Plendil

Package Leaflet: Information for the Patient

Plendil, 5 mg, prolonged-release tablets

Plendil, 10 mg, prolonged-release tablets

Felodipine

Read the package leaflet carefully before taking the medicine, as 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Plendil and what is it used for
• 2. Important information before taking Plendil
• 3. How to take Plendil
• 4. Possible side effects
• 5. How to store Plendil
• 6. Contents of the pack and other information

1. What is Plendil and what is it used for

Felodipine, the active substance of Plendil, belongs to a group of medicines called calcium antagonists. This medicine lowers blood pressure by widening small blood vessels. It does not affect the heart negatively. Plendil is used to treat high blood pressure and chest pain or angina pectoris caused by exertion or stress.

2. Important information before taking Plendil

When not to take Plendil:

• If you are pregnant. If you become pregnant while taking this medicine, inform your doctor as soon as possible.
• If you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
• If you have untreated heart failure.
• In the acute phase of a heart attack (myocardial infarction)
• If you have chest pain or angina pectoris lasting for 15 minutes or longer or if you have more severe angina than usual.
• If you have heart muscle disease or heart valve disease - until you have discussed it with your doctor.

Warnings and precautions

Felodipine, like other blood pressure-lowering medicines, can in rare cases lead to a significant decrease in blood pressure, which may cause inadequate blood flow to the heart in some patients. Symptoms of excessive blood pressure reduction and inadequate heart blood flow are often: dizziness and chest pain. If such symptoms occur, you should immediately consult a doctor. Before taking Plendil, you should discuss with your doctor, especially if you have liver function disorders. Taking Plendil can cause gum swelling. You should maintain good oral hygiene to reduce the risk of gum swelling (see section 4).

Children

Plendil is not recommended for children.

Plendil and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Some medicines, herbal preparations may affect the treatment with Plendil. These include:

• Cimetidine (used to treat stomach ulcers)
• Erythromycin (used to treat infections)
• Itaconazole (used to treat fungal infections)
• Ketoconazole (used to treat fungal infections)
• Medicines used to treat HIV infection, protease inhibitors (such as ritonavir)
• Medicines used to treat HIV infection (such as efavirenz, nevirapine)
• Phenytoin (used to treat epilepsy)
• Carbamazepine (used to treat epilepsy)
• Rifampicin (used to treat infections)
• Barbiturates (used to treat anxiety disorders, sleep disorders, and epilepsy)
• Tacrolimus (used in patients after organ transplantation)

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

Plendil with food and drink

You should not drink grapefruit juice while taking Plendil, as it may increase the effect of Plendil and increase the risk of side effects.

Pregnancy and breastfeeding

Pregnancy

Plendil should not be taken during pregnancy.

Breastfeeding

If you are breastfeeding or plan to breastfeed, inform your doctor. Plendil is not recommended for breastfeeding mothers. If you want to breastfeed, your doctor may choose a different treatment.

Driving and using machines

Plendil has a minor or moderate effect on the ability to drive and use machines. If you experience headaches, nausea, dizziness, or fatigue, your reaction may be impaired. Be cautious, especially during the initial treatment phase.

Plendil contains lactose, castor oil, and sodium

Plendil contains lactose, a type of sugar. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine. Plendil contains castor oil, which may cause gastrointestinal upset and diarrhea. Plendil contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Plendil

Always take Plendil exactly as your doctor has told you. If you are not sure, ask your doctor. Plendil prolonged-release tablets should be taken in the morning, swallowed with water. The tablets should not be divided, crushed, or chewed. This medicine can be taken without food or after a light meal with low fat and carbohydrate content.

Hypertension

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

Stable angina pectoris

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

If you have liver function disorders

The level of felodipine in your blood may be increased. Your doctor may reduce the dose of Plendil.

Elderly patients

Your doctor may start treatment with the lowest available dose.

Overdose of Plendil

If you have taken more than the prescribed dose of Plendil, you may experience very low blood pressure, and sometimes palpitations, rapid or, rarely, slow heart rate. Therefore, it is very important to take the prescribed dose of Plendil. If you experience symptoms such as fainting, inability to maintain balance, or dizziness, you should immediately contact your doctor.

Missed dose of Plendil

If you forget to take a tablet at the right time, you should skip that dose. Take the next dose at the right time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Plendil

If you stop taking this medicine, your symptoms may return. Before stopping Plendil, you should consult your doctor for advice. Your doctor will tell you how long to take the medicine. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Plendil can cause side effects, although not everybody gets them. If you experience any of the following symptoms, stop taking Plendil and contact your doctor immediately:

• Hypersensitivity and allergic reactions. Symptoms may include hives or swelling of the face, lips, mouth, tongue, or throat.

The following side effects have been reported. Most of them occur at the beginning of treatment or after increasing the dose of Plendil. If you experience any of these side effects and they persist, inform your doctor. Mild gum swelling has been reported in patients with inflammation in the mouth (gingivitis, periodontitis). Gum swelling can be prevented or resolved by maintaining good 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
• tingling, numbness, or burning sensation
• 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

• gum swelling (gingival hyperplasia)
• increased liver enzyme activity
• skin reactions caused by increased sensitivity to light
• inflammation of small blood vessels in the skin
• need to urinate frequently
• allergic reactions, such as fever or swelling of the lips and tongue

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor. You can also report side effects directly to the national reporting system via the website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Plendil

There are no special precautions for storage. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton, blister, and bottle after "EXP". The expiry date refers to the last day of that month. Do not use this medicine if the carton is damaged or tampered with. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Plendil contains

• The active substance is felodipine. Each tablet contains 5 mg (or 10 mg) of felodipine.
• The other ingredients are: Tablet core: Hydroxypropylcellulose Hypromellose 50 mPa·s Hypromellose 10000 mPa·s Lactose anhydrous Macrogolglycerol hydroxystearate Microcrystalline cellulose Propyl gallate Sodium silicate

Coating: Carnauba wax Iron oxide red (E172) Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000 Titanium dioxide (E171)

What Plendil looks like and contents of the pack

Plendil 5 mg prolonged-release tablet: pink, round, biconvex tablet with a diameter of 9 mm, with the inscription A/Fm on one side and 5 on the other. Plendil 10 mg prolonged-release tablet: reddish-brown, round, biconvex tablet with a diameter of 9 mm, with the inscription A/FE on one side and 10 on the other. Pack sizes of prolonged-release tablets 5 mg 14 tablets (blister with marked days of the week) 20 tablets (blister) 28 tablets (blister) 30 tablets (blister and plastic bottle) 50 tablets (pack divided into single doses) 90 tablets (blister) 98 tablets (blister with printed markings of the days of the week) 100 tablets (blister and plastic bottle) 500 tablets (plastic bottle adapted for dosing) Pack sizes of prolonged-release tablets 10 mg 14 tablets (blister with printed markings of the days of the week) 20 tablets (blister) 28 tablets (blister) 30 tablets (blister and plastic bottle) 50 tablets (pack divided into single doses) 90 tablets (blister) 98 tablets (blister with printed markings of the days of the week) 100 tablets (blister, plastic bottle, and plastic bottle adapted for dosing) 500 tablets (plastic bottle adapted for dosing) Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenwood GmbH Pharmazeutische Erzeugnisse Arabellastr. 17 81925 Munich Germany

Manufacturer

AstraZeneca AB Gärtunavägen 152 57 Södertälje Sweden Saneca Pharmaceuticals a.s. Nitrianska 100 920 27 Hlohovec Slovakia AstraZeneca Reims Production Parc industriel de la Pompelle Chemin de Vrilly 51100 Reims France

This medicinal product 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 the package leaflet: February 2024

Detailed information on this medicinal product is available on the website: www.urpl.gov.pl