AMLODIPINE TABLETS 5MG

Active substance: AMLODIPINE BESYLATE

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S1448 LEAFLET Amlodipine 20130227

PACKAGE LEAFLET: INFORMATION FOR USER

AMLODIPINE TABLETS 5mg
(amlodipine besilate)
Your medicine is known as Amlodipine Tablets 5mg but will be
referred to as Amlodipine throughout the following patient
information leaflet.
Information for other strength of Amlodipine Tablets (Amlodipine
Tablets 10mg) may be present in this leaflet.

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.
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)

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



hypericum perforatum (St. John’s Wort)





verapamil, diltiazem (heart medicines)

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





dantrolene (infusion for severe body temperature abnormalities)

If you have any further questions, ask your doctor or
pharmacist.



simvastatin (a cholesterol lowering medicine)



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.

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



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.

Taking Amlodipine with food and drink

In this leaflet:
1. What Amlodipine is and what it is used for

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.

2. Before you take Amlodipine
3. How to take Amlodipine

Pregnancy

4. Possible side effects

The safety of amlodipine in human pregnancy has not been
established.

5. How to store Amlodipine
6. Further information

If you think you might be pregnant, or are planning to get pregnant,
you must tell your doctor before you take Amlodipine.

1. WHAT AMLODIPINE IS AND WHAT IT IS USED FOR
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
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.

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.
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’.
3. HOW TO TAKE AMLODIPINE
Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist 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.

Take special care with Amlodipine

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.

You should inform your doctor if you have or have had any of the
following conditions:

Use in children and adolescents



Recent heart attack



Heart failure



Severe increase in blood pressure (Hypertensive crisis)



Liver disease



You are elderly and your dose needs to be increased

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 5 mg
tablets can be divided into halves to provide a 2.5 mg dose.
It is important to keep taking the tablets. Do not wait until your
tablets are finished before seeing your doctor.

Use in children and adolescents

If you take more Amlodipine than you should

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).

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.

For more information, talk to your doctor.

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
completely.



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 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.

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



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

4. POSSIBLE SIDE EFFECTS



Increased muscle tension

Like all medicines, Amlodipine can cause side effects, although not
everybody gets them.



Inflammation of blood vessels, often with skin rash



Sensitivity to light

Visit your doctor immediately if you experience any of the following
very rare, severe side effects after taking this medicine.



Disorders combining rigidity, tremor, and/or movement
disorders

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
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

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.
5. HOW TO STORE AMLODIPINE TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°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.



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.

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.

Common: affects 1 to 10 users in 100


Headache, dizziness, sleepiness (especially at the beginning of
treatment)



Palpitations (awareness of your heart beat), flushing

6. FURTHER INFORMATION



Abdominal pain, feeling sick (nausea)

What Amlodipine Tablets contains



Ankle swelling (oedema), tiredness



Each Amlodipine tablet contains 5mg of the active ingredient,
amlodipine (as the besilate).



Amlodipine Tablets also contain anhydrous dibasic calcium
phosphate, magnesium stearate, microcrystalline cellulose and
sodium starch glycolate.

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



What Amlodipine Tablets looks like and contents of the pack


Amlodipine Tablets are octagonal white tablet marked ‘Pfizer’
on one side and ‘AML 5’ with a breakline on the other.

Numbness or tingling sensation in your limbs; loss of pain
sensation



Amlodipine Tablets are available as blister packs of 28 tablets



Visual disturbances, double vision, ringing in the ears



Low blood pressure



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

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)

Manufacturer



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

This product is manufactured by Pfizer Manufacturing Deutschland
GmbH, Heinrich Mack Strasse, 35 89257 Illertissen, Germany.



Disorder in passing urine, increased need to urinate at night,
increased number of times of passing urine

POM



Inability to obtain an erection; discomfort or enlargement of the
breasts in men



Leaflet revision date: 27 February 2013

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

PL No. 19488/1448

S1448 LEAFLET Amlodipine 20130227

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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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