Co-amilofruse 2.5mg/20mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Amiloride hydrochloride; Furosemide

Saatavilla:

Wockhardt UK Ltd

ATC-koodi:

C03EB01

INN (Kansainvälinen yleisnimi):

Amiloride hydrochloride; Furosemide

Annos:

2.5mg ; 20mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 02020400; GTIN: 5012727900759 5012727902180

Pakkausseloste

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
• Removed pre-printed L.I.No. from pg1/2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMILOFRUSE 2.5MG/20MG TABLETS
CO-AMILOFRUSE 5MG/40MG TABLETS
CO-AMILOFRUSE 10MG/80MG TABLETS
Amiloride Hydrochloride and Furosemide
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, please
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.
WHAT IS IN THIS LEAFLET:
1. What Co-Amilofruse Tablets are and
what they are used for
2. What you need to know before you take
Co-Amilofruse Tablets
3. How to take Co-Amilofruse Tablets
4. Possible side effects
5. How to store Co-Amilofruse Tablets
6. Contents of the pack and other
information
1. WHAT CO-AMILOFRUSE TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is
Co-Amilofruse Tablets. Co-Amilofruse
Tablets contain two different medicines
called: furosemide and amiloride
hydrochloride. Both belong to a group of
medicines called diuretics (water tablets).
WHAT CO-AMILOFRUSE TABLETS ARE USED FOR
Co-Amilofruse 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.
HOW CO-AMILOFRUSE TABLETS WORK
Co-Amilofruse 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CO-AMILOFRUSE TABLETS
DO NOT TAKE CO-AMILOFRUSE

Valmisteyhteenveto

OBJECT 1
CO-AMILOFRUSE 2.5MG/20MG TABLETS
Summary of Product Characteristics Updated 11-Apr-2018 | Wockhardt UK
Ltd
1. Name of the medicinal product
Co-Amilofruse 2.5mg/20mg Tablets
2. Qualitative and quantitative composition
Furosemide 20mg
Amiloride Hydrochloride (dihydrate) 2.84mg
Excipient with known effect:
Lactose: 42.1mg per tablet
Sunset Yellow FCF: 0.1mg per tablet
Sodium: 0.1mg per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet for oral use.
4. Clinical particulars
4.1 Therapeutic indications
Co-Amilofruse 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
The starting dose is usually 40/5mg, subsequent dosage being adjusted
to suit the needs of the patient.
_Adults:_
One to two tablets to be taken in the morning.
_Children:_
Not indicated for children under 18 years of age.
_Elderly:_
The dosage should be adjusted according to 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 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 (see section 4.8), severe hyponatraemia, concomitant
potassium supplements or potassium
sparing diuretics, precomatose states associated with cirrhosis,
Addison's disease, and breast feeding
women.
Co-amilofruse is contraindicated in children and adolescents under 18
years of age as safety in this age
group has not yet been established.
Hypersensi