Spasmopan contain a medicine called ‘hyoscine N-butylbromide’. This belongs to a group of medicines called ‘antispasmodics’.

Spasmopan is used to relieve cramps in the muscles of your:

• Stomach
• Gut (intestine)
• Bladder and the tubes leading to the outside of your body (urinary system) Spasmopan can also be used in some diagnostic and therapeutic medical procedures where spasm may be a problem for example barium enema.

You should not be given Spasmopan if:

• You are allergic (hypersensitive) to hyoscine N-butylbromide or any of the other ingredients (listed in section 6).
• You have glaucoma (an eye problem).
• You have megacolon (a very enlarged bowel).
• You have something called ‘myasthenia gravis’ (a very rare muscle weakness problem).
• You have a very fast heart rate.
• You have difficulty or pain passing water (urine) such as men with prostate problems.
• You have gut blockage problems or a totally inactive gut.
• You are pregnant, likely to get pregnant or are breast-feeding.

You should not receive 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.

Warnings and precautions
Check with your doctor or pharmacist before having this medicine if:

• You have any heart problems.
• You have a fever.
• You have problems with your thyroid gland such as an overactive thyroid gland.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before receiving Spasmopan.

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

Other medicines and Spasmopan
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Spasmopan can affect the way some other medicines work. Also some other medicines can affect the way Spasmopan work.

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 or disopyramide
• Medicines for severe mental illness such as haloperidol or fluphenazine
• Medicines usually used for breathing problems such as salbutamol, ipratropium, tiotropium 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 receiving Spasmopan.

Pregnancy and breast-feeding
You should not be given Spasmopan if you are pregnant, likely to get pregnant or are breast-feeding.

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

Spasmopan contains sodium metabisulphite, potassium, sodium and benzyl alcohol
Spasmopan contains sodium metabisulphite. Each ml of Spasmopan 20 mg/ml Solution for Injection contains 1 mg sodium metabisulphite, which may rarely cause severe hypersensitivity reactions and bronchospasm.  

Spasmopan contains potassium. Each ml of Spasmopan 20 mg/ml Solution for Injection contains 0.0245 mmol (0.956 mg) potassium. This medicine contains potassium, less than 1 mmol (39 mg) per ml, i.e. essentially ‘potassium-free’.

Spasmopan contains sodium. Each ml of Spasmopan 20 mg/ml Solution for Injection contains 0.276 mg sodium. This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

Spasmopan contains benzyl alcohol. Each ml of Spasmopan 20 mg/ml Solution for Injection contains 10 mg benzyl alcohol:

• Benzyl alcohol may cause allergic reactions.
• Ask your doctor or pharmacist for advice if you are pregnant or breast‑feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
• Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Spasmopan is usually given by a doctor or nurse. Spasmopan should not be given every day for long periods of time.

Receiving the injection
Spasmopan may be given in two ways:

• By being slowly injected into a vein
• By an injection into a muscle
• Spasmopan may be diluted with other solutions if needed

How much will you be given

• You will usually be given one ampoule, but you may be given a further ampoule after half an hour if required
• If you are being given Spasmopan as part of an endoscopy your dose may need to be given more often
• You should not be given more than 5 ampoules in any 24-hour period

Spasmopan Ampoules are not recommended for children.

If you have more Spasmopan than you should
It is unlikely that you will be given too much of this medicine. However, tell the doctor or nurse if you think that you have been given too much.

Like all medicines, this medicine can cause side effects although not everybody gets them. The following side effects may happen with this medicine.

 Stop taking your medicine and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

• Allergic reactions such as skin rash, nettle rash, redness of the skin and itching
• Severe allergic reactions (anaphylaxis) such as difficulty breathing, feeling faint or dizzy (shock)
• Painful red eye with loss of vision

Other side effects:

• Dry mouth (affects fewer than 1 in 10 people)
• Dizziness (affects fewer than 1 in 10 people)
• Blurred vision (affects fewer than 1 in 10 people)
• Increased heart rate (affects fewer than 1 in 10 people)
• Constipation
• Abnormal sweating or reduced sweating
• Being unable to pass water (urine)
• Low blood pressure, for example feeling faint
• Flushing
• Dilated pupils
• Increased fluid pressure inside the eye

Pain at the place you had the injection may occur if you have been given hyoscine N-butylbromide into a muscle.

Although unlikely, in certain circumstances it may be possible that hyoscine N-butylbromide may pass into the brain and cause side effects, for example confusion.

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

Store below 30°C.

Protect from light.

Store in the original package.

Chemical and physical in-use stability has been tested for 24 hours at room temperature (20-25°C) and at (2-8°C).

From a microbiological point of view, the diluted solution should be used immediately.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

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.