Leaflet: information for the user

Ticlopidine cinfa 250 mg coated tablets

Ticlopidine hydrochloride

Read this leaflet carefully before you start taking this medicine, because 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 must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ticlopidina belongs to a group of medications called antiplatelet agents (which prevent blood clotting), thereby reducing the possibility of clot formation.

Ticlopidina is indicated in adults for:

• Prevention of the recurrence of cerebrovascular accidents when treatment with acetylsalicylic acid is not tolerated or considered inadequate.
• Prevention of thromboembolisms, especially coronary, in patients with arterial circulation disorders in the legs.
• Prevention and correction of platelet disorders during surgery with extracorporeal circulation or hemodialysis (artificial kidney).
• Prevention of the progression of microaneurysms in insulin-dependent diabetics with retinal disorders in early stages.
• Prevention of occlusions after coronary surgical procedures (heart surgery):
• • in aortocoronary bypass surgery,
  • in percutaneous transluminal coronary angioplasty with endovascular stent placement.

Do not forget to inform your doctor who prescribed this medication of all the diseases you currently have or have had in the past.

Do not take ticlopidina cinfa

• If you are allergic to ticlopidina or any of the other components of this medication (listed in section 6).
• If you have a predisposition to bleeding.
• If you have lesions prone to bleeding, such as gastric ulcers, acute cerebral hemorrhage, etc.
• If you have blood disorders that cause prolonged bleeding time, such as hemophilia, etc.
• If you have previously had blood disorders, such as a decrease in the number of white blood cells, granulocytes, or platelets (cells involved in blood coagulation).

Warnings and precautions

Consult your doctor or pharmacist before starting to take ticlopidina cinfa, as during treatment, undesirable effects may appear:

Blood and hemorrhagic effects may appear. Cases of blood component alterations such as agranulocytosis, pancytopenia, neutropenia, thrombotic thrombocytopenic purpura, and in rare cases, leukemia have been reported.

Severe and sometimes fatal blood and hemorrhagic effects may occur, especially associated with:

• Inadequate control, delayed diagnosis, and inappropriate therapeutic measures for adverse effects.
• Concomitant administration of anticoagulants or antiplatelet agents such as aspirin and NSAIDs. However, in the case of stent implantation, ticlopidina should be associated with low-dose aspirin for approximately one month after implantation.

To detect any blood abnormalities, your doctor will perform a blood test before starting treatment, and every 2 weeks during the first 3 months of treatment. Those patients who interrupt treatment within the first 90 days should have an additional analysis 2 weeks after discontinuation of treatment.

One of these adverse effects, called neutropenia (significant decrease in the number of white blood cells characterized by fever, throat inflammation, mouth ulcers) can be dangerous as it prevents the patient from fighting infections. It may appear in a low percentage of patients, mainly during the first 3 months of treatment.

Other undesirable effects that may appear are mainly: thrombocytopenia (decrease in the number of platelets) and/or hemostasis problems (prolonged or unexpected bleeding, hematomas, or skin spots, black stools. You should immediately discontinue medication and consult your doctor if any of these symptoms appear.

In some patients taking ticlopidina, a condition of thrombotic thrombocytopenic purpura may occur, which in some cases may be associated with severe consequences. It is characterized by a significant decrease in platelet count, anemia, neurological changes, kidney alterations, and fever. It usually occurs during the first 8 weeks of treatment.

Due to the risk of fatal outcome in case of suspected thrombotic thrombocytopenic purpura, it is recommended to consult a specialist.

This medication should be used with caution in patients with liver disorders. In case of suspected liver dysfunction, liver function tests should be performed, especially during the first months of treatment. Inform your doctor if symptoms of hepatitis appear, such as yellow skin and mucous membranes, light stools, dark urine.

In patients with kidney disorders, it is necessary to reduce the dose of ticlopidina or discontinue treatment if hemorrhagic or hematopoietic problems appear.

It should be investigated if patients have a history of hypersensitivity to another thienopyridine (such as clopidogrel, prasugrel) due to the risk of cross-reactivity between thienopyridines (see section 4 Possible adverse effects). Thienopyridines can cause moderate to severe allergic reactions, such as skin rash, angioedema, or hematological reactions.

This medication should be used with caution in patients who have a risk of bleeding. Although it is recommended not to associate it with heparins, oral anticoagulants, and antiplatelet agents (see section Other medications and ticlopidina cinfa), in exceptional cases where this association is made, close monitoring of the patient will be maintained.

Treatment with ticlopidina should be discontinued and your doctor should be consulted immediately if:

Bleeding may be more prolonged than usual under treatment with ticlopidina.

It is essential to inform your doctor of the use of this medication in case of surgical intervention or dental extractions, as your doctor may recommend temporary interruption of treatment. All patients should be carefully monitored for signs and symptoms of adverse reactions, especially during the first 3 months of treatment.

In case of doubt, consult your doctor or pharmacist.

Children and adolescents

The safety and efficacy of ticlopidina have not yet been established in children.

Other medications and ticlopidina cinfa

To avoid potential interactions between various medications, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, particularly if it is:

• An SSRI inhibitor (including but not limited to fluoxetine or fluvoxamine), a medication commonly used to treat depression.
• Pentoxifylline, a medication used to treat poor circulation in the arms and legs.
• Medications related to an increased risk of bleeding.
• Anticoagulants (heparin, antivitamins K).
• Antiplatelet agents (medications used to prevent thrombus formation).
• Aspirin (with the exception of stent implantation, in which ticlopidina may be associated with aspirin and should be strictly followed by your doctor's prescription) and derivatives.
• Non-steroidal anti-inflammatory drugs.
• Theophylline (a medication used to treat asthma).
• Digoxin (a medication used to treat heart failure).
• Phenobarbital (a medication used to treat epilepsy).
• Phenytoin (a medication used to treat epilepsy).
• Phenazone (a medication used to treat pain and fever).
• Ciclosporin (a medication used to prevent transplant rejection).
• Antacids and cimetidine (medications used to treat gastrointestinal ulcers).
• S-ketamine (an anesthetic medication).

Pregnancy and lactation

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

Pregnancy:

Treatment with this medication should be avoided during pregnancy.

Lactation:

Treatment with this medication should be avoided during lactation.

Driving and operating machinery

The possible adverse effects of ticlopidina, such as dizziness, may affect the ability to drive vehicles and operate machinery.

Ticlopidina cinfa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Remember to take your medication.

This medication has been prescribed to you personally in a specific situation:

• Do not take it in any other situation.
• Do not interrupt or prolong treatment without your doctor's indication.
• Do not advise anyone else.

Your dispensation cannot be repeated if your doctor does not indicate it explicitly on the prescription or without presenting a new prescription.

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

The administration route of ticlopidina is oral.

The recommended daily dose is 2 tablets per day, which means a maximum daily dose of 500 mg of ticlopidina.

It is recommended to take one tablet during meals and another during dinner.

Your doctor will inform you of the duration of your treatment with ticlopidina. Do not suspend treatment without consulting your doctor first.

If you take more ticlopidina cinfa than you should

If you take more ticlopidina than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

It has been proven that an overdose can cause a risk of bleeding. In case of intoxication, gastric lavage and general supportive measures are recommended.

If urgent correction of bleeding time is needed, a platelet transfusion may reverse the effects of ticlopidina.

If you forgot to take ticlopidina cinfa

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects that may occur are as follows:

Very common (may affect more than 1 in 10 people).

Common (may affect up to 1 in 10 people).

Uncommon (may affect up to 1 in 100 people).

Rare (may affect up to 1 in 1,000 people).

Very rare (may affect up to 1 in 10,000 people).

Frequency not known (cannot be estimated from available data).

Blood and lymphatic system disorders:

• Common: neutropenia, including severe neutropenia (see sectionWarnings and precautions), agranulocytosis.
• Uncommon: isolated thrombocytopenia or occasionally accompanied by hemolytic anemia, sepsis, andseptic shockthat may be fatal complications of agranulocytosis.
• Rare: cases of thrombotic thrombocytopenic purpura (combination of yellow skin and mucous membranes, skin rash, pallor, fever, weakness on one side of the body, and dark urine; thrombocytosis, pancitopenia, bone marrow aplasia, and leukemia (see section “Warnings and precautions”).

Vascular disorders:

• Uncommon:hematomas, ecchymosis, epistaxis, hematuria, conjunctival hemorrhage, peri- and postoperative bleeding, hemorrhages that may be severe and sometimes have been observed with fatal consequences.
• Rare:intracranial hemorrhage.

Gastrointestinal disorders:

• Common: diarrhea, nausea (usually appear during the first 3 months of treatment).
• Uncommon:gastroduodenal ulcer.
• Very rare:severe diarrhea with colitis (includes lymphocytic colitis).

Hepatobiliary disorders:

• Common:increased liver enzymes, increased alkaline phosphatase and transaminases (see sectionWarnings and precautions).
• Uncommon:increased bilirubin.
• Rare: hepatitis (cytolytic and/or cholestatic).
• Very rare: fulminant hepatitis, fatal hepatitis.

Skin and subcutaneous tissue disorders:

• Common:skin rash, particularly maculopapular or urticarial, accompanied by pruritus, these skin rashes may be generalized.
• Uncommon:dermatitis exfoliativa.
• Very rare:skin conditions with exfoliative lesions (cases of erythemamultiforme, Stevens-Johnson syndrome, and Lyell syndrome).
• Frequency not known: eczema/dermatitis.

Immune system disorders:

• Very rare: immune reactions with various manifestations such as allergic reactions, angioedema (generalized urticaria accompanied by inflammation of feet, hands, throat, lips, and respiratory tracts), joint pain, allergic inflammation of veins, lupus syndrome (serious skin and mucous membrane disease of unknown origin, sometimes accompanied by fatigue, weight loss, fever, arthritis, kidney involvement, convulsions, psychosis, and gastrointestinal disorders), renal problems (hypersensitivity nephritis sometimes with renal insufficiency and eosinophilia (increase in a certain group of white blood cells), anaphylaxis, Quincke edema,
• Frequency not known:cross-reactivity hypersensitivity between thienopyridines (such as clopidogrel, prasugrel) (see sectionWarnings and precautions).

Nervous system disorders:

• Common:headache, dizziness.
• Uncommon: sensory disorders (peripheral neuropathy).
• Rare:hearing sounds.

Respiratory, thoracic, and mediastinal disorders:

• Frequency not known:inflammation of the lungs.

General disorders and administration site conditions

• Very rare:fever.

Complementary examinations:

• Common:increased serum levels of cholesterol and triglycerides.

Reporting of adverse reactions

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

This medication does not require special storage conditions.

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 after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Ticlopidina cinfa composition:

The active ingredient is ticlopidine hydrochloride. Each tablet contains 250 mg of ticlopidine hydrochloride.

The other components are:

• Tablet core: microcrystalline cellulose, cornstarch, povidone, citric acid, magnesium stearate, stearic acid, anhydrous colloidal silica, and sodium carboxymethylcellulose (type A) (from potato).
• Tablet coating: titanium dioxide (E-171), hypromellose, and macrogol 400.

Product appearance and packaging contents

Ticlopidina cinfa is presented in the form of white, cylindrical, coated, biconvex, smooth tablets on one side and with the code “T250C” on the other.

It is presented in PVC-PVDC/Aluminum blisters. Each package contains 20 or 50 tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and manufacturer responsible

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta.

31620 Huarte (Navarra) - Spain.

Last review date of this leaflet:May 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/63680/P_63680.html

QR code to:https://cima.aemps.es/cima/dochtml/p/63680/P_63680.html