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FRUSENE TABLETS

Active substance(s): FUROSEMIDE / TRIAMTERENE

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2. What you need to know before you
take Frusene
Do not take Frusene if:
• you are allergic (hypersensitive) to
furosemide, triamterene or any of the
other ingredients of this medicine (listed in
section 6)
• you are allergic to sulfonamides, a type of
antibiotic
• you have kidney or serious liver problems
• you have been told that you have high levels
of potassium or low sodium in your blood.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Frusene if:
• you have a folic acid deficiency
• you have an enlarged prostate (hyperplasia
of the prostate)
• you have or think you have dementia
• you are taking any type of NSAIDs (NonSteroidal Anti-Inflammatory Drugs) such as
Ibuprofen or diclofenac
• you have or have had any kidney or liver
problems (including elderly patients) as you
may have to be closely monitored by your
doctor.
• you are diabetic
• you have had a heart attack and/or have
fluid in the lungs (pulmonary oedema)
• you are taking other medicines for your
heart or your blood pressure. Your doctor
may decide to alter the amount of the dose
of these once you start taking Frusene
• you have difficulty passing urine
• you have been told by your doctor that you
have an intolerance to some sugars.
• you are elderly, if you are on other
medications which can cause a drop in
blood pressure and if you have other medical
conditions that are risks for the drop of blood
pressure.
Children
Do not give this medicine to children

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3. How to take Frusene
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
For adults and older people:
• The usual dose is ½ to 2 tablets in the
morning, but your doctor may have told you
to take more than this.
• Do not take more than 6 tablets per day.
• The tablets have a score line which will help
you to cut them in half if this is necessary.
• Take Frusene Tablets with a glass of water on
an empty stomach.
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X

160 x 320

Paperweight: X

1/1 Black

Pharmacode: 433
Orion Oyj

Merja/PC/InDesing

The active ingredients of Frusene belong to a
group of medicines known as diuretics. They
work on your kidneys to get rid of excess
water from the body. You may have gone to
your doctor with problems such as swollen
ankles or feeling breathless. These and other
symptoms often occur because there is excess
water in your body.
• You have been prescribed these tablets to
help get rid of this excess water and you will
notice that you pass more urine soon after
you take your tablets.

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1. What Frusene is and what it is used for

MyriadPro / 10

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

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Frusene Tablets
(Furosemide and triamterene)

Blood Tests
Your doctor will need to check your blood tests
regularly.
Other medicines and Frusene
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking
any of the following:
• other diuretic agents such as amiloride,
spironolactone
• drugs used to treat high blood pressure
and heart conditions such as beta blockers,
digoxin, sotalol, ACE inhibitors, angiotensin
receptor blockers, calcium-channel blockers
and diuretics. If you have any questions ask
your doctor or pharmacist.
• drugs used to treat low blood pressure
• potassium supplements or drugs that alter
the body’s potassium or sodium levels
• muscle relaxants
• antibiotics (trimethoprim) and the antiviral
drug amantadine
• immunosuppressants such as ciclosporin
• drugs used to treat diabetes
• drugs used to treat dementia such as
risperidone
• lithium salts
• lipid lowering drugs (Cholestyramine,
cholestipol, clofibrate)
• antiepileptic agents such as phenobarbitol,
phenytoin and carbamazepine
• anti-inflammatory drugs including
corticosteroids and NSAIDs such as
ibuprofen
• drugs that alter your kidney function such as
aminoglycoside, cephalosporin antibiotics,
amphotericin B and NSAIDs
• drugs that alter your hearing such as
aminoglycoside antibiotics, cisplatin
• drugs that alter your hormones including
the contraceptive pill and some anticancer
medications.
• drugs used to treat asthma (theophylline).
Patients should note that smoking tobacco
can reduce the effect of Frusene.
Frusene with food and drink
Take Frusene Tablets with a glass of water on
an empty stomach. See Section 3.
Large amounts of glycyrrhizin which is
contained in liquorice can affect how well
Frusene works. If you are unsure ask your
doctor or pharmacist for advice.
Pregnancy and breast-feeding
It is not recommended that you take Frusene
whilst you are pregnant or breast- feeding. Your
doctor will decide if the benefits outweigh the
risks.
Ask your doctor or pharmacist for advice
before taking any medicine.
If you are pregnant or breast-feeding, think you
might be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
At the start of therapy some patients may
experience dizziness or vertigo. If this occurs
then you should not drive or use machinery.
Frusene 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.

295817

PACKAGE LEAFLET:
INFORMATION FOR THE USER

• You will find that you have the urge to pass
water soon after taking your Frusene. Because
of this it is better to take your tablet(s) first
thing in the morning, so that you pass any
extra water early in the day, leaving you free
to go about your usual routine, undisturbed.
If your work is at night, it will be better for
you to take your tablets in the evening.
Children
Frusene is not recommended for use in
children.
Patients with Liver or Kidney Problems
Your doctor may start your treatment at lower
doses and monitor you very closely before
increasing the dosage.
If you take more Frusene than you should
If you accidentally take too much Frusene, you
may get rid of too much water and become
dehydrated. You may notice this by feeling
dizzy or having muscle cramps. If this happens,
drink plenty of water and see your doctor as
soon as possible.
If you forget to take Frusene
If you forget to take your usual dose, take it as
soon as you remember, then go on as before.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Frusene
Do not stop taking this medicine without
telling your doctor first. If you have any further
questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects
If you experience any of the following
side effects, contact your doctor or go to
your nearest hospital casualty department
immediately:
• Blistering of the skin with or without
blistering of mouth, eyes or genitals
• Skin rashes including red, raised, lumpy,
itchy or spotty rash
• Difficulty breathing
Other side effects
If you experience any of the side effects in the
lists below, contact your doctor
Very common (seen in more than 1 in 100
patients)
• Dry mouth and feeling thirsty (dehydration)
• Changes in blood levels of minerals (sodium,
potassium, calcium, magnesium) which
can cause tiredness and confusion, muscle
twitching, fits and coma
• Lowered blood pressure
• Feeling sick or being sick
• Diarrhoea
• Sometimes your urine may look slightly blue
in colour; this is nothing to worry about.
Uncommon (seen in between 1 in 100 and 1 in
1000 patients)
• High levels of uric acid in the blood and gout
which may cause swollen and painful joints
• Changes in blood cholesterol and triglyceride
levels
• Low blood volume which may make you feel
light headed
• Bladder problems such as loss of control,
being unable to urinate or changes in
frequency
• Changes in bowel movements
• Changes in kidney function and higher levels
of creatinine in the blood
• Muscle cramps
• Dizziness
• Pins and needles
• Restlessness, tiredness or headache
• Problems with your sight
• Irregular heartbeat
• Low blood pressure
• Changes to blood sugar levels
• Unexpected bruising
• Deafness (sometimes irreversible)

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Rare (seen in less than 1 in 1000 patients)
• Problems with your immune system and
red blood cells which can cause weakness,
pale skin, breathlessness, bruising or make
infections more likely
• Loss of hearing or ringing in your ears
• Liver and kidney problems and pancreatitis
• Kidney stones
• Increased sensitivity to sunlight
• High temperature
• Weakness
Frequency not known
• Reduction in white blood cells
• High levels of calcium in urine
• Hearing loss caused by problems in inner ear
or nerves
• Acute generalised exanthematous pustulosis
(AGEP) (acute febrile drug eruption)
• Dizziness, fainting and loss of consciousness
(caused by symptomatic hypotension)
Effects on newborn (especially premature)
babies
• Closure of the patent arterial duct may be
hindered after birth
• Reduced kidney function and blood in the
urine (Nephrocalcinosis )
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 Frusene
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 blister strip and
on the container. The expiry date refers to
the last day of that month.
• Store the tablets in their original container.
• Do not store above 30°C.
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 to
protect the environment.
6. Contents of the pack and other
information
What Frusene contains
• The active substances are furosemide
(40 mg) and triamterene (50 mg).
• The other ingredients are lactose, maize
starch, pregelatinised starch, gelatin,
polysorbate 80, sodium starch glycolate and
magnesium stearate.
What Frusene looks like and contents of
the pack
Frusene tablets are round pale-yellowish
tablets and are available in blister strips of
14 tablets. Your doctor will decide how many
tablets to prescribe for you.
Marketing Authorisation Holder
Orion Corporation, Orionintie 1,
FIN-02200 Espoo, Finland.
Manufacturer
Orion Corporation,
Orionintie 1,
FIN-02200 Espoo, Finland
Orion Corporation,
Tengströminkatu 8,
FIN-20360 Turku, Finland
Distributed in the UK by:
Orion Pharma (UK) Limited,
Oaklea Court,
22 Park Street,
Newbury,
Berkshire,
RG14 1EA
This leaflet was last revised in 11/2015

26.11.2015 8:02:04

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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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