale yellow powder in packs 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

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Date of the most recent review of this summary: September 2021.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

This information is intended exclusively for healthcare professionals:

For additional information, please consult the Product Information (PI) of the product.

Instructions for use and handling

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

Preparation of Inyesprin solution

Reconstitute the contents of the vial immediately before use with 5 ml of water for injections. Administration may be performed via deep intramuscular (IM) injection, direct intravenous (IV) injection, or IV infusion using a suitable vehicle (sodium chloride solution, glucose solution, or sorbitol).

It is recommended to avoid mixing this medicinal product with other injectable drugs in the same syringe.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.

For administration instructions of Inyesprin, please refer to the PI.