Frumil 40mg/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:

5mg ; 40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020400; GTIN: 5000283652229 5000283652236

Patient Information leaflet

89032264 4/4
89032264 1/4
_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.
15-09-2017
IST FRUMIL 40/5MG GB I02
ISTRUZIONI
GB: GREAT BRITAIN
89032264
89030907
62C0007 V.1.0
00101010000
167 X 315MM DP
1
-
-
11 PT SU 12 PT
4, 1 / 4
• 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
Tablets
can change the levels of liver
enzymes or body fats known 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 TABLETS
• 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.
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. 6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT FRUMI

Summary of Product characteristics

OBJECT 1
FRUMIL
Summary of Product Characteristics Updated 18-May-2018 | SANOFI
1. Name of the medicinal product
Frumil 40 mg/5 mg Tablets
2. Qualitative and quantitative composition
The active ingredient is Furosemide 40.0mg and amiloride hydrochloride
equivalent to 5.0mg anhydrous
amiloride hydrochloride.
For excipients, see section 6.1
3. Pharmaceutical form
Tablets for oral administration.
4. Clinical particulars
4.1 Therapeutic indications
Frumil 40 mg/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 40 mg/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 warnings and prec