TICLOPIDINA 250 mg Coated Tablet

Зміст інструкції

1. TICLOPIDINA DOC Generici 250 mg tablets
   1. What is TICLOPIDINA DOC Generici and what it is used for
   2. What you need to know before taking TICLOPIDINA DOC Generici
   3. How to take TICLOPIDINA DOC Generici
   4. Possible side effects
   5. How to store TICLOPIDINA DOC Generici
   6. Contents of the pack and other information

TICLOPIDINA DOC Generici 250 mg tablets

Equivalent Medicine
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 doubts, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is TICLOPIDINA DOC Generici and what it is used for

TICLOPIDINA DOC Generici contains the active ingredient ticlopidine, belonging to the class of
antiplatelet agents, medicines that improve blood circulation by preventing the formation
of clots (thrombi).
TICLOPIDINA DOC Generici is used

• in the prevention of blockage of blood flow to the brain and heart (ischemia) in people who have a high risk of blood clot formation (peripheral obliterating arterial disease, previous myocardial infarction and recurrent or non-recurrent ischemia, ischemic stroke, unstable angina);
• in the prevention of closure of heart bypasses (aorto-coronary);
• during surgical procedures that require artificial circulation (extracorporeal circulation);
• during hemodialysis sessions;
• if you suffer from central retinal vein thrombosis;
• in people who have had a heart attack or ischemic attacks, only if they are intolerant to acetylsalicylic acid (ASA), or if therapy with acetylsalicylic acid has proven ineffective.

Given the side effects, this medicine should only be used in the cases listed above and performing the checks
indicated in the paragraph "Warnings and precautions" and carefully respecting what is reported in the paragraph
"Do not take TICLOPIDINA DOC Generici".

2. What you need to know before taking TICLOPIDINA DOC Generici

Do not take TICLOPIDINA DOC Generici

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have had alterations in blood cell levels (leukopenia, thrombocytopenia and agranulocytosis);
• if you suffer from bleeding disorders, such as bleeding (hemorrhagic diathesis) even prolonged;
• if you have lesions of the esophagus or stomach with a tendency to bleed (gastrointestinal ulcers, esophageal varices, etc.);
• if you suffer from disorders of the brain circulation (acute hemorrhagic stroke);
• if you have severe liver problems (severe hepatopathies);
• if you are taking other medicines that may interfere with bone marrow function (myelotoxic medicines);
• if you are pregnant and if you are breastfeeding;
• if you are being treated with medicines that prevent blood clotting and/or anticoagulants, used to improve blood flow.

Do not use this medicine for primary prevention unless you are affected by none of the conditions listed
in section 1.

Warnings and precautions
Consult your doctor or pharmacist before taking TICLOPIDINA DOC Generici.
Adverse events, sometimes serious, of a hematological and hemorrhagic nature may be observed. Alterations
in the levels of blood components such as agranulocytosis, pancytopenia and rare cases of leukemia have been
reported after marketing authorization, sometimes with fatal outcome (See section 4).
These serious events may be associated with:

• inadequate control, late diagnosis and inadequate treatment of side effects
• concurrent administration of anticoagulants or antiplatelet agents such as aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs). However, in the case of Stent implantation, ticlopidine must be associated with aspirin (100-325 mg per day) for about one month after implantation.

It is essential to strictly adhere to the indications, precautions and contraindications of ticlopidine.
Treatment should be carried out under strict medical supervision, especially during the first three months, for
the onset of any side effects.
If you notice the manifestation of any of the following conditions, immediately stop treatment and
inform your doctor:

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

If you suspect thrombotic thrombocytopenic purpura, consult a specialist, as there is a
high risk of death. Onset may be sudden and has been reported in most cases within the first 8 weeks from the start of therapy. Symptoms are a decrease in 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.
Restarting treatment with this medicine depends on your clinical condition and the results of
blood tests (hematological control), which must be performed urgently.
Have blood tests at the beginning of treatment and then every 2 weeks for the first 3 months of therapy and
within 15 days of any interruption of TICLOPIDINA DOC Generici, if such interruption occurs
within the first 3 months of therapy.
Stop treatment with this medicine in case of a decrease in white blood cells (neutropenia) and
a decrease in platelets (thrombocytopenia).
If you are to undergo minor surgical procedures, such as a tooth extraction, inform your doctor of
treatment with this medicine.
Stop treatment at least 10 days before surgery, to avoid the risk of
bleeding.
In case of emergency surgery, inform your doctor of the ongoing treatment, who will take
appropriate precautions to avoid the risk of bleeding.
Use this medicine with caution if you are at risk of bleeding (hemorrhage) and if you have liver problems
(hepatic dysfunction). Perform liver function tests periodically, especially during the first three
months of treatment.
If you suffer from kidney problems (renal insufficiency), consult your doctor who may reduce the dosage or
suspend treatment if bleeding problems or blood problems (hematopoietic disorders) occur.
Be careful when using TICLOPIDINA DOC Generici if you are allergic to other medicines similar to
ticlopidine (medicines belonging to the thienopyridine group), such as clopidogrel and prasugrel,
because episodes of cross-reactions may occur (See section 4). Taking these
medicines may cause allergic reactions from moderate to severe such as skin irritation (rash), swelling of the
face, especially around the eyes and mouth (angioedema or Quincke's edema), alteration of the levels of
platelets and white blood cells in the blood (thrombocytopenia and neutropenia).
Patients who have experienced an allergy to a thienopyridine may be at greater risk of
experiencing the same or another reaction to another thienopyridine. It is recommended to check 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 TICLOPIDINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Avoid using this medicine together with other medicines that can cause alterations in blood cells (myelotoxic medicines).
You must specifically inform your doctor if you are taking the following medicines as they may
increase the risk of bleeding (hemorrhage):

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

Inform your doctor and be particularly careful if you are taking any of the following medicines, as
it may be necessary to take specific precautions:

• theophylline, a medicine used to treat asthma, because it may be necessary to adjust the dosage;
• 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 used in case of transplants.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine if you are pregnant or breastfeeding, unless in cases of
absolute necessity.

Driving and using machines
The use of this medicine can cause dizziness and other side effects, which may alter the ability to
drive vehicles or use machinery.

3. How to take TICLOPIDINA DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
For prolonged treatments, the recommended dose is 1 or 2 tablets per day, to be taken during meals.

If you take more TICLOPIDINA DOC Generici than you should
In case of accidental intake of an excessive dose, contact your doctor immediately or go to the nearest
hospital.
Overdosage of this medicine may increase the risk of bleeding; if prolonged, it is necessary to
intervene through a platelet transfusion.
In case of severe stomach and intestinal problems, treatment includes inducing vomiting, gastric lavage and other supportive measures.

If you forget to take TICLOPIDINA DOC Generici
Do not take a double dose to make up for the missed tablet.

If you stop taking TICLOPIDINA DOC Generici
If you stop treatment with this medicine within the first three months, have a complete blood test
done, two weeks after stopping therapy. It is necessary to monitor blood parameters
until they return to normal.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Use of this medicine may cause the following side effects:

Common(may affect up to 1 in 10 people)

• decrease in white blood cells, also severe (neutropenia, agranulocytosis);
• headache, dizziness;
• alteration of liver function (increased liver enzymes, increased alkaline phosphatase and transaminases);
• diarrhea and nausea;
• skin irritations (rash, maculopapular or urticarial), 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 (hemolytic anemia);
• 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);
• bleeding complications, especially bruising, presence of blood in the urine (hematuria), or bleeding from the lower part of the eye (conjunctival hemorrhage), nosebleeds

(epistaxis) bleeding that occurs during surgery (peri-operative bleeding) and post-operative bleeding which may be severe and sometimes with fatal consequences;

• formation of lesions in the stomach and intestines (gastroduodenal ulcer);
• disorders of liver function (increased bilirubin);
• skin irritation associated with scaling (exfoliative dermatitis).

Rare(may affect up to 1 in 1000 people)

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

Very rare(may affect up to 1 in 10000 people)

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

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

• cross-reactivity of hypersensitivity between thienopyridines, such as clopidogrel and prasugrel (See section “Warnings and precautions”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the Italian Medicines Agency - Website: http://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 TICLOPIDINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 DOC Generici contains

• The active ingredient is ticlopidine hydrochloride. Each tablet contains 250 mg of the active ingredient.
• The other ingredients are microcrystalline cellulose, starch, methylcellulose, precipitated silica, magnesium stearate, titanium dioxide, gum arabic.

Description of the appearance of TICLOPIDINA DOC Generici and contents of the pack
Pack of 30 tablets of 250 mg.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano, Italy

Manufacturer
Mipharm S.p.A. - Via Bernardo Quaranta, 12 - 20141 Milano (Mi)
SPECIAL PRODUCT’S LINE S.p.A. - Strada Paduni, 240 - 03012 Anagni (FR)