Sudomyl

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pseudoephedrine hydrochloride 60mg;  ;  ;  

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

INN (International Name):

Pseudoephedrine hydrochloride 60 mg

Dosage:

60 mg

Pharmaceutical form:

Tablet

Composition:

Active: Pseudoephedrine hydrochloride 60mg       Excipient: Lactose monohydrate Magnesium stearate Maize starch

Units in package:

Blister pack, (not marketed), 30 tablets

Class:

Class B2 Controlled Drug

Prescription type:

Class B2 Controlled Drug

Manufactured by:

BASF PharmaChemikalien GmbH & Co KG

Product summary:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1974-06-12

Patient Information leaflet

1

SUDOMYL

_Pseudoephedrine hydrochloride 60mg Tablet_ 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
Please read this leaflet carefully before 
you start using Sudomyl. 
This leaflet answers some common 
questions about Sudomyl.  It does not 
contain all the available information.  It 
does not take the place of talking to 
your doctor or pharmacist. 
All medicines have risks and benefits
.

Your doctor has weighed the risks of 
you using Sudomyl against the benefits 
they expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT USING 
THIS MEDICINE, ASK YOUR DOCTOR OR 
PHARMACIST. 
Keep this leaflet with the medicine. 
You may need to read it again. 
WHAT SUDOMYL IS USED 
FOR 
Sudomyl is for the effective relief of:_ _

  Runny nose, 

  Sinus and nasal congestion, 

  Sinus pain due to congestion. 
Sudomyl reduces the swelling and 
secretions in the nose and sinuses, 
allowing you to breathe more easily.  It 
relieves the pressure behind the nose 
and eyes, which is the cause of sinus 
pain and headache. 
Your doctor may have prescribed 
Sudomyl for another reason. 
Ask your doctor if you have any 
questions about why Sudomyl has been 
prescribed for you. 
This medicine is only available with a 
doctor’s prescription. 
BEFORE YOU USE 
SUDOMYL 
_WHEN YOU MUST NOT USE IT _
DO NOT USE SUDOMYL IF YOU HAVE AN 
ALLERGY TO: 

  any medicine containing 
pseudoephedrine  

  any of the ingredients listed at the 
end of this leaflet. 
Some of the symptoms of an allergic 
reaction may include: 

  shortness of breath, 

  wheezing or difficulty breathing, 

  swelling of the face, lips, tongue or 
other parts of the body, 

  rash, itching or hives on the skin. 
DO NOT TAKE SUDOMYL IF�

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 6
1.
PRODUCT NAME
Sudomyl, Tablet, 60 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Pseudoephedrine Hydrochloride 60mg
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral - tablet
Presentation
Sudomyl is a white biconvex circular tablet with a diameter of about
8.5 mm.
Each tablet contains 60mg of Pseudoephedrine Hydrochloride.
Tablets cannot be halved.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Sudomyl is indicated for the effective relief of
•
runny nose;
•
sinus and nasal congestion; and
•
sinus pain due to congestion.
Sudomyl reduces the swelling and secretions in the nose and sinuses,
allowing the
patient to breathe more easily. It relieves the pressure behind the
nose and eyes, which
is the cause of sinus pain and headache.
4.2
Dose and method of administration
Adults and children over 12 years: One tablet if necessary, up to 3
times daily at
intervals of not less than 4 hours, with a maximum of 3 tablets in 24
hours.
Children under 12 years: Must not be used in children under 12 years
of age.
Elderly: There is no need for dosage reduction in the elderly.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 6
Do not exceed the recommended dose.
Do not halve the tablet.
If symptoms do not improve within seven days, consult your doctor.
4.3
Contraindications
Sudomyl is contraindicated for use in children under 12 years of age.
Pseudoephedrine is contraindicated for use in patients:
•
with known hypersensitivity or idiosyncratic reaction to
pseudoephedrine (or any
of the other ingredients in the product);
•
with severe hypertension or coronary artery disease;
•
taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs
within
the previous 14 days.
Refer to ‘INTERACTIONS’ for additional information.
4.4
Special warnings and precautions for use
Pseudoephedrine should be used with caution in patients with:
•
hypertension