Ticlopidine Mylan Generics

Package leaflet: Information for the patient

TICLOPIDINE MYLAN GENERICS 250 mg film-coated tablets

Ticlopidine hydrochloride
Generic medicine
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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TICLOPIDINA MYLAN GENERICS is and what it is used for

TICLOPIDINA MYLAN GENERICS contains the active substance ticlopidine, which belongs to the class of
antiplatelet agents—medicines that improve blood circulation by preventing the formation of blood clots (thrombi).
TICLOPIDINA MYLAN GENERICS is used

• to prevent blockage of blood flow to the brain and heart (ischaemia) in people who are at high risk of blood clot formation (peripheral arterial occlusive disease, previous myocardial infarction, recurrent transient ischaemic attacks, ischaemic stroke, unstable angina);
• to prevent closure of heart bypass grafts (aortocoronary bypasses);
• during surgical procedures requiring artificial circulation (extracorporeal circulation);
• during haemodialysis sessions;
• if you suffer from central retinal vein thrombosis;
• in patients who have had a heart attack or ischaemic attacks, only if they are intolerant to acetylsalicylic acid (ASA), or if treatment with acetylsalicylic acid has proven ineffective.

Due to its undesirable effects, this medicine should be used only when absolutely necessary and when it is not possible
to use another medicine different from TICLOPIDINA MYLAN GENERICS.

2. What you need to know before taking TICLOPIDINA MYLAN GENERICS

Do not take TICLOPIDINA MYLAN GENERICS

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have had abnormalities in blood cell levels (leukopenia, thrombocytopenia, agranulocytosis);
• if you suffer or have suffered from bleeding disorders (hemorrhagic diathesis), including prolonged bleeding;
• if you have esophageal or gastric lesions with a tendency to bleed (gastrointestinal ulcers, esophageal varices, etc.);
• if you suffer from cerebrovascular disorders (acute hemorrhagic stroke);
• if you have severe liver problems (severe hepatopathy);
• if you are taking other medicines that may interfere with bone marrow function (myelotoxic drugs);
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Do not use this medicine for primary prevention if you do not have any of the conditions listed in section 1.
Warnings and precautions
Talk to your doctor or pharmacist before taking TICLOPIDINA MYLAN GENERICS.
Adverse events, sometimes serious, of hematological and hemorrhagic nature may occur. Alterations in blood components such as agranulocytosis, pancytopenia, and rare cases of leukemia have been reported after marketing, sometimes with fatal outcome (see section 4).
Such serious events may be associated with:

• inadequate monitoring, delayed diagnosis, and inadequate treatment of adverse effects;
• concomitant administration of anticoagulants or antiplatelet agents such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). However, in the case of stent implantation, ticlopidine must be combined with aspirin (100–325 mg daily) for approximately one month after implantation.

It is essential to strictly follow the indications, precautions, and contraindications for ticlopidine.
Treatment must be carried out under close medical supervision, especially during the first three months, to monitor for possible adverse effects.
If you experience any of the following conditions, stop treatment immediately and inform your doctor:

• sore throat, fever, mouth sores (symptoms of neutropenia);
• bleeding, even prolonged, or bruising (hematomas), skin rash associated with bleeding (purpura), dark stools (symptoms of thrombocytopenia and/or coagulation disorders);
• skin rash associated with bleeding and decreased platelets (symptoms of thrombotic thrombocytopenic purpura);
• chest pain due to heart circulation problems (angina);
• yellowing of the skin (jaundice), dark urine, pale stools (symptoms of hepatitis).

If thrombotic thrombocytopenic purpura is suspected, consult a specialist immediately, as there is a high risk of death. Onset may be sudden, and in most cases has been reported within the first 8 weeks of starting therapy. Symptoms include decreased platelets (thrombocytopenia) and red blood cells (hemolytic anemia), neurological symptoms similar to transient ischemic attack (TIA) or stroke, kidney problems, and fever.
Resuming treatment with this medicine depends on your clinical condition and blood test results (hematological monitoring), which must be performed urgently.
Your doctor will prescribe blood tests at the beginning of treatment, then every 2 weeks during the first 3 months of therapy, and within 15 days of any interruption of TICLOPIDINA MYLAN GENERICS, if such interruption occurs within the first 3 months of treatment.
Your doctor will instruct you to discontinue treatment with this medicine if you develop low white blood cell count (neutropenia) or low platelet count (thrombocytopenia).
If you are undergoing minor surgical procedures, such as tooth extraction, inform your doctor about your treatment with this medicine.
Discontinue treatment at least 10 days before any surgical procedure to avoid the risk of bleeding.
In case of emergency surgery, inform your doctor about ongoing treatment so appropriate precautions can be taken to prevent bleeding risk.
Use this medicine with caution if you are at risk of bleeding and if you have liver problems (hepatic dysfunction). Your doctor may recommend periodic liver function tests, especially during the first three months of treatment.
If you suffer from kidney problems (renal insufficiency), consult your doctor, who may reduce the dose or discontinue treatment if bleeding or blood disorders (hematopoietic disorders) occur.
Be cautious when using Ticlopidina Mylan Generics if you are allergic to other medicines similar to ticlopidine (medicines belonging to the thienopyridine group), such as clopidogrel and prasugrel, as cross-reactions may occur (see section 4). Taking these medicines may cause allergic reactions ranging from moderate to severe, including skin rash, facial swelling, especially around the eyes and mouth (angioedema or Quincke's edema), and changes in platelet and white blood cell levels in the blood (thrombocytopenia and neutropenia).
Patients who have experienced allergy to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine. Cross-reactivity and signs of hypersensitivity should be monitored in patients with known allergy to thienopyridines.
Children and adolescents
The use of this medicine in children and adolescents is not recommended.
Other medicines and TICLOPIDINA MYLAN GENERICS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Avoid using this medicine together with other medicines that may cause blood cell abnormalities (myelotoxic drugs) (see section "Do not take TICLOPIDINA MYLAN GENERICS").
Inform your doctor if you are taking any of the following medicines in addition to TICLOPIDINA MYLAN GENERICS, as they may increase the risk of bleeding:

• non-steroidal anti-inflammatory drugs (NSAIDs);
• antiplatelet agents, medicines used to increase blood fluidity;
• acetylsalicylic acid (except in cases of stent implantation, where combination is allowed) and its derivatives;
• oral and parenteral anticoagulants (e.g., heparin), medicines that improve circulation;
• a selective serotonin reuptake inhibitor (including, but not limited to, fluoxetine or fluvoxamine), medicines usually used to treat depression;
• pentoxifylline, a medicine used for poor blood circulation in arms and legs.

Inform your doctor and exercise particular caution if you are taking any of the following medicines, as specific precautions may be necessary:

• theophylline, a medicine used to treat asthma, as dosage adjustment may be needed;
• digoxin, a medicine used to treat heart rhythm disorders;
• phenobarbital and phenytoin, medicines used to treat epilepsy;
• cimetidine and other medicines used to treat stomach disorders (antacids);
• cyclosporine, an immunosuppressive medicine used in transplant patients;
• ketamine, a medicine used in general anesthesia.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy or while breastfeeding, except in cases of absolute necessity.
Driving and using machines
This medicine may cause dizziness and other adverse effects that may impair your ability to drive or operate machinery.
TICLOPIDINA MYLAN GENERICS contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take TICLOPIDINE MYLAN GENERICS

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
For long-term treatment, the recommended dose is 1 or 2 tablets daily, taken during meals.

If you take more TICLOPIDINE MYLAN GENERICS than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Overdose with this medicine may increase the risk of bleeding; if severe, treatment may require platelet transfusion.
In case of serious gastrointestinal problems, management includes inducing vomiting, gastric lavage, and other supportive measures.

If you forget to take TICLOPIDINE MYLAN GENERICS
Do not take a double dose to make up for the missed tablet.

If you stop taking TICLOPIDINE MYLAN GENERICS
If you discontinue treatment with this medicine within the first three months, a complete blood test is required two weeks after stopping the treatment. Blood parameters must be monitored until they return to normal.

If you have any questions 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 everybody gets them.
The use of this medicine may cause the following side effects:
Common (may affect up to 1 in 10 people)

• decrease in white blood cells, even severe (neutropenia, agranulocytosis);
• headache, dizziness;
• altered liver function (increased liver enzymes, increased alkaline phosphatase and transaminases);
• diarrhoea and nausea;
• skin irritations (maculopapular or urticarial rash), often accompanied by itching;
• increased cholesterol and triglycerides.

Uncommon (may affect up to 1 in 100 people)

• decrease in platelets (thrombocytopenia), accompanied by a decrease in red blood cells (haemolytic anaemia);
• severe infection of the body (sepsis) and septic shock, which may occur as fatal complications of decreased white blood cells (agranulocytosis);
• sensory disturbances (peripheral neuropathy);
• haemorrhagic complications, especially bruising, presence of blood in urine (haematuria), or bleeding in the lower part of the eye (conjunctival haemorrhage), nosebleeds (epistaxis), bleeding during surgery (perioperative haemorrhage), and postoperative bleeding, which may be severe and sometimes fatal;
• formation of lesions in the stomach and intestine (gastroduodenal ulcer);
• disturbances in liver function (increased bilirubin);
• skin irritation associated with peeling (exfoliative dermatitis).

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

• decrease in all blood cells (pancytopenia), severe reduction in bone marrow activity (bone marrow aplasia), blood disorders (thrombotic thrombocytopenic purpura, leukaemia, and thrombocytosis);
• perception of sound in the ear (tinnitus);
• bleeding in the brain (intracerebral haemorrhage);
• liver disorders, such as hepatitis (cytolytic and/or cholestatic hepatitis);
• yellowish discoloration of the skin due to liver dysfunction (cholestatic jaundice).

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

• immune system disorders, such as allergic manifestations, anaphylaxis (severe allergic reaction), facial swelling, especially around eyes and mouth (Quincke's oedema), increased white blood cells (eosinophilia), joint pain (arthralgia), inflammation of blood vessels (vasculitis), irritant skin disorders, joint pain and fever (lupus-like syndrome), lung disorders (allergic pneumonitis), kidney disorders (hypersensitivity nephropathy which may be associated with renal failure);
• severe diarrhoea associated with inflammation of the intestine (colitis and lymphocytic colitis). If this effect is severe, stop taking this medicine;
• fatal hepatitis and fulminant hepatitis;
• allergic skin reactions (erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome);
• fever.

Not known (frequency cannot be estimated from the available data)

• cross-reactive hypersensitivity reactions among thienopyridines, such as clopidogrel and prasugrel (see section “Warnings and precautions”).
• itching, red-coloured skin rash (eczema/dermatitis);
• inflammation of the lungs with cough and breathing difficulties (interstitial lung disease) caused by allergic pneumonia.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 TICLOPIDINE MYLAN GENERICS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TICLOPIDINE MYLAN GENERICS contains

• The active substance is ticlopidine hydrochloride. Each tablet contains 250 mg of active substance.
• The other components are lactose, hydroxypropylcellulose, microcrystalline cellulose, talc, magnesium stearate, sodium croscarmellose, macrogol 6000, titanium dioxide (E171).

Description of the appearance of TICLOPIDINE MYLAN GENERICS and package contents
Pack containing 30 coated tablets.
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy
Manufacturer
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via Grignano 43
24041 Brembate (BG)
ABC Farmaceutici S.p.A.
Via Canton Moretti 29
10090 Località San Bernardo, Ivrea (TO)