PACKAGE LEAFLET: INFORMATION FOR THE USER
Zofenopril Mylan 30 mg film-coated tablets
Zofenopril calcium
Read all of this leaflet carefully before you start taking 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. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Zofenopril Mylan is and what it is used for
2.
Before you take Zofenopril Mylan
3.
How to take Zofenopril Mylan
4.
Possible side effects
5.
How to store Zofenopril Mylan
6.
Further information
1.
WHAT ZOFENOPRIL MYLAN IS AND WHAT IT IS USED FOR
Zofenopril Mylan belongs to a group of medicines known as ACE inhibitors (Angiotensin Converting
Enzyme Inhibitors). Zofenopril Mylan works by making your blood vessels wider. This helps your
blood pressure to fall. It also makes it easier for your heart to pump blood around your body.
Zofenopril Mylan can be used to treat
- High blood pressure – also called hypertension
- Heart attack (acute myocardial infarction) in people who may or may not show signs and
symptoms of heart failure, and who have not received treatment that helps dissolve blood clots
(thrombolytic therapy).
2.
BEFORE YOU TAKE ZOFENOPRIL MYLAN
Do not take Zofenopril Mylan
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if you are allergic (hypersensitive) to zofenopril calcium or any of the other ingredients of
Zofenopril Mylan
if you have had any previous allergic reaction to any other ACE inhibitor such as captopril or
enalapril
if you have a history of severe swelling of the face, tongue and throat (angioneurotic edema)
associated with previous ACE inhibitor therapy, or if you have ever got these symptoms without
any known reason (hereditary/idiopathic angioneurotic oedema)
If you are more than 3 months pregnant. (It is also better to avoid Zofenopril Mylan in early
pregnancy – see pregnancy breast-feeding section)
if you suffer from narrowing of the arteries to the kidneys
if you suffer from severe liver impairment.
if you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
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you have diabetes
you have psoriasis
you have liver problems
you have been told to limit the amount of salt in your diet, are having kidney dialysis, or have had
severe diarrhoea or sickness because zofenopril may cause your blood pressure to fall
you have kidney problems, including narrowed blood vessels in your kidneys (renal artery
stenosis) or have had a recent kidney transplant. Your doctor may need to reduce your dose
you have ever had “angioneurotic oedema” or “angioedema” after taking other medicines. The
signs include itching, red marks on the hands, feet and throat, swelling around the eyes and lips,
difficulty breathing
you are having treatment to reduce your reaction to insect bites, are undergoing dialysis, or if you
are having treatment of your blood by a machine to lower cholesterol (LDL apheresis) as there is a
risk of suffering an allergic reaction to zofenopril
you take potassium-sparing diuretics, extra potassium in your diet or a salt substitute that contains
potassium because zofenopril may increase your blood salt levels
you suffer from low blood pressure as zofenopril may cause your blood pressure to fall further
you have thickening of the heart walls resulting in obstruction of the blood flow from the left side
of the heart (hypertrophic cardiomyopathy) or a narrowing of the heart valve (aortic and mitral
valve stenosis)
you have abnormally high levels of the hormone aldosterone in your blood (primary
aldosteronism)
you are over 75 years of age; zofenopril should be used with caution
you are being anaesthetised (for an operation) inform your doctor. This will help the anaesthetist
to control your blood pressure and heart rate during the procedure
you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan,
telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
- aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
See also information under the heading “Do not take Zofenopril Mylan”.
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you must tell your doctor if you think you are (or might become) pregnant. Zofenopril is not
recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant,
as it may cause serious harm to your baby if used at that stage (see pregnancy breast-feeding
section).’
Other medicines and Zofenopril 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, or the following:
- Water tablets (diuretics) such as spironolactone, triamterene or amiloride are not recommended if
you are taking for supplements because these may increase the levels of potassium in your blood
- Lithium (for some types of mental illness) because zofenopril may cause the level of lithium in
your blood to increase
- Medicines for serious mental illness (psychosis), anaesthetics or narcotics because taking these
medicines at the same time as zofenopril my cause low blood pressure
- Other medicines for high blood pressure, including diuretics, ß-blockers and α-blockers; if taken
with zofenopril may cause your blood pressure to fall
- Cimetidine may increase the risk of low blood pressure
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Allopurinol (used to treat gout and kidney stones), procainamide (used to treat heart beat
problems), corticosteroids and medicines to suppress your immune system may increase the risk
of low white cell count
Ciclosporin increase because there is a risk of kidney problems when taken with zofenopril
Non-steroidal anti-inflammatory drugs (NSAIDs), (for pain or inflammation) may reduce the
effectiveness of zofenopril
Medicines for diabetes, such as insulin, because zofenopril may cause your blood sugar levels to
drop even further when taken with these medicines
Antacids (used to treat heartburn and stomach ulcer), because they reduce the effectiveness of
zofenopril
Medicines that affect your nervous system (known as Sympathomimetics) these may reduce the
effectiveness of zofenopril. Your doctor will tell you if this affects you
Certain types of haemodialysis because there is a risk of suffering an allergic reaction. Your
doctor will advise you if you are at risk
Nitroglycerine and other nitrates
Cytostatic agents
Tricyclic antidepressants
Gold injections for arthritis because it may lower blood pressure
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under
the headings “Do not take Zofenopril Mylan” and “Warnings and precautions”).
Taking Zofenopril Mylan with food and drink
You can take Zofenopril Mylan before, during or after food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally
advise you to stop taking Zofenopril Mylan before you become pregnant or as soon as you know you
are pregnant and will advise you to take another medicine instead of Zofenopril Mylan. Zofenopril
Mylan is not recommended in early pregnancy, and must not be taken when more than 3 months
pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Zofenopril Mylan is not
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.’
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
When driving vehicles or operating machines it should be remembered that occasionally drowsiness,
dizziness or weariness may occur.
3.
HOW TO TAKE ZOFENOPRIL MYLAN
Dosage
Always take Zofenopril Mylan exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Swallow tablets whole, or divided into halves, with water. You can take them before, during or after
meals.
Your doctor or pharmacist should tell you the frequency and duration of the treatment.
Adults with high blood pressure (hypertension)
The normal starting dose is 15 mg each day. Y our doctor may increase your dosage to find the dose
that suits you best. The usual effective dose is 30 mg each day. The maximum dose is 60 mg each
day in one single or 2 divided doses.
Adults with high blood pressure suffering from volume or salt depletion
The first Zofenopril Mylan tablets you take may make your blood pressure fall. If you are concerned
talk to your doctor or pharmacist. If you are taking water tablets (diuretics) then you will need to stop
taking them for two to three days before starting to take Zofenopril Mylan. The normal starting dose
is 15 mg each day but your doctor may start you on 7.5 mg each day if he feels this is more suitable
for you. With this product not all recommended dosages can be administered
Adults with heart failure
Your doctor will decide your dose.
Adults with kidney problems
If you have kidney problems, the doctor will alter the amount of zofenopril you take depending on
how well your kidneys are working.
Elderly
Your dose depends on how well your kidneys are working. Your doctor will tell you how much
Zofenopril Mylan to take.
Children
Zofenopril Mylan is not recommended for use in children.
If you take more Zofenopril Mylan than you should
Contact your doctor or go to the nearest hospital emergency department immediately. Take the
container and any remaining tablets with you. Signs and symptoms of overdose include: Extremely
low blood pressure, shock, stupor, abnormally slow heartbeat, electrolyte disturbances and kidney
failure.
If you forget to take Zofenopril Mylan
If you miss a dose do not worry. Take your normal dose when it is next due. Do not take a double
dose to make up for a forgotten tablet.
If you stop taking Zofenopril Mylan
If you suddenly stop taking Zofenopril Mylan you may suffer from side effects. If you need to stop
taking this medicine talk to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Zofenopril Mylan can cause side effects, although not everybody gets them.
Common side effects (affecting fewer than 1 in 10 people)
 Feeling unusually tired
 Feeling or being sick
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Dizziness
Headache
Cough
Uncommon side effects (affecting fewer than 1 in 100 people)
 Rash
 Weakness, muscle cramp
Rare side effects (affecting fewer than 1 in 1,000 people)
 Serious allergic reaction which causes swelling of the face or throat
The following adverse reactions have been observed associated with ACE inhibitor therapy.
Very common side effects (affecting more than 1 in 10 people)
 Severe low blood pressure
 Dizziness
 Feeling of weakness
 Impaired vision
Rare side effects (affecting fewer than 1 in 1,000 people)
 Muscle pain
 Muscle cramps
 Difficulty breathing
 Wheezing
 Inflamed and swollen sinuses causing pain, high temperature and tenderness
 An Itchy runny nose
 Swollen sore tongue
 Lung infection
 Abdominal pain
 Diarrhoea
 Constipation
 Dry mouth
 Itchy skin
 Severe skin reaction, blistering of the skin, mouth, eyes and genitals
 Hair loss
 Joint pain
 Depression
 Mood changes
 Sleeping problems
 Tingling, pins and needles
 Impotence
 Balance disorder
 Confusion
 Ringing in the ears
 Taste disturbance
 Increased sweating
 Flushing
Very rare side effects (affecting fewer than 1 in 10,000 people)
 Chest pain
 Excessive fluid in the bloody
 Dizziness, light-headedness or fainting when standing up
 Yellowing of the skin or whites of the eyes
 Dark urine, pale stools, fever
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Inflammation of the pancreas which causes severe pain in the abdomen and back
Lack of bowel movement
Sever reduction in blood cells which can cause weakness, bruising or make infections more
likely
Reduction in red blood cells which can make the skin pale or yellow and cause weakness or
breathlessness
Kidney problems
Faster heart beat
Irregular heart rhythms
Heart attack
Stroke
Bleeding of a ruptured blood vessel in the brain
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE ZOFENOPRIL MYLAN
Keep out of the reach and sight of children.
No special precautions for storage.
Do not use Zofenopril Mylan after the expiry date, which is stated on the blister, carton, label or bottle
after EXP. The expiry date refers to the last day of that month.
Zofenopril Mylan supplied in bottles should be used for no longer than 30 days after the bottle has first
been opened.
Do not use Zofenopril Mylan if you notice any discoloration of the tablets.
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.
FURTHER INFORMATION
What Zofenopril Mylan contains
The active substance is zofenopril calcium. Each tablet contains 30 mg of zofenopril calcium.
The other ingredients are Microcrystalline Cellulose, Pregelatinized starch (maize), Magnesium
Stearate, Hypromellose (E464), Titanium dioxide (E171), Macrogol 400 and Polysorbate 80
What Zofenopril Mylan looks like and contents of the pack
Zofenopril Mylan 30 mg film coated tablets are white, film-coated, capsule shaped tablets with “ZP
breakline 1” on one side and “M” on other side.
The tablet can be divided into equal halves.
Zofenopril Mylan is available in plastic bottles containing 500 tablets (hospital pack) or blister packs
of 7, 12 14, 28, 30, 56, 90 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
<[To be completed nationally]>
This medicinal product is authorised in Member States of the EEA under the following names
<[To be completed nationally]>
This leaflet was last revised in 2014-11-14