AMLODIPINE 5 MG TABLETS

Active substance: 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.
• 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 get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET

1.
2.
3.
4.
5.
6.

• suffer from heart failures
• have a hypertensive crisis (very high
blood pressure).
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.
Taking Amlodipine with food and drink
Amlodipine Tablets are for oral use and
should be swallowed with a drink of water.
Pregnancy and breast-feeding
Do not take Amlodipine if you are pregnant,
trying to become pregnant, or
breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.

What Amlodipine is and what it is used for
Before you take Amlodipine
3 HOW TO TAKE AMLODIPINE
How to take Amlodipine
Possible side effects
Always take Amlodipine exactly as your
How to store Amlodipine
doctor has told you. You should check with
Further information
your doctor or pharmacist if you are not
sure. The usual dosage instructions are given
below:
1 WHAT AMLODIPINE IS AND

WHAT IT IS USED FOR

• Amlodipine belongs to a group of drugs
called calcium-channel blockers. It relieves
heart problems by widening blood vessels
to allow more blood to flow through. This
helps to reduce blood pressure and relieve
the strain on the heart muscle.
• Amlodipine is used in the treatment of
high blood pressure and angina, including
the rare form, Prinzmetal's angina.
Amlodipine does not provide immediate
relief of chest pain from angina.

Adults (including the elderly)
The starting dose is one 5 mg tablet, once a
day. This may be increased to a maximum of
10 mg (two 5 mg tablets or one 10 mg tablet)
once a day.
Children
Not recommended.

If you take more Amlodipine than you should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
2 BEFORE YOU TAKE AMLODIPINE
doctor immediately. An overdose is likely to
Do NOT take Amlodipine:
cause redness of the skin and low blood
• if you are allergic (hypersensitive) to
pressure (dizziness and fainting). Please take
Amlodipine besilate or any of the other
this leaflet, any remaining tablets and the
ingredients of this medicine
container with you to the hospital or doctor
• if you are sensitive to any other calcium
so that they know which tablets were
channel blockers e.g. nifedipine, felodipine consumed.
• if you are pregnant, trying to become
pregnant, or breast-feeding
If you forget to take Amlodipine
• if you suffer from unstable angina
If you forget to take a tablet, take one as
(excluding Prinzmetal's angina) or aortic
soon as you remember, unless it is nearly
stenosis (a narrowing of the main artery
time to take the next one. Do not take a
leading from the heart)
double dose to make up for a forgotten
• if you have suffered a collapse of your
tablet. Take your next dose at the usual time.
blood circulation system (cardiogenic
shock).
4 POSSIBLE SIDE EFFECTS
Take special care with Amlodipine
Tell your doctor before you start to take this
medicine if you:
• have problems with your liver
• have had a heart attack within the last
month

Like all medicines, Amlodipine can cause
side effects, although not everybody gets
them.
If you experience the following, stop taking

Amlodipine and tell your doctor immediately • Pancreatitis (inflammation of the
or go to the casualty department at your
pancreas)
nearest hospital:
• Gastritis (inflammation of the stomach
lining) causing abdominal pain.
• Difficulty breathing and swelling of the
lips, face and neck.
If any of the side effects get serious, or if
you notice any side effects not listed in this
This is a very serious but very rare side
leaflet, please tell your doctor or
effect, which affects fewer than one person pharmacist.
in 10,000. You may need urgent medical
attention or hospitalisation.
HOW TO STORE AMLODIPINE

5

The following side effects have been
reported at the approximate frequencies
shown:
Common (affecting fewer than one person
in 10 but more than one person in 100):
• Headache
• Water retention causing swelling
• Sleepiness, tiredness
• Abdominal pain, nausea
• Flushing
• Dizziness
• Palpitations.
Uncommon (affecting fewer than one
person in 100 but more than one person in
1,000):
• Shortness of breath, fainting
• Indigestion, vomiting, dry mouth, altered
bowel habit
• Difficulty sleeping, mood changes
• Impotence, breast enlargement in men
• Problems with urination including an
increased need to urinate
• Changes to taste perception
• Low blood pressure
• Blocked or runny nose, sneezing
• Back, muscle or joint pain
• Rash, skin discoloration, increased
sweating, itching
• Visual disturbances
• Ringing in the ears
• Loss of sensation, muscle cramps
• Shaking, generally feeling unwell, feeling
of weakness
• Hair loss
• Weight increase or decrease
• Chest pain.
Very rare (affecting fewer than one person
in 10,000):
• Unusual bleeding or unexplained
bruising
• High level of blood sugar
• Inflammation of the blood vessels
• Coughing
• Enlarged gums
• Numbness or tingling in the hands and
feet
• Abnormal liver function test results
• Hepatitis
• Jaundice (yellowing of the skin and
whites of the eyes)
• Severe, red, itchy skin rash
• Heart attack, irregular heartbeat

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.

6

FURTHER INFORMATION

What Amlodipine contains:
• The active ingredient is amlodipine (as
besilate).
• The other ingredients are microcrystalline
cellulose, calcium hydrogen phosphate,
sodium starch glycolate and magnesium
stearate.
What Amlodipine looks like and contents of
the pack:
• Amlodipine 5 mg Tablets are white,
round, slightly arched tablets debossed
AB 5 on one side, plain on the other side
and are available in pack sizes of 15, 20,
28, 30, 50, 56, 84, 90, 98, 100, 112 and 300
tablets
• Amlodipine 10 mg Tablets are white,
round, slightly arched tablets, debossed
AB 10 and breakline on one side, plain on
the other side 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 and
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: March 2007.
PL00289/0487-88

86270-T

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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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