Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
APPRVED PROFESSIONAL INFORMATION FOR ZIALDEL  
SCHEDULING STATUS  
S2  
1. NAME OF THE MEDICINE  
ZIALDEL ORAL SOLUTION 5 mg/5 mL  
2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each 5 ml contains 5 mg cetirizine dihydrochloride.  
Excipients:  
Each ml contains 2,7 g sorbitol (sugar) and 2,5 mg sucralose (sweetener).  
For a full list of excipients, see Section 6.1.  
Preservative:  
Sodium benzoate 0,2 % m/v  
3. PHARMACEUTICAL FORM  
Oral solution  
ZIALDEL is a clear, colourless to yellow grape-flavoured liquid.  
4. CLINICAL PARTICULARS  
4.1 Therapeutic indications  
ZIALDEL is indicated for the treatment of allergic processes which respond to histamine H1 receptor  
antagonists:  
•
Respiratory: Allergic rhinitis, hay fever.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
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Cutaneous: Allergic skin conditions associated with pruritus e.g., urticaria.  
4.2 Posology and method of administration  
Posology  
Adults and children over the age of 12 years:  
Take 10 mL (10 mg) once daily.  
Children 6 to 12 years of age:  
Take 10 ml (10 mg) daily, either as a single dose or as divided doses of 5 ml (5 mg) in the morning  
and 5 ml (5 mg) in the evening.  
Children 2 to 6 years of age:  
Take 5 ml (5 mg) daily, either as a single dose or as divided doses of 2,5 ml (2,5 mg) in the morning  
and 2,5 ml (2,5 mg) in the evening.  
Special populations  
Elderly patients:  
No dose adjustment is necessary in elderly patients with normal renal function.  
Renal impairment:  
In patients with renal insufficiency (creatinine clearance less than 40 ml/min), the dose should be  
reduced to half the recommended daily dose.  
Hepatic impairment:  
In patients with moderate to severe hepatic impairment the dose should be reduced to half the  
recommended daily dose.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
Method of administration  
For oral use only  
4.3 Contraindications  
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Hypersensitivity to cetirizine dihydrochloride, hydroxyzine, any piperazine derivatives or to  
any of the excipients listed in section 6.1  
•
•
Patients with severe renal impairment where the creatinine clearance is less than 30 ml/min.  
ZIALDEL is contra-indicated in lactating women since the active ingredient is excreted in  
breast milk (see section 4.6).  
•
•
•
ZIALDEL is contra-indicated in pregnancy as the safety has not been established (see section  
4.6)  
Asthma, as it may cause airway obstruction in patients who have previously experienced  
adverse reactions to antihistamines.  
In children under 2 years of age, as safety and efficacy have not been demonstrated.  
4.4 Special warnings and precautions for use  
ZIALDEL lacks significant sedative effects. Patients should be warned, however, that a small number  
of individuals may experience sedation.  
Renal and hepatic impairment:  
The daily dose of ZIALDEL should be reduced in patients with renal insufficiency and patients with  
moderate to severe hepatic impairment (see section 4.2)  
Epilepsy:  
ZIALDEL should be used with caution in patients with epilepsy or patients at risk of convulsions.  
Alcohol:  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
Avoid alcohol intake while taking ZIALDEL.  
Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord  
lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary  
retention.  
Elderly patients are more susceptible to many of the adverse effects of cetirizine.  
ZIALDEL contains propylene glycol which may cause alcohol-like symptoms.  
Allergy skin tests are inhibited by antihistamines such as ZIALDEL and a wash-out period of 3 days is  
recommended before performing them (see section 4.5)  
Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not  
present before treatment initiation. In some cases, the symptoms may be intense and  
may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.  
Patients with hereditary fructose intolerance, should not take ZIALDEL.  
Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.  
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary  
intake of sorbitol (or fructose) should be taken into account.  
The content of sorbitol in medicines for oral use may affect the bioavailability of other medicines for  
oral use administered concomitantly.  
4.5 Interaction with other medicines and other forms of interaction  
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There are no known interactions between ZIALDEL and other medicines. Due to  
pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are  
expected with this medicine. Neither pharmacodynamic nor significant pharmacokinetic  
interaction was reported in interaction studies performed, notably with pseudoephedrine or  
theophylline (400 mg/day).  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
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There is no evidence of an interaction between cetirizine and cimetidine, ketoconazole,  
erythromycin, azithromycin, diazepam and glipizide.  
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption  
is decreased.  
In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause  
additional reductions in alertness and impairment of performance although cetirizine does not  
potentiate the effect of alcohol (0,5 g/l blood levels) (see section 4.7).  
4.6 Fertility, pregnancy and lactation  
Pregnancy  
ZIALDEL is contraindicated in pregnancy as the safety has not been established (see section 4.3)  
Breastfeeding  
ZIALDEL is contraindicated in lactating women since the active ingredient is excreted in breast milk  
(see section 4.3).  
Fertility  
Limited data is available on human fertility but no safety concern has been identified.  
4.7 Effects on ability to drive and use machines  
Patients should be warned that some individuals may experience sedation. It is therefore advisable to  
determine individual response before driving or performing complicated tasks.  
In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause additional  
reductions in alertness and impairment of performance although cetirizine does not potentiate the  
effect of alcohol (0.5 g/l blood levels) (see section 4.5).  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
4.8 Undesirable effects  
a. Summary of the safety profile  
ZIALDEL has potential adverse effects on the CNS, including somnolence, fatigue, dizziness and  
headache.  
b. Tabulated summary of adverse reactions  
Blood and lymphatic system disorders:  
Less frequent  
thrombocytopenia,  
agranulocytosis.  
leucopenia,  
haemolytic  
anaemia,  
Immune system disorders:  
Less frequent  
Hypersensitivity (including bronchospasm and angioedema),  
anaphylactic shock.  
Metabolism and nutrition disorders:  
Frequency unknown  
Psychiatric disorders:  
Frequent  
Increased appetite.  
Somnolence.  
Less frequent:  
Confusion,  
depression,  
insomnia,  
agitation,  
aggression,  
hallucinations.  
Frequency unknown  
Suicidal ideation, nightmares.  
Nervous system disorders:  
Frequent  
Dizziness, headache.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
Less frequent  
Paraesthesia, convulsions, tremor, tics.  
Frequency unknown  
Anxiety, nervousness, movement disorders, dysgeusia, syncope,  
dystonia, dyskinesia, amnesia, memory impairment.  
Eye disorders  
Less frequent  
accommodation disorder, blurred vision, oculogyration  
Ear and labyrinth disorders:  
Frequent unknown:  
Cardiac disorders:  
Less frequent  
Tinnitus,vertigo.  
Tachycardia, dysrhythmias, palpitations  
Vascular disorders  
Less frequent  
Hypotension  
Respiratory, thoracic and mediastinal disorders:  
Frequent  
Rhinitis, pharyngitis.  
Thickening of mucous  
Less frequent  
Gastrointestinal disorders:  
Frequent  
Diarrhoea, dry mouth, nausea.  
Less frequent  
Gastrointestinal discomfort, constipation.  
Hepatobiliary disorders:  
Less frequent  
abnormal hepatic function (increased transaminases, alkaline  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
phosphatase, gamma-GT and bilirubin), jaundice.  
Frequency not known  
hepatitis  
Skin and subcutaneous tissue disorders:  
Less frequent  
pruritus, rash, urticaria, angioedema, fixed drug eruption,  
photosensitivity, hair loss, sweating.  
Frequency unknown  
Acute generalized exanthematous pustulosis  
Musculoskeletal, connective tissue and bone disorders:  
Less frequent  
Myalgia  
Frequency unknown  
Renal and urinary disorders:  
Less frequent  
arthralgia  
Dysuria, enuresis, urinary retention.  
General disorders and administration site conditions:  
Frequent  
Fatigue, malaise, asthenia.  
Investigations:  
Less frequent  
Weight increased  
c. Description of selected adverse reactions  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not  
present before treatment initiation. In some cases, the symptoms may be intense and may require  
treatment to be restarted. The symptoms should resolve when the treatment is restarted.  
Reporting of suspected adverse reactions  
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows  
continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to  
report any suspected adverse to report any suspected adverse reactions to SAHPRA via the “6.04  
Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publication  
https://www.sahpra.org.za/document/adverse-drug-reactions-and-quality-problem-reporting-form/  
or to the Holder of certificate of registration through the mail: pvg.cdma@heterogroups.com.  
4.9 Overdose  
Symptoms:  
Symptoms after an overdose of ZIALDEL are mainly associated with CNS effects or with effects that  
suggest an anticholinergic effect. Drowsiness is an expected symptom of overdosage.  
Adverse events associated with overdosage include confusion, diarrhoea, dizziness, fatigue,  
headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia,  
tremor and urinary retention.  
Management:  
There is no known specific antidote to ZIALDEL. Should overdose occur, symptomatic or supportive  
treatment is recommended. Cetirizine is not effectively removed by dialysis.  
5 PHARMACOLOGICAL PROPERTIES  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
5.1 Pharmacodynamic properties  
Pharmacotherapeutic group: Antihistamine for systemic use, Piperazine derivatives  
ATC code: R06A E07  
Pharmacological classification: A 5.7.1 Antihistaminics  
Cetirizine dihydrochloride, a metabolite of hydroxyzine, is an anti-allergic medicine, with selective  
histamine H1 receptor antagonism devoid of any significant anticholinergic and anti-serotonin effects.  
The anti-allergic activity is exerted mainly via its effect on the release of mediators (such as  
histamine) combined with its selective H1 receptor-blocking action. Cetirizine reduces eosinophil  
recruitment caused by an antigen-antibody reaction.  
5.2 Pharmacokinetic Properties  
•
Absorption:  
Cetirizine is rapidly absorbed from the gastrointestinal tract; absorption is not reduced by food, though  
the rate may be decreased slightly. Peak blood levels of 300 ng/ml are reached within one hour after  
oral administration of cetirizine.  
•
Distribution:  
Cetirizine binds strongly to plasma proteins. The apparent volume of distribution is 0,5 l/kg.  
Biotransformation:  
Cetirizine is not subjected to extensive first pass metabolism.  
•
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Elimination:  
The terminal half-life is about 5 hours in children aged 2 to 6 years, 6 hours in children aged 6 to 12  
years and 10 hours in adults. This is consistent with the urinary excretion half-life of cetirizine.  
Approximately two thirds of the doses given to both children and adults are excreted via urinary  
excretion. The apparent plasma clearance is higher in children than in adults.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
•
Linearity/ non-linearity:  
Plasma levels are linear to the dose administered.  
Characteristics in specific groups of patients  
An increase in half-life and a decrease in total clearance occur in patients with impaired renal  
clearance (less than 40 mL/min) and hepatic deficiency (see section 4.2).  
6 PHARMACEUTICAL PARTICULARS  
6.1 List of excipients  
Cetirizine Hydrochloride  
Propylene glycol  
Sodium benzoate  
Sucralose  
Non crystallizing sorbitol solution  
Anhydrous citric acid  
Purified water  
ART Grape FL # 10273 composition  
Propylene glycol  
6.2 Incompatibilities  
Not applicable.  
6.3 Shelf life  
24 months  
6.4 Special precautions for storage  
Store at or below 25 °C. Protect from light.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ZIALDEL  
Dosage form and strength: Oral solution, Each 5 ml contains 5 mg cetirizine dihydrochloride  
Keep in the original container until required for use.  
KEEP OUT OF REACH OF CHILDREN.  
6.5 Nature and contents of container  
150 ml white, opaque, round PP bottle with a white, opaque PP child-resistant ribbed, plastic cap with  
opening illustrations embossed on the top, packed in an outer cardboard carton with 118mL fill  
volume.  
6.6 Special precautions for disposal  
No special requirements  
7 HOLDER OF CERTIFICATE OF REGISTRATION  
Hetero Drugs South Africa (Pty) Ltd  
Waterfall Corporate Campus, Building No.2,  
First Floor, 74 Waterfall Drive, Midrand, 2066  
Telephone number: 012 644 1220  
Fax number: 012 644 1564  
e-mail address: nokuthula.n@hetero.com  
8 REGISTRATION NUMBER(S)  
53/5.7.1/0404  
9 DATE OF FIRST AUTHORISATION  
12 March 2024  
10 DATES OF REVISION OF THE TEXT  
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