Enalapril 5mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Enalapril maleate

Pieejams no:

Milpharm Ltd

ATĶ kods:

C09AA02

SNN (starptautisko nepatentēto nosaukumu):

Enalapril maleate

Deva:

5mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 02050501; GTIN: 5060035110254

Lietošanas instrukcija

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
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 is Enalapril maleate Tablet and what
is it used for.
2.
What you need to know before you take
Enalapril maleate Tablets
3.
How to take Enalapril maleate Tablet
4.
Possible side effects
5.
How to store Enalapril maleate Tablet
6.
Contents of the pack and other information
1.
WHAT ENALAPRIL MALEATE TABLETS
ARE AND WHAT THEY ARE USED FOR
Enalapril maleate belongs to the class of
medicines called Angiotensin converting
enzyme inhibitors (ACE inhibitors). It works by
causing blood vessels to relax, lowering blood
pressure and increasing the supply of blood
and oxygen to the heart.
Enalapril maleate Tablets are used
•
To treat high blood pressure (hypertension)
•
To treat heart failure (weakening of heart
function). It can lower the need to go to
hospital and can help some patients live
longer.
•
To prevent signs of heart failure. The signs
include shortness of breath, tiredness after
light physical activity such as walking, or
swelling of the ankles and feet.
This medicine works by widening your blood
vessels. This lowers your blood pressure. The
medicine usually starts to work within an hour,
and the effect lasts for at least 24 hours. Some
people will require several weeks of treatment
until the best effect on your blood pressure is
seen.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ENALAPRIL MALEATE
TABLETS
DO NOT TAKE ENALAPRIL MALEATE TABLETS
•
If you are allergic (hypersensitive) to
enalapril maleate, any of the other ingredients
in these tablets or other ACE inhibitors (see
Section 6

Produkta apraksts

OBJECT 1
ENALAPRIL 5MG TABLETS
Summary of Product Characteristics Updated 25-Mar-2020 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Enalapril Maleate 5mg tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg Enalapril maleate.
Excipient: each tablet contains 79.8 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets
White to off-white round flat bevelled edged tablets marked with
“5” on one side and break line on the
other.
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of hypertension
• Treatment of symptomatic heart failure
• Prevention of symptomatic heart failure in patients with
asymptomatic left ventricular dysfunction
(ejection fraction ≤35%)
(See section 5.1).
4.2 Posology and method of administration
Posology
Food does not interfere with the absorption of enalapril.
The dose should be individualized according to patient pr