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Allergex Blister Pack 30’s
Product Description
SCHEDULING STATUS: S2
PROPRIETARY NAME: ALLERGEX® NON-DROWSY TABLETS
(AND DOSAGE FORM) (TABLET)
COMPOSITION:
Each tablet contains:
Loratadine (micronised) 10 mg
Contains sugar:
Lactose monohydrate 75 mg
PHARMACOLOGICAL CLASSIFICATION:
A: 5.7.1 Antihistaminics
PHARMACOLOGICAL ACTION:
Loratadine is a long acting piperidine antihistamine. 2
It is a selective H1 receptor antagonist which is a reversible, competitive inhibitor of histamine at H1 receptor sites.
Loratadine is a second generation H1 antagonist.
It does not readily cross the blood brain barrier.
Pharmacokinetics:
Peak plasma levels are reached within 1,5 hours and the clinical effect is achieved within 2 hours.
Excretion occurs equally via the faeces and the urine.
INDICATIONS:
The relief of symptoms associated with seasonal allergic rhinitis and chronic urticaria.
CONTRAINDICATIONS:
ALLERGEX NON DROWSY TABLETS is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
Safety in pregnancy and lactation has not been established.
The safe use of ALLERGEX NON DROWSY TABLETS in the elderly has not been established.
DOSAGE AND DIRECTIONS FOR USE:
One tablet to be taken once daily.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Most commonly reported side effects include fatigue, headache, somnolence and dry mouth.
Gastrointestinal side effects including nausea, vomiting, diarrhoea, gastritis or epigastric pain may occur.
Allergic symptoms like rashes and hypersensitivity reactions may occur.
Abnormal hepatic function, alopecia and anaphylaxis have also been reported.
Precautions:
ALLERGEX NON-DROWSY TABLETS lack significant sedative properties. However, patients should be advised that a small number of individuals may experience sedation. Therefore, the effect of the medicine on a particular patient should be ascertained before they drive or operate machinery. This effect can be compounded by the simultaneous intake of alcohol or other central nervous system depressants.
A lower dose should be administered to patients with hepatic impairment as they may have decreased clearance of loratadine; i.e. an initial dose of 5 mg once daily or 10 mg on alternate days.
Medicine/laboratory test interactions:
The use of ALLERGEX NON DROWSY TABLETS should be stopped several days before skin testing as antihistamines may suppress the positive skin response to allergen extracts.
Medicines known to inhibit the hepatic metabolism of loratadine include cimetidine, erythromycin, ketoconazole, quinidine, fluconazole and fluoxetine. These medicines should therefore not be administered concomitantly with loratadine as they may raise the plasma concentrations of loratadine.
However, no clinically significant consequences have been observed when these medicines are administered concomitantly.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “SIDE EFFECTS AND SPECIAL PRECAUTIONS”.
Cardiac effects such as tachycardia have been reported.
Headache and somnolence have also been reported with overdoses.
In the event of overdosage, treatment should be started immediately.
Treatment is symptomatic and supportive. Haemodialysis is not an effective means of removing loratadine or its metabolite from the body.
IDENTIFICATION:
White, 8 mm, round, flat tablets, with a breakline.
PRESENTATION:
Glass-clear, rigid, glossy, PVC film and aluminium foil blister packs of 7, 10, 14, 21 and 30 tablets.
STORAGE INSTRUCTIONS:
Store below 25 ºC.
Protect from light.
Do not remove the blister pack from the outer carton until required for use.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
36/ 5.7.1/0286
NAME AND ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
1 New Road
Erand Gardens
Midrand, 1685
Private Bag X69
Bryanston, 2021
www.adcock.com
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
- February 2004
- Allergex Non Drowsy Syrup packaging insert approved on 24 January 2003
| Pharma Code: 120 | Llllll |
| Size: 150 mm x ??? mm
Folded to: 150 mm x 35 mm |
|
SCHEDULING STATUS: S2
PROPRIETARY NAME: ALLERGEX® NON DROWSY SYRUP
(AND DOSAGE FORM) (SYRUP)
COMPOSITION:
Each 5 ml of ALLERGEX NON DROWSY SYRUP contains:
Loratadine (micronised) 5 mg
Preservative:
Sodium benzoate 0,1 % m/v
Contains sugar:
Sucrose 1 000 mg
PHARMACOLOGICAL CLASSIFICATION:
A: 5.7.1 Antihistaminics
PHARMACOLOGICAL ACTION:
Loratadine is a long acting piperidine antihistamine. 3
It is a selective H1-receptor antagonist which is a reversible, competitive inhibitor of histamine at H1-receptor sites.
Loratadine is a second generation (non-sedating) H1-receptor antagonist.
Following oral administration, peak plasma concentrations are achieved in 2 to 3 hours. Loratadine is metabolised in the liver to active metabolites by the hepatic microsomal P450 system.
It does not cross the blood brain barrier.
INDICATIONS:
The relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhoea, and itching of nose and throat.
ALLERGEX NON DROWSY SYRUP is also indicated for the relief of chronic idiopathic urticaria and other allergic dermatoses.
CONTRAINDICATIONS:
ALLERGEX NON DROWSY SYRUP is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
Safety in pregnancy and lactation has not been established.
The safe use of ALLERGEX NON DROWSY SYRUP in children under 2 years of age and in the elderly has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Children 2 to 5 years of age: 5 ml (1 medicine measure) once daily.
Children 6 to 12 years of age: 10 ml (2 medicine measures) once daily.
Adults and children 12 years of age and over: 10 ml (2 medicine measures) once daily.
The use of ALLERGEX NON DROWSY SYRUP should be limited to 14 days.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Gastrointestinal side effects including nausea, vomiting, diarrhoea or epigastric pain have been reported. Fatigue, headache, somnolence and dry mouth have also been reported.
Allergic symptoms like rashes and hypersensitivity reactions may occur.
Sedation and nervousness have been reported.
Abnormal hepatic function has also been reported less frequently.
Palpitations and arrhythmias have been reported.
Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia, although less frequent, have been reported.
Convulsions, sweating, myalgia, paraesthesia, extrapyramidal effects, tremor, sleep disturbances, depression, tinnitus, hypotension, and hair loss have been reported.
Photosensitivity may occur.
Precautions:
ALLERGEX NON DROWSY SYRUP lacks significant sedative properties. However, patients should be advised that a small number of individuals may experience sedation. Therefore, the effect of the medicine on a particular patient should be ascertained before they can drive or operate machinery.
Patients with hepatic impairment should be administered a reduced dose as they may have decreased clearance of loratadine; an initial dose of 5 ml once daily or 10 ml on alternate days is recommended.
Use with caution in patients with epilepsy due to less frequent reports of convulsions.
Cross sensitivity to related drugs may occur.
Drug/laboratory test interactions:
The use of ALLERGEX NON DROWSY SYRUP should be stopped approximately 48 hours before skin testing as antihistamines may suppress the positive skin response to allergen extracts.
Drugs known to inhibit the hepatic metabolism of loratadine include cimetidine, erythromycin, ketoconazole, quinidine, fluconazole and fluoxetine. These drugs should therefore not be administered concomitantly with loratadine as they may raise the plasma concentrations of loratadine. However, no clinically significant consequences have been observed when these drugs are administered concomitantly.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “SIDE EFFECTS AND SPECIAL PRECAUTIONS”.
Cardiac effects such as tachycardia have been reported.
Headache and somnolence have also been reported with overdoses.
In the event of overdosage, treatment should be started immediately.
Treatment is symptomatic and supportive.
Haemodialysis is not an effective means of removing loratadine or its metabolites from the body.
IDENTIFICATION:
ALLERGEX NON DROWSY SYRUP is a clear, colourless syrup having a characteristic peach odour and taste.
PRESENTATION:
Amber glass bottles of 100 ml and 150 ml syrup.
STORAGE INSTRUCTIONS:
Store in a well-closed container below 25 ºC. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
36/5.7.1/0008
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Adcock Ingram Limited
1 New Road
Erand Gardens
Midrand, 1685
Private Bag X69
Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24 January 2003
| Weight | 0.2 kg |
|---|
Brand
Allergex
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