30 mg and 60 mg prolonged-release tablets of
isosorbide mononitrate

1. What Isonova is and what it is used for

Isonova is used to prevent angina in the heart ( angina pectoris ). Isonova works by dilating the blood vessels and thereby facilitates the heart’s work in case of angina in the heart.


Isosorbide mononitrate contained in Isonova 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.

What you need to know before taking Isonova

Do not take Isonova:

  • 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 drugs for impotence or pulmonary arterial hypertension (PAH), such as Viagra (sildenafil), Cialis and Adcirca (tadalafil) and Levitra (vardenafil). These drugs are also called phosphodiesterase type 5 inhibitors.

Warnings and cautions

If you have any of the following conditions, talk to your doctor, pharmacist, or nurse before taking Isonova:

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

Other drugs and Isonova

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


When you are being treated with Isonova you must not use medicines for impotence ( erectile dysfunction ) or pulmonary arterial hypertension (PAH), such as Viagra (sildenafil), Cialis and Adcirca (tadalafil), and Levitra (vardenafil. These medicines are also called phosphodiesterase type 5 ). inhibitors.

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. Therefore, talk to your doctor before using Isonova during pregnancy.


Breast-feeding

It is not known whether isosorbide mononitrate passes into breast milk. Therefore, talk to your doctor before using Isonova during breastfeeding.

Driving and using machines

Isonova may impair the ability to react, as dizziness may occur when you take the medicine, which you should keep in mind when e.g. driving or using machines.


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. 

Isonova contains lactose

Isonova contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Isonova

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

The recommended dose is 60 mg once daily in the morning.

With the new adjustment, you can, to avoid headaches, give 30 mg for the first 2-4 days.


Isonova 30 mg: The tablets should be swallowed whole with ½ glass of liquid. The tablets must not be split, chewed, or crushed.


Isonova 60 mg: The tablet can be divided into two equal doses. Whole or divided tablets should not be chewed or crushed and should be swallowed with a glass of liquid.

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

If you take more Isonova 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 take Isonova

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


If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

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


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

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


Less common side effects are (may affect up to 1 in 100):


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


Very rare side effects are (may affect up to 1 in 10,000):

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 Isonova

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. The expiration date is the last day of the specified month.

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

  • The active substance is isosorbide mononitrate 30 mg and 60 mg
  • Other ingredients are:
    • Core: Hypromellose, carnauba wax, stearic acid, lactose monohydrate , magnesium stearate, colloidal anhydrous silica.
    • Coating: Talc, hypromellose, magnesium stearate, titanium dioxide (dye E 171), yellow iron oxide (dye E 172), macrogol.

What the medicine looks like and contents of the pack

Appearance

30 mg: creamy white, round (7mm) biconvex prolonged-release tablet .

60 mg: creamy white, oval prolonged-release tablet (7×13 mm), with a notch on both sides and marked “60” on one side. 

Pack sizes

Blister: 30, 50 or 100 prolonged-release tablets are.

Calendar blister: 98 prolonged-release tablets are.

Tablet can: 30 mg: 100 prolonged-release tablets are. 60 mg: 100 and 500 prolonged-release tablets .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Manufacturer

Viminco A / S, Lodshusvej 11, 4230 Skælskør, Denmark

or

Orifarm Generics A / S, Energivej 15, 5260 Odense S, Denmark

Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm 

info@orifarm.com

Muhammad Nadeem

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