Clonidine hydrochloride 50micrograms/5ml Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLONIDINE HYDROCHLORIDE

Available from:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

ATC code:

N02CX02

INN (International Name):

CLONIDINE HYDROCHLORIDE 50 µg/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

CLONIDINE HYDROCHLORIDE 50 µg/5ml

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2019-02-13

Patient Information leaflet

VAR/IA-010
1.3.1 Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLONIDINE HYDROCHLORIDE 50MICROGRAMS/5ML ORAL SOLUTION
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 medicine is Clonidine hydrochloride 50micrograms/5ml
Oral Solution but
it will be referred to as ‘Clonidine hydrochloride’ throughout
this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Clonidine hydrochloride is and what it is used for
2.
What you need to know before you take Clonidine hydrochloride
3.
How to take Clonidine hydrochloride
4.
Possible side effects
5.
How to store Clonidine hydrochloride
6.
Contents of the pack and other information
1.
WHAT CLONIDINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Clonidine hydrochloride belongs to a group of medicines called
vasodilators. Vasodilators
widen the blood vessels and this helps the blood to flow more easily.
Clonidine hydrochloride is used to prevent migraine attacks and
similar types of headache. It
is also used to prevent hot flushes that may occur in women during the
menopause (change of
life).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLONIDINE HYDROCHLORIDE
DO NOT TAKE CLONIDINE HYDROCHLORIDE IF:

you are pregnant, likely to get pregnant or are breast-feeding

you are allergic (hypersensitive) to clonidine or any of the other
ingredients listed in
section 6

you have a slow heart rate due to heart problems

you are already taking other medicines that contain clonidine.
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to yo

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clonidine hydrochloride 50micrograms/5ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 50micrograms clonidine
hydrochloride.
Excipients with known effect:
Each 5ml of oral solution contains 9mg methyl parahydroxybenzoate
(E218).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution
A clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
a)
The prophylactic management of migraine or recurrent vascular
headache.
b)
The management of vasomotor conditions commonly associated with the
menopause and
characterised by flushing.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
Initially 5ml (50micrograms) twice daily. If after two weeks there has
been no remission, increase to
7.5ml (75micrograms) twice daily.
The duration of treatment depends upon the severity of the condition.
If symptoms continue to occur the patient should be informed that it
may take 2-4 weeks until
Clonidine hydrochloride is fully effective.
ELDERLY:
No specific information on the use of this product in the elderly is
available.
Clinical trials have included patients over 65 years and no adverse
reactions specific to this age
group have been reported.
PAEDIATRIC POPULATION:
There is insufficient evidence for the application of clonidine in
children and adolescents younger
than 18 years. Therefore the use of clonidine is not recommended in
paediatric subjects under 18
years.
Page 2 of 8
PATIENTS WITH RENAL IMPAIRMENT
Clonidine hydrochloride should be used with caution in patients with
renal insufficiency. Careful
monitoring of blood pressure is required.
4.3
CONTRAINDICATIONS
Clonidine hydrochloride should not be used in patients with severe
bradyarrhythmia resulting from
either sick-sinus syndrome or AV block of 2nd or 3rd degree, or
hypersensitivity to the clonidine
hydrochloride or to any of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS