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PINMACTIL 80 MG PROLONGED-RELEASE FILM-COATED TABLETS

Active substance(s): FLUVASTATIN SODIUM / FLUVASTATIN SODIUM / FLUVASTATIN SODIUM

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Package leaflet: Information for the user

Pinmactil® 80 mg
prolonged-release
tablets
(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 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 Pinmactil is and what it is used for
2. What you need to know before you take Pinmactil
3. How to take Pinmactil
4. Possible side effects
5. How to store Pinmactil
6. Content of the pack and further information
1. What Pinmactil is and what it is used for
Pinmactil 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.
Pinmactil 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 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 Pinmactil 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.
2. What you need to know before you take Pinmactil
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 Pinmactil.
Do not take Pinmactil:
• if you are allergic (hypersensitive) to fluvastatin or
any of the other ingredients of Pinmactil 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 Pinmactil and
tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pinmactil.
• If you previously had a liver disease. Liver function
tests will normally be done before you start Pinmactil,
when the 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 disease
yourself or in your family.
• If you have 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.
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.

If during treatment with Pinmactil, 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.
Also tell your doctor or pharmacist if you have muscle
weakness that is constant. Additional tests and
medicines may be needed to diagnose and treat this.
Check with your doctor or pharmacist before taking
Pinmactil:
• if you have severe respiratory failure
If any of these apply to you, tell your doctor before
taking Pinmactil.
Your doctor will take a blood test before prescribing
Pinmactil.
Pinmactil 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.
Pinmactil and children/adolescents
Pinmactil 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 Pinmactil in
combination with nicotinic acid, cholestyramine or
fibrates in children and adolescents.
Other medicines and Pinmactil
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Pinmactil 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 Pinmactil.
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).
Pinmactil with food and drink
You can take Pinmactil with or without food.
Pregnancy and breast-feeding
Do not take Pinmactil 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 Pinmactil.
Take adequate precaution against pregnancy while
taking Pinmactil.
If you become pregnant while taking this medicine,
stop taking Pinmactil and see your doctor.
Your doctor will discuss with you the potential risk of
taking Pinmactil during pregnancy.
Driving and using machines
There is no information on the effects of Pinmactil on
your ability to drive and use machines.
3. How to take Pinmactil
Follow your doctor's instructions carefully. Do not
exceed the recommended dose.
Your doctor will recommend you to follow a lowcholesterol diet. Stay on this diet while taking Pinmactil.
How much Pinmactil to take
• The dose range for adults is 20 to 80 mg fluvastatin per
day and depends on the extent of cholesterol lowering
which needs to be achieved. Dose adjustments may be
made by your doctor at 4-week or longer intervals.
• For children (aged 9 years and older) the usual
starting dose is 20 mg fluvastatin per day. 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
Pinmactil to take.
Depending on how you respond to the treatment,
your doctor may suggest a higher or lower dose.
Please note that you cannot use Pinmactil 80 mg
prolonged-release tablets for all the above dosages.
Pinmactil is only available as 80 mg prolonged-release
tablets. For lower doses (20 mg and 40 mg), your
doctor will prescribe other fluvastatin medicines.

Date: 06 Mar 2015
Description Fluvastatin Sodium 80mg 250/500/98/100/28
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 592362

SAP No. N/A

Superceded Affiliate Item Code 314362
TrackWise PR No. 592362
MA No. 4569/0829

Vendor Job No. 249152
Proof No. 1
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

Time: 15:49
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 190 x 380mm

Body Text Size

10pt

When to take Pinmactil
If you are taking Pinmactil you can take your dose at
any time of the day.
Pinmactil can be taken with or without meals. Swallow
whole with a glass of water; do not divide, chew or
crush the tablet.
If you take more Pinmactil than you should
If you have accidentally taken too muchPinmactil, talk to
your doctor straight way. You may need medical attention.
If you forget to take Pinmactil
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 Pinmactil
To maintain the benefits of your treatment, do not stop
taking Pinmactil unless your doctor tells you to. You
must continue to take Pinmactil as directed to keep
the levels of your 'bad' cholesterol down. Pinmactil
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, Pinmactil 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, especially if this is constant. 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 erythematosus-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 sensibility.
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 will 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 or pharmacist.

5. How to store Pinmactil
Keep this medicine out of the sight and reach of
children.
Blisters: Keep the blisters in the outer carton in order to
protect from light.
Tablet bottle (glass and HDPE bottle): Keep the
container tightly closed in order to protect from
moisture and light.
Do not store above 30 ºC
Do not use Pinmactil after the expiry date, which
is stated on the blister, carton and tablet bottle,
respectively, after 'EXP'. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
medicines no longer required. These measures will
help to protect the environment.
6. Contents of the pack and other information
What Pinmactil contains:
• The active substance is: Fluvastatin. Each prolongedrelease tablet contains 80 mg fluvastatin (as
fluvastatin sodium).
• The other ingredients are:
Tablet core:
Povidone, microcrystalline cellulose, hydroxyethyl
cellulose mannitol, magnesium stearate
Film-coating:
Hypromellose 50, macrogol 6000, iron oxide yellow
(E172), titanium dioxide (E171).
What Pinmactil looks like and contents of the pack
Pinmactil are yellow, round, biconvex prolongedrelease tablets
Pack sizes:
Blister (OPA/Alu/PVC-Alu): 10, 14, 20, 28, 30, 50, 56, 60,
90, 98, 100 and 490 prolonged-release tablets.
HDPE bottle with desiccant and snap-on cap
(LDPE) with a tamper evident ring. Pack sizes of
250 prolonged-release tablets.
Glass bottle with desiccant and HDPE cap: 28, 98, 100,
250 and 500 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mylan
Potters Bar,
Hertfordshire,
EN6 1TL
United Kingdom
Manufacturer:
Actavis hf.
Reykjavikurvegi 78,
IS-222 Hafnarfjordur
Iceland
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000
Malta
This medicinal product is authorised in the Member
States of the EEA under the following names:
Belgium 'Fluvastatine Retard Mylan 80mg
tabletten met verlengde afgifte'
Czech Republic 'Fluvastatin Mylan 80 mg'
'Fluvastatin Mylan 80mg
Denmark
depottabletter'
Finland 
'Fluvastatin Mylan 80 mg
depottabletti'
'Fluvastatine Mylan L.P. 80 mg,
France
comprimé pelliculé à libération
prolongée'
Hungary 
'Fluvastatin-Generics [UK] 80 mg
retard tabletta'
Ireland 
'Statease XL 80mg prolongedrelease tablets'
Italy 'Fluvastatina Mylan Generics'
The Netherlands 'Fluvastatine Retard Mylan 80 mg,
tabletten met verlengde afgifte'
Poland 'Fluvagen'
Portugal 'Fluvastatina Mylan 80 mg
comprimidos de libertação
prolongada'
Slovakia 'Fluvastatin Mylan 80 mg'
Spain 'Fluvastatina MYLAN 80 mg
comprimidos de liberación
prolongada EFG'
UK 'Pinmactil 80 mg prolonged-release
tablet'

This leaflet was last revised in March 2015

Date: 06 Mar 2015
Description Fluvastatin Sodium 80mg 250/500/98/100/28
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 592362

SAP No. N/A

Superceded Affiliate Item Code 314362
TrackWise PR No. 592362
MA No. 4569/0829

Vendor Job No. 249152
Proof No. 1
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

592362

Time: 15:49
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 190 x 380mm

Body Text Size

10pt

Expand Transcript

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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