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This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

To get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Information line on 0800 198 5000.

The product codes for this leaflet are: PL 17901/0156, PL 17901/0155, PL 17901/0157

 

Plendil 2.5mg, 5mg & 10 mg

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AstraZeneca UK Limited


Horizon Place600 Capability GreenLutonBedfordshireLU1 3LU
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Plendil®

2.5 mg, 5 mg and 10 mg tablets

felodipine

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
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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).

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2. Before you take Plendil

Do not take Plendil if:

  • You are allergic (hypersensitive) to felodipine or any of the other ingredients in Plendil tablets (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 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.

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).
  • Phenytoin, carbamazepine or phenobarbital (for epilepsy).
  • Tacrolimus (used after kidney or liver transplant).

Taking Plendil with food and drink

Do not drink grapefruit juice while you are taking Plendil tablets. 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.

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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 crush or chew the tablets.
  • 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 5 mg tablet in the morning.
  • However, your doctor may start you on one 2.5 mg tablet.
  • Your doctor may increase the dose to 10 mg.

Adults with angina

  • The usual dose is one 5 mg tablet in the morning.
  • Your doctor may increase the dose up to 10 mg.

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.

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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 include:

  • Heart and circulation: faster heartbeat, swollen ankles, fainting.
  • Nervous system: pins and needles feeling in your toes or fingers.
  • Liver: liver problems shown on a blood test.
  • Digestive system: stomach pain, feeling sick or being sick, swollen gums. (If you already have swollen gums they may get worse. You can prevent this by careful dental hygiene.)
  • Urinary: passing water (urine) more often.
  • Joints and muscles: pain in joints and muscles.
  • Skin: skin inflammation, rash, itching, being sensitive to sunlight.
  • Sexual: being unable to get an erection (impotence).
  • Other: high temperature (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.

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5. How to store Plendil

  • Keep out of the reach and sight of children.
  • Do not use this medicine after the expiry date shown on the label. The expiry date refers to the last day of that month.
  • Do not store this medicine above 25°C.

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.

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6. Further Information

What Plendil contains

  • The active ingredient is felodipine. Plendil tablets contain 2.5 milligrams (mg), 5 mg or 10 mg of felodipine.
  • The other ingredients are polyoxyl 40 hydrogenated castor oil, hydroxypropyl cellulose, propyl gallate, hydroxypropyl methylcellulose, sodium aluminium silicate, microcrystalline cellulose, lactose anhydrous, sodium stearyl fumarate, macrogol, colours E171 and E172 and carnauba wax.

What Plendil looks like and contents of the pack

Plendil 2.5 mg tablets are yellow marked with A/FL on one side and 2.5 on the other side.

Plendil 5 mg tablets are pink marked with A/FM on one side and 5 on the other side.

Plendil 10 mg tablets are red-brown marked with A/FE on one side and 10 on the other side.

Plendil tablets come in blister strips containing 7 tablets which have the days of the week shown. A single pack contains 28 tablets as multiples of the 7 tablet blister strip.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Plendil is held by

AstraZeneca UK Limited
600 Capability Green
Luton
LU1 3LU
UK

Plendil is manufactured by

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
UK

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Reference number

Plendil 2.5 mg tablets: 17901/0155

Plendil 5 mg tablets: 17901/0156

Plendil 10 mg tablets: 17901/0157

This is a service provided by the Royal National Institute of the Blind.

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Leaflet prepared: November 2007.

© AstraZeneca 2007

Plendil is a trade mark of the AstraZeneca group of companies.

CV 07 0014a

P021902


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