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CHLORPHENAMINE TABLETS 4MG

Active substance(s): CHLORPHENAMINE MALEATE

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Transcript
Q2186

P0230T

Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
In this leaflet:
1. What Chlorphenamine Tablets are and what they are used for
2. Before you take Chlorphenamine Tablets
3. How to take Chlorphenamine Tablets
4. Possible side effects
5. How to store Chlorphenamine Tablets
6. Further information

Remember, this medicine is for YOU. Do not give it to someone else, even if their symptoms are
the same as yours. This medicine may harm them.
If you forget to take a dose:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for
your next dose, skip the missed dose and continue with the regular dosing schedule.
DO NOT DOUBLE THE DOSE.
If you have taken too many tablets:
If you think you have taken too many tablets, contact your doctor straight away or go to the
nearest hospital casualty department. Take with you any remaining tablets and the pack so that
the medicine can be identified.

4. Possible side effects

1. What Chlorphenamine Tablets are and what they are used for
The name of this medicine is Chlorphenamine.

This medicine is an antihistamine and is one of a group of medicines called alkylamines. It can
reduce the effects of histamine and has sedative activity.
This medicine is used to relieve the symptoms of allergic conditions, such as hay fever,
inflammation of the nose and upper airways, allergic reactions to medicines, nettle rash, local
itching, severe skin rash with swelling particularly of the mouth and throat, food allergies and
insect bites.

2. Before you take Chlorphenamine Tablets

Do not take these tablets if:
• You are allergic to other antihistamines, Chlorphenamine or to any of the other tablet
ingredients (see section 6).
• You have taken a monoamine oxidase inhibitor drug (MAOI) for depression within the last
fourteen days.

Check with your doctor before taking these tablets if:
• you suffer from epilepsy, raised intra-ocular pressure including glaucoma, high blood pressure
or heart disease, liver disease, bronchitis, asthma, an over active thyroid (thyrotoxicosis) or
have an enlarged prostate gland.
• you have an obstruction in your intestine or have difficulty passing urine or have a rare blood
disease called porphyria.
Taking other medicines:
Check with your doctor or pharmacist before taking these tablets if you are taking other
medicines, including any that you can buy without a prescription. This is especially important if
you are taking:
• other medicines containing an antihistamine, including products for the relief of coughs and
colds.
• medicines to treat high blood pressure such as clonidine or methyldopa.
• aspirin-like medicines (salicylates), cisplatin, paromomycin, vancomycin.
• central nervous system depressants (medicines which slow down the nervous system,
possibly causing drowsiness) such as sleeping tablets, tranquillisers, antidepressants or other
medicines for mental problems.
• anti-muscarinics such as atropine, amantadine, haloperidol, phenothiazines and
procainamide.
• anti-epileptics, especially phenytoin.
Other special warnings:
Effects on driving or operating machinery:
This medicine may cause drowsiness, dizziness, blurred vision and inco-ordination. Do not drive
or operate machinery if the medicine has this effect on you.
Alcohol:
Do not drink alcohol while you are taking these tablets. Alcohol will increase the drowsiness
produced by this medicine.
Pregnancy and breast feeding:
Talk to your doctor before taking this medicine if you are pregnant or breast feeding, as you
should NOT take unless your doctor thinks it is essential.

Important Information about an ingredient of this medicine:
Contains lactose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Chlorphenamine Tablets
Adults and children aged 12 years and over:
The normal dose is one tablet every 4-6 hours. Do not take more than 6 tablets in 24 hours.

Elderly:
Check with your doctor or pharmacist before taking this medicine as you may be more likely to get
side effects and you may need to take a lower daily dose.

Children:
The normal dose for children aged six to twelve years is half a tablet every 4-6 hours. Do not give
more than 6 half tablets in 24 hours.
This medicine is not meant for children under 6 years of age. Do not give it to a child under 6
years unless your doctor has prescribed it.
If this medicine has been prescribed by your doctor, he/she will decide the dose that is best for
you, the pharmacist’s label will also tell you how many tablets to take and how often. If you are not
sure about anything, ask your doctor or pharmacist.

(continued overleaf)

Like all medicines, Chlorphenamine can cause side effects, although not everybody gets them.
If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor, as
they may be signs of an allergic reaction to this medicine:
• skin rash, itchy or raised skin rash, peeling/blistering of the skin
• swelling of the face, mouth or throat
• difficulty breathing, wheezing or shortness of breath, fever
• increased sensitivity of the skin to the sun.
The following side effects have also been reported:
Very common effects (may affect more than 1 in 10 people):
• drowsiness which may cause you to fall asleep.
Common effects (may affect up to 1 in 10 people):
• dizziness
• abnormal co-ordination
• blurred vision
• difficulty concentrating
• nausea
• headache
• dryness of the mouth
• fatigue.
Other effects:
• blood disorders including a reduction in the numbers of red or white blood cells (signs include
pale skin, weakness, tiredness, breathlessness and can make infections more likely)
• retention of urine, difficult and painful urination
• irregular heartbeat
• lowering in blood pressure
• tightness of the chest
• double vision
• tremors, twitching, muscle weakness
• depression, irritability, confusion
• loss of appetite, vomiting, stomach pain or upset, indigestion, constipation and diarrhoea
• unusual excitement
• tingling, heaviness and weakness of the hands
• difficulty in sleeping, nightmares
• yellowing of the skin or whites of the eyes caused by liver or blood problems
• ringing in the ears
• dryness of the nose or throat, sometimes causing a cough, thickened bronchial secretions
which may cause phlegm
• nervousness.
Children or the elderly may be more susceptible to some side effects of this medicine, such as
drowsiness, dizziness, blurred vision, lack of co-ordination, confusion, excitation, feeling faint,
restlessness or nervousness.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or other healthcare professional. This
includes any possible side effects not listed in this leaflet. You can also report side effects directly
via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100
3352 (available from 10 am to 2 pm Mondays to Fridays) or fill in a paper form available from your
local pharmacy. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Chlorphenamine Tablets

Keep this medicine in the original package. Do not store above 25°C.
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that
are out of date, return them to your pharmacist for safe disposal.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

6. Further information
Ingredients:
Chlorphenamine tablets contain 4mg of the active ingredient chlorphenamine maleate. They also
contain the following other ingredients: lactose, maize starch, magnesium stearate, pregelatinised
starch, quinoline yellow lake (E104) and stearic acid.

What the medicine looks like:
Chlorphenamine Tablets are yellow in colour, engraved with a company logo on one side and a
breakline and B094 on the other side.
The medicine is available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
Who makes this medicine and holds the Product Licence:
The Product Licence Holder is Crescent Pharma Limited, Units 3 & 4, Quidhampton Business
Units, Polhampton Lane, Overton, Hants, RG25 3ED.
Manufactured by Surepharm Services Limited, Unit 2H, Bretby Business Park, Ashby Road East,
Bretby, Burton Upon Trent, Staffordshire, DE15 0YZ.
Date leaflet revised March 2013.
If you would like this leaflet in a different format please contact the licence holder at the above
address.

DIMENSIONS: 150 X 320mm
Folded size 40x150mm

Base Point Size: 8.5pt
BLACK
Surepharm
Q2186 Chlorphenamine PIL- 4mg
12/4/13
Pharma code: 128
150 x 320mm
folded size 40x150mm
17/4/13
2

Anne Brown

(If you have particular folding spac please provide)

P0255T

PATIENT INFORMATION LEAFLET

CHLORPHENAMINE Tablets 4mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
In this leaflet:
1. What Chlorphenamine Tablets are and what they are used for
2. Before you take Chlorphenamine Tablets
3. How to take Chlorphenamine Tablets
4. Possible side effects
5. How to store Chlorphenamine Tablets
6. Further information

1. What Chlorphenamine Tablets are and what they are used for

The name of this medicine is Chlorphenamine.
This medicine is an antihistamine and is one of a group of medicines called alkylamines. It can reduce the effects of histamine and has
sedative activity.
This medicine is used to relieve the symptoms of allergic conditions, such as hay fever, inflammation of the nose and upper airways,
allergic reactions to medicines, nettle rash, local itching, severe skin rash with swelling particularly of the mouth and throat, food allergies
and insect bites.

2. Before you take Chlorphenamine Tablets
Do not take these tablets if:
• You are allergic to other antihistamines, Chlorphenamine or to any of the other tablet ingredients (see section 6).
• You have taken a monoamine oxidase inhibitor drug (MAOI) for depression within the last fourteen days.
Check with your doctor before taking these tablets if:
• you suffer from epilepsy, raised intra-ocular pressure including glaucoma, high blood pressure or heart disease, liver disease,
bronchitis, asthma, an over active thyroid (thyrotoxicosis) or have an enlarged prostate gland.
• you have an obstruction in your intestine or have difficulty passing urine or have a rare blood disease called porphyria.

Taking other medicines:
Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy
without a prescription. This is especially important if you are taking:
• other medicines containing an antihistamine, including products for the relief of coughs and colds.
• medicines to treat high blood pressure such as clonidine or methyldopa.
• aspirin-like medicines (salicylates), cisplatin, paromomycin, vancomycin.
• central nervous system depressants (medicines which slow down the nervous system, possibly causing drowsiness) such as sleeping
tablets, tranquillisers, antidepressants or other medicines for mental problems.
• anti-muscarinics such as atropine, amantadine, haloperidol, phenothiazines and procainamide.
• anti-epileptics, especially phenytoin.

Other special warnings:
Effects on driving or operating machinery:
This medicine may cause drowsiness, dizziness, blurred vision and inco-ordination. Do not drive or operate machinery if the medicine
has this effect on you.
Alcohol:
Do not drink alcohol while you are taking these tablets. Alcohol will increase the drowsiness produced by this medicine.
Pregnancy and breast feeding:
Talk to your doctor before taking this medicine if you are pregnant or breast feeding, as you should NOT take unless your doctor thinks
it is essential.
Important Information about an ingredient of this medicine:
Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Chlorphenamine Tablets
Adults and children aged 12 years and over:
The normal dose is one tablet every 4-6 hours. Do not take more than 6 tablets in 24 hours.
Elderly:
Check with your doctor or pharmacist before taking this medicine as you may be more likely to get side effects and you may need to
take a lower daily dose.
Children:
The normal dose for children aged six to twelve years is half a tablet every 4-6 hours. Do not give more than 6 half tablets in 24 hours.
This medicine is not meant for children under 6 years of age. Do not give it to a child under 6 years unless your doctor has prescribed it.
If this medicine has been prescribed by your doctor, he/she will decide the dose that is best for you, the pharmacist’s label will also tell
you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
Remember, this medicine is for YOU. Do not give it to someone else, even if their symptoms are the same as yours. This medicine may
harm them.

(continued overleaf)

Measure bar should be 150mm at 100% scale

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Customer

Crescent Pharma

Colours Used

Description

CHLORPHENAMINE 4MG

Process Black

Item Code

P0255T

Profile

N/A

Size

210X297MM

Min. Point Size

9pt (Main Body) 6pt (Item code)

Market

UK

Language

ENGLISH

Proof By

michael.casingena

Proof No.

2

Date

30/10/2013

Artwork No.

464943/466539

Keyline (non-printing)

Pharma
Code

N/A

If you forget to take a dose:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose
and continue with the regular dosing schedule.
DO NOT DOUBLE THE DOSE.
If you have taken too many tablets:
If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department.
Take with you any remaining tablets and the pack so that the medicine can be identified.

4. Possible side effects

Like all medicines, Chlorphenamine can cause side effects, although not everybody gets them.
If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor, as they may be signs of an allergic reaction
to this medicine:
• skin rash, itchy or raised skin rash, peeling/blistering of the skin
• swelling of the face, mouth or throat
• difficulty breathing, wheezing or shortness of breath, fever
• increased sensitivity of the skin to the sun.

The following side effects have also been reported:
Very common effects (may affect more than 1 in 10 people):
• drowsiness which may cause you to fall asleep.
Common effects (may affect up to 1 in 10 people):
• dizziness
• abnormal co-ordination
• blurred vision
• difficulty concentrating
• nausea
• headache
• dryness of the mouth
• fatigue.
Other effects:
• blood disorders including a reduction in the numbers of red or white blood cells (signs include pale skin, weakness, tiredness,
breathlessness and can make infections more likely)
• retention of urine, difficult and painful urination
• irregular heartbeat
• lowering in blood pressure
• tightness of the chest
• double vision
• tremors, twitching, muscle weakness
• depression, irritability, confusion
• loss of appetite, vomiting, stomach pain or upset, indigestion, constipation and diarrhoea
• unusual excitement
• tingling, heaviness and weakness of the hands
• difficulty in sleeping, nightmares
• yellowing of the skin or whites of the eyes caused by liver or blood problems
• ringing in the ears
• dryness of the nose or throat, sometimes causing a cough, thickened bronchial secretions which may cause phlegm
• nervousness.
Children or the elderly may be more susceptible to some side effects of this medicine, such as drowsiness, dizziness, blurred vision,
lack of co-ordination, confusion, excitation, feeling faint, restlessness or nervousness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Chlorphenamine Tablets

Keep this medicine in the original package. Do not store above 25°C.
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your
pharmacist for safe disposal.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

6. Further information
Ingredients:
Chlorphenamine tablets contain 4mg of the active ingredient chlorphenamine maleate. They also contain the following other ingredients:
lactose, maize starch, magnesium stearate, pregelatinised starch, quinoline yellow lake (E104) and stearic acid.
What the medicine looks like:
Chlorphenamine Tablets are yellow in colour, engraved with a company logo on one side and a breakline and B094 on the other side.
The medicine is available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
Who makes this medicine and holds the Product Licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.
Date leaflet revised October 2013.
If you would like this leaflet in a different format please contact the licence holder at the above address.

Measure bar should be 150mm at 100% scale

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Customer

Crescent Pharma

Colours Used

Description

CHLORPHENAMINE 4MG

Process Black

Item Code

P0255T

Profile

N/A

Size

210X297MM

Min. Point Size

9pt (Main Body) 6pt (Item code)

Market

UK

Language

ENGLISH

Proof By

michael.casingena

Proof No.

2

Date

30/10/2013

Artwork No.

464943/466539

Keyline (non-printing)

Pharma
Code

N/A

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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