25mg / 50mg / 100 mg hard
prolonged-release capsules isosorbide mononitrate
What Monoket OD is and what it is used for
Monoket OD is used as a preventive treatment for angina in the heart ( angina pectoris ).
This drug works by dilating the blood vessels and thereby reducing the work of the heart.
Isosorbide mononitrate contained in Monoket OD may also be approved 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.
What you need to know before using Monoket OD
Do not use Monoket OD
- if you are allergic to isosorbide mononitrate , other nitrates or any of the other ingredients of this medicine (listed in section 6)
- if your heart has severely impaired pump function ( cardiogenic shock ), so that your blood pressure does not become high enough
- if you have a heart muscle disease that leads to thickening of the heart wall (obstructive hypertrophic cardiomyopathy )
- if you have inflammation of the pericardium (constrictive pericarditis)
- if you have accumulation of fluid between the heart and the pericardium ( cardiac tamponade )
- if you have acute circulatory failure ( shock or circulatory collapse)
- if you have very low blood pressure (systolic blood pressure below 90 mmHg)
- if you have a sharp decrease in blood volume (severe hypovolemia )
- if you are taking riociguat, a medicine for certain types of high blood pressure (so-called pulmonary hypertension )
- if you have severe anemia ( anemia ).
When using Monoket, do not use phosphodiesterase inhibitors ( PDE 5 inhibitors), such as sildenafil, tadalafil, or vardenafil, which are used for impotence as concomitant use with this medicine may lead to a severe drop in blood pressure which may damage the heart or brain (see also section Other medicines and Monoket).
Warnings and cautions
Talk to your doctor or pharmacist before using Monoket OD.
Take special care with this medicine
- if you have heart problems (such as acute heart attack or left ventricular dysfunction), low blood pressure , narrowing of large blood vessels or heart valve
- if you have problems with low blood pressure e.g. when getting up from sitting
- if you have increased pressure in the skull, anemia , too little oxygen in the blood or impaired thyroid function.
- if you have overactive or irritated bowel because this medicine may pass through the gastrointestinal tract too quickly, before complete release of the active substance.
Those who have these diseases should consult a doctor before starting treatment with this drug.
This medicine should not be used to treat an acute angina attack, as it does not have a fast enough effect to alleviate this condition.
Monoket OD and similar drugs have been shown to stop working or become less effective after being continuously taken in high doses. It is important to follow the dosing instructions to avoid this.
This medicine should not be used concomitantly with PDE 5 inhibitors (eg sildenafil, tadalafil, or vardenafil). Your treatment with this medicine should not be stopped for the use of medicines containing PDE -5 inhibitors.
Children
Safety and efficacy in children have not yet been established.
Other medicines and Monoket OD
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine should not be used concomitantly with certain impotence medicines ( PDE -5 inhibitors, which contain eg sildenafil, vardenafil, or tadalafil) as this may result in a severe drop in blood pressure which may cause permanent damage to the heart and brain.
Concomitant treatment with antihypertensive drugs (beta-blockers, calcium channel blockers, vasodilators, riociguat) and/or alcohol may potentiate the antihypertensive effect of Monoket OD. The same can happen with drugs for mental illness ( neuroleptics ) and depression (tricyclic antidepressants and MAO inhibitors ).
Concomitant treatment with migraine medication (dihydroergotamine) may affect raising blood pressure.
Ask your doctor if you are taking medicines containing sapropterin (also known as tetrahydrobiopterin or BH4) for certain metabolic diseases.
Monoket OD with food, drink and alcohol
Taking alcohol with this medicine may increase the blood pressure-lowering effect. Dizziness may occur when you take this medicine and the risk of getting dizzy increases if you drink alcohol at the same time.
Pregnancy, breastfeeding and fertility
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.
Limited experience of use during pregnancy. Therefore, consult a physician before using this medicine during pregnancy.
It is not known if this medicine passes into breast milk. The risk of affecting the child can not be ruled out. The need for this medicine and the benefits of breastfeeding must be weighed against the potential risks to the baby. Therefore consult a doctor before use during breastfeeding.
Driving and using machines
Dizziness may occur when you take this medicine. You should keep this in mind when driving or using machines, for example. The risk of dizziness increases if you drink alcohol at the same time.
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.
Monoket OD contains lactose and sucrose
This medicine contains lactose and sucrose. 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 use Monoket OD
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 capsule of 50 mg daily in the morning. Dose one can be gradually increased to 75 mg and up to 100 mg once daily if necessary and in consultation with a physician. At the beginning of treatment, a dose of 25 mg is recommended for the first 2-4 days to avoid headaches.
It is important to take the capsules at the same time each day.
If you have the impression that this medicine is too strong or too weak, talk to your doctor or pharmacist.
The capsules must not be chewed but swallowed whole with at least ½ glass of liquid.
If you use more Monoket OD than you should
Symptoms of overdose include headache, pale skin, sweating, weak pulse, nausea, vomiting, diarrhea, dizziness, rapid heartbeat, dizziness on rising and lowering of blood pressure.
If you experience any of the above symptoms due to overdose, stop taking this medicine. Lie down with slightly raised legs as it can relieve symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Angioedema :
Stop taking Monoket and contact a doctor immediately if you get any of the following symptoms ( angioedema ): swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing.
Very common (may affect more than 1 user in 10)
- Headache that usually disappears with continued use.
Common (may affect up to 1 in 10 people)
- Dizziness
- Nausea
- Feeling weak
- Low blood pressure when standing
- Increased heart rate.
Uncommon: (may affect up to 1 in 100 people)
- Vomiting
- Diarrhea
- Exacerbated symptoms of angina.
Rare (may affect up to 1 in 1,000 people)
- Allergic skin reactions (eg rash)
- Redness .
Has been reported (occurs in an unknown number of users)
- Angioedema
- Circulatory collapse (sometimes accompanied by slow irregular heartbeat and fainting)
- Low blood pressure
- Scaly skin
- Somnolence
- Heartburn
- Hypoxemia (lack of oxygenation of the blood).
Severe symptoms due to low blood pressure have been reported during treatment with this type of medication and include nausea, vomiting, restlessness, paleness, and excessive sweating.
How to store Monoket OD
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the carton 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.
Contents of the package and other information
Content declaration
One capsule contains:
- The active substance is isosorbide mononitrate 25 mg, 50 mg and 100 mg respectively
- The other ingredients are lactose monohydrate 6.7 mg, 13.4 mg and 26.5 mg respectively, sucrose, maize starch, talc, ethylcellulose, macrogol, hydroxypropylcellulose, gelatin, titanium dioxide (dye E171), iron oxide (dye E172).
What the medicine looks like and contents of the pack
Monoket OD hard prolonged-release capsules 25 mg:
98 prolonged-release capsules (pressure pack)
100 prolonged-release capsules (plastic jar, for dose dispensing only)
Monoket OD hard prolonged-release capsules 50 mg:
14 prolonged-release capsules (pressure pack)
98 prolonged-release capsules (pressure pack)
100 prolonged-release capsules (plastic jar, for dose dispensing only)
Monoket OD hard prolonged-release capsules 100 mg:
98 prolonged-release capsules (pressure pack)
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Merus Labs Luxco II S.à.RL
26-28, rue Edward Steichen
L-2540 Luxembourg
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel-Strasse 10
D-40789 Monheim
Germany