INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ASPEN CETIRIZINE 1 mg/mL

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ASPEN CETIRIZINE 1 mg/mL
(oral solution)

COMPOSITION:
Each 1 mL of ASPEN CETIRIZINE 1 mg/mL contains 1 mg
cetirizine dihydrochloride.
Contains sodium methylparahydroxybenzoate 0,155% m/v and sodium propylparahydroxybenzoate 0,0168% m/v as preservatives.
Does not contain sucrose or alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:
Cetirizine is a metabolite of hydroxyzine. It is a second-generation reversible, competitive inhibitor of histamine at the histamine-1 (H1) receptor. Cetirizine competes with histamine for the H1-receptor site. Cetirizine prevents, but does not reverse, pharmacological responses mediated by histamine, at the H1 receptor.
Pharmacokinetics:
Cetirizine is well absorbed from the gastro-intestinal tract and peak plasma concentrations are reached within 1 hour after oral administration. Pharmacokinetics are linear, with plasma concentrations increasing proportionately with increasing doses. The terminal half-life in adults is approximately 10 hours; in children aged 6 to 12 years 6 hours; in children aged 2 to 6 years, 5 hours. Cetirizine is eliminated faster in children, and slower in patients with hepatic or renal impairment (creatinine clearance <40 mL/min), with a resultant increase in half-life and decrease in clearance. Cetirizine does not undergo extensive first-pass metabolism. The cumulative urinary excretion represents about two thirds of the dose given in both adults and children.

INDICATIONS:
ASPEN CETIRIZINE is indicated for symptomatic relief of allergic conditions such as allergic rhinitis, and allergic skin conditions such as urticaria.

CONTRA-INDICATIONS:
Hypersensitivity to ASPEN CETIRIZINE or any of the ingredients.
Hypersensitivity to hydroxyzine.
Lactating women, since the active ingredient is excreted in breast-milk.
Pregnancy, as safety has not been established.
Children under the age of two years, as safety and efficacy have not been demonstrated.

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. The patient's ability to perform hazardous activities requiring mental alertness or physical coordination such as driving or operating machinery may be impaired.
Porphyria: Use with caution.

INTERACTIONS:
Concomitant use of alcohol and other sedating agents should be avoided. There is no evidence of an interaction between cetirizine and cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, glipizide, and pseudoephedrine.

PREGNANCY AND LACTATION:
Safety in pregnancy and lactation has not been established (see "CONTRA-INDICATIONS").

DOSAGE AND DIRECTIONS FOR USE:
Adults or children 12 years of age or older: 10 mg (10 mL) once daily
Children 6 to 12 years old: 10 mg (10 mL) daily, either as a single dose or as divided doses of 5 mL in the morning and 5 mL in the evening.
Children aged 2-6 years: 5 mg (5 mL) daily, either as a single dose or as divided dose: of 2.5 mL in the morning and 2.5 mL in the evening.
No dose adjustment is necessary in healthy elderly patients with normal renal function
Dosage in Renal impairment:
In patients with renal impairment, where the creatinine clearance is less than 40 mL/min, the recommended daily dose of cetirizine should be halved.
Dosage in Hepatic impairment:
In moderate to severe hepatic impairment half the recommended daily dose should be used.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Nervous system disorders
Less frequent: dizziness Frequency unknown: drowsiness, fatigue, anxiety, nervousness Vascular disorders
Frequency unknown: headache, angioedema
Respiratory, thoracic and mediastinal disorders
Frequency unknown: thickening of mucous
Gastrointestinal disorders
Less frequent: dry mouth, increased appetite, nausea, gastrointestinal discomfort
Skin and subcutaneous tissue disorders
Less frequent: skin rash
Frequency unknown: urticaria, pruritus
General disorders
Frequency unknown: malaise, asthenia
Special precautions:
ASPEN CETIRIZINE lacks significant sedative effects. Patients should be warned, however, that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks (see "WARNINGS"). This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants (see "INTERACTIONS").

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OFITS TREATMENT:
Drowsiness is an expected symptom of overdose. Overdose in children may produce agitation, somnolence, pruritus, rash, urinary retention, fatigue, tremor, and tachycardia. In the case of massive overdose, gastric lavage should be performed together with the usual supportive measures. There is no specific antidote.
Cetirizine is not effectively removed by dialysis.
FURTHER TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.

IDENTIFICATION:
ASPEN CETIRIZINE 1 mg/mL is a clear colourless solution with a banana flavour and odour.

PRESENTATION:
ASPEN CETIRIZINE 1 mg/mL is available in a 150 mL amber glass bottle with a white, tamper evident, screw cap.

STORAGE INSTRUCTIONS:
Store below 25ºC. Protect from light. Keep container tightly closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
42/5.7.1/0143

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THE PACKAGE INSERT:
12 March 2009

575397

New addition to this site: February 2010
Source: Pharmaceutical Industry

PATIENT INFORMATION LEAFLET

Read this entire leaflet carefully before you start taking ASPEN CETIRIZINE.
•        Keep this leaflet. You may need to read it again.
•        If you have further questions, please ask your doctor or pharmacist.
•        ASPEN CETIRIZINE has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

Schedule 2

ASPEN CETIRIZINE 1 mg/mL

(Oral Solution)

Cetirizine dihydrochloride

1. WHAT ASPEN CETIRIZINE CONTAINS
The active substance is cetirizine dihydrochloride 1 mg/mL.
The other ingredients are acetic acid, banana flavour, glycerol, saccharin sodium, sodium acetate trihydrate, sorbitol liquid and water.
Preservatives: sodium methylparahydroxybenzoate (0.155 % m/v), sodium propylparahydroxybenzoate (0.0168 % m/v).

2. WHAT ASPEN CETIRIZINE IS USED FOR
ASPEN CETIRIZINE is an antihistamine, a medicine used to prevent or relieve symptoms of allergies such as allergy of the nose, hay fever and allergic skin conditions with itching. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose and watery eyes.

3. BEFORE YOU TAKE ASPEN CETIRIZINE DO NOT TAKE ASPEN CETIRIZINE:
If you are allergic to cetirizine or any of the other ingredients of ASPEN CETIRIZINE.
If you are allergic to hydroxyzine.
If you are breastfeeding.
If you are pregnant.
Take special care with ASPEN CETIRIZINE:
ASPEN CETIRIZINE 1 mg/mL may cause some people to feel sleepy especially with alcohol. Find out if this happens to you before you drive or do work which is complicated or dangerous.
If you have liver or kidney problems you must take half the usual recommended dose.
Taking ASPEN CETIRIZINE with food and drink:
Intake of alcohol with ASPEN CETIRIZINE may make you feel sleepy.
Pregnancy and breastfeeding:
Do not take ASPEN CETIRIZINE if you are pregnant or breastfeeding.
Driving and using machinery:
ASPEN CETIRIZINE may cause some people to feel sleepy especially with alcohol. Find out if this happens to you before you drive or do work which is complicated or dangerous.
Taking other medicines with ASPEN CETIRIZINE 1 mg/mL:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ASPEN CETIRIZINE with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.

4. HOW TO TAKE ASPEN CETIRIZINE
Always take ASPEN CETIRIZINE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
If you have the impression that the effect of ASPEN CETIRIZINE is too strong or too weak, talk to your doctor or pharmacist.

The usual dose is as follows:
Adults or children 12 years of age or older:
10 mg (10 mL) once daily.
Children 6 to 12 years old:        10 mg (10 mL) daily, either as a single dose or as divided doses of 5 mL in the morning and 5 mL in the evening.
Children 2 to 6 years old: 5 mg (5 mL) daily, either as a single dose or as divided doses of 2.5 mL in the morning and 2.5 mL in the evening.
In patients with kidney or liver problems, the dosage should be reduced to half the usual recommended dose.
If you take more ASPEN CETIRIZINE 1 mg/mL than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.
Drowsiness is a symptom of overdose. Overdosage in children can cause agitation, sleepiness, itching, rash, urinary retention, tiredness, shaking and an increase in the rate of heart beat.
If you forget to take ASPEN CETIRIZINE:
If you miss a dose of ASPEN CETIRIZINE, take it as soon as you remember and then continue as before. Do not take a double dose to make up for forgotten individual doses.

5. POSSIBLE SIDE-EFFECTS
ASPEN CETIRIZINE can have side-effects.
Not all side-effects reported for ASPEN CETIRIZINE are included in this leaflet. Should your general health worsen while taking ASPEN CETIRIZINE, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happen, stop taking ASPEN CETIRIZINE and tell your doctor immediately or go to the casualty department at your nearest hospital:
Swelling of the face, lips or tongue which may cause difficulty in breathing
Rash or itching
These are all very serious side-effects. If you have them, you may have had a serious allergic reaction to ASPEN CETIRIZINE. You may need urgent medical attention or hospitalisation. All of these very serious side-effects are rare.
Tell your doctor if you notice any of the following:
Dizziness, unusual excitement, nervousness, restlessness or irritability.
Headache, drowsiness, tiredness, lack of energy, feeling unwell.
Dryness of mouth.
Increase or loss of appetite.
Stomach upset, stomach pain, nausea, vomiting.

6. STORING AND DISPOSING OF ASPEN CETIRIZINE
Store below 25ºC. Protect from light. Keep container tightly closed.
Return all unused medicine to your pharmacist. Do not dispose of unused medicine drains or sewerage systems (e.g. toilets).
KEEP OUT OF REACH OF CHILDREN

7. PRESENTATION OF ASPEN CETIRIZINE
ASPEN CETIRIZINE 1 mg/mL is supplied in 150 mL amber glass bottles with white tamper evident screw caps.

8. IDENTIFICATION OF ASPEN CETIRIZINE
This medicine is a clear, colourless solution with a banana smell and taste.

9. REGISTRATION NUMBER:
42/5.7.1/0143

10. NAME AND ADDRESS OF REGISTRATION HOLDER:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

11. DATE OF PUBLICATION
12 March 2009

575397

New addition to this site: February 2010
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2010