®
®
“NORMIGORE” is a trade mark
135635
une maladie qui peut provoquer un saignement interne (comme un ulcère de l'estomac).
des troubles de la coagulation favorisant des hémorragies internes (saignement au sein d'un
tissu, d'un organe ou d'une articulation).
une blessure grave récente.
une intervention chirurgicale récente (y compris dentaire).
une intervention chirurgicale (y compris dentaire) prévue dans les 7 jours à venir.
-
-
-
-
-
NormiGore
Clopidogrel 75 mg
Film - coated tablets
NormiGore
Clopidogrel 75 mg
Comprimés pelliculés
In this leaflet:
1. What NormiGore is and what it is used for
2. Before you take NormiGore
3. How to take NormiGore
4. Possible side effects
5. How to store NormiGore
6. Further information
1. What NormiGore is and what is it used for
NormiGore belongs to a group of medicines called antiplatelet medicinal products. Platelets are
very small structures in the blood, smaller than red or white blood cells, which clump together
during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the
chances of blood clots forming (a process called thrombosis).
NormiGore is taken to prevent blood clots (thrombi) forming in hardened blood vessels
(arteries), a process known as atherothrombosis, which can lead to atherothrombotic events
(such as stroke, heart attack, or death).
You have been prescribed NormiGore to help prevent blood clots and reduce the risk of these
severe events because:
2. Before you take NormiGore
Do not take NormiGore:
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before
taking NormiGore.
Take special care with NormiGore:
If any of the situations mentioned below apply to you, you should tell your doctor before taking
NormiGore:
• if you have a risk of bleeding such as:
NormiGore is not intended for use in children or adolescents.
Taking other medicines
Some other medicines may influence the use of NormiGore or vice versa.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
The use of oral anticoagulants (medicines used to reduce blood clotting) with NormiGore is not
recommended.
You should specifically tell your doctor if you take a non steroidal anti-inflammatory drug, usually
used to treat painful and/or inflammatory conditions of muscle or joints, or if you take heparin or
any other medicine used to reduce blood clotting. If you have experienced severe chest pain
(unstable angina or heart attack), you may be prescribed NormiGore in combination with
acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period) should
generally not cause a problem, but prolonged use in other circumstances should be discussed
with your doctor.
Taking NormiGore with food and drink
Food/meals have no influence. NormiGore may be taken with or without food.
Pregnancy and breast-feeding
It is preferable not to use this product during pregnancy and breast feeding.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your
pharmacist before taking NormiGore. If you become pregnant while taking NormiGore, consult
your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
While taking NormiGore, consult your doctor about the breast feeding of a baby. Ask your doctor
or pharmacist for advice before taking any medicine.
Driving and using machines
NormiGore is unlikely to affect your ability to drive or to use machines.
Important information about some of the ingredients of NormiGore
NormiGore contains lactose and hydrogenated castor oil.
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
Hydrogenated castor oil may cause stomach upset or diarrhea.
3. How to take NormiGore
Always take NormiGore exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may
give you 300 mg of NormiGore (4 tablets of 75 mg) once at the start of treatment. Then, the
usual dose is one 75 mg tablet of NormiGore per day to be taken orally with or without food, and
at the same time each day.
You should take NormiGore for as long as your doctor continues to prescribe it.
If you take more NormiGore than you should:
Contact your doctor or the nearest emergency department because of the increased risk of
bleeding.
If you forget to take NormiGore:
If you forget to take a dose of NormiGore, but remember within 12 hours of your usual time, take
your tablet straightaway and then take your next tablet at the usual time. If you forget for more
than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to
make up for the forgotten individual doses.
If you stop taking NormiGore:
Do not stop the treatment. Contact your doctor or pharmacist before stopping.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, NormiGore can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:
While you are taking NormiGore:
In addition, your doctor may identify changes in your blood or urine test results.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. How to store NormiGore
Keep all medicines out of reach of children.
Do not use NormiGore after the expiry date which is stated on the carton and on the blister.
Do not use NormiGore if you notice any visible sign of deterioration.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Further information
What NormiGore contains
The active substance is: Clopidogrel bisulfate equivalent to 75 mg of clopidogrel.
The other ingredients are: Mannitol (E421), hydrogenated castor oil, microcrystalline cellulose with
addition of silica, low-substituted hydroxypropylcellulose and pregelatinised starch in the tablet
core, and lactose monohydrate, hypromellose (E464), triacetin (E1518), red iron oxide (E172),
yellow iron oxide (E172), black iron oxide (E172) and titanium dioxide (E171) in the tablet coating.
What NormiGore looks like and contents of the pack
NormiGore 75 mg tablets are round, biconvex, pink, unscored film-coated tablets. They are
supplied in carton box containing 28 tablets in aluminum / aluminum blisters.
THIS IS A MEDICAMENT
Medicament is a product which affects your health, and its consumption contrary to
instructions is dangerous for you.
Follow strictly the doctor's prescription, the method of use and the instructions of the
pharmacist who sold the medicament.
The doctor and the pharmacist are experts in medicines, their benefits and risks.
Do not by yourself interrupt the period of treatment prescribed for you.
Do not repeat the same prescription without consulting your doctor.
Keep all medicaments out of the reach of children.
•
•
•
•
•
•
Council of Arab Health Ministers, Union of Arab Pharmacists
Read this entire leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
-
-
-
-
Veuillez lire attentivement l'intégralité de cette notice avant de prendre ce médicament.
Gardez cette notice, vous pourriez avoir besoin de la relire.
Si vous avez d'autres questions, si vous avez un doute, demandez plus d'informations à
votre médecin ou votre pharmacien.
Ce médicament vous a été personnellement prescrit. Ne le donnez jamais à quelqu'un
d'autre, même en cas de symptômes identiques, cela pourrait lui être nocif.
Si l'un des effets indésirables devient grave ou si vous remarquez un effet indésirable non
mentionné dans cette notice, parlez-en à votre médecin ou votre pharmacien.
-
-
-
-
You have a condition of hardening of arteries (also known as atherosclerosis), and
You have previously experienced a heart attack, stroke or have a condition known as peripheral
arterial disease, or
You have experienced a severe type of chest pain known as 'unstable angina' or 'myocardial
infarction' (heart attack). For the treatment of this condition your doctor may have placed a stent
in the blocked or narrowed artery to restore effective blood flow. You should also be given
acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower
fever as well as to prevent blood clotting) by your doctor.
-
-
-
fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.
signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not
associated with bleeding which appears under the skin as red pinpoint dots and/or confusion
(see 'Take special care with NormiGore').
swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These
may be the signs of an allergic reaction.
-
-
-
a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues,
organs or joints of your body).
a recent serious injury.
a recent surgery (including dental).
a planned surgery (including dental) in the next seven days.
-
-
-
-
-
If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of NormiGore;
If you have a medical condition that is currently causing bleeding such as a stomach ulcer or
bleeding within the brain;
If you suffer from severe liver disease.
•
•
•
if you have had a clot in an artery of your brain (ischemic stroke) which occurred within the last
seven days.
if you are taking another type of medicine (see 'Taking other medicines').
if you have kidney or liver disease.
•
•
•
You should tell your doctor if a surgery (including dental) is planned.
You should also tell your doctor immediately if you develop a medical condition that includes
fever and bruising under the skin that may appear as red pinpoint dots, with or without
unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see
'Possible side effects').
If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to
the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and
injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned
by your bleeding, you should contact your doctor straightaway (see 'Possible side effects').
Your doctor may order blood tests.
You should tell your doctor or pharmacist if you notice any side effect not listed in the 'Possible
side effects' section of this leaflet or if you notice that a side effect gets serious.
•
•
•
•
•1. Qu’est-ce que NormiGore et dans quel cas est-il utilisé
NormiGore appartient à une classe de médicaments appelés antiagrégants plaquettaires. Les
plaquettes sont de très petits éléments circulant dans le sang, de taille inférieure à celles des
globules rouges et blancs, et qui s'agrègent lors de la coagulation du sang. En empêchant cette
agrégation, les antiagrégants plaquettaires réduisent le risque de formation de caillots sanguins
(phénomène appelé thrombose).
NormiGore est utilisé pour éviter la formation de caillots sanguins (thrombus) dans les
vaisseaux sanguins (artères) devenus rigides. Cette maladie également appelée athérothrom-
bose peut conduire à la survenue d'évènements athérothrombotiques (tels que l'accident
vasculaire cérébral, la crise cardiaque, ou le décès).
On vous a prescrit NormiGore pour empêcher la formation de caillots sanguins et réduire le
risque de survenue de tels évènements graves car:
Qu’est-ce que NormiGore et dans quel cas est-il utilisé
Quelles sont les informations à connaitre avant de prendre NormiGore
Comment prendre NormiGore
Quels sont les effets indésirables éventuels
Comment conserver NormiGore
Informations supplémentaires
1.
2.
3.
4.
5.
6.
2.
Ne prenez jamais NormiGore:
Quelles sont les informations à connaitre avant de prendre
NormiGore
Si vous pensez être dans l'un de ces cas ou en cas de doute, consultez votre médecin avant de
prendre NormiGore.
Faites attention avec NormiGore:
Si l’une des situations mentionnées ci-dessous s'applique à votre cas, vous devez en avertir
votre médecin avant de prendre NormiGore:
• Si vous avez un risque hémorragique tel que:
NormiGore n’est pas destiné aux enfants ou aux adolescents.
Prise d'autres médicaments
Certains médicaments peuvent exercer une influence sur l'utilisation de NormiGore ou vice-versa.
Veuillez indiquer à votre médecin ou à votre pharmacien si vous prenez ou si vous avez pris
récemment un autre médicament, même s'il s'agit d'un médicament obtenu sans ordonnance.
La prise d'anticoagulants oraux (médicaments utilisés pour diminuer la coagulation du sang)
n’est pas recommandée lors d'un traitement par NormiGore.
Vous devez informer avec précision votre médecin si vous prenez un anti-inflammatoire
non-stéroïdien, médicament utilisé habituellement pour traiter les maladies douloureuses et/ou
inflammatoires des muscles ou des articulations, on si vous prenez de l’héparine ou tout autre
médicament utilisé pour diminuer la coagulation du sang.
Si vous avez eu une douleur thoracique grave (angor instable ou crise cardiaque), NormiGore
peut vous être prescrit en association avec de l'acide acétylsalicylique, substance présente dans
de nombreux médicaments utilisés pour soulager la douleur et faire baisser la fièvre. Une
utilisation occasionnelle d'acide acétylsalicylique (pas plus de 1000 mg sur une période de 24
heures) ne doit généralement pas poser de problèmes, mais une utilisation prolongée dans
d'autres circonstances doit être discutée avec votre médecin.
Aliments et boissons
Les aliments n'ont pas d'influence. NormiGore peut être pris avec ou sans aliments.
Pendant la prise de NormiGore:
Vous avez des artères qui se sont rigidifiées (aussi connu sous le nom d'athérosclérose), et
Vous avez déjà eu une crise cardiaque, un accident vasculaire cérébral ou vous avez une
artériopathie des membres inférieurs, ou
Vous avez eu une douleur thoracique grave connue sous le nom "d'angor instable" ou
"d'infarctus du myocarde" (crise cardiaque). Pour cela, vous avez pu bénéficier d'une pose de
stent dans l'artère bouchée ou rétrécie afin de rétablir une circulation sanguine efficace. Votre
médecin doit également vous prescrire de l'acide acétylsalicylique (substance présente clans
de nombreux médicaments utilisée pour soulager la douleur et faire baisser la fièvre, mais
aussi pour prévenir la formation de caillots sanguins).
-
-
-
Si vous êtes allergique (hypersensible) au clopidogrel ou à l'un des autres composants
contenus dans NormiGore;
Si vous avez une maladie actuellement responsable d'un saignement tel qu'un ulcère de l’estomac
ou un saignement dans le cerveau;
Si vous souffrez d'insuffisance hépatique sévère.
•
•
•
Si vous avez eu un caillot dans une artère de votre cerveau (accident vasculaire cérébral
ischémique) survenu dans les sept derniers jours.
Si vous prenez d'autres médicaments (voir "Prise d'autres médicaments").
Si vous présentez une maladie du foie ou des reins.
•
•
•
Vous devez avertir votre médecin si une intervention chirurgicale est programmée (y compris
dentaire).
Vous devez aussi avertir votre médecin immédiatement si vous présentez une maladie incluant
fièvre et bleus sous la peau, pouvant apparaitre comme des petites têtes d'épingles rouges,
accompagnée ou non de fatigue extrême inexpliquée, confusion, jaunissement de la peau ou
des yeux (jaunisse) (voir "Quels sont les effets indésirables éventuels").
Si vous vous coupez ou si vous vous blessez, l'arrêt du saignement peut nécessiter plus de
temps que d'habitude. Ceci est lié au mode d'action de votre médicament qui empêche la
formation de caillots sanguins. Dans le cas de coupures ou blessures superficielles (par
exemple au cours du rasage), vous ne devriez généralement rien constater d'anormal.
Cependant, si ce saignement vous préoccupe, vous devez en avertir immédiatement votre
médecin (voir "Quels sont les effets indésirables éventuels").
Votre médecin pourra vous demander de pratiquer des examens sanguins.
Vous devez informer votre médecin ou votre pharmacien si vous présentez des effets
indésirables non mentionnés dans le paragraphe "Quels sont les effets indésirables éventuels"
de cette notice ou si vous ressentez un des effets mentionnés comme grave.
•
•
•
•
•
The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is
bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma
(unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number
of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
If you experience prolonged bleeding when taking NormiGore
If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the
way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries
e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your
bleeding, you should contact your doctor straightaway (see 'Take special care with NormiGore').
Other side effects reported with NormiGore are:
Common side effects (affects 1 to 10 patients in 100): Diarrhea, abdominal pain, indigestion or
heartburn.
Uncommon side effects (affects 1 to 10 patients in 1000): Headache, stomach ulcer, vomiting,
nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness,
abnormal touch sensation.
Rare side effect (affects 1 to 10 patients in 10,000): Vertigo.
Very rare side effects (affects less than 1 patient in 10,000): jaundice; severe abdominal pain with
or without back pain; fever, breathing difficulties sometimes associated with cough; generalized
allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the
mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular
pain; taste disorders.
Dans cette notice:
Manufactured by
Zaklad Farmaceutyczny Adamed Pharma S.A. - Poland
Marketing Authorization Holder
ARWAN Pharmaceutical Industries Jadra, Lebanon
LE0018-01
Revision date: January 2013