Download 1.3.1.3 Package Leaflet

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl – 7,834
(NL/H/0179/001-002/IA/034)
ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
DMA
Isosorbidemononitrate
20 mg / 40 mg tablets
1.3.1.3 Package Leaflet
NL/H/0179/001-002
Property of Sandoz GmbH
Confidential
May not be used, divulged or otherwise disclosed
without the consent of Sandoz GmbH
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20161116
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Sandoz
1.3.1 spc-label-pl - common-pl – 7,834
(NL/H/0179/001-002/IA/034)
ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
Page 2 of 9
20161116
551-024A.00 551-024B.00
Business use only
Sandoz
1.3.1 spc-label-pl - common-pl – 7,834
(NL/H/0179/001-002/IA/034)
ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
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Package leaflet: Information for the user [nationally completed name] 20 mg tablets
[nationally completed name] 40 mg tablets
Isosorbidemononitrate
Read all of this leaflet carefully before you start using this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet
What is in this leaflet:
1. What [nationally completed name] is and what it is used for
2. What you need to know before you take [nationally completed name]
3. How to take [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. What [nationally completed name] is and what it is used for
[nationally completed name] belongs to a group of medicines called nitrate vasodilators.
These work by relaxing the blood vessels of the heart, reducing the strain on the heart making
it easier to pump blood.
[nationally completed name] may be used to prevent an attack of angina pectoris (heart
cramp).
[nationally completed name] is not suitable for the treatment of acute attacks of angina
pectoris.
2. What you need to know before you before you take [nationally completed
name]
Do not take [nationally completed name] if you:
 are allergic (hypersensitive) to
- isosorbide mononitrate or,
- any of the other ingredients (listed in section 6) or,
- other nitrates (the group of medicines that isosorbide mononitrate belongs to)
 have any condition where your blood pressure is very low or your blood is not
circulating properly (such as shock)
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Sandoz
1.3.1 spc-label-pl - common-pl – 7,834
(NL/H/0179/001-002/IA/034)
ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
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


have suffered from a head injury or bleeding in the brain
are dehydrated due to illness such as diarrhea or being sick
have heart problems such as severe narrowing (stenosis) of the heart valves (mitral or
aortic valve) or an inflammation of the heart surface or progressive heart failure due to
long term lung disease
 have had a recent heart attack
 have raised pressure in your head
 have severe anaemia (low level of red blood cells)
 take medicines used to treat male erection dysfunction (such as sildenafil, tadalafil or
vardenafil. See also section 2 “Taking other medicines”).
Do not take [nationally completed name] if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using [nationally completed name] if you:
 suffer from a severe brain disease (cerebral sclerosis or cerebral ischaemia)
 suffer from an enlarged heart muscle (hypertrophic cardiomyopathy)
 have certain heart problems such as an acute attack of angina pectoris, obstruction of the
blood vessels of the heart (coronary heart disease), damage to the heart muscle
(hypertrophic obstructive cardiomyopathy), narrowing of the heart valves (aortic of mitral
stenosis)
 have severe liver problems.
Other medicines and [nationally completed name]
Talk to your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines , including medicines obtained without a prescription.
It may be necessary to change your dose or, in some cases, to stop one of the medicines. It is
especially important for your doctor to know if you are taking:
 medicines used to control blood pressure or heart function,
 medicines used to treat migraine (dihydroergotamine) and,
DO NOT TAKE [nationally completed name] with medicines to treat male erection
dysfunction (inhibitors of an enzyme called phosphodiesterase type 5, including amongst
others sildenafil, tadalafil or vardenafil). If you take these medicines together with
[nationally completed name], a severe and possibly dangerous fall in blood pressure can
occur. This would result in collapse, unconsciousness and could be fatal.
[nationally completed name] with and alcohol
You are advised not to drink alcohol with this medicine.
Pregnancy and breastfeeding
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ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
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If you are pregnant or breast-feeding, 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
Be careful if you drive or operate machinery if you take this medicine. [nationally completed
name] may not directly affect your ability to drive or operate machinery. However, side
effects such as dizziness may interfere with this ability, particularly together with alcohol.
You should not drive a vehicle or operate a machine or perform tasks that require alertness if
you experience these symptoms.
[nationally completed name] contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. How to take [nationally completed name]
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow the tablets with water, you can take them with or without food.
You should take the last daily dose at the end of the afternoon.
The recommended doses are:
 Starting dose: 10 mg 2 to 3 times daily.
 Maintenance dose: 40-80 mg daily divided in 2 to 3 doses.
 Maximum dose: 40 mg 2 to 3 times daily.
Considerations for treatment and treatment discontinuation
Treatment should be started in a gradual manner, especially in patients under treatment with
diuretics or other antihypertensive drugs. It is advised to take the dose in a sitting position
when one or more of the following situations are applicable: at the start of the treatment, in
case of elderly patients or when higher doses than the maintenance dose are given. Long
maintenance treatment should be withdrawn in a gradual manner to prevent a rebound
phenomenon and overlapping treatment should be started to avoid the risk of angina pectoris
(chest pain with or without radiation, nausea and sweating) e.g. on-demand nitrates.
[Nationally completed name] and older people
Older patients (aged 65 years or above) generally need lower starting doses than other adult
patients. Your doctor will advise you about this.
If you take more [nationally completed name] than you should
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Sandoz
1.3.1 spc-label-pl - common-pl – 7,834
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ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
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If you take more [nationally completed name] than you should, talk to a doctor or go to a
hospital straight away.
Take the medicine pack with you so that the doctor knows what you have taken.
You may develop slower or higher heart beat low blood pressure, paleness, transpiration,
weak pulse, higher heart rate, light-headedness when rising up, headache, weakness,
dizziness, sickness, vomiting, diarrhea, difficulty breathing, shock or coma..
If you forget to take [nationally completed name]
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it
as soon as you remember it and then take the next dose at the right time.
If you stop taking [nationally completed name]
Do not suddenly stop taking [nationally completed name] without talking to your doctor. The
doctor may need to slowly lower the dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking [nationally completed name] and see a doctor or go to hospital straight
away, if you notice any of the following serious side effects:
Common (may affect up to 1 in 10 people)
 fast heart beat
Uncommon (may affect up to 1 in 100 people))
 slow heart beat
 severe fall in blood pressure, collapse or fainting.
Other side effects include:
Very common (may affect more than 1 in 10 people)
 headache (especially when you first start taking [nationally completed name]).
Common (may affect up to 1 in 10 people)
 a decrease in blood pressure, dizziness or faintness when standing up due to low blood
pressure, a racing heart beat, drowsiness, dizziness and weakness may also occur
(especially when [nationally completed name] is used for the first time or when your dose
is increased).
Uncommon (may affect up to 1 in 100 people)
Business use only
Sandoz
1.3.1 spc-label-pl - common-pl – 7,834
(NL/H/0179/001-002/IA/034)
ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
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worsening of angina due to very low blood pressure
feeling or being sick
skin rash, itching
flushing (e.g. in the face).
Very rare (may affect up to 1 in 10,000 people)
 skin rash with flaking or peeling.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in Appendix
V. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store [nationally completed name]
Keep this medicine out of the sight and reach of children.
Do not use [nationally completed name] after the expiry date which is stated on the carton and
blister after ‘EXP’. The expiry date refers to the last day of that month.
Store below 25ºC in the original packaging in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What [nationally completed name] contains
[nationally completed name] 20 mg tablets:
The active substance is isosorbidemononitrate.
Each tablet contains 20 mg isosorbidemononitrate.
[nationally completed name] 40 mg tablets:
The active substance is isosorbidemononitrate.
Each tablet contains 40 mg isosorbidemononitrate.
The other ingredients are:
Business use only
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1.3.1 spc-label-pl - common-pl – 7,834
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ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
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Lactose, talc, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycollate,
magnesium stearate.
What [nationally completed name] looks like and contents of the pack
[nationally completed name] 20 mg tablet is a white, biplanar round tablet with bevelled
edges, scored on one side, inscription on reverse side ‘20’
The tablets can be divided into equal halves.
[nationally completed name] 40 mg tablet is a white, biplanar round tablet with bevelled
edges, scored on one side, inscription on reverse side ‘40’
The tablets can be divided into equal halves.
Packsizes:
20 mg tablets
PVC/Aluminium blister containing 30,40,50,80 or 500 tablets.
Polypropylene tablet container containing 30 tablets.
40 mg tablets
PVC/Aluminium blister containing 20, 30, 40, or 500 tablets.
Polypropylene tablet container containing 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
[To be completed nationally]
Manufacturer:
Lek Pharmaceuticals d.d.
Verovškova 57
SI-1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Salutas Pharma GmbH
Dieselstraße 5
70839 Gerlingen
Germany
Business use only
Sandoz
1.3.1 spc-label-pl - common-pl – 7,834
(NL/H/0179/001-002/IA/034)
ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET
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This medicinal product is authorised in the Member States of the EEA under the
following names:
The Netherlands:
Isosorbidemononitraat Sandoz 20
Isosorbidemononitraat Sandoz 40
Spain:
Mononitrato de Isosorbida Sandoz 20 mg comp. EFG
Mononitrato de Isosorbida Sandoz 40 mg comp. EFG
This leaflet was last approved in {MM/YYYY}
[To be completed nationally]