0.5 mg / 2.5 mg per 2.5 mL solution nebulizer
ipratropium bromide and salbutamol
What Ipratropium / Salbutamol Orion is and what it is used for
This medicine is called Ipratropium / Salbutamol Orion. The active substances are ipratropium bromide and salbutamol . Ipratropium bromide and salbutamol both belong to the group of bronchodilators. They make it easier for you to breathe by opening up the airways. This is done by the drug preventing the smooth muscles surrounding the airways from contracting and thus keeping the airways open. Ipratropium bromide works by blocking nerve signals to the muscles around the airways. Salbutamol acts by stimulating the beta 2 – receptor in your muscles.
Ipratropium / Salbutamol Orion is used to treat breathing problems in people from 12 years of age with long-term breathing difficulties ( chronic obstructive pulmonary disease (COPD) such as chronic bronchitis, emphysema ). Ipratropium / Salbutamol Orion provides relief from wheezing, shortness of breath, and tightness in the chest.
You should use it with an aid called a ‘nebulizer’. The nebulizer converts the medicine into a vapor that you must inhale.
Ipratropium bromide and salbutamol contained in Ipratropium / Salbutamol Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Ipratropium / Salbutamol Orion
Do not use Ipratropium / Salbutamol Orion
- if you know that your heart is enlarged or that you have hypertrophic obstructive cardiomyopathy (HOCM). This means that the wall between the two chambers of the heart thickens and blocks blood flow.
- if you have abnormally fast heartbeats (called tachycardia )
- if you are allergic to salbutamol , ipratropium bromide, atropine (including medicines similar to atropine) or any of the other ingredients of this medicine (see section 6).
- if you are pregnant, unless your doctor considers it absolutely necessary. This is because there is a lack of information on the safe use of ipratropium bromide and salbutamol together in pregnant women.
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ipratropium / Salbutamol Orion.
Warnings and cautions
Talk to your doctor before using Ipratropium / Salbutamol Orion:
- if you have or think you may have an eye disease called glaucoma (increased pressure in the eyes) or if you have any other eye disease. Your doctor may recommend that you protect your eyes while using Ipratropium / Salbutamol Orion.
- if you know that you (if you are a man) have an enlarged prostate or if you have problems emptying your bladder
- if you have recently had a heart attack
- if you have arterial problems or leg pain when walking
- if you have a history of heart disease, irregular heartbeat or angina (tell your doctor before taking this medicine)
- if you have diabetes
- if you have an overactive thyroid gland
- if you have cystic fibrosis
- if you have been told that you have an adrenal tumor, called a “pheochromocytoma”. This is a rare tumor that is not malignant. Using the inhaler may make the symptoms worse.
Caries in the teeth have been reported in connection with the use of salbutamol. It is recommended, especially in children, to be careful with proper oral hygiene and to make regular check-ups.
Contact your doctor if you suddenly feel worse in your breathing or if the prescribed dose does not give you the effect you are used to. Do not increase the dose without consulting your doctor.
If you are taking high doses of Ipratropium / Salbutamol Orion for a long time, your blood potassium levels should be measured, especially if you are taking certain medicines at the same time such as cortisone ( corticosteroids ), medicines that increase your urine production ( diuretics ) or other medicines that open up the airways such as theophylline (xanthines).
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before using Ipratropium / Salbutamol Orion
Children and young people
Ipratropium / Salbutamol Orion should not be used in children under 12 years of age
Other medicines and Ipratropium / Salbutamol Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Ipratropium / Salbutamol Orion may affect the way some other medicines work. Some other medicines may also affect the way Ipratropium / Salbutamol Orion works.
Some medicines may affect Ipratropium / Salbutamol Orion and may cause more severe side effects or reduce the effect of Ipratropium / Salbutamol Orion. You must always tell your doctor if you are taking any of the following medicines:
- other medicines that help you with your breathing, e.g. salbutamol , or prevents the symptoms e.g. beclomethasone dipropionate. These may increase the effect of Ipratropium / Salbutamol Orion and make the side effects more severe.
- beta blockers , i.e. medicines that are often used for heart problems such as chest pain during exertion (angina), irregular heartbeats or arrhythmias , and high blood pressure ( hypertension ). This includes drugs like propranolol, which can cause the potassium level in the blood to drop when given at the same time as Ipratropium / Salbutamol Orion.
- drugs called “beta-mimetics” such as fenoterol for respiratory distress
- certain antidepressants (antidepressants). This class of drugs includes, for example, monoamine oxidase inhibitors (eg phenelzine) and tricyclic antidepressants (eg amitriptyline).
- Digoxin (for heart problems) can cause heart rhythm problems when taken at the same time as Ipratropium / Salbutamol Orion.
- drugs called anticholinergics. These can be used to treat colic pain, Parkinson’s disease , difficulty emptying the bladder or difficulty controlling the bladder or intestines.
- The salbutamol component of Ipratropium / Salbutamol Orion may cause a decrease in the amount of potassium in the blood ( hypokalaemia ). The risk of this happening is greater if you take Ipratropium / Salbutamol Orion at the same time as any other asthma treatment with inhaled cortisone or cortisone tablets, or with diuretics. A low level of potassium in the blood can cause muscle weakness, twitching and abnormal heart rhythm. Your doctor may need to take blood samples to test your potassium levels from time to time.
- Anesthetics can increase the heart’s sensitivity to salbutamol . If you are going to have surgery, you will be closely monitored. Your doctor may decide to stop treatment with Ipratropium / Salbutamol Orion if you are having surgery. If you are going to be anesthetized in a hospital (to be anesthetized), tell the anesthetist which medicines you are taking.
Ipratropium / Salbutamol Orion with food, drink and alcohol
Ipratropium / Salbutamol Orion is not affected by food and drink.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Do not use Ipratropium / Salbutamol Orion if you are pregnant unless your doctor decides that the benefits to you outweigh the possible risks to your baby.
Ipratropium / Salbutamol Orion may be used during breastfeeding. Ask your doctor, pharmacist, or nurse before taking this medicine while breastfeeding.
Driving and using machines
If you experience side effects such as dizziness, difficulty focusing, and blurred vision when treated with Ipratropium / Salbutamol Orion, you should avoid doing things that may involve risks, e.g. drive a car or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Ipratropium / Salbutamol Orion
Ipratropium / Salbutamol Orion is for inhalation use. The nebulizer solution should be inhaled through the mouth after nebulization.
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or nurse. Follow these instructions for the best results. If you have any further questions on the use of this leaflet, ask your doctor, pharmacist, or nurse.
The recommended dose for adults and children over 12 years is a single dose, three or four times a day.
Elderly patients should take the dose recommended for adults.
You should always start your treatment with the lowest recommended dose (a single dose container ). In very severe cases, two single-dose containers may be required for symptom relief.
Inhalation of one of the drugs should be discontinued when sufficient symptom relief has been achieved.
Use for children and adolescents
Ipratropium / Salbutamol Orion is not recommended for use in children below 12 years of age.
How much to take and how often is stated on the label.
Do not swallow or inject this medicine.
Never take more medicine than your doctor has prescribed. Tell your doctor if your breathing problems get worse or if the medicine does not provide the same relief for your breathing problems as before, or if you use the blue fast-acting inhaler more often than usual.
Your doctor may need to check how well your medicine is working and in some cases need to replace it.
Ipratropium / Salbutamol Orion should be used with a suitable nebulizer e.g. a PARI LC PLUS nebulizer or jet nebulizer. Read the complete instructions for use for the nebuliser in the information supplied with the PARI LC PLUS before you start inhaling.
Instructions for use
- Prepare the nebulizer for use according to the manufacturer’s instructions and the doctor’s recommendations.
- Carefully remove a single-dose container from the labeled strip by twisting and pulling. Never use a single-dose container that has already been opened or if the nebuliser solution is discolored (Fig. A).
- Hold the single-dose container upright and turn off the lid (Fig. B).
- Squeeze the contents into the chamber of your nebulizer (Figure C).
- Follow the manufacturer’s instructions and your doctor’s advice on how to assemble and use the nebulizer.
- After using the nebulizer, discard the nebulizer solution left in the chamber. The nebuliser solution remaining in the single-dose container should also be discarded.
- Thoroughly clean the nebulizer according to the manufacturer’s instructions.
Do not dilute the nebuliser solution or mix it with other medicines unless your doctor tells you to.
The single-dose containers of Ipratropium / Salbutamol Orion do not contain preservatives and it is therefore important that the contents are used immediately after opening. You must take a new container each time you use Ipratropium / Salbutamol Orion in your nebulizer.
Partially used, opened, or damaged single-dose containers should be discarded. Never use a single-dose container that has been opened before.
It is important to follow these instructions to avoid contaminating the nebulizer solution in the single-dose container.
Swallow not the nebulizer solution and use it for injection.
Do not allow the nebulizer solution or vapor to enter the eyes. If any of the liquid or vapor accidentally gets into your eyes, you may experience painful, stinging, or red eyes, dilated pupils, blurred vision, seeing colors or light. If this happens, consult a doctor for advice. If you have eye problems at any other time, consult a doctor for advice.
If you use more Ipratropium / Salbutamol Orion than you should
If you have taken a slightly larger dose than usual, you may feel your heart beating faster (palpitations) or shaking. Other symptoms may include chest pain, altered blood pressure, redness, restlessness, or dizziness. These symptoms usually go away within a few hours. The amount of potassium in the blood may decrease and the doctor may want to check the potassium content of the blood by taking blood samples from time to time and measuring the level. Tell your doctor if you are worried about any symptoms or if they do not go away.
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you need to see a doctor or hospital, take all your medicines with you, including those that are over-the-counter. If possible, they should remain in their original packaging. Bring this leaflet and show it to your doctor.
If you forget to use Ipratropium / Salbutamol Orion
If you forget to take a dose at the right time, take it as soon as you remember. If it is time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Ipratropium / Salbutamol Orion
Your doctor will tell you how long to use Ipratropium / Salbutamol Orion. You should not stop using Ipratropium / Salbutamol Orion without first talking to a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and require medical attention.
Tell your doctor immediately if you notice any of the following serious side effects, you may need urgent medical attention
- If your asthma or wheezing worsens immediately after inhaling Ipratropium / Salbutamol Orion, or if it becomes more difficult for you to breathe and you become short of breath, do not take more Ipratropium / Salbutamol Orion without using your fast-acting inhaler immediately. Your doctor may prescribe another treatment for your illness.
- If you think you may be allergic to Ipratropium / Salbutamol Orion or you may have had an allergic reaction to the nebuliser solution, including skin rash, itching and hives, in severe cases swelling that may affect your tongue, lips or face, sudden difficulty breathing and drops in blood pressure that can cause dizziness. Then stop using Ipratropium / Salbutamol Orion immediately and contact a doctor immediately.
Side effects can occur with the following frequency:
Common, affects up to 1 in 10 people
- dry mouth
Uncommon affects up to 1 in 100 people
- feeling dizzy or spinning ( vertigo )
- severe heartbeat
- increased systolic blood pressure
- fast heartbeat
- irritation of the throat
- speech difficulties
- difficulty emptying the bladder
- skin reactions
Rare affects up to 1 in 1,000 people
- severe allergic reaction that may cause difficulty breathing or dizziness
- allergic reactions such as hives and itching
- swelling of the face, lips and tongue
- decreased potassium levels in the blood
- mental health problems
- increased sweating
- eye pain or other eye problems, such as blurred vision, mydriasis (enlarged pupils ) and glaucoma (increased pressure in the eyes).
- irregular heartbeats
- lowered blood pressure
- heart failure
- difficulty breathing and shortness of breath
- swelling in the throat
- diarrhea, constipation, vomiting or other problems with the gastrointestinal tract
- taste changes
- caries in the teeth
- muscle pain
- weakness and cramps
- dryness in the throat
- swelling in the mouth
- inflammation of the oral mucosa ( stomatitis )
- Mood swings
Some people can get chest pain (due to angina), but it is not known exactly how often this happens. Tell your doctor as soon as possible if you get these symptoms while you are being treated with Ipratropium / Salbutamol Orion, but do not stop taking this medicine unless your doctor tells you to.
You may also have abnormally low potassium levels in your blood (called hypokalaemia ). If this happens, your doctor will check your blood potassium levels.
- aerosol one accidentally enters the eyes you may get painful burning or red eyes, dilated pupils , blurred vision, seeing colors or light. If this happens, talk to your doctor. If you have problems with your eyes at other times, talk to your doctor for advice.
Reporting of side effects ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly to
The Medical Products Agency
751 03 Uppsala
By reporting side effects, you can help increase drug safety information.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Ipratropium / Salbutamol Orion
Keep this medicine out of the sight and reach of children.
Store in a cold place. Do not freeze. Do not store above 25 ° C.
For single use only. Use immediately after opening the single-dose container.
Discard immediately after first use.
Partially used, opened, or damaged single-dose containers should be disposed of in accordance with local requirements.
Store the nebulizer solution in the outer bag or carton. Sensitive to light. Do not use this medicine if you notice that the nebuliser solution is cloudy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
- The active substances are ipratropium bromide and salbutamol . Each vial (2.5 ml) Ipratropium / Salbutamol Orion contains 0.5 mg ipratropium bromide (equivalent to 525 micrograms ipratropium bromide monohydrate and 2.5 mg salbutamol (as sulphate).
- The other ingredients are sodium chloride, water for injections and sulfuric acid (for pH adjustment).
What the medicine looks like and contents of the pack
What the medicine looks like and the contents of the pack
The single-dose container is an FFS (Plastic Form fill Seal) ampoule containing 2.5 ml of clear, colorless nebuliser solution, repackaged in five single-dose containers in a three-layer foil pouch and then in cardboard containing 10, 20, 40, 60, 80, or 100 single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation Orion Pharma
Orion Corporation Orion Pharma, Joensuunkatu 7, FI-24100 Salo, Finland
Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018, Antwerp, Belgium
AMRING FARMA SRL, Mircea Eliade Boulevard Nr. 7, Block 1, Floor 1, Ap. 3, Sector 1,
S&D Pharma CZ, spol. s ro, Theodor 28, Pchery (Pharmos as a facility), 27308, Czech Republic
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Orion Pharma AB