Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL17780/0565.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).
What is in this leaflet:
1. What Dicycloverine hydrochloride Tablets are and what they are used for. 2. What you need to know before you take Dicycloverine hydrochloride Tablets. 3. How to take Dicycloverine hydrochloride Tablets. 4. Possible side effects. 5. How to store Dicycloverine hydrochloride Tablets. 6. Contents of the pack and other information
1. What Dicycloverine hydrochloride Tablets are and what they are used for
What Dicycloverine hydrochloride Tablets are
Dicycloverine hydrochloride Tablets (dicycloverine) contain a medicine called dicycloverine hydrochloride.
This belongs to a group of medicines called antispasmodics.
What Dicycloverine hydrochloride Tablets are used for
Cramps.
Pain in the stomach or intestine (gut).
Stomach or intestine (gut) problems - such as irritable bowel.
How Dicycloverine hydrochloride Tablets work
Dicycloverine hydrochloride Tablets work by relaxing the muscles in your stomach and gut (intestine). It stops sudden muscle contractions (spasms). In doing this, it relieves cramps, pain, bloating, wind and discomfort.
2. What you need to know before you take Dicycloverine
Do not take Dicycloverine hydrochloride Tablets if:
You are allergic (hypersensitive) to dicycloverine hydrochloride or any of the other ingredients of this medicine (see Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking dicycloverine.
Warnings and precautions
Take special care with Dicycloverine hydrochloride Tablets. Check with your doctor or pharmacist before taking your medicine if:
You have glaucoma (signs include painful eyes with blurred vision)
You have an enlarged prostate
You have indigestion or heart burn caused by a ‘hiatus hernia’ (where part of your stomach pushes through the diaphragm)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and dicycloverine
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. Dicycloverine should not be taken at the same time as other medicines. This is because dicycloverine may affect the way other medicines work. Also some medicines may affect the way dicycloverine works.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking this medicine if:
You are pregnant, might become pregnant, or think you may be pregnant
You are breast-feeding or planning to breast-feed
Driving and using machines
You may feel dizzy, tired or sleepy or have blurred eyesight whilst taking this medicine. If this happens, do not drive or use any tools or machines.
Dicycloverine hydrochloride Tablets contain lactose, glucose and sucrose
Dicycloverine hydrochloride Tablets contain sugars (lactose, sucrose and glucose). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine
3. How to take Dicycloverine hydrochloride Tablets
Taking this medicine
Take this medicine by mouth
Swallow the tablets with a glass of water
Take before or after meals
How much to take
The usual dose is:
Adults and children 12 years of age or older
One or two tablets 3 times each day
Children 2 to 11 years of age
One tablet 3 times each day
Dicycloverine hydrochloride Syrup is also available for use in this age group
If you take more Dicycloverine hydrochloride Tablets than you should
Talk to your doctor or go to a hospital straight away. Remember to take any medicine that is left with you so the doctor knows what you have taken.
The following effects may happen: headache, feeling dizzy, feeling sick, dry mouth or difficulty in swallowing, blurred eyesight and hot dry skin.
If you forget to take Dicycloverine hydrochloride Tablets
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Dicycloverine hydrochloride Tablets
Keep taking this medicine until your doctor tells you to stop. Do not stop taking dicycloverine just because you feel better. If you stop, your cramps or pain may come back.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Dicycloverine hydrochloride Tablets and see a doctor or go to a hospital straight away if;
You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:
Dry mouth or thirst
Feeling dizzy
Feeling tired or sleepy
Blurred eyesight
Rash
Loss of appetite (anorexia)
Feeling sick (nausea) or being sick (vomiting)
Constipation
Headache
Difficulty or pain on passing water (urine)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Dicycloverine hydrochloride Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Dicycloverine hydrochloride Tablets contains
Each tablet contains 10mg of the active substance, dicycloverine hydrochloride
The other ingredients are: lactose, calcium hydrogen phosphate, icing sugar (sucrose and starch), maize starch, glucose liquid, magnesium stearate and purified water
What Dicycloverine hydrochloride Tablets looks like and contents of the pack
White, round, biconvex tablets with a ‘M’ in two concentric circles on one side.
They are supplied in blister packs of 100 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Pharma UK Limited 12 New Fetter Lane London EC4A 1JP United Kingdom
Manufacturer
Opella Healthcare Poland Sp. z o.o. ul. Lubelska 52 35-233 Rzeszów Poland
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.