Ipramol Steri-Neb 0.5mg/2.5mg Per 2.5ml Nebuliser Solution
o
IPRAMOL STERI-NEB 0.5MG / 2.5 MG PER 2.5ML NEBULISER SOLUTION
Ipratropium bromide and salbutamol
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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 Ipramol Steri-Neb ampoules are and what they are used for
2. What you need to know before you use Ipramol Steri-Neb ampoules
3. How to use Ipramol Steri-Neb ampoules
4. Possible side effects
5. How to store Ipramol Steri-Neb ampoules
6. Contents of the pack and other information
1 WHAT IPRAMOL STERI-NEB AMPOULES ARE AND WHAT THEY ARE USED FOR
Your medicine is called Ipramol Steri-Neb ampoules 0.5mg / 2.5mg per 2.5 ml Nebuliser Solution. The active ingredients are ipratropium bromide and salbutamol. 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 will relieve wheezing, shortness of breath and chest tightness by opening up your airways.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE YOUR IPRAMOL STERI-NEB AMPOULES
Do not use Ipramol Steri-Neb ampoules:
• if you are allergic (hypersensitive) to ipratropium or salbutamol or any of the other ingredients in 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 fast heart beat (called 'tachyarrhythmia').
• If you have an enlarged heart or a condition known as hypertrophic obstructive cardiomyopathy, where wall between the two sides of heart becomes thicker and blocks the blood flow.
If you are not sure, talk to your doctor or pharmacist before using Ipramol.
Warnings and precautions
Talk to your doctor or pharmacist before using Ipramol:
• 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 ampoules;
• 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.
Children and adolescents
Ipramol 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
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 heart beats or arrhythmias and high blood pressure (called hypertension). They include drugs such as propranolol. These drugs oppose the 'airway opening' effects of Ipramol;
• certain drugs to treat depression (such "antidepressants" 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 the 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, 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 because it contains salbutamol, which may lead to a positive test result.
Ipramol 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. If it occurs do not drive or use tools or machines.
3 HOW TO USE IPRAMOL STERI-NEB AMPOULES
Ipramol Steri-Neb ampoules are 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 ampoules are 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 (diagram A).
• Hold the ampoule upright and twist off the cap (diagram B).
• Squeeze the contents into the reservoir of your nebuliser (diagram C).
• 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-Nebs 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-Nebs in your nebuliser.
Belgium
Germany
Denmark
Greece
Italy
Poland
Portugal
Romania
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.
If you use more Ipramol Steri-Neb ampoules than you should
If you have taken a slightly larger dose than usual, you may notice a faster heart beat (palpitations) or tremor. Other symptoms might include chest pain, changes in blood pressure, flushing, restlessness or dizziness. These effects usually wear off in a few hours. The level of potassium in your blood may fall and the doctor may want to monitor the potassium in your blood by taking a blood test to measure the levels from time to time. Tell your doctor if you are worried by any of these symptoms or if they persist.
If you have taken more medicine than you should have taken, tell your doctor immediately or go to the nearest hospital. If you need to visit a doctor or need to go into hospital then you should take all of your medicines with you, including any you may have bought without a prescription; these should be in their original packaging if at all possible. Take this leaflet with you to show the doctor.
If you forget to use Ipramol Steri-Neb Ampoules
If you forget to take a dose at the right time, take it as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
If you stop using Ipramol Steri-Neb
You should not stop taking Ipramol Steri-Neb without prior discussion with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 POSSIBLE SIDE EFFECTS
Like all medicines Ipramol Steri-Nebs can cause side effects, although not everybody gets them.
Some of the side-effects may be serious and require medical intervention.
Serious 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-Nebs but use your short-acting 'reliever' inhaler straightaway. You should stop using Ipramol Steri-Nebs 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 Ampoules straightaway and contact your doctor immediately.
A reduction in the level of potassium (hypokalaemia) in the blood due to the salbutamol component of Ipramol Steri-Nebs 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-Nebs 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.
Occurrence rates for Side effects
Uncommon: may affect up to 1 in 100 people
• headaches
• palpitations or fast heartbeat
• dryness of the mouth
• nausea (feeling sick)
• cough
• speech difficulties
• dizziness
• increased blood pressure
• feeling nervousness
• tremor
Rare: may affect up to 1 in 1,000 people
• allergic reactions including swelling of the tongue, lips and face
• breathing difficulties and shortness of breath
• sweating
• flushing
• reduced blood pressure
• vomiting (being sick)
• upset stomach / upset bowels (including intestinal blockage)
• difficulty in passing urine (water)
• itching
• rashes
• muscular pains, weakness and cramps
• memory disorders
• anxiety and depression
• 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, but do not stop using this medicine unless told to do so.
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: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5 HOW TO STORE IPRAMOL STERI-NEB AMPOULES
Keep this medicine out of the sight and reach of children.
Do not use Ipramol Steri-Nebs after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Keep Ipramol Steri-Neb Ampoules in the box they came in. Store in original packaging in order to protect from light. Store below 25°C. Do not freeze.
Do not take this medicine if you notice the solution is discoloured or cloudy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help protect the environment.
6 CONTENTS OF THE PACK AND OTHER INFORMATION
What Ipramol Steri-Neb Ampoules contain
• the active substances are 0.5 milligram of ipratropium bromide (as the monohydrate) and 2.5 milligrams of salbutamol (as the sulphate)
• the other ingredients are sodium chloride, water for injections and dilute hydrochloric acid.
What Ipramol Steri-Neb Ampoules look like and contents of the pack
Each Ipramol Steri-Neb consists of a plastic ampoule containing a clear solution. Strips of 5 ampoules are packed into foil laminate pouches, which in turn are packed into cardboard cartons containing 5, 10, 15, 20, 25, 30, 40, 50 or 60 ampoules and 2 x 30 ampoule-pack, then packed into a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Norton Healthcare Ltd T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom
Manufacturer:
IVAX Pharmaceuticals UK, Preston Brook, Runcorn, Cheshire, WA7 3FA, UK.
This medicinal product is authorised in the Member States of the EEA under the following names
Finland Ipramol 0.5mg / 2.5mg per 2.5ml
Sumutinliuos
Ireland Ipramol Steri-Neb 0.5mg / 2.5mg
per 2.5ml Nebuliser Solution The Netherlands Ipramol 0.5mg / 2.5mg per 2.5 ml Verneveloplossing
Sweden Ipramol 0.5mg / 2.5mg losning
for nebulisator
United Kingdom Ipramol Steri-Neb 0.5mg / 2.5mg per 2.5ml Nebuliser Solution Nebu-Iprasal 0,5 mg/2,5 mg verneveloplossing Ipramol TEVA 0,5 mg + 2,5 mg /2,5 ml Steri-Neb Losung fur einen Vernebler Ipramol Steri-Neb Ipramol Steri-Neb 0,5/2,5mg ova 2,5ml AiaAuga yia Eionvop ps Ekvs^wth
Ipramol 0.5mg / 2.5mg per 2.5ml Soluzione da nebulizzare Ipramol Steri-Neb Ipramol 0.5 mg/dose + 2.5 mg/ dose Solupao para inalapao por nebulizapao
Ipratropiu/salbutamol TEVA 0.5/2.5mg per 2.5ml solutie de inhalat prin nebulizator
This leaflet was last revised on December 2014.
'Steri-Neb' is a trademark
'Ipramol' is a registered trade mark