Patient Information Leaflet

Plendil 5 mg prolonged-release tablets

Felodipine

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor.
• This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section4.

1. What Plendil is and what it is used for

2. What you need to know before you start taking Plendil

3. How to take Plendil

4. Possible side effects

5. Storage of Plendil

6. Contents of the pack and additional information

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

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

Do not take Plendil

• if you are pregnant. Inform your doctor as soon as possible if you become pregnant while taking this medication.
• if you are allergic to felodipine or any of the other components of this medication (listed in section 6).
• if you have uncompensated heart failure.
• if you have had an acute myocardial infarction (heart attack).
• if you have recent chest pain or angina that lasts more than 15 minutes or is more intense than usual.
• if you have heart valve disease or heart muscle disease, until you have consulted your doctor.

Warnings and precautions

Plendil, like other medications that lower blood pressure, may cause, in rare cases, a marked decrease in blood pressure that can lead to inadequate blood supply to the heart in some patients. Symptoms of excessively low blood pressure and inadequate blood supply to the heart itself, 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 may cause your gums to swell. Practice good oral hygiene to prevent gum swelling (see section 4).

Children

Plendil is not recommended for use in children.

Plendil with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.Some medications/herbal supplements may affect treatment with Plendil.

Some examples are:

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

Medications containing St. John's Wort (Hypericum perforatum) (herbal supplement used for treating depression) may reduce the effects of Plendil and should be avoided.

Plendil with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

Do not use Plendil if you are pregnant.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Plendil is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and operating machinery

Plendil may have a slight or moderate effect on your ability to drive or operate machinery. If you experience headaches, nausea, dizziness, or fatigue, your reaction time may be impaired. It is recommended to exercise caution, especially at the beginning of treatment.

Plendil contains lactose, ricin oil, and sodium

Plendil contains lactose, a type of sugar. If your doctor has told you that you have a certain sugar intolerance, consult your doctor before taking this medication.

Plendil contains ricin oil, which may cause stomach discomfort and diarrhea.

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication should be taken as directed by your doctor.In case of doubt, 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 medication can be taken on an empty stomach or with a light, low-fat, or low-carbohydrate meal.

Hypertension

The treatment should be initiated with 5 mg once a day. If necessary, your doctor may increase the dose or add another medication to lower blood pressure. The usual dose for the treatment of this disease over long periods is 5-10 mg once a day. In elderly patients, a starting daily dose of 2.5 mg may be considered.

Stable angina

The treatment should be initiated with 5 mg once a day, and if necessary, your doctor may increase the dose to 10 mg once a day.

Liver problems

The concentrations of the medication in the blood may increase. Your doctor may reduce your dose.

Elderly patients

Your doctor may initiate treatment with the lowest available dose.

Overdose of Plendil

If you take more Plendil than you should, you may experience very low blood pressure and sometimes palpitations, rapid or slow heart rate, or rarely, a slow heart rate. Therefore, it is very important to take the number of doses prescribed by your doctor. If you experience symptoms such as weakness, slight 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 medication and the amount ingested.

Missed dose of Plendil

If you forget to take a tablet, omit the dose completely. Take the next dose at the correct time. Do not take a double dose to compensate for the missed doses.

Discontinuation of Plendil treatment

If you stop taking this medication, your disease may recur. Consult your doctor and ask for advice before stopping Plendil. Your doctor will inform you about how long you should take the medication.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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

A mild swelling of the gums has been reported in patients with mouth inflammation (gingivitis/periodontitis). Swelling can be prevented or reversed with 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
• Redness

Uncommon: may affect up to 1 in 100 people

• Abnormally fast heart rate
• Palpitations
• Low blood pressure (hypotension)
• Nausea
• Abdominal pain
• Burning/tingling/numbness
• Rash or itching
• Fatigue
• Dizziness

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

• Fainting
• Vomiting
• Urticaria
• 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 sun hypersensitivity
• Inflammation of the skin capillaries
• Frequent urination
• Hypersensitivity reactions such as fever or inflammation of the lips or tongue

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

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

Keepthis medicationout of the reach and sight of children.

Do not usethis medicationafter the expiration date that appears onthe box, blister pack, andthebottleafter “EXP”. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe that the packaging is torn or damaged.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Plendil

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

• The other componentsare:

Tablet core:

Hydroxypropyl cellulose

50 mPa·s hypromellose

10,000 mPa·s hypromellose

Anhydrous lactose (lactose)

Macrogolglycerol hydroxystearate (ricin oil)

Microcrystalline cellulose

Propylene glycol alginate

Aluminum sodium silicate

Sodium stearate fumarate

Coating:

Carnauba wax

Brown-red iron oxide (E172)

Yellow iron oxide (E172)

6 mPa·s hypromellose

Polyethylene glycol 6000

Titanium dioxide (E171)

Appearance of the product and contents of the package

Plendil 5mg 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 9mm.

Prolonged-release tablets of 5 mg

14tablets (blisters with the days of the week printed)

20tablets (blisters)

28tablets (blisters with the days of the week printed)

30tablets (blisters and plastic bottle)

50tablets (unit dose)

90tablets (blisters)

98tablets (blisters with the days of the week printed)

100tablets (blisters and plastic bottle)

500tablets (plastic bottle for dispensing the dose)

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Glenwood GmbH

Pharmazeutische Erzeugnisse

Arabellastr.17

81925 Munich

Germany

Manufacturer responsible:

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 medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with 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

Last review date of this leaflet:May 2024

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/