Aclotin

Package Leaflet: Information for the User

Aclotin, 250 mg, Film-Coated Tablets

Ticlopidine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Aclotin and what is it used for
• 2. Important information before taking Aclotin
• 3. How to take Aclotin
• 4. Possible side effects
• 5. How to store Aclotin
• 6. Package contents and other information

1. What is Aclotin and what is it used for

Aclotin is a medication that inhibits platelet aggregation and the release of platelet clotting factors. It prevents the formation of arterial and venous thrombi and prolongs bleeding time and reduces blood viscosity.

Aclotin is used:

• to reduce the risk of ischemic stroke in patients who have had a previous episode of cerebral ischemia (after an ischemic stroke, transient ischemic attacks),
• to prevent severe ischemic events (especially in the coronary arteries) in patients with intermittent claudication due to atherosclerosis of the lower limbs,
• to prevent thrombosis in arteriovenous shunts in patients undergoing hemodialysis.

2. Important information before taking Aclotin

When Not to Take Aclotin

• If you are allergic to ticlopidine or any of the other ingredients of this medicine (listed in section 6);
• If you have a bleeding disorder;
• If you have a disease that may cause bleeding, such as stomach or duodenal ulcers, acute hemorrhagic stroke;
• If you have a blood disease characterized by prolonged bleeding time;
• If you have or have had blood disorders, such as a decrease in the number of white blood cells (leukopenia), a significant decrease in the number of granulocytes (agranulocytosis) or a decrease in the number of platelets (thrombocytopenia).

If the patient experiences any of the following symptoms, they should inform their doctor immediately: fever, sore throat, oral ulcers (which may indicate a decrease in the number of granulocytes), prolonged or unusual bleeding, easy bruising, petechiae, black stools (which may indicate a decrease in the number of platelets or disorders of mechanisms responsible for preventing bleeding) or jaundice, dark urine or pale stools (which may indicate liver inflammation).

Warnings and Precautions

Before starting to take Aclotin, you should discuss it with your doctor or pharmacist:

• Aclotin should be used mainly in patients with hypersensitivity or lack of effective response to salicylic acid.
• Ticlopidine may cause blood disorders, sometimes severe, such as a decrease in the number of certain white blood cells (severe neutropenia), total or almost total lack of granulocytes (agranulocytosis) or a decrease in the number of platelets (thrombocytopenia) and a disease caused by platelet aggregation in the vessel with accompanying thrombocytopenia (thrombotic thrombocytopenic purpura). You should strictly follow your doctor's recommendations regarding blood tests during and after treatment.
• If you experience any of the following symptoms: fever, sore throat, oral ulcers (which may indicate a decrease in the number of granulocytes), prolonged or unusual bleeding, easy bruising, petechiae, black stools (which may indicate a decrease in the number of platelets or disorders of mechanisms responsible for preventing bleeding) or jaundice, dark urine or pale stools (which may indicate liver inflammation), you should inform your doctor immediately.
• The occurrence of thrombocytopenia, hemolytic anemia, neurological symptoms (similar to stroke symptoms), kidney dysfunction, and fever may indicate thrombotic thrombocytopenic purpura. Since this disease can be life-threatening, you should contact your doctor immediately if you experience any of these symptoms.
• Ticlopidine should be used with caution if there is a risk of bleeding.
• If your doctor considers it necessary to take ticlopidine and oral anticoagulants, antiplatelet agents, heparin, or nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, they will closely monitor your treatment and condition.
• If you are going to have even a minor surgical procedure (e.g., tooth extraction), you must inform your doctor about taking Aclotin. Treatment with ticlopidine should be discontinued at least 10 days before the planned surgical procedure.
• If you have or have had kidney or liver disease (it may be necessary to reduce the dose of Aclotin).

Aclotin and Other Medications

You should inform your doctor about all medications you are currently taking or have recently taken, as well as medications you plan to take, including those that are available without a prescription.

You should especially inform your doctor about the use of the following medications:

• nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid and other salicylates (medications used to treat inflammation and reduce pain)
• antiplatelet agents (medications used to prevent platelet aggregation)
• oral anticoagulants or heparin (medications used to thin the blood)
• theophylline (a medication used to treat asthma or chronic obstructive pulmonary disease)
• pentoxifylline (a medication used to treat circulatory disorders in the hands and feet)
• digoxin (a heart medication)
• phenytoin (a medication used to treat epilepsy)
• cyclosporine (a medication used to suppress the immune system)
• antipyrine (phenazone) (a medication with analgesic properties)
• antacids
• cimetidine (a medication used to treat stomach ulcers and gastrointestinal disorders)
• selective serotonin reuptake inhibitors (including fluoxetine or fluvoxamine) (medications commonly used to treat depression).

Aclotin with Food and Drink

Aclotin should be taken with food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medication. Aclotin should not be used during pregnancy and breastfeeding, unless your doctor considers it absolutely necessary.

Driving and Operating Machinery

Aclotin may cause dizziness, which can affect your ability to drive and operate machinery.

Aclotin Contains Lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medication.

3. How to Take Aclotin

This medication should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor.

The usual dose of Aclotin is:

Adults: orally, usually 250 mg (1 film-coated tablet) twice a day, with food.

Children and adolescents under 18 years: Aclotin is not recommended for use in children under 18 years due to the lack of data on safety and efficacy.

Patients with renal impairment:

Caution should be exercised. In cases of severe renal impairment, your doctor may consider reducing the dose of Aclotin.

Patients with hepatic impairment:

Caution should be exercised. In some patients with liver failure, your doctor may consider reducing the dose of Aclotin.

Overdose of Aclotin

In case of overdose, you should immediately contact your doctor, who will take appropriate action (if necessary: inducing vomiting or gastric lavage, monitoring the patient, symptomatic treatment).

Missed Dose of Aclotin

If you miss a dose, you should take it as soon as possible. However, if the time for the next dose is near, you should skip the missed dose. You should not take a double dose to make up for the missed dose.

Stopping Treatment with Aclotin

Stopping treatment with Aclotin will result in the loss of its beneficial effect in the conditions for which it is taken.

If you have any further questions about taking this medication, you should consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Aclotin can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• changes in blood test results (decrease, sometimes significant, in the number of neutrophils or agranulocytosis),
• headache, dizziness,
• gastrointestinal disorders, such as diarrhea, nausea, vomiting,
• increased liver enzyme activity,
• skin rashes, often with itching,
• increased blood lipid levels.

Uncommon side effects (may affect up to 1 in 100 people):

• decrease in the number of platelets, exceptionally with hemolytic anemia,
• sepsis and septic shock as a fatal complication of agranulocytosis,
• anorexia,
• peripheral neuropathy,
• bleeding of various types and severity (including life-threatening), such as bruising, petechiae, nosebleeds, hematuria, gastrointestinal bleeding, bleeding in the conjunctiva, bleeding during and after surgery,
• stomach or duodenal ulcers,
• increased bilirubin levels in the blood,
• exfoliative dermatitis.

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

• decrease in the number of red blood cells, white blood cells, and platelets (pancytopenia), bone marrow suppression, potentially fatal thrombotic thrombocytopenic purpura,
• tinnitus,
• intracerebral bleeding,
• liver dysfunction, such as hepatitis, cholestatic jaundice.

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

• allergic reactions,
• increased eosinophil count (eosinophilia),
• anaphylaxis,
• angioedema,
• arthralgia,
• vasculitis,
• lupus erythematosus,
• allergic respiratory disorders,
• hypersensitivity reactions in the kidneys (sometimes leading to kidney failure),
• severe diarrhea with colitis,
• lymphocytic colitis,
• liver dysfunction,
• fulminant hepatitis, sometimes fatal,
• severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome),
• fever.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Aclotin

Store in a temperature below 25°C. Store in the original package.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiry date stated on the carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.

Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Aclotin Contains

• The active substance of Aclotin is ticlopidine hydrochloride.
• The other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose (E 460), stearic acid (E 570), hypromellose, titanium dioxide (E 171), macrogol 6000.

What Aclotin Looks Like and Contents of the Package

Aclotin is a film-coated tablet.

The medication is packaged in blisters of 20 tablets made of Al/PVC foil, placed in a cardboard box.

20 film-coated tablets (1 blister of 20 tablets)

60 film-coated tablets (3 blisters of 20 tablets)

Marketing Authorization Holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

ICN Polfa Rzeszów S.A.

ul. Przemysłowa 2

35-959 Rzeszów, Poland

Bausch Health Poland sp. z o.o.

ul. Przemysłowa 2

35-959 Rzeszów, Poland

Date of Last Revision of the Package Leaflet: