Plendil

Package leaflet: Information for the patient

Plendil, 5 mg, prolonged-release tablets
Plendil, 10 mg, prolonged-release tablets
felodipine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor. See section 4.

Leaflet contents

1. What Plendil is and what it is 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 Plendil is and what it is used for

Felodipine, the active substance in Plendil, belongs to a group of medicines called calcium antagonists. This medicine lowers blood pressure by dilating small blood vessels. It does not adversely affect heart function.
Plendil is used in the treatment of high blood pressure (hypertension) and chest pain, including angina pectoris, which may be triggered by exertion or stress.

2. Important information before using Plendil

When not to use Plendil:

• If the patient is pregnant. If pregnancy occurs while taking this medicine, the patient should inform the doctor as soon as possible.
• If the patient is allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
• If the patient has uncontrolled heart failure.
• During the acute phase of myocardial infarction (heart attack).
• If the patient experiences chest pain or angina lasting for 15 minutes or longer, or if angina is more severe than usual.
• If the patient has heart muscle or heart valve disease – until a discussion with the doctor has taken place.

Warnings and precautions
Felodipine, like other medicines that lower blood pressure, may in rare cases lead to a significant drop in blood pressure, which in some patients may cause inadequate blood supply to the heart. Symptoms of excessive reduction in blood pressure and insufficient blood supply to the heart muscle often include: dizziness and chest pain.
If such symptoms occur, the patient should contact a doctor immediately.
Before taking Plendil, consult a doctor, especially if the patient has impaired liver function.
Taking Plendil may cause swelling of the gums. Good oral hygiene should be maintained to reduce the likelihood of gum swelling (see section 4).

Children
Plendil is not recommended for use in children.

Plendil with other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some medicines and herbal preparations may affect treatment with Plendil.
Such medicines include:

• cimetidine (a medicine used to treat stomach ulcers)
• erythromycin (a medicine used to treat infections)
• itraconazole (a medicine used to treat fungal infections)
• ketoconazole (a medicine 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 (a medicine used to treat epilepsy)
• carbamazepine (a medicine used to treat epilepsy)
• rifampicin (a medicine used to treat infections)
• barbiturates (medicines used to treat anxiety disorders, sleep disorders, and epilepsy)
• tacrolimus (a medicine used in organ transplant patients)

Herbal preparations containing St. John's wort (Hypericum perforatum) (a herbal product used to treat depression) may reduce the effectiveness of Plendil and should therefore be avoided.

Plendil with food and drink
Do not drink grapefruit juice while taking Plendil, as it may enhance the effect of Plendil and increase the risk of adverse effects.

Pregnancy and breastfeeding
Pregnancy
Plendil must not be used during pregnancy.

Breastfeeding
If the patient is breastfeeding or planning to breastfeed, she should inform her doctor. Plendil is not recommended for breastfeeding mothers. If the patient wishes to breastfeed, the doctor may choose an alternative treatment.

Driving and using machines
Plendil has a minor or moderate effect on the ability to drive and operate machinery. If the patient experiences headache, nausea, dizziness, or fatigue, reaction ability may be impaired. Caution is advised, especially during the initial phase of treatment.

Plendil contains lactose, castor oil, and sodium
Plendil contains lactose, which is a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Plendil contains castor oil, which may cause indigestion and diarrhoea.
Plendil contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Plendil
Plendil should always be taken as prescribed by the doctor. If in doubt, consult the doctor.
Plendil extended-release tablets should be taken in the morning – swallowed whole with water. Tablets must not be divided, crushed, or chewed. This medicine may be taken without food or after a light meal low in fat and carbohydrates.

Hypertension
Treatment should be initiated with a dose of 5 mg once daily. If necessary, the doctor may increase the dose or add another antihypertensive medicine. The usual maintenance dose for long-term treatment of this condition 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 initiated with a dose of 5 mg once daily, and if necessary, the doctor may increase the dose to 10 mg once daily.

If the patient has impaired liver function
Blood levels of felodipine may be increased. The doctor may reduce the dose of the medicine.

Elderly patients
The doctor may initiate treatment with the lowest available dose.

Taking more Plendil than prescribed
If more doses of Plendil than prescribed are taken, very low blood pressure may occur, sometimes accompanied by palpitations, fast or, rarely, slow heart rate. It is therefore very important that the patient takes only the number of doses prescribed by the doctor. If symptoms such as faintness, inability to maintain balance, or dizziness occur, the patient should contact a doctor immediately.

Missing a dose of Plendil
If the patient forgets to take a tablet at the scheduled time, the missed dose should be skipped. The next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Plendil
If the patient stops taking this medicine, symptoms of the disease may return. Before stopping Plendil, the patient should consult the doctor for advice. The treating doctor will inform the patient how long the medicine should be taken.

If there are any further doubts regarding the use of this medicine, consult the doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, discontinue taking Plendil and contact your doctor immediately:

• Hypersensitivity and allergic reactions. Symptoms may include raised skin lesions (blisters) or swelling of the face, lips, mouth, tongue or throat.

The following adverse reactions have been reported. Most of these reactions occur at the beginning of treatment or after an increase in dose. If such reactions occur, they are usually transient and their intensity decreases over time. If any of the following symptoms develop and persist, inform your doctor.
Mild gum enlargement has been observed in patients with inflammation of the mouth (gingivitis, periodontitis). Gum enlargement can be prevented or reversed 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 of the face

Uncommon: may affect up to 1 in 100 people

• abnormally rapid heartbeat
• palpitations
• low blood pressure (hypotension)
• nausea
• abdominal pain
• burning, tingling or numbness sensations
• rash or itching
• feeling of fatigue
• dizziness

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

• fainting
• vomiting
• urticaria (hives)
• joint pain
• muscle pain
• impotence, sexual disturbances

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

• gingivitis (gum swelling)
• increased liver enzyme activity
• skin reactions due to increased sensitivity to light
• inflammation of small skin blood vessels
• increased frequency of urination
• hypersensitivity reactions, e.g. fever or swelling of lips and tongue

Other adverse reactions may also occur. If any disturbing or unusual symptoms occur during treatment with Plendil, contact your doctor immediately.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Plendil

No special storage instructions are required for this medicine.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle after the
"EXP" abbreviation. The expiry date refers to the last day of the stated month.
Do not use this medicine if the packaging is broken or damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. Such measures 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 10,000 mPa·s
  Anhydrous lactose
  Glyceryl hydroxystearate polyglycol
  Microcrystalline cellulose
  Propyl gallate
  Sodium aluminosilicate
  Sodium stearyl fumarate

Tablet 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, marked 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, marked A/FE on one side and 10 on the other.

Pack sizes of prolonged-release tablets 5 mg:
14 tablets (blister with days of the week marked)
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 days of the week)
100 tablets (blister and plastic bottle)
500 tablets (plastic bottle adapted for dose measurement)

Pack sizes of prolonged-release tablets 10 mg:
14 tablets (blister with printed 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 days of the week)
100 tablets (blister, plastic bottle, and plastic bottle adapted for dose measurement)
500 tablets (plastic bottle adapted for dose measurement)

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

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