60 mg prolonged-release tablet
isosorbide mononitrate

What Is Isororbide Mononitrate Mylan is and what it is used for

Isosorbide mononitrate Mylan contains isosorbide mononitrate and belongs to a group of medicines called nitrates. This type of medicine works by dilating the blood vessels around the heart and thus facilitates the blood supply to the heart and other parts of the body. Isosorbide mononitrate Mylan is a prolonged-release tablet that provides a slow release of the drug in the body.

Isosorbide mononitrate Mylan is used in the prophylaxis of angina pectoris. Isosorbide mononitrate Mylan, on the other hand, is not intended for the treatment of sudden chest pain ( acute angina). If you have an acute attack of angina, another medicine should be used. Do not stop your treatment with Isosorbide Mononitrate Mylan without first consulting your doctor or pharmacist.

Isosorbide mononitrate contained in Isosorbide mononitrate Mylan may also be authorized for the treatment of other conditions not mentioned in this leaflet. 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 you take Isosorbide mononitrate Mylan 

Do not take Mylan Isosorbide Mononitrate:

  • if you are allergic to isosorbide mononitrate , other nitrates or any of the other ingredients of this medicine (listed in section 6).
  • if you suffer from another heart disease, such as inflammation of the pericardium (pericarditis), fluid in the pericardium ( cardiac tamponade ), disease of the heart muscle ( cardiomyopathy ), or heart valve disease
  • if you are taking sildenafil or a similar medicine, the so-called “phosphodiesterase type 5 inhibitor” normally used to treat erectile dysfunction
  • if you have very low blood pressure or problems with blood flow to the brain which may be due to problems with blood pressure or blood vessels, e.g. stroke or brain damage
  • if you have suffered a so-called cardiogenic shock that can occur after a heart attack when the body can not pump around enough blood in the body

Warnings and cautions

Talk to your doctor or pharmacist before taking Mylan Isosorbide Mononitrate.

  • if you have severe anemia ( anemia )
  • if you have hypothyroidism ( hypothyroidism )
  • if you have increased pressure inside the brain ( intracranial pressure )
  • if you have severe liver or kidney problems
  • if you are malnourished or unable to regulate your body temperature ( hypothermia ) or develop this during treatment
  • if you have hypoxemia (low oxygen content in the blood, due to lung disease for example).

Other medicines and Isosorbide mononitrate Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Do not take Isosorbide mononitrate Mylan with sildenafil or another phosphodiesterase type 5 inhibitors normally used to treat male impotence. If you use any of these medicines to treat erection problems, concomitant use of Isosorbide mononitrate Mylan may cause severe and potentially dangerous drops in blood pressure. This can cause you to faint or even have a heart attack.

If you are taking any of the following medicines, you must talk to your doctor or pharmacist.

  • cardiac drugs such as beta-blockers , e.g. sotalol, carvedilol
  • diuretics ( diuretics ), e.g. furosemide , hydrochlorothiazide
  • antidepressant drugs (so-called tricyclic antidepressants ), e.g. mirtazapine, trimipramine
  • medicines for the treatment of anxiety and mental problems such as tranquilizer
  • alprostadil ( prostaglandin ), which is also used to treat erectile dysfunction
  • dihydroergotamine (used to treat migraines )
  • drugs with antihypertensive effect as their effect may be enhanced (including vasodilators, other antihypertensive agents, calcium channel blockers and angiotensin II receptor antagonists)
  • aldesleukin, a drug used to treat cancer

Isosorbide mononitrate Mylan with alcohol

Alcohol can increase the blood pressure-lowering effect and can also make you sleepy. Consumption of alcohol during treatment should therefore be avoided.

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.

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy or weak.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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

Isosorbide mononitrate Mylan 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.

How to take Mylan Isosorbide Mononitrate

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

The recommended starting dose is half a tablet (30 mg) per day, the first two or four days. The tablet can be divided into two equal doses.

The recommended dose one after this is one tablet (60 mg) daily in the morning. If needed, the dose can be increased to 2 tablets (120 mg) daily in the morning.

The tablets should be swallowed with half a glass of water in the morning.

The tablets should not be crushed or chewed, even if they can be divided into two equal doses if necessary.

During treatment

When you take this medicine, you may see remnants of the tablet in your stool. This does not mean that the drug is less effective. The active substance in the tablet dissolves in the gastrointestinal tract and leaves a part of the tablet that can end up in the stool.

Use for children and adolescents

This medicine is not recommended for children or adolescents.

If you take more Mylan Isosorbide Mononitrate 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.

Signs of overdose may include headache, fatigue, redness, nausea, vomiting, increased heart rate, diarrhea, dizziness or dizziness, and fainting, which may be due to low blood pressure. Large amounts of this drug can cause bluish discoloration of the skin e.g. lips or changes in breathing, e.g. shortness of breath or slower breathing. If you suddenly experience any of the above, lie down with slightly raised legs as it can relieve the symptoms.

If you forget to take Mylan Isosorbide Mononitrate

Do not take a double dose to make up for a forgotten dose. If it is almost time for your next dose, skip the missed dose and take the next dose as usual.

If you stop taking Mylan Isosorbide Mononitrate

Do not stop taking this medicine without consulting a doctor or pharmacist as your chest pain may recur or worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects of isosorbide mononitrate are most common at the beginning of treatment.

If you experience any of the following, seek medical attention immediately:

  • signs of very low blood pressure such as:pale, cold, damp or bluish skin- rapid, shallow breathing- fast heartbeat with dizziness- weak pulseconfusion, anxiety or unconsciousness.

These can be signs of circulatory failure, a condition that can lead to an insufficient supply of oxygen to the brain, kidneys, skin, and other body parts (occurs in an unknown number of users).

Other side effects are

Very common (may affect more than 1 user in 10)

  • headache

Common (may affect up to 1 in 10 people)

  • dizziness
  • fatigue
  • low blood pressure
  • increased heart rate
  • nausea

Uncommon (may affect up to 1 in 100 people)

  • reddening of the skin
  • vomiting
  • diarrhea

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

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

  • pain, tenderness or weakness in muscles not caused by exertion ( myalgia )

Has been reported (occurs in an unknown number of users)

  • somnolence
  • aggravated symptoms of angina ( angina pectoris )
  • slow pulse
  • low blood pressure that causes dizziness when you get up
  • scaly or flaky skin, blisters
  • allergic skin reactions such as lumps, redness and itching of the skin

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 Isosorbide mononitrate Mylan

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage instructions.

Used before the expiry date which is stated after “Exp”. 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 pack and other information

Content declaration

– The active substance is isosorbide mononitrate. Each tablet contains 60 mg of isosorbide mononitrate.

– The other ingredients are microcrystalline cellulose, heavy kaolin, magnesium stearate, anhydrous colloidal silica. Tablet coatings contain synthetic paraffin, solid paraffin, hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “Isosorbide mononitrate Mylan contains lactose”), macrogol, iron oxide yellow (E172), iron oxide black (E172), iron oxide red (E172).

What the medicine looks like and contents of the pack

Isosorbide mononitrate Mylan is a light yellow, elliptical, film-coated tablet marked ‘IM’ break notch ’60’ on one side and a break notch on the other.

Isosorbide mononitrate Mylan is available in plastic jars, with or without plastic filling at the top of the jar, as well as in blister packs of 7, 14, 28, 30, 60, 90, 98, 100, 100×1 (single-dose packs), and 250 tablets.

Not all pack sizes may be marketed.

Marketing and manufacturing authorization holder

Mylan AB, Box 23033, 104 35 Stockholm

Phone: 08-555 22 750, Fax: 08-555 22 751, E-mail: inform@mylan.se

Muhammad Nadeem

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