What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

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: PL 31862/0024.


Dicycloverine Hydrochloride 10 mg & 20 mg tablets

Package leaflet: information for the user

Dicycloverine Hydrochloride 10 mg & 20mg Tablets

Dicycloverine Hydrochloride

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 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 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).
    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.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Dicycloverine Hydrochloride Tablets 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.

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 may affect the way other medicines work. Also some medicines may affect the way Dicycloverine Hydrochloride Tablets work.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby or are planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

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 in this medicine

Dicycloverine Hydrochloride 10 mg and 20 mg 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 medicinal product.

3. How to take Dicycloverine Hydrochloride Tablets

Taking this medicine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  • 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.

Your doctor will tell you which dose to use.

Children aged 2 to 11 years

  • 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. 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.

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 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.

Store below 25°C.

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 protect the environment.

6. Contents of the pack and other information

What Dicycloverine Hydrochloride Tablets contains

  • The active substance is dicycloverine hydrochloride, 10 mg in the 10 mg tablet and 20 mg in the 20 mg tablet.
  • The other ingredients are: povidone K30, maize starch, calcium hydrogen phosphate anhydrous, lactose monohydrate (140 M), magnesium stearate.

What Dicycloverine Hydrochloride Tablets looks like and contents of the pack

Dicycloverine Hydrochloride 10 mg Tablets

Dicycloverine Hydrochloride 10 mg Tablets are white to off white, round, biconvex tablets, engraved with “10” on one side and plain on the other.

They are available in opaque PVC/PVDC/aluminium blisters in pack sizes of 100 tablets. Each blister contains 10 tablets.

Dicycloverine Hydrochloride 20 mg Tablets

Dicycloverine Hydrochloride 20 mg Tablets are white to off white, round, biconvex tablets, engraved with “20” on one side and plain on the other.

They are available in opaque PVC/PVDC/aluminium blisters in pack sizes of 84 tablets. Each blister contains 14 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Creo Pharma Ltd
Felsted Business Centre
Felsted
Essex
CM6 3LY

Manufacturer

Simvis Pharmaceuticals S.A.
Asklipiou 4-6
Kryoneri
Attiki, 145 68
Greece

This leaflet was last revised in August 2019

CRE-DCV-PIL-363_15

24PAC0004