Package leaflet: information for the patient

TICLOPIDINA PENSA 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

TICLOPIDINA PENSA contains the active substance ticlopidine, which belongs to the class of platelet aggregation inhibitors, medicines that improve blood circulation by preventing the formation of blood clots (thrombi).
TICLOPIDINA PENSA 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 with or without recurrent ischaemia, ischaemic stroke, unstable angina);
to prevent closure of heart bypass grafts (aorto-coronary bypass);
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 absolutely necessary and when it is not possible to use another medicine instead of TICLOPIDINA PENSA.

2. What you should know before taking TICLOPIDINE PENSA

Do not take TICLOPIDINE PENSA

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, 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 phase hemorrhagic cerebrovascular accidents);
if you have severe liver problems (severe hepatopathy);
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 PENSA.
Adverse events, sometimes serious, of hematological and hemorrhagic nature may occur. Alterations in 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 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). 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 experience any of the following conditions, stop treatment immediately and inform 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 reduced 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 reduced platelets (thrombocytopenia) and red blood cells (hemolytic anemia), neurological symptoms similar to transient ischemic attack (TIA) or stroke, kidney problems, 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, then every 2 weeks during the first 3 months of therapy, and within 15 days of any interruption of TICLOPIDINE PENSA, if such interruption occurs within the first 3 months of treatment.
Stop 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 surgical procedure 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 risk.
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 three 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 PENSA
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 blood cell abnormalities (myelotoxic medicines).
Inform your doctor if you are taking the following medicines in addition to TICLOPIDINE PENSA, 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 particular 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 cardiac 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, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine may cause dizziness and other adverse effects that could impair your ability to drive or operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take TICLOPIDINA PENSA

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 PENSA than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Overdose with this medicine may increase the risk of bleeding; if prolonged, treatment may require platelet transfusion.
In case of severe gastrointestinal problems, management includes induction of vomiting, gastric lavage, and other supportive measures.
If you forget to take TICLOPIDINA PENSA
Do not take a double dose to make up for the missed tablet.
If you stop taking TICLOPIDINA PENSA
If you discontinue treatment with this medicine within the first three months, a complete blood test should be performed two weeks after stopping the 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 everybody gets 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 (increase in liver enzymes, increase in alkaline phosphatase and transaminases);
diarrhoea. This occurs mainly during the first three months of treatment and usually resolves within 1–2 weeks without discontinuing therapy;
nausea;
skin irritations (maculopapular or urticarial rash), often accompanied by itching;
increase in 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, 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 desquamation (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 sound 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), facial swelling especially around 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, Lyell's syndrome);
fever.

Reporting of side effects
If you experience any side effects, 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 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 TICLOPIDINE PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
The expiry date shown refers to the product stored correctly in its original packaging.
Store this medicine at a temperature not exceeding 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What TICLOPIDINA PENSA contains

The active substance is ticlopidine hydrochloride. Each film-coated tablet contains 250 mg of active substance.
The other components are microcrystalline cellulose, sodium croscarmellose, corn starch, hydroxypropylcellulose, magnesium stearate.
Coating: hypromellose, talc, titanium dioxide (E171).

Description of the appearance of TICLOPIDINA PENSA and contents of the pack
Pack size: 30 film-coated tablets.
Marketing Authorization Holder
PENSA PHARMA S.p.A.
Via Ippolito Rosellini, 12
20124 Milan
Italy
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012, Anagni (FR)
Italy
OR, when the batch number starts with the letter A:
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
via R. Follereau, 25
Nembro (BG)
Italy