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PERINDOPRIL/AMLODIPINE 4 MG/5 MG TABLETS

Active substance(s): AMLODIPINE BESYLATE / PERINDOPRIL TERT-BUTYLAMINE / AMLODIPINE BESYLATE / PERINDOPRIL TERT-BUTYLAMINE / AMLODIPINE BESYLATE / PERINDOPRIL TERT-BUTYLAMINE

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Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
CONSILIENT HEALTH

Perindopril/Amlodipine 4 mg/5 mg tablets
Perindopril/Amlodipine 4 mg/10 mg tablets
Perindopril/Amlodipine 8 mg/5 mg tablets
Perindopril/Amlodipine 8 mg/10 mg tablets
Perindopril tert-butylamine/Amlodipine

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 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. See section 4.
What is in this leaflet
1. What Perindopril/Amlodipine is and what it is used for
2. What you need to know before you take Perindopril/
Amlodipine
3. How to take Perindopril/Amlodipine
4. Possible side effects
5. How to store Perindopril/Amlodipine
6. Contents of the pack and other information

1. What Perindopril/Amlodipine is and what
it is used for
Perindopril/Amlodipine is prescribed for treatment of high
blood pressure (hypertension) and/or treatment of stable
coronary artery disease (a condition where the blood supply
to the heart is reduced or blocked).
Patients already taking perindopril and amlodipine
from separate tablets may instead receive one tablet of
Perindopril/Amlodipine which contains both ingredients.
Perindopril/Amlodipine is a combination of two active
ingredients, perindopril and amlodipine. Perindopril is an ACE
(angiotensin converting enzyme) inhibitor. Amlodipine is a
calcium antagonist (which belongs to a class of medicines
called dihydropyridines). Together they work to widen and
relax the blood vessels, which results in a reduction of blood
pressure. Blood can flow through the body more easily and
the heart does not need to work so hard.

2. What you need to know before you take
Perindopril/Amlodipine
Do not take Perindopril/Amlodipine:
• if you are allergic to perindopril tert-butylamine or any
other ACE inhibitor, amlodipine besylate or any other
dihydropyridines, or any of the other ingredients of this
medicine (listed in section 6),
• if you are more than 3 months pregnant. (It is also better
to avoid Perindopril/Amlodipine in early pregnancy – see
pregnancy section.),
• if you have experienced symptoms such as wheezing,
swelling of the face or tongue, intense itching or severe
skin rashes with previous ACE inhibitor treatment or if you
or a member of your family have had these symptoms in
any other circumstances (a condition called angioedema),








if you have cardiogenic shock (when the heart is unable
to supply sufficient blood to the body), aortic stenosis
(narrowing of the main blood vessels leading from the
heart) or unstable angina (chest pain that may occur when
resting),
if you have severe low blood pressure (severe hypotension),
if you suffer from heart failure (the heart fails to pump
blood adequately resulting in the shortness of breath or
peripheral swellings such as swelling of the legs, ankles or
feet) after an acute heart attack,
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 Perindopril/
Amlodipine:
• if you have hypertrophic cardiomyopathy (cardiac muscle
disease) or renal artery stenosis (narrowing of the artery
which supplies the kidney with blood),
• if you have any other heart problems,
• if you have impaired liver function,
• if you have kidney problems or if you are receiving dialysis,
• if you have collagen vascular disease (disease of the
connective tissue) such as systemic lupus erythematosus
or scleroderma,
• if you have diabetes,
• if you are on a salt restricted diet or use salt substitutes
which contain potassium (a well balanced potassium blood
level is essential),
• if you are taking any of the following medicines used to
treat high blood pressure:
– an angiotensin II receptor blocker (ARBs) (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
Perindopril/Amlodipine”.
You must tell your doctor if you think you are (or might
become) pregnant. Perindopril/Amlodipine 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 section).
When you are taking Perindopril/Amlodipine, you should also
inform your doctor or the medical staff if you:
• are going to have a general anaesthetic and/or major
surgery,
• have recently suffered from diarrhoea or vomiting (being
sick),
• are to undergo LDL apheresis (the removal of cholesterol
from your blood by a machine),
• are going to have desensitisation treatment to reduce the
effects of an allergy to bee or wasp stings.
Children and adolescents
Perindopril/Amlodipine is not recommended for use in
children and adolescents.
Other medicines and Perindopril/Amlodipine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
You should avoid Perindopril/Amlodipine with:
• lithium (used to treat mania or depression),
• estramustine (used in cancer therapy),
• potassium-sparing diuretics (spironolactone, triamterene),
potassium supplements or salt substitutes containing
potassium.

Treatment with Perindopril/Amlodipine can be affected by
other medicines. Make sure to tell your doctor if you are
taking any of the following medicines as special care may
be required:
• other medicines for high blood pressure, including diuretics
(medicines which increase the amount of urine produced
by the kidneys),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for
pain relief or high dose acetylsalicylic acid,
• medicines to treat diabetes (such as insulin),
• medicines to treat mental disorders such as depression,
anxiety, schizophrenia etc (e.g. tricyclic antidepressants,
antipsychotics, imipramine-like antidepressants,
neuroleptics),
• immunosuppressants (medicines which reduce the
defence mechanism of the body) used for the treatment
of auto-immune disorders or following transplant surgery
(e.g. ciclosporin),
• tacrolimus (used to control your body’s immune response,
enabling your body to accept the transplanted organ),
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of an irregular heart beat),
• vasodilators including nitrates (products that widen the
blood vessels),
• heparin (medicines used to thin blood),
• ephedrine, noradrenaline or adrenaline (medicines used to
treat low blood pressure, shock or asthma),
• baclofen used to treat muscle stiffness in diseases such
as multiple sclerosis,
• some antibiotics such as rifampicin, erythromycin
• clarithromycin (for infections caused by bacteria),
• antiepileptic agents such as carbamazepine, phenobarbital,
phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (medicines used for treatment
of fungal infections),
• alpha-blockers used for the treatment of enlarged prostate

DPMockUp057772_3

CONFIDENTIAL











such as prazosin, alfuzosin, doxazosin, tamsulosin,
terazosin,
amifostine (used to prevent or reduce side effects caused
by other medicines or radiation therapy that are used to
treat cancer),
corticosteroids (used to treat various conditions including
severe asthma and rheumatoid arthritis),
gold salts, especially with intravenous administration (used
to treat symptoms of rheumatoid arthritis),
simvastatin (cholesterol lowering medicine),
ritonavir, indinavir, nelfinavir (so called protease inhibitors
used to treat HIV),
hypericum perforatum (St. John’s Wort),
verapamil, diltiazem (heart medicines),
dantrolene (infusion for severe body temperature
abnormalities).

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 Perindopril/Amlodipine” and “Warnings and
precautions”

Perindopril/Amlodipine may lower your blood pressure even
more if you are already taking other medicines to treat your
high blood pressure.
Perindopril/Amlodipine with food and drink
Perindopril/Amlodipine should be taken before a meal.
Grapefruit juice and grapefruit should not be consumed
by people who are taking Perindopril/Amlodipine. This
is because grapefruit and grapefruit juice can lead to
an increase in the blood levels of the active ingredient
amlodipine, which can cause an unpredictable increase in
the blood pressure lowering effect of Perindopril/Amlodipine.

Pregnancy and breast-feeding
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.
Pregnancy
The safety of amlodipine in human pregnancy has not been
established. You must tell your doctor if you think you are (or
might become) pregnant. Your doctor will normally advise
you to stop taking Perindopril/Amlodipine before you become
pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Perindopril/
Amlodipine. Perindopril/Amlodipine 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Perindopril/Amlodipine 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.
Driving and using machines
Perindopril/Amlodipine does not affect alertness but you
might experience dizziness or weakness due to low blood
pressure which could affect your ability to drive or operate
machinery. You are advised not to drive a car or operate
machinery until you know how Perindopril/Amlodipine
affects you.

3. How to take Perindopril/Amlodipine
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Swallow your tablet with a glass of water, preferably at the
same time each day, in the morning, before a meal. Your
doctor will decide on the correct dose for you. This will
normally be one tablet per day. Perindopril/Amlodipine will
usually be prescribed for patients already taking perindopril
and amlodipine from separate tablets.
If you take more Perindopril/Amlodipine than you
should
If you take too many tablets, contact your nearest accident
and emergency department or tell your doctor immediately.
The most likely symptoms of overdose are low blood
pressure which can make you feel dizzy or faint. If this
happens, lying down with your legs raised can help.
If you forget to take Perindopril/Amlodipine
It is important to take your medicine every day as regular
treatment works better. However, if you forget to take a dose
of Perindopril/Amlodipine, take the next dose at the usual
time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Perindopril/Amlodipine
As the treatment with Perindopril/Amlodipine is usually
life-long, you should discuss with your doctor before you
stop taking your tablets.


















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.
If you experience any of the following, stop taking the
medicinal product at once and tell your doctor immediately:
• Sensation of noises in the ears (tinnitus) (Common: may
affect up to 1 in 10 people)

Foamy or dark urine, swelling, excessive thirst or any
similar signs which would indicate kidney problems
(Uncommon: may affect up to 1 in 100 people)
Signs indicating disorders of the blood, e.g. fever, sore
throat, tiredness, unexplained bruising, bleeding, mouth
ulcers (Very rare: may affect up to 1 in 10,000 people)
Inflamed pancreas which may cause severe abdominal and
back pain accompanied with feeling very unwell (Very rare:
may affect up to 1 in 10,000 people)
Signs indicating liver problems, e.g. yellowing of the skin,
nausea, stomach pain (Very rare: may affect up to 1 in
10,000 people)
Gastro-intestinal disorders (nausea, vomiting, abdominal
pain, dyspepsia or difficulty of digestion, diarrhoea,
constipation) (Common: may affect up to 1 in 10 people)
Swelling of the face, lips, mouth, tongue or throat, difficulty
in breathing (angioedema) (Uncommon: may affect up to
1 in 100 people)
Severe dizziness or fainting due to low blood pressure
(Common: may affect up to 1 in 10 people)
Unusual fast or irregular heart beat (Uncommon: may
affect up to 1 in 100 people), chest pain (angina) or heart
attack (Very rare: may affect up to 1 in 10,000 people)
Weakness of arms or legs, or problems speaking which
could be sign of a possible stroke (Very rare: may affect up
to 1 in 10,000 people)
Sudden wheeziness, chest pain, shortness of breath, or
diffuculty in breathing (bronchospasm) (Uncommon: may
affect up to 1 in 100 people)
Severe skin reactions including intense skin rash, hives,
reddening of the skin over your whole body, severe itching,
blistering, peeling and swelling of the skin, inflammation
of mucous membranes (Stevens Johnson Syndrome) or
other allergic reactions (Very rare: may affect up to 1 in
10,000 people)

Other side effects include:

CONFIDENTIAL

PERINDOPRIL
Common: may affect up to 1 in 10 people
• Headache
• Dizziness
• Vertigo
• Pins and needles
• Vision disturbances
• Cough
• Shortness of breath (dyspnoea)
• Allergic reactions (such as skin rashes, itching)
• Muscle cramps
• Feeling of weakness
• Taste disturbances
Uncommon: may affect up to 1 in 100 people
• Mood swings
• Sleep disturbances
• Dry mouth
• Intense itching or severe skin rashes
• Formation of blister clusters over the skin
• Impotence (inability to obtain an erection)
• Sweating
• Excess of eosinophils (a type of white blood cells)
• Tachycardia (fast heart beat)
• Myalgia (muscle pain)
• Chest pain
• Malaise (general feeling of illness/feeling unwell)
• Oedema peripheral (swelling of the ankles)
• Fever
• Change in laboratory parameters: high blood level of
potassium reversible on discontinuation, low level of
sodium, hypoglycaemia (very low blood sugar level) in case
of diabetic patients, increased blood urea, and increased
blood creatinine
Rare: may affect up to 1 in 1,000 people
• Changes in laboratory parameters: Increased level of liver
enzymes, high level of serum bilirubin
Very rare: may affect up to 1 in 10,000 people






Confusion
Eosinophilic pneumonia (a rare type of pneumonia)
Rhinitis (blocked up or runny nose)
Sudden kidney failure

Not known: cannot be estimated from the available data
• Vasculitis (inflammation of blood vessels) often with
skin rash
AMLODIPINE
Very common: may affect more than 1 in 10 people
• Oedema (fluid retention)
Common: may affect up to 1 in 10 people
• Headache (especially at the beginning of treatment),
dizziness, sleepiness
• Palpitations (awareness of your heart beat), flushing
• Visual disturbances, double vision
• Muscle cramps
• Ankle swelling
Other side-effects that have been reported include the
following list. If any of these get serious, or if you notice any
side-effects not listed in this leaflet, please tell your doctor or
pharmacist.
Uncommon: may affect up to 1 in 100 people
• Mood changes, anxiety, depression, sleeplessness
• Trembling, taste abnormalities, fainting
• Numbness or tingling sensation in your limbs; loss of pain
sensation
• Low blood pressure
• Sneezing/running nose caused by inflammation of the
lining of the nose (rhinitis)
• Cough
• Dry mouth, vomiting (being sick)
• Hair loss, increased sweating, itchy skin, red patches on
skin, skin discolouration
• Disorder in passing urine, increased need to urinate at
night, increased number of times of passing urine






Inability to obtain an erection; discomfort or enlargement of
the breasts in men
Pain, feeling unwell
Joint or muscle pain, back pain
Weight increase or decrease

Rare: may affect up to 1 in 1,000 people
• Confusion
Very rare: may affect up to 1 in 10,000 people
Excess sugar in blood (hyperglycaemia)
A disorder of the nerves which can cause weakness,
tingling or numbness
• Swelling of the gums
• Abdominal bloating (gastritis)
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor, and/or movement
disorders



Store in the original package in order to protect from light
and moisture.
This medicine does not require any special temperature
storage conditions.
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 Perindopril/Amlodipine contains
• The active substances are perindopril tert-butylamine and
amlodipine.
Perindopril/Amlodipine 4 mg/5 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine
(equivalent to 3.34 mg perindopril) and 5 mg amlodipine
(as besilate).
Not known: cannot be estimated from the available data
Perindopril/Amlodipine 4 mg/10 mg tablets
• Trembling, rigid posture, mask-like face, slow movements
Each tablet contains 4 mg perindopril tert-butylamine
and a shuffling, unbalanced walk
(equivalent to 3.34 mg perindopril) and 10 mg
amlodipine (as besilate).
Reporting of side effects
Perindopril/Amlodipine 8 mg/5 mg tablets
If you get any side effects, talk to your doctor or pharmacist.
Each tablet contains 8 mg perindopril tert-butylamine
This includes any possible side effects not listed in this
(equivalent to 6.68 mg perindopril) and 5 mg amlodipine
leaflet. You can also report side effects directly Yellow Card
(as besilate).
Scheme, Website: www.mhra.gov.uk/yellowcard.
Perindopril/Amlodipine 8 mg/10 mg tablets
By reporting side effects you can help provide more
Each tablet contains 8 mg perindopril tert-butylamine
information on the safety of this medicine.
(equivalent to 6.68 mg perindopril) and 10 mg
amlodipine (as besilate).
5. How to store Perindopril/Amlodipine
• The other ingredients are sodium hydrogen carbonate,
microcrystalline cellulose (E460), pregelatinised maize
Keep this medicine out of the sight and reach of children.
starch, sodium starch glycolate (type A), colloidal
Do not use this medicine after the expiry date which is stated
anhydrous silica and magnesium stearate (E572).
on the packaging. The expiry date refers to the last day of
that month.

What Perindopril/Amlodipine looks like and contents
of the pack
Perindopril/Amlodipine 4 mg/5 mg tablets: this
medicinal product is presented as white to almost white,
round, slightly biconvex tablets with bevelled edges.
Perindopril/Amlodipine 4 mg/10 mg tablets: this
medicinal product is presented as white to almost white,
capsule shaped, biconvex tablets scored on one side. The
score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Perindopril/Amlodipine 8 mg/5 mg tablets: this
medicinal product is presented as white to almost white,
round, biconvex tablets with bevelled edges.
Perindopril/Amlodipine 8 mg/10 mg tablets: this
medicinal product is presented as white to almost white,
round, biconvex tablets with bevelled edges and a score line
on one side. The tablet can be divided into equal doses.
The tablets are available in carton boxes of 5, 7, 10, 14, 20,
28, 30, 50, 60, 90 and 100 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5,
27472 Cuxhaven, Germany
Distributed by:
Consilient Health (UK) Ltd., No.1 Church Road,
Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in 02/2017

P0593

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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