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Dicycloverine Hydrochloride 10mg Tablets

Document: leaflet MAH GENERIC_PL 20117-0256 change

PACKAGE LEAFLET: INFORMATION FOR THE USER


M9RNINGSIDE

Dicycloverine Hydrochloride healthcare

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


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


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.


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


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:


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.


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