Allergex 4 mg Tablets

ALLERGEX TABLETS is used for the treatment of allergic and anaphylactic conditions such as hay fever, vasomotor rhinitis (allergy in the nose when the small blood vessels in the nose dilate causing nasal congestion), urticaria (itchy rash that appears on the skin), angioedema (swelling under the skin), drug reactions, contact dermatitis, atopic dermatitis, insect bites, pruritus and pruritus vulvae.

Do not take ALLERGEX TABLETS

• If you are hypersensitive (allergic) to chlorphenamine maleate or any of the other ingredients of ALLERGEX TABLETS (listed in section 6)
• If you suffer from recurrent seizures (Epilepsy)
• If you suffer from acute attacks of asthma.
• ALLERGEX TABLETS should not be administered to Premature infants and new-born babies.

Warnings and precautions

Take special care with ALLERGEX TABLETS

• The use of this medicine leads to drowsiness which is worsened by the simultaneous intake of alcohol. Patients should be warned not to drive a motor vehicle or operate machinery as impaired decision making could lead to accidents.
• If you consume other central nervous system depressants eg sedatives and tranquilizers (sleeping tablets which result in a calming effect). This may lead to drowsiness and impaired concentration.
• If you suffer from prostatic hypertrophy (enlarged prostate).
• If you suffer from increased pressure in the eye (glaucoma).
• If you suffer from urinary retention (unable to empty your bladder)
• ALLERGEX TABLETS may suppress positive skin test results and should be stopped several days before the test.

Other medicines and ALLERGEX TABLETS:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

• Medicines that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Medicines to treat epilepsy (phenytoin)
• Medicines used to treat depression, Parkinson's disease, or other diseases
• Medicines that stop the action of the enzyme monoamine oxidase (antidepressants).

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding your baby, think you may be pregnant or planning to have a baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine. Safety of ALLERGEX TABLETS in pregnancy and breastfeeding has not been established.

Driving and using machinery

ALLERGEX TABLETS may make you sleepy and reduce your level of concentration or alertness. Do not drive or operate any tools or machines as this medicine may interfere with your ability to do these safely. Taking this medicine with alcohol and other medicines to treat depression may worsen these effects.

It is not always possible to predict to what extent ALLERGEX TABLETS may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which ALLERGEX TABLETS affects them.

Children and adolescents

The use of ALLERGEX TABLETS in children under 6 years of age is not recommended. ALLERGEX TABLETS contains lactose. Patients with the rare hereditary conditions of lactose or galactose intolerance should not take ALLERGEX TABLETS. ALLERGEX TABLETS contains lactose which has an effect on the control of your blood sugar if you have diabetes mellitus.

Do not share this medicine with any other person. Always take ALLERGEX TABLETS exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

The usual dose is:

• Adults and children 12 years or older: One 4 mg ALLERGEX tablet every 4 to 6 hours, up to a maximum of 24 mg in 24 hours.
• Children 6 to 12 years: 2 mg (Half a ALLERGEX tablet) every 4 to 6 hours, up to a maximum of 12 mg in 24 hours.
• Children up to 6 years: Use is not recommended.

If you take more ALLERGEX TABLETS than you should:

• In the event of overdosage, consult your doctor or pharmacist even if you do not notice the symptoms. If neither is available, contact the nearest hospital or poison control centre.
• Symptoms of overdosage include Central Nervous System (CNS) stimulation and antimuscarinic effects, including impaired balance (ataxia), excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur.
• In adults, the usual symptoms are of the CNS depression with drowsiness, coma and convulsions. Low blood pressure (hypotension) may also occur. Elderly patients are more susceptible to the CNS depression and hypotensive effects even at therapeutic levels.

If you forget to take ALLERGEX TABLETS

Do not take a double dose to make up for forgotten individual doses. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the dose that you missed.

ALLERGEX TABLETS can have side effects. Not all side effects reported for ALLERGEX TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this ALLERGEX TABLETS, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking ALLERGEX TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, and mouth or throat, which may cause difficulty in swallowing or breathing.
• rash
• fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to ALLERGEX TABLETS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department if you notice any of the following:

• chest tightness
• angina
• changes in the way your heart beats
• difficulty breathing
• signs of recurrent infections such as fever or sore throat,
• less urine than is normal for you,
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• sedation (calming or relaxing state)
• incoordination
• dizziness
• Blurred vision
• Headache
• Nausea (feeling that one is about to vomit)

Frequency unknown

• vomiting (to be sick)
• diarrhoea (frequent or loose watery stools)
• constipation
• Increased appetite
• Stomach pain
• dry mouth
• allergic reactions and cross sensitivity to related medicines
• anorexia (loss of appetite)
• muscle weakness
• painful urination
• tachycardia (increased heart rate)
• tremors (shaking)
• convulsions (an episode of spasm(s) and reduced consciousness)
• tightness of the chest
• hypotension (low blood pressure)
• tinnitus (ringing in the ears)

Store at or below 30 °C in airtight containers. Protect from light.

KEEP OUT OF REACH OF CHILDREN

Store in the original package/container

Keep the container tightly closed

Store in outer carton until required for use.

Do not store in a bathroom

Do not use after the expiry date stated on the label/carton/bottle.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g toilets)