Cardioplen Xl 5mg Prolonged Release Tablets
567 FR00271 V5 CARDIOPLEN 567 FR00271 V5 23/06/15 15:19 Pagel
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 leafet. See section 4.
1. What Cardioplen is and what it is used for
Cardioplen XL Prolonged Release Tablets contain felodipine which belongs to a group of medicines called calcium-channel blockers that act on the cardiovascular system (the heart and blood vessels). Cardioplen has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your anginal attacks. They are called prolonged release tablets because they are manufactured in a way that allows the felodipine to be released and slowly absorbed by your body over a period of several hours.
In high blood pressure, felodipine works by widening the blood vessels. This creates less resistance to the blood flow, and results in lower blood pressure, which in turn reduces the strain on your heart.
In angina, felodipine works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occurring when extra strain is placed upon the heart.
2. What you need to know before you take Cardioplen
Do not take Cardioplen:
• if you are allergic to felodipine, other calcium-channel blockers (e.g. amlodipine, nisoldipine or nifedipine) or any of the other ingredients in Cardioplen
• if you are pregnant, likely to become pregnant or are breast-feeding
• if you have been told that you have a narrowing of the aortic valve in your heart
• if you have experienced a collapse which was caused by a heart problem
• if the severity or frequency of your angina has rapidly worsened over a matter of hours or days
• if you have had a heart attack during the last month or have other severe heart problems.
Take special care with Cardioplen and always tell your doctor if:
• you suffer from low blood pressure with abnormal rapid heartbeats
• you have a poorly functioning left ventricle of your heart
• you suffer from liver problems.
Taking other medicines
Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Cardioplen. This is especially important if you are likely to have an anaesthetic or an operation.
In particular, tell your doctor if you are taking:
• cimetidine, to treat stomach ulcers
• the antibiotic erythromycin, to treat bacterial infections
• Medicines to treat fungal infections, including itraconazole and Ketoconazole
• ritonavir, to treat HIV infection
• tacrolimus, used after kidney or liver transplants
• Any other medicines to lower blood pressure
• phenytoin, carbamazepine or phenobarbital, to treat seizures or epilepsy. If you are already taking any of these medicines, your doctor may prescribe higher than normal doses of Cardioplen for you to take.
Taking Cardioplen with food and drink
Do not drink grapefruit juice at the same time or soon after taking Cardioplen because grapefruit juice can increase the blood levels of felodipine and affect the way it works. It is best to take your tablets on an empty stomach or after a light meal.
Pregnancy, breast-feeding and fertility
Do not take Cardioplen if you are pregnant, trying to become pregnant or are breastfeeding.
Driving and using machines:
If you feel dizzy or extremely tired after taking Cardioplen, then do not drive or operate machinery.
Important information about some of the ingredients of Cardioplen
Cardioplen contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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Always take Cardioplen exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.
The label on the carton will tell you how many tablets you should take and when. It is very important that you take your tablets regularly. Do not stop treatment even if you feel better unless told to do so by your doctor.
Cardioplen is formulated so that you only have to take your tablets once a day. It is important that you take your tablets at the same time each day, preferably in the morning on an empty stomach or after a light meal. Your tablets must be swallowed whole with a glass of water and not with grapefruit juice. Do not break or chew your tablets.
High blood pressure
Adults and the elderly: the usual dose is 5 mg once a day. Your doctor may decide to increase your dose to a maximum of 20 mg of Cardioplen once a day or prescribe another medicine to treat your high blood pressure for you to also take whilst you are taking Cardioplen.
If you are elderly, your doctor may prescribe a lower starting dose of 2.5 mg for you to take once a day.
Adults: the usual dose is 5 mg once a day. Your doctor may decide to increase your dose to a maximum of 10 mg of Cardioplen once a day.
Do not stop taking your medicine until your doctor tells you.
Children must not take this medicine.
If you take more Cardioplen than you should
If you accidentally take more Cardioplen than you should, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.
If you forget to take Cardioplen
Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Cardioplen can cause side effects, although not everyone gets them. Allergic reactions, although serious, have been reported in isolated cases. If you experience any of the following, contact your doctor or casualty department immediately:
• swelling of the face and throat
• itchy red rash
If you experience chest pains when you first start taking Cardioplen, contact your doctor immediately.
The following side effects do not usually last long and are most likely to occur when you first start to take your medicine or if your dose has been increased. If they continue or if you are worried, contact your doctor or pharmacist immediately:
dizziness and tiredness reddening of the skin
Also, some people experience:
• swelling of the ankles
• swollen gums
• skin inflammation, rash or itching
• skin sensitive to light
• pain in joints and muscle aches
• pins and needles in your toes and fingers
• feeling sick
• abnormal liver blood test
• rapid heartbeat
• swelling of the hands or feet caused by fluid build up under the skin
• worsening of swollen gums. This can be prevented by careful dental hygiene.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the YellowCard Scheme at www.mhra.gov.uk/yellowcard. 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 store above 25°C. Store in the original packaging.
• Do not use Cardioplen after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
• 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 protect the environment.
What Cardioplen contains:
• The active substance in your tablets is felodipine. Each tablet contains 2.5 mg, 5 mg or 10 mg of felodipine.
• The other ingredients are lactose monohydrate, cellulose microcrystalline, talc, hypromellose, povidone, propyl gallate, silica colloidal anhydrous, magnesium stearate, ferric oxide yellow (E172), ferric oxide red (E172), titanium dioxide (E171) and propylene glycol.
What Cardioplen looks like and the contents of the pack:
Cardioplen XL Tablets are round and biconvex in shape and are available in blister packs of 28
tablets. Each strength can be identified by its colour and marking.
2.5 mg tablets are yellow and marked with "2.5"
5 mg tablets are light pink and marked with "5"
10 mg tablets are reddish brown and marked with "10"
Marketing Authorisation Holder and Manufacturer:
The Marketing Authorisation holder and manufacturer is Chiesi Limited, 333 Styal Road, Manchester,
M22 5LG, UK.
This leaflet was last approved in 07/2015 FR00271.V5 / CP0025/5