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Active substance(s): AMLODIPINE BESILATE

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AMLODIPINE 5 mg and 10 mg
Package leaflet: Information for the user

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
• 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 symptoms
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.

• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body
temperature abnormalities)
• tacrolimus (used to control your body’s
immune response, enabling your body to
accept the transplanted organ)
• clarithromycin (for infections caused by
• simvastatin (cholesterol lowering
Amlodipine may lower your blood
pressure even more if you are already
taking other medicines to treat your high
blood pressure.

Amlodipine with food and drink
Grapefruit juice and grapefruit should not
be consumed by people who are taking
Amlodipine. This is because grapefruit and
grapefruit juice can lead to an increase in
What is in this leaflet:
the blood levels of the active ingredient
1. What Amlodipine is and what it is used for amlodipine, which can cause an
2. What you need to know before you take unpredictable increase in the blood
pressure lowering effect of Amlodipine.
3. How to take Amlodipine
Pregnancy and breast-feeding
4. Possible side effects
5. How to store Amlodipine
6. Contents of the pack and other information The safety of amlodipine in human
pregnancy has not been established. If you
What Amlodipine is and what it is think you might be pregnant, or are
used for
planning to get pregnant, you must tell
Amlodipine contains the active substance your doctor before you take Amlodipine.
amlodipine which belongs to a group of
medicines called calcium antagonists.
It is not known whether amlodipine is
passed into breast milk. If you are
Amlodipine is used to treat high blood
pressure (hypertension) or a certain type of breast-feeding or about to start
breast-feeding you must tell your doctor
chest pain called angina, a rare form of
before taking Amlodipine.
which is Prinzmetal’s or variant angina.
If you are pregnant or breast-feeding, think
In patients with high blood pressure your
medicine works by relaxing blood vessels, you may be pregnant or planning to have a
baby, ask your doctor or pharmacist for
so that blood passes through them more
easily. In patients with angina Amlodipine advice before taking this medicine.
works by improving blood supply to the
Driving and using machines
heart muscle which then receives more
Amlodipine may affect your ability to drive
oxygen and as a result chest pain is
or use machines. If the tablets make you
prevented. Your medicine does not provide feel sick, dizzy or tired, or give you a
immediate relief of chest pain from angina. headache, do not drive or use machines
and contact your doctor immediately.
What you need to know before


you take Amlodipine

Do not take Amlodipine:
• If you are allergic to amlodipine, or any
of the other ingredients of this medicine
listed in section 6, or to any other calcium
antagonists. This may be itching,
reddening of the skin or difficulty in
• If you have severe low blood pressure
• If you have narrowing of the aortic heart
valve (aortic stenosis) or cardiogenic
shock (a condition where your heart is
unable to supply enough blood to the
• If you suffer from heart failure after a
heart attack.
Take special care with Amlodipine
You should inform your doctor if you have
or have had any of the following
• Recent heart attack
• Heart failure
• Severe increase in blood pressure
(Hypertensive crisis)
• Liver disease
• You are elderly and your dose needs to
be increased.
Children and adolescents
Amlodipine has not been studied in children
under the age of 6 years. Amlodipine
should only used for hypertension in
children and adolescents from 6 years to
17 years of age (see section 3).
For more information, talk to your doctor.
Other medicines and Amlodipine
Tell your doctor or pharmacist if you are
taking, have recently taken any other
medicines, including medicines obtained
without a prescription.
Amlodipine may affect or be affected by
other medicines, such as:
• ketoconazole, itraconazole (anti-fungal
• ritonavir, indinavir, nelfinavir (so called
protease inhibitors used to treat HIV)
• rifampicin, erythromycin (antibiotics)
• Hypericum Perforatum (St. John’s Wort)

Amlodipine contains sodium
This medicine contains less than 1 mmol
sodium (23 mg) per tablet, which means is
essentially ‘sodium-free’.


How to take Amlodipine

Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
The recommended initial dose is Amlodipine
5 mg once daily. The dose can be increased
to Amlodipine 10 mg once daily.
Your medicine can be used before or after
food and drinks. You should take your
medicine at the same time each day.
Swallow the tablet with a glass of water.
Do not take Amlodipine with grapefruit
Use in children and adolescents
For children and adolescents (6-17 years old),
the recommended usual starting dose is
2.5 mg a day. The maximum recommended
dose is 5 mg a day. Amlodipine 2.5 mg is
not currently available. The 2.5 mg dose
can be obtained with Amlodipine 5 mg
tablets as these tablets can be divided into
two equal doses.
Amlodipine 10 mg tablets can also be
divided into equal doses.
It is important to keep taking the tablets.
Do not wait until your tablets are finished
before seeing your doctor.
If you take more Amlodipine than you should
Taking too many tablets may cause your
blood pressure to become low or even
dangerously low. You may feel dizzy,
lightheaded, faint or weak. If blood
pressure drop is severe enough shock can
occur. Your skin could feel cool and clammy
and you could lose consciousness. Seek
immediate medical attention if you take too
many Amlodipine tablets.
If you forget to take Amlodipine
Do not worry. If you forget to take a tablet,
leave out that dose completely. Take your
next dose at the right time. Do not take a
double dose to make up for a missed dose.

• Excess sugar in blood (hyperglycaemia)
• A disorder of the nerves which can cause
weakness, tingling or numbness
• Cough, swelling of the gums
• Abdominal bloating (gastritis)
• Abnormal liver function, inflammation of
the liver (hepatitis), yellowing of the skin
(jaundice), liver enzyme increase which
may have an effect on some medical tests
• Increased muscle tension
4 Possible side effects
• Inflammation of blood vessels, often with
Like all medicines, this medicine can cause
skin rash
side effects, although not everybody gets
• Sensitivity to light
• Disorders combining rigidity, tremor,
and/or movement disorders.
Visit your doctor immediately if you
experience any of the following very rare,
Not known: frequency cannot be estimated
severe side effects after taking this medicine. from the available data.
If you stop taking Amlodipine
Your doctor will advise you how long to
take your medicine. Your condition may
return if you stop using your medicine
before you are advised.
If you have any further questions on the
use of this medicine, ask your doctor or

• Sudden wheeziness, chest pain,
shortness of breath or difficulty in
• Swelling of eyelids, face or lips
• Swelling of the tongue and throat which
causes great difficulty breathing
• 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
• Heart attack, abnormal heart beat
• Inflamed pancreas which may cause
severe abdominal and back pain
accompanied with feeling very unwell.

• Trembling, rigid posture, mask-like face,
slow movements and a shuffling,
unbalanced walk.
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 Yellow Card Scheme at:
By reporting side effects you can help
provide more information on the safety of
this medicine.


How to store Amlodipine

Keep this medicine out of the sight and
reach of children.
Do not store above 25°C. Store in the
original packaging. Keep the blister in the
outer carton.
Do not use this medicine after the expiry
Very common: may affect more than 1 in 10 date that is stated on the label and carton
after ‘EXP’.. The expiry date refers to the
last day of that month.
• Oedema (fluid retention)
Do not take these tablets if there are any
The following common side effects have
signs of discolouration or deterioration of
been reported. If any of these cause you
the tablets.
problems or if they last for more than one Do not throw away any medicines via
week, you should contact your doctor.
wastewater or household waste. Ask your
pharmacist how to throw away medicines
Common: may affect up to 1 in 10 people
you no longer use. These measures will
• Headache, dizziness, sleepiness
help protect the environment.
(especially at the beginning of treatment)
Contents of the pack and other
• Palpitations (awareness of your heart
beat), flushing
• Abdominal pain, feeling sick (nausea)
What Amlodipine contains:
• Altered bowel habits, diarrhoea,
• The active ingredient is amlodipine (as
constipation, indigestion,
• Tiredness, weakness
• The other ingredients are
• Visual disturbances, double vision
microcrystalline cellulose, calcium
• Muscle cramps
hydrogen phosphate, sodium starch
• Ankle swelling
glycolate and magnesium stearate.
The following very common side effect has
been reported. If this causes you problems
or if it lasts for more than one week, you
should contact your doctor.

Other side effects that have been reported What Amlodipine looks like and contents
include the following list. If any of these
of the pack:
get serious, or if you notice any side effects
• Amlodipine 5 mg round white tablet,
not listed in this leaflet, please tell your
8 mm in diameter. One side is slightly
doctor or pharmacist.
concave with a breakline and debossed
Uncommon: may affect up to 1 in 100 people
‘A5’. The other side is slightly convex and
plain and are available in pack sizes of
• Mood changes, anxiety, depression,
15, 20, 28, 30, 50, 56, 84, 90, 98, 100, 112
and 300 tablets.
• Trembling, taste abnormalities, fainting,
• Amlodipine 10 mg round white tablet,
• Numbness or tingling sensation in your
11 mm in diameter. One side is slightly
limbs; loss of pain sensation
concave with a breakline and debossed
• Ringing in the ears
‘A10’. The other side is slightly convex
• Low blood pressure
and plain and are available in pack sizes
• Sneezing/running nose caused by
of 14, 15, 20, 28, 30, 50, 56, 84, 90, 98,
inflammation of the lining of the nose
100 and 112 tablets.
Not all pack sizes may be marketed.
• Cough
• Dry mouth, vomiting (being sick)
• Hair loss, increased sweating, itchy skin, Marketing Authorisation Holder and
red patches on skin, skin discolouration
• Disorder in passing urine, increased need Marketing Authorisation Holder
to urinate at night, increased number of
TEVA UK Limited, Eastbourne, BN22 9AG
times of passing urine
• Inability to obtain an erection; discomfort Manufacturer
or enlargement of the breasts in men
TEVA Pharmaceutical Works Private
• Pain, feeling unwell
Limited Company
• Joint or muscle pain, muscle cramps,
H-4042 Debrecen, Pallagi ut 13,Hungary
back pain
• Weight increase or decrease.
This leaflet was last revised in April 2016
Rare: may affect up to 1 in 1,000 people

PL 00289/0487-88

• Confusion.
Very rare: may affect up to 1 in 10,000 people
• Decreased numbers of white blood cells,
decrease in blood platelets which may
result in unusual bruising or easy
bleeding (red blood cell damage)


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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.