Dicycloverine Hydrochloride 10mg/5ml Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HEALTHCARE
Dicycloverine Hydrochloride
10mg/5ml Oral Solution
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 Oral Solution is and what it is used for
2. What you need to know before you take Dicycloverine Oral Solution
3. How to take Dicycloverine Oral Solution
4. Possible side effects
5. How to store Dicycloverine Oral Solution
6. Contents of the pack and other information
Dicycloverine Oral Solution, called dicycloverine for short in the rest of the leaflet, 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.
Other medicines and Dicycloverine Oral Solution
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 should not be taken at the same time as other medicines. This is because Dicycloverine can affect the way other medicines work. Also some medicines can affect the way Dicycloverine works. Dicycloverine Oral Solution with food
Dicycloverine should be taken before or after meals. Do not take Dicycloverine 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 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 Oral Solution. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Dicycloverine Oral Solution
Sodium benzoate 6 mg/5 ml: this may increase jaundice (yellowing of the skin and eyes) in pre-term and full-term jaundiced neonates.
Invert syrup (a mixture of fructose and glucose) 4.25g/5ml: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This should be taken into account if you have diabetes mellitus.
2. What you need to know before you take Dicycloverine Oral Solution
Do not take Dicycloverine Oral Solution if:
- You are allergic to dicycloverine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- The person being given this medicine is under 6 months of age.
Warnings and precautions
Talk to your doctor or pharmacist before using dicycloverine 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.
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.
• Take before or after meals.
How much to take
The usual dose is:
Adults
• 5 ml to 10 ml (10 mg - 20mg) three times each day.
• Take the oral solution before or after meals.
Children aged 2 to 12 years
• 5 ml (10 mg) three times each day.
• Take the oral solution before or after meals.
Children aged 6 months to 2 years
• 2.5 ml to 5 ml (5 mg - 10 mg) three or four times each day.
• Give 15 minutes before feeds.
• Do not give more than 20 ml (40 mg) in a 24 hour period.
Directions for opening the bottle and using the pipette for Dicycloverine Oral Solution
Instructions for opening the bottle and using the dosing syringe
• Remove cap from the bottle.
• Fit the adaptor into the neck of the bottle, it is not necessary to remove after use.
• While the bottle is sitting on a firm, flat surface, hold it steady with one hand. With the other hand insert the tip of the syringe into the adaptor.
• Invert the bottle (turn upside-down).
• Slowly pull back the plunger of the syringe until the mark that matches the number of mg or ml to be taken is just visible.
• If large bubbles can be seen in the syringe, slowly push the plunger back into the syringe. This will force the medicine back into the bottle. Repeat the above step again.
• Return the bottle to its original position, and remove the dosing syringe.
• The contents of the syringe may be emptied directly into the mouth by slowly pushing down the plunger of the syringe.
• Close the bottle.
• Rinse the dosing syringe with water. If you take more Dicycloverine Oral Solution 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 Oral Solution
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 taking Dicycloverine Oral Solution
Keep taking Dicycloverine 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
• 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.
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 label and on the carton after EXP. The expiry date refers to the last day of that month. This medicine should be used within 6 months after first opening.
This medicinal product does not require any special temperature storage conditions. Keep the medicine in the amber bottle as supplied. Do not store it in any other container. Replace the cap securely after every use.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Dicycloverine Oral Solution 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),
What Dicycloverine Oral Solution contains
Each 5 ml contains 10 mg of the active ingredient, dicycloverine hydrochloride.
The other ingredients are: invert syrup (contains fructose and glucose); citric acid monohydrate (E 330); sodium benzoate (E 211); cherry flavour (contains acetic acid (E 260), propylene glycol (E 1520) and triethyl citrate (E 1505)); vanilla flavour (contains propylene glycol (E 1520)); blackcurrant flavour (contains propylene glycol (E 1520)); raspberry flavour (contains acetic acid (E 260), propylene glycol (E 1520) and triacetin (E 1518)) and purified water.
What Dicycloverine Oral Solution looks like and contents of the pack
Dicycloverine Oral Solution is a clear to pale yellow coloured liquid, with a characteristic odour and taste. Supplied in either 100 ml, 120 ml or 150 ml amber glass or PET bottles with tamper evident child resistant closure and a dosing pipette.
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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