Chlorphenamine Maleate 4mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
HAYLEVE
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 used for
2. What you need to know before you take Hayleve
3. How to take Hayleve
4. Possible side effects
5. How to store Hayleve
6. Contents of the pack and other information
1. WHAT HAYLEVE IS AND WHAT IT IS USED FOR
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 epilepsy
• have liver, kidney, or heart disease, severe high blood pressure
• have bronchitis, asthma or bronchiectasis
• have an enlarged prostate gland
• have glaucoma.
Hayleve with alcohol
Hayleve may increase the effects of alcohol. Therefore DO NOT DRINK ALCOHOL whilst taking Hayleve.
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 Hayleve.
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 worse.
Hayleve contains lactose
If you know you have an intolerance to lactose or other sugars tell your doctor or pharmacist before taking Hayleve.
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.
Dosage
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.
Elderly:
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 dose.
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 bruising.
• Experience difficulty passing urine.
• Collapse.
The following side effects may occur:
• headache
• dry mouth
• diarrhoea
• indigestion
• loss of appetite
• aches and pains in the stomach area
• weakness, weariness
• difficulty concentrating
• blurred vision
• 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
• dizziness
• tightness of the chest
• thickening of phlegm
• lack of co-ordination
• muscle weakness, twitching
• ringing in the ears
• irritability
• nightmares
• over-excitement in children
• confusion
• nausea
• vomiting
• depression
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 tightly closed.
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 OTHER INFORMATION
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 yellow (E104).
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,
PC.1060, Cyprus
Manufacturer
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
CL0140/P/PIL-Br/CL2