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 is: PL17780/0966.
Amlodipine Zentiva tablets
Amlodipine Zentiva 2.5 mg Tablets
Amlodipine Zentiva 5 mg Tablets
Amlodipine Zentiva 10 mg Tablets
1. What Amlodipine Zentiva is and what it is used for
2. What you need to know before you take Amlodipine Zentiva
3. How to take Amlodipine Zentiva
4. Possible side effects
5. How to store Amlodipine Zentiva
6. Contents of the pack and other information
Amlodipine Zentiva contains the active substance Amlodipine Besilate which belongs to a group of medicines called calcium antagonists.
Amlodipine Zentiva 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 Zentiva 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 Zentiva if you have or have had any of the following conditions:
Amlodipine Zentiva has not been studied in children under the age of 6 years. Amlodipine Zentiva should only be used for hypertension in children and adolescents from 6 to 17 years of age (see section 3). For more information, talk to your doctor.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.. Amlodipine Zentiva may affect or be affected by other medicines, such as:
Amlodipine Zentiva 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 Zentiva. 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 Zentiva.
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 breastfeeding or about to start breast-feeding you must tell your doctor before taking Amlodipine Zentiva.
Amlodipine Zentiva 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.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
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 5 mg once daily. The dose can be increased to 10 mg once daily.
This medicine can be used before or after food and drinks. You should take this medicine at the same time each day with a drink of water. Do not take Amlodipine Zentiva 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.
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 Zentiva 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 to.
It is important to keep taking the tablets.
Do not wait until your tablets are finished before seeing your doctor.
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):
Not known (frequency cannot be estimated from the available data):
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.
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/blister after EXP. The expiry date refers to the last day of that month.
Store below 25°C, in the original package in order to protect from light.
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.
Each 2.5 mg tablet contains Amlodipine Besilate equivalent to 2.5 mg amlodipine.
Each 5 mg tablet contains Amlodipine Besilate equivalent to 5 mg amlodipine.
Each 10 mg tablet contains Amlodipine Besilate equivalent to 10 mg amlodipine.
The other ingredients are microcrystalline cellulose, sodium starch glycolate A, calcium hydrogen phosphate, magnesium stearate.
Amlodipine Zentiva 2.5 mg tablets: white to off-white uncoated round biconvex tablets with diameter 5 mm.
Amlodipine Zentiva 5 mg tablets: white to almost white oblong tablets, size 9x4.5 mm, with a scoreline on one side, debossed with “A” and “5” marks left and right of the scoreline. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Amlodipine Zentiva 10 mg tablets: white to almost white oblong tablets, size 12x6 mm, with a scoreline on one side, debossed with “A” and “10” marks left and right of the scoreline. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Amlodipine Zentiva 2.5mg, 5mg and 10mg Tablets are available either in transparent PVC/PVDC/Aluminium blisters, transparent PVC/Aluminium blisters or white PVC/PVDC/ Aluminium blisters.
The pack contains 28 tablets.
This leaflet was last revised in August 2022