Propantheline Tablets 15mg
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 anti-spasmodics 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 25°C. 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