Patient leaflet - HYOSCINE BUTYLBROMIDE 10 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Hyoscine Butylbromide 10 mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if you do not feel better or if you feel worse after two weeks.
What is in this leaflet
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1. What Hyoscine Butylbromide Tablets are and what they are used for
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2. What you need to know before you take Hyoscine Butylbromide Tablets
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3. How to take Hyoscine Butylbromide Tablets
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4. Possible side effects
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5. How to store Hyoscine Butylbromide Tablets
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6. Contents of the pack and other information
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1. What Hyoscine Butylbromide Tablets are and what they are used for
The name of your medicine is Hyoscine Butylbromide 10 mg Film-coated Tablets (called Hyoscine Butylbromide Tablets in the rest of this leaflet). Hyoscine Butylbromide Tablets contain a medicine called hyoscine butylbromide. This medicine is to relieve the abdominal cramps which cause pain and discomfort associated with Irritable Bowel Syndrome. It belongs to a group of medicines called antispasmodics. It works by relaxing the cramping muscles of your bowel.
What is Irritable Bowel Syndrome (IBS)?
Irritable Bowel Syndrome is often just called ‘IBS’. Although the precise cause is unknown, the muscles of the bowel appear to be very sensitive to things like:
- Stress, eating and drinking habits
- Food allergies or intolerances
- Stimulants such as coffee
- Hormonal factors.
Such things can trigger painful abdominal cramps or spasms if you have a sensitive bowel. You may also feel bloated, with excess wind and abdominal discomfort. Sometimes IBS can include diarrhoea or constipation.
2. what you need to know before you take hyoscine butylbromide tablets
Do not take Hyoscine Butylbromide Tablets if:
- you are allergic to hyoscine butylbromide or any of the other ingredients of this medicine (listed in section 6)
- you are intolerant to or cannot digest some sugars (as the tablet coating contains a small amount of lactose)
- 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 Hyoscine Butylbromide Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Hyoscine Butylbromide Tablets if any of the following apply to you, even if you know you have IBS, in case your abdominal pain may be something else:
- You are 40 years or over and it is some time since your last attack of IBS or the symptoms are different this time
- you have recently passed blood from the bowel
- you have severe constipation
- you are feeling sick or vomiting
- you have lost your appetite or lost weight
- you have difficulty or pain passing water (urine)
- you have a fever
- you have recently travelled abroad (in case you have picked up a stomach bug)
- you have a very fast heart rate or other heart problems
- you have been treated by a doctor for a severe sweating problem.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Hyoscine Butylbromide 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.
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 Tablets can affect the way some other medicines work, and some other medicines can affect the way Hyoscine Butylbromide Tablets work.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Antihistamines – used to treat hay fever and other allergies
- Tetracyclic or tricyclic medicines – used to treat depression and some types of pain
- Antipsychotic medicines such as butyrophenones or phenothiazines – used to treat severe mental illness such as schizophrenia
- Dopamine antagonists such as metoclopramide for feeling sick
- Beta 2 adrenergic medicines such as salbutamol inhalers for asthma
- Quinidine or disopyramide – used to control your heart beat
- Amantadine – used for Parkinson’s disease and flu
- Anticholinergic medicines such as tiotropium, ipratropium or atropine-like medicines – usually inhaled to treat breathing problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hyoscine Butylbromide Tablets.
Pregnancy, breast-feeding and fertility
Do not take this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Driving and using machines
Some people may have temporary blurring of vision while taking this medicine. If this happens to you, wait until your vision returns to normal before driving or using any tools or machines.
Hyoscine Butylbromide Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. how to take hyoscine butylbromide tablets
Always take your medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Hyoscine Butylbromide Tablets should not be taken continuously for more than two weeks. Talk to your pharmacist or doctor if you develop new symptoms or if your symptoms get worse or have not improved over two weeks.
Taking this medicine
- Swallow the tablet whole with water.
- Do not break, crush or chew the tablets.
How much to take
Adults and children 12 years or over:
- Start by taking 1 tablet three times a day.
- You can increase your dose to a maximum of 2 tablets four times a day, if needed.
Hyoscine Butylbromide Tablets are not recommended for children under 12 years.
If you take more Hyoscine Butylbromide Tablets than you should
If you take more Hyoscine Butylbromide Tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you even if there are no Hyoscine Butylbromide Tablets left.
If you forget to take Hyoscine Butylbromide Tablets
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Mild side effects that do not normally require medical treatment:
Uncommon – may affect up to 1 in 100 people
- Dry mouth.
- Abnormal sweating or reduced sweating.
If any of these side effects get troublesome or seem serious to you please tell your pharmacist or doctor.
If you get any of the side effects described below stop taking this medicine and tell your doctor straight away. You may need urgent medical treatment: Uncommon – may affect up to 1 in 100 people
- Skin reactions such as urticaria and pruritus (itching).
- Tachycardia (increased heart rate).
Rare – may affect up to 1 in 1,000 people
- Problems emptying the bladder.
Isolated events – some side effects are so rare that it is not known how many people may be affected.
- Anaphylactic reaction and shock – this is a severe type of allergic reaction. An itchy rash may spread all over the body, as well as swelling. You may have difficulty in breathing and may lose consciousness.
- Dyspnoea (difficult or laboured breathing).
- Allergic reactions (hypersensitivity) such as skin rash and erythema (patchy red skin).
- If you experience a painful red eye with loss of vision after taking this medicine, stop taking it and tell your doctor straight away. You may have an eye problem called glaucoma and need urgent medical attention.
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 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 hyoscine butylbromide 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 and carton 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 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.
6. contents of the pack and other information
What Hyoscine Butylbromide Tablets contain
- The active substance is hyoscine butylbromide. Each film-coated tablet contains 10 mg of hyoscine butylbromide.
- The other ingredients are:
What Hyoscine Butylbromide Tablets look like and contents of the pack
Hyoscine Butylbromide 10 mg Film-coated Tablets are white to off-white round, biconvex, film-coated tablets with ‘10’ debossed on one side and plain on other side.
Pack size of 8, 10, 12, 20, 24 and 40 tablets are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
Unit C, Harcourt Way
Leicester, LE19 1WP, UK
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way
Loughborough, LE11 5GW, UK
This leaflet was last revised in October 2021.