CLOX 250 mg Coated Tablet

Зміст інструкції

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

CLOX250 mg tablets
Ticlopidine hydrochloride

Read this leaflet carefully before you start taking this medicine because 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 they have the same symptoms as you, as it may 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 CLOX is and what it is used for
• 2. What you need to know before you take CLOX
• 3. How to take CLOX
• 4. Possible side effects
• 5. How to store CLOX
• 6. Contents of the pack and other information

1. What is CLOX and what is it used for

CLOX 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, preventing this aggregation, antiplatelet drugs prevent the
formation of blood clots (thrombi).
CLOX is used:

• in the secondary prevention of blockage of blood flow to the brain and heart (ischemia) in patients who have a high risk of blood clot formation (thrombi) in blood vessels, 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 (ASA), a drug known as aspirin, has not been effective or is not possible because you are intolerant to acetylsalicylic acid;
• you have an obstruction of the arteries in the legs (peripheral obliterating arteriopathy);
• you suffer from unstable angina, a condition that manifests with chest pain that occurs even when at rest;
• in the prevention of the closure of blood 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 and artificial circulation (extracorporeal circulation);
• in case of blood clot formation (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 CLOX

Do not take CLOX if:

• you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you have bleeding in a blood vessel of the brain (acute haemorrhagic stroke);
• you are predisposed 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 CLOX”);
• you have severe liver problems;
• you are pregnant or breastfeeding, unless otherwise indicated by your doctor (see “Pregnancy and breastfeeding”).

Do not use this medicine for the primary prevention of thrombosis, i.e. if you do not have any condition listed in section 1.

Warnings and precautions
Consult your doctor or pharmacist before taking CLOX.
Use this medicine with caution if:

• you are at risk of bleeding (haemorrhage);
• you suffer from kidney problems (renal insufficiency), in which case your doctor may reduce your dosage;
• if you have liver problems, as it is more likely that adverse effects on the liver will occur, including cases of hepatitis (liver inflammation), especially in the first months of treatment. Be careful: if you notice signs of hepatitis during therapy with CLOX, such as yellowing of the skin or eyes (jaundice), dark urine, pale stools, STOP TAKING CLOX AND CONSULT YOUR DOCTOR IMMEDIATELY (see section 4 - “Possible side effects”).

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

• you are taking other medicines that act on the blood clotting mechanisms such as: medicines that thin the blood (oral or injectable anticoagulants such as heparin), medicines used against pain and inflammation (acetylsalicylic acid or NSAIDs) (see section “Other medicines and CLOX”);
• you have to undergo a minor surgical procedure, such as a tooth extraction;
• you have to undergo surgery, as therapy with CLOX should be stopped at least ten days before the operation;
• you have to undergo emergency surgery, so that appropriate precautions can be taken to avoid the risk of haemorrhage.

Adverse effects on the blood
CLOX increases the risk of adverse effects on the blood, especially during the first 3 months of treatment. If you notice during therapy with CLOX:

• 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 pinprick to extensive 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 CLOX AND CONSULT YOUR DOCTOR IMMEDIATELY (see section 4 – “Possible side effects”).

Blood tests
Your doctor will prescribe some blood tests at the beginning of therapy with CLOX and then every two weeks for the first three months of therapy, to assess 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 tell you to stop treatment with this medicine in case of a decrease in white blood cells (neutropenia) and a decrease in platelets (thrombocytopenia).
Your doctor will prescribe a complete blood test even after stopping treatment with CLOX. If necessary, he will ask you to repeat the test until the blood parameters return to normal values.

Children and adolescents
The use of CLOX is not recommended for children and adolescents.

Other medicines and CLOX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, as some medicines can interact with each other or increase the risk of serious side effects.
Do not take CLOX 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 CLOX”).
Tell your doctor if you are taking:

• medicines that increase the fluidity of the blood (antiplatelet agents) (see “Risk of bleeding”);
• oral or parenteral anticoagulants (such as heparin) that improve blood circulation (see “Risk of bleeding”);
• medicines used against pain and inflammation, NSAIDs such as acetylsalicylic acid or salicylic acid derivatives (except in cases of stent implantation where the association is permitted) (see “Risk of bleeding”);
• theophylline, a medicine used in respiratory diseases such as asthma;
• phenobarbital and phenytoin, medicines used to treat some forms of epilepsy;
• digoxin, a medicine used to treat heart rhythm disorders;
• antacids or cimetidine, medicines used to treat stomach disorders, such as ulcers;
• cyclosporine, a medicine that lowers 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
CLOX should not be used during pregnancy and breastfeeding, except in cases of absolute necessity.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
CLOX can cause dizziness. Be careful before driving vehicles or using machinery.

3. How to take CLOX

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

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

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

If you stop taking CLOX
It is important to 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 CLOX AND SEE 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), altered heartbeat with possible sudden drop in blood pressure (anaphylactic shock). These reactions are very rare;
• severe blood infection (sepsis) manifested by fever, increased rapid breathing, increased heart rate, confusion and sudden drop in blood pressure (septic shock). These reactions are uncommon side effects.

The use of this medicine may cause the following side effects:

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

• decrease in neutrophils or granulocytes in the blood, manifested by fever, sore throat, mouth ulcers, general malaise and widespread pain. If this occurs, stop taking CLOX 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 (hypercholesterolemia) or triglycerides (hypertriglyceridemia) 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 (thrombocytopenia) manifested by prolonged or unexpected bleeding, red spots on the skin of varying sizes from a pinpoint to extensive patches (ecchymosis, purpura), dark stools. In exceptional cases, it is also possible to have destruction of red blood cells with a consequent decrease in number (hemolytic anemia). If this occurs, stop taking CLOX and consult your doctor immediately (see section 2 - “Side effects on the blood”);
• bleeding, bruising and red spots (ecchymosis) on the skin, nosebleeds (epistaxis) or conjunctiva of 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 CLOX and consult your doctor immediately (see section 2 - “Side effects on the blood”);
• severe infection of the body (sepsis) and septic shock that may occur as fatal complications of a decrease in white blood cells (agranulocytosis);
• alteration of sensitivity (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, altered consciousness or vision. If this occurs, stop taking CLOX 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 CLOX and consult your doctor immediately(see section 2 - “Warnings and precautions”);
• decrease in all blood cells (pancytopenia) due to problems with the bone marrow (bone marrow aplasia), leukemia (a blood cancer), increase in platelets in the blood (thrombocytosis);
• perception of ringing sounds in the ears (tinnitus);
• brain bleeding (cerebral hemorrhage).

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

• immune system disorders, such as allergic manifestations, anaphylaxis (severe allergic reaction), swelling of the face, especially around the eyes and mouth (angioedema or Quincke's edema), increased white blood cells (eosinophilia), joint pain (arthralgia), inflammation of blood vessels (vasculitis), skin disorders of an irritative type, joint pain and fever (lupoid syndrome), lung disorders (allergic pneumopathy), kidney disorders (hypersensitivity nephropathy which may be associated with renal failure);
• 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). If the effect is severe, stop taking this medicine;
• very severe (fulminant) hepatitis and with fatal outcome;
• immune system disorders, such as allergic manifestations, anaphylaxis (severe allergic reaction), swelling of the face, especially around the eyes and mouth (angioedema or Quincke's edema),
• 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 CLOX

Keep this medicine out of 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 reported on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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

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

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

Marketing authorisation holder and manufacturer

AIC Holder
I.B.N. Savio S.r.l. - Via del Mare, 36 - Pomezia (RM)

Manufacturer
Special Product’s Line S.p.A.- Strada Paduni, 240 – Anagni (FR)