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.
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
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 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.
2. What you need to know before you take
Amlodipine
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.
- 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
Warnings and precautions
Talk to your doctor or pharmacist before taking you
should inform your doctor 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
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.
Other medicines and Amlodipine
Tell your doctor or pharmacist if you are taking or
have recently taken or might take 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)
- hypericum perforatum (St. John’s Wort)
- verapamil, diltiazem (heart medicines)
- dantrolene (infusion for severe body temperature
abnormalities)
- tacrolimus, sirolimus, temsirolimus, and
everolimus (medicines used to alter the way your
immune system works)
- simvastatin (cholesterol lowering medicine)
- cyclosporine (an immunosuppressant)
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 think you might be
pregnant, or are planning to get pregnant, you must
tell your doctor before you take Amlodipine.
Breast-feeding
Amlodipine has been shown to pass into breast milk
in small amounts. 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
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 this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
The recommended initial dose is Amlodipine 5 mg
once daily. The dose can be increased to Amlodipine
10 mg once daily.
This 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.
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 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.
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.
Visit your doctor immediately if you experience any
of the following 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, toxic
epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart beat
• Inflamed pancreas which may cause severe
abdominal and back pain accompanied with
feeling very unwell
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.
Very common: may affect more than 1 in 10 people
• Oedema (fluid retention
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: 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
• Ankle swelling
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
• 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)
• 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
• Pain, feeling unwell
• Joint or muscle pain, back pain
• Weight increase or decrease
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,
decrease in blood platelets which may result in
unusual bruising or easy bleeding
• Excess sugar in blood (hyperglycaemia)
• A disorder of the nerves which can cause
muscular 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
• 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 Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Amlodipine
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date which
is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away 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.
- The other ingredients are microcrystalline
cellulose, calcium hydrogen phosphate, sodium
starch glycolate, magnesium stearate.
What Amlodipine looks like and contents of the
pack
Tablet.
Amlodipine 5 mg tablets
White or almost white, flat, bevelled edges,
barrel-shaped tablet debossed with "C" on one side and
"58" on the other side. The size is 7.9 mm x 5.6 mm.
Amlodipine 10 mg tablets
White or almost white, flat, bevelled edges, round
[diameter 9.5 mm] tablet debossed with "C" on one side
and "59" on the other side.
Amlodipine tablets are available in PVC/
PVdC-Aluminium blister.
Pack sizes:
Blister pack: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84,
90, 98, 100, 120, 200, 250, 300 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far
Brizebbugia BBG 3000
Malta
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Germany Amlodipin PUREN 5 mg/
10 mg Tabletten
Spain Amlodipino Aurobindo 5 mg/
10 mg comprimidos EFG
Italy Amlodipina Aurobindo 5 mg/
10 mg compresse
Malta Amlodipine Aurobindo 5 mg/
10 mg Tablets
Poland Amlodipine Aurobindo
Romania Amlodipina Aurobindo 5 mg/
10 mg comprimate
Sweden Amlodipin Aurobindo 5 mg/
10 mg tabletter
United Kingdom Amlodipine 5 mg/ 10 mg tablets
This leaflet was last approved in 05/2020.
Package leaflet:
Information for the user
Amlodipine 5 mg tablets
Amlodipine 10 mg tablets
Amlodipine
P15XXXXX
Black
