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AMLODIPINE 5 MG TABLET

Active substance(s): AMLODIPINE MESILATE MONOHYDRATE

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CP.AML.JNT.T.SH.V1P1

PATIENT INFORMATION LEAFLET

taken an overdose, you may appear flushed (your skin will look red), or
you may feel dizzy or faint. If blood pressure drop is severe enough shock
can occur. Your skin could feel cool or clammy and you could lose
consciousness.

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 more questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to anyone else. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects that are not listed in the leaflet, please tell your doctor or pharmacist.

Pharmacode

Pharmacode

AMLODIPINE 5mg AND 10mg TABLETS

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

WHAT AMLODIPINE TABLETS ARE AND WHAT THEY ARE

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

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

If you see another doctor or go into hospital for any reason, tell them that
you are taking Amlodipine Tablets.

Amlodipine Tablets may be used to treat:
• high blood pressure (hypertension); and
• a certain type of chest pain called angina, a rare form of which is
Prinzmetal’s or variant angina.

Taking Amlodipine Tablets with food and drink
You should not drink grapefruit juice or eat grapefruit while taking this
medicine. Grapefruit and grapefruit juice can lead to an increase in the
blood levels of amlodipine, which can cause an unpredictable increase in
its blood pressure lowering effect.

In patients with high blood pressure, these medicines work 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. Amlodipine Tablets do not immediately relieve chest pain
caused by angina.

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMLODIPINE TABLETS

Do not take Amlodipine Tablets if you:
• have ever had an allergic reaction to amlodipine or any of the
ingredients in the tablet listed in section 6, or to any other calcium
antagonist. An allergic reaction may include a rash, itching, difficulty
breathing or swelling of the face, lips, throat or tongue;
• have very low blood pressure (hypotension) so that you feel faint or
dizzy;
• have cardiogenic shock (a condition where your heart cannot pump
enough blood for your body’s needs);
• have heart failure due to a heart attack;
• have narrowing of the heart valve of the aorta (aortic stenosis)
Take special care with Amlodipine Tablets
You should inform you doctor if you have or have had any of the following
conditions:
• Recent heart attack;
• Heart failure;
• Liver disease;
• You are elderly and your dose needs to be increased;
• Severe increase in blood pressure (Hypertensive crisis).
Use in 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.
Taking other medicines and Amlodipine
Please tell your doctor or pharmacist if you are taking or have recently
taken other medicines, including medicines obtained without a
prescription.
Amlodipine may affect or be affected by other medicines, such as:
• diltiazem, verapamil (heart medicines)
• ketoconazole, itraconazole (antifungal medicines used to treat thrush
and ringworm)
• ritonavir, indinavir, nelfinavir (antivirals used in treatment of HIV
infections)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St John’s wort (a herbal remedy for mild depression)
• dantrolene (infusion for severe body temperature abnormalities)
• simvastatin (a drug used to control elevated cholesterol)

If you stop taking Amlodipine Tablets
Take this medicine for as long as your doctor tells you to, as you may
become unwell if you stop.

4. POSSIBLE SIDE EFFECTS

The name of your medicine is Amlodipine 5mg Tablets or Amlodipine 10mg Tablets.
We refer to them as Amlodipine Tablets or amlodipine throughout this leaflet.

1. USED FOR

If you forget to take Amlodipine Tablets
If you forget to take a tablet, take one as soon as you remember, unless it
is nearly time to take the next one. Never take two doses together. Take
the remaining doses at the correct time.

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 Tablets.
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 Tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Taking Amlodipine Tablets may affect your ability to drive or use machinery
because amlodipine could cause side effects such as dizziness,
headaches, nausea or tiredness, all of which could affect your ability to
concentrate.

3. HOW TO TAKE AMLODIPINE TABLETS
Swallow these tablets with a glass of water at the same time each day. You
can take the tablets either before or after meals.
Follow your doctor’s instructions. Check the pharmacy label to see how
many tablets to take and how often to take them. If you are still not sure,
ask your pharmacist or doctor. The usual doses are described below.
Adults
One 5mg tablet once a day. Your doctor may increase the dose to one
10mg tablet once a day.
Children and adolescents
For children and adolescents, (6-17 years old), the recommended usual
starting dose is 2.5mg a day. The maximum recommended dose is 5mg a
day. Amlodipine 2.5mg is not currently available and the 2.5mg dose
cannot be obtained with Amlodipine 5mg or 10mg Tablets as these tablets
are not manufactured to break into two equal halves.
Elderly
As for adults (one 5mg tablet a day). Your doctor will closely monitor your
response to any increase in the dose.
Patients with liver disease
Your doctor may give you a different dose to normal.
If you take more Amlodipine Tablets than you should
If you (or someone else) swallow a lot of tablets all together, or if you think
a child has swallowed any of the tablets, contact your nearest hospital
casualty department or your doctor immediately. Take your medication and
the packaging with you to the doctor or casualty department. If you have

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Like all medicines, Amlodipine Tablets can cause side effects, although not
everybody gets them.
If any of the following reactions happen, stop taking Amlodipine
Tablets and tell your doctor immediately or contact the casualty
department at your nearest hospital:
• swelling of the eyelids, face, lips
• swelling of the tongue and throat which causes great difficulty breathing
• sudden wheeziness, chest pain, difficulty breathing or swallowing
• severe skin reactions including itching, rash, peeling of the skin and
extensive reddening, blistering or swelling of the skin, inflammation of
mucous membranes (Stevens-Johnson syndrome) or other allergic
reactions
• heart attack, abnormal heart beat,
• inflamed pancreas which can cause severe abdominal and back
pain accompanied with feeling very unwell.
Other known side effects are as follows. Tell your doctor if you notice or
are worried by any of the side effects listed.
Common (affects 1 to 10 users in 100)
• headache, drowsiness, dizziness (especially at the start of treatment)
• flushing of the face and feeling hot
• feeling sick, stomach ache
• tiredness
• palpitations (irregular or forceful heart beat)
• swollen ankles
Uncommon (affects 1 to 10 users in 1,000)
• enlargement or discomfort of the breasts in men
• a general feeling of being unwell, weakness
• change in taste, dry mouth
• involuntary shakiness, numbness, tingling or pins and needles
• loss of pain sensation
• increased sweating
• sight problems, double vision
• problems sleeping, irritability, depression, mood changes
• fainting
• low blood pressure
• sneezing/runny nose caused by inflammation of the lining of the nose
(rhinitis)
• being sick, diarrhoea, constipation, indigestion
• itchy skin, red patches on skin, skin discolouration
• hair loss
• muscle cramps, back, muscle or joint pain
• passing urine more often, night time urinating
• inability to obtain an erection
• weight loss or gain
• ringing in the ears

Dimensions: 210mm x 297mm
Proof No and Date: 3

01/10/2014

Revision: INITIATION
ARTWORK FOR SUBMISSION
Supersedes: n/a

5. HOW TO STORE AMLODIPINE TABLETS
Do not use the tablets after the end of the expiry month (use-by date)
shown on the product packaging.
Do not store the tablets above 30°C.
Store in the original package.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN
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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Amlodipine Tablets contain
• The active substance is amlodipine as amlodipine mesilate
monohydrate.
Each tablet contains 5mg or 10mg of amlodipine.
• The other ingredients are microcrystalline cellulose, anhydrous calcium
hydrogen phosphate, sodium starch glycolate type A and magnesium
stearate.
What Amlodipine Tablets look like and the contents of the pack
Amlodipine Tablets are white to off-white, round and biconvex and come in
two strengths – 5mg and 10mg.
The 5mg tablets have the number ‘5’ embossed on one side and the 10mg
tablets have the number ‘10’ embossed on one side, together with a
breakline.
Amlodipine Tablets are available in blister packs containing 10, 14, 20, 28,
30, 50, 98, 100 or 200 tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder:
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent,
TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This medicinal product is authorised in the member states of the EEA
under the following names.
United Kingdom:
Amlodipine 5mg Tablets
Amlodipine 10mg Tablets
Ireland:
Amlotan 5mg Tablets
Amlotan 10mg Tablets
This leaflet was last revised in July 2014.

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
• raised blood sugar levels (hyperglycaemia)
• problems feeling through fingers and toes due to nerve problems
(peripheral neuropathy)
• inflammation of the blood vessels, often with skin rash
• abdominal bloating (gastritis)
• cough
• swollen gums
• raised liver enzymes (detected in a blood test), yellowing of the skin or
whites of the eyes (jaundice, hepatitis)
• increased muscle tension
• sensitivity to light
• disorders combining rigidity, tremor and/or movement disorders
Tell your doctor or pharmacist if you notice any other effects not
listed.

Colours

Product: Amlodipine 5mg & 10mg Tablets JNT PIL
Item Code: CP.AML.JNT.T.SH.V1P1

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, Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

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CP.AML.JNT.T.SH.V1P1

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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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