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Active substance(s): CHLORPHENAMINE MALEATE / CHLORPHENAMINE MALEATE / CHLORPHENAMINE MALEATE
CHLORPHENAMINE MALEATE 4 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told to you.
- This medicine is available without prescription. However, you still need to take
Hayleve carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- you must talk to a doctor if you do not feel better or if you feel worse.
WHAT IS IN THIS LEAFLET
1. What Hayleve is and what it is
2. What you need to know before you
3. How to take Hayleve
4. Possible side effects
5. How to store Hayleve
6. Contents of the pack and other
1. WHAT HAYLEVE IS AND WHAT IT IS
Hayleve is used to treat the allergic symptoms of
hayfever and other allergies.
The active ingredient is chlorphenamine maleate, an
antihistamines which can help to relieve the
symptoms of some allergies, rhinitis (runny and itchy
nose) and itchy skin rashes, it can be used to treat
the itchiness, redness, swelling, tenderness and
irritation that can be caused by:
hayfever and other allergies e.g. pet , house, dust
mite and mould spore allergies
skin allergies and dermatitis
nettle rash and urticaria (hives)
prickly heat and heat rash
reactions to foods, food additives or medicines
insect bites and stings
the itchy rash of chickenpox
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE HAYLEVE
Do not take Hayleve if you
are allergic to Chlorphenamine, any of the other
ingredients in the tablets (listed in section 6 of this
leaflet) or to other antihistamines
are taking monoamine oxidase inhibitors
(MAOIs) prescribed for depression or have taken
them within the last 14 days
Warning and precautions
Talk to your doctor or pharmacist before taking this
medicine if you
have liver, kidney, or heart disease, severe high
have bronchitis, asthma or bronchiectasis
have an enlarged prostate gland
Hayleve with alcohol
Hayleve may increase the effects of alcohol.
Therefore DO NOT DRINK ALCOHOL whilst taking
Other medicines and Hayleve
Tell your doctor or pharmacist if you are taking or
have recently taken, any other medicines, even
medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may
affect how Hayleve tablets work:
Medicines to treat anxiety or to help you sleep
Phenytoin (for epilepsy)
If you are taking other medicines containing other
antihistamines, including products for the relief of
colds and coughs.
If you go into hospital or have treatment for other
conditions, tell the doctor that you are taking
Pregnancy and breast-feeding
If you are pregnant, planning a pregnancy or are
breast-feeding, ask your doctor or pharmacist for
advise before taking Hayleve.
Driving and using machines
Hayleve may cause drowsiness, dizziness, blurred
vision or lack of co-ordination. Do not drive or
operate machinery if you are affected in this way and
do not drink alcohol, as it can make these effects
Hayleve contains lactose
If you know you have an intolerance to lactose or
other sugars tell your doctor or pharmacist before
3. HOW TO TAKE HAYLEVE
The tablets can be divided into equal doses.
Always take Hayleve exactly as described in this
leaflet or as your pharmacist or doctor has told you. If
you are not sure how to take this medicine talk to
your doctor or pharmacist.
The recommended doses are given below:
Adults and children over 12 years of age
One tablet every 4-6 hours. Do not take more than
6 tablets in 24 hours.
Children aged 6 - 12 years
Half a tablet every 4-6 hours. Do not give more than
6 half tablets in 24 hours.
Talk to your doctor or pharmacist before you take this
medicine as you may be more likely to get side
effects including confusion and you may need to take
a lower daily dose.
Do not give to children under 6 years
Do not take more than the recommended dose.
If you take more Hayleve than you should
Contact your doctor or go to a hospital immediately.
Show them the package or container. Do not drive if
you have taken too many tablets.
If you forget to take Hayleve
Take one as soon as you remember, unless it is
nearly time to take your next scheduled dose.
Do not take a double dose to make up for a forgotten
If you stop taking Hayleve
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
If your symptoms persist, see your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hayleve can cause side effects,
although not everybody gets them.
Additional side effects in children
Children and the elderly are likely to be more
sensitive to the effects of Hayleve.
The most common side effect is drowsiness. This
drowsiness can be helpful if symptoms are
particularly troublesome at night.
STOP TAKING this medicine and tell your doctor
or go to a hospital immediately if you:
Experience a severe allergic reaction swelling of
the face, lips, mouth or throat leading to difficulty
in breathing or swallowing; raised and itchy skin.
Experience liver problems.
Experience anaemia or unexplained bleeding or
Experience difficulty passing urine.
The following side effects may occur:
loss of appetite
aches and pains in the stomach area
fast or irregular heart beat
low blood pressure
serious allergic reaction, which may cause
difficulty in breathing or dizziness
skin rash, redness, itching or hives
sensitivity to sunlight
tightness of the chest
thickening of phlegm
lack of co-ordination
muscle weakness, twitching
ringing in the ears
over-excitement in children
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 HAYLEVE
Keep out of the reach and sight of children.
Store below 25°C and protect from light. Store in the
original package or container and keep the container
Do not use these tablets after the expiry date, which
is stated on the package or container. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. CONTENTS OF THE PACK AND
What Hayleve contains
The active ingredient in Hayleve tablets is
chlorphenamine maleate BP. The other ingredients
are lactose, maize starch, povidone, magnesium
stearate, sodium starch glycollate and quinoline
What Hayleve looks like and contents of the pack
Hayleve tablets are round pale yellow tablets with a
break line engraved on one side.
The tablets come in containers of 100, 500 and 1000
tablets and in blister packs of 10, 28, 30 and 60
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia,
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 07/2016
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.