Patient Information Leaflet

TICLOPIDINE EG 250 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What TICLOPIDINE EG is and what it is used for
What you need to know before taking TICLOPIDINE EG
How to take TICLOPIDINE EG
Possible side effects
How to store TICLOPIDINE EG
Contents of the pack and other information

1. What TICLOPIDINE EG is and what it is used for

TICLOPIDINE EG 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).
TICLOPIDINE EG is used

to prevent blockage of blood flow to the brain and heart (ischaemia) in people who have a high risk of blood clot formation (peripheral arterial occlusive disease, previous myocardial infarction with or without recurrent ischaemia, ischaemic stroke, unstable angina);
to prevent closure of heart bypass grafts (aorto-coronary bypass);
during surgical procedures requiring artificial circulation (extracorporeal circulation);
during haemodialysis sessions;
if you suffer from central retinal vein thrombosis;
in people 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 adverse effects, this medicine should be used only when absolutely necessary and when treatment with another medicine different from TICLOPIDINE EG is not possible.

2. What you need to know before taking TICLOPIDINE EG

Do not take TICLOPIDINE EG

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, and agranulocytosis);
if you suffer from coagulation disorders, such as bleeding (hemorrhagic diathesis), even prolonged;
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 medicines);
if you are pregnant or 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 TICLOPIDINE EG.
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 authorization, 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 platelet anti-aggregation medicines such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). However, in the case of stent implantation, ticlopidine must be associated with aspirin (100–325 mg daily) for approximately one month after implantation.

It is essential to strictly follow the instructions, 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 irritation associated with bleeding (purpura), dark stools (symptoms of thrombocytopenia and/or coagulation disorders);
skin irritation associated with bleeding and reduced platelets (symptoms of thrombotic thrombocytopenic purpura);
chest pain due to circulatory disorders of the heart (angina);
yellowing of the skin (jaundice), dark urine, pale stools (symptoms of hepatitis). In case of suspected thrombotic thrombocytopenic purpura, consult a specialist immediately, as there is a high risk of death. Onset may be sudden, and in most cases it has been observed within the first 8 weeks of starting therapy. Symptoms include reduced platelets (thrombocytopenia) and red blood cells (hemolytic anemia), neurological symptoms similar to those of a transient ischemic attack (TIA) or stroke, kidney disorders, 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 and then every 2 weeks during the first 3 months of therapy, and within 15 days of any interruption of TICLOPIDINE EG, if such interruption occurs within the first 3 months of treatment.
Your doctor will instruct you to stop treatment with this medicine if you develop low white blood cells (neutropenia) or low platelets (thrombocytopenia).
If you are scheduled for minor surgical procedures, such as tooth extraction, inform your doctor that you are taking this medicine.
Stop treatment at least 10 days before any surgery to avoid the risk of bleeding.
In case of emergency surgery, inform your doctor about ongoing treatment so that appropriate precautions can be taken to avoid the risk of bleeding.
Use this medicine with caution if you are at risk of bleeding (hemorrhage) or have liver problems (hepatic dysfunction). Perform periodic liver function tests, especially during the first three months of treatment.
If your doctor considers it absolutely necessary, in addition to TICLOPIDINE EG, he or she may prescribe other medicines that thin the blood; in such cases, your doctor will keep you under close monitoring and instruct you to perform certain blood tests at regular intervals.
If you have kidney problems (renal insufficiency), consult your doctor, who may reduce the dose or discontinue treatment if bleeding problems or blood disorders (hematopoietic disorders) occur.
After 1–4 months of treatment, some blood values (cholesterol and triglycerides) may increase, regardless of age, sex, or health status, without affecting the risk of cardiovascular disease.
Generally, within the first 3 months of treatment, a skin rash may appear, which disappears within a few days after stopping treatment.
Children and adolescents
The use of this medicine in children and adolescents is not recommended.
Other medicines and TICLOPIDINE EG
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 medicines).
Inform your doctor if you are taking any of the following medicines in addition to TICLOPIDINE EG, as this may increase the risk of bleeding (hemorrhage):

non-steroidal anti-inflammatory drugs (NSAIDs);
platelet anti-aggregation medicines, 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 (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 pay particular attention if you are taking any of the following medicines, as specific precautions may be necessary:

theophylline, a medicine used to treat asthma, because dosage adjustment may be required;
digoxin, a medicine used in the treatment of 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 cases.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine if you are pregnant or 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.
TICLOPIDINE EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take TICLOPIDINE EG

Take this medicine exactly as directed by your doctor.
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 EG 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, treatment includes induction of vomiting, gastric lavage, and other supportive measures.
If you forget to take TICLOPIDINE EG
Do not take a double dose to make up for the forgotten tablet.
If you stop taking TICLOPIDINE EG
If you discontinue treatment with this medicine within the first three months, your doctor will prescribe a complete blood test two weeks after stopping therapy. Blood parameters must be monitored until they return to normal.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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, sometimes severe (neutropenia, agranulocytosis);
headache, dizziness;
alteration of liver function (increase in liver enzymes, increase in alkaline phosphatase and transaminases);
diarrhoea and nausea;
skin irritations (maculopapular or urticarial rash), often accompanied by itching;
increase in 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 systemic infection (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), bleeding in the lower part of the eye (conjunctival haemorrhage), nosebleeds (epistaxis), bleeding during surgery (perioperative haemorrhage) and postoperative haemorrhage, which may be severe and sometimes fatal;
formation of lesions in the stomach and intestine (gastroduodenal ulcer);
disturbances in liver function (increase in bilirubin);
skin irritation associated with desquamation (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, thrombocytosis);
perception of ringing or other noise 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), swelling of the face, especially around eyes and mouth (Quincke's oedema), increase in white blood cells (eosinophilia), joint pain (arthralgia), inflammation of blood vessels (vasculitis), irritative 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;
skin allergic reactions (erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome);
fever.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TICLOPIDINE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 EG contains

The active substance is ticlopidine hydrochloride. Each tablet contains 250 mg of ticlopidine hydrochloride.
The other components are: maize starch, microcrystalline cellulose, magnesium stearate, precipitated silica, polyvinylpyrrolidone K30, anhydrous lactose, hypromellose, titanium dioxide, polyethylene glycol 6000.

Description of the appearance of TICLOPIDINE EG and pack sizes
Pack containing 30 coated tablets.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 20136 Milan - Italy
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno, 48 – 20089 Quinto de' Stampi – Rozzano (MI) - Italy
Special Product's Line S.p.A., Strada Paduni, 240 - 03012 Anagni (FR) - Italy