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FRUMIL 40 MG/5 MG TABLETS

Active substance: FUROSEMIDE

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62C0006

89028843

4/4

13-05-2015
IST FRUMIL 40/5MG GB I02

Istruzione

89026687

89028843

PACK. ITEM:
167 x 304,8 DP
3

1
-

4e1

11 pt su 13 pt

How Frumil Tablets work
Frumil Tablets work 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.

0011001010

What Frumil Tablets are used for
Frumil Tablets 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.

GB: GREAT BRITAIN

What Frumil Tablets are
The name of your medicine is Frumil 40mg/5mg
Tablets (called Frumil Tablets throughout this
leaflet). Frumil Tablets contain two different
medicines called: furosemide and amiloride
hydrochloride. Both belong to a group of
medicines called diuretics (water tablets).

Sanofi S.p.A.

1. What Frumil Tablets are and
what they are used for

Warnings and precautions
Talk to your doctor or pharmacist before
taking Frumil Tablets if:
c You have difficulty in passing water (urine)
c You are 65 years of age or older
c You have liver or kidney problems
c You are an elderly patient with dementia and
are also taking risperidone
c You have diabetes
c You have low blood pressure or feel dizzy
when you stand up
c You have prostate problems
c You have gout
c 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
c You are going to have a glucose test
c You are taking any other water tablets
c You have systemic lupus erythematosus
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Frumil Tablets.

„ Reflex Blue

© Sanofi, 1983 - 2015

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

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

This leaflet was last revised in 05/2015

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.

Arkhé S.n.c.

This leaflet does not contain all the
information about your medicine. If you have
any questions or are not sure about anything,
ask your doctor or pharmacist.

Phone 0845 372 7101 for help

Tel. 0862.404140
fax 0862.404140

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.

Manufacturer
Sanofi S.p.A.
Strada Statale 17, Km 22,
67019 Scoppito (L’Aquila),
Italy

Is this leaflet hard to see or
read?

Do not take Frumil Tablets if:
² You are allergic (hypersensitive) to
furosemide, amiloride hydrochloride or any
of the other ingredients of this medicine
(listed in Section 6)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
² You are allergic to sulphonamides such as
sulfadiazine or co-trimoxazole
² You have severe problems with your kidneys
² You have severe liver problems
² Your doctor has told you that you have a
low blood volume or are dehydrated
² You are not passing any water (urine)
² You have too much or too little potassium or
sodium in your blood (shown in blood tests)
² You have an illness called ‘Addison’s
Disease’. This can make you feel tired and
weak.
² You are breast-feeding (see “Pregnancy and
breast-feeding” section below)
² You are taking other medicines which
change the amount of potassium in your
blood (see “Taking other medicines” section
below)
² If the person taking the medicine is under
18 years. Frumil Tablets are not suitable for
children
Do not take Frumil Tablets if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Frumil Tablets.

4 - Modifica Testo reg.

• Keep this medicine out of the sight and
reach of children.
• Do not take Frumil Tablets after the expiry
date which is stated on the carton and
blister pack after EXP. The expiry date refers
to the last day of that month
• Store below 25°C. Keep the blister strip in
the outer carton in order to protect from
light and moisture.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com

Furosemide 40mg
Amiloride Hydrochloride 5mg

3 - Modifica Testo reg.

5. How to store Frumil Tablets

What Frumil Tablets look like and
contents of the pack
Frumil Tablets are orange, evenly mottled
circular tablets with bevel edges and ‘FRUMIL’
embossed on one side, with a breakline on the
other side.
Your tablets are available in blister packs of 4, 7,
28, 56 and 1400 tablets or bottles containing 50,
100 or 500 tablets.
Not all pack sizes may be marketed.

Frumil 40mg/5mg
Tablets

2. What you need to know before you take
Frumil Tablets

2 - Modifica dimensione logo

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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.

What Frumil Tablets contain
One of the active ingredients in this medicine
is furosemide 40mg. This is the new name for
frusemide 40mg. The ingredient itself has not
changed
• The active substances are furosemide
and amiloride hydrochloride. Each tablet
contains 40mg furosemide and 5mg amiloride
hydrochloride (as anhydrous)
• The other ingredients are lactose, maize
starch, microcrystalline cellulose, sodium
starch glycollate, talc, sunset yellow dye (E110),
colloidal anhydrous silica and magnesium
stearate

PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

89028843 1/4

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

6. Contents of the pack and other
information

1 - Prima realizzazione

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
• 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.
• Symptoms vary considerably between
patients but the most common are: joint
aches and pains, swollen joints, headaches,
increased sensitivity to sunlight, skin
rashes, kidney problems, fatigue and
weakness, mouth ulcers, hair loss, anxiety
and depression, fevers and night sweats,
abdominal pain, chest pain, shortness
of breath, anaemia (Systemic lupus
erythematosus)

Other medicines and Frumil Tablets
Please tell your doctor or pharmacist if you
are taking or have recently taken, or might
take 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 Tablets work.

62C0006

89028843

2/4

13-05-2015
IST FRUMIL 40/5MG GB I02

Istruzione

89026687

89028843

PACK. ITEM:
167 x 304,8 DP
3

2
-

2e3

11 pt su 13 pt

If you have any further questions on
the use of this medicine, ask your doctor
or pharmacist.

0011001010

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.

Tell a doctor as soon as possible if you
have any of the following side effects:
• Problems hearing or ringing in the ears
(tinnitus). This especially affects people who
already have problems with their kidneys
• Deafness
• 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

Sanofi S.p.A.

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

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

If you forget to take Frumil Tablets
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.

Arkhé S.n.c.

If you take more Frumil Tablets than you
should
If you think you may have taken more
Frumil Tablets than you should, or if a child
has swallowed any of your tablets, tell your
doctor or got 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. 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.

GB: GREAT BRITAIN

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

„ Reflex Blue

How much Frumil Tablets 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.

Tell a doctor straight away if you notice
any of the following serious side effects –
you may need urgent medical treatment
• 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 Tablets 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.

Tel. 0862.404140
fax 0862.404140

Frumil Tablets contain Sunset Yellow and
Lactose
This medicine contains:
• 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

Taking this medicine
• 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

4 - Modifica Testo reg.

Driving and using machines
You may feel dizzy or unwell after taking
Frumil Tablets. If this happens, do not drive or
use any tools or machines.

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

3 - Modifica Testo reg.

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 breastfeeding or planning to breast-feed. Ask your
doctor or pharmacist for advice before taking
any medicine if you are pregnant or breastfeeding.

Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.

2 - Modifica dimensione logo

The following medicines can increase the
chance of side effects when taken with
Frumil Tablets:
• 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 foodpipe (gullet)

Pregnancy and breast-feeding
Do not take Frumil Tablets 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.

4. Possible side effects

89028843 3/4

The following medicines can affect the way
Frumil Tablets work and increase the
chance of you getting side effects:
• 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 Tablets.
• Theophylline - used for wheezing or
difficulty in breathing
• Phenytoin - used for epilepsy. This can lower
the effect of Frumil Tablets

3. How to take Frumil Tablets

1 - Prima realizzazione

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

• 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

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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