LESCOL XL 80MG PROLONGED RELEASE TABLETS

Active substance: FLUVASTATIN SODIUM

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SZ03705LT03A

Package leaflet:
Information for the user

NANDOVAR XL 80 mg
Prolonged Release Tablets

with an increased risk of heart disease and stroke.
- in adult patients with high blood levels of cholesterol
- in adult patients with high blood levels of both cholesterol
and triglycerides (another sort of blood lipid)

• Your doctor can also prescribe Nandovar XL to prevent
further serious cardiac events (e.g. heart attack) in patients
after they already went through a heart catheterisation, with
an intervention in the heart vessel.

Fluvastatin

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.

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

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

Nandovar XL contains the active fluvastatin sodium which
belongs to a group of medicines known as statins, which are
lipid-lowering medicines: they lower the fat (lipids) in your
blood. They are used in patients whose conditions cannot be
controlled by diet and exercise alone.

• Nandovar XL is a medicine used to treat raised levels of
fats in the blood in adults, in particular total cholesterol
and so called “bad” or LDL cholesterol, which is associated

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

Follow all the doctor’s instructions carefully. They may differ
from the general information contained in this leaflet.

Read the following explanations before you take Nandovar XL.

Do not take Nandovar XL
• if you are allergic (hypersensitive) to fluvastatin or any of the
other ingredients of Nandovar XL listed in section 6 of this
leaflet.
• if you currently have liver problems, or if you have
unexplained, persistently high level of certain liver enzymes
(transaminases).
• if you are pregnant or breast-feeding (see “pregnancy and
breast-feeding”).
If any of these apply to you, do not take Nandovar XL and tell
your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nandovar XL.
• if you previously had a liver disease. Liver function tests will
normally be done before you start Nandovar XL, when your
dose is increased and at various intervals during treatment
to check for side effects.
• if you have a kidney disease.
• if you have a thyroid disease (hypothyroidism).
• if you have a medical history of muscle diseases yourself or
in your family.
• if you had muscle problems with another lipid-lowering medicine.
• if you regularly drink large amounts of alcohol.
• if you have a serious infection.
• if you have very low blood pressure (signs may include

dizziness, light-headedness).
• if you have controlled or uncontrolled excessive muscle exercise.
• if you are about to have an operation.
• if you have severe metabolic, endocrine or electrolyte
disorders such as decompensated diabetes and low blood
potassium.
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While you are on this medicine your doctor will monitor you
closely if you have diabetes or are at risk of developing
diabetes. You are likely to be at risk of developing diabetes if
you have high levels of sugars and fats in your blood, are
overweight and have high blood pressure.
Check with your doctor or pharmacist before taking
Nandovar XL:
• if you have severe respiratory failure.

If any of these apply to you, tell your doctor before taking
Nandovar XL. Your doctor will take a blood test before
prescribing Nandovar XL.

If during treatment with Nandovar XL, you develop symptoms
or signs such as nausea, vomiting, loss of appetite, yellow eye
or skin, confusion, euphoria or depression, mental slowing,
slurred speech, sleep disturbance, tremors or easy bruising or
bleeding, these may be signs of liver failure. In such case
contact a doctor immediately.

Nandovar XL and people over 70 years
If you are over 70 years your doctor may want to check if you
have risk factors for muscular diseases. You may need specific
blood tests.
Nandovar XL and children/adolescents
Nandovar XL has not been investigated and is not intended for
the use in children below 9 years. For dose information in
children and adolescents over 9 years, see section 3.
There is no experience with the use of Nandovar in
combination with nicotinic acid, cholestyramine or fibrates in
children and adolescents.

Other medicines and Nandovar XL
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines including medicines
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obtained without a prescription.
Nandovar XL can be taken on its own or with other
cholesterol-lowering medicines prescribed by your doctor.

After intake of a resin, e.g. cholestyramine (primarily used to
treat high cholesterol) wait at least 4 hours before taking
Nandovar XL.
Tell your doctor and pharmacist if you are taking any of the
following:
• Ciclosporin (a medicine used to suppress the immune system).
• Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid
sequestrants (medicines used to lower bad cholesterol levels).
• Fluconazole (a medicine used to treat fungal infections).
• Rifampicin (an antibiotic).
• Phenytoin (a medicine used to treat epilepsy).
• Oral anticoagulants like warfarin (medicines used to reduce
blood clotting).
• Glibenclamide (a medicine used to treat diabetes).
• Colchicines (used to treat gout).
Nandovar XL with food and drink
You can take Nandovar XL with or without food.

Pregnancy and breast-feeding
Do not take Nandovar XL if you are pregnant or breast-feeding
as the active ingredient may lead to harm to your unborn child,
and it is not known whether the active ingredient is excreted in
human breast milk. If you are pregnant, consult your doctor or
pharmacist before taking Nandovar XL.
Take adequate precaution against pregnancy while taking
Nandovar XL.
If you become pregnant while taking this medicine, stop taking
Nandovar XL and see your doctor.
Your doctor will discuss with you the potential risk of taking
Nandovar XL during pregnancy.
Driving and using machines
There is no information on the effects of Nandovar XL on your
ability to drive and use machines.

3. How to take Nandovar XL

Follow your doctor’s instructions carefully. Do not exceed the
recommended dose.
1115265-SDZ 13B/B-GB

draft: 44030938
laetus code: 1840
mat.no.: 1115265-SDZ 13B/B-GB

TYPO FORMAT Description:
NANDOVAR XL
Lea et
80 MG. FCT.
Dimensions:

148 x 297 mm

BAR CODE

1840

Old version:

Country:

GB

C.T.M.

Item Number:
:

Version

Date

Colors:

REBECA G.CONDE / v.1 / 08/11/2013

1115265-SDZ 13A/B-GBG

Artwork Proof Box

1115265-SDZ 13B/B-GB

Text Free Color:

Prod.Side:

Ref: Variation N006 + N007 - BROMI
HORIZONTAL
TEXT

Visual Distintive N.A.
1 X 3 mm.

1 mm.
2 mm.

50 g/ m2 ± 3 g
ANVERSO/
RECTO

Proof no.
005.0

Date prepared:
28/11/2013

Colours:
Black
Dimensions: 297 x 148 mm

Font size:
7pt
Fonts:
Helvetica

Your doctor will recommend you to follow a low-cholesterol
diet. Stay on this diet while taking Nandovar XL.

How much Nandovar XL to take
• The dose for adults is 80 mg per day. Dose adjustments
may be made by your doctor at 4-week or longer intervals.
• For children (aged 9 years and older) the maximum daily
dose is 80 mg. Dose adjustments may be made by your
doctor at 6-week intervals.

Your doctor will tell you exactly how many tablets of Nandovar
XL to take. Depending on how you respond to the treatment,
your doctor may suggest a higher or lower dose.

When to take Nandovar XL
You can take your Nandovar XL dose at any time of the day.
Nandovar XL can be taken with or without meals. Swallow
whole with a glass of water.

If you take more Nandovar XL than you should
If you have accidentally taken too much Nandovar XL, talk to
your doctor straight away. You may need medical attention.

If you forget to take Nandovar XL
Take one dose as soon as you remember. However, do not
take it if there is less than 4 hours before your next dose. In
this case take your next dose at the usual time. Do not take a
double dose to make up for the one that you missed.

If you stop taking Nandovar XL
To maintain the benefits of your treatment, do not stop taking
Nandovar XL unless your doctor tells you to. You must
continue to take Nandovar XL as directed to keep the levels of
your ‘bad’ cholesterol down. Nandovar XL will not cure your
condition but it does help control it. Your cholesterol levels
need to be checked regularly to monitor your progress.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nandovar XL can cause side effects,
although not everybody gets them.
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available
data.

Some rare or very rare side effects could be serious: get
medical help immediately.
• if you have unexplained muscle pain, tenderness or
weakness. These might be early signs of a potentially
severe muscle degradation. This can be avoided if your
doctor stops your treatment with fluvastatin as quickly as
possible. These side effects have also been found with
similar medicines of this class (statins).
• if you have unusual tiredness or fever, yellowing of the skin
and eyes, dark coloured urine (signs of hepatitis).
• if you have signs of skin reactions such as skin rash, hives,
redness, itching, swelling of the face, eyelids, and lips.
• if you have skin swelling, difficulty in breathing, dizziness
(signs of severe allergic reaction).
• if you bleed or bruise more easily than normal (signs of
decreased number of blood platelets).
• if you have red or purple skin lesions (signs of blood vessel
inflammation).
• if you have red blotchy rash mainly on the face which may
be accompanied by fatigue, fever, nausea, loss of appetite
(signs of lupus erythematous-like reaction).
• if you have severe upper stomach pain (signs of inflamed
pancreas).
If you experience any of these, tell your doctor straight away.
Other side effects: tell your doctor if they worry you.
Common:
Difficulty in sleeping, headache, stomach discomfort,
abdominal pain, nausea, abnormal blood test values for
muscle and liver.

Very rare:
Tingling or numbness of the hands or feet, disturbed or
decreased sensitivity.
Not known:
Impotence.

Other possible side effects
• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression
• Breathing problems including persistent cough and/or
shortness of breath or fever
• Diabetes. This is more likely if you have high levels of
sugars and fats in your blood, are overweight and have high
blood pressure. Your doctor may monitor you while you are
taking this medicine.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

5. How to store Nandovar XL

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the pack. The expiry date refers to the last day of
that month.
• Do not store Nandovar XL tablets above 30°C. Store in the
original package in order to protect from moisture.
• Do not use this medicine if you notice that the pack is
damaged or shows signs of tampering.
• Leave your Nandovar XL tablet in the blister pack until
required for use, in order to protect from moisture.
• 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.

6. Contents of the pack and other information

What Nandovar XL contains
• The active substance is fluvastatin sodium
Each Nandovar XL 80 mg tablet contains 84.24 mg
fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
The other ingredients of Nandovar XL 80 mg tablets are:
cellulose microcrystalline, hypromellose, hydroxypropyl
cellulose, potassium hydrogen carbonate, povidone,
magnesium stearate, macrogol 8000, iron oxide yellow (E172),
titanium dioxide (E171).

What Nandovar XL looks like and contents of the pack
• Nandovar 80 mg prolonged-release tablets are yellow,
round, slightly biconvex with bevelled edges. They have the
letters “LE” on one side and “NVR” on the other.
• Bottles: The prolonged-release tablets are supplied in packs
of 20 (samples not for sale or parts of hospital packs), 28,
30, 50, 98 or 100 (2 x 50 or 1 x 100) tablets and in hospital
packs of 300 (15 x 20) or 600 (30 x 20) tablets.
• Blisters: The prolonged-release tablets are supplied in
packs of 7, 14, 28 (4 x 7 or 2 x 14), 28 (in a perforated unit
dose blister), 30, 42, 49 (7 x 7), 56 (8 x 7), 70, 84, 90 or 98
(14 x 7 or 7 x 14) tablets and in hospital packs of 28, 56, 98
or 490 tablets.
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Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the
local representative of the Marketing Authorisation Holder:
The Marketing Authorisation Holder is:
Novartis Pharmaceuticals UK Limited

Trading as:
Sandoz Pharmaceuticals, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,United Kingdom.
Nandovar XL tablets are distributed by:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, United Kingdom.

Nandovar XL tablets are released onto the market by:
Novartis Pharmaceuticals UK Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, United Kingdom or
Novartis Pharmaceuticals UK Limited, Wimblehurst Road,
Horsham, West Sussex, RH12 5AB, United Kingdom.

If you would like any more information, or would like this leaflet
in a different format, please contact Medical Information at
Novartis Pharmaceuticals UK Ltd, telephone number
01276 698370.
This leaflet was last revised in 11/2013.
1840

draft: 44030938
laetus code: 1840
mat.no.: 1115265-SDZ 13B/B-GB

A

TYPO FORMAT Description:
NANDOVAR XL
Lea et
80 MG. FCT.
Dimensions:

148 x 297 mm

BAR CODE

1840

Old version:

Country:

GB

C.T.M.

Item Number:
:

Date

Colors:

REBECA G.CONDE / v.1 / 08/11/2013

1115265-SDZ 13A/B-GBG

Artwork Proof Box

1115265-SDZ 13B/B-GB
Version

Text Free Color:

Prod.Side:

Ref: Variation N006 + N007 - BROMI
HORIZONTAL
TEXT

Visual Distintive N.A.
1 X 3 mm.

SZ03705LT03A
1115265-SDZ 13B/B-GB

1 mm.
2 mm.

50 g/ m2 ± 3 g
REVERSO/
RECTO

Proof no.
005.0

Date prepared:
28/11/2013

Colours:
Black
Dimensions: 297 x 148 mm

Font size:
7pt
Fonts:
Helvetica

Expand view ⇕

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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