Pil 2743

Package leaflet: Information for the patient
Amlodipine 5 mg Tablets
Amlodipine 10 mg Tablets
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 tablets contain 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 a 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.
• If you have severe low blood pressure (hypotension).
• If the blood flow from the left side of your heart is obstructed (e.g. if you have narrowing of
the aortic heart valve (aortic stenosis)).
• If you suffer from heart failure after a heart attack.
• If you suffer from cardiogenic shock (a condition where your heart is unable to supply enough
blood to the body).
Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine if you have, or have had, any of the
following conditions:
• Heart failure.
• Severe increase in blood pressure (Hypertensive crisis).
• Liver disease.
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During treatment
Talk to your doctor:
• If you are elderly and your dose needs to be increased as special care needs to be taken when
dosage is increased in elderly patients.
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.
Other medicines and Amlodipine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Amlodipine may affect or be affected by other medicines, such as:

• anti-fungal medicines (e.g. ketoconazole, itraconazole)
• so called protease inhibitors used to treat HIV (e.g. ritonavir, indinavir, nelfinavir)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• hypericum perforatum (St. John’s wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body temperature abnormalities)
• simvastatin (a medicine to reduce blood cholesterol levels)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to change the way your
immune system works). Amlodipine may increase the levels of this medicine in your blood.
• ciclosporin (if you have had a kidney transplant and are taking ciclosporin) as amlodipine may
alter the amount of this medicine in your blood.
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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
The safety of amlodipine in human pregnancy has not been established.

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 this medicine. Your doctor will
only recommend you take this medicine if the benefits of the treatment outweigh any risks to the baby.
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. These side effects may occur especially at
the beginning of the treatment.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially
‘sodium-free’.
3. How to take Amlodipine
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Always take this medicine exactly as your doctor or pharmacist 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.
Your medicine can be taken before or after food and drinks. You should take your medicine at the
same time each day with a drink of water.
Patients with liver problems

Your doctor may ask you to take a lower dose and carry out frequent checks, if you are suffering from
liver problems.
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.
The tablet can 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 or have a rapid heartbeat. If blood pressure drop is severe
enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness.
Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may
develop up to 24-48 hours after intake. 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 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, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking this medicine and contact your doctor
or go to the nearest hospital casualty department straight away:
• Swelling of eyelids, face lips, tongue and throat which causes great difficulty in breathing or
swallowing
• 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 or irregular heartbeat, faster heart rhythm
• Inflamed pancreas which may cause severe abdominal and back pain accompanied with
feeling very unwell
• Yellowing of the skin or eyes, pale stools, dark urine or stomach pain (these may be signs of
liver problems such as inflammation of the liver (hepatitis) or jaundice).
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•
• Difficulty in speaking or swallowing, loss of balance control, mask-like face, shuffling walk,
stiffness of arms and legs, trembling or shaking of hands or fingers (extrapyramidal
syndrome).
Other possible side effects:
Very common (may affect more than 1 in 10 people)

• Swelling which may be due to retention of fluid in the tissues
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 which includes diarrhoea and
constipation, indigestion
• Ankle swelling, tiredness, unusual weakness
• Visual disturbances including double vision
• Shortness of breath, muscle cramps
Uncommon (may affect up to 1 in 100 people)

• Mood changes (including feeling anxious), feeling depressed, sleeplessness
• Trembling, taste abnormalities, fainting
• Numbness or tingling sensation in your limbs; decreased sensation
• Ringing in the ears
• Decreased heart rate
• 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, rash and
hives, purple patches on the skin
• 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, chest pain, feeling unwell
• Joint or muscle pain, back pain
• Weight increase or decrease
Rare (may affect up to 1in 1,000 people)

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

• An increase in infections or fever eg. sore throat, mouth ulcers that you get (due to decreased
number of white blood cells), or if you notice that you bruise or bleed more easily or without
explanation (due to decrease in the number of blood platelets)
• Excess sugar in blood (hyperglycaemia)
• A disorder of the nerves which can cause weakness, tingling or numbness
• Swelling of the gums
• Bleeding of the gums (gingival bleeding)
• Abdominal bloating (gastritis)
• Liver enzyme increase which may be due to liver problems such as blockage in the bile duct
• ‘Measles’ like skin rash. This may be associated with a high fever and joint pains (erythema
multiforme)
• Peeling of the skin over large areas of the body
• Inflammation of blood vessels, often with skin rash
• Skin sensitivity to light
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• 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 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.
Do not use this medicine after the expiry date which is stated on the carton and the bottle or blister
after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not use this medicine if you notice any discolouration of the tablets.
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 tablets contain

• The active substance is amlodipine.
• Each tablet contains 5 mg or 10 mg of amlodipine (as besilate)
• The other ingredients are calcium hydrogen phosphate, cellulose microcrystalline, sodium
starch glycolate (type A), magnesium stearate.
What Amlodipine Tablets looks like and contents of the pack

Amlodipine 5 mg tablets are white coloured, round biconvex tablets debossed with “5” on one side
and scored on the other side. The tablet can be divided into equal doses.
Amlodipine 10 mg tablets are white coloured, round biconvex tablets debossed with “10” on one side
and scored on the other side. The tablet can be divided into equal doses.
Amlodipine tablets are packed in blisters containing 10, 14, 28, 30, 50, 56, 60, 90, 100, 180 tablets per
pack.
Amlodipine tablets are packed in bottles containing 28, 30, 56, 100, 180, 500 tablets per pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
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Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.
Mylan UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom
This leaflet was last revised in 07/2022
Page 6 of 6

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Package leaflet: Information for the patient

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

Do not take Amlodipine:

Warnings and precautions

Children and adolescents

Other medicines and Amlodipine

Amlodipine may affect or be affected by other medicines, such as:

Amlodipine with food and drink

Pregnancy and breast-feeding

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

Driving and using machines

3. How to take Amlodipine

Patients with liver problems

Use in children and adolescents

The tablet can be divided into equal doses.

If you take more Amlodipine than you should

If you forget to take Amlodipine

If you stop taking Amlodipine

4. Possible side effects

Other possible side effects:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

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

Reporting of side effects

5. How to store Amlodipine

Keep this medicine out of the sight and reach of children.

Store in the original package in order to protect from light.

6. Contents of the pack and other information

What Amlodipine tablets contain

What Amlodipine Tablets looks like and contents of the pack

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

This leaflet was last revised in 07/2022

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