TICLOPIDINA 250 mg Coated Tablet

Зміст інструкції

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

TICLOPIDINA ALTER 250 mg film-coated tablets

Ticlopidine hydrochloride

Equivalent Medicinal Product
Read this leaflet carefully before you start 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is TICLOPIDINA ALTER and what it is used for

TICLOPIDINA ALTER contains the active substance ticlopidine, belonging to the class of
antiplatelet agents, medicines that improve blood circulation by preventing the
formation of clots (thrombi).
TICLOPIDINA ALTER 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 not, 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 when it is irreplaceable and it is
not possible to follow a treatment with another medicine, different from TICLOPIDINA ALTER.

2. What you need to know before taking TICLOPIDINA ALTER

Do not take TICLOPIDINA ALTER

• 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 (haemorrhagic 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 haemorrhagic 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 antiplatelet and/or anticoagulant medicines, used to improve blood flow.

Do not use this medicine for primary prevention if you do not have any condition
listed in section 1.

Warnings and precautions
Consult your doctor or pharmacist before taking TICLOPIDINA ALTER.
Adverse events, sometimes serious, of a haematological and haemorrhagic nature may be observed.
Alterations in the levels of all blood cells such as agranulocytosis, pancytopenia and rare cases of
leukaemia have been reported after marketing, sometimes with fatal outcome
(See section 4).
Such 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 non-steroidal 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 the
treatment and inform your doctor:

• sore throat, fever, mouth sores (symptoms of neutropenia);
• bleeding even prolonged or bruises (haematomas), skin irritation associated with bleeding (purpura), dark stools (symptoms of thrombocytopenia and/or coagulation disorders);
• skin irritation associated with bleeding and decreased platelets (symptoms of thrombotic thrombocytopenic purpura);
• 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. The onset may be sudden and in most cases has been reported within the first 8 weeks of starting therapy. Symptoms are decreased
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.
Perform 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 ALTER, if such interruption
occurs within the first 3 months of therapy.
Stop treatment with this medicine in case of decreased white blood cells
(neutropenia) and decreased platelets (thrombocytopenia).
If you need to undergo minor surgical procedures, such as a tooth extraction, inform your doctor
of the 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 (haemorrhage) and if you
have liver problems (hepatic dysfunction). Periodically perform liver function tests, especially during the first
months of treatment.
If you suffer from kidney problems (renal insufficiency), consult your doctor who may reduce the dosage
or stop treatment if bleeding problems or blood problems (hematopoietic disorders) occur.

Children and adolescents
The use of this medicine in children and adolescents is not recommended.

Other medicines and TICLOPIDINA ALTER
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).
Tell your doctor if you are taking the following medicines in addition to TICLOPIDINA ALTER, as it may
increase the risk of bleeding (haemorrhage):

• non-steroidal 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.

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

• theophylline, a medicine used to treat asthma, because the dosage may need to be adjusted;
• 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 case of transplants.

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

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

TICLOPIDINA ALTER contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with a
intolerance to certain sugars, contact him before taking this medicine.

3. How to take TICLOPIDINA ALTER

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 ALTER 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 involves inducing vomiting, gastric
lavage and other supportive measures.

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

If you stop taking TICLOPIDINA ALTER
If you stop treatment with this medicine within the first three months, have a complete blood
test, 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 everyone 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, even severe (neutropenia, agranulocytosis);
• headache, dizziness;
• alteration of liver function (increased liver enzymes, increased alkaline phosphatase and transaminases);
• diarrhea and nausea;
• skin irritations (maculopapular or urticarial rash), often accompanied by itching and may also be widespread;
• 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 bruises or bluish spots on the skin (ecchymosis), 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 hemorrhage) and post-operative bleeding which may be severe and sometimes fatal;
• formation of lesions in the stomach and intestines (gastroduodenal ulcer);
• disorders of 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, leukemia and thrombocytosis);
• perception of a sound in the ear (tinnitus);
• brain hemorrhages (intracerebral);
• liver disorders, such as hepatitis (cytolytic and/or cholestatic hepatitis);
• yellowish discoloration of the skin due to a malfunction of the liver (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 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 pneumopathy), 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.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http:// www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can
contribute to providing more information on the safety of this medicine.

5. How to store TICLOPIDINA ALTER

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 “Scad.”.
The expiry date refers to the last day of that month. This date applies to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in 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 ALTER contains

• The active ingredient is ticlopidine hydrochloride. Each tablet contains 250 mg of active ingredient.
• The other ingredients are lactose,hydroxypropylcellulose, microcrystalline cellulose, talc, magnesium stearate, sodium croscarmellose, polyethylene glycol 6000, titanium dioxide.

Description of the appearance of TICLOPIDINA ALTER and contents of the pack
Pack of 30 film-coated tablets.

Marketing Authorisation Holder
Laboratori Alter S.r.l.
via Egadi, 7
20144 MilanoItaly

Manufacturer
Officina Farmaceutica
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via R. Follereau, 25
24027 Nembro (BG)
Italy
ABC Farmaceutici S.p.A. Cantone Moretti, 29, Località San Bernardo 10090 Ivrea (TO)