Ifapidin

Leaflet accompanying the packaging: information for the user

IFAPIDIN

250 mg, coated tablets

Ticlopidine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ifapidin and what is it used for
• 2. Important information before taking Ifapidin
• 3. How to take Ifapidin
• 4. Possible side effects
• 5. How to store Ifapidin
• 6. Contents of the pack and other information
• 1. What is Ifapidin and what is it used for

The active substance of Ifapidin, ticlopidine, inhibits platelet aggregation and the release of substances involved in the blood clotting process, preventing the formation of arterial and venous thrombi. The mechanism of action of ticlopidine involves the inhibition of ADP-dependent binding of fibrinogen to the glycoprotein receptor (IIb and IIIa) of platelets. Ticlopidine reduces fibrinogen levels, prolongs bleeding time, and reduces blood viscosity. After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. Anti-aggregatory activity is detectable after 48 hours of administration, reaching its maximum after 5-8 days. After discontinuation of the drug, bleeding time and the results of other platelet function tests normalize within a week. Ticlopidine is metabolized mainly in the liver and excreted in the urine (50%-60% of the administered dose) and feces (20%-30% of the administered dose). Ticlopidine, as a selective platelet aggregation inhibitor, is used to treat vascular diseases and prevent their complications:

• prevention of ischemic strokes, prevention of transient ischemic attacks (TIA),
• prevention of reocclusion after myocardial infarction and prevention of secondary infarctions,
• prevention of thrombosis of peripheral vessels in the course of atherosclerosis of the lower limbs,
• prevention of secondary atherosclerotic and diabetic angiopathy.

Additionally - in surgery before and after procedures using extracorporeal circulation, during hemodialysis - it improves dialysis efficiency, has a protective effect on platelets, and reduces the amount of heparin administered. Therapeutically and preventively in platelet disorders.

2. Important information before taking Ifapidin

When not to take Ifapidin

• 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 tendency to bleed (e.g. hemophilia).
• If the patient has other diseases associated with bleeding or a tendency to bleed, such as active gastric or duodenal ulcer or acute phase of hemorrhagic stroke.
• If the patient has a disease affecting the production of blood cells, so-called bone marrow disease or a disease affecting blood clotting associated with prolonged bleeding time.
• If the patient has severe liver failure.
• If the patient has had diseases associated with a decrease in the number of white blood cells or platelets in the past.
• If the patient has a decreased number of certain white blood cells (neutropenia) or platelets (thrombocytopenia).
• In healthy individuals for primary prevention of blood clots (thrombosis).

Warnings and precautions

Before starting treatment with Ifapidin, discuss it with your doctor or pharmacist.

• Ifapidin should always be taken as directed by your doctor.
• If the patient has had allergic reactions (hypersensitivity) to another thienopyridine (such as clopidogrel, prasugrel; ticlopidine also belongs to this class) in the past, they should inform their doctor before starting treatment with Ifapidin. Patients who have had a mild to severe allergic reaction (such as rash or angioedema [swelling of the face or throat]) and (or) hematologic reaction (thrombocytopenia and neutropenia) to one thienopyridine may be at increased risk of developing the same or another reaction to another thienopyridine.
• Tell your doctor about all previous and current diseases that occurred before and during treatment with Ifapidin.
• Taking Ifapidin requires special caution in patients with liver function disorders and therefore, in any circumstances, the doctor should be informed if the patient has liver disease.
• Taking the medicine increases the risk of bleeding, so before any planned or emergency surgical or dental procedure that may involve bleeding, tell your doctor or dentist that you are taking Ifapidin.
• During treatment (especially during the first 3 months), laboratory tests should be performed at regular intervals, as determined by the doctor.
• If persistent or severe diarrhea or nausea occurs during treatment, discontinue the medicine and consult a doctor.
• Immediately consult a doctor if any of the following symptoms occur: symptoms of skin allergic reaction (e.g. hives, swelling of hands, eyelids, throat, and external genitalia/angioedema), fever, sore throat, oral mucosa ulcers, pinpoint hemorrhagic spots on the skin or bleeding from mucous membranes, hematoma, symptoms of transient cerebral ischemia (numbness, difficulty speaking, weakness of one side of the body, drooping of the corner of the mouth, double vision, dizziness, balance disorders), stroke, confusion, prolonged or unusual bleeding, dark stools, very severe weakness, pallor, jaundice, dark urine, discolored stools.

Children and adolescents

Due to the lack of experience, it is not recommended to use Ifapidin in children and adolescents.

Ifapidin and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Due to the increased risk of bleeding, concomitant use of Ifapidin and the following medicines requires special caution and careful regular monitoring in accordance with the doctor's instructions:

• non-steroidal anti-inflammatory drugs (usually prescribed for musculoskeletal disorders, inflammation, fever, and pain),
• other platelet aggregation inhibitors,
• various anticoagulant drugs (e.g. acenocoumarol) and heparins,
• salicylic acid derivatives (acetylsalicylic acid, a substance present in many medicines used to relieve pain and combat fever, as well as to prevent blood clotting),
• selective serotonin reuptake inhibitors (including fluoxetine or fluvoxamine), medicines most commonly used to treat depression,
• pentoxifylline, a medicine used to treat circulatory disorders in the hands and feet.

Avoid concomitant use of Ifapidin and the following medicines or exercise special caution and careful regular monitoring in accordance with the doctor's instructions:

• theophylline (usually prescribed for shortness of breath),
• digoxin (usually prescribed for heart failure and/or irregular heartbeat),
• cyclosporine (prescribed after organ transplantation to prevent rejection of transplanted organs),
• phenytoin (prescribed for epilepsy or facial pain),

Concomitant use of Ifapidin and the following medicines requires special caution:

• antacids,
• cimetidine (an anti-ulcer medicine that works by reducing the amount of acid in the stomach).

Taking Ifapidin with food

Ifapidin should be taken during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Ifapidin is not recommended during pregnancy and breastfeeding, except in cases where the doctor considers it absolutely necessary.
Breastfeeding
If treatment with Ifapidin is necessary during breastfeeding, breastfeeding should be discontinued.
Fertility
No impairment of fertility has been observed.

Driving and operating machinery

Very rarely, the medicine may cause dizziness, tinnitus, and may impair concentration. If any of these symptoms occur, do not drive or perform activities that involve an increased risk of accidents and consult a doctor. Recommendations for restricting or prohibiting driving and performing activities that involve an increased risk of accidents should be determined by the doctor individually for each patient.

3. How to take Ifapidin

Always take this medicine as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults

The recommended dose is 1 tablet twice a day. The medicine should be taken during meals.
Patients over 65 years of age
The medicine can be taken in the usual dose used for adults.
Use in children
It is not recommended to use Ifapidin in children due to the lack of sufficient data on safety and efficacy.
Liver failure
Taking Ifapidin requires special caution in patients with liver failure. If jaundice, dark urine, or discolored stools (symptoms that may be related to hepatitis) occur, discontinue the medicine and inform your doctor (see also "Possible side effects").

Taking a higher dose of Ifapidin than recommended

Overdose of Ifapidin can be dangerous, so if you have taken more tablets than recommended, immediately contact your doctor or go to the emergency department of the nearest hospital. Overdose may cause gastrointestinal symptoms. Overdose of the medicine may increase the risk of bleeding.

Missing a dose of Ifapidin

If you miss a dose, try to take it as soon as possible. However, if it is close to the time of the next dose, do not take a double dose to make up for the missed tablet.

Stopping treatment with Ifapidin

Do not stop taking the medicine on your own or prematurely (unless you experience severe side effects), as this may cause the disease to recur.
If you have any further doubts about taking 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.

Immediately consult a doctor if you experience any of the following symptoms:

Bleeding, fever, infection

Frequent(may occur in up to 1 in 10 patients)

• headache, dizziness, fever, sore throat, oral ulcers (neutropenia).

Uncommon(may occur in up to 1 in 100 patients)

• bleeding into the skin and mucous membranes (pinpoint red spots [petechiae] on the skin and mucous membranes, dark stools [thrombocytopenia])
• hematoma, nosebleeds, unusual bleeding, bleeding into the eyes, bleeding that may occur during and after surgical procedures (sometimes fatal)
• high fever, infectious oral ulcers, throat, skin, and anal area (agranulocytosis). Sepsis and septic shock may be fatal complications of agranulocytosis (see "Bleeding, fever, infection").

Rare(may occur in up to 1 in 1,000 patients)

• fever, pinpoint red spots (petechiae), with or without symptoms such as unexplained weakness, pallor, symptoms of transient cerebral ischemia (numbness, difficulty speaking, weakness of one side of the body, double vision, balance disorders, etc.), symptoms of stroke, confusion, prolonged or unusual bleeding, jaundice, dark urine, discolored stools (thrombotic thrombocytopenic purpura; TTP).

Allergic reaction:

Very rare(may occur in up to 1 in 10,000 patients)

• hives, difficulty breathing, nausea, dizziness, weakness (anaphylaxis),
• significant swelling of the hands, eyelids, throat, and genital area (angioedema), allergic pneumopathy (allergic interstitial pneumonia), allergic nephritis, sometimes leading to kidney failure.

Other side effects

Very rare(may occur in up to 1 in 10,000 patients)
During ticlopidine treatment, Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported, manifested initially as red, round, or oval patches or spots, often with centrally located blisters on the torso. Additional symptoms to look out for are oral, throat, nose, genital, and conjunctival ulcers (red, swollen eyes). The skin changes are often accompanied by flu-like symptoms. The rash may worsen, becoming generalized blisters or skin peeling.
Persistent and/or severe diarrhea (severe diarrhea with colitis), nausea.
Symptoms of hepatitis/liver failure: jaundice, dark urine, discolored stools
Uncommon(may occur in up to 1 in 100 patients)
Severe skin peeling (exfoliative dermatitis).
Gastric and duodenal ulcer: burning pain in the upper abdomen, most severe on an empty stomach, meals may bring temporary improvement. Complications such as bleeding or perforation of the stomach or intestines may occur.
If any of these symptoms occur, discontinue the medicine immediately.

List of side effects (and frequency of side effects):

Frequent (may occur in up to 1 in 10 patients)

• During treatment with Ifapidin, changes in the results of some laboratory parameters may occur. A decrease in the number of white blood cells may occur, in very rare cases in a severe form. Severe symptoms, oral ulcers, fever, sore throat, associated with a decrease in the number of white blood cells (agranulocytosis), occurred mainly during the first 3 months of treatment.
• dizziness, headaches
• diarrhea and nausea
• increased liver enzyme activity (increased alkaline phosphatase and transaminases)
• skin rash (often with itching). Skin symptoms may spread over the entire body surface.
• increased cholesterol and triglyceride levels in serum (fatty material in the blood).

Uncommon (may occur in up to 1 in 100 patients)

• decrease in platelet count (which may be accompanied by anemia due to red blood cell destruction)
• sepsis and septic shock may be fatal complications of agranulocytosis (see "Bleeding, fever, infection")
• bleeding (see "Bleeding, fever, infection")
• unusual sensations, numbness, and tingling of limbs (peripheral neuropathy)
• gastric and duodenal ulcer (see "Other side effects")
• increased bilirubin levels in the blood
• exfoliative dermatitis (see "Other side effects").

Rare (may occur in up to 1 in 1,000 patients)

• decrease in red blood cell count, white blood cell count, platelet count, bone marrow failure, leukemia, increased platelet count
• tinnitus
• intracerebral bleeding
• hepatitis.

Very rare (may occur in up to 1 in 10,000 patients)

• immunological reactions with various symptoms: anaphylactic reaction, angioedema, allergic interstitial pneumonia, allergic nephritis, joint pain, vasculitis, lupus-like syndrome, allergic neuritis, and increased eosinophil count (a type of white blood cell)
• severe diarrhea with colitis (see "Other side effects")
• hepatitis with a fatal outcome (see "Other side effects")
• (erythema multiforme), Stevens-Johnson syndrome, exfoliative dermatitis (see "Other side effects")
• fever.

Frequency not known (cannot be estimated from the available data)

• cross-sensitivity between thienopyridines (such as clopidogrel, prasugrel)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ifapidin

Store in a temperature below 25°C.
Keep the medicine out of sight and reach of children.

6. Contents of the pack and other information

What Ifapidin contains

The active substance of Ifapidin is ticlopidine hydrochloride. Each coated tablet contains 250 mg of ticlopidine hydrochloride.
The other ingredients are: microcrystalline cellulose, potato starch, citric acid monohydrate, stearic acid, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E 171).

What Ifapidin looks like and contents of the pack

Appearance of tablets:white or almost white, round, biconvex coated tablets with the letter "E" and the number "421" embossed on one side.
Pack sizes:
20 coated tablets (2 blisters of 10 tablets or 1 blister of 20 tablets) and 60 coated tablets (6 blisters of 10 tablets or 3 blisters of 20 tablets).
Blisters made of aluminum/PVC in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

EGIS Pharmaceuticals PLC
Kereszturi út 30-38
1106 Budapest
Hungary

Manufacturer

EGIS Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary
To obtain more detailed information, contact the local representative of the marketing authorization holder.
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00
Date of last revision of the leaflet:14.10.2022