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Last updated on emc:11 Feb 2021
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Undesirable Effects Pharmacological Properties Interactions Posology Contraindications Excipients Storage precautions
1. Name of the medicinal product
MACKENZIES SMELLING SALTS
2. Qualitative and quantitative composition
Contains not less than 8.820g Ammonia Liquor 880/890 and 0.539g Eucalyptus Oil.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
White granules.
4. Clinical particulars
4.1 Therapeutic indications
1) Traditionally used for the symptomatic relief of catarrh and head colds.
4.2 Posology and method of administration
Posology
Inhale vapour through nostrils as required.
Do not use for children under 3 months of age.
Method of Administration
Inhalant.
4.3 Contraindications
Do not use for children under 3 months of age.
4.4 Special warnings and precautions for use
None known.
The product labelling includes the following statements:
Not to be taken.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No special precautions are considered necessary.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
No special requirements are anticipated.
5. Pharmacological properties
5.1 Pharmacodynamic properties
ATC code:R01A X
Ammonia is employed in the product as a reflex stimulant.
Eucalyptus oil is an essential oil.
5.2 Pharmaco*kinetic properties
Not applicable.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Also contains glycerol, soft soap, tapioca, water.
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
6.4 Special precautions for storage
Store in a cool place.
6.5 Nature and contents of container
The product container is a uniquely-shaped amber glass bottle with black HDPE cap with LDPE liner.
Pack size: 17ml
6.6 Special precautions for disposal and other handling
Not applicable.
Administrative Data
7. Marketing authorisation holder
Teva UK Limited
Ridings Point,
Whistler Drive,
Castleford,
WF10 5HX,
United Kingdom
8. Marketing authorisation number(s)
PL 00289/2207
9. Date of first authorisation/renewal of the authorisation
16.10.86 (Product Licence of Right issued: 27.7.73)
Renewed: 14.5.92; 11.7.97
10. Date of revision of the text
29/01/2021
I'm well-versed in pharmaceutical information and medical guidelines. Let's break down the details provided in the article about "MACKENZIES SMELLING SALTS":
Name of the Medicinal Product
- MACKENZIES SMELLING SALTS
Qualitative and Quantitative Composition
- Active Ingredients:
- Contains not less than 8.820g of Ammonia Liquor 880/890
- 0.539g of Eucalyptus Oil
- Excipients are listed in section 6.1
Pharmaceutical Form
- Form: White granules
Clinical Particulars
Therapeutic Indications
- Traditionally used for the symptomatic relief of catarrh and head colds.
Posology and Method of Administration
- Posology: Inhale vapour through nostrils as required.
- Age Restriction: Not to be used for children under 3 months of age.
- Method of Administration: Inhalant.
Contraindications
- Age Restriction: Do not use for children under 3 months of age.
Special Warnings and Precautions for Use
- No specific warnings or precautions mentioned.
- Labeling includes statements like "Not to be taken," "If symptoms persist consult your doctor," and "Keep out of reach of children."
Interactions, Effects, and Precautions
- Interaction with Other Medicinal Products: None known.
- Pregnancy and Lactation: No special precautions are considered necessary.
- Effects on Ability to Drive and Use Machines: None known.
- Undesirable Effects: None known.
- Overdose: No special requirements anticipated.
Pharmacological Properties
Pharmacodynamic Properties
- ATC code: R01A X
- Ammonia: Used as a reflex stimulant.
- Eucalyptus Oil: An essential oil.
Pharmaco*kinetic Properties
- Not applicable.
Preclinical Safety Data
- No relevant pre-clinical data specific to the prescriber beyond what's included in other sections of the SPC.
Pharmaceutical Particulars
Excipients
- Glycerol, soft soap, tapioca, water
Incompatibilities
- None known.
Shelf Life and Storage
- Shelf Life: Three years from the date of manufacture.
- Storage: Store in a cool place.
Nature and Contents of Container
- Container: Uniquely-shaped amber glass bottle with a black HDPE cap with LDPE liner.
- Pack Size: 17ml
Special Precautions and Administrative Data
- Special Precautions for Disposal and Handling: Not applicable.
- Marketing Authorization Holder: Teva UK Limited
- Marketing Authorization Number(s): PL 00289/2207
- Date of First Authorization/Renewal: 16.10.86 (Product Licence of Right issued: 27.7.73)
- Date of Revision of the Text: 29/01/2021
This information is crucial for healthcare professionals to ensure safe and effective usage of MACKENZIES SMELLING SALTS, addressing dosage, contraindications, pharmacological properties, and more.
