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DORISIN XL 80MG PROLONGED RELEASE TABLETS

Active substance(s): FLUVASTATIN SODIUM

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Package leaflet: Information for the user
Dorisin XL 80mg prolonged release tablets
80mg 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 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Dorisin XL 80mg prolonged release tablets is
and what it is used for
2. W
 hat you need to know before you take Dorisin XL
80mg prolonged release tablets
3. H
 ow to take Dorisin XL 80mg prolonged release
tablets
4. Possible side effects
5. H
 ow to store Dorisin XL 80mg prolonged release
tablets
6. Contents of the pack and other information
1. W
 hat Dorisin XL 80mg prolonged release
tablets is and what it is used for
Dorisin XL 80mg prolonged release tablets 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.
•D
 orisin XL 80mg prolonged release tablets 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)
•Y
 our doctor can also prescribe Dorisin XL 80mg
prolonged release tablets 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. W
 hat you need to know before you take
Dorisin XL 80mg prolonged release tablets
Do not take Dorisin XL 80mg prolonged release
tablets
• I f you are allergic to fluvastatin or any of the other
ingredients of this medicine (listed in section 6).
• I f you currently have liver problems or if you have
unexplained, persistently high level of certain liver
enzymes (transaminases).
• I f you are pregnant or breast-feeding (see “pregnany
and breast-feeding”).
If any of these apply to you, do not take Dorisin XL
80mg prolonged release tablets and tell your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Dorisin XL 80mg prolonged release tablets
• if you previously had a liver disease. Liver function
tests will normally be done before you start Dorisin
XL 80mg prolonged release tablets, 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 lipidlowering medicine.
• if you regularly drink large amounts of alcohol.
• I f you are taking or have taken in the last 7 days a
medicine called fusidic acid, (a medicine for bacterial
infection) orally or by injection. The combination
of fusidic acid and Dorisin XL 80mg prolonged
release tablets can lead to serious muscle problems
(rhabdomyolysis).
Also tell your doctor or pharmacist if you have a 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 Dorisin XL 80mg prolonged release
tablets:
• if you have severe respiratory failure
If any of these apply to you, tell your doctor before
you take Dorisin XL 80mg prolonged release tablets.
Your doctor will take a blood test before prescribing
Dorisin XL 80mg prolonged release tablets.
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.
People over 70 years of age
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.
Children and adolescents
Dorisin XL 80mg prolonged release tabletshas 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 Dorisin XL
80mg prolonged release tablets in combination with
nicotinic acid, cholestyramine or fibrates in children
and adolescents.
Other medicines and Dorisin XL 80mg prolonged
release tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including medicines obtained without a prescription.
• If you need to take oral fusidic acid to treat a
bacterial infection you will need to temporarily
stop using this medicine. Your doctor will tell
you when it is safe to restart Dorisin XL 80mg
prolonged release tablets. Taking Dorisin XL
80mg prolonged release tablets with fusidic
acid may rarely lead to muscle weakness,
tenderness or pain (rhabdomyolysis). See
more information regarding rhabdomyolysis in
section 4.
Dorisin XL 80mg prolonged release tablets 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 Dorisin XL 80mg prolonged release
tablets.
Tell your doctor and pharmacist if you are taking any
of the following:
•C
 iclosporin (a medicine used to suppress the immune
system).
•F
 ibrates (e.g. gemfibrozil), nicotinic acid or bile
acid sequestrants (medicines used to lower bad
cholesterol levels).
•F
 luconazole (a medicine used to treat fungal
infections).
• Rifampicin (an antibiotic).
• Phenytoin (a medicine used to treat epilepsy).
•O
 ral anticoagulants like warfarin (medicines used to
reduce blood clotting).
• Glibenclamide (a medicine used to treat diabetes).
• Colchicines (used to treat gout).
Dorisin XL 80mg prolonged release tablets with
food and drink
You can take Dorisin XL 80mg prolonged release tablets
with or without food
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Do not take Dorisin XL 80mg prolonged release tablets
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 Dorisin
XL 80mg prolonged release tablets. Use reliable
contraception for the whole time that you are taking
Dorisin XL 80mg prolonged release tablets.
If you become pregnant while taking this medicine,
stop taking Dorisin XL 80mg prolonged release tablets
and see your doctor.
Driving and using machines
There is no information on the effects of Dorisin XL

80mg prolonged release tablets on your ability to drive
and use machines.
3. How to take Dorisin XL 80mg prolonged
release tablets
Always take this medicine exactly as your doctor has
told you. Check with your doctor if you are not sure.
Do not exceed the recommended dose.
Your doctor will recommend you to follow a lowcholesterol diet. Stay on this diet while taking Dorisin
XL 80mg prolonged release tablets.
How much Dorisin XL 80mg prolonged release tablets
to take
•T
 he dose range for adults is 20 to 80 mg 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.
•F
 or children (aged 9 years and older) the usual
starting dose is 20 mg 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 capsules or
tablets of Dorisin XL 80mg prolonged release tablets
to take.
Depending on how you respond to the treatment, your
doctor may suggest a higher or lower dose.
When to take Dorisin XL 80mg prolonged release
tablets
If you are taking Dorisin XL 80mg prolonged release
tablets tablets you can take your dose at any time of
the day.
Dorisin XL 80mg prolonged release tablets can be
taken with or without meals. Swallow whole with a
glass of water.
If you take more Dorisin XL 80mg prolonged
release tablets than you should
If you have accidentally taken too much Dorisin XL
80mg prolonged release tablets, talk to your doctor
straight away. You may need medical attention.
If you forget to take Dorisin XL 80mg prolonged
release tablets
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 a forgotten
dose.
If you stop taking Dorisin XL 80mg prolonged
release tablets
To maintain the benefits of your treatment, do not
stop taking Dorisin XL 80mg prolonged release tablets
unless your doctor tells you to. You must continue to
take Dorisin XL 80mg prolonged release tablets as
directed to keep the levels of your ‘bad’ cholesterol
down. Dorisin XL 80mg prolonged release tablets 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
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Very common: (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the
available data).
Some rare or very rare effects could be serious: get
medical help immediately.
• I f 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 drugs of this class (statins).
• I f you have unusual tiredness or fever, yellowing of the
skin and eyes, dark coloured urine (signs of hepatitis).
• I f you have signs of skin reactions such as skin rash,
hives, redness, itching, swelling of the face, eyelids,
and lips.
• I f you have skin swelling, difficulty in breathing,
dizziness (signs of severe allergic reaction).
• I f you bleed or bruise more easily than normal (signs

of decreased number of platelets).
• I f you have red or purple skin lesions (signs of blood
vessel inflammation).
• I f 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).
• I f 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.
Very rare:
Tingling or numbness of the hands or feet, disturbed
or decreased sensibility.
Other possible side effects
•S
 leep disturbances, including insomnia and
nightmares
•M
 emory loss
• Sexual difficulties
• Depression
•B
 reathing problems including persistent cough and/
or shortness of breath or fever
•D
 iabetes. 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.
Not known
• Muscle weakness that is constant
Reporting of side effects
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 Yellow Card Scheme at: www.mhra.
gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this
medicine.”
5. How to store Dorisin XL 80mg prolonged
release tablets
Do not store above 30°C.
Store in the original package in order to protect from
moisture.
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 carton and blister.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Dorisin XL 80mg prolonged release tablets
contains
The active substance is: fluvastatin sodium.
Each Dorisin XL 80mg prolonged release tablets tablet
contains 84.2mg fluvastatin sodium equivalent to 80 mg
fluvastatin free acid.
The other ingredients of Dorisin XL 80mg prolonged
release tablets are:
Tablet core: Carrageenan, Magnesium stearate
Film-coating: Hydroxypropyl cellulose, Hypromellose
6cP, Iron oxide yellow, Titanium dioxide, Macrogol
8000, Iron oxide red
What Dorisin XL 80mg prolonged release tablets
looks like and contents of the pack
Dorisin XL 80mg prolonged release tablets are dark
yellow, round, biconvex tablets and are packed in
Aluminium/Aluminium blisters strips.
Each pack of Dorisin XL 80mg prolonged release tablets
contains 7 or 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing
Authorisation
Manufacturer

Holder

and

Marketing Authorisation Holder
Pharmathen International SA, 4 Dervenakion str., 153
51 Pallini, Hellas
Manufacturer
Pharmathen SA, 6 Dervenakion str., 153 51 Pallini,
Hellas
This leaflet was last revised in

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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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