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.

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Dicycloverine 20 mg 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.

Active substance: Dicycloverine hydrochloride

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What you need to know before you take it

e Dicycloverine hydrochloride Tablets

following effects may happen: headache, feeling dizzy, feeling sick, dry mouth or difficulty in swallowing, blurred

How to take it

Dicycloverine hydrochloride Tablets 4. Possible side effects 5. How to store Dicycloverine hydrochloride Tablets

Possible side effects

ike all medicines, this medicine can cause side effects,

although not everybody gets them.

Pregnancy, breastfeeding and fertility 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.

you. If you are not sure, talk to your doctor or pharmacist

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

ide effects get serious or lasts longer than a few ays. Also tell them if you notice any side effects

ot listed in this leaflet:

  • Feeling tired or sleepy
  • Blurred eyesight

intolerance to some sugars, contact your doctor before

  • Rash

taking this medicinal product.

  • Loss of appetite (anorexia)

Dicycloverine hydrochloride Tablets

.

a

blurred vision)

  • If you have an enlarged prostate

pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  • If you have indigestion or heart burn caused by a

Taking this medicine

'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

What Dicycloverine hydrochloride 10 mg and 20 mg Tablets looks like and contents of the pack Dicycloverine Hydrochloride 10 mg Tablets are white to

off white, circular, flat beveled edge, uncoated tablet debossed with "S10" on one side and plain on other side. Dicycloverine Hydrochloride 20 mg Tablets are white to off white, circular, flat beveled edge uncoated tablet debossed with "S" and "20" separated by break-line on one side and plain on other side.

Dicycloverine Hydrochloride 10 mg Tablets are available

Flamingo Pharma (UK) Limited, The Bloc,

38 Springfield Way,

  • Headache

Anlaby, Hull,

  • Difficulty or pain on passing water (urine)

HU10 6Ru,

United Kingdom

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side

This leaflet was last revised in 07/2020.

° Take this medicine by mouth

  • Swallow the tablets with a glass of water

effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA

[POM] PL 43461/0041

° Take before or after meals

Yellow Card in the Google Play or Apple App Store.

PL 43461/0042

Code : MPLLDICXXXXTBCOMFPLXXX038V02

Customer / Livery : FPU UK

Colour Scheme :

Ref. Artwork : MPLLDICXXXXTBCOMFPLXXX038V01

Black Prepared By Artwork

hat Dicycloverine hydrochloride 10 mg and 20 mg Tablets contains

  • Each tablet contains 10 mg or 20 mg of the active substance, dicycloverine hydrochloride.
  • The other ingredients are lactose monohydrate, maize starch, povidone, purified talc, colloidal anhydrous ] and magnesium stearate.

Manufacturer:

_

  • Constipation
  • If you have glaucoma (signs include painful eyes with | Always take this medicine exactly as your doctor or

Reviewed & Checked By Pkg. Development

Approved by

Regulatory

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Flamingo Pharma (UK) Ltd. 1° Floor, Kirkland House, 11-15 Peterborough Road, Harrow, Middlesex, HA1 2AX, United Kingdom.

Dicycloverine hydrochloride Tablet contains lactose If you have been told by your doctor that you have an

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CRS Ure

Marketing Authorization Holder

  • Dry mouth or thirst

HYDROCHLORIDE TABLETS

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.

n cartons containing Aluminium-PVC/PVDC blister packs of 100's along with a leaflet inside and Dicycloverine Hydrochloride 20 mg Tablets are available in cartons containing Aluminium-PVC/PVDC blister packs of 84's, 100's along with a leaflet inside. Not all pack sizes may be marketed.

  • Feeling dizzy

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This medicinal product does not require any special storage conditions.

  • You have an allergic reaction. The signs may include:
  • Feeling sick (nausea) or being sick (vomiting)

Warnings and precautions –

stated on the label. The expiry date refers to the last day

of that month.

swallowing and not to divide into equal doses.

Tell your doctor or pharmacist if any of the following

.

Do not use this medicine after the expiry date which is

The score line is only to facilitate breaking for ease of

your lips, face, throat or tongue.

or breathing problems, swelling of your lips, face, throat | Machines.

Keep this medicine out of the sight and reach of children.

Stop taking Dicycloverine hydrochloride Tablets and see a doctor or go to a hospital straight away if: a rash, swallowing or breathing problems, swelling of

Do not take Dicycloverine hydrochloride Tablets: Driving and using machines

  • If you are allergic to dicycloverine hydrochloride or any of You may feel dizzy, tired or sleepy or have blurred the other ingredients of this medicine (listed in Section 6), eyesight whilst taking Dicycloverine hydrochloride Signs of an allergic reaction include: a rash, swallowing __ Tablets. If this happens, do not drive or use any tools or or tongue. Do not take this medicine if any of the above apply to

How to store it

DICYCLOVERINE HYDROCHLORIDE TABLETS

Children 2 to 11 years of age

  • 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 symptoms 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.

Pai CMS ee Re TABLETS ARE AND WHAT THEY ARE USED FOR

By reporting side effects you can help provide more nformation on the safety of this medicine.

The usual dose is:

Marketing

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Contents of the pack and other information

250 mm

Dicycloverine hydrochloride Tablets contain a medicine alled dicycloverine hydrochloride. This belongs to a group of medicines called antispasmodics. Dicycloverine hydrochloride Tablets are used for Cramps Pain in the stomach or intestine (gut) Stomach or intestine (gut) problems – such as irritable

bowel. Dicycloverine hydrochloride Tablets work by relaxing the uscles in your stomach and gut (intestine). It stops sudden muscle contractions (spasms). In doing this, t relieves cramps, pain, bloating, wind and discomfort.

PR SS eae eS DICYCLOVERINE HYDROCHLORIDE TABLETS

eyesight and hot dry skin. If you forget to take Dicycloverine hydrochloride Tablets If you forget to take Dicycloverine hydrochloride Tablets, take it as soon as you remember it. However, if it is nearly

to your doctor or pharmacist before taking Dicycloverine hydrochloride Tablets.

time for the next dose, skip the missed dose. Do not take

a double dose to make up for a forgotten tablet dose. f you stop taking Dicycloverine hydrochloride Tablets eep taking Dicycloverine hydrochloride Tablets until your

Other medicines and Dicycloverine hydrochloride Tablets

Tell your doctor or pharmacist if you are taking, have

doctor tells you to stop. Do not stop taking Dicycloverine

recently taken or might take any other medicines. This includes medicines obtained 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.

ydrochloride Tablets just because you feel better. f you stop, your cramps or pain may come back. f you have any further questions on the use of this edicine, ask your doctor or pharmacist.

Frequently asked questions about Dicycloverine 20 mg Tablets

How do I take Dicycloverine 20 mg Tablets?

Dicycloverine 20 mg Tablets comes as tablet containing 20mg. 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 20 mg Tablets?

The active substance in Dicycloverine 20 mg Tablets is dicycloverine hydrochloride.

Are there equivalent medicines to Dicycloverine 20 mg Tablets?

Medicines with the same active substance, strength and form include: Dicycloverine 20mg tablets, Dicycloverine hydrochloride 20 mg Tablets, Dicycloverine hydrochloride 20 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 20 mg 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 20 mg 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Dicycloverine hydrochloride (7 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

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 and children over 12 years:

1 tablet three times a day before or after meals

Method of administration

Oral

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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 20 mg Tablets contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 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 40 mg/day) have not shown that dicycloverine hydrochloride increases the risk of foetal abnormalities if administered during the first trimester of pregnancy.

Fertility:

Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60 mg per day for an adult person) and have revealed no evidence of impaired fertility or harm to the foetus due to dicycloverine. Since the risk of teratogenicity cannot be excluded with absolute certainty for any product, the drug should be used during pregnancy only if clearly needed.

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 to a nursing mother.

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 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 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 20 mg 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.

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