PLENDIL 5 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Plendil 5 mg prolonged-release tablets

Felodipine

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 leaflet. See section 4.

Contents of the pack

1. What is Plendil and what is it used for
2. What you need to know before you take Plendil
3. How to take Plendil
4. Possible side effects
5. Storage of Plendil
6. Contents of the pack and other information

1. What is Plendil and what is it used for

Plendil contains the active substance felodipine. This belongs to a group of medicines called calcium antagonists. It lowers blood pressure by dilating the blood vessels. It does not negatively affect heart function.

Plendil is used to treat high blood pressure (hypertension) and chest pain caused by, for example, exercise or stress (angina pectoris).

2. What you need to know before you take Plendil

Do not take Plendil

• if you are pregnant. You should inform your doctor as soon as possible if you become pregnant while taking this medicine.
• if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
• if you have uncompensated heart failure.
• if you have had a heart attack (myocardial infarction).
• if you have recently developed chest pain or angina pectoris that lasts more than 15 minutes or is more severe than usual.
• if you have a heart valve disease or heart muscle disease, until you have consulted your doctor.

Warnings and precautions

Plendil, like other medicines that lower blood pressure, can occasionally cause a marked decrease in blood pressure, which in some patients may lead to inadequate blood supply to the heart. Symptoms of low blood pressure and inadequate blood supply to the heart often include dizziness and chest pain. If you experience these symptoms, contact emergency services immediately.

Consult your doctor before starting to take Plendil, especially if you have liver problems.

Taking Plendil can cause gum swelling. Practice good oral hygiene to prevent gum swelling (see section 4).

Children

Plendil is not recommended for use in children.

Taking Plendil with other medicines

Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines/plants may affect treatment with Plendil.

Some examples are:

• cimetidine (a medicine for stomach ulcers)
• erythromycin (a medicine for infections)
• itraconazole (a medicine for fungal infections)
• ketoconazole (a medicine for fungal infections)
• medicines for treating HIV - protease inhibitors (such as ritonavir)
• medicines for treating HIV infection (such as efavirenz, nevirapine)
• phenytoin (a medicine for epilepsy)
• carbamazepine (a medicine for epilepsy)
• rifampicin (a medicine for infections)
• barbiturates (medicines for anxiety, sleep disorders and epilepsy)
• tacrolimus (a medicine used in organ transplants)

Medicines containing St. John's Wort (Hypericum perforatum) (a herbal medicine used to treat depression) may reduce the effects of Plendil and should therefore be avoided.

Taking Plendil with food and drink

Do not drink grapefruit juice if you are being treated with Plendil, as this may increase the effect of Plendil and the risk of adverse reactions.

Pregnancy and breast-feeding

Pregnancy

Do not use Plendil if you are pregnant.

Breast-feeding

Tell your doctor if you are breast-feeding or plan to breast-feed. Plendil is not recommended for breast-feeding mothers and your doctor may choose another treatment for you if you wish to breast-feed.

Driving and using machines

Plendil may have a minor or moderate influence on the ability to drive and use machines. If you experience headache, nausea, dizziness or fatigue, your reaction time may be altered. It is recommended to be cautious, especially at the start of treatment.

Plendil contains lactose, castor oil and sodium

Plendil contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Plendil contains castor oil, which may cause stomach upset and diarrhea.

Plendil contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Plendil

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor again.

Plendil prolonged-release tablets should be taken in the morning and swallowed with water. The tablet should not be divided, crushed or chewed. This medicine can be taken on an empty stomach or with a light, low-fat or low-carbohydrate meal.

Hypertension

Treatment should be started with 5 mg once daily. If necessary, your doctor may increase the dose or add another medicine to lower blood pressure. The usual dose for long-term treatment of this condition is 5-10 mg once daily. In elderly patients, a starting dose of 2.5 mg daily may be considered.

Stable angina pectoris

Treatment should be started with 5 mg once daily and if necessary, your doctor may increase the dose to 10 mg once daily.

If you have liver problems

The levels of the medicine in the blood may increase. Your doctor may reduce the dose.

Elderly patients

Your doctor may start treatment with the lowest available dose.

If you take more Plendil than you should

If you take more than the recommended number of doses of Plendil, you may experience very low blood pressure and sometimes palpitations, rapid heart rate or, rarely, slow heart rate. Therefore, it is very important that you take the number of doses prescribed by your doctor. If you experience symptoms such as weakness, mild dizziness or vertigo, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Plendil

If you forget to take a tablet, skip the dose completely. Take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Plendil

If you stop taking this medicine, your condition may recur. Consult your doctor and ask for advice before stopping Plendil. Your doctor will tell you how long you should take the medicine.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking Plendil and contact your doctor immediately:

• Hypersensitivity and allergic reactions: signs may include skin rash (hives) or swelling of the face, lips, mouth, tongue or throat.

The following side effects have been identified. Most of these effects occur at the start of treatment or after a dose increase. If such reactions occur, they are usually transient and decrease in intensity over time. If you experience any of the following symptoms persistently, please inform your doctor.

A slight swelling of the gums has been reported in patients with inflammation of the mouth (gingivitis/periodontitis). The swelling can be avoided or reversed by careful oral hygiene.

Very common: may affect more than 1 in 10 people

• Swelling of the ankles

Common: may affect up to 1 in 10 people

• Headache
• Flushing

Uncommon: may affect up to 1 in 100 people

• Abnormal heart rhythm
• Palpitations
• Low blood pressure (hypotension)
• Nausea
• Abdominal pain
• Burning/stinging/tingling
• Rash or itching
• Fatigue
• Dizziness

Rare: may affect up to 1 in 1,000 people

• Fainting
• Vomiting
• Hives
• Joint pain
• Muscle pain
• Impotence/sexual dysfunction

Very rare: may affect up to 1 in 10,000 people

• Gingivitis (inflamed gums)
• Increased liver enzymes
• Skin reactions due to hypersensitivity to sunlight
• Inflammation of the blood vessels in the skin
• Frequent need to urinate
• Hypersensitivity reactions such as fever or inflammation of the lips or tongue

Other side effects may occur. If you experience any unpleasant or unusual effects while taking Plendil, contact your doctor immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Plendil

No special storage conditions are required.

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 and bottle after “EXP”. The expiry date is the last day of the month stated.

Do not use this medicine if the packaging is damaged or broken.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plendil

• The active substance is felodipine. Each tablet contains 5 mg of felodipine.

• The other ingredients are:

Core of the tablet:

Hydroxypropyl cellulose

Hypromellose 50 mPa·s

Hypromellose 10000 mPa·s

Anhydrous lactose (lactose)

Macrogolglycerol hydroxystearate (castor oil)

Microcrystalline cellulose

Propyl gallate

Sodium aluminosilicate

Sodium stearyl fumarate

Coating:

Carnauba wax

Brown-red iron oxide (E172)

Yellow iron oxide (E172)

Hypromellose 6 mPa·s

Polyethylene glycol 6000

Titanium dioxide (E171)

Appearance of the product and pack contents

Plendil 5 mg prolonged-release tablet, the tablet is pink, round, biconvex, engraved with A/Fm on one side and 5 on the other, with a diameter of 9 mm.

Prolonged-release tablets of 5 mg

14 tablets (blister with days of the week printed)

20 tablets (blister)

28 tablets (blister with days of the week printed)

30 tablets (blister and plastic bottle)

50 tablets (unit dose)

90 tablets (blister)

98 tablets (blister with days of the week printed)

100 tablets (blister and plastic bottle)

500 tablets (plastic bottle for dispensing)

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Glenwood GmbH

Pharmazeutische Erzeugnisse

Arabellastr.17

81925 Munich

Germany

Manufacturer:

AstraZeneca AB

Gärtunavägen

152 57 Södertalje

Sweden

AstraZeneca Reims Production

Parc industriel de la Pompelle

Chemin de Vrilly

51100 Reims

France

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovakia

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Cyprus, Czech Republic, Estonia, Finland, Greece, Ireland, Italy, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland): Plendil

France: Flodil

Germany: Modip

Date of last revision of this leaflet:May 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/