Skip to Content

UK Edition. Click here for US version.


Active substance(s): AMLODIPINE BESILATE

View full screen / Print PDF » Download PDF ⇩

AMLODIPINE 5 mg and 10 mg

Read all of this leaflet carefully before you
start taking this medicine.
• 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. 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.

1. What Amlodipine is and what it is used
2. Before you take Amlodipine
3. How to take Amlodipine
4. Possible side effects
5. How to store Amlodipine
6. Further information



• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body
temperature abnormalities).
Amlodipine may lower your blood
pressure even more if you are already
taking other medicines to treat your high
blood pressure.
Taking 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
the blood levels of the active ingredient
amlodipine, which can cause an
unpredictable increase in the blood
pressure lowering effect of Amlodipine.
The safety of amlodipine in human
pregnancy has not been established. If you
think you might be pregnant, or are
planning to get pregnant, you must tell
your doctor before you take Amlodipine.

It is not known whether amlodipine is
passed into breast milk. If you are
1 WHAT AMLODIPINE IS AND WHAT breast-feeding or about to start
breast-feeding you must tell your doctor
before taking Amlodipine.
Amlodipine contains the active substance
amlodipine which belongs to a group of
Ask your doctor or pharmacist for advice
medicines called calcium antagonists.
before taking any medicine.
Amlodipine is used to treat high blood
pressure (hypertension) or a certain type of
chest pain called angina, a rare form of
which is Prinzmetal’s or variant angina.
In patients with high blood pressure your
medicine works by relaxing blood vessels,
so that blood passes through them more
easily. In patients with angina Amlodipine
works by improving blood supply to the
heart muscle which then receives more
oxygen and as a result chest pain is
prevented. Your medicine does not provide
immediate relief of chest pain from angina.



Do NOT take Amlodipine:
• If you are allergic (hypersensitive) to
amlodipine, or any of the other
ingredients of your 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.

Driving and using machines
Amlodipine may affect your ability to drive
or use machines. If the tablets make you
feel sick, dizzy or tired, or give you a
headache, do not drive or use machines
and contact your doctor immediately.
Important information about some of the
ingredients of Amlodipine
This medicine contains less than 1 mmol
sodium (23 mg) per tablet, which means is
essentially ‘sodium-free’.



Always take Amlodipine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
The usual 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 juice.

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
Take special care with Amlodipine
with Amlodipine 5 mg tablets as these
tablets can be divided into two equal doses.
You should inform your doctor if you have or
Amlodipine 10 mg tablets can also be
have had any of the following conditions:
divided into equal doses.
• Recent heart attack
• Heart failure
It is important to keep taking the tablets.
• Severe increase in blood pressure
Do not wait until your tablets are finished
(Hypertensive crisis)
before seeing your doctor.
• Liver disease
If you take more Amlodipine than you
• You are elderly and your dose needs to
be increased.
Taking too many tablets may cause your
Use in children and adolescents
blood pressure to become low or even
Amlodipine has not been studied in children dangerously low. You may feel dizzy,
under the age of 6 years. Amlodipine should lightheaded, faint or weak. If blood
only used for hypertension in children and pressure drop is severe enough shock can
adolescents from 6 years to 17 years of age occur. Your skin could feel cool and clammy
(see section 3).
and you could lose consciousness. Seek
For more information, talk to your doctor.
immediate medical attention if you take too
many Amlodipine tablets.
Taking other medicines
If you forget to take Amlodipine
Please tell your doctor or pharmacist if you
Do not worry. If you forget to take a tablet,
are taking or have recently taken any other
leave out that dose completely. Take your
medicines, including medicines obtained
next dose at the right time. Do not take a
without a prescription.
double dose to make up for a missed dose.
Amlodipine may affect or be affected by
other medicines, such as:
If you stop taking Amlodipine
• ketoconazole, itraconazole (anti-fungal
Your doctor will advise you how long to
take your medicine. Your condition may
• ritonavir, indinavir, nelfinavir (so called
return if you stop using your medicine
protease inhibitors used to treat HIV)
before you are advised.
• rifampicin, erythromycin, clarithromycin
If you have any further questions on the
use of this medicine, ask your doctor or
• Hypericum Perforatum (St. John’s Wort)

28 August 2015




Like all medicines, Amlodipine can cause
side effects, although not everybody gets
Visit your doctor immediately if you
experience any of the following very rare,
severe side effects after taking this
• 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.
The following common side effects have
been reported. If any of these cause you
problems or if they last for more than one
week, you should contact your doctor.



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.



Keep out of the reach and sight of children.
Do not store above 25°C. Store in the
original packaging. Keep the blister in the
outer carton. Do not use Amlodipine after
the expiry date that is stated on the outer
packaging. The expiry date refers to the last
day of that month. Do not take these tablets
if there are any signs of discolouration or
deterioration 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.



What Amlodipine contains:
• The active ingredient is amlodipine (as
Common: affects 1 to 10 users in 100
• The other ingredients are
microcrystalline cellulose, calcium
• Headache, dizziness, sleepiness
hydrogen phosphate, sodium starch
(especially at the beginning of treatment)
glycolate and magnesium stearate.
• Palpitations (awareness of your heart
beat), flushing
What Amlodipine looks like and contents
• Abdominal pain, feeling sick (nausea)
of the pack:
• Ankle swelling (oedema), tiredness.
• Amlodipine 5 mg round white tablet, 8
Other side effects that have been reported
mm in diameter. One side is slightly
include the following list. If any of these
concave with a breakline and debossed
get serious, or if you notice any side effects
‘A5’. The other side is slightly convex and
not listed in this leaflet, please tell your
plain and are available in pack sizes of
doctor or pharmacist.
15, 20, 28, 30, 50, 56, 84, 90, 98, 100, 112
and 300 tablets.
Uncommon: affects 1 to 10 users in 1,000
• Amlodipine 10 mg round white tablet, 11
• Mood changes, anxiety, depression,
mm in diameter. One side is slightly
concave with a breakline and debossed
• Trembling, taste abnormalities, fainting,
‘A10’. The other side is slightly convex
and plain and are available in pack sizes
• Numbness or tingling sensation in your
of 14, 15, 20, 28, 30, 50, 56, 84, 90, 98,
limbs; loss of pain sensation
100 and 112 tablets.
• Visual disturbances, double vision,
ringing in the ears
Not all pack sizes may be marketed.
• Low blood pressure
Marketing Authorisation Holder and
• Sneezing/running nose caused by
inflammation of the lining of the nose
Marketing Authorisation Holder
• Altered bowel habits, diarrhoea,
TEVA UK Limited, Eastbourne, BN22 9AG
constipation, indigestion, dry mouth,
vomiting (being sick)
• Hair loss, increased sweating, itchy skin,
red patches on skin, skin discolouration
TEVA Pharmaceutical Works Private
• Disorder in passing urine, increased need Limited Company
to urinate at night, increased number of
H-4042 Debrecen, Pallagi ut 13,Hungary
times of passing urine
• Inability to obtain an erection; discomfort This leaflet was last revised: August 2015
or enlargement of the breasts in men
PL 00289/0487-88
• Weakness, pain, feeling unwell
• Joint or muscle pain, muscle cramps,
back pain
• Weight increase or decrease.
Rare: affects 1 to 10 users in 10,000
• Confusion.
Very rare: affects less than 1 user in 10,000
• Decreased numbers of white blood cells,
decrease in blood platelets which may
result in unusual bruising or easy
bleeding (red blood cell damage)
• 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
• Increased muscle tension
• Inflammation of blood vessels, often with
skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor,
and/or movement disorders.


28 August 2015

Expand view ⇕

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.