FRUMIL TABLETS

Active substance: FUROSEMIDE

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Ref: 0181/130812/1/F

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Frumil Tablets
Patient Information Leaflet

Do not take this medicine, and tell your doctor, if you are taking:

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 any further questions, ask your doctor or 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

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The following medicines can affect the way Frumil work and increase
the chance of you getting side effects:

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In this leaflet:
1 What Frumil are and what they are used for
2 Before you take Frumil
3 How to take Frumil
4 Possible side effects

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5 How to store Frumil

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6 Further information

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What Frumil are and what they are used for

What Frumil are
The name of your medicine is Frumil 40mg/5mg Tablets (called Frumil
throughout this leaflet). Frumil contain two different medicines called:
furosemide and amiloride hydrochloride. Both belong to a group of
medicines called diuretics (water tablets).
What Frumil are used for
Frumil can be used to stop the build up of extra water in your body. This
extra water can cause swollen ankles, shortness of breath and feeling more
tired than usual.
How Frumil work
Frumil works by helping you to pass more water (urine) than you usually do.
If the extra water in your body is not removed, it can put extra strain on the
heart, blood vessels, lungs, kidneys or liver.
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Before you take Frumil

Do not take this medicine and tell your doctor if:

* You are allergic (hypersensitive) to furosemide, amiloride hydrochloride or
any of the other ingredients of Frumil (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
* You are allergic to sulphonamides such as sulfadiazine or co-trimoxazole
* You have severe problems with your kidneys
* You have severe liver problems
* Your doctor has told you that you have a low blood volume or are
dehydrated
* You are not passing any water (urine)
* You have too much or too little potassium or sodium in your blood (shown
in blood tests)
* You have an illness called ‘Addison's Disease’. This can make you feel
tired and weak
* You are breast-feeding (see “Pregnancy and breast-feeding” section
below)
* You are taking other medicines which change the amount of potassium in
your blood (see “Taking other medicines” section below)
* If the person taking the medicine is under 18 years. Frumil are not
suitable for children
Do not take Frumil if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking Frumil.
Take special care with Frumil
Check with your doctor or pharmacist before taking your medicine if:

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You have difficulty in passing water (urine)
You are 65 years of age or older
You have liver or kidney problems
You are an elderly patient with dementia and are also taking risperidone
You have diabetes
You have low blood pressure or feel dizzy when you stand up
You have prostate problems
You have gout
You feel dizzy or dehydrated. This can happen if you have lost a lot of
water through being sick, having diarrhoea or passing water very often. It
can also happen if you are having trouble drinking or eating
You are going to have a glucose test
You are taking any other water tablets

If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Frumil.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines you buy without a prescription,
including herbal medicines. This is because Frumil Tablets can affect the
way some other medicines work. Also, some medicines can affect the way
Frumil works.

Medicines which change the amount of potassium in your blood. These
include potassium supplements such as potassium chloride or certain
water tablets (diuretics) such as triamterene

Medicines such as ramipril, enalapril, perindopril (called ‘ACE inhibitors’) or
losartan, candesartan, irbesartan (called ‘angiotensin II receptor
antagonists’). Your doctor may need to change the dose of your tablets or
ask you to stop taking them
Medicines for high blood pressure or heart problems. Your doctor may
need to change the dose of your medicine
Medicines used as a general anaesthetic for relaxing your muscles during
surgery
Medicines for diabetes. These may not work as well when you are taking
Frumil
Theophylline - used for wheezing or difficulty in breathing
Phenytoin - used for epilepsy. This can lower the effect of Frumil

The following medicines can increase the chance of side effects when
taken with Frumil:

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Lithium - used for mental illnesses. To help stop side effects your doctor
may need to change the dose of your lithium and check the amount of
lithium in your blood.
Cisplatin - used for some cancers
Digoxin - used for heart problems. Your doctor may need to change the
dose of your medicine.
Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and
inflammation such as aspirin, ibuprofen, ketoprofen or indometacin
Carbamazepine - used for epilepsy
Aminoglutethimide - used for breast cancer
Ciclosporin - used to stop the rejection of organs after a transplant
Methotrexate - used for cancers of the skin, joint or bowel diseases
Carbenoxolone - used for ulcers of the food-pipe (gullet)
Reboxetine - used for depression
Amphotericin - used for fungal infections if used for a long time
Corticosteroids - used for inflammation such as prednisolone
Liquorice - often used in cough medicines if taken in large amounts
Probenecid (used with another HIV medicine)
Medicines for infection such as gentamicin, amikacin, neomycin, netilmicin,
tobramycin, vancomycin or high doses of cephalosporins
Medicines used as injections before X-ray examinations
Medicines used for constipation (laxatives) if used for a long time such as
bisacodyl or senna
Medicines for asthma when given in high doses such as salbutamol,
terbutaline sulphate, salmeterol, formoterol or bambuterol
Other water tablets (diuretics) such as bendroflumethiazide. Your doctor
may need to change the dose of your medicine

Pregnancy and breast-feeding
Do not take Frumil if you are pregnant. Talk to your doctor before taking this
medicine if you are pregnant, might become pregnant, or think you might be
pregnant.
Do not breast-feed if you are taking Frumil Tablets. This is because small
amounts may pass into the mothers milk. Talk to your doctor before taking
this medicine if you are breast-feeding or planning to breast-feed. Ask your
doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.
Driving and using machines
You may feel dizzy or unwell after taking Frumil. If this happens, do not drive
or use any tools or machines.
Important information about some of the ingredients of Frumil
This medicine contains:

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A colour called ‘sunset yellow E110’. This may cause allergic reactions
Lactose. If you have been told by your doctor that you cannot tolerate
some sugars, talk to your doctor before taking this medicine

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How to take Frumil

Always take Frumil exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Taking this medicine

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Take this medicine by mouth
Swallow the tablets whole with a drink of water
If you feel the effect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor

Ref: 0181/130812/1/B

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Frumil Tablets
Patient Information Leaflet (continued)

Blood tests

How much Frumil to take
The usual dose is one or two tablets first thing in the morning. Your doctor
will tell you how many tablets to take.

Frumil can change the levels of liver enzymes or body fats known as
cholesterol and triglycerides shown up on blood tests.

If you are taking sucralfate (a medicine for stomach ulcers)
Do not take sucralfate at the same time as Frumil. Take your dose at least 2
hours before or after Frumil. This is because it can affect the way your
medicine works.

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

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How to store Frumil

If you take more Frumil than you should
If you think you may have taken more Frumil than you should, or if a child
has swallowed any of your tablets, tell your doctor or go to your nearest
hospital casualty department straight away. Remember to take with you any
medicine that is left so the doctor knows what you have taken.

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The following effects may happen: dry mouth, feeling thirsty, muscle pain or
cramps, feeling sick or being sick (vomiting), weak or uneven heartbeat,
feeling dizzy, weak or sleepy.

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.

If you forget to take Frumil
If you forget a dose, take it as soon as you remember it. Then continue the
following morning as normal. Do not take a double dose to make up for a
forgotten dose.

EXPIRY DATE
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets
to your pharmacist (chemist) for safe disposal. Only keep this medicine, if
your doctor tells you to. If your tablets becomes discoloured or shows any
other signs of deterioration, consult your pharmacist (chemist) who will tell
you what to do.

If you stop taking Frumil
Keep taking Frumil until your doctor tells you to stop taking it.

Keep out of the sight and reach of children.
Do not store above 25°C. Store in a dry place and protect from light.
Do not take your tablets out of the blister strip until it is time to take your
dose.

Blood tests
Your doctor may carry out blood tests to check that the levels of some salts
in the blood are at the correct levels.
6
If you have any further questions on the use of this product, ask your doctor
or pharmacist

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Possible side effects

Like all medicines, Frumil can cause side effects, although not everybody
gets them.
Tell a doctor straight away if you notice any of the following serious
side effects – you may need urgent medical treatment

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If you have an allergic reaction. The signs may include inflammation of the
kidney (nephritis), swollen ankles or high blood pressure, skin rashes,
change in skin colour, severe blistering of the skin, being more sensitive to
the sun than usual, high temperature (fever), and itching
Severe allergic reactions. The signs may include shock such as difficulty in
breathing, cold clammy skin, pale skin colour and racing heart beat
Severe stomach or back pain. These could be signs of ‘pancreatitis’
Bruising more easily, getting more infections, feeling weak or tired more
than usual. Frumil can affect the number of blood cells, causing serious
blood problems.
Increased thirst, headache, feeling dizzy or light-headed, fainting,
confusion, muscle or joint pains or weakness, cramps or spasms, stomach
upsets or uneven heartbeats.
These could be signs of dehydration or changes in your normal body
chemicals. Severe dehydration can also lead to blood clots or ‘gout’
You notice yellowing of your skin or eyes and your urine becomes darker
in colour. These could be signs of a liver problem. In patients who already
have liver problems, a more serious liver problem known as liver
encephalopathy may occur. Symptoms include forgetfulness, fits, mood
changes and coma.
Blistering or peeling of the skin around the lips, eyes, mouth, nose and
genitals, flu-like symptoms and fever. This could be a condition called
Stevens-Johnson syndrome. In a more severe form of the condition called
Toxic Epidermal Necrolysis, layers of the skin may peel off to leave large
areas of raw exposed skin all over the body

Tell a doctor as soon as possible if you have any of the following side
effects:

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Problems hearing or ringing in the ears (tinnitus). This especially affects
people who already have problems with their kidneys
Tingling or feeling numb on the skin
Small changes in your mood such as feeling agitated or anxious.
Headaches, feeling dizzy or light-headed when standing up quickly. Also
loss of concentration, slower reactions, feeling sleepy or weak, problems
with your sight, dry mouth. This could be due to low blood pressure

Tell your doctor or pharmacist if any of the following side effects get
serious or lasts longer than a few days, or if you notice any side effects
not listed in this leaflet

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Feeling sick (nausea) or a general feeling of being unwell, diarrhoea and
being sick (vomiting) and constipation
People with bladder and prostate problems may notice pain when passing
water. This is due to an increase in the amount of water passed
If you have diabetes you may be less able to control the levels of glucose
in your blood
Passing more water (urine) than you usually do. This normally happens 1
or 2 hours after taking this medicine

Further information

What Frumil contains:
Each tablet contains 40mg furosemide (frusemide) and amiloride
hydrochloride equivalent to 5mg anhydrous amiloride hydrochloride as the
active ingredients.
Your medicine also contains the following inactive ingredients:
lactose, microcrystalline cellulose, sodium starch glycollate, magnesium
stearate, maize starch, talc, colloidal anhydrous silica and sunset yellow
(E110).
What this medicine looks like and contents of the pack
Frumil are round, orange tablets with a score line and marked 'FRUMIL' on
one side.
Each calendar blister pack contains 28 tablets.
IMPORTANT
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours.
This leaflet does not tell you everything about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist
(chemist). He/she will have additional information about this medicine and
will be able to advise you.
Manufacturer and Licence Holder
The tablets are manufactured by Sanofi-Aventis SpA, Strada Statale 17, km.
22, 67019 Scoppito (L’Aquila), Italy and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

PL Number: 15184/0181

Frumil is a registered trademark of Rorer Health Care Limited.
Revision date: 13/08/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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