Cetirizine Hydrochloride 5mg/5ml Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetirizine Hydrochloride 5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetirizine hydrochloride 5mg/5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
Clear, colourless, flavoured solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of perennial rhinitis, seasonal allergic rhinitis (hay fever) and chronic idiopathic urticaria in adults and children over 6 years of age, and additionally for the symptomatic treatment of seasonal allergic rhinitis in children between the ages of 2 and 5.
4.2 Posology and method of administration
For oral use.
Adults and children over 12 years of age: 10ml once daily Children aged between 6 and 11: Either 5ml twice daily or 10ml once a day. Children aged between 2 and 5: Either 2.5ml twice daily or 5ml once a day. Not recommended for children under 2 years of age.
Elderly: The usual adult dose is recommended.
In patients with renal insufficiency, the dosage should be reduced to half that of the usual daily dose.
4.3 Contraindications
Hypersensitivity to cetirizine hydrochloride or any of the other ingredients. Lactating women.
4.4 Special warnings and precautions for use
This medicinal product contains sorbitol, sodium, glycerol, methyl and propyl parahydroxy benzoates.
When taken according to the dosage recommendations, each 10ml dose contains up to 3.5g of sorbitol. Sorbitol is broken down in the digestive system by substances called enzymes, into fructose and thus is unsuitable for patients who suffer from fructose intolerance. Sorbitol can cause stomach upset and diarrhoea.
The daily dose, 10ml, of this product contains approximately 3.2mg of sodium, and excessive consumption of sodium may be harmful to people on a low sodium diet.
Glycerol can be harmful in high doses. May cause headache, stomach upset and diarrhoea.
Methyl and Propyl parahydroxy benzoate have been known to cause urticaria, but is generally a delayed reaction, such as contact dermatitis. Rarely immediate reaction with urticaria and bronchospasm.
The elimination of cetirizine may be impaired in patients with impaired hepatic and renal function. Caution should be exercised when administering cetirizine to these patients (see section 4.2 Posology, section 4.3 Contraindications)
In some patients, long-term treatment with cetirizine may lead to an increased risk of caries due to mouth dryness. The patients should therefore be informed about the importance of oral hygiene.
4.5 Interaction with other medicinal products and other forms of interaction
Cetirizine may potentiate the effects of alcohol. It is advisable to avoid excessive alcohol consumption while taking this medicine. Caution is recommended with the concomitant use of CNS depressants.
Allergy testing - Use of cetirizine must be discontinued three days before allergy tests.
4.6 Fertility, Pregnancy and lactation
Although no adverse effects have been reported in animal studies, no information is available on the use of cetirizine hydrochloride in human pregnancy. As with all medicines therefore, its use should be avoided during pregnancy.
Contraindicated whilst breast-feeding, as cetirizine hydrochloride is excreted in breast milk.
4.7 Effects on ability to drive and use machines
Cetirizine hydrochloride does not usually cause drowsiness when taken at the recommended dose, however, patients should be warned not to drive or operate machinery if any effects are apparent.
4.8
Undesirable effects
The daily dose may be divided in patients experiencing occasional mild and transient side effects affecting the nervous and gastrointestinal systems. For adults and children over 12 years of age, this would mean taking 5 ml in the morning and 5 ml in the evening. For children aged 2 to 11, see section 4.2 (Posology).
Frequency estimates: Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1,000); Very rare (<1/10,000):
Blood and lymphatic system disorders:
Very rare: thrombocytopenia
Immune system disorders:
Rare: Allergic reactions; (see Skin and subcutaneous disorders)
Very rare: Anaphylactic shock
Psychiatric disorders:
Uncommon: Agitation
Rare: Aggression, confusion, depression, hallucination, insomnia
Nervous system:
Common: Drowsiness
Uncommon: Headache, dizziness, paraesthesia.
Rare: Convulsions, movement disorders Very rare: Dysgeusia, syncope
Eye disorders:
Very rare: Accommodation disorder, blurred vision
Cardiac disorders:
Rare: Tachycardia
Gastrointestinal disorders:
Common: dry mouth
Uncommon: gastrointestinal disorders (nausea, diarrhoea, abdominal pain, dyspepsia)
Hepatobiliary disorders
Rare: Abnormal hepatic function (increased transaminases, alkaline phosphatase, gamma-GT, bilirubin)
Skin and subcutaneous tissue disorders:
Uncommon: Skin rash, pruritus Rare: Urticaria
Very rare: Angioedema, erythema multiforme
Renal and urinary disorders:
Very rare: Dysuria, enuresis, micturition difficulties
General disorders
Uncommon: asthenia, malaise Rare: Oedema, weight increase
4.9 Overdose
There is limited experience of overdosing. 20 mg to a 2-year-old, 30 mg to a 3-year-old and 40 mg to an 11-year-old did not give any symptoms. 60 mg to a 4-year-old gave mild intoxication, 400 mg to a 14-year-old gave mild symptoms, while 400 to 500 mg to an adult gave no symptoms at all.
a) Symptoms
Cetirizine has a low sedative and anticholinergic effect. Adverse events reported after intake of at least five times the recommended daily dose are confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus. Restlessness, sedation, somnolence, stupor, tachycardia, tremor and urinary retention.
b) Management
Should overdose occur, symptomatic or supportive measures are recommended. The patient should be kept under clinical observation for at least four hours after ingestion, and the blood pressure, heart rate and vital signs monitored until stable. In symptomatic cases, ECG should be performed.
The benefit of gastric lavage is uncertain. Oral activated charcoal (50 g for an adult, 10-15 g for a child) should be considered if more than 2.5 mg/kg cetirizine has been ingested within one hour,
There is no specific antidote.
Cetririzine is not effectively removed by dialysis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: R06A E07
Cetirizine hydrochloride is a piperizine derivative and metabolite of hydroxyzine. It is a potent antihistamine with a low potential for drowsiness at the usual doses, and with additional anti-allergic properties. It is a selective H1 antagonist with negligible effects on other receptors and is therefore virtually free from anti-cholinergic and anti-serotonin effects.
5.2 Pharmacokinetic properties
Cetirizine hydrochloride is rapidly absorbed from the gastro-intestinal tract after oral administration, with peak plasma concentrations occurring in 30 - 60 minutes. It is highly bound to plasma proteins and has an elimination half-life of about 10 hours in adults, and about 6 hours in children. It is excreted primarily in the urine mainly as unchanged drug. It is detected in breast milk.
5.3 Preclinical safety data
No data of relevance which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Sorbitol solution (70%)
Glycerol
Sodium Citrate
Citric acid
Propylene glycol
Monoammonium Glycyrrhizinate
Purified water
Flavours
Pineapple Singapore flavour (flavouring agent and propylene glycol) Sweet orange No. 1(flavouring agent and propylene glycol)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened: 3 years After opening: 6 months
6.4 Special precautions for storage
No special precautions for storage.
6.5 Nature and contents of container
Pack size: 200ml bottle.
Packaging: Type III amber glass bottle with Tamper proof polypropylene closure and Polyethylene Terepthalate (PET) amber bottle with Tamper proof polypropylene closure.
6.6 Special precautions for disposal
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Cipla (EU) Limited Hillbrow House Hillbrow Road Esher Surrey
8 MARKETING AUTHORISATION NUMBER(S)
PL 36390/0023
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/11/2011
10 DATE OF REVISION OF THE TEXT
22/11/2013