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DICYCLOVERINE ORAL SOLUTION - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - DICYCLOVERINE ORAL SOLUTION

1

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

1. what dicycloverine oral solution is and what it is used for

Dicycloverine hydrochloride, the active ingredient of Dicycloverine Oral Solution is one of a group of medicines called anticholinergic antispasmodics. It is used to relieve painful bowel cramps. The anticholinergic action helps to relax the muscles of the intestine and relieve the painful symptoms.

2. what you need to know before you take dicycloverine oral solution

You should not take Dicycloverine Oral Solution until you are sure it is safe for you to do so.

Do not give or take Dicycloverine Oral Solution

  • If you are allergic to dicycloverine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • To babies under 6 months old as it may be dangerous for them.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dicycloverine Oral Solution if you:

  • are pregnant or think that you may be pregnant
  • are breast-feeding
  • have glaucoma (an eye condition involving increased pressure within the eye and resulting in poor vision)
  • have an enlarged prostate gland (this causes difficulty in passing urine)
  • have a hiatus hernia (a condition with symptoms such as acid and food regurgitation and heartburn).

Other medicines and Dicycloverine Oral Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Dicycloverine Oral Solution with food and drink

Dicycloverine Oral Solution may be taken before or after meals.

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 for advice before taking this medicine.

Pregnancy

The safety of dicycloverine hydrochloride for use during pregnancy has not been fully established. Hence, it should be taken only if there is a clear need for it.

Breast-feeding

As it has not been established that dicycloverine does not pass in the breast milk, it should be used with caution in lactating mothers.

Driving and using machines

The effects of dicycloverine hydrochloride on the ability to drive and operate machinery have not been established. Hence do not drive or use machinery when you are on Dicycloverine Oral Solution unless you are sure your judgement and co-ordination are not affected.

Information about ingredients of Dicycloverine Oral Solution

Dicycloverine Oral Solution contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Contains 2.33 g (5ml) and 4.67 g (10ml) of sucrose per dose. This should be taken into account in patients with diabetes mellitus.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

This medicine contains 0.25 mg of sodium benzoate in each 1ml.

3. how to take dicycloverine oral solution

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

The recommended dose is:

Adults and Children over 12 years old

One to Two 5ml spoonfuls three times a day. Your doctor will tell you which dose to use.

Use in children

Children aged 2 – 12 years old

One 5ml spoonful three times a day

The above doses may be taken before or after meals.

Children aged 6 months – 2 years old

Half to One 5ml spoonful three or four times a day. This should be given 15 minutes before feeding. Do not give more than four 5ml spoonfuls in any one day.

If you take more Dicycloverine Oral Solution than you should

It is important to stick to the dose on the label of the medicine. If you or someone else takes too much medicine, contact your doctor or nearest hospital emergency department immediately. Always take any medicine left over with you and also the box, as this will allow easier identification of the medicine.

If you forget to take Dicycloverine Oral Solution

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare: may affect up to 1 in 1,000 people

  • drowsiness/ti­redness
  • blurred vision
  • constipation
  • sickness or lack of appetite
  • headache
  • rash
  • difficulty in passing urine
  • vomiting.

Not known: frequency cannot be estimated from the available data

  • Some people may feel dizzy, thirsty or have a dry mouth.

If you experience any of the above problems or any other unwanted effects, tell your doctor or pharmacist.

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 effects directly via the Yellow Card Scheme at: 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 oral solution

  • 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 carton. The expiry date refers to the last day of that month.
  • Store your medicine in the original container. Do not store above 25°C.
  • Store away from heat and direct sunlight.
  • 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 to protect the environment.

6. contents of the pack and other information

What Dicycloverine Oral Solution contains

The name of this medicine is Dicycloverine Oral Solution.

The active substance in your oral solution is dicycloverine hydrochloride. Each 5ml Spoonful contains 10mg of the active ingredient dicycloverine hydrochloride respectively. Other ingredients include Sodium benzoate, Sucrose, Citric acid monohydrate, Sodium citrate, Flavour Cherry-ST4545/25, Flavour Raspberry-AF-2283, Flavour Vanilla-AF-2268 and Flavour Blackcurrant-AF-2285.

What Dicycloverine Oral Solution looks like and contents of the pack

Dicycloverine Oral solution is a Pale yellow coloured, clear, flavoured Solution. Each Bottle contains 120ml of Solution.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL UK

Manufacturer

Mercury Pharmaceuticals Ltd,

Capital House, 85 King William Street, London EC4N 7BL, UK.

This leaflet was prepared in January 2020.

LF-119581–01

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

A ALIMENTARY TRACT AND METABOLISM DRUGS

A03 DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

A03A DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

A03AA Synthetic anticholinergics, esters with tertiary amino group for functional gastrointestinal disorders

A03AA07 dicycloverine

Frequently Asked Questions

What is Dicycloverine oral solution used for?

Dicycloverine oral solution is primarily used to relieve muscle spasms in the digestive tract. It helps manage conditions like irritable bowel syndrome (IBS) and other gastrointestinal disorders.

How does Dicycloverine work in the body?

Dicycloverine works by relaxing the smooth muscles in the gut, reducing spasms and cramping. This helps ease discomfort associated with abdominal pain.

What are the common side effects of Dicycloverine?

Common side effects may include dry mouth, dizziness, blurred vision, and constipation. If you experience severe side effects, contact your doctor immediately.

Can I drink alcohol while taking Dicycloverine?

It is advisable to avoid alcohol while taking Dicycloverine, as it can increase drowsiness and may intensify side effects.

Is Dicycloverine safe for pregnant women?

Dicycloverine should be used during pregnancy only if prescribed by a healthcare provider. Consult your doctor to weigh the benefits and risks.

Can children take Dicycloverine oral solution?

Dicycloverine is generally not recommended for children under 6 years old. Always consult a pediatrician before administering medication to children.

How should I store Dicycloverine oral solution?

Store Dicycloverine oral solution at room temperature, away from direct sunlight and moisture. Keep it out of reach of children.

What should I do if I miss a dose of Dicycloverine?

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and resume your regular schedule. Do not double up on doses.

Can I stop taking Dicycloverine abruptly?

It’s important to consult your healthcare provider before stopping Dicycloverine. They can provide guidance on how to safely discontinue use.

Does Dicycloverine interact with other medications?

Yes, Dicycloverine may interact with other medications such as antihistamines, muscle relaxants, and certain antidepressants. Inform your doctor about all medications you are taking.

What should I do if I experience an allergic reaction to Dicycloverine?

If you experience difficulty breathing, swelling of your face or throat, or severe rash after taking Dicycloverine, seek emergency medical attention right away.

How long does it take for Dicycloverine to work?

Dicycloverine typically starts to relieve symptoms within 30 minutes to an hour after taking it. However, individual responses may vary.

Can I take Dicycloverine on an empty stomach?

You can take Dicyclovelrine with or without food. However, if it causes stomach upset, try taking it with food to minimize discomfort.

Are there any dietary restrictions while taking Dicycloverine?

There are no specific dietary restrictions when taking Dicycloverine, but maintaining a balanced diet can help manage gastrointestinal symptoms more effectively.

Is it safe to drive while taking Dicycloverine?

Dicycloverine may cause dizziness or drowsiness in some individuals. If you experience these side effects, it's best to avoid driving or operating heavy machinery until you know how it affects you.

How long can I take Dicycloverine for my symptoms?

The duration of treatment should be determined by your healthcare provider based on your specific condition and response to therapy. Do not exceed the recommended duration without consulting them.

Can older adults use Dicycloverine safely?

Older adults may be more sensitive to the side effects of Dicycloverine. It’s important they discuss their health conditions with their healthcare provider before use.

What should I tell my doctor before starting Dicycloverine?

Inform your doctor about any allergies, pre-existing conditions (especially glaucoma or prostate issues), and all medications you're currently taking before starting Dicycloverine.

Can I use over-the-counter medications while on Dicycloverine?

Consult your healthcare provider before using any over-the-counter medications while taking Dicycloverine, as some may interact negatively.

Where can I find more information about my medication?

You can find more information about Dicycloberin from reputable online health resources or by consulting your pharmacist or healthcare provider for guidance.