AMLODIPINE10 MG TABLETS

Active substance: AMLODIPINE BESILATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MORE INFORMATION ON AMLODIPINE
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 tests
• Increased muscle tension
• Inflammation of blood vessels, often
with skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor,
and/or movement disorders
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.

Amlodipine
Read all of this leaflet
carefully before you start
taking 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 Amlodipine is and what it is
used for
2. Before you take Amlodipine
3. How to take Amlodipine
4. Possible side effects
5. How to store Amlodipine
6. Further information

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1. WHAT AMLODIPINE
IS AND WHAT IT IS
USED FOR

UNITED KINGDOM

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
breathing.
• If you have severe low blood pressure
(hypotension).
• 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 body).
• 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
conditions:
• Recent heart attack
• Heart failure
• Severe increase in blood pressure
(Hypertensive crisis)
• Liver disease
• You are elderly and your dose needs
to be increased
Use in children and adolescents
Amlodipine has not been studied in
children under the age of 6 years.
Amlodipine should only be 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.
Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.

YOU WILL FIND MORE ABOUT AMLODIPINE
ON THE BACK OF THIS LEAFLET

Seite 1

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Amlodipine contains the active
substance amlodipine which belongs
to a group of medicines called calcium
antagonists.
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.

2. BEFORE YOU
TAKE AMLODIPINE

5. HOW TO STORE
AMLODIPINE

Keep out of the reach and sight of
children.
Do not use your medicine after the
expiry date which is stated on the pack
after ‘EXP’. The expiry date refers to
the last day of that month.
Do not store above 25 °C.
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.

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6. FURTHER
INFORMATION

What Amlodipine contains
The active substance in Amlodipine
5 mg tablets is amlodipine (as besilate).
The active substance in Amlodipine
10 mg tablets is amlodipine (as besilate).

The other ingredients are dibasic
calcium phosphate, magnesium
stearate, microcrystalline cellulose
and sodium starch glycolate.
What Amlodipine looks like and
contents of the pack
5 mg tablets: white to off-white,
emerald-shaped tablets engraved
AML-5 and breaker score on one side
and Pfizer logo on the other side.
10 mg tablets: white to off-white,
emerald-shaped tablets engraved
AML-10 on one side and Pfizer logo
on the other side.
The score line is only to facilitate
breaking for ease of swallowing and
not to divide into equal doses.
Amlodipine 5 mg tablets are available
in blister packs containing 4, 10, 14,
20, 28, 30, 50, 60, 98, 100, 300,
500 tablets and in unit dose blister
packs containing 50x1 and 500x1
tablets.
Amlodipine 10 mg tablets are available
in blister packs containing 4, 10, 14,
20, 28, 30, 50, 60, 90, 98, 100, 300,
500 tablets and in unit dose blister
packs containing 50x1 and 500x1
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Pfizer Manufacturing
Deutschland GmbH
Heinrich-Mack-Strasse 35
89257 Illertissen
Germany
This leaflet was approved in
MM/YYYY
Ref: dxAML 2_0 UK

Pfizer Limited
Sandwich, England

530780m

Seite 4

By signing this artwork copy the market confirms
that this document has been checked completely,
i.e. the correctness of all aspects (text, dosage
values, spelling, font size etc.) is certified. In case
of alterations the concerned parts must be marked
clearly. The market approval of this document
authorizes the plant to print the contents of this
proof. The market takes full responsibility for
correctness of this print proof

Amlodipine
5mg and 10 mg tablets

PFI_K0_530780m_GBR_GI AML 5/10 mg T RO KLEB 29.03.12 12:19 Seite 2

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.
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.

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4. POSSIBLE SIDE
EFFECTS

Like all medicines, Amlodipine
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) 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.

Common: affects 1 to 10 users in 100
• Headache, dizziness, sleepiness
(especially at the beginning of
treatment)
• Palpitations (awareness of your heart
beat), flushing
• Abdominal pain, feeling sick (nausea)
• Ankle swelling (oedema), tiredness
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: affects 1 to 10 users
in 1,000
• Mood changes, anxiety, depression,
sleeplessness
• Trembling, taste abnormalities,
fainting, weakness
• Numbness or tingling sensation in
your limbs; loss of pain sensation
• Visual disturbances, double vision,
ringing in the ears
• Low blood pressure
• Sneezing/running nose caused by
inflammation of the lining of the nose
(rhinitis)
• Altered bowel habits, diarrhoea,
constipation, indigestion, 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
• 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

MORE INFORMATION ON AMLODIPINE
Amlodipine may affect or be affected
by other medicines, such as:
• ketoconazole, itraconazole
(anti-fungal medicines)
• ritonavir, indinavir, nelfinavir
(so called protease inhibitors used to
treat HIV)
• rifampicin, erythromycin,
clarithromycin (antibiotics)
• hypericum perforatum (St. John’s
Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body
temperature abnormalities)
• simvastatin (a cholesterol lowering
medicine)
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.
Pregnancy
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.
Breast-feeding
It is not known whether amlodipine
is passed into breast milk. If you are
breast-feeding or about to start
breast-feeding you must tell your
doctor before taking Amlodipine.
Ask your doctor or pharmacist for
advice before taking any medicine.
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.

UNITED KINGDOM

YOU WILL FIND MORE ABOUT AMLODIPINE
ON THE BACK OF THIS LEAFLET

Seite 3

UNITED KINGDOM

Important information about
some of the ingredients of
Amlodipine
This medicine contains less than
1 mmol sodium (23 mg) per tablet,
which means it is essentially
‘sodium-free’.

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3. HOW TO TAKE
AMLODIPINE

Always take your medicine exactly as
your doctor has told you. You should
check with your doctor or phamacist if
you are not sure.
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 with a drink 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 and the 2.5 mg dose
cannot be obtained with Amlodipine
5 mg tablets as these tablets are not
manufactured to break into two equal
halves.
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.

YOU WILL FIND MORE ABOUT AMLODIPINE
ON THE BACK OF THIS LEAFLET

Seite 2

By signing this artwork copy the market confirms
that this document has been checked completely,
i.e. the correctness of all aspects (text, dosage
values, spelling, font size etc.) is certified. In case
of alterations the concerned parts must be marked
clearly. The market approval of this document
authorizes the plant to print the contents of this
proof. The market takes full responsibility for
correctness of this print proof

MORE INFORMATION ON AMLODIPINE

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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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