FOLPIK XL 5 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

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Folpik XL 2.5 mg prolonged-release tablets

Folpik XL 5 mg prolonged-release tablets Folpik XL 10 mg prolonged-release tablets

felodipine

Package leaflet: Information for the patient

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.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Folpik XL is and what it is used for

• 2. What you need to know before you take Folpik XL

• 3. How to take Folpik XL

• 4. Possible side effects

• 5. How to store Folpik XL

• 6. Contents of the pack and other information

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What Folpik XL is and what it is used for

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

Folpik 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).

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What you need to know before you take Folpik XL

Do not take Folpik 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 ofthis 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

Folpik 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 Folpik XL, especially if you have problems with your liver.

Taking Folpik 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 Folpik XL is not recommended in children.

Other medicines and Folpik 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 Folpik 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 Folpik XL and should therefore be avoided.

Folpik XL with food and drink

Do not drink grapefruit juice if you are treated with Folpik XL, as this may increase the effect of Folpik XL and the risk of side effects.

Pregnancy and breast-feeding Pregnancy

Do not use Folpik XL if you are pregnant.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Folpik XL is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

Driving and using machines

Folpik 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,

Folpik XL contains lactose

Folpik 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.

How to take Folpik XL

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If you have liver problems

The level of felodi pi ne 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 Folpik XL than you should

If you take more than the recommended number of doses of Folpik 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, light-headedness or dizziness, contact your doctor immediately.

If you forget to take Folpik 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 Folpik XL

If you stop taking this medicine your condition may return, Please consult your doctor and seek advice before you stop taking Folpik XL. Your doctor will advise you how long to take your medicine.

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

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 Folpik 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 ofthese 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 upto 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)
• 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 freguently
• 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 Folpik 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 via the Yellow Card Scheme at: www,mhra.gov,uk/y­ellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Folpik 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.

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Contents of the pack and other information

What Folpik XL contains:

The active substance is felodipine. Each tablet contains 2.5mg, 5mg or 10 mg of felodipine.

The other ingredients are:

• 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)

In addition the 5 and 10 mg tablets contain:

• iron oxide red (E 172)