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AMLODIPINE 10 MG TABLETS

Active substance(s): AMLODIPINE BESILATE

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AMLODIPINE 5 mg and 10 mg
TABLETS
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
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 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.

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

2

you take Amlodipine

Amlodipine contains sodium
This medicine contains less than 1 mmol
Do not take Amlodipine:
sodium (23 mg) per tablet, which means is
• If you are allergic to amlodipine, or any essentially ‘sodium-free’.
of the other ingredients of this
3 How to take Amlodipine
medicine listed in section 6, or to any
other calcium antagonists. This may be
Always take this medicine exactly as your
itching, reddening of the skin or
doctor or pharmacist has told you. Check
difficulty in breathing.
• If you have severe low blood pressure with your doctor or pharmacist if you are
not sure.
(hypotension)
The recommended initial dose is Amlodipine
• If you have narrowing of the aortic
5
mg once daily. The dose can be increased
heart valve (aortic stenosis) or
to Amlodipine 10 mg once daily.
cardiogenic shock (a condition where
your heart is unable to supply enough Your medicine can be used before or after
blood to the body)
food and drinks. You should take your
• If you suffer from heart failure after a
medicine at the same time each day.
heart attack.
Swallow the tablet with a glass of water. Do
not take Amlodipine with grapefruit juice.
Take special care with Amlodipine
You should inform your doctor if you have Use in children and adolescents
or have had any of the following conditions: For children and adolescents (6-17 years old),
the recommended usual starting dose is
• Recent heart attack
2.5 mg a day. The maximum recommended
• Heart failure
dose is 5 mg a day. Amlodipine 2.5 mg is
• Severe increase in blood pressure
not currently available. The 2.5 mg dose
(Hypertensive crisis)
can be obtained with Amlodipine 5 mg
• Liver disease
• You are elderly and your dose needs to tablets as these tablets can be divided into
two equal doses.
be increased.
Amlodipine 10 mg tablets can also be
Children and adolescents
divided into equal doses.
Amlodipine has not been studied in children
It is important to keep taking the tablets.
under the age of 6 years. Amlodipine
Do not wait until your tablets are finished
should only used for hypertension in
before seeing your doctor.
children and adolescents from 6 years to
17 years of age (see section 3).
If you take more Amlodipine than you should
For more information, talk to your doctor.
Taking too many tablets may cause your
blood pressure to become low or even
Other medicines and Amlodipine
dangerously low. You may feel dizzy,
Tell your doctor or pharmacist if you are
lightheaded, faint or weak. If blood
taking, have recently taken any other
pressure drop is severe enough shock can
medicines, including medicines obtained
occur. Your skin could feel cool and clammy
without a prescription.
and you could lose consciousness. Seek
Amlodipine may affect or be affected by
immediate medical attention if you take too
other medicines, such as:
many Amlodipine tablets.
• ketoconazole, itraconazole (anti-fungal
If you forget to take Amlodipine
medicines)
• ritonavir, indinavir, nelfinavir (so called Do not worry. If you forget to take a tablet,
leave out that dose completely. Take your
protease inhibitors used to treat HIV)
next dose at the right time. Do not take a
double dose to make up for a missed dose.

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 pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Visit your doctor immediately if you
experience any of the following very rare,
severe side effects after taking this medicine.
• Sudden wheeziness, chest pain, shortness
of breath or difficulty in breathing
• 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, toxic epidermal necrolysis)
or other allergic reactions
• Heart attack, abnormal heart beat
• Inflamed pancreas which may cause
severe abdominal and back pain
accompanied with feeling very unwell.

• 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
• Inflammation of blood vessels, often
with skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor,
and/or movement disorders.
Not known: frequency cannot be estimated
from the available data.
• 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:
www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects
you can help provide more information on
the safety of this medicine.

The following very common side effect has 5 How to store Amlodipine
been reported. If this causes you problems
Keep this medicine out of the sight and
or if it lasts for more than one week, you
reach of children.
should contact your doctor.
Do not store above 25°C. Store in the
Very common: may affect more than 1 in
original packaging. Keep the blister in the
10 people
outer carton.
Do not use this medicine after the expiry
• Oedema (fluid retention)
date that is stated on the label and carton
The following common side effects have
after ‘EXP’.. The expiry date refers to the
been reported. If any of these cause you
last day of that month.
problems or if they last for more than one Do not take these tablets if there are any
week, you should contact your doctor.
signs of discolouration or deterioration of
the tablets.
Common: may affect up to 1 in 10 people
Do not throw away any medicines via
• Headache, dizziness, sleepiness
wastewater or household waste. Ask your
(especially at the beginning of treatment) pharmacist how to throw away medicines
• Palpitations (awareness of your heart
you no longer use. These measures will
beat), flushing
help protect the environment.
• Abdominal pain, feeling sick (nausea)
• Altered bowel habits, diarrhoea,
6 Contents of the pack and other
information
constipation, indigestion,
• Tiredness, weakness
What Amlodipine contains:
• Visual disturbances, double vision
• The active ingredient is amlodipine (as
• Muscle cramps
besilate).
• Ankle swelling
• The other ingredients are

microcrystalline cellulose, calcium
Other side effects that have been reported
hydrogen phosphate, sodium starch
include the following list. If any of these
glycolate and magnesium stearate.
get serious, or if you notice any side effects
not listed in this leaflet, please tell your
What Amlodipine looks like and contents
doctor or pharmacist.
of the pack:
Uncommon: may affect up to 1 in 100 people • Amlodipine 5 mg round white tablet,
• Mood changes, anxiety, depression,
sleeplessness
• Trembling, taste abnormalities,
fainting, weakness
• Numbness or tingling sensation in your
limbs; loss of pain sensation
• Ringing in the ears
• 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, muscle cramps,
back pain
• Weight increase or decrease.
Rare: may affect up to 1 in 1,000 people
• Confusion.

8 mm in diameter. One side is slightly
concave with a breakline and debossed
‘A5’. The other side is slightly convex and
plain and are available in pack sizes of
15, 20, 28, 30, 50, 56, 84, 90, 98, 100, 112
and 300 tablets.

• Amlodipine 10 mg round white tablet,
11 mm in diameter. One side is slightly
concave with a breakline and debossed
‘A10’. The other side is slightly convex
and plain and are available in pack sizes
of 14, 15, 20, 28, 30, 50, 56, 84, 90, 98,
100 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG
Manufacturer
TEVA Pharmaceutical Works Private
Limited Company
H-4042 Debrecen, Pallagi ut 13,Hungary
This leaflet was last revised in
December 2017

Very rare: may affect up to 1 in 10,000 people PL 00289/0487-88
• Decreased numbers of white blood
cells, decrease in blood platelets which
may result in unusual bruising or easy
bleeding (red blood cell damage)

EAS2034a

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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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