Hyoscine butylbromide 10 mg coated tablets

• 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.

1. What Hyoscine butylbromide coated tablets are and what they are used for
2. What you need to know before you take Hyoscine butylbromide coated tablets
3. How to take Hyoscine butylbromide coated tablets
4. Possible side effects
5. How to store Hyoscine butylbromide coated tablets
6. Contents of the pack and other information

• You are allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients (listed in section 6)
• You have glaucoma (an eye problem)
• You have something called ‘myasthenia gravis’ (a very rare muscle weakness problem)
• You have a suspected or confirmed blockage of the bowel
• You have a condition where the bowel is blocked and does not work properly (paralytic or obstructive ileus). Symptoms include severe abdominal pain with lack of stools and/or nausea/vomiting
• You have a very enlarged bowel (megacolon)
• You are pregnant, likely to get pregnant, or are breast-feeding

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 this medicine.

Check with your doctor or pharmacist before taking your medicine if:

• You have a very fast heart rate or other heart problems
• You have a problem with your thyroid gland such as an overactive thyroid gland
• You have difficulty or pain passing water (urine) such as men with Prostate problems
• You have constipation
• You have a fever

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hyoscine butylbromide coated tablets.

Check with your doctor or pharmacist straight away if you have unexplained abdominal pain which persists or worsens or occurs with:

• fever
• feeling sick
• being sick
• changes in your bowel movements
• abdominal tenderness
• low blood pressure
• feeling faint or,
• blood in your bowel movements

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines. This is because hyoscine butylbromide can affect the way some other medicines work. Also some other medicines can affect the way hyoscine butylbromide works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• Medicines for depression called “tetracyclic antidepressants” or “tricyclic antidepressants” such as doxepin
• Medicines for allergies and travel sickness called “antihistamines”
• Medicines to control your heart beat such as quinidine and disopyramide
• Medicines for severe mental illness called ‘antipsychotics’ such as haloperidol or fluphenazine
• Medicines usually used for breathing problems such as tiotropium, ipratropium or atropine-like medicines
• Amantadine – for Parkinson’s disease and flu
• Metoclopramide – for feeling sick (nausea)

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hyoscine butylbromide coated tablets.

Do not take Hyoscine butylbromide coated tablets if you are pregnant, likely to get pregnant or are breast-feeding.

Some people may have sight problems while taking this medicine. If this happens to you, wait until your sight returns to normal before driving or using any tools or machines.

Hyoscine butylbromide coated tablets contain sucrose. Talk to your doctor or pharmacist before taking this medicine if they have told you that you cannot tolerate or digest some sugars.

• Take your tablets with water.
• Do not break, crush or chew the tablets.

Adults and children over 12 years

• The usual dose is two tablets 4 times a day.
• For Irritable Bowel Syndrome, your doctor may give you a lower starting dose of one tablet 3 times a day. This dose may be increased, if further relief is necessary.

Children 6-12 years

• The usual dose is one tablet 3 times a day.

Hyoscine butylbromide is not recommended for children under 6 years.

If you take more Hyoscine butylbromide coated tablets than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you even if there are no Hyoscine butylbromide coated tablets left.

• If you forget a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

• Allergic reactions such as skin reactions e.g. nettle rash, itching (affects fewer than 1 in 100 people), rash, redness of the skin
• Severe allergic reactions (anaphylactic shock) such as difficulty breathing, feeling faint or dizzy (shock)
• Painful red eye with loss of vision

• Dry mouth (affects fewer than 1 in 100 people)
• Abnormal sweating or reduced sweating (affects fewer than 1 in 100 people)
• Increased heart rate (affects fewer than 1 in 100 people)
• Being unable to pass water (urine) (affects fewer than 1 in 1,000 people)

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 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.

The active substance is hyoscine butylbromide. Each tablet contains 10 mg hyoscine butylbromide.

The other ingredients are calcium hydrogen phosphate dihydrate, maize starch, tartaric acid, silica colloidal anhydrous, and stearic acid. The tablet coating contains sucrose, talc, hypromellose 2910, glycerol monostearate, triglycerides medium chain, poly vinyl alcohol, macrogol 4000 and polysorbate 80.

Hyoscine butylbromide coated tablets are white to off-white, sugar coated circular, biconvex tablets plain on both sides.

Hyoscine butylbromide coated tablets are marketed in white opaque PVC/PVdC-Aluminium foil blister packs.

Pack sizes: 56 tablets

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