DESLOMED SYRUP

Country: Suður-Afríka

Tungumál: enska

Heimild: South African Health Products Regulatory Authority (SAHPRA)

Fáanlegur frá:

Adcock Ingram Limited

Skammtar:

See ingredients

Lyfjaform:

SYRUP

Samsetning:

EACH 5,0 ml SYRUP CONTAINS DESLORATADINE 2,5 mg

Leyfisstaða:

Registered

Leyfisdagur:

2014-03-07

Upplýsingar fylgiseðill

ADCOCK INGRAM LIMITED DESLOMED SYRUP
43/5.7.1/0079
PATIENT INFORMATION LEAFLET
_____________________________________________________________________________________
Date: 6 May 2022
Page 1 of 7
Initials: A.G
SCHEDULING STATUS S2
PROPRIETARY NAME AND PHARMACEUTICAL DOSAGE FORM
DESLOMED SYRUP
Actives substance per 5 ml is:
Desloratadine 2,5 mg
Preservatives:
Sodium benzoate 0,1% m/v
Sugar free
Contains sweeteners:
Blend ADI 450 (acesulfame potassium and sucralose) 1,50 mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
_DESLOMED SYRUP is available without a doctor’s prescription, for
you to treat a mild illness. _
_Nevertheless, you still need to use DESLOMED SYRUP carefully to get
the best results from it. _
•
Keep this leaflet. You may need to read it again.
•
Do not share DESLOMED SYRUP_ _with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
1. WHAT DESLOMED SYRUP_ _IS AND WHAT IT IS USED FOR
DESLOMED SYRUP is an antihistamine that provides relief of seasonal
hay fever.
The active substance is: Desloratadine 2,5 mg
The other ingredients are:
Citric acid anhydrous, colour FD&C yellow No. 6, disodium edetate,
liquid maltitol, orange flavour
type sweet 96472-33, propylene glycol, sodium citrate, sorbitol
solution
ADCOCK INGRAM LIMITED DESLOMED SYRUP
43/5.7.1/0079
PATIENT INFORMATION LEAFLET
_____________________________________________________________________________________
Date: 6 May 2022
Page 2 of 7
Initials: A.G
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLOMED SYRUP
DO NOT USE DESLOMED SYRUP
•
If you are pregnant
•
if you are breastfeeding
•
if you are allergic to any of the syrup ingredients.
•
if you are allergic to any other antihistamines
•
if you have porphyria
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH DESLOMED SYRUP:
•
Tell your doctor if you suffer from liver or kidney disease.
•
Tell your doctor if you have ever had any unusual or allergic reaction
to DESLOMED
SYRUP
•
Efficacy and

Vara einkenni

ADCOCK INGRAM LIMITED DESLOMED SYRUP
43/5.7.1/0079
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
__________________________________________________________________________________
Date: 6 May 2022
Page 1 of 9
Initials: A.G
SCHEDULING STATUS:
S2
1.NAME OF MEDICINE:
DESLOMED SYRUP
STRENGTH
Desloratadine 2,5 mg
PHARMACEUTICAL FORM
Syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each 5 ml of DESLOMED SYRUP contains:
Desloratadine 2,5 mg
Preservative:
Sodium benzoate 0,1% _m/v_
Sugar free
Contains sweeteners:
Blend ADI 450 (acesulfame potassium and sucralose) 1,50 mg
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
A clear, orange coloured aqueous solution with a sweet orange odour.
ADCOCK INGRAM LIMITED DESLOMED SYRUP
43/5.7.1/0079
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
__________________________________________________________________________________
Date: 6 May 2022
Page 2 of 9
Initials: A.G
4. CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
DESLOMED SYRUP is indicated for symptomatic relief of seasonal types
of allergy that present with
symptoms such as rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Children 2 to 5 years of age_:
2,5 ml (1,25 mg) once a day, with or without food.
_Children 6 to 11 years of age_:
5 ml (2,5 mg) once a day, with or without food.
_Adults and adolescents (12 years of age and over)_:
10 ml (5 mg) once a day, with or without food._ _
Patients with hepatic or renal impairment should be given 5 mg
DESLOMED SYRUP on alternate days
initially.
4.3 CONTRAINDICATIONS:
Hypersensitivity to active substance or to any of the excipients.
Pregnancy and lactation (see section 4.6).
Cross sensitivity to other antihistamines.
Porphyria.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with the rare hereditary condition of sorbitol or maltitol
intolerance should not take
DESLOMED SYRUP.
ADCOCK INGRAM LIMITED DESLOMED SYRUP
43/5.7.1/0079
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
_________________________________________________________________