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AMLODIPINE 10MG/5ML ORAL SOLUTION

Active substance(s): AMLODIPINE BESILATE / AMLODIPINE BESILATE

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Package Leaflet: Information for the user

Amlodipine 10mg/5ml Oral Solution
Read all of this leaflet
carefully before you start
taking this medicine because
it contains important
information for you.







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 only. Do not
pass it on to others. It may harm
them, even if their signs of
illness 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.

The name of your medicine is
Amlodipine 10mg/5ml Oral Solution
but it will be referred to as Amlodipine
throughout this leaflet.

Warnings and precautions

Fertility

Talk to your doctor or pharmacist
before taking Amlodipine 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

The data on effect of amlodipine on
human fertility is not sufficient. In
rats, amlodipine has shown adverse
effects on male fertility.

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.

Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicine. This
includes medicines obtained without
a prescription and herbal medicines.
Amlodipine may affect or be affected
by other medicines, such as:


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.
You must talk to your doctor if you
do not feel better or if you feel
worse.

2. What you need to know
before you take Amlodipine

Do not take Amlodipine if:







You are allergic 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.
You have severe low blood
pressure (hypotension).
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).
You suffer from heart failure
after a heart attack.

PIL/UK/MFG069/10/v2

Amlodipine may make you feel sick,
produce dizziness or tiredness, or
may give you a headache. You
should not drive, operate complex
machinery or take part in other
potentially hazardous activities until
you know whether you are affected.
Amlodipine contains:
Methyl parahydroxybenzoate
(E218): This may cause an allergic
reaction (possibly delayed).
Glycerol (E422): May cause
headache, stomach upset and
diarrhoea.

Other medicines and
Amlodipine

What is in this leaflet:
1. What Amlodipine is and what it is
used for
2. What you need to know before
you take Amlodipine
3. How to take Amlodipine
4. Possible side effects
5. How to store Amlodipine
6. Contents of the pack and other
information

Driving and using machines












Ketoconazole, itraconazole
(anti-fungal medicines)
Ritonavir, indinavir, nelfinavir (so
called protease inhibitors used to
treat HIV)
Rifampicin, erythromycin,
clarithromycin (antibiotics)
Hypericum perforatum (St.
John’s Wort)
Verapamil, diltiazem (heart
medicines)
Dantrolene (infusion for severe
body temperature abnormalities)
Simvastatin (a cholesterol-lowering
medicine)
Tacrolimus (used to control your
body’s immune response, enabling
your body to accept the
transplanted organ)
Clarithromycin (for infections
caused by bacteria).

Amlodipine may lower your blood
pressure even more if you are
already taking other medicines to
treat your high blood pressure.
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 and
breast-feeding
Pregnancy
The safety of amlodipine in human
pregnancy has not been established.
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask
your doctor for advice before taking
this medicine.
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.

3. How to take Amlodipine
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
If you have the impression that the
effect of Amlodipine is too strong or
too weak, talk to your doctor or
pharmacist as soon as possible.
Doses (For higher strength
10mg/5ml oral solution)
Your doctor will determine what dose
is appropriate for you.
For Adults:



The usual initial dose is 5mg
(2.5ml) once daily.
The dose can be increased to
10mg (5ml) once daily.

‘It is recommended to use the lower
strength (5mg/5ml) of Amlodipine
when a lower dose (<5mg) is
required.’
‘It is recommended to use the higher
strength (10mg/5ml) of Amlodipine
when a higher dose is required.’
For children and adolescents (617 years old):




The usual initial dose in children
and adolescents is 2.5mg once
daily, which is not attainable with
this strength. The measuring
spoon supplied does not have the
required 1.25ml graduation mark.
The dose can be increased to 5mg
(2.5ml) once daily.

‘It is recommended to use the lower
strength (5mg/5ml) of Amlodipine
when a lower dose (<5mg) is
required.’
‘It is recommended to use the higher
strength (10mg/5ml) of Amlodipine
when a higher dose is required.’
It is important to keep taking the
medicine. Do not wait until your
medicine is finished before seeing
your doctor.
Amlodipine is not recommended
for use in children under 6 years.
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.
Method of administration

Use the 2.5-5ml double-ended
spoon supplied in the pack to
measure the required dose (see
figure below).

Swallow the solution.

TURN OVER



Wash the spoon with clean water
after taking every dose.

2.5-5ml double-ended Spoon

Uncommon side effects (may
affect up to 1 in 100 people):






If you take more Amlodipine
than you should
Overdose may cause your blood
pressure to become low or even
dangerously low. You may feel dizzy,
light-headed, faint or weak. If your
blood pressure drop is severe
enough, shock can occur. Your skin
could feel cool and clammy and you
could lose consciousness.
Call your doctor or go to your
nearest hospital casualty department
straight away. Take the medicine
pack with you.












If you forget to take Amlodipine
If you forget a dose, take it as soon
as you remember. However, if it is
nearly time for the next dose, skip
the missed dose.
Do not take a double dose to make
up for a forgotten dose.
If you stop taking Amlodipine



Do not stop taking Amlodipine
unless your doctor tells you to.
If you stop taking Amlodipine
suddenly or before your doctor
tells you, there is an increased
risk of your condition returning.

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.
Stop taking Amlodipine and
contact your doctor immediately
if you develop the following
symptoms:










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

Other side effects are:
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)
Ankle swelling (oedema),
tiredness





Rare (may affect up to 1 in 1,000
people):

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

Decreased numbers of white
blood cells which may cause
unexplained fever, sore throat
and flu-like symptoms
(leukopenia).

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

Inflammation of blood vessels,
often with skin rash

Sensitivity to light

Disorders combining rigidity,
tremor, and/or movement
disorders
Not known (cannot be estimated
from the available data):

Trembling, rigid posture,
mask-like face, slow movements
and a shuffling, unbalanced walk.
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


PIL/UK/MFG069/10/v2

Mood changes, anxiety,
depression, sleeplessness
Trembling, taste abnormalities,
fainting, weakness
Numbness or tingling sensation
in your limbs (paraesthesia);
loss of pain sensation
Visual disturbances, double
vision, ringing or buzzing 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
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
in passing urine
Inability to obtain an erection,
discomfort or enlargement of
breasts in men
Weakness, pain, feeling unwell
Joint or muscle pain, muscle
cramps, back pain
Weight increase or decrease

Keep out of the sight and reach
of children.











Do not use after the expiry date
which is printed on the carton
and bottle label after ‘Exp’. The
expiry date refers to the last day
of that month.
Store in a refrigerator (2°C to
8°C).
For 100ml and 150ml packs:
Discard 30 days after first
opening.
For 300ml pack: Discard 60 days
after first opening.
Do not use this medicine if you
notice that the solution becomes
discoloured or shows any signs
of deterioration. Seek the advice
of your pharmacist.
Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to dispose of
medicines you no longer use.
These measures will help protect
the environment.

6. Contents of the pack and
other information
What Amlodipine contains
The active substance is amlodipine
(as amlodipine besilate).
Each 5ml of oral solution contains
10mg amlodipine
Each ml of oral solution contains
2mg amlodipine.
The other ingredients are methyl
parahydroxybenzoate (E218),
propylene glycol (E1520), disodium
phosphate anhydrous (E339),
sodium dihydrogen phosphate
dihydrate, purified water and
glycerol (E422).
What Amlodipine looks like and
contents of the pack
Amlodipine is a clear, greenish
yellow coloured oral solution. It
comes in an amber glass bottle with
a child-resistant plastic cap. The
pack also contains a 2.5-5ml double
ended spoon.
Amlodipine 10mg/5ml Oral Solution is
supplied in bottles containing 100ml,
150ml and 300ml of oral solution.
Not all pack sizes may be marketed
POM
Marketing Authorisation Holder
and Manufacturer:
Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK.
If this leaflet is hard to see or
read, please
call +44 (0) 208 515 3700
for help.
This leaflet was revised in 02/2017.

Expand Transcript

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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