Package leaflet: Information for the patient

Ticlopidine Aurobindo 250 mg film-coated tablets

Equivalent medicine
Please read all of 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 other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ticlopidina Aurobindo is and what it is used for

Ticlopidina Aurobindo 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 Aurobindo 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 and recurrent ischaemia, ischaemic stroke, unstable angina);
to prevent the closure of heart bypass grafts (aortocoronary bypass);
when artificial circulation (extracorporeal circulation) is required;
during haemodialysis sessions;
in patients with 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.

2. What you need to know before taking Ticlopidine Aurobindo

Do not take Ticlopidine Aurobindo

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 from coagulation disorders, such as bleeding (past or current hemorrhagic diathesis), even prolonged;
if you have lesions in the esophagus or stomach with a tendency to bleed (gastrointestinal ulcers, esophageal varices, etc.);
if you suffer from cerebrovascular disorders (acute phase of 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.

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 Aurobindo.
Adverse events, sometimes serious, of hematological and hemorrhagic nature may occur.
Alterations in blood components have been observed, such as a decrease in white blood cells
(agranulocytosis), a decrease in all blood cells (pancytopenia), and rare cases of leukemia after
marketing (see section 4).
These serious events may be associated with:

inadequate monitoring, delayed diagnosis, and inadequate treatment of side effects;
concomitant administration of anticoagulants or antiplatelet agents such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). You must strictly follow the indications, precautions, and contraindications for ticlopidine.

Your doctor should monitor your treatment, especially during the first three months, for the
possible onset of side effects.
If you notice any of the following conditions, stop treatment immediately and consult your doctor
without delay:

sore throat, fever, mouth ulcers (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 a decrease in platelets (symptoms of thrombotic thrombocytopenic purpura);
yellowing of the skin (jaundice), dark urine, pale stools (symptoms of hepatitis).

Contact your doctor if you experience thrombocytopenia, hemolytic anemia, neurological symptoms similar to those of a transient ischemic attack (TIA) or stroke, kidney problems, or fever (symptoms of thrombotic thrombocytopenic purpura).
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 for the first 3 months of therapy, and within 15 days of any interruption of Ticlopidine Aurobindo, 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 a decrease in white blood cells (neutropenia) or a decrease in 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 surgery to avoid the risk of bleeding.
If you need emergency surgery, inform your doctor that you are currently taking this medicine.
This medicine should be used with caution if you are being treated with selective serotonin reuptake inhibitors (SSRIs).
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 have kidney problems (renal insufficiency), consult your doctor, who may reduce the dose or discontinue treatment if bleeding or blood-related problems (hematopoietic disorders) occur.
Be cautious when using Ticlopidine Aurobindo 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, such as 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 shown an allergic reaction to a thienopyridine may have an increased risk of experiencing the same or another reaction to another thienopyridine. It is recommended to monitor for cross-reactivity and signs of hypersensitivity in patients with a known allergy to thienopyridines.
Children and adolescents
The use of this medicine in children and adolescents is not recommended.
Other medicines and Ticlopidine Aurobindo
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 changes in blood cells (myelotoxic drugs).
Inform your doctor if you are taking the following medicines in addition to Ticlopidine Aurobindo, 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 (heparin), medicines that improve circulation;
pentoxifylline, a medicine used for poor blood circulation in the arms and legs;
a selective serotonin reuptake inhibitor (including, but not limited to, fluoxetine or fluvoxamine), medicines usually used to treat depression.

Inform your doctor and be especially careful 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 immunosuppressant medicine used in transplant patients;
ketamine, a medicine used in general anesthesia.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use TICLOPIDINE AUROBINDO during pregnancy or breastfeeding only if strictly necessary.
Driving and using machines
TICLOPIDINE AUROBINDO may affect your ability to drive or operate machinery.
Ticlopidine Aurobindo contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Ticlopidina Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you.
If you are in any doubt, 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 Ticlopidina Aurobindo than you should
If you accidentally take too high a dose, contact your doctor immediately or go to the nearest hospital.
Overdose with this medicine may increase the risk of bleeding.
In case of serious stomach and intestinal problems, treatment includes inducing vomiting, gastric lavage, and other supportive measures.
If you forget to take Ticlopidina Aurobindo
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Ticlopidina Aurobindo
If you discontinue treatment with this medicine within the first three months, a complete blood test should be performed two weeks after stopping therapy. Blood parameters must be monitored until they return to normal.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
The use of this medicine may cause the following adverse effects:
Common (may affect up to 1 in 10 people)

decrease in white blood cells, even 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;
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 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), 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 (increase in 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 (aplastic anaemia), blood disorders (thrombotic thrombocytopenic purpura, leukaemia, and thrombocytosis);
perception of ringing in the ear (tinnitus);
brain haemorrhage (intracerebral);
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 (angioedema), increase in white blood cells (eosinophilia), joint pain (arthralgia), inflammation of blood vessels (vasculitis), irritant-type 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, and Lyell's syndrome);
fever.

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

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

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Ticlopidine Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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. Contents of the pack and other information

What Ticlopidina Aurobindo contains

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

Description of the appearance of Ticlopidina Aurobindo and contents of the pack
Pack containing 30 film-coated tablets.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy
Manufacturer
Special Product’s Line S.p.A.
Via Campobello, 15
00040 Pomezia (Roma)
Italy
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via R. Follereau, 25
24027 Nembro (BG)
Italy