Frumil LS 20mg/2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiloride hydrochloride; Furosemide

Available from:

Sanofi

ATC code:

C03EB01

INN (International Name):

Amiloride hydrochloride; Furosemide

Dosage:

2.5mg ; 20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020400; GTIN: 5000283652243 5000283652250

Patient Information leaflet

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_PACK. ITEM:_
ARKHÉ S.N.C.
Tel. [phone]
fax [phone]
1 - Prima realizzazione
 REFLEX BLUE
SANOFI S.P.A.
Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.
14-09-2017
IST FRUMIL LS 20/2,5MG
GB I02
ISTRUZIONI
GB: GREAT BRITAIN
89032265
89030906
62C0007 V.1.0
00101100000
167 X 315MM DP
1
-
-
11 PT SU 12 PT
4, 1 / 4
• 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)
• Lichenoid reactions, characterized as small,
itchy reddish-purple, polygon-shaped lesions
on the skin, genitals or in the mouth.
BLOOD TESTS
Frumil LS can change the levels of liver
enzymes or body fats such as cholesterol and
triglycerides shown up on blood tests.
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. 5. HOW TO STORE FRUMIL LS TABLETS
• Keep this medicine out of the sight and reach
of children.
• Do not take Frumil LS 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.
Medicines should not be disposed of

Summary of Product characteristics

OBJECT 1
FRUMIL LS
Summary of Product Characteristics Updated 18-May-2018 | SANOFI
1. Name of the medicinal product
Frumil LS 20 mg/2.5 mg Tablets
2. Qualitative and quantitative composition
The active ingredient is Furosemide 20.0mg and amiloride hydrochloride
equivalent to 2.5mg anhydrous
amiloride hydrochloride.
For excipients, see section 6.1
3. Pharmaceutical form
Tablets for oral administration.
4. Clinical particulars
4.1 Therapeutic indications
Frumil LS 20 mg/2.5 mg Tablets is a potassium sparing diuretic which
is indicated where a prompt
diuresis is required. It is of particular value in conditions where
potassium conservation is important:
congestive cardiac failure, nephrosis, corticosteroid therapy,
oestrogen therapy and for ascites associated
with cirrhosis.
4.2 Posology and method of administration
Adults: One or two tablets to be taken in the morning.
Children: Not recommended for children under 18 years of age as safety
and efficacy have not been
established.
Elderly: The dosage should be adjusted according to the diuretic
response; serum electrolytes and urea
should be carefully monitored.
4.3 Contraindications
Patients with hypovolaemia or dehydration (with or without
accompanying hypotension). Patients with an
impaired renal function and a creatinine clearance below 30ml/min per
1.73 m
2
body surface area, anuria
or renal failure with anuria not responding to furosemide, renal
failure as a result of poisoning by
nephrotoxic or hepatotoxic agents or renal failure associated with
hepatic coma, hyperkalaemia, severe
hypokalaemia, severe hyponatraemia, concomitant potassium supplements
or potassium sparing diuretics,
precomatose states associated with cirrhosis, Addison's disease, and
breast feeding women.
Frumil LS 20 mg/2.5 mg Tablets is contraindicated in children and
adolescents under 18 years of age as
safety in this age group has not yet been established.
Hypersensitivity to furosemide, amiloride, sulphonamides or
sulphonamide derivatives, or any of the
excipients of the product.
4.4 Special