For the relief of colds, influenza, hayfever, sinusitis, acute rhinitis, post nasal drip and nasal allergies.
1. Scheduling Status
Item
Details
Scheduling status
S2
2. Product Name and Dosage Form
Item
Details
Product name
HISTACON CAPSULES
Dosage form
Capsules
3. Composition
Each capsule contains:
Ingredient
Quantity per capsule
Chlorphenamine maleate
2 mg
Phenylephrine hydrochloride
5 mg
Paracetamol
200 mg
Caffeine
30 mg
Additional information:
Item
Details
Sugar content
Sugar-free
Preservatives
Methyl paraben and propyl paraben
4. Category and Class
Item
Details
Pharmacological classification
A 5.8
Class description
Preparations for the common cold including nasal decongestants
5. Pharmacological Action
HISTACON CAPSULES is described as an analgesic and antipyretic preparation with antihistaminic and decongestant action.
6. Indications
HISTACON CAPSULES is indicated for relief of:
Indications
Colds
Influenza
Hay fever
Sinusitis
Acute rhinitis
Post-nasal drip
Nasal allergies
7. Contraindications
HISTACON CAPSULES should not be used in the following cases:
Contraindication / condition
Hypersensitivity to any ingredient
Severe liver impairment
Hyperthyroidism
Aneurysm
Hypertension
Arteriosclerosis
Certain cardiovascular disorders
Use with monoamine oxidase inhibitors
Use within 14 days of stopping monoamine oxidase inhibitors
Use with tricyclic antidepressants
Late pregnancy where sympathomimetic amines are inadvisable
8. Warnings and Special Precautions
HISTACON CAPSULES should not be used continuously for more than 10 days without consulting a doctor.
The medicine may cause drowsiness and impaired concentration. These effects may be worsened by alcohol or other central nervous system depressants. Patients who are affected should avoid driving, operating machinery, or performing hazardous tasks.
Special precautions include:
Ingredient / area
Precaution
Paracetamol
Use caution in kidney or liver impairment
Phenylephrine
Use caution in cardiovascular disease, diabetes, glaucoma, and hyperthyroidism
Chlorphenamine
Use caution in narrow-angle glaucoma, urinary retention, and prostatic hypertrophy
Caffeine
Use caution in peptic ulceration, hypertension, hyperthyroidism, cardiac arrhythmias, hepatic dysfunction, chronic alcoholism, lung disease, and older patients
Possible side effects listed for the active ingredients include:
Ingredient
Possible side effects
Paracetamol
Allergic skin reactions and blood disorders
Phenylephrine
Central nervous system effects and cardiovascular effects
Chlorphenamine
Sedation, gastrointestinal effects, antimuscarinic effects, paradoxical central nervous system stimulation, seizures, and blood disorders
Caffeine
Gastrointestinal irritation, central nervous system stimulation, insomnia, headache, anxiety, tremor, sleeplessness, and palpitations
13. Overdosage
The document gives detailed overdose information, especially for paracetamol.
Early symptoms may include:
Early overdose symptoms
Pallor
Nausea
Vomiting
Anorexia
Abdominal pain
Liver damage may appear 12 to 48 hours after ingestion.
Serious complications may include:
Serious complications
Metabolic acidosis
Renal failure
Cardiac arrhythmias
Encephalopathy
Coma
Death
Immediate medical consultation or hospital care is required in overdose.
Treatment described includes urgent specialised care, gastric lavage in certain cases, and antidote therapy such as acetylcysteine or methionine. The document provides intravenous and oral acetylcysteine regimens and states that acetylcysteine is effective if administered within 8 hours of overdose.
14. Identification
Item
Description
Capsule type
Opaque gelatin capsule
Size
No. 1
Cap colour
Blue
Body colour
White
Contents
Fine white powdery granulate
15. Presentation
Item
Details
Pack size
1,000 capsules
Container
White high-density polyethylene jar
Closure
White flat cap
Liner
Low-density polyethylene liner
Insert
White foam insert
16. Storage Instructions
Storage requirement
Store at or below 25 °C
Store in a dry place
Keep well closed
Keep in the original packaging until required
Keep out of reach of children
17. Registration and Holder
Item
Details
Registration number
C839
Act
Act 101/1965
Holder of certificate of registration
Pharmacare Limited
Address
Healthcare Park, Woodlands Drive, Woodmead 2191
18. Publication Information
Item
Details
Date of registration
Old medicine
Most recent amendment approved by the Authority
01 September 1970
Other registration details
Botswana and Namibia registration details are listed in the original professional information document
