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AMLODIPINE 10 MG TABLETS

Active substance: AMLODIPINE BESILATE

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TEVA UK Ref:

Version:

231-30-62137-ZB LEA AMLODIPINE A/S TAB TUK
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 you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
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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03 June 2015

(antibiotics)
• Hypericum Perforatum (St. John’s Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body
temperature abnormalities).
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.

WHAT AMLODIPINE IS AND WHAT
Breast-feeding
IT IS USED FOR

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

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 is used to treat high blood
pressure (hypertension) or a certain type of Ask your doctor or pharmacist for advice
chest pain called angina, a rare form of
before taking any medicine.
which is Prinzmetal’s or variant angina.
Driving and using machines
In patients with high blood pressure your
Amlodipine may affect your ability to drive
medicine works by relaxing blood vessels, or use machines. If the tablets make you
so that blood passes through them more
feel sick, dizzy or tired, or give you a
easily. In patients with angina Amlodipine headache, do not drive or use machines
works by improving blood supply to the
and contact your doctor immediately.
heart muscle which then receives more
oxygen and as a result chest pain is
Important information about some of the
prevented. Your medicine does not provide ingredients of Amlodipine
immediate relief of chest pain from angina. This medicine contains less than 1 mmol
sodium (23 mg) per tablet, which means is
essentially ‘sodium-free’.
BEFORE YOU TAKE AMLODIPINE

2

Do NOT take Amlodipine:

3

• 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 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.

HOW TO TAKE AMLODIPINE

Always take Amlodipine 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.
Your medicine can be used before or after
food and drinks. You should take your
medicine at the same time each day.
Swallow the tablet with a glass 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. The 2.5 mg dose can be obtained
with Amlodipine 5 mg tablets as these
tablets can be divided into two equal
doses.
Amlodipine 10 mg tablets can also be
divided into equal doses.
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
Taking other medicines
pressure drop is severe enough shock can
Please tell your doctor or pharmacist if you occur. Your skin could feel cool and clammy
are taking or have recently taken any other and you could lose consciousness. Seek
medicines, including medicines obtained
immediate medical attention if you take too
without a prescription.
many Amlodipine tablets.
Amlodipine may affect or be affected by
other medicines, such as:
If you forget to take Amlodipine
• ketoconazole, itraconazole (anti-fungal
Do not worry. If you forget to take a tablet,
medicines)
leave out that dose completely. Take your
• ritonavir, indinavir, nelfinavir (so called
next dose at the right time. Do not take a
protease inhibitors used to treat HIV)
double dose to make up for a missed dose.
• rifampicin, erythromycin, clarithromycin

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TEVA UK Ref:

Version:

231-30-62137-ZB LEA AMLODIPINE A/S TAB TUK
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.

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.

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03 June 2015

• Inflammation of blood vessels, often with
skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor,
and/or movement disorders.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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.

5

HOW TO STORE AMLODIPINE

• 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.

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.

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.

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.

Common: affects 1 to 10 users in 100

6

FURTHER INFORMATION

• Headache, dizziness, sleepiness
(especially at the beginning of treatment) What Amlodipine looks like and contents
• Palpitations (awareness of your heart
of the pack:
beat), flushing
• Abdominal pain, feeling sick (nausea)
• Amlodipine 5 mg round white tablet,
• Ankle swelling (oedema), tiredness.
8 mm in diameter. One side is slightly
concave with a breakline and debossed
Other side effects that have been reported
‘A5’. The other side is slightly convex and
include the following list. If any of these
plain and are available in pack sizes of
get serious, or if you notice any side effects
15, 20, 28, 30, 50, 56, 84, 90, 98, 100, 112
not listed in this leaflet, please tell your
and 300 tablets.
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.

• Amlodipine 10 mg round white tablet,
11 mm in diameter. One side is slightly
concave with a breakline and debossed
‘A10’. The other side is slightly convex
and plain 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: June 2015
PL 00289/0487-88

Rare: affects 1 to 10 users in 10,000
• Confusion.
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

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62137-ZB

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl-00289-0487-0488-amlodipine-5mg-and-10mg-tablets

APPROVALS
Signed by
Arun Ramachandran

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Meaning of Signature
Regulatory Affairs Approval

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Server Date
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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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