30 mg, 60 mg, 120 mg prolonged-release tablets are
isosorbide mononitrate

1. What Imdur is and what it is used for

Imdur works by dilating the blood vessels and thereby facilitates the heart’s work in case of angina in the heart.

Imdur is used as a preventive treatment for angina in the heart ( angina pectoris ).

Isosorbide mononitrate contained in Imdur may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Imdur

Do not use Imdur

  • if you are allergic to isosorbide mononitrate or any of the other ingredients of this medicine (listed in section 6).
    • in shock
    • at low blood pressure
    • in heart muscle disease (constrictive cardiomyopathy )
    • in certain diseases of the pericardium (constrictive pericarditis, pericardial tamponade)
    • concomitantly with phosphodiesterase type 5 inhibitors, such as Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil)

Warnings and cautions

Talk to your doctor before using Imdur if you have any of the following conditions:

  • brain injury
  • heart disease
  • decreased blood oxygen content ( hypoxemia )
  • anemia ( anemia )
  • hypothyroidism ( hypothyroidism )

Other medicines and Imdur

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect or be affected by treatment with Imdur.

When you are treated with Imdur, you must not use phosphodiesterase type 5 inhibitors, such as Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil), which are used for impotence ( erectile dysfunction ).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Experience with use during pregnancy is limited.

Breast-feeding

It is not known whether isosorbide mononitrate passes into breast milk.

Driving and using machines

Imdur may impair your ability to react, as dizziness may occur when you take the medicine, which you should keep in mind when driving or using machines, for example.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Imdur

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide on a dose to suit you. The recommended dose is 60 mg once daily.

The tablets for the lower strengths, 30 mg, and 60 mg, are divisible. Whole or divided tablets should not be chewed or crushed and should be swallowed with at least 1/2 glass of liquid.

The contents of the Imdur tablet are surrounded by a shell, which can pass unaffected through the intestine. The tablet can thus look completely intact, while the active substance is released during the passage through the gastrointestinal tract.

If you use more Imdur than you should  

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Imdur

Do not take a double dose to make up for a forgotten tablet.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

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

  • headache (the headache disappears after a few weeks of treatment)
  • low blood pressure which can cause dizziness and nausea
  • increased heart rate .

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

  • vomiting
  • diarrhea.

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

  • fainting spells
  • rash
  • itching .

Isolated cases of muscle pain ( myalgia ) have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Imdur

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 carton after “Exp”.

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. Contents of the packaging and other information

Content declaration

1 prolonged-release tablet contains:

  • The active substance is: isosorbide mononitrate 30 mg, 60 mg and 120 mg respectively.
  • The other ingredients are: magnesium stearate, silica, paraffin, hypromellose, hydroxypropylcellulose, sodium aluminosilicate, macrogol, dye (titanium dioxide E171), dye (iron oxide E172); only in 30 mg and 60 mg prolonged-release tablets .

Other ingredients are included so that the prolonged-release tablet can be manufactured.

What the medicine looks like and contents of the pack

Prolonged-release tablets are 30 mg: pink, oval with notch, marked A / II.

Prolonged-release tablets are 60 mg: light yellow, oval with a notch, marked A / ID.

Prolonged-release tablets are 120 mg: white, oval, marked A / IF.

Marketing Authorization Holder and Manufacturer

TopRidge Pharma (Ireland) Limited, 6-9 Trinity Street, Dublin 2, Ireland.

Manufacturer

Laboratorios Alcalá Farma, SL Avenida de Madrid, 82, Alcalá de Henares, Madrid, 28802, Spain.

Muhammad Nadeem

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