Allerway Side Effects

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Answer the side-effect intent for allerway without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Allerway?

Allerway contains the active ingredient Levocetirizine dihydrochloride.

• Active ingredient — Levocetirizine dihydrochloride
• Registration number — 43/5.7.1/0815
• Registration holder — Dr. Reddy’s Laboratories (Pty) Ltd

It is approved for:

• 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)

Common side effects of Allerway

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Less frequent side effects

• Seizure (fits)
• Abnormal heartbeats
• Recurring thoughts of or preoccupation with suicide, aggressive or agitated behaviour. Side effects – frequency unknown:
• Hallucinations (false perceptions), depression
• These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Frequently reported side effects include:
• Shortness of breath
• Headache
• Somnolence/drowsiness
• Pins and needles
• Dizziness
• Fainting
• Tremor (shaking)
• Distortion of the sense of taste
• Tiredness
• Sore throat, runny or stuffy nose
• Dry mouth, constipation
• Problems with sleeping. Less frequently reported side effects include:
• Hepatitis (inflammation of the liver), abnormal liver function tests
• Problems with vision
• Nausea (feeling sick), vomiting, abdominal pain, diarrhoea and gastro- intestinal (affecting the stomach and intestines) discomfort
• Skin reactions, rashes, skin eruption, urticaria (swelling, redness and itchiness of the skin), itchiness
• Muscular pain
• Feeling of weakness, feeling unwell
• Insomnia (inability to sleep). Side effects with unknown frequencies include:
• Weight gain
• Increased appetite
• Nightmares
• Blurred vision, oculogyration (eyes having uncontrolled circular movements)
• Sensation of rotation or movement
• Increased heart rate
• Joint pain
• Painful or difficult urination, inability to completely empty the bladder
• Swelling caused by fluid
• Swelling caused by excess fluid trapped in your body’s tissues
• Pruritus (intense itching) upon discontinuation

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you or your child are hypersensitive (allergic) to levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or any other substances with a similar chemical structure or to one of the other ingredients of ALLERWAY 5
• if you are pregnant or breastfeeding your baby
• if you or your child have a severe impairment of kidney function (severe kidney failure with creatinine clearance below 10 ml/min)
• if you or your child are on dialysis
• if your child is under the age of 6 years

Use with care, and tell your doctor, if

• Some patients being treated with ALLERWAY 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 5. This may have an effect on alertness and ability to drive and use 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 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 5 may cause seizure aggravation
• If you are scheduled for allergy testing, ask your doctor if you should stop taking ALLERWAY 5 for several days before testing. This medicine may affect your allergy test results
• ALLERWAY 5 is not suitable for children under the age of 6

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking ALLERWAY 5
• • Do not take ALLERWAY 5 if you are breastfeeding your baby, since the active ingredient (levocetirizine dihydrochloride) passes into breast milk
• • Do not take ALLERWAY 5 if you are pregnant or planning to become pregnant, as safety during pregnancy has not been established

Interactions and medicines to check

The approved leaflet names these interactions.

• Central nervous system depressants (medicines used to slow down brain activity) and that may make you sleepy (such as other cold or allergy medicine, sleeping pills, muscle relaxers, and medicines for seizures, depression, or anxiety)
• Ritonavir (a medicine used to treat HIV/AIDS infection)
• Theophylline (a medicine used to treat respiratory diseases such as asthma). ALLERWAY 5 with food and alcohol You may take ALLERWAY 5 with or without food. ALLERWAY 5 should be taken with liquid. Caution is advised if ALLERWAY 5 is taken at the same time as alcohol or other medicines acting on the brain. In sensitive patients, the simultaneous use of ALLERWAY 5 and alcohol or medicines acting on the brain may have effects on alertness, impairment of performance and ability to drive and use machines

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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