Minoxidil YES PDS 2.5 mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

YES Pharmaceutical Development Services GmbH Basler Straße 7 61352 Bad Homburg , Germany

ATC code:

C02DC01

INN (International Name):

MINOXIDIL 2.5 mg

Pharmaceutical form:

TABLET

Composition:

MINOXIDIL 2.5 mg

Prescription type:

POM

Therapeutic area:

ANTIHYPERTENSIVES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-11-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MINOXIDIL YES PDS TABLETS
(Minoxidil YES PDS 2.5 mg Tablets)
(Minoxidil YES PDS 10 mg Tablets)
minoxidil
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of your product is Minoxidil YES PDS 2.5 mg or 10 mg Tablets,
but it will be referred to as
Minoxidil YES PDS Tablets throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Minoxidil YES PDS Tablets are and what they are used for
2.
What you need to know before you take Minoxidil YES PDS Tablets
3.
How to take Minoxidil YES PDS Tablets
4.
Possible side effects
5.
How to store Minoxidil YES PDS Tablets
6.
Contents of the pack and other information
1.
WHAT MINOXIDIL YES PDS TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine is prescribed by your doctor to lower your blood
pressure and belongs to a group of
medicines called antihypertensive drugs. The active substance is
minoxidil.
Minoxidil YES PDS Tablets are used, when other medicines – even in
combination (usual triple
combination) – cannot achieve adequate blood pressure control
(therapy-resistant hypertension).
Minoxidil YES PDS Tablets should be given in conjunction with a
medicine to help your body get rid
of excess water (diuretic) and a medicine to inhibit the effect of
adrenaline (beta-blocker) (see section
2).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINOXIDIL YES PDS TABLETS
DO NOT TAKE MINOXIDIL YES PDS TABLETS
•
If you are allergic (hypersensitive) to minoxidil or any of the other
ingredients of this medicine
(listed in section 6).
•
If you suffer fr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Minoxidil YES PDS 2.5 mg Tablets
Minoxidil YES PDS 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil YES PDS 2.5 mg Tablets
Each tablet contains 2.5 mg of minoxidil.
Minoxidil YES PDS 10 mg Tablets
Each tablet contains 10 mg of minoxidil.
Excipients with known effect
Each 2.5 mg tablet contains 55.81 mg of lactose.
Each 10 mg tablet contains 223.25 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Minoxidil YES PDS 2.5 mg Tablets
Round, white to off white tablets, approximately 5.5 mm in diameter,
with score line on one
side and “2.5” engraved on the other side. The score line is not
intended for breaking the
tablet.
Minoxidil YES PDS 10 mg Tablets
Round, white to off white tablets, approximately 9 mm in diameter,
with score line on one
side and “10” engraved on the other side. The tablet can be
divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension when maximum therapeutic doses of other
antihypertensive drugs,
even when used in combination (combination of beta-adrenergic blocking
agent with a
diuretic and a vasodilator or comparable triple combinations), have
not shown sufficient
success (therapy-resistant hypertension).
Minoxidil should be given in conjunction with a diuretic and a
beta-adrenergic blocking agent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Patients over 12 years and adults _
The recommended starting dose is 5 mg per day. If required, this
dosage can later be increased
to 20 mg, and then to 40 mg daily (given as a single dose or in two
divided doses). Dose
increases should be made at increments of 5 mg to 10 mg minoxidil per
day at intervals of
three or more days. If a dose of 50 mg of minoxidil has been reached,
the dose may be
increased by 25 mg minoxidil per day to a maximum dose of 100 mg per
day.
If the desired decrease of diastolic blood pressure exceeds 30 mmHg,
the dosage should be
divided into two