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The product code(s) for this leaflet are: PL 08553/0234, PL 08553/0235.
Amlodipine 5 mg and 10 mg Tablets
Amlodipine 5 mg and 10 mg Tablets
Amlodipine maleate
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
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.
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:
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, 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.
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
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.
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.
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.
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.
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. 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.
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.
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.
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
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.
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.
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
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.
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 07/2022