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DICYCLOVERINE HYDROCHLORIDE 20MG TABLETS

Active substance(s): DICYCLOVERINE HYDROCHLORIDE / DICYCLOVERINE HYDROCHLORIDE / DICYCLOVERINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dicycloverine Hydrochloride
10mg Tablets
20mg Tablets

Dicycloverine hydrochloride
Read all of this leaflet carefully before you
start using 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
Dicycloverine Hydrochloride Tablets contains
a medicine called dicycloverine hydrochloride.
This is an antispasmodic, and it relieves, prevents,
or lowers the number of muscle spasms that occur.
It is used to treat cramps, pain in the stomach
or gut (intestine), and stomach or gut (intestine)
problems such as irritable bowel. Muscle spasms
play a part in all of these. Dicycloverine works
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 Hydrochloride Tablets
Do not take Dicycloverine Hydrochloride
Tablets:
- if you are allergic to dicycloverine
hydrochloride or any of the other ingredients
of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Dicycloverine Hydrochloride Tablets if:
- You have painful eyes with blurred vision
(glaucoma).
- You have an enlarged prostate.
- You have heart burn or indigestion caused by
a hiatus hernia, which is 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.
Other medicines and Dicycloverine
Hydrochloride Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take 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 can affect the way other medicines work.
Also some medicines can affect the way
Dicycloverine Hydrochloride Tablets work.
Dicycloverine Hydrochloride Tablets with food
Dicycloverine Hydrochloride Tablets should
be taken before or after meals. Do not take
Dicycloverine Hydrochloride Tablets with food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Dicycloverine Hydrochloride Tablets should
not cause any problems in respect of driving or
using machines. However, 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.
Dicycloverine Hydrochloride Tablets contain
lactose
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 take Dicycloverine Hydrochloride
Tablets
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
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
• Either one 10 mg tablet or one 20 mg tablet,
three times each day.
Children aged 2 to 12 years of age
• One 10 mg tablet three times each day.
For children at the younger end of the age
range, a tablet is not a suitable dosage form,
and Dicycloverine Hydrochloride 10mg/5ml Oral
Solution is more appropriate.
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. You may have the following effects:

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 missed dose.
If you stop using 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.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
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 last 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 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.
This medicinal product does not require any
special storage conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other
information
What Dicycloverine Hydrochloride Tablets
contain
- The active substance is dicycolverine
hydrochloride, 10 mg in the 10 mg tablet,
and 20 mg in the 20 mg tablet.
- The other ingredients (excipients) are lactose
monohydrate, cellulose microcrystalline
(E 460), starch, maize pregelatinised and
magnesium stearate (E 470b).
What Dicycloverine Hydrochloride Tablets
look like and contents of the pack
Dicycloverine Hydrochloride 10 mg Tablets:
White to off-white flat, beveled edged, round,
6.5mm diameter tablets with “D1” debossed
on one side.
Dicycloverine Hydrochloride 20 mg Tablets:
White to off-white flat, beveled edged, round,
8.5mm diameter tablets with “D2” debossed
on one side.
The tablets are packed in opaque, white
250 micron PVC blisters with 20 micron
aluminium lidding foil. Blisters contain either
7 or 10 tablets.
Packs of 50 (blisters of 10), 84 (blisters of 7),
90 (blisters of 10), 100 (blisters of 10),
168 (blisters of 7), or 180 tablets (blisters of 10)
are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd
115, Narborough Road
Leicester
LE3 0PA, UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough LE11 5GW
UK
This leaflet was last revised in August 2016.

M0256LAMUKNAS-001

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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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