Duronitrin

Package leaflet: Information for the patient

Duronitrin 60 mg prolonged-release tablets

Isosorbide-5-mononitrate
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Duronitrin is and what it is used for

Duronitrin contains the active substance isosorbide-5-mononitrate, which belongs to a group of medicines called organic nitrates.
Organic nitrates work by dilating blood vessels, thereby improving blood flow to the heart.
Duronitrin is indicated:

• for maintenance therapy of coronary insufficiency (heart disease characterized by obstruction of the coronary arteries, the blood vessels supplying blood to the heart)
• for prevention of angina pectoris attacks (heart disease characterized by chest pain)
• for recovery treatment of heart function following a myocardial infarction, also in combination with other medicines used to treat heart diseases (cardiotonic agents and diuretics)
• for treatment of chronic heart failure (a disease characterized by the heart's inability to supply adequate blood to the body), also in combination with other medicines used to treat heart diseases (cardiotonic agents and diuretics).
  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 to any of the other ingredients of this medicine (listed in section 6)
• if you are suffering from shock (a condition in which blood flow to peripheral tissues is inadequate to maintain vital functions)
• if you have hypotension (low blood pressure)
• if you suffer from severe cardiomyopathy (heart muscle disease) presenting with fatigue and breathing difficulties
• if you have pericarditis (an inflammation of the membrane surrounding the heart)
• if you are taking sildenafil or other medicines for erectile dysfunction known as "phosphodiesterase-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 to the brain is impaired)
• if you have hypotension (low blood pressure).

Occasionally, tablet residues may pass through the intestine without disintegrating and may be visible in the stool; if this occurs, it does not mean that the medicine has not been properly released.
Children
The safety and efficacy of this medicine in children have not been established; therefore, use in children is not recommended.
Other medicines and Duronitrin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking sildenafil or other medicines used to treat erectile dysfunction, known as phosphodiesterase-5 inhibitors.
Do not take sildenafil or other phosphodiesterase-5 inhibitors if you are being treated with Duronitrin, as they may enhance the vasodilatory effect of Duronitrin, causing serious adverse effects such as syncope (fainting) or myocardial infarction (see section “Do not take Duronitrin”).
Duronitrin with food and alcohol
Food does not significantly affect the absorption of Duronitrin; therefore, this medicine may be taken with or without food.
Concurrent consumption of alcohol may increase the hypotensive effects and reduce reflex responses; therefore, avoid using alcohol together with this medicine.
Driving and using machines
At the beginning of treatment with Duronitrin, you may experience dizziness, and therefore this medicine may impair your ability to drive or operate machinery; exercise particular caution if you are responsible for driving or operating machinery.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist 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 exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.

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

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

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

If you take more Duronitrin than you should

Symptoms
If you take too much Duronitrin, you may experience the following symptoms:
pulsating headache, restlessness, flushing, cold sweats, nausea, vomiting, dizziness, syncope (fainting), tachycardia (increased heart rate), and sudden drop in blood pressure.

Treatment
If you take an excessive dose of Duronitrin, contact your doctor or go to the nearest hospital immediately.
Treatment includes inducing vomiting and administering activated charcoal. In case of a severe drop in blood pressure, lie down in a supine position with your legs elevated. Your doctor may, if necessary, administer intravenous fluids.

If you forget to take Duronitrin
Do not take a double dose to make up for a forgotten tablet.
If you have any doubts about how to use 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 by the following frequency:
Common (may affect up to 1 in 10 people):

• low blood pressure, increased heart rate
• headache, dizziness
• nausea

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

• vomiting, diarrhoea

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

• fainting
• skin rash, itching

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

• muscle pain.

Headache, which may occur at the beginning of treatment, usually disappears with continued therapy.
Symptoms such as dizziness, nausea and fainting associated with low blood pressure generally disappear during continued treatment.
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 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 special storage conditions.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• 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 Duronitrin contains

• The active substance is isosorbide-5-mononitrate. Each tablet contains 60 mg of isosorbide-5-mononitrate.
• The other components are: aluminium silicate; hard 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
Prolonged-release yellow tablets (capable of releasing the medicine slowly over time), packaged in blisters in a carton containing 30 tablets.
Marketing Authorisation Holder
Topridge Pharma (Ireland) Limited, 6-9 Trinity Street, Dublin (Ireland)
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden