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Aller Calm Allergy Relief Tablets

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Document: leaflet MAH BRAND_PL 00142-0209 change

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ALLERCalm

65mm


allergy relief tablets

Chlorphenamine Maleate 4mg


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Read all of this leaflet carefully before you start

taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours.

Index

1.    What ALLERcalm Allergy Relief tablets are and what they are used for

2.    Before you take

3.    How to take

4.    Possible side effects

5.    How to store

6.    Further information

1. What ALLERcalm Allergy Relief tablets are and what they are used for

ALLERcalm Allergy Relief tablets contain chlorphenamine maleate which belongs to a group of medicines called antihistamines.

ALLERcalm Allergy Relief tablets may be used to control the symptoms of allergic conditions such as:

•    hay fever.

•    runny nose.

•    itchy skin rash with irregular raised patches (hives).

•    swelling of the face, lips, tongue or throat.

•    food allergy.

•    reactions to drugs or vaccines.

•    insect bites.

2. Before you take

Do not take ALLERcalm Allergy Relief tablets if you:

• are allergic (hypersensitive) to chlorphenamine maleate, any of the other ingredients in ALLERcalm Allergy Relief tablets (see section 6) or other antihistamines (used for allergies).

• are taking monoamine oxidase inhibitors (MAOIs) or you have taken MAOIs within the previous 14 days, (used for depression and Parkinson’s disease) e.g. phenelzine or tranylcypromine.

Check with your doctor or pharmacist

before taking ALLERcalm Allergy Relief tablets if you have:

   epilepsy.

•    an enlarged prostate.

•    increased pressure in the eye (glaucoma).

   liver disease.

•    inflammation or widening of the airways (bronchitis or bronchiectasis).

•    an overactive thyroid gland.

   high blood pressure.

   heart or blood vessel disease.

   asthma.

Taking other medicines

Please tell your doctor or pharmacist if you are

taking or have recently taken any other medicines, obtained with or without a prescription.

Especially:

•    hypnotics (sleeping tablets) e.g. nitrazepam.

•    anxiolytics (used for anxiety) e.g. diazepam.

•    monoamine oxidase inhibitors (MAOIs) (used for depression and Parkinson’s disease) e.g. phenelzine or tranylcypromine. Do not take ALLERcalm Allergy Relief tablets if you are taking or you have taken MAOIs within the previous 14 days.

•    phenytoin (used for epilepsy).

Pregnancy and breast-feeding

If you are pregnant (particularly in the last three months) or are planning to become pregnant, speak to your doctor before taking any medicine. Taking ALLERcalm Allergy Relief tablets is not recommended if you are breast-feeding.

Driving and using machines

ALLERcalm Allergy Relief tablets may make you feel drowsy, dizzy, have blurred vision or affect your reactions. Make sure you are not affected before you drive or operate machinery.

210mm +/- 0.5mm to centre line of next eye mark    83.6mm


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3. How to take

Speak to your doctor before drinking alcohol with ALLERcalm Allergy Relief tablets, the effects of alcohol may be increased.

Swallow the tablets with water.

Doses:

Adults and children aged 12 years and over: one

tablet every 4-6 hours, up to a maximum of six tablets a day (24mg a day). If you are elderly, you may be more likely to get side effects such as confusion.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include drowsiness, fits or seizures, temporary pause in breathing, muscle spasm of neck, shoulders and body, circulatory failure including irregular heart beat, anticholinergic effects (dry mouth, fever, constipation, blurred or double vision, difficulty passing water (urine), dilation of the pupil of the eye, glaucoma and blockage of the small intestine), a mental or behavioural disorder, stimulation of the nervous system e.g. excitement or agitation.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

4. Possible side effects

Like all medicines, ALLERcalm Allergy Relief tablets can cause side effects, although not everybody gets them.

Contact your doctor immediately if you notice signs of:

   an allergic reaction: swelling of the face, lips, tongue or throat, skin reactions such as an itchy skin rash or skin that is red, flaky or peeling, sensitivity to sunlight or artificial light (e.g. sun beds), narrowing of the airways causing difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    sedation ranging from slight drowsiness to deep sleep, inability to concentrate, unusual tiredness or weakness, blurred vision, headaches, dizziness, in coordination, ringing or buzzing in the ears, irritability, nightmares, excitement (especially in children), confusion (especially in the elderly).

•    stomach or intestine disturbances such as feeling or being sick or diarrhoea, dry mouth, stomach pain, indigestion, loss of appetite.

•    difficulty in passing water.

•    palpitation, irregular or racing heart beat, low blood pressure.

•    tight chest, thickening of phlegm.

•    liver problems including yellowing of the skin or whites of the eyes (jaundice).

•    changes in the number and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.

•    pale or red irregular raised patches with severe itching (hives).

•    twitching, muscular weakness.

•    depression.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

5. How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Do not use ALLERcalm Allergy Relief tablets after the expiry date stated on the label/carton/bottle. 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 ALLERcalm Allergy Relief tablets

contain

•    The active substance (the ingredient that makes the tablet work) is chlorphenamine maleate. Each tablet contains 4mg of the active substance.

•    The other ingredients are calcium sulphate, magnesium stearate, maize starch, E172, E460.

What ALLERcalm Allergy Relief tablets look like and contents of the pack

ALLERcalm Allergy Relief tablets are yellow, circular, biconvex, uncoated tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in November 2008.


65mm


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Actavis

Actavis, Barnstaple, EX32 8NS, UK