J Collis Browne's mixture

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Peppermint oil; Morphine anhydrous

Available from:

Thornton & Ross Ltd

ATC code:

A07DA52

INN (International Name):

Peppermint oil; Morphine anhydrous

Dosage:

300nanolitre/1ml ; 200microgram/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5011309892215 5011309892314

Patient Information leaflet

FRONT FACE TOP
MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
45ml/100ml
22913812
338 x 148mm flat (29 x 148mm folded)
2
10.05.2016
J.Collis Browne's Mixture
Yes
A
gill.kennedy
657378
12741
Addition of hyperalgesia warning
Helvetica
Process Black
Keyline (Does not print)
22913812
Datamatrix:
VERIFIED
J. COLLIS BROWNE’S
MIXTURE
(morphine, peppermint oil)
IMPORTANT INFORMATION ABOUT J. COLLIS BROWNE’S
MIXTURE
• This medicine relieves the symptoms of
coughs and diarrhoea in adults and children
over 12 years.
DO NOT TAKE….
• If you have breathing problems.
• Or give to children under 12 years.
• Avoid drinking alcohol while taking this
medicine. See section 2.
•
• Different doses are needed depending on
whether you t
ake this medicine for a cough or
for diarrhoea. See section 3.
NOW READ THE REST OF THE LEAFLET BEFORE YOU
USE THIS MEDICINE. IT INCLUDES OTHER
INFORMATION WHICH MIGHT BE ESPECIALLY
IMPORTANT FOR YOU.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If you notice any side effects not listed in this
leaflet please tell your doctor or pharmaci
st.
1. WHAT THE MEDICINE IS FOR
J. Collis Browne’s Mixture relieves coughs and
the symptoms of diarrhoea. The medicine
contains morphine which helps calm and reduce
the effects of diarrhoea and griping pains. It also
contains peppermint oil which calms the
stomach and relieves flatulence and griping.
If you have diarrhoea, it is also important to
drink plenty of fluids to avoid becoming
dehydrated.
2. BEFORE YOU USE THIS
MEDICINE
DO NOT USE THE MEDICINE IF YOU OR
YOUR CHILD HAVE….
• An ALLERGY to any of the ingredients listed in
section 6, or to menthol.
• SHALLOW BREATH OR BREATHING DIFFICULTIES.
• HEART PROBLEMS.
• A HEAD INJURY or PERSISTENT HEADACHE.
• An ASTHMA at

Summary of Product characteristics

OBJECT 1
J COLLIS BROWNE'S MIXTURE
Summary of Product Characteristics Updated 12-May-2016 | Thornton &
Ross Ltd
1. Name of the medicinal product
J Collis Browne's Mixture.
2. Qualitative and quantitative composition
Each 5ml contains:
Morphine hydrochloride equivalent to 1.0mg anhydrous Morphine
Peppermint Oil 1.5 microlitre
3. Pharmaceutical form
Aqueous based mixture.
4. Clinical particulars
4.1 Therapeutic indications
For the alleviation of coughs and the symptoms of diarrhoea.
4.2 Posology and method of administration
Oral
Adults and Children over 12 years of age.
For coughs: One to two 5 ml medicinal teaspoonsful. May be repeated
every four hours.
For diarrhoea: Two to three 5 ml medicinal teaspoonsful. May be
repeated once or twice at four hourly
intervals if required.
Elderly and debilitated patients; use with caution; a reduced dose can
be recommended by a doctor.
Children under 12 years old: Not recommended
4.3 Contraindications
Hypersensitivity to the active substances, to any of the excipients or
to menthol.
Children under the age of 12 years.
Acute respiratory depression, chronic obstructive pulmonary disease,
acute alcoholism, risk of paralytic
ileus, acute ulcerative colitis, acute abdomen, delayed gastric
emptying, raised intra-cranial pressure and
head injury, and phaeochromocytoma. It should not be given during an
attack of asthma or to patients
with heart failure secondary to chronic lung disease.
Concurrent administration with monoamine oxidase inhibitors (MAOIs) or
within 2 weeks of
discontinuation of their use.
Acute hepatic disease
Obstructive bowel disorders
Pancreatitis
Coma
Convulsive disorders
Administration of some opioid analgesics to patients taking a
monoamine oxidase inhibitor (MAOI) has
been associated with very severe and sometimes fatal reactions. If the
use of J Collis Browne's Mixture is
considered essential, then great care should be taken in patients
taking MAOIs or within 14 days of
stopping MAOIs (see section 4.5).
4.4 Special warnings and precautions for use
Use with care