EFIENT 5 мг Фильм-coated таблетки

Содержание инструкции

1. Efient 10 mg film-coated tablets, 5 mg film-coated tablets
   1. What is Efient and what it is used for
   2. What you need to know before taking Efient
   3. How to take Efient
   4. Possible side effects
   5. How to store Efient
   6. Package contents and other information

Efient 10 mg film-coated tablets, 5 mg film-coated tablets

prasugrel

Read this leaflet carefully before you start 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 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 Efient is and what it is used for
• 2. What you need to know before you take Efient
• 3. How to take Efient
• 4. Possible side effects
• 5. How to store Efient
• 6. Contents of the pack and other information

1. What is Efient and what it is used for

Efient, which contains the active substance prasugrel, belongs to a group of medicines called
antiplatelet agents. Platelets are very small cells that circulate in the blood. When a
blood vessel is damaged, for example if it is cut, platelets clump together to
help form a blood clot (thrombus). Therefore, platelets are essential for
stopping bleeding. If clots form inside a hardened blood vessel,
such as an artery, they can be very dangerous because they can block the passage of blood,
causing a heart attack (myocardial infarction), stroke or death. Clots in the arteries that carry
blood to the heart can also reduce the passage of blood to the heart itself, causing unstable angina
(severe chest pain).
Efient inhibits platelet aggregation and therefore reduces the possibility of blood
clots forming.
Efient has been prescribed for you because you have previously had a heart attack or unstable angina
and were treated with a procedure aimed at opening blocked heart arteries. You may also have
had one or more stents placed in the blocked or narrowed artery to restore blood flow.
Efient reduces the likelihood that you will have another heart attack or stroke or die from one of
these atherothrombotic events. Your doctor will also prescribe you acetylsalicylic acid (i.e.
aspirin), another antiplatelet agent.

2. What you need to know before taking Efient

Do not take Efient

• If you are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can be recognised by symptoms such as skin rash, itching, swelling of the face, swelling of the lips or difficulty breathing. If any of these occur, tell your doctor immediately.
• If you have a medical condition that causes ongoing bleeding, such as bleeding in the stomach or intestine.
• If you have previously had a stroke or a transient ischaemic attack (TIA).
• If you suffer from severe liver disease.

Warnings and precautions

• Before taking Efient:

Talk to your doctor before taking Efient
If any of the situations mentioned below apply to you, tell your doctor before taking Efient:

• If you have a condition with an increased risk of bleeding such as:
• 75 years of age or older. Your doctor will prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients over 75 years of age
• a recent serious injury
• a recent surgical procedure (including some dental procedures)
• recent or recurrent bleeding in the stomach or intestine (e.g. a gastric ulcer or a colon polyp)
• a body weight less than 60 kg. Your doctor will prescribe a daily dose of 5 mg of Efient if your weight is less than 60 kg
• moderate kidney or liver disease
• if you are taking certain medicines (see “Other medicines and Efient”)
• if you are due to have a planned surgical procedure (including some dental procedures) in the next seven days. Your doctor may advise you to temporarily stop taking Efient due to an increased risk of bleeding
• If you have had allergic (hypersensitivity) reactions to clopidogrel or any other antiplatelet medicine, tell your doctor before starting treatment with Efient. If you then take Efient and experience allergic reactions which can be recognised as a skin rash, itching, swelling of the face, swelling of the lips or difficulty breathing, you must tell your doctor immediately.
• While taking Efient:

Tell your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopenic Purpura (TTP), which includes the appearance of fever and bruising under the skin that
may appear as very small red dots, with or without unexplained profound fatigue,
confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible
side effects’).

Children and adolescents
Efient should not be used in children and adolescents under 18 years of age.

Other medicines and Efient
Tell your doctor if you are taking, have recently taken or might take any other
medicines, including those available without a prescription, food supplements and herbal remedies.
It is particularly important that you inform your doctor if you are being treated with:

• clopidogrel (an antiplatelet medicine),
• warfarin (an anticoagulant),
• “non-steroidal anti-inflammatory drugs” to relieve pain and reduce fever (such as ibuprofen, naproxen, etoricoxib). If taken in combination with Efient these medicines may increase the risk of bleeding.

Tell your doctor if you are taking morphine or other opioids (used to treat severe pain).
Only take other medicines while you are being treated with Efient if your doctor says it is okay to do so.

Pregnancy and breastfeeding
Tell your doctor if you are pregnant or planning to become pregnant while
taking Efient. You should only use Efient after discussing with your doctor the potential benefits and any
potential risk to the unborn child.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that Efient will affect your ability to drive vehicles or use machines.

Efient contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, contact your
doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

3. How to take Efient

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The usual dose of Efient is 10 mg per day. Treatment will begin with a single dose of 60 mg.
If your body weight is less than 60 kg or if you are over 75 years of age, the dose is 5 mg of Efient
per day.
Your doctor will also tell you to take acetylsalicylic acid, and will tell you the exact dose to take (usually
between 75 mg and 325 mg per day).
You can take Efient with or without food. Take Efient every day at approximately the same time. Do not
crush or break the tablet.
It is important that you inform your doctor, pharmacist and dentist that you are taking Efient.

If you take more Efient than you should
Contact your doctor or the nearest hospital immediately due to the risk of excessive bleeding. Show
your Efient pack to the doctor.

If you forget to take Efient
If you forget to take a dose, take one tablet as soon as you remember. If you forget to
take the dose for the whole day, simply take your normal dose of Efient the next day. Do not take a double
dose to make up for a missed dose. For packs of 14, 28, 56 84 and 98 tablets, you can check the day on
which you took the last Efient tablet by checking the calendar printed on the blister.

If you stop taking Efient
Do not stop taking Efient without consulting your doctor. If you stop taking Efient
too soon, the risk of a myocardial infarction may be greater.
If you have any further questions on 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.
You should immediatelycontact your doctor if you notice any of the following side effects:

• Sudden drowsiness or weakness in an arm, leg or face, especially if limited to one side of the body.
• Sudden confusion, difficulty speaking or understanding what others are saying.
• Sudden difficulty walking or loss of balance or coordination.
• Sudden dizziness or severe headache without a known cause. All of the above may be signs of a stroke. Stroke is an uncommon side effect of Efient in patients who have never had a stroke or transient ischemic attack (TIA).

Also immediatelycontact your doctor if you notice any of the following side effects:

• Fever and bruising under the skin that may appear as very small red spots, with or without unexplained profound fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 ‘BEFORE TAKING EFIENT’).
• A skin rash, itching, or swelling of the face, swelling of the lips/tongue or difficulty breathing. All of these can be signs of a serious allergic reaction (see section 2 ‘What you need to know before taking Efient’).

You should promptlycontact your doctor if you notice any of the following side effects:

• Blood in your urine.
• Bleeding from the rectum, blood in your stools or black, tarry stools.
• Uncontrollable bleeding, for example from a cut.

All of the above may be signs of bleeding, the most common side effect with
Efient. Although uncommon, serious bleeding can be life-threatening.

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

• Bleeding in the stomach or intestine
• Bleeding from the site of a needle puncture
• Nosebleed
• Skin rash
• Small red bruises on the skin (petechiae)
• Blood in the urine
• Hematoma (bleeding under the skin at the site of an injection, or in a muscle, causing swelling)
• Low hemoglobin or low red blood cell count (anemia)
• Bruising

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

• Allergic reaction (skin rash, itching, swelling of the lips/tongue or difficulty breathing)
• Spontaneous bleeding from the eye, rectum, gums or abdomen around internal organs
• Bleeding after surgery
• Coughing up blood
• Blood in the stools

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

• Low number of platelets in the blood
• Subcutaneous hematoma (bleeding under the skin causing swelling)

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 listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Efient

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the packaging after
EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from air and moisture.
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. Package contents and other information

What Efient contains

• The active ingredient is prasugrel. Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride). Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
• Other excipients are:

Microcrystalline cellulose, mannitol (E421), sodium croscarmellose, hypromellose (E464),
magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron
oxide red (only for 10 mg tablets) (E172), iron oxide yellow (E172) and talc.

Description of the appearance of Efient and package contents
Efient 10 mg: The tablets are beige in color and double arrow-shaped, with “10 MG” engraved on
one side and “4759” on the other side.
Efient 5 mg: The tablets are yellow in color and double arrow-shaped, with “5 MG” engraved on a
side and “4760” on the other side.
Efient is available in packs of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
SUBSTIPHARM
24 rue Erlanger
75016 Paris
France

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen
Germany
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/ Belgien
SUBSTIPHARM
Tél/Tel: 080077098

Lietuva
SUBSTIPHARM
Tel: +33 1 43 18 13 00

България
Zentiva, k.s.
Тел.: +359 24417136

Luxembourg/Luxemburg
SUBSTIPHARM
Tél/Tel: 80024806

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111

Magyarország
Zentiva Pharma Kft.
Tel: +36 1 299 1058

Danmark
Kurantis ApS
Tlf.: +45 33 60 89 88

Malta
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Deutschland
SUBSTIPHARM
Tel: 08001801783

Nederland
SUBSTIPHARM
Tel: 08000228089

Eesti
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Norge
Kurantis ApS
Tlf: +45 33 60 89 88

Ελλάδα
ΦΑΡΜΑΣΕΡΒ ΕΛΛΑΣ Α.Ε.Β.Ε.
Τηλ: +30 210 620 8372

Österreich
SUBSTIPHARM
Tel: 0800298153

España
SUBSTIPHARM
Tel: 900993317

Polska
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +48 22 566 21 00

France
SUBSTIPHARM
Tél: +33 1 43 18 13 00

Portugal
SUBSTIPHARM
Tel: 800833006

Hrvatska
SUBSTIPHARM
Tel: +33 1 43 18 13 00

România
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Ireland
SUBSTIPHARM
Tel: 1800300170

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408

Ísland
Kurantis ApS
Simi: +45 33 60 89 88

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010

Italia
SUBSTIPHARM
Tel: 800780088

Suomi/Finland
Kurantis ApS
Puh./Tel: +45 33 60 89 88

Κύπρος
SUBSTIPHARM
Τηλ: +33 1 43 18 13 00

Sverige
Kurantis ApS
Tel: +45 33 60 89 88

Latvija
SUBSTIPHARM
Tel.: +33 1 43 18 13 00

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.