Plendil 2.5mg Tablets
Plendil® 2.5mg Tablets
(felodipine)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Plendil Tablets are available in the following strengths: 2.5mg, 5mg and 10mg. Plendil 2.5mg Tablets will be referred to as Plendil throughout the leaflet.
Read all of this leaflet carefully before you start taking this medicine.
■ 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. Do not pass it on to others. 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 not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Plendil is and what it is used for
2. Before you take Plendil
3. How to take Plendil
4. Possible side effects
5. How to store Plendil
6. Further information
1. What Plendil is and what it is used for
Plendil contains a medicine called felodipine. This belongs to a group of medicines called "calcium channel blockers". Plendil is used to treat high blood pressure (hypertension) or to prevent a painful heart condition called angina.
It works by making your blood vessels relax and widen. This helps to lower your blood pressure and to prevent chest pain (angina).
2. Before you take Plendil
Do not take Plendil if:
■ You are allergic (hypersensitive) to felodipine or any of the other ingredients in Plendil (see section 6 "Further information").
■ You are allergic to dihydropyridine medicines (such as nifedipine or amlodipine).
■ You have something called unstable angina (angina that is not well controlled by medical treatment).
■ You have severe heart problems.
■ You have had a heart attack in the last month.
■ You have something called cardiogenic shock (a serious condition where the heart is unable to supply enough blood to the body).
■ You have a disease of the cardiac valves or cardiac muscle (hypertrophic cardiomyopathy).
■ You are pregnant or trying to get pregnant (see "Pregnancy and breast-feeding" below).
Do not take Plendil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Plendil.
Take special care with Plendil
Before you take Plendil, tell your doctor if:
■ You have liver problems.
■ You have heart problems (i.e. faster heart beats, high and/or low blood pressure).
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes herbal medicines and medicines that you buy without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
■ Cimetidine (for ulcers)
■ Erythromycin (for bacterial infections)
■ Itraconazole or ketoconazole (for fungal infections)
■ HIV protease inhibitors (such as ritonavir)
■ Phenytoin, carbamazepine or phenobarbital (for epilepsy)
■ Tacrolimus (used after kidney or liver transplant)
■ Rifampicin (used for treatment of tuberculosis)
■ St John's Wort (Hypericum perforatum) (used to treat depression and anxiety)
■ Barbiturates (a sedative)
■ Efavirenz or Nevirapine (used to treat HIV)
■ Warfarin (used to thin the blood)
■ Ciclosporin (mainly used by transplant patients but also used to treat rheumatoid arthritis and psoriasis)
Taking Plendil with food and drink
Do not drink grapefruit juice while you are taking Plendil. It
can affect the way the medicine works.
Pregnancy and breast-feeding
■ Do not take Plendil if you are pregnant or trying to get pregnant. This is because Plendil can harm your unborn baby.
■ If you are breast-feeding, talk to your doctor before taking Plendil.
Driving and using machines
If you feel dizzy after taking this medicine, do not drive or use any tools or machines.
Important information about some of the ingredients of Plendil
Plendil contain lactose anhydrous, which is a type of sugar.
If you have been told by your doctor that you are intolerant to some sugars, talk to your doctor before taking this medicine.
3. How to take Plendil
Always take Plendil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
■ Swallow your tablet(s) whole with a drink of water. Do not divide, crush or chew the tablets.
■ Tablet(s) can be taken without food or following a light meal not high in fat or carbohydrates (sugar).
■ Your tablets are in a pack with the days of the week shown. This will help you to remember when to take them.
Adults with high blood pressure (hypertension)
■ The usual dose is one 5mg tablet in the morning.
■ However, your doctor may start you on one 2.5mg tablet.
■ Your doctor may increase the dose to 10mg.
Adults with stable angina
■ The usual dose is one 5mg tablet in the morning.
■ Your doctor may increase the dose up to 10mg.
The Elderly (over 65 years)
■ For high blood pressure (hypertension) - the usual dose is one 2.5mg tablet in the morning.
■ In the elderly, the lowest available dose should be used for initial treatment.
Children (under 18 years)
■ There is limited experience with the use of Plendil in children (below the age of 18 years). Therefore Plendil should not be given to children.
People with liver problems
■ If you suffer from liver problems your doctor may give you a lower dose of Plendil.
If you take more Plendil than you should
If you have taken more Plendil than prescribed by your doctor, tell your doctor or go to the nearest hospital straight away. Take the Plendil medicine with you.
If you forget to take Plendil
■ If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
■ Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Plendil can cause side effects, although not everybody gets them.
If any of the following happen to you, stop taking Plendil and tell a doctor straight away:
■ Chest pain and dizziness at the same time.
■ An allergic reaction. The signs may include raised lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat.
Other possible side effects:
Very common (affects more than 1 in 10 people)
■ Swelling of the feet and ankles
Common (affects less than 1 in 10 people)
■ Headaches
■ Flushing of your skin
Uncommon (affects less than 1 in 100 people)
■ Faster heartbeat
■ Pounding heartbeat (palpitations)
■ Pins and needles feeling in your toes or fingers
■ Stomach pain
■ Feeling sick (nausea)
■ Rash
■ Itching
■ Dizziness
■ Feeling tired
■ Low blood pressure. This may make you feel faint or dizzy
Rare (affects less than 1 in 1,000 people)
■ Fainting
■ Being sick
■ Pain in joints
■ Pain in muscles
■ Being unable to get an erection (impotence)
■ Lumpy rash (hives)
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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Plendil
■ Keep out of the sight and reach of children.
■ Do not use Plendil after the expiry date shown on the label. The expiry date refers to the last day of that month.
■ Do not store above 25°C.
■ Store in the original package.
■ If your doctor decides to stop the treatment, return any leftover tablets to the pharmacist. Only keep them if your doctor tells you to.
■ If the tablets appear discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.
■ 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. Further information
What Plendil contains
■ The active ingredient is felodipine. Each modified-release tablet contains felodipine 2.5mg in an extended release formulation.
■ The other ingredients are: carnauba wax, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide (E172), lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, polyoxy 40 hydrogenated castor oil, propyl galate, aluminium sodium silicate, sodium stearyl fumarate, titanium dioxide (E171) and water purified.
Plendil® is a registered trademark of AstraZeneca group of companies.
If you wish to receive this leaflet in Braille, large font or audio format please contact 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name: Plendil 2.5mg Tablets Reference number: 08929/0553
POM
Very rare (affects less than 1 in 10,000 people)
■ Enlarged gums (if you already have enlarged gums they may get worse. You can prevent this by careful dental hygiene)
■ Increased levels of liver enzymes
■ Skin inflammation
■ Sensitivity to sunlight
■ Passing water (urine) more often, normally during the
daytime
■ Allergic reaction (anaphylaxis i.e. swelling of your face, lips, mouth, tongue or throat, fever)
You may get any of the following side effects at the beginning of treatment or if your dose has been increased:
■ Flushing, headaches, faster or pounding heartbeat, feeling dizzy or tired.
Do not be alarmed by this list of possible side effects. You may not get any of them. 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.
What Plendil looks like and contents of the pack
Plendil are yellow, circular, biconvex, film coated tablets coded A/FL on one side and 2.5 on the reverse.
Plendil comes in a bottle containing 30 tablets.
Manufacturer
Plendil is manufactured by: AstraZeneca AB, S-151 85 Sodertalje, Sweden.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0553
Leaflet revision and issue date (Ref): 17.10.14
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