Package leaflet: Information for the user

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

Prasugrel
Generic medicine
Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Drullub is and what it is used for
What you need to know before taking Drullub
How to take Drullub
Possible side effects
How to store Drullub
Contents of the pack and other information

1. What Drullub is and what it is used for

Drullub, 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 in helping to stop bleeding. However, if clots form inside a hardened blood vessel, such as an artery, they can be very dangerous because they may block the flow of blood, causing a heart attack (myocardial infarction), stroke, or death. Clots in the arteries supplying blood to the heart can also reduce blood flow to the heart muscle, causing unstable angina (severe chest pain).
Drullub inhibits platelet aggregation and therefore reduces the likelihood of blood clots forming.
Drullub has been prescribed for you because you have previously had a heart attack or unstable angina and have been 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. Drullub reduces the likelihood that you will have another heart attack or stroke or die from such atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (for example, aspirin), another antiplatelet medicine.

2. What you need to know before taking Drullub

Do not take Drullub

If you are allergic to prasugrel or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a skin rash, itching, swelling of the face, swelling of the lips, or difficulty breathing. If any of these occur, inform your doctor immediately.
If you have a medical condition causing active bleeding, such as bleeding in the stomach or intestines.
If you have previously had a stroke or a transient ischemic attack (TIA).
If you suffer from severe liver disease.

Warnings and precautions
Before taking Drullub:
Talk to your doctor before taking Drullub
If any of the following conditions apply to you, inform your doctor before taking Drullub:
If you have a condition that increases your risk of bleeding, such as:

Age 75 years or older. Your doctor will prescribe a daily dose of 5 mg, as there is an increased risk of bleeding in patients over 75 years of age.
Recent severe trauma
Recent surgery (including certain dental procedures)
Recent or recurrent bleeding in the stomach or intestines (e.g., gastric ulcer or colon polyp)
Body weight less than 60 kg. Your doctor will prescribe a daily dose of 5 mg of Drullub if your body weight is below 60 kg.
Moderate kidney or liver disease
If you are taking certain medicines (see below “Other medicines and Drullub”)
If you are scheduled for elective surgery (including certain dental procedures) within the next seven days. Your doctor may advise you to temporarily stop taking Drullub due to an increased risk of bleeding.
If you have had allergic reactions (hypersensitivity) to clopidogrel or to any other antiplatelet medicine, inform your doctor before starting treatment with Drullub. If, after starting Drullub, you experience allergic reactions such as skin rash, itching, swelling of the face, swelling of the lips, or difficulty breathing, you must inform your doctor immediately.
While taking Drullub:
Inform your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopenic Purpura (TTP), which may include fever and bruising under the skin appearing as tiny red spots, with or without unexplained severe fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).

Children and adolescents
Drullub must not be used in children and adolescents under 18 years of age.
Other medicines and Drullub
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription, dietary 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), or with "non-steroidal anti-inflammatory drugs" to relieve pain and reduce fever (such as ibuprofen, naproxen, etoricoxib). When taken together with Drullub, these medicines may increase the risk of bleeding.
Inform your doctor if you are taking morphine or other opioids (used to treat severe pain).
Take other medicines while on Drullub treatment only if your doctor says you may do so.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant, trying to become pregnant, or breastfeeding while taking Drullub. You should use Drullub only after discussing with your doctor the potential benefits and any possible risks to your unborn child.
The use of prasugrel during breastfeeding is not recommended.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Drullub will affect your ability to drive or operate machinery.
Drullub contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Drullub

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
The usual dose of Drullub is 10 mg daily. Treatment will start with a single 60 mg dose. If your body weight is less than 60 kg or if you are over 75 years of age, the dose is 5 mg of Drullub daily. Your doctor will also instruct you to take acetylsalicylic acid—he or she will tell you the exact dose to take (usually between 75 mg and 325 mg daily).
You may take Drullub with or without food. Take Drullub at approximately the same time each day.
5 mg: Do not crush or break the tablet.
10 mg: The tablet may be divided into two equal doses by breaking it once only. Do not
crush the tablet.
It is important that you inform your doctor, dentist, and pharmacist that you are taking Drullub.
If you take more Drullub than you should
Contact your doctor or the nearest hospital immediately due to the risk of excessive bleeding. Show your doctor the Drullub packaging.
If you forget to take Drullub
If you forget to take a dose, take one tablet as soon as you remember. If you forget to take the dose for the entire day, simply take your usual dose of Drullub the next day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Drullub
Do not stop treatment with Drullub without first consulting your doctor; stopping treatment with Drullub too early may increase the risk of myocardial infarction.
If you have any questions 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.
You must immediately contact your doctor if you notice any of the following side effects:

Sudden drowsiness or weakness in one arm, one leg or one side of the 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 sudden severe headache with no known cause.
All of the above may be signs of a stroke. Stroke is an uncommon side effect of Drullub in patients who have never had a stroke or transient ischaemic attack (TIA).

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

Fever and bruising under the skin appearing as tiny red spots, with or without unexplained severe tiredness, confusion, or yellowing of the skin or eyes (jaundice) (see section 2, 'What you need to know before taking Drullub').
A skin rash, itching, or swelling of the face, swelling of the lips/tongue, or shortness of breath. All of these may be signs of a serious allergic reaction (see section 2, 'What you need to know before taking Drullub').
You must promptly contact your doctor if you notice any of the following side effects:
Blood in the urine.
Bleeding from the rectum, blood in the stool, or black stools.
Uncontrolled bleeding, for example from a cut.

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

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

Bleeding in the stomach or intestines
Bleeding at the site of an injection
Nosebleeds
Skin rash
Small red bruises on the skin (purpura)
Blood in the urine
Haematoma (bleeding under the skin at the site of an injection or in a muscle, causing swelling)
Low haemoglobin or low red blood cell count (anaemia)
Bruising

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

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

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

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

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 https://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 Drullub

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after Exp.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via 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 Drullub contains

The active substance is prasugrel (as bromide salt). Each film-coated tablet contains 5 or 10 mg of prasugrel (as bromide salt).
The other components are: Tablet core: microcrystalline cellulose, mannitol, hypromellose, low-substituted hydroxypropylcellulose, glyceryl dibehenate, sucrose stearate.
Film coating (5 mg): partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol/polyethylene glycol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Film coating (10 mg): partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol/polyethylene glycol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Drullub and package contents
Drullub 5 mg: Yellow, oval, film-coated tablets, marked with "P5" on one side and smooth on the other side.
Drullub 5 mg film-coated tablets are available in blisters containing 28 film-coated tablets.
Drullub 10 mg: Beige, oval, film-coated tablets, marked with "P10" on one side and a score line on the other side.
Drullub 10 mg film-coated tablets are available in blisters containing 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SF Group S.r.l.
Via Tiburtina, 1143
00156 – Rome
Italy

Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 – Zagreb
Croatia