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S1442-43 LEAFLET Amlodipine 20120419

Amlodipine may affect or be affected by other medicines, such as:


ketoconazole, itraconazole (anti-fungal medicines)

(amlodipine besilate)

ritonavir, indinavir, nelfinavir (so called protease inhibitors used
to treat HIV)

rifampicin, erythromycin, clarithromycin (antibiotics)

Your medicine is known as above but will be referred to as
Amlodipine throughout the following patient information leaflet.

hypericum perforatum (St. John’s Wort)

verapamil, diltiazem (heart medicines)

Read all of this leaflet carefully before you start taking this

dantrolene (infusion for severe body temperature abnormalities)

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

Amlodipine may lower your blood pressure even more if you are
already taking other medicines to treat your high blood pressure.

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

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.

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

The safety of amlodipine in human pregnancy has not been
If you think you might be pregnant, or are planning to get pregnant,
you must tell your doctor before you take Amlodipine.

5. How to store Amlodipine
6. Further information



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.

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.

Ask your doctor or pharmacist for advice before taking any
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
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
which means it is essentially ‘sodium-free’.

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.

Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

If you have severe low blood pressure (hypotension).

The usual initial dose is Amlodipine 5 mg once daily. The dose can
be increased to Amlodipine 10 mg once daily.

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).

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.

If you suffer from heart failure after a heart attack.
Use in children and adolescents

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

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.

You are elderly and your dose needs to be increased

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

Use in 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.
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 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

Very rare: affects less than 1 user in 10,000

Do not worry. If you forget to take a tablet, leave out that dose

Decreased numbers of white blood cells, decrease in blood
platelets which may result in unusual bruising or easy bleeding
(red blood cell damage)

Do not take a double dose to make up for a missed dose.

Excess sugar in blood (hyperglycaemia)

If you stop using 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

A disorder of the nerves which can cause weakness, tingling or

Cough, swelling of the gums

Abdominal bloating (gastritis)

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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

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.

Inflammation of blood vessels, often with skin rash

Sensitivity to light

Disorders combining rigidity, tremor, and/or movement

Take your next dose at the right time.

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

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

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 Tablets should be stored below 30°C.

Do not use after the expiry date printed on the carton label or
blister strip.

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

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


Palpitations (awareness of your heart beat), flushing

What Amlodipine contains

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

Amlodipine tablets come in two strengths, 5mg and 10mg. The
5mg tablets contains active substance is 5 mg amlodipine (as
amlodipine besilate) and 10mg tablets contains 10 mg
amlodipine (as amlodipine besilate)

Amlodipine Tablets also contain the following: anhydrous
dibasic calcium phosphate, magnesium stearate,
microcrystalline cellulose and sodium starch glycolate
What Amlodipine looks like and contents of the pack

Mood changes, anxiety, depression, sleeplessness

Trembling, taste abnormalities, fainting, weakness

Numbness or tingling sensation in your limbs; loss of pain

Visual disturbances, double vision, ringing in the ears

Low blood pressure

Sneezing/running nose caused by inflammation of the lining of
the nose (rhinitis)

Amlodipine comes in blister packs of 30 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Altered bowel habits, diarrhoea, constipation, indigestion, dry
mouth, vomiting (being sick)


Hair loss, increased sweating, itchy skin, red patches on skin,
skin discolouration

This product is manufactured by Farmasierra SA Ctra. N-1 Km
26200, 28700 S. Sebastian de los Reyes, Madrid, Spain.

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


The 5mg tablet is white and coded 'AML-5' on one side and has the
Pfizer logo on the reverse.
The 10mg tablet is white and coded 'AML breakline 10' on one side
and has the Pfizer logo on the reverse.

PL No. 19488/1442

Amlodipine 10mg Tablets

PL No. 19488/1443

Amlodipine 5mg Tablets

Leaflet revision date: 19 April 2012
S1442-43 LEAFLET Amlodipine 20120419

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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.