CLONIDINE HYDROCHLORIDE 25 MICROGRAM TABLETS

Active substance: CLONIDINE HYDROCHLORIDE

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Booklet PIL

Auden Mckenzie

Outside Front Page

Outside Back Page

Group

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to dispose
of medicines no longer required. These measures will help to protect the environment.

PATIENT INFORMATION LEAFLET

Clonidine Hydrochloride 25 microgram Tablets

6. Further information
What Clonidine Hydrochloride 25 microgram Tablets contain
Active substance:
Each tablet contains clonidine hydrochloride 25 micrograms.
Other ingredients: Microcrystalline cellulose, maize starch, pregelatinised maize starch, lactose
monohydrate, talc, sodium starch glycolate Type A and magnesium stearate.
Each box of Clonidine Hydrochloride 25 microgram Tablets contains 112 white to off-white, circular
tablets with ‘CD 25’ engraved on one side, in 4 blister strips of 28 tablets each.

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.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Clonidine Hydrochloride and what is it used for?
2. Before you take Clonidine Hydrochloride 25 microgram Tablets
Do not take Clonidine Hydrochloride 25 microgram Tablets…
Other things to do or know before you take the tablets
Taking other medicines
Pregnancy and breast feeding
Driving and using machines
Important information about some of the ingredients in Clonidine Hydrochloride
25 microgram Tablets
3. How to take Clonidine Hydrochloride 25 microgram Tablets
§
§
§
§
§
§

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House
Bury Street, Ruislip
Middlesex

§
Usual recommended dose
§
If you forget to take a dose
§
If you take too many tablets
4. Possible side effects

HA4 7TL
UK

5. How to store Clonidine Hydrochloride 25 microgram Tablets

Manufacturer

6. Further information

Auden Mckenzie (Pharma Division) Ltd
Mckenzie House

1. What is Clonidine Hydrochloride and what is it used for?

Bury Street, Ruislip

Clonidine Hydrochloride 25 microgram Tablets belong to a group of medicines called ‘vasodilators’,
which cause widening of the blood vessels and therefore an increase in blood flow.

Middlesex
HA4 7TL
Product

Clonidine Hydrochloride 25mcg Tablets (AM)

Strength

25 mcg

Pack Size(s)

112

Artwork

Patient Information Leaflet - Bafna

PIL Code

P0094-10-02/3

Supersedes (PIL Code)

P0094-10-02/2

Author

MP-AUD

Date

03.11.10

Artwork Reference / Version

P0094-10-02/3 DS - rev 10.04.2013

AW/V

002/1

Notes

Variation
PL 17507/0094

Your doctor has prescribed Clonidine Hydrochloride 25 microgram Tablets for you to prevent attacks of
migraine and similar types of headache. The tablets are also used to prevent hot flushes that may
occur in women during the menopause (‘change of life’).

UK
This leaflet was last approved in April 2013.

For information in large print, tape, CD or Braille, telephone 01895 627 420

Scaling 1:1
Mc kenzie House, Bury Street,

Pantone
Process
Black

Ruislip, Middlesex HA4 7TL.
Tel: 01895 627 420
info@audemmc kenzie.com

§
Auden Mckenzie

if you think that you may have had an allergic, or any other type of, reaction to Clonidine
Hydrochloride 25 microgram Tablets, or a similar medicine, in the past. An allergic reaction may
be recognised as a rash, itching, swollen face or lips, or shortness of breath;
if you have a slow heart rate resulting from a disease of the heart called ‘sick-sinus syndrome’ or
severe heart problems.

Clonidine Hydrochloride 25 microgram Tablets must only be used to treat the condition(s) your doctor
has given you this medicine for.
P0094-10-02/3

© Auden Mc kenzie (Pharma Division) Ltd,

Do not take Clonidine Hydrochloride 25 microgram Tablets:
§

Clonidine Hydrochloride 25 microgram Tablets
PL 17507/0094
PA 1352/4/1
Auden Mckenzie (Pharma Division) Ltd.

Colour Specifications

2. Before you take Clonidine Hydrochloride 25 microgram Tablets

Page 4 of 4

Page 1 of 4

Inside Page 2

Auden Mckenzie

Inside Page 3

Other things to do or know before you take the tablets

Group

If the answer to any of the following questions is ‘Yes’, you may still be able to take Clonidine
Hydrochloride 25 microgram Tablets, but you should discuss this with your doctor before taking the
tablets:

3. How to take Clonidine Hydrochloride 25 microgram Tablets
Take the tablets by mouth, exactly as your doctor, pharmacist or medicine label tells you to.

§

Do you have cerebrovascular disease (problems with blood flow to the brain)?

§

Do you have heart or severe kidney problems?

§

Do you suffer from cold and numb hands and feet, eg Raynaud’s disease?

Adults over 18 years:

Two to three tablets twice a day

§

Do you suffer from constipation?
Have you ever suffered from depression?

Children & Adolescents:

§

The use of clonidine is not recommended in paediatric patients
under 18 years.

The usual recommended dose is as follows:

As you may get dry eyes whilst taking this medicine, this may be a problem if you wear contact lenses.
Taking other medicines

The tablets should be swallowed whole with water, with or without food.
It may take 2 to 4 weeks for the medicine to work properly.

Always tell your doctor if you are taking any other medicines (including those you bought yourself
without a prescription) because taking some medicines together with Clonidine Hydrochloride
25 microgram Tablets can be harmful.

If you take too many tablets
Contact your doctor or pharmacist as soon as possible. Always take the labelled medicine container
with you whether or not there are any Clonidine Hydrochloride 25 microgram Tablets left.

In particular, you should tell your doctor if you are taking any of the following medicines, as they can
affect the way the tablets work:

If you forget to take a dose
Take a dose as soon as you remember, then carry on as before.

§

certain medicines used to lower blood pressure (antihypertensives and alpha-blockers); alphablockers are medicines also used to treat swelling of the prostate gland

§

certain medicines that relax blood vessels (vasodilators)

§

water tablets (diuretics)

§

medicines which are often used to slow the heart rate or lower the blood pressure (beta blockers)

§

medicines used to treat heart failure (cardiac glycosides)

§

certain medicines used to treat depression (tricyclic antidepressants)

§

other antidepressants, eg mirtazapine

§

certain medicines used to relieve anxiety such as tranquillisers, hypnotics (and also alcohol)
(neuroleptics)

4. Possible side effects
Like all medicines, these tablets may cause side effects, although not everyone gets them.

Pregnancy and breast feeding
Tell the doctor if you are pregnant, think you might be pregnant or are trying to become pregnant.
Clonidine Hydrochloride 25 microgram Tablets can reach your baby and may lower your baby’s heart
rate.
Clonidine Hydrochloride 25 microgram Tablets are not recommended for use while breast feeding; tell
your doctor if you are breast feeding.

Clonidine Hydrochloride 25 microgram Tablets may occasionally cause drowsiness, a dry mouth,
dizziness, nausea (feeling sick) and restlessness at night. A fall in blood pressure on standing, which
can cause light headed feelings or dizziness (orthostatic hypotension), has been reported, but only
following the first time a high dose was taken.
Other possible side effects include vomiting, headache, generally feeling unwell (malaise), reduction in
sexual desire (libido), tingling or numbness of the hands or feet, hallucinations (visions), confusion and
blurred vision. Irregular heart beat has also been reported.
Rarely, constipation, an inability to get or maintain an erection (impotence) and problems with the
blood flow in the limbs (eg Raynaud’s type symptoms) have occurred. A brief rise in blood sugar levels
has also been reported.
Very rarely, and only after very high doses of clonidine, there have been reports of hypersensitivity
(allergic) reactions (including skin rash, localised swelling of the face, tongue and lips, and difficulty
with breathing), hair loss (alopecia), problems with awareness, nightmares, enlargement of male
breast tissue, pain in the parotid gland (a gland below the ear), feeling depressed, dry nose and eyes
(this may be a problem for people who wear contact lenses).
Very rarely, a condition known as pseudo-obstruction of the large bowel has been seen; symptoms
include colicky pain, constipation and vomiting.

Driving and using machines
Medicines like Clonidine Hydrochloride 25 microgram Tablets may occasionally cause drowsiness. If
you are affected in this way, do not drive or operate machinery.

If you experience any of these side effects and they continue, or become troublesome, please tell your
doctor or pharmacist. Also tell your doctor or pharmacist if you experience any other effect not
mentioned above.

112

Important information about some of the ingredients in Clonidine Hydrochloride 25 microgram
Tablets

5. How to store Clonidine Hydrochloride 25 microgram Tablets

Artwork

Patient Information Leaflet - Bafna

PIL Code

P0094-10-02/3

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

Supersedes (PIL Code)

P0094-10-02/2

Author

MP-AUD

Date

03.11.10

Artwork Reference / Version

P0094-10-02/3 DS - rev 10.04.2013

AW/V

002/1

Notes

Variation
PL 17507/0094

Product

Clonidine Hydrochloride 25mcg Tablets (AM)

Strength

25 mcg

Pack Size(s)

Page 2 of 4

Colour Specifications

Scaling 1:1
© Auden Mc kenzie (Pharma Division) Ltd,
Mc kenzie House, Bury Street,

Pantone
Process
Black

Ruislip, Middlesex HA4 7TL.
Tel: 01895 627 420
info@audemmc kenzie.com

Keep out of the reach and sight of children.
Do not use Clonidine Hydrochloride 25 microgram Tablets after the expiry which is stated on the blister
and carton. The expiry date refers to the last day of that month.

Page 3 of 4

Booklet PIL

Auden Mckenzie

Outside Front Page

Outside Back Page

Group

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to dispose
of medicines no longer required. These measures will help to protect the environment.

PATIENT INFORMATION LEAFLET

Clonidine Hydrochloride 25 microgram Tablets

6. Further information
What Clonidine Hydrochloride 25 microgram Tablets contain
Active substance:
Each tablet contains clonidine hydrochloride 25 micrograms.
Other ingredients: Microcrystalline cellulose, maize starch, pregelatinised maize starch, lactose
monohydrate, talc, sodium starch glycolate Type A and magnesium stearate.
Each box of Clonidine Hydrochloride 25 microgram Tablets contains 112 white to off-white, circular
tablets with ‘CD 25’ engraved on one side, in 4 blister strips of 28 tablets each.

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.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Clonidine Hydrochloride and what is it used for?
2. Before you take Clonidine Hydrochloride 25 microgram Tablets
Do not take Clonidine Hydrochloride 25 microgram Tablets…
Other things to do or know before you take the tablets
Taking other medicines
Pregnancy and breast feeding
Driving and using machines
Important information about some of the ingredients in Clonidine Hydrochloride
25 microgram Tablets
3. How to take Clonidine Hydrochloride 25 microgram Tablets
§
§
§
§
§
§

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House
Bury Street, Ruislip
Middlesex

§
Usual recommended dose
§
If you forget to take a dose
§
If you take too many tablets
4. Possible side effects

HA4 7TL
UK

5. How to store Clonidine Hydrochloride 25 microgram Tablets

Manufacturer

6. Further information

TioFarma BV,
Benjamin Franklinstraat 9,

1. What is Clonidine Hydrochloride and what is it used for?

Oud-Beijerland,

Clonidine Hydrochloride 25 microgram Tablets belong to a group of medicines called ‘vasodilators’,
which cause widening of the blood vessels and therefore an increase in blood flow.

The Netherlands.

Product

Clonidine Hydrochloride 25mcg Tablets (TIO)

Strength

25 mcg

Pack Size(s)

112

Artwork

Patient Information Leaflet - Tiofarma

PIL Code

P0094-10-01/3

Supersedes (PIL Code)

P0094-10-01/2

Author

MP-AUD

Date

02.06.11

Artwork Reference / Version

P0094-10-01/3 DS - rev 10.04.2013

AW/V

002/1

Notes

Variation amemdments.
PL 17507/0094

Your doctor has prescribed Clonidine Hydrochloride 25 microgram Tablets for you to prevent attacks of
migraine and similar types of headache. The tablets are also used to prevent hot flushes that may
occur in women during the menopause (‘change of life’).
This leaflet was last approved in April 2013.

For information in large print, tape, CD or Braille, telephone 01895 627 420

Scaling 1:1
Mc kenzie House, Bury Street,

Pantone
Process
Black

Ruislip, Middlesex HA4 7TL.
Tel: 01895 627 420
info@audemmc kenzie.com

§
Auden Mckenzie

if you think that you may have had an allergic, or any other type of, reaction to Clonidine
Hydrochloride 25 microgram Tablets, or a similar medicine, in the past. An allergic reaction may
be recognised as a rash, itching, swollen face or lips, or shortness of breath;
if you have a slow heart rate resulting from a disease of the heart called ‘sick-sinus syndrome’ or
severe heart problems.

Clonidine Hydrochloride 25 microgram Tablets must only be used to treat the condition(s) your doctor
has given you this medicine for.
P0094-10-01/3

© Auden Mc kenzie (Pharma Division) Ltd,

Do not take Clonidine Hydrochloride 25 microgram Tablets:
§

Clonidine Hydrochloride 25 microgram Tablets
PL 17507/0094
PA 1352/4/1
Auden Mckenzie (Pharma Division) Ltd.

Colour Specifications

2. Before you take Clonidine Hydrochloride 25 microgram Tablets

Page 4 of 4

Page 1 of 4

Inside Page 2

Auden Mckenzie

Inside Page 3

Other things to do or know before you take the tablets

Group

If the answer to any of the following questions is ‘Yes’, you may still be able to take Clonidine
Hydrochloride 25 microgram Tablets, but you should discuss this with your doctor before taking the
tablets:

3. How to take Clonidine Hydrochloride 25 microgram Tablets
Take the tablets by mouth, exactly as your doctor, pharmacist or medicine label tells you to.

§

Do you have cerebrovascular disease (problems with blood flow to the brain)?

§

Do you have heart or severe kidney problems?

§

Do you suffer from cold and numb hands and feet, eg Raynaud’s disease?

Adults over 18 years:

Two to three tablets twice a day

§

Do you suffer from constipation?
Have you ever suffered from depression?

Children & Adolescents:

§

The use of clonidine is not recommended in paediatric patients
under 18 years.

The usual recommended dose is as follows:

As you may get dry eyes whilst taking this medicine, this may be a problem if you wear contact lenses.
Taking other medicines
Always tell your doctor if you are taking any other medicines (including those you bought yourself
without a prescription) because taking some medicines together with Clonidine Hydrochloride
25 microgram Tablets can be harmful.
In particular, you should tell your doctor if you are taking any of the following medicines, as they can
affect the way the tablets work:

The tablets should be swallowed whole with water, with or without food.
It may take 2 to 4 weeks for the medicine to work properly.
If you take too many tablets
Contact your doctor or pharmacist as soon as possible. Always take the labelled medicine container
with you whether or not there are any Clonidine Hydrochloride 25 microgram Tablets left.
If you forget to take a dose
Take a dose as soon as you remember, then carry on as before.

§

certain medicines used to lower blood pressure (antihypertensives and alpha-blockers); alphablockers are medicines also used to treat swelling of the prostate gland

§

certain medicines that relax blood vessels (vasodilators)

§

water tablets (diuretics)

Like all medicines, these tablets may cause side effects, although not everyone gets them.
Clonidine Hydrochloride 25 microgram Tablets may occasionally cause drowsiness, a dry mouth,
dizziness, nausea (feeling sick) and restlessness at night. A fall in blood pressure on standing, which
can cause light headed feelings or dizziness (orthostatic hypotension), has been reported, but only
following the first time a high dose was taken.

4. Possible side effects

§

medicines which are often used to slow the heart rate or lower the blood pressure (beta blockers)

§

medicines used to treat heart failure (cardiac glycosides)

§

certain medicines used to treat depression (tricyclic antidepressants)

§

other antidepressants, eg mirtazapine

§

certain medicines used to relieve anxiety such as tranquillisers, hypnotics (and also alcohol)
(neuroleptics)

Pregnancy and breast feeding
Tell the doctor if you are pregnant, think you might be pregnant or are trying to become pregnant.
Clonidine Hydrochloride 25 microgram Tablets can reach your baby and may lower your baby’s heart
rate.

P0094-10-01/3
P0094-10-01/2

Clonidine Hydrochloride 25 microgram Tablets are not recommended for use while breast feeding; tell
your doctor if you are breast feeding.

Clonidine Hydrochloride 25mcg Tablets (TIO)

Strength

112

Artwork

Patient Information Leaflet - Tiofarma

PIL Code

P0094-10-01/3

Supersedes (PIL Code)

Very rarely, and only after very high doses of clonidine, there have been reports of hypersensitivity
(allergic) reactions (including skin rash, localised swelling of the face, tongue and lips, and difficulty
with breathing), hair loss (alopecia), problems with awareness, nightmares, enlargement of male
breast tissue, pain in the parotid gland (a gland below the ear), feeling depressed, dry nose and eyes
(this may be a problem for people who wear contact lenses).

Medicines like Clonidine Hydrochloride 25 microgram Tablets may occasionally cause drowsiness. If
you are affected in this way, do not drive or operate machinery.

If you experience any of these side effects and they continue, or become troublesome, please tell your
doctor or pharmacist. Also tell your doctor or pharmacist if you experience any other effect not
mentioned above.

Important information about some of the ingredients in Clonidine Hydrochloride 25 microgram
Tablets

5. How to store Clonidine Hydrochloride 25 microgram Tablets

25 mcg

Pack Size(s)

Rarely, constipation, an inability to get or maintain an erection (impotence) and problems with the
blood flow in the limbs (eg Raynaud’s type symptoms) have occurred. A brief rise in blood sugar levels
has also been reported.

Very rarely, a condition known as pseudo-obstruction of the large bowel has been seen; symptoms
include colicky pain, constipation and vomiting.

Driving and using machines
Product

Other possible side effects include vomiting, headache, generally feeling unwell (malaise), reduction in
sexual desire (libido), tingling or numbness of the hands or feet, hallucinations (visions), confusion and
blurred vision. Irregular heart beat has also been reported.

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

Keep out of the reach and sight of children.
Do not use Clonidine Hydrochloride 25 microgram Tablets after the expiry which is stated on the blister
and carton. The expiry date refers to the last day of that month.

P0094-10-01/2

Author

MP-AUD

Date

02.06.11

Artwork Reference / Version

P0094-10-01/3 DS - rev 10.04.2013

AW/V

002/1

Notes

Variation amemdments.
PL 17507/0094

Page 2 of 4

Colour Specifications

Scaling 1:1
© Auden Mc kenzie (Pharma Division) Ltd,
Mc kenzie House, Bury Street,

Pantone
Process
Black

Ruislip, Middlesex HA4 7TL.
Tel: 01895 627 420
info@audemmc kenzie.com

Page 3 of 4

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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