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AMLODIPINE TABLETS 5MG

Active substance: AMLODIPINE BESYLATE

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S1448 LEAFLET Amlodipine 20150617

PATIENT INFORMATION LEAFLET

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 (Amlodipine Tablets
10mg) also may be present in this leaflet.

Other medicines and Amlodipine
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 because it contains important information for you.



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.






This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

tacrolimus (medicine used to alter the way your immune system
works)



simvastatin (cholesterol lowering medicine)



cyclosporine (an immunosuppressant)

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

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



What is in this leaflet:

Amlodipine with food and drink

3. How to take Amlodipine

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.

4. Possible side effects

Pregnancy and breast-feeding

5. How to store Amlodipine

Pregnancy

6. Contents of the pack and other information

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

1. WHAT AMLODIPINE IS AND WHAT IT IS USED FOR

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
2. What you need to know before you take 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 this 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. This medicine does not provide immediate
relief of chest pain from angina.

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..
Amlodipine contains sodium

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMLODIPINE

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 this medicine listed in section 6, or to any
other calcium antagonists. This may be itching, reddening of the
skin or difficulty in breathing.

3. HOW TO TAKE AMLODIPINE
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.



If you have severe low blood pressure (hypotension).



The recommended 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).

This medicine can be used before or after food and drinks. You
should take this 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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

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.

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 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.
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.
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 forgotten dose.

If you stop taking Amlodipine
Your doctor will advise you how long to take this medicine. Your
condition may return if you stop using this 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.

Very rare: may affect up to 1 in 10,000 people


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



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

Visit your doctor immediately if you experience any of the following
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

Disorders combining rigidity, tremor, and/or movement
disorders
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. 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
By reporting side effects you can help provide more information on
the safety of this medicine.

The following very common side effect has been reported. If this
causes you problems or if it lasts for more than one week, you
should contact your doctor.

5. HOW TO STORE AMLODIPINE


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Very common: may affect more than 1 in 10 people



Do not store above 25°C.

Ankle swelling (oedema)



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.

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.

Common: may affect up to 1 in 10 people


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



Palpitations (awareness of your heart beat), flushing



Abdominal pain, feeling sick (nausea)



Altered bowel habits, diarrhoea, constipation, indigestion



Tiredness, weakness



Visual disturbances, double vision



Muscle cramps

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: may affect up to 1 in 100 people

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Amlodipine contains


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.



Mood changes, anxiety, depression, sleeplessness



Trembling, taste abnormalities, fainting



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)

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.



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

Manufacturer



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

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



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



Pain, feeling unwell



Joint or muscle pain, back pain

 Weight increase or decrease
Rare: may affect up to 1 in 1,000 people


Confusion

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.



Amlodipine Tablets are available as blister packs of 28 tablets

POM

PL: 19488/1448

Leaflet revision date: 17 June 2015
S1448 LEAFLET Amlodipine 20150617

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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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