Informations for option: Pinefeld Xl 10mg Tablets, show other option

Select option:

1. Pinefeld Xl 10mg Tablets
2. Pinefeld Xl 10mg Tablets

PATIENT INFORMATION LEAFLET

Pinefeld XL 10mg Prolonged-Release Film-Coated Tablets

(Felodipine)

What this medicine is and what it is used for

The active ingredient in Pinefeld XL is felodipine which belongs to a group of medicines called calcium channel blockers. These work by blocking the effects of calcium on the blood vessels (narrowing of the blood vessels) which helps the blood vessels to relax and widen, increasing the blood flow and supply of oxygen to the heart, reducing the heart's workload.

Pinefeld is used to treat the following:

■    High blood pressure (hypertension)

■    To prevent angina (chest pain)

The name of this medicine is Pinefeld XL 10mg Prolonged-Release Film-Coated Tablets (felodipine) and is referred to as Pinefeld throughout this leaflet

What you need to know before you take Pinefeld

Do not take Pinefeld if:

■    You are allergic (hypersensitive) to felodipine, other calcium channel blockers or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information")

■    You have a weakened heart that is unable to pump blood around the body (cardiogenic shock)

■    You have a narrowing of the aortic valve in the heart, restricting the blood flow (aortic stenosis)

■    You suffer from an insufficient blood supply to the heart muscle which can cause chest pain (unstable angina pectoris)

■    You have had a severe heart attack within the last month (acute myocardial infarction)

■    You suffer from heart failure or heart disease

■    You are pregnant, think you may be pregnant or are planning to have a baby (see "Pregnancy and breastfeeding" section)

■    You suffer from a severe sensitivity of the skin to sunlight (acute porphyria)

Warnings and precautions

Talk to your doctor before taking Pinefeld:

■    If you suffer from heart problems such as:

o Left ventricle of your heart is (severely) functioning poorly

o Low blood pressure (hypotension) o Faster heartbeat (tachycardia) o Reduced blood flow to the heart muscle by a partial or complete blockage of the arteries (myocardial ischaemia)

■    If you suffer from liver disorders

■    If you suffer from swelling of the gums (gingivitis) or a serious gum infection that damages the soft tissue and destroys the bone that supports the teeth (periodontitis). Mild enlargement of the gums can be avoided or reversed by careful dental hygiene.

■    Different types of prolonged-release medicines do not necessarily all have the same effect. When changing treatment from a different type of prolonged-release felodipine medicine to Pinefeld (felodipine) medicine, blood pressure should be monitored and the dose amended as appropriate.

Other medicines and Pinefeld

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

The dose of Pinefeld may need to be decreased if taken with the following medicines

■    Medicines used to treat stomach ulcers such as cimetidine (H2-receptor antagonists)

■    Medicines used to treat fungal infections such as itraconazole, ketoconazole (azole antifungals)

■    Medicines used to treat bacterial infections such as erythromycin (macrolide antibiotics)

■    Medicines used to treat HIV infection (HIV protease inhibitors) such as ritonavir

The dose of Pinefeld may need to be increased if taken with the following medicines

■    Medicines used to control seizures and epilepsy such as carbamazepine, phenytoin (anticonvulsant)

■    Medicines used to treat HIV infection such as efavirenz, nevirapine (Non-Nucleoside Reverse Transcriptase Inhibitors [NNRTIs])

■    St John's Wort, a herbal remedy used to treat

depression

■    Medicines used to treat anxiety and sleep disorders such as phenobarbital (barbiturates)

■    Medicines used to treat bacterial infections such as rifampicin (antibiotics)

Other medicines which may interact with or be affected by Pinefeld

■    Medicines used to treat high blood pressure e.g. atenolol (antihypertensives)

■    Medicines used to treat depression e.g. imipramine, amitriptyline (tricyclic antidepressants)

■    Hydrochlorothiazide, used to reduce the water content of the blood and in turn the volume of blood circulating in the body by increasing the volume of urine produced by the body (diaretics)

■    Medicines used to reduce the body's immunity when receiving organ transplant such as ciclosporin, tacrolimus (immunosuppressants)

Taking Pinefeld with food and drink:

■    During treatment with Pinefeld, a low-fat, low-carbohydrate diet should be followed.

■    These tablets may be taken with or without food.

■    During treatment with Pinefeld, it is advisable not to drink alcohol (see "Driving and using machines" section).

■    Grapefruit juice should be avoided during treatment with Pinefeld. Grapefruit juice can affect the amount of felodipine (the active ingredient in Pinefeld) in the blood.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, Pinefeld must not be taken.

Breast feeding

If you are breast-feeding, Pinefeld should not be taken as felodipine (the active ingredient in Pinefeld) is passed into breast milk.

Driving and using machines

Pinefeld may cause dizziness or tiredness. This is more likely to occur at the start of treatment, following a dose increase, when medication is changed or if you drink alcohol. If either of these symptoms are experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

Pinefeld 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.

How to take Pinefeld

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

■    These tablets are to be taken orally, in the morning, with sufficient fluid (e.g. water).

■    These tablets should be swallowed whole. Do not break, chew or crush these tablets because they will be absorbed into the body too quickly.

■    During treatment with Pinefeld, a low-fat, low-carbohydrate diet should be followed.

■    These tablets may be taken with or without food.

■    Grapefruit juice should be avoided during treatment with Pinefeld. Grapefruit juice can affect the amount of felodipine (the active ingredient in Pinefeld) in the blood.

Adults:

■    The recommended starting dose is 5mg once daily. The usual maintenance dose is 5-10mg once daily. Doses higher than 20mg daily are not usually required.

■    Depending on the therapeutic response, the dose can be decreased to 2.5mg if applicable.

Continued....

■    Depending on the therapeutic response, the dose can be increased to 10mg once daily or another antihypertensive medicine added (Pinefeld can be used in combination with beta-blockers, ACE inhibitors or diuretics). Dose increases should occur at intervals of at least 2 weeks.

Older people

The recommended starting dose of 5mg should be adjusted. Subsequent dose increases should be undertaken with particular caution.

Patients with kidney disorders

■    Dose adjustment is not required for patients with impaired kidney function.

■    Caution should be taken in patients with severely impaired kidney function.

Patients with liver disorders

■    Patients with impaired liver function may have increased concentrations of felodipine (the active ingredient in Pinefeld) in their blood and may require a lower dose of Pinefeld.

■    In patients with mild to moderately impaired liver function, the recommended starting dose should be lowered to the minimum dose of Pinefeld.

■    The dose should only be increased after carefully balancing the benefits against the risks.

■    Pinefeld should not be used in patients with severely impaired liver function.

Use in children

Pinefeld Tablets are not recommended for children.

If you taken more Pinefeld than you should:

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. The symptoms of overdose are; excessive widening of the veins and arteries of the outer parts of the body (peripheral vasodilatation) with low blood pressure (hypotension) and rarely a slower heartbeat (bradycardia).

If you forget to take Pinefeld

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose.

If you stop taking Pinefeld

■    It is important that you keep taking Pinefeld for as long as your doctor has told you to.

■    If treatment with Pinefeld is stopped abruptly, a hypertensive crisis (severe increase in blood pressure that can result in irreversible organ damage and/or lead to a stroke) may occur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Pinefeld can cause side effects, although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

■    Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness

■    Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)

■    Swelling of parts of the body (peripheral oedema)

Very common side effects (may affect more than 1 in 10 people)

■    Ringing in the ears (tinnitus)

Common side effects (may affect up to 1 in 10 people)

■    Headache. This is usually only temporary and appears at the start of treatment or following a dose increase

■    Reddening of the face (flushing). This is usually only temporary and appears at the start of treatment or following a dose increase

Uncommon side effects (may affect up to 1 in 100 people)

■    Faster heartbeat (tachycardia)

■    Feeling your heartbeat (palpitations). This is usually only temporary and appears at the start of treatment or following a dose increase

■    Dizziness. This is usually only temporary and appears at the start of treatment or following a dose increase

■    Tingling or numbness in the hands or feet (paraesthesia)

■    Shakiness (tremors)

■    Low blood pressure (hypotension)

■    Stomach pain

■    Feeling sick (nausea)

■    Diarrhoea

■    Constipation

■    Difficulty in breathing (dyspnoea)

■    Restlessness

■    Weight gain

■    Skin rashes (exanthema)

■    Severe itching (pruritis)

■    Sweating

■    Tiredness, weakness or lack energy (fatigue). This is usually only temporary and appears at the start of treatment or following a dose increase

Rare side effects (may affect up to 1 in 1000 people)

■    Fainting (syncope)

■    Inability to have or maintain an erection (impotence) or sexual problems

■    Skin rashes with the formation of wheals (urticaria)

■    Being sick (vomiting)

■    Muscle pain (myalgia)

■    Pain or swelling in the joints (arthralgia)

Very rare side effects (may affect up to 1 in 10,000

people)

■    Swelling/inflammation of gums [gingival hyperplasia/gingivitis] (can be prevented/reversed by careful dental hygiene)

■    Liver function disorders (detected by blood tests)

■    Frequent need to urinate (pollakisuria)

■    Fever

■    Peeling of the skin over large areas of the body (exfoliative dermatitis)

■    Abnormal sensitivity of the skin to sunlight (photosensitivity)

■    Inflammation of the blood vessels (leucocycoclastic vasculitis)

■    Excessive development of the male breast (gynaecomastia)

■    Abnormally heavy and prolonged menstrual period at regular intervals (menorrhagia)

■    Heart attack (myocardial infarction)

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 internet at

www.mhra.gsi.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

0 How to store Pinefeld

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

■    Store in the original package.

■    Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month.

■    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 to protect the environment.

□ Contents of the pack and other information

What Pinefeld contains:

Each prolonged-released film-coated tablet contains 10mg of felodipine.

The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium laurilsulfate, hypromellose, magnesium stearate, macrogol 4000, iron oxide (E172) and titanium dioxide (E171).

What Pinefeld looks like and contents of the pack:

Pinefeld are grey-red, round, biconvex, prolonged-release, film-coated tablets with an approximate diameter of 9mm, with the imprint F10 on one side.

Pinefeld is available in:

Pinefeld Tablets are available in packs of 7, 14, 28 or 98 tablets.

Not all pack sizes may be marketed.

Product Licence Number:

PL 11311/0342

Marketing Authorisation Holder:

Tillomed Laboratories Ltd,

3 Howard Road, Eaton Socon, St Neots,

Cambridgeshire, PE19 8ET,

United Kingdom.

Manufacturer:

Salutas Pharma GmbH Otto-Von-Guericke-Allee 1 39179 Barleben.

Germany.

This leaflet was last revised in September 2014

Hard to Read? Phone 0800 970 6115 for help

Till-Ver.4s