Allergy Relief Antihistamine Tablets
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CHLORPHENAMINE MALEATE 4 mg TABLETS
^Read all of this leaflet carefully because it contains important information for you'
- This medicine is available without prescription. However, you still need to take Chlorphenamine 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.
- You must contact a doctor if your symptoms worsen or do not improve.
- 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.
THIS LEAFLET CONTAINS
1. What Chlorphenamine is for
2. Before you take Chlorphenamine
3. How to take Chlorphenamine
4. Possible side effects
5. How to store Chlorphenamine
6. Further information
1. WHAT CHLORPHENAMINE IS FOR
Chlorphenamine is an antihistamine. Antihistamines
help to relieve the symptoms of some allergies. Chlorphenamine can be used:
• to relieve the symptoms of hayfever and rhinitis (runny and itchy nose)
• for skin allergies such as rash, itching and urticaria (hives)
• to treat allergic reactions to foods, medicines or insect bites
• to treat swelling of the face or throat due to fluid build up.
2. BEFORE YOU TAKE CHLORPHENAMINE
Do not take Chlorphenamine 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
(for depression) or have taken them within the last 14 days
• are a child under 1 years of age.
Take special care with Chlorphenamine
Tell your doctor or pharmacist before you take this medicine if you
• have epilepsy
• have liver or heart problems, severe high blood pressure
• have difficulty passing urine
• have asthma or other lung problems
• have an overactive thyroid gland
• have an enlarged prostate gland
• have increased eye ball pressure (glaucoma).
Chlorphenamine may increase the effects of alcohol. Therefore DO NOT DRINK ALCOHOL whilst taking Chlorphenamine.
Taking other medicines
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 Chlorphenamine tablets work:
• Medicines for depression including monoamine oxidase inhibitors
• Medicines to treat anxiety or to help you sleep
• Medicines to relieve cramps and spasms in medical conditions such as irritable bowel syndrome (IBS), poor bladder control and Parkinson's disease
• Phenytoin for epilepsy
• Lopinavir to treat viral infections.
If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Chlorphenamine.
Pregnancy and breast-feeding
If you are pregnant, planning a pregnancy or are breast-feeding, ask your doctor or pharmacist for advice before taking Chlorphenamine.
Driving and using machines
Chlorphenamine 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.
Important information about some of the ingredients of Chlorphenamine
This medicine contains lactose. If you know you have an intolerance to lactose or other sugars tell your doctor or pharmacist before taking Chlorphenamine.
3. HOW TO TAKE CHLORPHENAMINE
The tablets should be swallowed whole, with a glass of water.
If your doctor has prescribed this medicine, always take Chlorphenamine exactly as your doctor has told you. Otherwise, follow the instructions below. If you are not sure how to take this medicine talk to your doctor or pharmacist.
Dosage
The usual dosage instructions are given below: Adults (including the elderly) 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.
Children aged 3 - 5 years
Quarter of a tablet every 4-6 hours. Do not give
more than 6 quarter tablets in 24 hours.
Children aged 1 - 2 years
Quarter of a tablet twice a day. Do not give more than 2 quarter tablets in 24 hours.
A syrup form of this medicine may be more suitable for babies and young children.
Children under 1 years of age
Not recommended.
If you take more Chlorphenamine than you should
Contact your doctor or go to a hospital immediately. Show them the package or container.
An overdose is likely to cause drowsiness, dry mouth, lack of co-ordination, shaking, a very high temperature, hallucinations, fits, problems urinating, irregular heart beat, abnormal muscle movements or breathing problems whilst asleep.
If you forget to take Chlorphenamine
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Chlorphenamine can cause side effects, although not everybody gets them.
Children and the elderly are likely to be more sensitive to the effects of Chlorphenamine.
If the following very serious but rare side effect occurs, STOP TAKING this medicine and tell your doctor or go to a hospital immediately:
• a severe allergic reaction (swelling of the face, lips, mouth or throat leading to difficulty in breathing or swallowing; skin rash or hives).
Other side effects include:
Common side effects:
The most common side effect is drowsiness. It often occurs at the start of treatment and usually disappears with continued treatment.
Less common side effects:
• headache
• dry mouth
• nausea
• vomiting
• diarrhoea
• indigestion
• loss of appetite
• aches and pains in the stomach area
• weakness, weariness
• difficulty concentrating
• blurred vision
• difficulty passing urine.
Rare side effects:
• fast or irregular heart beat
• palpitations
• low blood pressure
• serious allergic reaction, which may cause difficulty in breathing or dizziness
• skin rash, redness, itching or hives
• sensitivity to sunlight
• inflammation of the liver (hepatitis), which may result in yellowing of the skin or whites of the eyes (jaundice)
• reduction in the red blood cells (anaemia), which can make the skin pale and cause weakness or breathlessness
• other blood disorders causing unexplained bleeding, bruising, sore throat, general illness or fever
• dizziness
• tightness of the chest
• thickening of phlegm
• lack of co-ordination
• muscle weakness, twitching
• ringing in the ears
• irritability
• depression
• nightmares
• over-excitement in children
• confusion in the elderly.
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.
5. HOW TO STORE CHLORPHENAMINE
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. FURTHER INFORMATION
What Chlorphenamine contains
The active ingredient in Chlorphenamine tablets is chlorphenamine maleate BP. The other ingredients are lactose, maize starch, povidone, magnesium stearate, sodium starch glycollate and quinoline yellow (E104).
What Chlorphenamine looks like and contents of the pack
Chlorphenamine 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 Ltd.
11 Boumpoulinas, Nicosia 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 10/2014
CL0140/P/PIL/CL1