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 10mg tablets
⚠ 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. 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 (dicycloverine) 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.
What you need to know before you take it
e Dicycloverine Do not take Dicycloverine hydrochloride Tablets if: × You are allergic (hypersensitive) to dicycloverine hydrochloride or any of the other ingredients of this medicine (see 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.
Warnings and precautions Take special care with Dicycloverine hydrochloride Tablets. Check with your doctor or pharmacist before taking your medicine 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 this medicine. Other medicines and dicycloverine Tell your doctor or pharmacist if you are taking or have recently taken 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 may affect the way other medicines work. Also some medicines may affect the way dicycloverine works. Pregnancy and breast-feeding Talk to your doctor or pharmacist before taking this medicine if:
- You are pregnant, might become pregnant, or think you may be pregnant
- You are breast-feeding or planning to breast-feed Driving and using machines You may feel dizzy, tired or sleepy or have blurred eyesight whilst taking this medicine. If this happens, do not drive or use any tools or machines. Dicycloverine hydrochloride Tablets contain lactose, glucose and sucrose Dicycloverine hydrochloride Tablets contain sugars (lactose, sucrose and glucose). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine
How to take it
Dicycloverine hydrochloride Tablets 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
- One or two tablets 3 times each day Children 2 to 11 years of age
- One tablet 3 times each day
- Dicycloverine hydrochloride Syrup is also available for use in this age group
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. Do not take a double dose to make up for a forgotten dose. If you stop taking Dicycloverine hydrochloride Tablets Keep taking this medicine 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. 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
Possible 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.
How to store it
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. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Dicycloverine hydrochloride Tablets contains
- Each tablet contains 10mg of the active substance, dicycloverine hydrochloride
- The other ingredients are: lactose, calcium hydrogen phosphate, icing sugar (sucrose and starch), maize starch, glucose liquid, magnesium stearate and purified water What Dicycloverine hydrochloride Tablets looks like and contents of the pack White, round, biconvex tablets with a 'M' in two concentric circles on one side. They are supplied in blister packs of 100 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Zentiva Pharma UK Limited 12 New Fetter Lane London EC4A 1JP United Kingdom Manufacturer Opella Healthcare Poland Sp. z o.o. ul. Lubelska 52 35-233 Rzeszów Poland 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 last revised in March 2022 © Zentiva 2022
839512 1065030920
PACKAGE LEAFLET: INFORMATION FOR THE USER
Frequently asked questions about Dicycloverine 10mg tablets
How do I take Dicycloverine 10mg tablets?
Dicycloverine 10mg tablets comes as tablet containing 10mg. 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 10mg tablets?
The active substance in Dicycloverine 10mg tablets is dicycloverine hydrochloride.
Are there equivalent medicines to Dicycloverine 10mg tablets?
Medicines with the same active substance, strength and form include: Dicycloverine 10 mg Tablets, Dicycloverine hydrochloride 10 mg Tablets, Dicycloverine hydrochloride 10 mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Dicycloverine 10mg tablets, 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 10mg tablets 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+
1. Name of the medicinal product
Dicycloverine Hydrochloride 10mg Tablets
2. Qualitative and quantitative composition
Each tablet contain 10 mg of dicycloverine hydrochloride
Excipients with known effect:
Each tablet contains 126.5 mg lactose, 49.50 mg sucrose and 6.10 mg glucose liquid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets
White, round, biconvex tablets with a 'M' in two concentric circles on one side
4. Clinical particulars
4.1. Therapeutic indications
Smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract.
4.2. Posology and method of administration
Posology
Adults: 10-20mg three times daily before or after meals.
Children (2-12 years): 10mg three times daily.
Method of administration
Oral
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1
Known idiosyncrasy to dicycloverine hydrochloride.
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.
Dicycloverine hydrochloride Tablets contain lactose, sucrose and glucose.
Patients with rare hereditary problems of fructose intolerance, rare glucose-galactose malabsorption or sucrase-isomaltase insufficency should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
None stated.
4.6. Fertility, pregnancy and lactation
Pregnancy
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..
Breast-feeding
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 tablets. 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 Yellow Card Scheme Website: 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 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.
5. Pharmacological properties
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders,
ATC code: A03AA07
Dicycloverine hydrochloride relieves smooth muscle spasm of the gastrointestinal tract.
Animal studies indicate that this action is achieved via a dual mechanism;
(1) a specific anticholinergic effect (antimuscarinic at the ACh-receptor sites) and
(2) a direct effect upon smooth muscle (musculotropic).
5.2. Pharmacokinetic properties
Distribution and Biotransformation
After a single oral 20mg dose of dicycloverine hydrochloride in volunteers, peak plasma concentration reached a mean value of 58ng/ml in 1 to 1.5 hours. 14C labelled studies demonstrated comparable bioavailability from oral and intravenous administration.
Elimination
The principal route of elimination is via the urine.
5.3. Preclinical safety data
None stated.
6. Pharmaceutical particulars
6.1. List of excipients
Lactose
Calcium Hydrogen Phosphate
Icing Sugar*
Maize Starch
Glucose Liquid**
Magnesium Stearate
Purified Water
* mixture of Sucrose 97%
Starch 3%
** equivalent to 4.8mg Glucose Solids
6.2. Incompatibilities
Not applicable
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Opaque blue 250 micron PVC blisters with aluminium foil 20 micron, or securitainers, or amber glass bottles with wadded U/F caps.
Pack size: 100 tablets.
6.6. Special precautions for disposal and other handling
Not applicable
7. Marketing authorisation holder
Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
8. Marketing authorisation number(s)
PL 17780/0565
9. Date of first authorisation/renewal of the authorisation
19/04/2011
10. Date of revision of the text
23/02/2022
💬 Ask about this leaflet
Ask anything about Dicycloverine 10mg tablets. 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.