DURONITRIN 60 mg Таблетки С Пролонгированным Высвобождением

Содержание инструкции

1. Duronitrin 60 mg prolonged-release tablets
   1. What is Duronitrin and what is it used for
   2. What you need to know before taking Duronitrin
   3. How to take Duronitrin
   4. Possible side effects
   5. How to store Duronitrin
   6. Contents of the pack and other information

Duronitrin 60 mg prolonged-release tablets

Isosorbide-5-mononitrate

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours, as it could 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 Duronitrin is and what it is used for
• 2. What you need to know before you take Duronitrin
• 3. How to take Duronitrin
• 4. Possible side effects
• 5. How to store Duronitrin
• 6. Contents of the pack and other information

1. What is Duronitrin and what is it used for

Duronitrin contains the active ingredient isosorbide-5-mononitrate, belonging to the group of medicines
called organic nitrates.
Organic nitrates work by dilating blood vessels, facilitating blood flow to the heart.
Duronitrin is indicated:

• in the maintenance therapy of coronary insufficiency (heart disease characterized by an obstruction of the coronary arteries, the blood vessels that carry blood to the heart)
• in the prevention of angina pectoris attacks (heart disease that manifests with chest pain)
• in the recovery treatment of heart function after a heart attack, even in association with other medicines to treat heart diseases (cardiotonic and diuretic medicines)
• in the treatment of chronic heart failure (disease characterized by the heart's inability to provide the body with an adequate amount of blood), even in association with other medicines to treat heart diseases (cardiotonic and diuretic medicines). Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Duronitrin

Do not take Duronitrin

• if you are allergic to isosorbide-5-mononitrate or any of the other ingredients of this medicine (listed in section 6)
• in case of shock (a condition in which blood flow to the peripheral tissues is inadequate to maintain vital functions)
• if you suffer from hypotension (low blood pressure)
• if you suffer from severe heart muscle diseases that manifest with fatigue and difficulty breathing (cardiomyopathy)
• if you suffer from pericarditis (an inflammation of the membrane surrounding the heart)
• if you are taking sildenafil or other medicines to treat erectile dysfunction called “phosphodiesterase type 5 inhibitors” (see section “Other medicines and Duronitrin”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Duronitrin:

• if you suffer from severe cerebral sclerosis (a disease in which blood flow in the brain is compromised)
• if you suffer from hypotension (low blood pressure).

Occasionally, tablet residues may pass through the intestine without disintegrating and
may be visible in the stool; if this happens, it does not mean that the medicine has not been
released adequately.

Children
The safety and efficacy of the medicine in children have not been established, therefore use in
children is not recommended.

Other medicines and Duronitrin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking sildenafil or other medicines used to treat
erectile dysfunction, called phosphodiesterase type 5 inhibitors.
Do not take sildenafil or other phosphodiesterase type 5 inhibitors if you are being treated with Duronitrin,
as they may increase the vasodilating effect of Duronitrin causing serious side effects,
such as syncope (fainting) or heart attack (see section “Do not take Duronitrin”).

Duronitrin with food and alcohol
Food does not significantly affect the absorption of Duronitrin, therefore this medicine
can be taken with or without food.
Simultaneous consumption of alcohol may increase hypotensive effects and reduce reflexes, therefore
avoid concomitant use of alcohol.

Driving and using machines
At the beginning of treatment with Duronitrin you may develop dizziness and therefore this medicine
may be dangerous for driving or using machines; take particular care if you are engaged in
driving or operating machinery.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine, as the
safety and efficacy of Duronitrin during pregnancy and breastfeeding have not been established.

3. How to take Duronitrin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

• The recommended dose is one tablet a day to be taken in the morning, unless otherwise prescribed by your doctor.
• The tablets can be taken with or without food.
• The tablet can be divided into equal parts.
• The whole tablets, or if necessary the divided halves, must not be chewed or crushed and must be swallowed whole with half a glass of water.
• To avoid the onset of headache, treatment may be started with half a tablet a day for the first 2-4 days of therapy.

Duronitrin is not indicated for the treatment of acute angina attacks. In these situations your doctor will
prescribe appropriate therapy (sublingual, buccal nitroglycerin tablets or spray formulations
).

Use in children
The safety and efficacy of the medicine in children have not been established, therefore use in
children is not recommended.

If you take more Duronitrin than you should

Symptoms
In the event of taking an excessive dose of Duronitrin, you may experience the following symptoms:
throbbing headache, excitement, flushing, cold sweats, nausea, vomiting,
dizziness, syncope (fainting), tachycardia (increased heart rate) and a sudden decrease
in blood pressure.

Treatment
In the event of taking an excessive dose of Duronitrin, consult your doctor or go to the nearest
hospital.
Treatment consists of inducing vomiting and administering activated charcoal. In case of severe
decrease in blood pressure, lie down in a supine position with your legs raised. The doctor, if
necessary, may administer fluids intravenously.

If you forget to take Duronitrin
Do not take a double dose to make up for the missed tablet.
If you have any doubts 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 everybody gets them.
The possible side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people):

• lowering of blood pressure, increased heartbeats
• headache, dizziness
• nausea

Uncommon (may affect up to 1 in 100 people):

• vomiting, diarrhea

Rare (may affect up to 1 in 1000 people):

• fainting
• skin rashes, itching

Very rare (may affect up to 1 in 10000 people):

• muscle pain.

Headache, which may occur at the beginning of treatment, usually disappears with the
continuation of therapy.
Symptoms such as dizziness, nausea and fainting associated with lowering of blood pressure, generally disappear
during the continuation of therapy.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Duronitrin

• Keep this medicine out of the reach and sight of children.
• This medicine does not require any particular storage conditions.
• Do not use this medicine after the expiry date that is stated on the pack after SCAD. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in waste water 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 Duronitrin contains

• the active ingredient is isosorbide-5-mononitrate. Each tablet contains 60 mg of isosorbide-5-mononitrate.
• the other ingredients are: aluminium silicate; solid paraffin; magnesium stearate; hydroxypropylcellulose; anhydrous colloidal silica; hypromellose; macrogol 6000; titanium dioxide (E171); yellow iron oxide (E172).

Description of the appearance of Duronitrin and contents of the pack
Yellow sustained-release tablets (capable of releasing the medicine slowly over time), packaged in blisters in a carton of 30 tablets.

Marketing Authorisation Holder
Topridge Pharma (Ireland) Limited, 6-9 Trinity Street, Dublin (Ireland)

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden