PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Parmid® XL 2.5 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Parmid XL is and what it is used for

2.    What you need to know before you take Parmid XL

3.    How to take Parmid XL

4.    Possible side effects

5.    How to store Parmid XL

6.    Contents of the pack and other information

What Parmid XL is and what it is used for

Medicines containing St John’s wort (Hypericum perforatum) (herbal product used to treat depression) may reduce the effect of Parmid XL and should therefore be avoided.

Parmid 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.

Parmid 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 Parmid XL

Do not take Parmid XL

•    if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6)

•    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 suffer from uncompensated heart failure.

•    if you have disease of a heart valve or heart muscle, until you have talked to your doctor.

•    if you are pregnant. You should tell your doctor as soon as possible if you become pregnant while using this medicine.

Warnings and precaution

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

Taking Parmid 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 Parmid XL is not recommended in children.

Other medicines and Parmid XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines/herbal remedies can affect treatment with Parmid 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 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)

Parmid XL with food and drink

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

Pregnancy and breast-feeding

Pregnancy

Do not take Parmid XL if you are pregnant. Breast-feeding

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

Driving and using machines

Parmid 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.

Parmid XL contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 How to take Parmid XL

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Parmid XL prolonged 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

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 Parmid XL than you should

If you take more than the recommended number of doses of Parmid 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.

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If you forget to take Parmid 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 Parmid XL

If you stop taking this medicine your condition may return. Please consult your doctor and seek advice before you stop taking Parmid 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 or pharmacist.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

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 Parmid XL and tell a doctor straight away:

•    Hypersensitivity and allergic reactions: The signs may include raised lumps on your skin (weals) 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

What Parmid XL contains

•    The active substance is felodipine. One

prolonged-release tablet contains 2.5 mg of felodipine.

•    The other ingredients are:

Tablet core: lactose monohydrate, sodium laurilsulfate, hypromellose, microcrystalline cellulose, magnesium stearate.

Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000, iron oxide, yellow (E172).

What Parmid XL looks like and contents of the pack

Parmid XL Prolonged-release Tablets are round, pale yellow, biconvex film-coated tablets; embossment “2.5” on one side of the tablet.

Your tablets come in

•    blister packs of 7, 14, 20, 28, 30, 50, 56, 60, 100 and 112 prolonged-release tablets.

•    plastic containers of 100 and 250 prolonged-release tablets.

Not all pack sizes and pack types may be marketed.

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Common: may affect up to 1 in 10 people

•    Flushing

•    Headache

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

or

Lek Pharmaceuticals d.d. Verovskova 57, 1526 Ljubljana, Slovenia

or

LEK S.A, ul. Podlipie 16, 95-010 Strykow, Poland or

LEK S.A, ul. Domaniewska 50 C, 02-672 Warsaw, Poland

Rare: may affect up to 1 in 1,000 people    This leaflet was last revised in 05/2015.

•    Nettle rash

•    Fainting

•    Vomiting

•    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 Parmid XL, check with your doctor right away.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Parmid XL

Keep this medicine out of the sight and reach of children.

Do not use Parmid XL after the expiry date “EXP” which is stated on the packaging. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Plastic container:

Do not store above 25°C after first opening. Shelf-life after first opening: 6 months.

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