Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Dicycloverine Hydrochloride 10mg/5ml Oral Solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Dicycloverine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Dicycloverine contains a medicine called dicycloverine hydrochloride. This belongs to a group of medicines called antispasmodics.
What Dicycloverine is used for:
• • •
Cramps Pain in the stomach or intestine (gut) Stomach or intestine (gut) problems – such as irritable bowel.
How Dicycloverine works
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.
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► You are allergic (hypersensitive)
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 ► The person being given this medicine is under 6 months of age. 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dicycloverine 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).
This medicine contains 3.696g of a mixture of fructose, glucose and sucrose per 5ml dose. This should be taken into account in patients with diabetes mellitus. May be harmful to the teeth, if the product is used for two weeks or more. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. This medicine also contains 4mg sodium benzoate and 14.735mg propylene glycol per 5ml dose. This medicine contains less than 1 mmol sodium (23 mg) per 5ml dose, that is to say essentially 'sodium-free'.
What you need to know before you take it
e Dicycloverine
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
TURN OVER
Double-ended Spoon
If you take more Dicycloverine than you should Talk to your doctor or go to the nearest hospital casualty department straight away. Take the medicine pack with you, this is so that 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 If you forget a dose, take it as soon as you remember. 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 forgotten dose.
If you stop taking Dicycloverine Keep taking this medicine until your doctor tells you to stop. Do not stop taking Dicycloverine just because you feel better.
Tell your doctor or pharmacist if any of the following side effects gets 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 at: 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.
How to take it
Dicycloverine Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dicycloverine. How much to take The usual dose is: Other medicines and Adults Dicycloverine ► One to two 5ml spoonful (10-20mg) Tell your doctor or pharmacist if you three times each day are taking, have recently taken or ► Take the solution before or after might take any other medicines. meals. This includes medicines obtained Children aged 2 to 12 years without a prescription and herbal ► One 5ml spoonful (10mg) three medicines. times each day ► Take the solution before or after Dicycloverine should not be taken at meals. the same time as other medicines. This is because Dicycloverine can Children aged 6 months to affect the way other medicines work. 2 years Also some medicines can affect the ► Half to one 5ml spoonful way Dicycloverine work. (5-10mg) three or four times each day Pregnancy and ► Give 15 minutes before feeds breast-feeding ► Do not give more than four 5ml spoonful (40mg) in a 24 hour period. If you are pregnant or breast-feeding, think you may be pregnant or are Method of administration: planning to have a baby, ask your ► Take this medicine by mouth. ► Use the 2.5-5ml double-ended spoon doctor or pharmacist for advice supplied in the pack (see below) to before taking this medicine. measure the required dose. Driving and using machines ► This medicine may be diluted. If this You may feel dizzy, tired or sleepy or is done, take the oral solution have blurred eyesight whilst taking immediately after dilution. Dicycloverine. If this happens, do not drive or use any tools or machines.
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► If you have any further questions,
Do not take Dicycloverine if:
Dicycloverine contains:
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► Keep this leaflet. You may need
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Dicycloverine 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.
sight and reach of children.
► Do not use this medicine after
How to store it
Dicycloverine
If you stop, your cramps or pain may come back.
► Keep this medicine out of the
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
the expiry date, which is printed on the carton and bottle 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 use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist. ► Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Dicycloverine contains The active substance is dicycloverine hydrochloride. Each 5ml solution contains 10mg dicycloverine hydrochloride. The other ingredients are citric acid monohydrate (E330), sucralose (E955), invert syrup (contains glucose, sucrose and fructose), sodium benzoate (E211), strawberry flavour (contains propylene glycol (E1520) and natural flavouring substances) and purified water. What Dicycloverine looks like and contents of the pack Dicycloverine is a clear, light yellow to yellow oral solution with a strawberry flavour. It is supplied in an amber glass bottle with a tamper-evident child-resistant plastic screw cap. The pack also contains a 2.5-5ml double ended spoon. Dicycloverine is supplied in bottles containing 100ml, 120ml and 300ml solution. Not all pack sizes may be marketed POM Marketing Authorisation Holder and Manufacturer: SyriMed, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. 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 revised in 03/2021.
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Frequently asked questions about Dicycloverine Hydrochloride 10mg/5ml Oral Solution
How do I take Dicycloverine Hydrochloride 10mg/5ml Oral Solution?
Dicycloverine Hydrochloride 10mg/5ml Oral Solution comes as oral solution containing 10mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Dicycloverine Hydrochloride 10mg/5ml Oral Solution?
The active substance in Dicycloverine Hydrochloride 10mg/5ml Oral Solution is dicycloverine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Dicycloverine Hydrochloride 10mg/5ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Dicycloverine Hydrochloride 10mg/5ml Oral Solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dicycloverine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Dicycloverine Hydrochloride is a smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract. The commonest of these are irritable colon (mucous colitis, spastic colon).
4.2. Posology and method of administration
Adults
One to two 5ml spoonfuls (10-20mg) three times daily before or after meals.
Children (2-12 years):
One 5ml spoonful (10mg) three times daily.
Children (6 months - 2 years)
5-10mg three or four times daily 15 minutes before feeds. Do not exceed a daily dose of 40mg.
Dicycloverine Hydrochloride is contraindicated in children under 6 months of age (see sections 4.3 and 4.4).
Method of administration:
For oral administration.
If it is necessary to dilute Dicycloverine Hydrochloride Oral Solution, this may be done using syrup or if diluted immediately prior to use with water.
4.3. Contraindications
Hypersensitivity to dicycloverine hydrochloride or any of the excipients listed in section 6.1.
Known idiosyncrasy to dicycloverine hydrochloride.
Infants under 6 months of age.
4.4. Special warnings and precautions for use
Products containing dicycloverine hydrochloride should be used with caution in any patient with or suspected of having glaucoma or prostatic hypertrophy. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition. There are reports of infants, 3 months of age and under, administered dicycloverine hydrochloride syrup who have evidenced respiratory symptoms (breathing difficulty, shortness of breath, breathlessness, respiratory collapse, apnoea) as well as seizures, syncope, asphyxia, pulse rate fluctuations, muscular hypotonia and coma. The above symptoms have occurred within minutes of ingestion and lasted 20-30 minutes. The symptoms were reported in association with dicycloverine hydrochloride syrup therapy but the cause and effect relationship has neither been disproved or proved. The timing and nature of the reactions suggest that they were a consequence of local irritation and/or aspiration, rather than to a direct pharmacological effect. Although no causal relationship between these effects observed in infants and dicycloverine administration has been established, dicycloverine hydrochloride is contra-indicated in infants under 6 months of age.
Excipient(s) warning:
This medicine contains invert sugar. Patients with rare hereditary fructose intolerance (HFI), glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. May be harmful to the teeth, if the medicine is intended for use for two weeks or more.
This medicine contains less than 1 mmol sodium (23 mg) per 5ml dose, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
None reported.
4.6. Fertility, pregnancy and lactation
Epidemiological studies in pregnant women with products containing dicycloverine hydrochloride (at doses up to 40mg/day) have not shown that dicycloverine hydrochloride increases the risk of foetal abnormalities if administered during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60mg per day for an adult person) and have revealed no evidence of impaired fertility or harm to the foetus due to dicycloverine hydrochloride. Since the risk of teratogenicity cannot be excluded with absolute certainty for any product, the drug should be used during pregnancy only if the benefit outweighs the risk.
It is not known whether dicycloverine is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dicycloverine is administered during breast-feeding.
4.7. Effects on ability to drive and use machines
None stated.
4.8. Undesirable effects
Side-effects seldom occur with dicycloverine. However, in susceptible individuals, dry mouth, thirst and dizziness may occur. On rare occasions, fatigue, sedation, blurred vision, rash, constipation, anorexia, nausea and vomiting, headache and dysuria have also been reported.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms of dicycloverine hydrochloride overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin. Treatment may include emetics, gastric lavage and symptomatic therapy if indicated.
💬 Ask about this leaflet
Ask anything about Dicycloverine Hydrochloride 10mg/5ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.