Allerway Meltaway 5 mg Tablets

ALLERWAY MELTAWAY 5 is an antiallergic medication. ALLERWAY MELTAWAY 5 is used to treat symptoms associated with allergic conditions, such as:

• Seasonal and year-round allergic rhinitis (nose and eye itching, watery eyes, stuffy or runny nose, sneezing)
• Long-term hives/nettle rash with no known cause (chronic idiopathic urticaria).

Do not take ALLERWAY MELTAWAY 5:

• if you or your child are hypersensitive (allergic) to levocetirizine dihydrochloride or any other substances with a similar chemical structure or to one of the other ingredients of ALLERWAY MELTAWAY 5 (see “What ALLERWAY MELTAWAY 5 contains”)
• if you are pregnant or breastfeeding your baby (see “Pregnancy and breastfeeding”)
• if you or your child have a severe impairment of kidney function (severe kidney failure with creatinine clearance below 10 mL/min).
• if your child is under the age of 6 years

Warnings and precautions

Some patients being treated with ALLERWAY MELTAWAY 5 may experience sedative effects such as drowsiness or sleepiness. The simultaneous use of alcohol or medicines affecting the central nervous system may add to these effects caused by ALLERWAY MELTAWAY 5. This may have an effect on alertness and ability to drive and use machines (see “Driving and using machines”).

Take special care if you have predisposing factors of urinary retention (inability to completely empty your bladder) (eg., spinal cord lesions, prostatic hyperplasia (enlarged prostate)) as ALLERWAY MELTAWAY 5 may increase the risk of urinary retention.

If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of ALLERWAY MELTAWAY 5 may cause seizure aggravation.

If you are scheduled for allergy testing, ask your doctor if you should stop taking ALLERWAY MELTAWAY 5 for several days before testing. This medicine may affect your allergy test results.

Always take ALLERWAY MELTAWAY 5 exactly as described in this leaflet or as your doctor or pharmacist have told you. You should check with your doctor or pharmacist if you are not sure.

ALLERWAY MELTAWAY 5 tablet should be placed on the tongue and should be sucked, not chewed, until complete disintegration. The resulting suspension has to be swallowed with saliva. ALLERWAY MELTAWAY 5 can be taken with or without water and may be taken with or without food.

The usual dose is:

• Adults or adolescents aged 12 years and older: The daily recommended dose is one tablet.
• Children aged 6 to 12 years: The daily recommended dose is one tablet. ALLERWAY MELTAWAY 5 must not be used in children under 6 years of age.

Kidney and liver impairment

Adults with impaired kidney function may be given a lower dose according to the severity of their kidney disease, the dose will be determined by your doctor. In children with impaired kidney function, the dose will be chosen on the basis of body weight. Patients who have severe impairment of kidney function (creatinine clearance below 10 mL/min) must not take ALLERWAY MELTAWAY 5. No adaptation of the dose is necessary in elderly patients, provided their kidney function is normal. Patients who only have impaired liver function should take the usual prescribed dose. Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of their kidney disease; the dose will be determined by your doctor.

If you have the impression that the effect of ALLERWAY MELTAWAY 5 is too strong or too weak, tell your doctor or pharmacist.

If you take more ALLERWAY MELTAWAY 5 than you should:

• An overdose may cause drowsiness in adults.
• Children may initially show agitation and restlessness followed by drowsiness. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ALLERWAY MELTAWAY 5:

Do not take a double dose to make up for a forgotten individual doses, just continue taking the amounts stated in the dosage instructions.

If you stop taking ALLERWAY MELTAWAY 5:

Stopping treatment should have no negative effects. However, pruritus (intense itching) may occur if you stop taking ALLERWAY MELTAWAY 5, even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

ALLERWAY MELTAWAY 5 can have side effects. Not all side effects reported for ALLERWAY MELTAWAY 5 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ALLERWAY MELTAWAY 5, please consult your health care provider for advice.

If any of the following happens, stop taking ALLERWAY MELTAWAY 5 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the mouth, tongue, face and/or throat
• breathing or swallowing difficulties (chest tightness or wheezing)
• hives (red and lumpy skin rash)
• rash or itching
• sudden fall in blood pressure leading to collapse or shock, which may be fatal.

These are all very serious side effects. If you have them, you may have had a very serious allergic reaction to ALLERWAY MELTAWAY 5. You may need urgent medical attention or hospitalisation.

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

• seizures (fits)
• palpitations (irregular heartbeat)
• hallucinations (false perceptions), recurring thoughts of or preoccupation with suicide, depression, aggressive or agitated behaviour.

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:

• sleep disorders
• headache
• somnolence/drowsiness
• dry mouth, diarrhoea, constipation
• exhaustion

Less frequent side effects:

• nausea, gastro-intestinal (affecting the stomach and intestines) discomfort, abdominal pain, vomiting
• feeling of weakness, feeling unwell

Side effects with unknown frequencies:

• allergic reactions
• convulsions
• pins and needles
• dizziness, fainting, sensation of rotation or movement
• tremor (shaking)
• distortion of the sense of taste
• visual disturbances, blurred vision, oculogyration (eyes having uncontrolled circular movements)
• palpitations (irregular heartbeat), increased heart rate
• shortness of breath
• liver inflammation
• skin reactions, urticaria (swelling, redness and itchiness of the skin), rashes, pruritis (itchiness), skin eruption
• muscular pain, joint pain
• painful or difficult urination, inability to completely empty the bladder
• oedema (swelling)
• increased appetite, weight increase
• hallucinations (false perceptions), recurring thoughts of or preoccupation with suicide, depression, aggressive or agitated behaviour
• insomnia (inability to sleep), nightmare
• abnormal liver function
• pruritus (intense itching) upon discontinuation

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ALLERWAY MELTAWAY 5.

Store all medicines out of reach of children. Store at or below 30 °C. The blisters must be kept in the carton until required for use. Do not store in bathrooms. Do not use after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).