Ticlopidine Dorom

Package leaflet: Information for the patient

Ticlopidina Dorom 250 mg film-coated tablets

ticlopidine hydrochloride
Equivalent medicine
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, consult 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 may 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:

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

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

Ticlopidina Dorom contains the active substance ticlopidine, which belongs to a group of
medicines called platelet aggregation inhibitors, capable of improving blood circulation by
preventing the formation of blood clots (thrombi).
Ticlopidina Dorom is used:

• to prevent events involving blockage of blood flow to the brain and heart (cerebral and cardiovascular occlusive ischemia) in people who have a high risk of blood clot formation (e.g. those with peripheral arterial disease, previous myocardial infarction, recurrent transient ischemic attacks, ischemic stroke, or unstable angina); in individuals who have had a heart attack or transient ischemic attacks, only if they are intolerant to acetylsalicylic acid (ASA), or if treatment with acetylsalicylic acid has not been effective.
• to prevent the closure of heart bypass grafts (aortocoronary bypasses);
• during surgical procedures requiring the use of a biomedical device to maintain normal cardio-circulatory function (extracorporeal circulation);
• during hemodialysis sessions;
• in cases of obstruction (thrombosis) of the central retinal vein.

2. What you should know before taking Ticlopidina Dorom

Do not take Ticlopidina Dorom

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have or have previously had abnormalities in the levels of certain blood cells (leucopenia, thrombocytopenia, and agranulocytosis);
• if you suffer from coagulation disorders or are prone to bleeding (hemorrhagic diathesis), or if you have a disease affecting your hematopoietic system (the set of organs and tissues involved in blood cell production);
• if you have lesions that could bleed, such as in the esophagus or stomach (gastrointestinal ulcers, esophageal varices, etc.);
• in case of stroke (acute hemorrhagic cerebrovascular accidents);
• if your liver function is severely impaired (severe hepatopathy);
• if you are taking other medicines that may interfere with the function of your bone marrow (myelotoxic medicines);
• if you are pregnant, unless your doctor considers it strictly necessary;
• if you are breastfeeding, unless your doctor considers it strictly necessary.

Do not use this medicine to prevent blood clots if you do not have any of the conditions listed in section 1.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ticlopidina Dorom.

During treatment with Ticlopidina Dorom, adverse events, even serious ones, may occur, including hematological (involving the blood, such as agranulocytosis, pancytopenia, and rare cases of leukemia) and hemorrhagic events (bleeding episodes).

For this reason, treatment with this medicine must always be under strict medical supervision, especially during the first three months of treatment, to prevent the occurrence of possible adverse effects.

Be cautious when using Ticlopidina Dorom 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 allergy 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.

Pay special attention and consult your doctor before taking Ticlopidina Dorom if:

• your liver function is impaired or suspected to be impaired;
• your kidney function is impaired (renal insufficiency), as it may be necessary to reduce the dose or discontinue treatment if hematological or hemorrhagic problems occur;
• you are already taking anticoagulant medicines (e.g., heparin) or antiplatelet agents such as aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs), as this increases the risk of hemorrhagic events (see also “Other medicines and Ticlopidina Dorom”);
• you need to undergo minor surgery (e.g., tooth extraction) while being treated with Ticlopidina Dorom to avoid the risk of prolonged bleeding; you should discontinue treatment approximately 10 days before the procedure, as directed by your doctor;
• you need to undergo emergency surgery; inform your doctor about your ongoing treatment with Ticlopidina Dorom, as appropriate precautions will be taken to avoid the risk of bleeding.

This medicine should be used with caution if you are undergoing treatment with selective serotonin reuptake inhibitors (SSRIs).

Moreover, you must pay particular attention, stop treatment, and contact your doctor immediately if you experience:

• sore throat, fever, and lesions (ulcers) in the mouth or throat, as these could be symptoms of reduced white blood cell levels (neutropenia);
• prolonged bleeding or bruising (hematomas), inflammation of small blood vessels in the skin causing red-violet skin discoloration due to bleeding (purpura), or dark stools, as these could be symptoms of reduced platelet levels (thrombocytopenia) or coagulation disorders;
• altered consciousness and fever associated with low platelet count, low hemoglobin concentration in the blood (hemolytic anemia), and kidney disorders; neurological symptoms similar to those of an ischemic attack (TIA) or stroke could indicate a rare but serious condition known as "thrombotic thrombocytopenic purpura";
• yellowing of the skin (jaundice), dark urine, and pale stools, as these could be symptoms of impaired liver function (hepatitis);
• severe diarrhea.

Laboratory tests

During treatment with Ticlopidina Dorom or if you discontinue treatment within the first 3 months of therapy, your doctor will regularly prescribe blood tests (complete blood count) to monitor whether the levels of blood components change.

Your doctor will discontinue treatment with this medicine if you develop a severe decrease in white blood cells (neutropenia) or platelets (thrombocytopenia).

Additionally, your doctor will periodically perform clinical examinations to check for symptoms of possible blood disorders and to monitor your liver function, especially during the first three months of treatment.

Children and adolescents

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

Other medicines and Ticlopidina Dorom

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must specifically inform your doctor if you are taking:

• 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 the arms and legs.

The use of Ticlopidina Dorom should be avoided together with medicines that may interfere with proper bone marrow function (myelotoxic medicines).

The following medicines, when taken together with Ticlopidina Dorom, may increase the risk of bleeding (hemorrhage):

• non-steroidal anti-inflammatory drugs (NSAIDs);
• other antiplatelet agents, used to increase blood fluidity and thereby improve blood circulation;
• acetylsalicylic acid and derivatives (anti-inflammatory medicines);
• oral and parenteral anticoagulants (heparin), used to increase blood fluidity and thereby improve blood circulation.

Moreover, it is important to pay particular attention and inform your doctor if you are taking any of the following medicines, as interactions may occur and in some cases dose adjustment may be necessary:

• theophylline (used for the treatment of asthma);
• digoxin (a medicine used in the treatment of cardiac rhythm disorders);
• phenobarbital (used as a sedative, particularly in epilepsy);
• phenytoin (used for the treatment of epilepsy);
• S-ketamine (used in general anesthesia);
• antipyrine (a medicine used to reduce fever, relieve rheumatic pain, and reduce pain of various origins);
• cimetidine and other anti-acid medicines (used for the treatment of stomach disorders);
• cyclosporine (an immunosuppressive medicine used in transplant cases).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Ticlopidina Dorom should not be used during pregnancy unless your doctor considers it strictly necessary.

Breastfeeding

Ticlopidina Dorom should not be used during breastfeeding unless your doctor considers it strictly necessary.

Driving and using machines

This medicine may cause dizziness and other adverse effects that could impair your ability to drive or operate machinery. Do not drive or operate machinery until you know how Ticlopidina Dorom affects you.

3. How to take Ticlopidina Dorom

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose for long-term therapy is 1 - 2 tablets daily, to be taken during meals.
If you take more Ticlopidina Dorom than you should
If you take more Ticlopidina Dorom than prescribed, inform your doctor immediately or go to the nearest hospital. Taking an excessive dose of this medicine may increase the risk of bleeding and cause stomach and intestinal problems.
If you forget to take Ticlopidina Dorom
Do not take a double dose to make up for the missed tablet.
If you stop taking Ticlopidina Dorom
Consult your doctor if you intend to discontinue the treatment.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and contact your doctor immediately if you experience even just
one of the following symptoms:

• skin rash and itching, even widespread, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema). These may be signs of severe allergic reactions that could lead to collapse (anaphylactic shock);
• severe skin reactions with appearance of red spots or widespread blisters and skin peeling, sometimes accompanied by fever (Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis);
• sore throat, fever and mouth or throat sores (ulcers), as these could be symptoms of a decrease in your white blood cell levels (neutropenia);
• bleeding, even prolonged, or bruising (haematoma), inflammation of small blood vessels in the skin causing a red-purple skin rash due to bleeding (purpura), or dark stools, as these could be symptoms of a decrease in your platelet levels (thrombocytopenia) or coagulation disorders;
• changes in consciousness and fever associated with decreased platelet count, low haemoglobin levels in the blood (haemolytic anaemia), and kidney problems; neurological symptoms similar to those of a transient ischaemic attack (TIA) or stroke could be signs of a rare but serious condition known as "thrombotic thrombocytopenic purpura";
• yellowing of the skin (jaundice), dark urine and pale stools, as these could be symptoms of liver function impairment (hepatitis);
• severe diarrhoea associated with inflammation of the intestine (colitis).

Common (may affect up to 1 in 10 people)

• reduction, sometimes severe, in the number of white blood cells in the blood (agranulocytosis, neutropenia);
• headache, dizziness;
• diarrhoea and nausea;
• changes in levels of certain liver enzymes (alkaline phosphatase and transaminases);
• skin rashes, often accompanied by itching, even widespread (rash, maculopapular rash or urticaria);
• increased cholesterol and triglyceride levels.

Uncommon (may affect up to 1 in 100 people)

• reduced platelet levels (thrombocytopenia), sometimes accompanied by a decrease in red blood cells (haemolytic anaemia);
• severe systemic infection (sepsis) and septic shock, which may occur as fatal complications of reduced white blood cell count (agranulocytosis);
• sensory disturbance (peripheral neuropathy);
• haemorrhagic complications, especially bruising, nosebleeds (epistaxis), blood in the urine (haematuria), or bleeding of the inner eyelids (conjunctival haemorrhage), bleeding occurring during or after surgery (perioperative and postoperative haemorrhage), which may be severe and sometimes fatal;
• formation of stomach and intestinal lesions (gastroduodenal ulcer);
• liver function disorders (increased blood bilirubin);
• skin irritation associated with peeling (exfoliative dermatitis).

Rare (may affect up to 1 in 1,000 people)

• reduction in all blood cells (pancytopenia);
• severe reduction in bone marrow activity (bone marrow aplasia);
• a serious condition known as "thrombotic thrombocytopenic purpura", characterised by low platelet count, low haemoglobin levels in the blood (haemolytic anaemia), and neurological symptoms similar to those of a transient ischaemic attack (TIA) or stroke;
• blood cell tumour (leukaemia);
• excessive increase in platelet count (thrombocytosis);
• ringing in the ears (tinnitus);
• bleeding in the brain;
• inflammation of the liver (cytolytic and/or cholestatic hepatitis);
• yellowish discoloration of the skin due to liver malfunction (cholestatic jaundice).

Very rare (may affect up to 1 in 10,000 people)

• immune system disorders: allergic reactions, even severe (anaphylactic), facial swelling, especially around the eyes and mouth (angioedema), increased levels of a certain type of white blood cells in the blood (eosinophilia), joint pain (arthralgia),
  inflammation of blood vessels (vasculitis), inflammation and lesions in various body tissues
  (systemic lupus erythematosus), altered lung function
  (allergic pneumonitis), altered kidney function (hypersensitivity nephropathy which may be associated with kidney failure);

• severe liver inflammation (fatal outcome hepatitis and fulminant hepatitis);

• fever;

• severe diarrhoea associated with inflammation of the intestine (colitis);

• severe skin reactions with appearance of red spots or widespread blisters and skin peeling, especially on legs, arms, hands and feet, which may extend to the face and lips, sometimes accompanied by fever (Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis).

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

• allergic reaction to medicines similar to ticlopidine, such as clopidogrel and prasugrel (See section “Warnings and precautions”);
• itching, red-coloured skin rash (eczema/dermatitis);
• lung inflammation with cough and difficulty breathing (interstitial lung disease) caused by hypersensitivity pneumonitis.

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

5. How to store Ticlopidina Dorom

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the container 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 Ticlopidina Dorom contains

• The active substance is ticlopidine hydrochloride. Each film-coated tablet contains 250 mg of ticlopidine hydrochloride.
• The other components are: microcrystalline cellulose, maize starch, hypromellose, magnesium stearate, titanium dioxide, povidone, anhydrous colloidal silica, and macrogols.

Description of the appearance of Ticlopidina Dorom and contents of the pack
Ticlopidina Dorom is supplied in a box containing 30 film-coated tablets in blister packs.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno 48 - 20089 Quinto de’ Stampi - Rozzano (MI), Italy
or
Merckle GmbH - Ludwig-Merckle Straße 3 - 89143 Blaubeuren (Germany)