Pinefeld XL (felodipine) 10mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your 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.

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

• You are allergic to felodipine, other calcium channel blockers or any of the other ingredients of this medicine (listed in section 6)
• 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)

Talk to your doctor before taking Pinefeld:

• If you suffer from heart problems such as:
  • Low blood pressure (hypotension)
  • Faster heartbeat (tachycardia)
  • 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.

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.

Medicines which may interact with or be affected by Pinefeld:

• 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, rifampicin (antibiotics)
• Medicines used to treat HIV infection (HIV protease inhibitors) such as ritonavir and efavirenz, nevirapine (Non-Nucleoside Reverse Transcriptase Inhibitors [NNRTIs])
• Medicines used to control seizures and epilepsy such as carbamazepine, phenytoin (anticonvulsant)
• 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 reduce the body’s immunity when receiving organ transplant such as tacrolimus (immunosuppressants)

• 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.

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.

Pinefeld may cause headache, feeling sick (nausea), dizziness or tiredness (fatigue). This is more likely to occur at the start of treatment. If any of these symptoms are experienced, it may be necessary to avoid driving or operating machinery.

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

• The recommended starting dose is 5mg once daily.
• The standard 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.
• Depending on the therapeutic response, the dose can be increased to 10mg once daily
• Another antihypertensive medicine may be added if necessary.
• Dose increases should occur at intervals of at least 2 weeks.

Treatment should be started with the lowest available dose.

• Dose adjustment is not required for patients with impaired kidney function.
• Caution should be taken in patients with severely impaired kidney function.

• 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.
• In patients with mild to moderately impaired liver function, the recommended starting dose should be the lowest minimum dose of Pinefeld.
• The dose should only be increased after balancing the benefits against the risks.
• Pinefeld should not be used in patients with severely impaired liver function.

Pinefeld Tablets are not recommended for children.

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).

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.

• 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 may cause irreversible organ damage and/or stroke) may occur.

• 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)

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)

• 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)
• Low blood pressure (hypotension)
• Faster heartbeat (tachycardia)
• Feeling your heartbeat (palpitations)
• Stomach pain
• Feeling sick (nausea)
• Skin rashes
• Severe itching (pruritis)
• 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)
• Abnormal sensitivity of the skin to sunlight (photosensitivity)
• Inflammation of the blood vessels (leukocycoclastic vasculitis)

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 at www.mhra.gov.uk/yellowcard or search for 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.

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).

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