30 mg prolonged-release tablet is
isosorbide mononitrate
1. What Isomex is and what it is used for
Isomex contains the active ingredient isosorbide mononitrate, which belongs to a group of medicines called nitrates. This type of medicine works by dilating the blood vessels, thereby facilitating the heart’s work in case of angina in the heart.
Isomex is used to prevent angina in the heart ( angina pectoris ).
Isosorbide mononitrate contained in Isomex 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 Isomex
Do not use Isomex
- if you are allergic to isosorbide mononitrate or any of the other ingredients of this medicine (listed in section 6)
- if you are taking medicines to treat impotence or pulmonary arterial hypertension (PAH) at the same time ; for example Viagra (sildenafil), Cialis (tadalafil), or Levitra (vardenafil). See section “Other medicines and Isomex”.
- if you suffer from failing circulation ( acute circulatory failure , shock )
- if you have a disease in your heart muscle (constrictive cardiomyopathy )
- if you have certain diseases of the pericardium (constrictive pericarditis, pericardial tamponade)
- if you have early signs of a heart attack (chest pain or pressure over the chest, pain spreading to your jaw or shoulder, nausea, sweating).
- if you are also taking riociguat. See section “Other medicines and Isomex”.
Warnings and cautions
Talk to your doctor or pharmacist before taking Isomex
- if you suffer from severely reduced blood flow to the brain
- if you have any heart disease
- if you have anemia ( anemia )
- if you have low blood oxygen ( hypoxemia )
- if you have unstable blood pressure such as low blood pressure ( hypotension ) and decreased blood volume ( hypovolemia )
- if you have hypothyroidism ( hypothyroidism )
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
Children
This medicine is not intended for use in children.
Other medicines and Isomex
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Some medicines may affect or be affected by treatment with Isomex.
Do not use Isomex at the same time as medicines such as Viagra (sildenafil), Cialis (tadalafil), or Levitra (vardenafil), which are used for impotence ( erectile dysfunction ) or pulmonary arterial hypertension (PAH). If you are taking such a medicine while taking Isomex, it may cause a severe drop in blood pressure which may lead to fainting or heart attack. Do not use Isomex at the same time as riociguat as this may cause abnormally low levels
of blood pressure. Isomex should not be used at the same time as dihydroergotamine as it may
enhance the antihypertensive effect of dihydroergotamine.
Drugs that dilate blood vessels or lower blood pressure can affect the effect of Isomex.
Isomex with food, drink and alcohol
Taking alcohol while taking Isomex may make your blood pressure worse and you may feel dizzy or faint.
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.
As a precautionary measure, it is best to avoid using Isomex during pregnancy.
Pregnancy
There is limited experience with the use of Isomex during pregnancy. Therefore, consult a doctor before taking Isomex during pregnancy.
Breast-feeding
It is unknown whether isosorbide mononitrate is excreted in human milk. Risk to the breastfeeding child cannot be ruled out. Therefore, you should not use Isomex during breastfeeding.
Driving and using machines
Isomex can cause headaches and dizziness. You should not drive, use advanced machines or engage in any other potentially hazardous activities until you know if this medicine affects your ability to perform these activities.
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.
Isomex contains lactose
Isomex contains a sugar called 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 Isomex
Always take this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide which dose is right for you. The usual dose for adults is 60 mg (two tablets) of Isomex once daily in the morning.
Your doctor may ask you to start with a lower dose so that the risk of you getting a headache when you start taking Isomex is less. Your doctor may prescribe a different dosage depending on your symptoms, your age, and other medicines you are taking. Dose one can be increased to 120 mg daily.
Use for the elderly
Dose one for elderly patients (over 65 years) is the same as for adults.
Method of administration
Isomex should be swallowed whole and must not be crushed or chewed. Always swallow the tablets with at least half a glass of water. The tablets can be taken with or without food.
Sometimes some users may see remnants of the tablet in the stool. This is normal and does not mean that the medicine has not been absorbed into the body.
If you take more Isomex than you should
If you have ingested too much 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 throbbing headache, nervousness, redness, cold sweats, nausea, vomiting, dizziness, fainting, and rapid heartbeat. 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 Isomex
Do not take a double dose to make up for a forgotten dose.
If you stop taking Isomex
Do not suddenly stop taking Isomex tablets as this may make your angina worse. If your treatment is to be stopped, this should be done gradually. Be sure to follow your doctor’s instructions.
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.
Contact a doctor immediately if you get any of the following symptoms as they may be severe;
- dizziness, nausea (common, may affect up to 1 in 10 people)
- fainting (rare, may affect up to 1 in 1,000 people)
Other side effects are
Common (may affect up to 1 in 10 people)
- headache that disappears or subsides with continued use
- low blood pressure – which can cause dizziness and nausea
- palpitations ( tachycardia )
Uncommon (may affect up to 1 in 100 people)
- vomiting
- diarrhea
Rare (may affect up to 1 in 1,000 people)
- rash, itching
Very rare (may affect less than 1 in 10,000 users)
- Muscle pain ( myalgia )
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 Isomex
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.
No special storage instructions.
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 . Each tablet contains 30 mg of isosorbide mononitrate .
- The other ingredients are: hypromellose, lactose monohydrate , pregelatinized starch , magnesium stearate, anhydrous colloidal silica.
What the medicine looks like and contents of the pack
Isomex tablets are white/off-white, oval prolonged-release tablets.
Isomex is available in a bottle containing 100 tablets or in a blister pack containing 28 or 98 tablets.
Not all pack sizes may be marketed.
Manufacturer
Recipharm Fontaine
Rue de Près Potets
21121 Fontaine-lès-Dijon
France
Local representative
Astimex Pharma AB
Isafjordsgatan 36
164 40 Kista
Tel. 08-5151 1535
info@astimex.se
This medicinal product is authorized under the European Economic Area under the names:
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