40 mg prolonged-release tablet is
Isosorbide-5-mononitrate

1. What Ismo Retard is and what it is used for

Ismo Retard contains isosorbide mononitrate which dilates the blood vessels and thereby reduces the work of the heart in angina pectoris.

Preventive treatment of angina pectoris ( angina pectoris ).

Isosorbide mononitrate contained in Ismo Retard 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 taking Ismo Retard

Do not take Ismo Retard

  • if you are allergic to isosorbide-5-mononitrate or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to organic nitrates
  • if you suffer from severe impaired blood circulation or shock
  • if your heart has severely impaired pump function ( cardiogenic shock ), so that your blood pressure does not become high enough
  • if you have decreased blood volume (severe hypovolemia )
  • if you have pericarditis
  • if you have accumulation of fluid in the pericardium around the heart ( cardiac tamponade )
  • if you are also taking phosphodiesterase ‑5 ‑ inhibitors, e.g. sildenafil, vardenafil or taldalfil

Warnings and cautions

Talk to your doctor or pharmacist before taking Ismo Retard.

Consult a physician before starting treatment with Ismo Retard if you: 

  • have hypertrophic obstructive cardiomyopathy (heart muscle disease)
  • have low blood pressure
  • have problems with low blood pressure , e.g. when getting up from sitting ( orthostatic circulatory dysregulation)
  • have disease of the blood vessels in the brain ( cerebrovascular disease)
  • have narrowing of the heart valves (aortic stenosis and / or mitral stenosis )
  • has increased pressure in the skull
  • have anemia ( anemia )
  • have a lack of oxygenation of the blood ( hypoxemia )
  • has impaired thyroid function
  • is malnourished
  • have low body temperature ( hypothermia )
  • recently had a heart attack
  • taking drugs to lower blood pressure et

Ismo Retard is not suitable for the treatment of acute angina attack or myocardial infarction.

Drugs of the phosphodiesterase -5 inhibitor type must not be taken at the same time as Ismo Retard. Ingestion of Ismo Retard within 24 hours after ingestion of phosphodiesterase -5 inhibitors should be done with caution due to the risk of severe hypotension.

Reduced effect of Ismo Retard so-called tolerance development and that the reduced effect also applies to nitrates other than isosorbide mononitrate so-called cross-tolerance has been described.

If Ismo Retard is taken, transient hypoxia ( hypoxemia ) may occur.

If you have coronary heart disease, it can lead to a lack of oxygen in the heart muscles.

Children

The safety and efficacy of Ismo Retard in children have not been established.

Other medicines and Ismo Retard

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

Ismo Retard must not be used at the same time as drugs of the phosphodiesterase -5 inhibitor type, e.g. sildenafil, vardenafil, and tadalafil as it can lead to a sharp drop in blood pressure, impaired blood supply ( ischemia ), and disturbed blood circulation with permanent damage to the heart and brain. 

If you are taking the following medicines at the same time as Ismo Retard, the blood pressure-lowering (hypotensive) effect of Ismo Retard may be increased:

  • other vasodilators (vasodilators)
  • antihypertensives (medicines to treat high blood pressure ) e.g. ACE inhibitors, beta-blockers , calcium channel blockers and diuretics ( diuretics )
  • neuroleptics (medicines for certain mental illnesses)
  • sapropterin (drug used to lower the level of the amino acid phenylalanine in the blood of patients with phenylketonuria)
  • tricyclic antidepressants (used for depression)

Ismo Retard with alcohol

Concomitant treatment with Ismo and alcohol consumption may potentiate the antihypertensive effect of Ismo Retard.

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:

Limited experience of use during pregnancy. Therefore, consult a doctor before using Ismo Retard during pregnancy.

Breast-feeding:

It is not known if Ismo Retard passes into breast milk. Therefore consult a doctor before use during breastfeeding.

Driving and using machines

Ismo Retard may impair the ability to react. This should be taken into account when increased attention is required, eg when driving or using machines. This applies above all at the beginning of the treatment or when the treatment is changed and in connection with alcohol.

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.

Ismo Retard contains sucrose, milk sugar (lactose) and liquid glucose

Ismo Retard contains 20 mg milk sugar ( lactose ) per tablet.

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 Ismo Retard

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

Dose one is determined by the doctor who adjusts it individually for you.

The recommended dose is 1 prolonged-release tablet (40 mg) in the morning. If necessary, the dose can be increased to 2 prolonged-release tablets (80 mg) in the morning.

Ismo Retard provides a controlled, slow-release, which is why prolonged-release tablets are dosed once a day. Thereby a range with low nitrate concentration is obtained. Ismo Retard starts operating after about half an hour. The maximum effect is reached 2-4 hours after taking the tablet. The effect lasts at least 12 hours.

Discontinuation of treatment with Ismo Retard should be done gradually so that the symptoms of angina do not worsen.

The prolonged-release tablets should be swallowed whole with liquid (eg a glass of water). The prolonged-release tablets must not be shared.

If you take more Ismo Retard 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.

Symptoms of overdose may include: decreased blood pressure with impaired blood circulation ( orthostatic dysregulation), increased heart rate (reflex tachycardia), palpitations ( palpitations ), pulsating headache, anxiety ( excitation ), reddening of the skin, cold sweats, weakness ( asthenia ), dizziness, dizziness stupor ), fainting, nausea, vomiting, and diarrhea.

If you forget to take Ismo Retard

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

If you forget to take a tablet, take it the same day as soon as you remember. Continue treatment, as usual, the next morning.

If you stop taking Ismo Retard

You may feel unwell if you suddenly stop taking Ismo Retard. Tell your doctor if you stop taking this medicine.

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.

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

  • headache (so-called “nitrate headache”). Occurs frequently at the beginning of treatment and usually disappears after a few weeks of treatment.

Common ( may affect up to 1 in 10 people) 

  • dizziness
  • low blood pressure ( hypotension )
  • elevated heart rate ( tachycardia )
  • nausea

Uncommon (may affect up to 1 in 100 people)

  • vomiting
  • transient redness ( erythema )

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

  • fainting
  • allergic skin reactions

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 Ismo Retard

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

Used before 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-5-mononitrate, 40 mg per prolonged-release tablet
  • The other ingredients are titanium dioxide (E171), sucrose, anhydrous lactose , magnesium stearate, kaolin, colloidal anhydrous silica, povidone, talc, glucose , liquid, macrogol 35000, eudrogit E 12.5, montana glycol wax.

What the medicine looks like and contents of the pack

100 prolonged-release tablets (white, round, about 7 mm)

Marketing Authorization Holder and Manufacturer

Holder of a marketing authorization

Riemser Pharma GmbH

An der Wiek 7

DE-17493 Greifswald – Insel Riems 

Germany

Manufacturer

Kern Pharma SL

Polygono Ind. Colon II

Venus II

08228 Terrassa (Barcelona)

Spain

Muhammad Nadeem

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