Active ingredient
- amlodipine maleate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 08553/0234, PL 08553/0235.
Amlodipine 5 mg and 10 mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Amlodipine 5 mg and 10 mg Tablets
Amlodipine maleate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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
Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine.
You should inform your doctor if you have or have had any of the following conditions:
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, 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:
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.
3. How to take Amlodipine
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.
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 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 side effects after taking this medicine.
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
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
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
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
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 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 pack after ‘Expiry:’ The expiry date refers to the last day of that month.
Do not store above 25° C. Store in the original package.
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 to protect the environment.
6. Content of the pack and other information
What Amlodipine contains
The active substance is amlodipine. Each tablet contains 5 mg amlodipine or 10 mg amlodipine (as maleate).
The other ingredients are microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, Magnesium stearate.
What Amlodipine looks like and contents of the pack
Amlodipine 5 mg are white, round, smooth surfaced tablets with bevelled edges, embossed R on one side and 177 on the other side.
Amlodipine 10 mg are white, oval biconvex, smooth surface tablets embossed R on one side and 178 on the other side.
Both 5mg and 10mg strengths are available in pack sizes of 28 tablets.
Marketing Authorisation Holder and Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Amlodipine 5mg Tablets (PL 08553/0234)
Amlodipine 10mg Tablets (PL 08553/0235)
This leaflet was last revised in 08/2018
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