Numark Antihistamine 4mg Tablets
NUMARKO
Antihistamine and Allergy Relief 4mg Tablets
Chlorphenamine Maleate
Patient Information Leaflet
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 this medicine is and what it is used for
2. Before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Further information
1. What this medicine is and what it is used for
The full name of this medicine is Numark Antihistamine and Allergy Relief 4mg Tablets but within the leaflet it will be referred to as this medicine.
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 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 this medicine
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 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, 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 breastfeeding:
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 this medicine
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 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)
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 there 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 effect more than 1 in 10 people):
• drowsiness which may cause you to fall asleep
Common effects (may effect up to 1 in 10 people):
• dizziness
• abnormal co-ordination
• blurred vision
• dificulty concentrating
• nausea
• headache
• dryness of 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 this medicine
Keep this medicine in the original package. Do not store above 250C.
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 pharamacist for safe disposal. KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
6. Further information
Ingredients:
This medicine contains 4mg of the active ingredient chlorphenamine maleate. It also contains the following other ingredients: lactose, maize starch, magnesium stearate, pregelatinised starch, guinoline yellow lake (E104) and stearic acid.
What the medicine looks like:
This medicine is 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 2016.
If you would like this leaflet in a different format please contact the licence holder at the above address.