Klodin

Package leaflet: Information for the patient

KLODIN 250 mg tablets

Ticlopidine hydrochloride
Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 KLODIN is and what it is used for

KLODIN contains ticlopidine, an active substance belonging to a group of medicines called
antiplatelet agents. Platelets are blood components that clump together during blood
coagulation. By preventing this clumping, antiplatelet medicines help avoid the formation
of blood clots (thrombi).
KLODIN is used:

• to prevent the formation of blood clots (thrombi) in blood vessels in patients at particularly high risk, for example if:
• you have had a stroke;
• you have already had a mini-stroke (TIA) or a heart attack, and treatment with acetylsalicylic acid (a medicine commonly known as aspirin) is ineffective or not possible;
• you have a blockage in the arteries of the legs (peripheral arterial disease);
• you have had a heart attack;
• you suffer from unstable angina, a condition characterized by chest pain occurring even at rest;
• to prevent occlusion of blood vessels that have undergone bypass surgery (a procedure performed to restore blood flow in a blocked vessel);
• during heart surgeries requiring the heart to be stopped (extracorporeal circulation);
• in case of blood clots in the eye (central retinal vein thrombosis);
• in patients undergoing blood purification through an artificial kidney (haemodialysis).

2. What you need to know before taking KLODIN

Do not take KLODIN if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you have bleeding in a blood vessel of the brain;
• you are prone to bleeding (haemorrhagic diathesis), for example, you have blood disorders causing coagulation problems;
• 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 reduction in blood cells: white blood cells (leucopenia), granulocytes (agranulocytosis), or platelets (thrombocytopenia);
• you are taking medicines that affect the bone marrow (myelotoxic) and that could cause a reduction in blood cells (see "Other medicines and KLODIN");
• you have severe liver problems.

KLODIN must not be used for thrombosis prevention in patients who have not already had thrombosis 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 you may be more likely to experience liver-related side effects, including cases of hepatitis (liver inflammation), especially during the first months of treatment. Be careful: if during treatment with KLODIN you notice signs of hepatitis, such as yellowing of the skin or eyes (jaundice), dark urine, or pale stools, STOP TAKING KLODIN AND CONTACT YOUR DOCTOR IMMEDIATELY (see section 4 - "Possible side effects").

Risk of bleeding

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

• you are taking other medicines that affect blood clotting, such as: blood-thinning medicines (anticoagulants like heparin), or medicines used for pain and inflammation (acetylsalicylic acid or NSAIDs) (see section "Other medicines and KLODIN");
• you need to undergo surgery (including dental procedures), as treatment with KLODIN should be stopped at least ten days before the procedure.

Blood-related side effects

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

• fever, sore throat, mouth ulcers, general malaise and widespread pain, which may be signs of infection due to reduced neutrophils or granulocytes in the blood;
• prolonged or unexpected bleeding, red spots on the skin ranging from small dots to large bruises (ecchymoses, purpura), dark stools, which may indicate reduced platelets;
• fever, bleeding or bruising, fatigue, confusion, headache, weakness in arms or legs, changes in consciousness or vision, which may be signs of thrombotic thrombocytopenic purpura (a condition that can be fatal). IN ALL THESE CASES, STOP TAKING KLODIN AND CONTACT YOUR DOCTOR IMMEDIATELY (see section 4 - "Possible side effects").

Blood tests

During treatment with KLODIN, your doctor will prescribe regular blood tests to monitor for possible changes in blood parameters. If test results are abnormal, your doctor will assess whether your treatment needs to be adjusted.

Your doctor will also prescribe a complete blood count after stopping treatment with KLODIN. If necessary, you may be asked to repeat the test until blood parameters return to normal levels.

Children and adolescents

KLODIN is not indicated for use in children and adolescents.

Other medicines and KLODIN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Since some medicines may interact with each other or increase the risk of serious side effects, do not take KLODIN if you are taking medicines that affect the bone marrow (myelotoxic) and that could cause a reduction in blood cells (see "Do not take KLODIN").

Inform your doctor if you are taking:

• medicines that thin the blood (anticoagulants or antiplatelets), such as heparin (see "Risk of bleeding");
• medicines used for pain and inflammation, such as acetylsalicylic acid, salicylate 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 conditions or high blood pressure;
• antacids or cimetidine, medicines used to treat stomach disorders, such as ulcers;
• cyclosporine, a medicine that suppresses the immune system 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, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.

Do not take KLODIN during pregnancy or breastfeeding unless your doctor considers it absolutely necessary.

Driving and using machines

KLODIN may cause dizziness. Exercise caution before driving vehicles or operating machinery.

3. How to take KLODIN

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 tablets daily, taken orally during meals.
If you take more KLODIN than you should, you may experience adverse effects on the stomach or intestine; furthermore, the risk of bleeding is increased.
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital, as appropriate measures will be necessary.
If you forget to take KLODIN
Do not take a double dose to make up for the forgotten dose. Consult your doctor to find out what to do.
If you stop taking KLODIN
It is important that you take this medicine regularly; do not stop treatment without consulting your doctor.
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 everyone will experience them.
STOP TAKING KLODIN AND CONTACT YOUR DOCTOR IMMEDIATELY if you experience any of the following:

• severe allergic reactions, such as swelling (Quincke's edema) of the face, eyes, lips, or throat, breathing difficulties, chest tightness (allergic pneumopathy), changes in heart rhythm possibly leading to a sudden drop in blood pressure (anaphylactic shock). These reactions are very rare;
• severe blood infection (sepsis) presenting with fever, rapid breathing, increased heart rate, confusion, and sudden drop in blood pressure (septic shock). These reactions are uncommon side effects.

Inform your doctor if, during treatment with KLODIN, you notice the following:
Common side effects (may affect up to 1 in 10 people)

• decrease in neutrophils or granulocytes in the blood, presenting with fever, sore throat, mouth ulcers. If this occurs, stop taking KLODIN and consult your doctor immediately (see section 2 - "Side effects affecting the blood");
• more or less sudden appearance of skin lesions, such as discolored spots or widespread rash (maculopapular or urticarial rash), possibly accompanied by itching;
• headache, dizziness;
• diarrhoea, nausea;
• increased levels of cholesterol (hypercholesterolaemia), fats (hypertriglyceridaemia), 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, presenting with prolonged or unexpected bleeding, red spots on the skin of variable size from pinpoint to extensive areas (ecchymoses, purpura), dark stools. In rare cases, destruction of red blood cells may also occur, leading to a reduced count (haemolytic anaemia). If this occurs, stop taking KLODIN and consult your doctor immediately (see section 2 - "Side effects affecting the blood");
• bleeding such as bruising and red spots (ecchymoses) on the skin, nosebleeds (epistaxis) or eye bleeding, blood in the urine (haematuria), bleeding during or after surgery, which may be severe and sometimes fatal. If this occurs, stop taking KLODIN and consult your doctor immediately (see section 2 - "Side effects affecting the blood");
• disturbances of sensation (peripheral neuropathy);
• stomach or duodenal ulcer;
• increased bilirubin levels in the blood;
• skin inflammation and peeling.

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

• thrombotic thrombocytopenic purpura, presenting with fever, bleeding or bruising, fatigue, confusion, headache, weakness in arms or legs, changes in consciousness or vision. If this occurs, stop taking KLODIN and consult your doctor immediately (see section 2 - "Side effects affecting 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), possibly due to bone marrow problems (aplastic anaemia), leukaemia (a blood cancer), increased platelets in the blood (thrombocytosis);
• ringing in the ears (tinnitus);
• bleeding within the brain (intracerebral haemorrhage).

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 changes in urine production (hypersensitivity nephropathy);
• inflammation of blood vessels (vasculitis) or connective tissue (lupus-like syndrome);
• severe skin rashes with redness, peeling, and/or blister formation (e.g., erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome);
• severe diarrhoea with intestinal inflammation (colitis);
• very severe (fulminant) hepatitis, potentially fatal;
• fever.

Reporting of side effects
If you experience any side effect, 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 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 strong direct light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information
6. Package contents and other information
What KLODIN contains
The active substance is: ticlopidine hydrochloride.
One tablet contains: 250 mg of ticlopidine hydrochloride.
The other components are: microcrystalline cellulose, corn starch, methylcellulose, precipitated silica, magnesium stearate, titanium dioxide (E171), gum arabic.

Description of the appearance of KLODIN and package contents
KLODIN is available in a pack containing 30 tablets.

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