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FOLPIK XL 5MG PROLONGED RELEASE TABLETS

Active substance(s): FELODIPINE

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DE/H/0352/02-04

Package leaflet: Information for the patient
Folpil XL 2.5 mg prolonged-release tablets
Folpil XL 5 mg prolonged-release tablets
Folpil XL 10 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.
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. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1.
What Folpil XL is and what it is used for
2.
What you need to know before you take Folpil XL
3.
How to take Folpil XL
4.
Possible side effects
5.
How to store Folpil XL
6.
Contents of the pack and other information

1.

What Folpil XL is and what it is used for

Folpil XL contains the active substance felodipine. This belongs to a group of medicinces called calcium
antagonists. It lowers blood pressure by dilating small blood vessels. It does not negatively affect the heart
function.
Folpil XL is used in the treatment of high blood pressure (hypertension) and heart and chest pain brought on
by for example exercise or stress (angina pectoris).

What you need to know before you take Folpil XL
Do not take Folpil XL:
if you are pregnant. You should tell your doctor as soon as possible if you become pregnant while
using this medicine.
if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
if you suffer from uncompensated heart failure.
if you have acute myocardial infarction (heart attack).
if you have chest pain of recent onset, or angina pectoris that is lasting for more than 15 minutes or
longer or is more severe than usual.
if you have disease of a heart valve or heart muscle, until you have talked to your doctor.
Warnings and precautions
Folpil XL, like other blood-pressure lowering medicinal products, may in rare cases lead to pronounced low
blood pressure which in some patients may result in an inadequate supply of blood to the heart. Symptoms of
excessive low blood pressure and inadequate blood supply to the heart itself, frequently include dizziness
and chest pain. If you experience these symptoms, seek emergency care immediately.
Talk to your doctor before taking Folpil XL, especially if you have problems with your liver.

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Taking Folpil XL may cause your gums to become swollen. Practice good oral hygiene to help avoid your
gums from swelling (see section 4).
Children
The use of Folpil XL is not recommended in children.
Other medicines and Folpil XL
Tell your doctor if you are taking, have recently taken or might take any other medicines. Some
medicines/herbal remedies can affect treatment with Folpil XL
Examples are:
cimetidine (medicine to treat gastric ulcers)
erythromycin (medicine to treat infections)
itraconazole (medicine to treat fungi)
ketoconazole (medicine to treat fungi)
medicines to treat HIV infection, protease inhibitors (such as ritonavir)
medicines to treat HIV infection (such as efavirenz, nevirapine)
phenytoin (medicine to treat epilepsy)
carbamazepine (medicine to treat epilepsy)
rifampicin (medicine to treat infections)
barbiturates (medicine to treat anxiety, sleeping problems and epilepsy)
tacrolimus (medicine used in organ transplantations)
Medicines containing St John’s wort (Hypericum perforatum) (herbal product used to treat depression) may
reduce the effect of Folpil XL and should therefore be avoided.
Folpil XL with food and drink
Do not drink grapefruit juice if you are treated with Folpil XL as this may increase the effect of Folpil XL
and the risk of side effects.
Pregnancy and breast-feeding
Pregnancy
Do not use Folpil XL if you are pregnant.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Folpil XL is not recommended for
mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breastfeed.
Driving and using machines
Folpil XL can have minor or moderate influence on your ability to drive and use machines. If you
experience headache, nausea, dizziness or fatigue your ability to react may be impaired. Caution is
recommended especially at the start of treatment.
Folpil XL contains lactose
Folpil XL contains lactose that is a type of sugar. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to take Folpil XL

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Folpil XL extended release tablets should be taken in the morning and be swallowed with water. The tablet
must not be divided, crushed or chewed. This medicine can be taken without food or following a light meal
not high in fat or carbohydrates.
Hypertension
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Treatment should be started with 5 mg once a day. If necessary, your doctor may increase the dose or add
another blood-pressure lowering medicine. The usual dose when treating this disease for a long time is 5-10
mg once a day. 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 a day and if needed, your doctor may increase the dose to 10 mg
once a day.
If you have liver problems
The level of felodipine in your blood may be increased. Your doctor may lower the dose.
Elderly people
Your doctor may initiate treatment with the lowest available dose.
If you take more Folpil XL than you should
If you take more than the recommended number of doses of Folpil XL you may suffer from very low blood
pressure and sometimes palpitations, high 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 feeling faint, lightheadedness or dizziness, contact your doctor immediately.
If you forget to take Folpil XL
If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Folpil XL
If you stop taking this medicine your condition may return. Please consult your doctor and seek advice
before you stop taking Folpil XL. Your doctor will advise you how long to take your 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 any of the following happen to you, stop taking Folpil XL and tell a doctor straight away:

Hypersensitivity and allergic reactions: The signs may include raised lumps on your skin (wheals) or
swelling of your face, lips, mouth, tongue or throat.
The following undesirable effects have been identified. Most of these reactions appear at start of treatment or
after a dose increase. Should such reactions occur, they are usually brief and diminish in intensity with time.
If you experience any of the following symptoms and they persist, please tell your doctor.
Mild enlargement of the gums has been reported in patients with an inflammation in the mouth
(gingivitis/periodontitis). The enlargement can be avoided or reversed by careful oral hygiene.
Very common: may affect more than 1 in 10 people

Ankle swelling
Common: may affect up to 1 in 10 people

Headache

Flushing
Uncommon: may affect up to 1 in 100 people

Abnormally rapid heart rate

Palpitations

Too low blood pressure (hypotension)
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Nausea
Abdominal pain
Burning/prickling/numbness
Rash or itching
Fatigue
Dizziness

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

Fainting

Vomiting

Nettle rash

Pain in joints

Muscular pain

Impotence/sexual dysfunction
Very rare: may affect up to 1 in 10,000 people

Gingivitis (swollen gums)

Increased liver enzymes

Skin reactions due to increased sensitivity to sunlight

Inflammation of small blood vessels of the skin

A need to pass water frequently

Hypersensitivity reactions such as fever or swelling of the lips and tongue
Other undesirable effects may occur. If you have any bothersome or unusual reaction while taking Folpil XL,
check with your doctor right away.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of
this medicine. By reporting side effects, you can help provide more information on the safety of this
medicine.

5.
How to store Folpil XL
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 and blister after EXP. The expiry
date refers to the last day of that month.
Do not store above 25 °C.
Do not use this medicine if you notice the packaging is torn or damaged.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Folpil XL contains
-

The active substance is felodipine.
Each tablet contains 2.5 mg felodipine.
Each tablet contains 5 mg felodipine.
Each tablet contains 10 mg felodipine.
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The other ingredients are
2.5 mg
Microcrystalline cellulose
Lactose monohydrate
Hypromellose
Povidone K25
Propyl gallate (Ph.Eur.)
Colloidal anhydrous silica
Magnesium stearate (Ph.Eur.)
Talc
Propylene glycol
Iron oxide yellow (E 172)
Titanium dioxide (E 171)
5 mg
10 mg
Microcrystalline cellulose
Lactose monohydrate
Hypromellose
Povidone K25
Propyl gallate (Ph.Eur.)
Colloidal anhydrous silica
Magnesium stearate (Ph.Eur.)
Talc
Propylene glycol
Iron oxide yellow (E 172)
Iron oxide red (E 172)
Titanium dioxide (E 171)
What Folpil XL looks like and contents of the pack
2.5 mg
Folpil XL 2.5 mg prolonged-release tablets are round, yellow and film-coated.
5 mg
Folpil XL 5 mg prolonged-release tablets are round, light pink and film-coated.
10 mg
Folpil XL 10 mg prolonged-release tablets are round, reddish brown and film-coated.
2.5 mg
They are available in blister packs containing 10, 20, 28, 30, 50, 100 and 100x1 prolonged-release tablets.
They are available in bottle packs containing 100 and 250 prolonged-release tablets.
5 mg
10 mg
They are available in blister packs containing 20, 28, 30, 30x1, 50, 50x1, 98, 100, 100x1 and 250 prolongedrelease tablets.
They are available in bottle packs containing 100 and 250 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ratiopharm GmbH, Graf-Arco-Strasse 3,
D-89079 Ulm, Germany.
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This medicinal product is authorised in the Member States of the EEA under the following names:
2.5 mg
Denmark:
Finland:
Germany:
Iceland:
Sweden:
United Kingdom:

Felodipin Teva 2,5 mg depottabletter
Felodipin ratiopharm 2,5 mg depottabletti
Felodipin-ratiopharm 2,5 mg Retardtabletten
Felodipin ratiopharm 2,5 mg, forðatöflur
Felodipin Teva 2,5 mg depottablett
Folpik XL 2.5 mg prolonged release Tablets

5 mg
Austria:
Denmark:
Finland:
Germany:
Iceland:
Luxembourg:
Norway:
Sweden:
United Kingdom:

Felodipin ratiopharm retard 5 mg-Filmtabletten
Felodipin Teva 5 mg depottabletter
Felodipin ratiopharm 5 mg depottabletti
Felodipin-ratiopharm 5 mg Retardtabletten
Felodipin ratiopharm 5 mg, forðatöflur
Felodipin-ratiopharm 5 mg Retardtabletten
Felodipin ratiopharm 5 mg depottablett
Felodipin Teva 5 mg depottablett
Folpik XL 5 mg prolonged release Tablets

10 mg
Denmark:
Finland:
Germany:
Iceland:
Luxembourg:
Norway:
Sweden:
United Kingdom:

Felodipin Teva 10 mg depottabletter
Felodipin ratiopharm 10 mg depottabletti
Felodipin-ratiopharm 10 mg Retardtabletten
Felodipin ratiopharm 10 mg, forðatöflur
Felodipin-ratiopharm 10 mg Retardtabletten
Felodipin ratiopharm 10 mg depottablett
Felodipin Teva 10 mg depottablett
Folpik XL 10 mg prolonged release Tablets

This leaflet was last revised in April 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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