KLODIN 250 mg Coated Tablet

Зміст інструкції

1. What is KLODIN and what is it used for
2. What you need to know before taking KLODIN
3. How to take KLODIN
4. Possible side effects
5. How to store KLODIN

KLODIN250 mg tablets
Ticlopidine hydrochloride
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is KLODIN and what is it used for

KLODIN contains ticlopidine, an active ingredient belonging to a group of drugs called
antiplatelet agents. Platelets are elements of the blood that aggregate together during blood
coagulation. By preventing this aggregation, antiplatelet agents avoid the formation
of blood clots (thrombi).
KLODIN is used:

• to prevent the formation of clots in blood vessels (thrombi) in patients at particular risk, for example if:
• you have had a stroke;
• you have already had a mini-stroke (TIA) or a heart attack, and therapy with acetylsalicylic acid (a drug known as aspirin) is not effective or is not possible;
• you have an obstruction of the arteries in the legs (peripheral obliterating arteriopathy);
• you have had a heart attack;
• you suffer from unstable angina, a condition that manifests with chest pain that occurs even when at rest;
• to avoid the occlusion of vessels that have undergone bypass surgery (a procedure performed to restore blood flow in an obstructed vessel);
• during surgical operations performed on the heart that require a stopped heart (extracorporeal circulation);
• in case of thrombi in the eye (central retinal vein);
• in patients undergoing blood purification through an artificial kidney (hemodialysis).

2. What you need to know before taking KLODIN

Do not take KLODIN if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you have bleeding in the brain;
• you are prone to bleeding (haemorrhagic diathesis), for example you have blood diseases that cause problems with blood clotting;
• you have any medical condition that puts you at risk of internal bleeding, such as a stomach or intestinal ulcer, or oesophageal varices;
• you have or have had a decrease in blood cells: white blood cells (leucopenia), granulocytes (agranulocytosis) or platelets (thrombocytopenia);
• you are taking medicines that have effects on the bone marrow (myelotoxic) and that could cause a decrease in blood cells (see “Other medicines and KLODIN”);
• you have severe liver problems.

KLODIN should not be used for the prevention of blood clots in patients who have not already had
blood clots or who are not particularly at risk for this condition.

Warnings and precautions
Talk to your doctor or pharmacist before taking KLODIN if:

• you have kidney problems;
• you have liver problems, as it is more likely that you will experience side effects affecting the liver, including cases of hepatitis (liver inflammation), especially in the first few months of treatment. Be careful: if you notice signs of hepatitis during therapy with KLODIN, such as yellowing of the skin or eyes (jaundice), dark urine, pale stools, STOP TAKING KLODIN AND CONSULT YOUR DOCTOR IMMEDIATELY (see section 4 - “Possible side effects”).

Risk of bleeding
KLODIN increases the risk of bleeding (haemorrhage). Tell your doctor if:

• you are taking other medicines that affect the blood clotting mechanisms, such as: blood thinners (anticoagulants such as heparin), medicines used against pain and inflammation (acetylsalicylic acid or NSAIDs) (see section “Other medicines and KLODIN”);
• you are going to have surgery (including dental surgery), as therapy with KLODIN should be stopped at least ten days before the surgery.

Blood-related side effects
KLODIN increases the risk of side effects affecting the blood, especially in the first 3 months of
treatment. If you notice during therapy with KLODIN:

• fever, sore throat, mouth ulcers, general malaise and widespread pain, possible signs of infection caused by a decrease in neutrophils or granulocytes in the blood;
• prolonged or unexpected bleeding, red spots on the skin of varying sizes from a pinpoint to large patches (bruises, purpura), dark stools, possible signs of a decrease in platelets;
• fever, bleeding or bruising, fatigue, confusion, headache, loss of strength in the arms or legs, changes in consciousness or vision, possible signs of thrombotic thrombocytopenic purpura (a condition that can also be fatal). IN ALL THESE CASES, STOP TAKING KLODIN AND CONSULT YOUR DOCTOR IMMEDIATELY (see section 4 - “Possible side effects”).

Blood tests
During therapy with KLODIN, your doctor will prescribe you regular blood tests to evaluate
possible changes in blood parameters. If the results of these tests are altered, your
doctor will assess the need to change your therapy.
Your doctor will also prescribe a complete blood test after stopping treatment with
KLODIN. If necessary, they will ask you to repeat the test until the blood parameters return
to normal values.

Children and adolescents
KLODIN is not indicated for children and adolescents.

Other medicines and KLODIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Because some medicines can interact with each other or increase the risk of side effects, even
serious ones, do not take KLODIN if you are taking medicines that have effects on the bone marrow
(myelotoxic) and that could cause a decrease in blood cells (see “Do not take KLODIN”).
Tell your doctor if you are taking:

• blood thinners (anticoagulants or antiplatelet agents) such as heparin (see “Risk of bleeding”);
• medicines used against pain and inflammation such as acetylsalicylic acid, salicylic acid derivatives, NSAIDs or antipyrine (see “Risk of bleeding”);
• theophylline, a medicine used for respiratory diseases such as asthma;
• phenobarbital and phenytoin, medicines used to treat certain forms of epilepsy;
• digoxin, beta-blockers, calcium channel blockers or diuretics, medicines used for heart disease or high blood pressure;
• antacids or cimetidine, medicines used to treat stomach disorders, such as ulcers;
• cyclosporine, a medicine that suppresses the body's defenses and is used in transplants or autoimmune diseases;
• 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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
Do not take Klodin during pregnancy and breastfeeding, unless your doctor considers it
absolutely necessary.

Driving and operating machinery
KLODIN can cause dizziness. Be careful before driving vehicles or using
machinery.

3. How to take KLODIN

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult
your doctor or pharmacist.
The recommended dose is 1 or 2 tablets per day, to be taken orally (oral use) during
meals.

If you take more KLODIN than you should, you may experience undesirable effects on the stomach or
intestines; furthermore, the risk of bleeding is increased.
In case of accidental intake of an excessive dose of KLODIN, contact your
doctor immediately or go to the nearest hospital, as appropriate measures are necessary.

If you forget to take KLODIN
Do not take a double dose to make up for a missed dose. Consult your doctor to find out
how to proceed.

If you stop taking KLODIN
It is important that you take this medicine regularly; do not interrupt the treatment without
consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING KLODIN AND CONTACT YOUR DOCTOR IMMEDIATELY if
any of the following occur:

• severe allergic reactions, such as swelling (angioedema) of the face, eyes, lips, throat, difficulty breathing and chest tightness (allergic pneumopathy), changes in heart rate with possible sudden drop in blood pressure (anaphylactic shock). These reactions are very rare;
• severe blood infection (sepsis) manifested by fever, rapid increase in breathing, increased heart rate, confusion and sudden drop in pressure (septic shock). These reactions are uncommon side effects.

Inform your doctor if you notice any of the following during treatment with KLODIN:

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

• decrease in neutrophils or granulocytes in the blood, manifested by fever, sore throat, ulcers in the mouth. If this occurs, stop taking KLODIN and consult your doctor immediately(see section 2 - “Side effects on the blood”);
• more or less sudden appearance of skin lesions, for example, color changes in patches or widespread (maculopapular or urticarial rash) with possible itching;
• headache, dizziness;
• diarrhea, nausea;
• increased levels of cholesterol (cholesterolemia) or fats (triglyceridemia) or liver enzymes (such as alkaline phosphatase and transaminases) in the blood.

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

• decrease in platelets manifested by prolonged or unexpected bleeding, red spots on the skin of varying sizes from a pinpoint to extensive patches (ecchymoses, purpura), dark stools. In exceptional cases, destruction of red blood cells with a consequent decrease in number (hemolytic anemia) may also occur. If this occurs, stop taking KLODIN and consult your doctor immediately(see section 2 - “Side effects on the blood”);
• bleeding such as bruises and red spots (ecchymoses) on the skin, nosebleeds (epistaxis) or in the eye, blood in the urine (hematuria), bleeding during or after surgery, which may also be severe and sometimes fatal. If this occurs, stop taking KLODIN and consult your doctor immediately(see section 2 - “Side effects on the blood”);
• altered senses (peripheral neuropathy);
• ulcer of the stomach or duodenum;
• increased bilirubin in the blood;
• inflammation and exfoliation of the skin.

Rare side effects(may affect up to 1 in 1000 people)

• thrombotic thrombocytopenic purpura manifested by fever, bleeding or bruising, fatigue, confusion, headache, loss of strength in the arms or legs, changes in consciousness or vision. If this occurs, stop taking KLODIN and consult your doctor immediately(see section 2 - “Side effects on the blood”);
• yellowing of the skin or eyes (jaundice), dark urine and pale stools (possible signs of hepatitis). If this occurs, stop taking KLODIN and consult your doctor immediately(see section 2 - “Warnings and precautions”);
• decrease in all blood cells (pancytopenia) also due to bone marrow problems (bone marrow aplasia), leukemia (a blood cancer), increased platelets in the blood (thrombocytosis);
• ringing in the ears (tinnitus);
• bleeding inside the brain (intracerebral).

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

• back or joint pain (arthralgia);
• increased eosinophils in the blood (eosinophilia);
• kidney damage with possible alteration of urine production (hypersensitivity nephropathy);
• inflammation of blood vessels (vasculitis) or connective tissue (lupoid syndrome);
• severe skin rashes with redness, exfoliation and/or blistering (e.g. erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome);
• severe diarrhea with inflammation of the intestine (colitis);
• very severe (fulminant) hepatitis with fatal outcome;
• fever.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://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 KLODIN

Keep this medicine out of the sight and reach of children.
Store this medicine at room temperature, away from intense and direct light.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

6. Contents of the pack and other information

What KLODIN contains
The active ingredient is: ticlopidine hydrochloride.
One tablet contains: 250 mg of ticlopidine hydrochloride.
The other ingredients are: microcrystalline cellulose, corn starch, methylcellulose, precipitated silica, magnesium stearate, titanium dioxide (E171), gum arabic.

Description of the appearance of KLODIN and contents of the pack
KLODIN is available in packs of 30 tablets.

Marketing Authorisation Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)

Marketing Authorisation Holder
CHIESI FARMACEUTICI S.p.A.- Via Palermo, 26/A - Parma

Manufacturers
Special Product’s Line S.p.A.- Via Fratta Rotonda Vado Largo, 1 – Anagni (FR)