NEOFEL XL 2.5MG PROLONGED RELEASE TABLETS

Active substance: FELODIPINE

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(felodipine)

Take special care with Neofel XL
Before you take Neofel XL you should tell your doctor if you:
• have a liver disorder
• are breast-feeding

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Do not take Neofel XL if you:
• are allergic (hypersensitive) to felodipine, other dihydropyridine calcium antagonists
or any of the other ingredients in the tablets (these are listed in Section 6, Further
Information)
• suffer from severe chest pain due to a lack of blood and oxygen to the heart
(unstable angina pectoris)
• are pregnant, planning to become pregnant or you suspect you are pregnant
• have narrowing of one of the valves in the heart (aortic stenosis)
• have had a heart attack (myocardial infarction) within the last 4 weeks
• have or develop cardiogenic shock (where the heart is unable to supply sufficient blood to
the body)

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If you are elderly, your doctor may start you on a lower dose of 2.5 mg once a day.
Angina
The usual starting dose is 5 mg once a day. This may be increased by your doctor to 10 mg
once a day if necessary.

Dosage
Always take Neofel XL exactly as your doctor has told you to. You should check with your
doctor or pharmacist if you are not sure. The label on the carton will tell you how many
tablets you should take and when.
Your doctor will decide on the right starting dose for you and on any increase in the dose
depending on your condition and whether you are taking any other medicines. Do not change
your dose unless your doctor tells you to do so.
The usual doses for Neofel XL are as follows:
Hypertension (High Blood Pressure)
The usual starting dose is 5 mg once a day. If necessary, the dose may be increased by your
doctor to give you the best response. The usual maintenance dose is 5-10 mg a day. Doses
above 20 mg are not usually needed.

3. HOW TO TAKE NEOFEL XL

Neofel XL is used to treat high blood pressure (hypertension) and prevent attacks of angina (a
painful condition where there is a lack of blood and oxygen to the heart).

2. BEFORE YOU TAKE NEOFEL XL

Important information about some of the ingredients of Neofel XL
This product 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.

It may still be all right for you to take Neofel XL and your doctor will be able to decide what is
suitable for you. Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Taking your medicine with food and drink
It is recommended that Neofel XL should be taken without food or with a light meal.
Grapefruit juice can affect the amount of Neofel XL (felodipine) in the blood; therefore
patients should not consume grapefruit juice during treatment with this medicine.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, likely to become pregnant or suspect you are
pregnant. Tell your doctor or pharmacist if you are breast-feeding and they will decide if this
medicine is right for you. Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machinery
These tablets should not affect your ability to drive. However, if you feel light-headed or
dizzy, do not drive and check with your doctor or pharmacist.

The active ingredient in Neofel XL is felodipine which is one of a group of medicines called
dihydropyridine calcium antagonists. These work by blocking the entry of calcium into muscle
cells. Neofel XL (felodipine) affects the muscle in blood vessels more than other muscles. It
causes a relaxation of the muscle and a widening of the blood vessels. As the blood vessels
get wider, blood pressure falls and the heart does not need to work so hard to pump blood
around the body, reducing the risk of angina.

1. WHAT NEOFEL XL ARE AND WHAT THEY ARE USED FOR

In this leaflet:
1. What Neofel XL are and what they are used for
2. Before you take Neofel XL
3. How to take Neofel XL
4. Possible side effects
5. How to store Neofel XL
6. Further information

The name of this medicine is Neofel XL Prolonged Release Tablets (felodipine), which will be
referred to as Neofel XL throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others; it may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

• suffer from a condition which affects the chambers of your heart and may prevent
them from working properly (left ventricular dysfunction)
Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines as
they may decrease or increase the effect of Neofel XL:
• other medicines for treating high blood pressure including diuretics (water tablets)
• cimetidine for the treatment of stomach ulcers
• erythromycin and clarithromycin used to treat bacterial infections
• nelfinavir, ritovinavir and indinavir for the treatment of HIV
• ketoconazole and itraconazole used to treat fungal infections
• medicines for the treatment of convulsions or epilepsy (e.g. phenytoin, carbamazepine or
phenobarbital).
• tacrolimus an immunosupressive drugs used to prevent organ transplant rejection

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PATIENT INFORMATION LEAFLET
NEOFEL XL 2.5, 5 & 10 MG
PROLONGED RELEASE TABLETS

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NEOFEL XL
2.5, 5 & 10 MG
(felodipine)

NEOFEL XL
2.5, 5 & 10 MG
(felodipine)

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The following effects have been reported:
Very common side effects (seen in more than 1 in 10 patients)
• headache
• flushing
Common side effects (seen in less than 1 in 10 patients but in more than 1 in 100 patients)
• swollen ankles (peripheral oedema)
Uncommon side effects (seen in less than 1 in 100 patients but in more than 1 in 1000
patients)
• dizziness
• tingling or numbness of the skin (paraesthesia) e.g. pins and needles, skin rash, itching
(puritus)
• fast heart beat (tachycardia), palpitations
• feeling sick (nausea), abdominal pain
• tiredness (fatigue)
Rare side effects (seen in less than 1 in 1000 patients)
• fainting (syncope), low blood pressure (hypotension), reduced blood supply to the heart
muscle (myocardial ischaemia)
• impotence, sexual dysfunction
• being sick (vomiting)
• hives (urticaria)
• joint or muscle pain (arthralgia, myalgia)
Very rare side effects (seen in less than 1 in 10,000 patients)
• allergic reactions, swelling of the skin (angioedema), sensitivity to light (exposure to sunlight
may occasionally aggrevate skin rash)

• any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids,
face, lips or throat.
• other allergic reactions, urticaria (hives)

Like all medicines, Neofel XL can cause side effects although not everybody gets them. If
you get any of the following symptoms after taking these tablets, you should stop taking
Neofel XL and contact your doctor immediately:

4. POSSIBLE SIDE EFFECTS

If you have any further questions about this product ask your doctor or pharmacist.

Neofel XL are for use in Adults only.
Method of Administration
Neofel XL should be swallowed whole with half a glass of water. The tablets should be taken
regularly in the morning without food or with a light meal. Patients should not consume
grapefruit juice during treatment with this medicine. The tablets should not be chewed or
crushed.
If you take more Neofel XL than you should
If you have accidentally taken more than your prescribed dose, contact your nearest hospital
casualty department or tell your doctor or pharmacist immediately. Remember to take the
pack and any remaining tablets with you. The most common signs and symptoms of
overdose are a fall in blood pressure (causing dizziness and light-headedness) accompanied
by a drop in heart rate.
If you forget to take Neofel XL
It is important that you take your medicine every day. However, if you forget to take one or
more doses, take your next dose when it is due and then go on as prescribed. Do not take a
double dose to make up for a forgotten dose.

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This leaflet was last approved in November 2012.

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Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release: Fannin (UK) Limited, 42-46 Booth Drive,
Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.

Your medicine is available in blister packs of 10, 20, 28, 30, 50, 56 or 100 tablets (not all pack
sizes may be marketed).

Neofel 10 mg XL Prolonged Release Tablets are reddish brown, round, biconvex film coated
prolonged-release tablets with imprint ‘10’

Neofel 5 mg XL Prolonged Release Tablets are light pink, round, biconvex film coated
prolonged-release tablets with imprint ‘5’.

Neofel 2.5 mg XL Prolonged Release Tablets are yellow, round, biconvex film coated
prolonged-release tablets with imprint ‘2.5’.

What Neofel XL look like and the contents of the pack:

The other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose,
povidone, propyl gallate, colloidal anhydrous silica, magnesium stearate, ferric oxide (E172),
titanium dioxide (E171), talc and propylene glycol.

What Neofel XL contain:
The active ingredient is felodipine. Each tablet contains 2.5, 5 or 10 mg of felodipine.

6. FURTHER INFORMATION

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

Keep all medicines out of the reach and sight of children.

Do not take this medicine after the expiry date stated on the carton. The expiry date refers to
the last day of that month.

Do not store your tablets above 25°C. Store in the original package.

5. HOW TO STORE NEOFEL XL

• gum swelling (gum hyperplasia, gingivitis). Patients with gingivitis/periodontitis an
inflammation of the mouth and gums have reported mild gum swelling.
• increased liver enzymes (symptoms may include feeling sick or more tired than usual,
stomach pain or a yellowing of the skin or whites of the eyes)
• small vessel inflammatory disease (leucocytoclastic vasculitis)
• polyuria (passage of large volumes of urine)
• fever
Aggravation of angina has been reported in a small number of patients when first starting
treatment
If any of these side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

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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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