Vonodiol 100 mcg / 20 mcg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levonorgestrel; Ethinylestradiol

Available from:

Theramex Ireland Limited

ATC code:

G03AA; G03AA07

INN (International Name):

Levonorgestrel; Ethinylestradiol

Dosage:

100 mcg/ 20 microgram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol

Authorization status:

Not marketed

Authorization date:

2009-08-07

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VONODIOL 100 MCG/20 MCG FILM-COATED TABLET
Levonorgestrel / Ethinylestradiol
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the first
year or when restarting a combined hormonal contraceptive following a
break of 4 or more weeks
•
Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see section
2 “Blood clots”)
WHAT IS IN THIS LEAFLET
1.
What Vonodiol is and what it is used for
2.
What you need to know before you take Vonodiol
3.
How to take Vonodiol
4.
Possible side effects
5.
How to store Vonodiol
6.
Contents of the pack and other information
1.
WHAT VONODIOL IS AND WHAT IT IS USED FOR
•
Vonodiol is a contraceptive pill used to prevent pregnancy.
•
Each tablet contains a small amount of two different female hormones,
namely levonorgestrel and
ethinylestradiol.
•
Contraceptive pills that contain two hormones are called
‘combination pills.’
Vonodiol is called a ‘low-dose’ contraceptive pill because it
contains only a small amount of hormones.
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VONODIOL
_ _
GENERAL NOTES
Before you start using Vonodiol you should read the information on
blood clots in section 2. It is
particularly important to read the symptoms of a blood

Summary of Product characteristics

Health Products Regulatory Authority
20 December 2022
CRN00D6Q4
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vonodiol 100 mcg / 20 mcg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mcg levonorgestrel and 20 mcg
ethinylestradiol
Excipient(s) with known effect
Each tablet contains 89.38 mg of lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Tablets are pink and rounded.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Vonodiol should take into consideration the
individual woman's current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with
Vonodiol compares with other combined hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Additional information about special populations
_Children and adolescents_
Vonodiol is only indicated after the menarche.
_Elderly patients_
Does not apply. Vonodiol is not indicated after menopause.
_Patients with hepatic impairment_
Vonodiol is contraindicated in women with severe hepatic disease (see
section 4.3).
_Patients with renal impairment_
No specific studies have been performed in patients with renal
insufficiency. The available data do not give cause a change of
treatment for this patient group.
Method of administration
Oral use
Posology
HOW TO TAKE VONODIOL TABLETS
Tablets must be taken orally in the order directed on the blister
package at about the same time every day, with some liquid if
necessary. One tablet is to be taken daily for 21 consecutive days.
Each subsequent pack is started after a 7-day tablet-free
interval, during which time a withdrawal bleed usually occurs. This
usually starts within 2 to 3 days after the last tablet and may
not end before the next pack is started.
Health Products Regulatory Authority
20 December 2022
CRN00D6Q4
Page 2 of 15
HOW TO START VONODIOL

No preced