TEXT FOR NON-MARKETED PACKS

J. COLLIS BROWNE’S TABLETS LEAFLET

PL 00240/0092

J.Collis Browne’s Tablets

(morphine hydrochloride, light kaolin, calcium carbonate)

Important information about J.Collis Browne’s Tablets

•    This medicine relieves the symptoms of 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.

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 pharmacist.

1.    What the medicine is for

J.Collis Browne’s Tablets relieve the symptoms of occasional diarrhoea. The medicine contains morphine which helps calm and reduce the effects of diarrhoea. They also contain kaolin which helps remove toxic and other substances from the digestive system, and calcium carbonate which helps increase the bulk of solid waste and neutralizes excess stomach acid.

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.

•    Shallow breath or breathing difficulties.

•    A head injury or persistent headache.

•    An asthma attack.

•    Taken MAOIs (monoamine oxidase inhibitors) for depression within the last two weeks.

•    A blocked intestine or inflammation of your colon or rectum.

•    An addiction to alcohol.

•    Liver or kidney disease.

•    Heart failure.

•    Fits or seizures.

•    A coma.

•    High levels of alkali in the blood.

•    High levels of calcium in the blood.

•    Reduced stomach acid.

•    Phaeochromocytoma (a rare tumor of the adrenal glands).

•    Severe abdominal pain.

•    Or your child is under 12 years old.

^^Talk to your doctor if you or your child have...

•    Kidney or liver problems.

•    High or low blood pressure.

•    Prostate problems.

•    An underactive thyroid gland.

•    An addiction to drugs such as painkillers or morphine.

•    A history of asthma.

•    Heart problems.

•    A low sodium diet.

•    Problem associated with high calcium levels in the blood.

•    Or are elderly, or weakened, as these people can react differently to the medicine and may eed a lower dose.

^^Talk to your doctor or pharmacist if you or your child are taking..

•    Any tranquillisers/sedatives (e.g. diazepam, lorazepam).

•    Any antidepressants (e.g. MAOIs, SSRIs amitriptyline, tricyclics, moclobemide).

•    Any sleeping tablets (e.g. temazepam, promethazine).

•    Any medicine for mental illness (e.g. chlorpromazine, haloperidol, phenothiazines, sulpiride).

•    Any medicine to treat epilepsy (e.g. carbamazepine, phenytoin, gabapentin).

•    Any medicine for a heart problem (e.g. mexiletine, cardiac glycosides such as digoxin, dipyridamole).

•    Medicies for high blood pressure (e.g. esmolol, ACE inhibitors such as captopril, enalapril,fosinopril).

•    Medicines to thin the blood (e.g. warfarin).

•    Alcohol.

•    Aspirin.

•    Cimetidine or lansoprazole for a stomach ulcer.

•    Metoclopramide or domperidone for nausea and vomiting.

•    Cisapride for gastric reflux.

•Antibiotics (e.g. rifampicin, ciprofloxacin, isoniazid, and other quinolones, cefaclor, cefpodoxime, tetracyclines, azithromycin).

•    Antifungals (e.g. itraconazole, ketoconazole).

•    Antivirals (e.g. ritonavir, atazanavir, tipranavir, fosamprenavir).

•    Antihistamines (e.g. sedating: promethazine, and non sedating: fexofenadine).

•    Medicines to treat malaria (e.g. chloroquine, hydroxychloroquine).

•    Sodium oxybate for daytime sleepiness.

•    Baclofen a muscle relaxant.

•    Bisphosponates for osteoporosis.

•    Mycophenolate used to suppress the immune system.

•    Levothyroxine for thyroid problems.

•    Penacillamine for arthritis.

•    Rosuvastatin to lower cholesterol.

•    Medicines to get rid of excess water (e.g. thiazides).

•    Deflazacort, a corticosteroid.

•    Ulipristal, used for emergency contraception.

•    Mineral supplements (e.g. fluoride, iron, zinc).

^Pregnant or breastfeeding

J. Collis Browne’s Tablets should not be used in pregnancy or breastfeeding unless the doctor has told you to do so.

^^Driving and using Machinery

This medicine may cause drowsiness or other side effects which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). If you are affected do not drive or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However , you would not be committing an offence if:

o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o It was not affectiong your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

^^Important information about some of the ingredients

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use this medicine

Take this medicine by mouth.

^^Adults and children over 12 years

• Take two or three tablets every 4 hours, but not more than 6 doses in 24 hours.

Children under 12 years

¹ Do not give to children 12 years unless your doctor tells you to.

DO NOT EXCEED THE STATED DOSE.

As well as taking these tablets you must also make sure that you replace fluids lost during diarrhoea.

If your symptoms persist for longer than 2 days you should ask your doctor for advice.

^^If you take too many

If you accidentally take too many tablets, see a doctor straight away. Take the pack with you to show which medicine you have swallowed.

^^If you forget a dose

Take the next dose as soon as you remember. Do not take a double dose. You can then carry on with the normal dose at the correct time.

4. Possible side effects

Like all medicines J.Collis Browne’s Tablets can have side effects, although these don’t affect everyone.

Possible side effects are:

•    Allergic reactions (rash, itching, wheezing).

•    Feeling sick.

•    Being sick.

•    Constipation, stomach cramps or wind.

•    Drowsiness.

•    Sleep disturbances.

•    Confusion, dizziness or fainting.

•    Difficulty in passing urine or reduced amounts of urine when you do urinate.

•    Spasms.

•    Dry mouth.

•    Sweating.

•    Headache.

•    A flushed face.

•    Vertigo.

•    Changes in heart rate.

•    High blood pressure.

•    Fluid retention.

•    Palpitations (awareness of your heartbeat).

•    Low blood pressure or body temperature.

•    Hallucinations (seeing or hearing things).

•    Restlessness or mood changes.

•    Addiction.

•    Pinpoint pupils.

•    Visual disturbances.

•    Absence of periods.

•    Loss of sex drive.

•    An increased sensitivity to pain.

If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    Storing this medicine

•    Keep it out of the sight and reach of children.

•    There are no special storage conditions for storing this medicine.

•    Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.

•    Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine. These measures will help to protect the environment.

6.    Further information What is in this medicine

The active ingredients per tablet are:

morphine hydrochloride 0.35mg, light kaolin 750mg, calcium carbonate 200mg.

The other ingredients are:

magnesium stearate, sodium polymetaphosphate, sucrose, talc, pink dye (E127), liquorice powder, peppermint flavour.

What the medicine looks like

J.Collis Browne’s Tablets are flat mottled pink tablets with ‘J.Collis Browne’ embossed on one face. They are available in blister packs of 18 or 36 tablets.

Marketing authorisation holder and manufacturer

Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK.

This leaflet was last revised in February 2016

J.Collis Browne’s is a trade mark of Thornton & Ross Ltd.