Dicycloverine Hydrocholoride 20mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dicycloverine hydrochloride 20mg Tablets
Read all of this leaflet carefully before you start
taking this medicine
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Dicycloverine hydrochloride Tablets are and what they are used for
2. 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. Further information
1. What Dicycloverine hydrochloride Tablets are and what they are used for
What Dicycloverine hydrochloride Tablets are
Dicycloverine hydrochloride Tablets 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. Before you take Dicycloverine hydrochloride Tablets
1^1 Do not take Dicycloverine hydrochloride BIS Tablets if:
x You are allergic (hypersensitive) to dicycloverine hydrochloride or any of the other ingredients in Dicycloverine hydrochloride Tablets (see Section 6: Further information)
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 hydrochloride Tablets.
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 Dicycloverine hydrochloride Tablets.
I Taking other medicines
Please 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 hydrochloride Tablets should not be taken at the same time as other medicines. This is because Dicycloverine hydrochloride Tablets may affect the way other medicines work. Also some medicines may affect the way Dicycloverine hydrochloride Tablets work. Pregnancy and breast-feeding Talk to your doctor or pharmacist before taking this medicine if: You are pregnant, might become pregnant, or thinkyou may be pregnant You are breast-feeding or planning to breast-feed
I Driving and using machines
You may feel dizzy, tired or sleepy or have blurred eyesight whilst taking Dicycloverine hydrochloride Tablets.
If this happens, do not drive or use any tools or machines Important information about some of the ingredients of Dicycloverine hydrochloride Tablets 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. Howto 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 tablet 3 times each day Children 2 to 11 years of age
• Dicycloverine hydrochloride 20mg Tablets should not be used in this age group.
• Dicycloverine hydrochloride 10mg Tablets and Dicycloverine hydrochloride Syrup are 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.
If you stop taking Dicycloverine hydrochloride Tablets
Keep taking Dicycloverine hydrochloride Tablets until your doctor tells you to stop. Do not stop taking Dicycloverine hydrochloride Tablets just because you feel better. If you stop, your cramps or pain may come back.
4. Possible side effects
Like all medicines, Dicycloverine hydrochloride Tablets 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 at www.mhra.gov.uk/yellowcard. By reportingside effects you can help provide more information on the safety of this medicine.
5. How to store Dicycloverine hydrochloride Tablets
Keep this medicine in a safe place where children cannot see or reach it
Do not use Dicycloverine hydrochloride Tablets 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. Further Information
What Dicycloverine hydrochloride Tablets contains
• Each tablet contains 20mg 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
Dicycloverine hydrochloride 20mg Tablets are white oval biconvex tablets with ‘SI76’ on one side. They are supplied in blister packs of 84 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Zentiva,
One Onslow Street,
Guildford, Surrey,
GLJ1 4YS, UK
Manufacturer Sanofi-Aventis Sp. z o.o. ul. Lubelska 52 35-233 Rzeszow 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.
This leaflet was last revised in April 2014 © Zentiva 2014
521561
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3. How to take Dicycloverine hydrochloride Tablets
Dicycloverine hydrochloride® 20mg Tablets
Read all of this leaflet carefully before you start
taking this medicine
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Dicycloverine hydrochloride Tablets are and what they are used for
2. 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. Further information
1. What Dicycloverine hydrochloride Tablets are and what they are used for
What Dicycloverine hydrochloride Tablets are
Dicycloverine hydrochloride Tablets 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. Before you take Dicycloverine hydrochloride Tablets
a Do not take Dicycloverine hydrochloride Tablets if:
x You are allergic (hypersensitive) to dicycloverine hydrochloride or any of the other ingredients in Dicycloverine hydrochloride Tablets (see Section 6: Further information)
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 hydrochloride Tablets.
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 Dicycloverine hydrochloride Tablets.
IBM Taking other medicines
Please 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 hydrochloride Tablets should not be taken at the same time as other medicines. This is because Dicycloverine hydrochloride Tablets may affect the way other medicines work. Also some medicines may affect the way Dicycloverine hydrochloride Tablets work. 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
SB Driving and using machines
You may feel dizzy, tired or sleepy or have blurred eyesight whilst taking Dicycloverine hydrochloride Tablets.
If this happens, do not drive or use any tools or machines Important information about some of the ingredients of Dicycloverine hydrochloride Tablets 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
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 tablet 3 times each day Children 2 to 11 years of age
• Dicycloverine hydrochloride 20mg Tablets should not be used in this age group.
• Dicycloverine hydrochloride 10mg Tablets and Dicycloverine hydrochloride Syrup are 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.
If you stop taking Dicycloverine hydrochloride Tablets
Keep taking Dicycloverine hydrochloride Tablets until your doctor tells you to stop. Do not stop taking Dicycloverine hydrochloride Tablets just because you feel better. If you stop, your cramps or pain may come back.
4. Possible side effects
Like all medicines, Dicycloverine hydrochloride Tablets 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
• Head ache
• Difficulty or pain on passing water (urine)
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. Further Information
What Dicycloverine hydrochloride Tablets contains
• Each tablet contains 20mg 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
Dicycloverine hydrochloride 20mg Tablets are white oval biconvex tablets with ‘S176’ on one side. They are supplied in blister packs of 84 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Zentiva,
One Onslow Street,
Guildford, Surrey,
GU1 4YS, UK
Manufacturer
Sanofi Synthelabo Limited
Fawdon Manufacturing Centre
Edgefield Avenue, Fawdon
Newcastle Upon Tyne
NE3 3TT United Kingdom
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.
This leaflet was last revised in January 2011 © Zentiva 2011
5. How to store Dicycloverine hydrochloride Tablets
Keep this medicine in a safe place where children cannot see or reach it
Do not use Dicycloverine hydrochloride Tablets 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.
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