Package leaflet: Information for the user

Aclotin, 250 mg, coated tablets
Ticlopidini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Aclotin is and what it is used for
Important information before taking Aclotin
How to take Aclotin
Possible side effects
How to store Aclotin
Contents of the pack and other information

1. What Aclotin is and what it is used for

Aclotin is a medicine that inhibits platelet aggregation (clumping) and the release of platelet clotting factors. It prevents the formation of arterial and venous thrombi, prolongs bleeding time, and reduces blood viscosity.
Aclotin is used:

to reduce the risk of ischemic stroke in patients who have previously experienced episodes of cerebral ischemia (after ischemic stroke or transient ischemic attacks),
to prevent severe ischemic events (particularly in the coronary vessels) in patients with atherosclerosis of the lower limb arteries during intermittent claudication,
to prevent thrombosis in arteriovenous fistulas in patients undergoing hemodialysis.

2. Important information before using Aclotin

When not to use Aclotin

If the patient is allergic to ticlopidine or any of the other ingredients of this medicine (listed in section 6);
If the patient has a bleeding disorder;
If the patient has a disease that may cause bleeding, e.g. peptic ulcer, acute haemorrhagic stroke;
If the patient has a blood disorder associated with prolonged bleeding time;
If the patient currently has or has previously had blood disorders such as reduced white blood cell count (leukopenia), marked reduction in one type of white blood cells – granulocytes (agranulocytosis), or reduced platelet count (thrombocytopenia).

Warnings and precautions

Before starting treatment with Aclotin, discuss this with your doctor or pharmacist:

Aclotin should be used mainly in patients with hypersensitivity or inadequate response to salicylic acid.
Ticlopidine may cause blood disorders, sometimes severe, such as reduced number of certain white blood cells (acute neutropenia), complete or near-complete absence of granulocytes (agranulocytosis), reduced platelet count (thrombocytopenia), or a disease caused by platelet clumping within blood vessels accompanied by thrombocytopenia (thrombotic thrombocytopenic purpura). It is essential to strictly follow the doctor's instructions regarding regular blood tests during and after treatment.
If any of the following symptoms occur: fever, sore throat, oral ulcers (which may indicate reduced granulocyte count), prolonged or unusual bleeding, easy bruising, purpura, tarry stools (which may indicate reduced platelet count or disorders in mechanisms preventing bleeding), or jaundice, dark urine or pale stools (which may indicate liver inflammation), these may be caused by ticlopidine and should be reported to the doctor immediately.
The occurrence of thrombocytopenia, haemolytic anaemia, neurological symptoms (similar to stroke), kidney function disorders, and fever may indicate thrombotic thrombocytopenic purpura. Since this condition may be life-threatening, medical attention should be sought immediately if these symptoms appear.
Ticlopidine should be used with caution if there is a risk of bleeding.
If the doctor considers it necessary to use ticlopidine together with oral anticoagulants, antiplatelet drugs, heparin, or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, treatment will be closely monitored and the patient's condition carefully controlled.
If the patient is scheduled for even minor surgical procedures (e.g. tooth extraction), it is essential to inform the doctor about taking Aclotin. Treatment with ticlopidine should be discontinued at least 10 days before any planned surgery.
If the patient currently has or has previously had kidney or liver disease, dosage adjustment of Aclotin may be required.

Aclotin and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. Especially inform about the use of the following medicines:

Non-steroidal anti-inflammatory drugs, including acetylsalicylic acid and other salicylates (medicines used to treat inflammation and to reduce pain)
Antiplatelet drugs (medicines used to prevent platelet aggregation)
Oral anticoagulants or heparin (medicines used to thin the blood)
Theophylline (a medicine used in the treatment of asthma or chronic obstructive pulmonary disease)
Pentoxifylline (a medicine used to treat circulation disorders in hands and feet)
Digoxin (a cardiac medicine)
Phenytoin (a medicine used in the treatment of epilepsy)
Cyclosporine (a medicine used to suppress the body's immune response)
Antipyrine (phenazone) (a medicine with analgesic properties)
Medicines that neutralize gastric acid
Cimetidine (a medicine used in the treatment of gastric and duodenal ulcers)
Selective serotonin reuptake inhibitors (including, but not limited to, fluoxetine or fluvoxamine) (medicines commonly used in the treatment of depression)

Aclotin with food and drink

Aclotin should be taken during meals.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. Aclotin must not be used during pregnancy or breastfeeding unless absolutely necessary, as determined by the doctor.

Driving and operating machinery

Aclotin may cause dizziness, which may impair the ability to drive or operate machinery.

Aclotin contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Aclotin

This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor.
The usual dose of Aclotin is:
Adults: orally, usually 250 mg (1 coated tablet) twice daily, taken with meals.
Children and adolescents under 18 years of age: Aclotin is not recommended for use in children under 18 years of age due to lack of data on safety and efficacy.
Patients with renal impairment:
Caution is advised. In case of severe renal insufficiency, the physician may consider it necessary to reduce the dose of Aclotin.
Patients with hepatic impairment:
Caution is advised. In some patients with liver insufficiency, the physician may consider it necessary to reduce the dose of Aclotin.
Use of a higher than recommended dose of Aclotin
In case of Aclotin overdose, seek immediate medical attention. The physician will initiate appropriate management (if necessary: induction of vomiting or gastric lavage, patient monitoring, symptomatic treatment).
Missed dose of Aclotin
If a dose of the medicine is missed at the scheduled time, take it as soon as possible. However, if the time for the next dose is approaching, skip the missed dose. Do not take a double dose to make up for the missed dose.
Discontinuation of Aclotin
Discontinuing treatment with Aclotin results in the loss of the beneficial effect of the medicine in the conditions for which it is taken.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.

Common adverse reactions (may occur in up to 1 in 10 people):

changes observed in blood tests (reduction, sometimes significant, in the number of neutrophils or agranulocytosis),
headache, dizziness,
gastrointestinal disorders, e.g. diarrhoea, nausea, vomiting,
increased liver enzyme activity,
skin rashes, often with itching,
increased blood lipid levels.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

reduced platelet count, rarely with haemolytic anaemia,
sepsis and septic shock as a fatal complication of agranulocytosis,
loss of appetite,
sensory disturbances (so-called peripheral neuropathy),
various types and degrees of bleeding (including life-threatening), i.e. bruising, petechiae, nosebleeds, haematuria, gastrointestinal bleeding, conjunctival haemorrhage, bleeding during and after surgery,
gastric and (or) duodenal ulceration,
increased blood bilirubin levels,
exfoliative dermatitis.

Rare adverse reactions (may occur in up to 1 in 1000 people):

reduced number of red blood cells, white blood cells and platelets (pancytopenia), bone marrow suppression, potentially fatal thrombotic thrombocytopenic purpura,
tinnitus,
intracerebral haemorrhage,
liver function disorders, i.e. hepatitis, cholestatic jaundice.

Very rare adverse reactions (may occur in up to 1 in 10,000 people):

allergic reactions,
increased number of eosinophils (eosinophilia),
anaphylaxis,
angioedema,
joint pain,
vasculitis,
systemic lupus erythematosus,
allergic respiratory disorders,
hypersensitivity reactions affecting the kidneys (sometimes leading to kidney failure),
severe diarrhoea with colitis,
lymphocytic colitis,
liver function disorders,
fulminant hepatitis, including fatal cases,
very severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome),
fever.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Aclotin

Store below 25°C. Keep in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aclotin contains

The active substance is ticlopidine hydrochloride.
The other ingredients are: monohydrate lactose, maize starch, microcrystalline cellulose (E 460), stearic acid (E 570), hypromellose, titanium dioxide (E 171), polyethylene glycol 6000.

What Aclotin looks like and contents of the pack
Aclotin is in the form of film-coated tablets.
The medicine is packed in Al/PVC blisters with 20 tablets per blister, placed in a cardboard box.
20 film-coated tablets (1 blister containing 20 tablets)
60 film-coated tablets (3 blisters containing 20 tablets each)
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów, Poland