What Ipramol Steri-Neb is and what it is used for

• Your medicine is called Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml Nebuliser Solution. The active ingredients are ipratropium bromide and salbutamol sulfate. Ipratropium bromide and salbutamol both belong to a group of medicines called bronchodilators, which help to improve your breathing by opening up your airways. This is achieved by preventing the contraction of the smooth muscles surrounding the airways, therefore allowing the airways to remain open. Ipratropium bromide acts by blocking the nerve signals that go to the muscles surrounding the airways, and salbutamol acts by stimulating specific receptors in the muscles.
• Ipramol Steri-Neb is used to treat breathing problems in people with long-standing breathing difficulties in an illness called ‘chronic obstructive pulmonary disease’ or ‘COPD’. Ipramol Steri-Neb will relieve wheezing, shortness of breath and chest tightness by opening up your airways.

What you need to know before you use Ipramol Steri-Neb

Do not use Ipramol Steri-Neb:

• if you are allergic to ipratropium or salbutamol or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to medicines that contain atropine or medicines like atropine
• if you suffer from abnormal heart rhythms including a very fast heart beat (called ‘tachyarrhythmia’)
• if you have an enlarged heart or a condition known as hypertrophic obstructive cardiomyopathy, where the wall between the two sides of the heart becomes thicker and blocks the blood flow.

Warnings and precautions

Talk to your doctor or pharmacist before using Ipramol Steri-Neb:

• if you suffer from or think you may suffer from an eye condition known as glaucoma (increased pressure in the eyes) or if you suffer from any other eye conditions. Your doctor may advise you to protect your eyes when using Ipramol Steri-Neb;
• if you are male and you know that you have an enlarged prostate or if you have problems passing urine (water);
• if you have had a recent heart attack (myocardial infarction); if you have problems with your arteries or get pain in your legs when you walk;
• if you have a history of heart disease, irregular heart rhythm or angina (please tell your doctor before starting this medication);
• if you have diabetes;
• if you have an overactive thyroid gland;
• if you suffer from cystic fibrosis;
• if you have been told that you have a tumour of the adrenal gland called pheochromocytoma.

A condition known as lactic acidosis has been reported in association with high therapeutic doses of salbutamol, mainly in patients being treated for an acute bronchospasm (see section 3 and 4). Increase in lactate levels may lead to shortness of breath and hyperventilation even though there may be improvement in your wheezing. If you feel that your medicine is not working as well as usual and you need to use the nebuliser more than your doctor has recommended, immediately talk to a doctor.

Children and adolescents

• Ipramol Steri-Neb is not recommended in children 12 years of age and younger, as safety and efficacy have not been established in this age group.

Other medicines and Ipramol Steri-Neb

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

Certain medicines may interact with Ipramol Steri-Neb and may worsen side effects or reduce the effect of Ipramol Steri-Neb. You must always tell your doctor if you are taking any of the following medicines:

• other asthma medicines, including inhalers and tablets for asthma and including treatments
• known as “relievers” such as salbutamol and “preventers” such as beclometasone dipropionate.

These may increase the effect of Ipramol Steri-Neb and increase the severity of side effects;

• beta-blockers i.e. medicines that are commonly used to treat heart conditions such as chest pain that occurs on exertion (called angina pectoris), irregular heartbeats or arrhythmias and high blood pressure (called hypertension). They include drugs such as propranolol. These drugs oppose the ‘airway opening’ effects of Ipramol Steri-Neb;
• certain drugs to treat depression (such “anti-depressants” are drugs that are prescribed for patients suffering from depression and anxiety). This class of drug includes medicines such as monoamine oxidase inhibitors (e.g. phenelzine) or tricyclic antidepressants (e.g. amitriptyline);
• digoxin (for heart problems) may cause heart rhythm problems when given with Ipramol Steri-Neb;
• diuretics (“water tablets”) and steroid tablets (these are medicines that reduce inflammation such as prednisolone). These drugs may increase risk of low potassium levels;
• anaesthetic agents may increase the susceptibility of the effects of salbutamol on the heart – you will be monitored closely or your doctor might decide to discontinue Ipramol Steri-Neb if you are going to have an operation.

If you are going to have a general anaesthetic in hospital or at the dentist, please tell the anaesthetist what drugs you are taking.

If you have to provide a urine sample as part of a routine sport drug test, tell the person giving the test that you are taking Ipramol Steri-Neb because it contains salbutamol, which may lead to a positive test result.

Ipramol Steri-Neb with food and drink

• Food and drink have no influence on Ipramol Steri-Neb.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Ipramol Steri-Neb should not be used during pregnancy or breast feeding unless your doctor decides that the benefits to the mother outweigh the risk to the baby.

Driving and using machines

• You may feel dizzy, or have difficulty in focusing or experience blurred vision while taking Ipramol Steri-Neb. If this occurs do not drive or use tools or machines.

How to use Ipramol Steri-Neb

Ipramol Steri-Neb is for inhalation use after nebulisation.
Always use Ipramol Steri-Neb exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or nurse if you are not sure.
The recommended dose for adults and children over 12 years of age is the contents of one ampoule, three or four times a day.
Elderly patients should take the usual adult dose.
Ipramol Steri-Neb is not recommended for children under 12 years of age. The label will tell you how much to take and how often to take it.
Never use more medicine than your doctor has told you to. Tell your doctor if your breathing problems get worse or your medicine does not provide as much relief from your breathing problems as before or if you are using your blue short-acting “reliever” inhaler more often than is usual for you.

Instructions for Use

• Prepare your nebuliser for use according to the manufacturer’s instructions and advice from your doctor.
• Carefully remove an ampoule from the labelled strip by twisting and pulling. Never use an ampoule that has been opened already or if the solution is discoloured.
• Hold the ampoule upright and twist off the cap.
• Squeeze the contents into the reservoir of your nebuliser.
• Follow the manufacturer’s instructions and the advice from your doctor on how to assemble and how to use your nebuliser.
• After you have used your nebuliser, throw away any solution that is left in the reservoir. Any solution left in the ampoule should also be thrown away.
• Clean your nebuliser thoroughly according to the manufacturer’s instructions. It is important that the nebuliser is kept clean.

Do not dilute the solution or mix it with other medicines, unless your doctor tells you to.
The single dose ampoules of Ipramol Steri-Neb do not contain preservatives and therefore it is important to use the contents immediately after opening. A new ampoule must be used each time you use Ipramol Steri-Neb in your nebuliser.
Partly used, opened or damaged ampoules should be discarded. You should never use an ampoule, which has been opened earlier.
It is important that you follow these instructions in order to avoid any contamination of the nebuliser solution within the ampoules.
Do not swallow the solution or use it in injections.
Do not allow the solution or mist to enter your eyes.

Possible Side Effects

If your asthma or wheezing gets worse immediately after inhaling Ipramol Steri-Neb Nebuliser Solution, or your breathing becomes more difficult and you become short of breath do not take any more Ipramol Steri-Neb but use your short-acting ‘reliever’ inhaler straight away. You should stop using Ipramol Steri-Neb and should contact your doctor immediately. Your doctor may prescribe alternative treatment for your condition.

If you experience eye pain or eye discomfort, blurred vision or red eyes, or if you see halos or coloured spots then you should contact your doctor straightaway as treatment for these symptoms may be required

If you think that you may be allergic to Ipramol Steri-Neb Nebuliser Solution or if you think you may be having an allergic reaction to the solution then you should stop using Ipramol Steri-Neb straight away and contact your doctor immediately.

A reduction in the level of potassium (hypokalaemia) in the blood due to the salbutamol component of Ipramol Steri-Neb can occur – and this may cause muscle weakness, twitching or abnormal heart rhythm. This is more likely to happen if you are taking Ipramol Steri-Neb with some other asthma treatments, with inhaled steroids or steroid tablets or with diuretics (“water tablets”). Your doctor may need to take a blood test to measure your potassium levels from time to time.

So, the side effects:

• headaches
• palpitations or fast heart beat dryness of mouth
• nausea (feeling sick)
• mouth and throat irritation
• cough
• speech difficulties
• dizziness
• increased blood pressure restlessness
• tremor
• difficulty in passing urine (water).

Rare side effects

• allergic reactions including swelling of the tongue, lips and face breathing difficulties and shortness of breath
• sweating
• flushing
• reduced blood pressure
• irregular heart rhythm
• chest pain (due to cardiac problems)
• vomiting (being sick)
• upset stomach/upset bowels (including intestinal blockage)
• itching
• rashes
• muscular pains, weakness and cramps
• memory disorders
• anxiety
• hyperactivity in children
• eye pain or other problems with the eyes including blurring of vision, excessive dilation of the pupil of the eye and glaucoma (increased pressure in the eyes)
• low potassium levels in your blood.

Although it is not known exactly how often this happens, some people might experience chest pain (due to problems such as angina). Tell your doctor as soon as possible if you develop these symptoms whilst receiving treatment with Ipramol Steri-Neb, but do not stop using this medicine unless told to do so.

References:

http://www.hpra.ie/img/uploaded/swedocuments/5561e110-c808-4917-98d9-f416fbac60ec.pdf

https://www.drugs.com/uk/ipramol-steri-neb-0-5mg-2-5mg-per-2-5ml-nebuliser-solution-leaflet.html

https://www.netdoctor.co.uk/medicines/allergy-asthma/a6252/atrovent-ipratropium-bromide/

https://mri.cts-mrp.eu/human/downloads/IE_H_0163_001_FinalSPC.pdf