Ticlopidine Alter

Patient Information Leaflet

TICLOPIDINE ALTER 250 mg Film-coated Tablets

Ticlopidine hydrochloride
Generic Medicine
Please 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TICLOPIDINE ALTER is and what it is used for
2. What you need to know before taking TICLOPIDINE ALTER
3. How to take TICLOPIDINE ALTER
4. Possible side effects
5. How to store TICLOPIDINE ALTER
6. Package contents and other information

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

Ticlopidina Alter 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 Alter is used:

• for the prevention of blocked 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, recurrent or non-recurrent ischaemia, ischaemic stroke, unstable angina);
• for the prevention of 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 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 side effects, this medicine should only be used when it is indispensable and when treatment with another medicine, different from Ticlopidina Alter, is not possible.

2. What you need to know before taking TICLOPIDINE ALTER

Do not take TICLOPIDINE ALTER

• 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 counts (leucopenia, thrombocytopenia, and agranulocytosis);
• if you suffer from coagulation disorders, such as bleeding (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 disorders affecting cerebral 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 or 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 of the conditions listed in section 1.
Warnings and precautions
Talk to your doctor or pharmacist before taking TICLOPIDINE ALTER.
Adverse events, sometimes serious, of hematological and hemorrhagic nature may occur.
Alterations in blood cell counts, 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 monitoring, delayed diagnosis, and inadequate management of side 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 of ticlopidine.
Treatment must be carried out under close medical supervision, especially during the first three months, to monitor for possible side effects.
If you notice any of the following symptoms, stop treatment immediately and contact 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);
• 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 low platelet count (thrombocytopenia), low red blood cell count (hemolytic anemia), neurological symptoms similar to transient ischemic attack (TIA) or stroke, kidney dysfunction, and fever.
Resuming treatment with this medicine depends on your clinical condition and blood test results (hematological monitoring), which must be performed urgently.
Perform 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 ALTER, if such interruption occurs within the first 3 months of treatment.
Discontinue treatment with this medicine if you develop low white blood cell count (neutropenia) or low platelet count (thrombocytopenia).
If you are scheduled for minor surgical procedures, such as tooth extraction, inform your doctor about your treatment with 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 appropriate precautions can be taken to prevent bleeding.
Use this medicine with caution if you are at risk of bleeding and if you have liver problems (hepatic dysfunction). Perform periodic 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 dose or discontinue treatment if bleeding or blood disorders (hematopoietic disorders) occur.
Children and adolescents
The use of this medicine in children and adolescents is not recommended.
Other medicines and TICLOPIDINE 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 may cause blood cell abnormalities (myelotoxic medicines).
Inform your doctor if you are taking the following medicines in addition to TICLOPIDINE ALTER, 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.

Inform your doctor and pay special 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 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.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or 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 side effects that could impair your ability to drive or operate machinery.
TICLOPIDINE ALTER contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take TICLOPIDINA ALTER

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 TICLOPIDINA ALTER than you should
If you accidentally take an excessive dose, contact your doctor immediately or go to the nearest hospital.
Overdose with this medicine may increase the risk of bleeding; if severe, treatment requires platelet transfusion.
In case of serious stomach and intestinal problems, treatment includes 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 forgotten tablet.
If you stop taking TICLOPIDINA ALTER
If you discontinue treatment with this medicine within the first three months, perform 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 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 everyone experiences 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;
• altered 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, and may be widespread;
• increased cholesterol and triglycerides.

Uncommon (may affect up to 1 in 100 people)

• decrease in platelets (thrombocytopenia), associated with 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 or blue spots on the skin (ecchymoses), 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 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 (bone marrow aplasia), blood disorders (thrombotic thrombocytopenic purpura, leukaemia, and thrombocytosis);
• perception of ringing or 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 the 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, and Lyell's syndrome);
• fever.

Reporting of side effects
If you experience any side effect, 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 the 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 TICLOPIDINE ALTER

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. This date applies to the product in its original, unopened packaging, stored correctly.
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 ALTER contains

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

Description of the appearance of TICLOPIDINE ALTER and pack contents
Pack containing 30 film-coated tablets.
Marketing Authorization Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan
Italy
Manufacturer
Officina Farmaceutica
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via R. Follereau, 25
24027 Nembro (BG)
Italy
ICE S.p.A.
Cantone Moretti, 29, Località San Bernardo
10090 Ivrea (TO)
Italy
January 2026