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PINEFELD XL 10MG TABLETS

Active substance(s): FELODIPINE

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PATIENT INFORMATION LEAFLET

Pinefeld XL 10mg Prolonged-Release FilmCoated Tablets
(Felodipine)
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.





Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you 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
2
3

What this medicine is and what it is used for
4
What you need to know before you take Pinefeld 5
How to take Pinefeld
6

1 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.

Possible side effects
How to store Pinefeld
Contents of the pack and other information

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,
Pinefeld is used to treat the following:
amitriptyline (tricyclic antidepressants)
 High blood pressure (hypertension)
 Hydrochlorothiazide, used to reduce the water content
 To prevent angina (chest pain)
of the blood and in turn the volume of blood
circulating in the body by increasing the volume of
The name of this medicine is Pinefeld XL 10mg
urine produced by the body (diaretics)
Prolonged−Release Film−Coated Tablets (felodipine) and  Medicines used to reduce the body’s immunity when
is referred to as Pinefeld throughout this leaflet
receiving organ transplant such as ciclosporin,
tacrolimus (immunosuppressants)

What you need to know before

2 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.

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.

3 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.
The dose of Pinefeld may need to be decreased if taken
 These tablets may be taken with or without food.
with the following medicines
 Grapefruit juice should be avoided during treatment
 Medicines used to treat stomach ulcers such as
with Pinefeld. Grapefruit juice can affect the amount
cimetidine (H2−receptor antagonists)
of felodipine (the active ingredient in Pinefeld) in the
 Medicines used to treat fungal infections such as
blood.
itraconazole, ketoconazole (azole antifungals)
 Medicines used to treat bacterial infections such as
Adults:
erythromycin (macrolide antibiotics)
 The recommended starting dose is 5mg once daily.
 Medicines used to treat HIV infection (HIV protease
The usual maintenance dose is 5−10mg once daily.
inhibitors) such as ritonavir
Doses higher than 20mg daily are not usually
required.
The dose of Pinefeld may need to be increased if taken
 Depending on the therapeutic response, the dose can
with the following medicines
be decreased to 2.5mg if applicable.
 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])
Continued....
 St John’s Wort, a herbal remedy used to treat
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.

Hard to Read?

Phone

0800 970 6115

for help
Till−Ver.4s

 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.






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.

If you taken more Pinefeld than you should:
If you accidentally take too many tablets, contact your
5 How to store Pinefeld
doctor or nearest hospital emergency department
immediately for advice. Remember to take this leaflet or
 Keep this medicine out of the sight and reach of
any remaining tablets with you. The symptoms of
children.
overdose are; excessive widening of the veins and
 Store in the original package.
arteries of the outer parts of the body (peripheral
 Do not use this medicine after the expiry date which is
vasodilatation) with low blood pressure (hypotension)
stated on the carton/blister after EXP. The expiry date
and rarely a slower heartbeat (bradycardia).
refers to the last day of that month.
If you forget to take Pinefeld
 Do not throw away any medicines via wastewater or
Take it as soon as you remember, unless it is nearly time
household waste. Ask your pharmacist how to throw
for your next dose. If you miss a dose do not take a
away medicines you no longer use. These measures
double dose to make up for a forgotten dose.
will help to protect the environment.
If you stop taking Pinefeld
Contents of the pack and
 It is important that you keep taking Pinefeld for as
6 other information
long as your doctor has told you to.
 If treatment with Pinefeld is stopped abruptly, a
hypertensive crisis (severe increase in blood pressure What Pinefeld contains:
Each prolonged−released film−coated tablet contains
that can result in irreversible organ damage and/or
10mg of felodipine.
lead to a stroke) may occur.
The other ingredients are: microcrystalline cellulose,
lactose monohydrate, sodium laurilsulfate, hypromellose,
magnesium stearate, macrogol 4000, iron oxide (E172)
and titanium dioxide (E171).

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

4 Possible side effects

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.

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)

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
Very common side effects (may affect more than 1 in
10 people)
Marketing Authorisation Holder:
 Ringing in the ears (tinnitus)
Tillomed Laboratories Ltd,
3 Howard Road, Eaton Socon, St Neots,
Common side effects (may affect up to 1 in 10
Cambridgeshire, PE19 8ET,
people)
United Kingdom.
 Headache. This is usually only temporary and appears
at the start of treatment or following a dose increase
Manufacturer:
 Reddening of the face (flushing). This is usually only
Salutas Pharma GmbH
temporary and appears at the start of treatment or
Otto−Von−Guericke−Allee 1
following a dose increase
39179 Barleben.
Germany.
Uncommon side effects (may affect up to 1 in 100
people)
This leaflet was last revised in September 2014
 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

Hard to Read?

Phone

0800 970 6115

for help
Till−Ver.4s

Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Pinefeld XL Tablets
Tablets
PIL
165 mm x 420 mm
Font SansSerif −Min.Text 8pt
Till−Ver.4s
11/09/2014
1 − Pantone Black CVC

Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

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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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