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PROPANTHELINE TABLETS 15MG

Active substance(s): PROPANTHELINE BROMIDE

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PATIENT INFORMATION LEAFLET

Propantheline 15 mg Tablets
PROPANTHELINE BROMIDE
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINDISHED
ALL THE PRESCRIBED COURSE OF PROPANTHELINE
BROMIDE.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOU DOCTOR OR PHARMACIST FOR
MORE INFORMATION.
What is in your medicine?
The name of this medicine is Propantheline tablets 15 mg.
It contains a substance called Propantheline Bromide BP.
Propantheline Bromide is available as a film-coated tablet
containing 15 mg Propantheline Bromide, together with the
ingredients lactose, microcrystalline cellulose, colloidal
anhydrous
silica,
magnesium
stearate,
hydroxypropylmethylcellulose, diethylphthalate, Opaspray
K-1F-3048 and Opaspray K-1-2410.
The tablets are round and convex in shape, and pale pink
in colour. They are available in containers of 50, 100, 500
and 1,000 and in blister-packs of 28 tablets.
The name and address of the Product Licence holder of
Propantheline Bromide tablets 15 mg is Chelonia
Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia,
P.C. 1060, Cyprus
The manufacturer of Propantheline Bromide tablets 15 mg
is DDSA Pharmaceuticals Ltd., 310 Old Brompton Road,
London SW5 9JQ
How do Propantheline Bromide Tablets 15 mg work?
The tablets belong to a group of medicines known as antispasmodics which act by reducing the movements of the
bowel and secretions in the stomach.
Why have you been prescribed Propantheline Bromide
tablets 15 mg
This medicine is used for the treatment of disorders in the
gastrointestinal tract which involve muscle spasm. They
are also used for adults who have problems holding their
urine, which results in wetting (enuresis), and for excessive
sweating (hyperhidrosis).
If you are not sure why you have been prescribed
Propantheline Bromide tablets 15 mg then please ask your
doctor.
Before taking this medicine
Before taking these tablets tell your doctor if you have ever
had any unusual or allergic reactions to Propantheline

Bromide tablets 15 mg or any of the other ingredients of
these tablets.
Tell your doctor if you are pregnant, planning a
pregnancy or are breast-feeding a baby.
Also tell your doctor or pharmacist is you are allergic to any
other substances such as food, preservatives or dyes.
This product contains lactose. If your doctor has told you
that you have an intolerance to some sugars, contact you
doctor before taking this medicine.
Do not use Propantheline Bromide tablets 15 mg if you
have suffered or suffer from:
• Blocking of the movements of the bowel or of the
urinary tract.
• Pyloric stenosis (closure of the outlet of the stomach).
• Intestinal atony (loss of strength in the intestinal
muscles).
• Severe ulcerative colitis
• Toxic megacolon (enlargement of the large bowel)
• Hiatus hernia with inflammation of the gullet, known as
reflux oesophagitis,
• Myasthenia gravis (weakening of the muscles)
• Prostate gland problems which may cause difficulty
urinating
• Glaucoma (increase of pressure inside the eyeball.
• Increased sensitivity to Propantheline Bromide.
You may not be able to take Propantheline Bromide if you
have undergone an ilestomy or colostomy.
You may need a lower dose or special monitoring during
treatment if you:
• are elderly
• have a disease of the nervous system
• have liver or kidney problems
• have an over-active thyroid gland
• have heart problems or have had a heart attack
• have high blood pressure
• have Down’s syndrome
• suffer from acid reflux
• have a fever or high temperature
• are exposed to high temperature enironments
Use in pregnancy and breast feeding
There is evidence that medicines of this type may product
minor deformities of the developing baby. In view of this,
Propantheline Bromide tablets 15 mg should not be used in
pregnancy unless the doctor considers it essential.
It is not known whether Propantheline Bromide passes into
human breast milk, and in view of this Propantheline
Bromide tablets 15 mg should not be used during breastfeeding unless considered absolutely essential. The
production of breast milk may be reduced.
Can you take Propantheline Bromide tablets 15 mg
with other medicines
It is important that your doctor is aware of any other
medicines that you are taking, whether it is prescribed or
bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking
any of the following medicines, as they may affect how
Propantheline works;
• Medicines used as painkillers such as paracetamol
and nefopam
• Medicines called anti-arrhythmics used to treat
irregular heartbeats
• Antidepressants
• Antifungals such as ketoconazole
• Antihistamines
• Medicines that act against infections such as
nitrofurantoin
• Medicines for mental health problems such as
haloperidol, clozapine and phenthiazines
• Digoxin for the treatment of mild to moderate heart
failure
• Domperidone used to treat nausea, vomiting or
bloating
• Medcines used for Parkinson’s disease such as
amantadine and levodopa
• Memantine for the treatment of dementia associated
with Alzheimer’s disease
• Metoclopramide used for nausea and vomiting
• Medicines known as nitrates used to prevent and treat
angina
Also tell your doctor if you are, or have been, taking drugs
in this group of medicines such as dicyclomine
hydrochloride (to treat spasm of the muscles), hyoscine
butylbromide (for the relief of irritation of the bowel and
painful periods).
Effects on ability to drive and to use machines.
Propantheline Bromide tablets 15 mg may produce
drowsiness or blurring of vision and therefore you should
not drive or operate machinery if affected in this way.
Proper use of this medicine
Take this medicine by mouth and only in the doses
prescribed by your doctor. Do not take more of it and do
not take it more often or for a longer time that your doctor
ordered.
Common dosage
This medicine is to be taken by mouth at least one hour
before meals.
Adults:
In peptic ulcer the initial starting dose is 1 tablet before
each meal and 2 tablets at bedtime. Subsequently the
dosage should be adjusted according to the individual
response to this medicine.
Up to 8 tablets daily in divided doses may be required.
Elderly:
The dose is the same as for adults. However, the elderly
are more likely to experience side-effects; in particular

glaucoma (increased eyeball pressure) and inability to pass
urine and your doctor will adjust the dose accordingly.
Children:
These tablets are not recommended for use in children
under 16 years of age.
What to do if too many tablets are taken at the same
time
If you think you have taken too many of your tablets, call
your doctor straight away or go the nearest hospital
casualty department. Always keep any remaining tablets in
the container in which they were given to you, so that the
medicine can be identified by the doctor or pharmacist at
the hospital. Also tell them whether you have taken any
other medicines.
What if you miss a dose?
If you miss a dose, skip the missed dose and go back to
your regular dosing schedule. Do not take two doses at
once.
If you feel that this medicine is not working well after you
have taken it for a short time (one to two weeks) do not
increase the dose, instead check with your doctor.
What side-effect can occur when taking Propantheline
Bromide tablets 15 mg?
Side effects that may occur include:
• dryness of the mouth with difficulty in swallowing, and
thirst
• The pupils may becoming larger with loss of or
difficulty in focusing, and sensitivity to light, increased
pressure in the eyeball
• Dryness of the skin, reduced sweating (a condition
known as heat-stroke)
• slowing of the heartbeat followed by increased heart
beating; alteration in the rhythm of the heartbeat
• Difficulty in starting to pass urine, and not being able to
pass urine, constipation
• Reduced fluid in the airways
• Occasional confusion (particularly in the elderly) and
dizziness
• Occasional nausea and vomiting
If you notice any of the above reactions or side effects, or if
you notice any unusual or worrying changes, contact your
doctor.
Storing your medicine
You must keep this medicine in a safe place where children
cannot get it. Your medicine could harm them.
Keep your medicine in a dry place and store below 25ºC.
Keep container tightly closed.
If your doctor tells you to stop the treatment, return any of
the remaining tablets to the doctor or pharmacist. On the
label you will find the words ‘Expiry date’ followed by
numbers indication the day, month and year. This is the
date after which the medicine is no longer fit for use. Do not

use the medicine after this date but return it to your doctor
or pharmacist.
A Reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as
yours.
Product License No.: PL 33414/0094
This leaflet was prepared in January 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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