0.5 mg / 2.5 mg per 2.5 mL, solution nebulizer
ipratropium bromide, salbutamol sulfate
1. What Ipramol is and what it is used for
Your medicine is called Ipramol. The active substances are ipratropium bromide and salbutamol . Both ipratropium bromide and salbutamol belong to a class of medicines called bronchodilators, which facilitate breathing by widening the airways. The smooth muscles that surround the airways are prevented from contracting and thus the airways are kept open. Ipratopium bromide works by blocking the nerve signals sent to the muscles that surround the airways, and salbutamol works by stimulating specific receptors in the muscles.
Ipramol is used to treat breathing problems in people who have long-term breathing difficulties due to a disease called “chronic obstructive pulmonary disease” or “COPD”. Ipramol relieves wheezing, shortness of breath, and tightness in the chest by dilating your airways.
Ipratropium bromide and salbutamol contained in Ipramol 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.
2. What you need to know before you use Ipramol
Do not use Ipramol
- if you are allergic to ipratropium bromide or salbutamol or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to medicines containing atropine or similar medicines
- if you have heart rhythm disorders, e.g. fast pulse or palpitations (called tachyarrhythmia )
- If you know that your heart is enlarged or you have a condition called hypertrophic obstructive cardiomyopathy , then the wall between the two sides of the heart becomes thicker and blocks blood flow.
If you are not sure, talk to your doctor or pharmacist before taking Ipramol.
Warnings and cautions
Talk to your doctor or pharmacist before using Ipramol:
- 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 Ipramol;
- if you are a man and know that you have an enlarged prostate or if you have problems emptying your bladder (urinating);
- if you have recently had a heart attack; if you have other vascular problems or get leg pain when you walk;
- if you have previously had heart disease, irregular heartbeat or angina (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 informed that you have an adrenal tumor.
A condition called lactic acidosis (increased acidity ( lactic acid ) in the blood) has been reported with high doses of salbutamol, especially in patients being treated for acute bronchospasm (tracheal spasm) (see sections 3 and 4). An increase in lactate levels (lactic acid level) can lead to difficulty breathing and hyperventilation (rapid and shallow breathing) even if other symptoms such as wheezing improve. If you experience that your medicine does not work as well as usual and you need to use the nebulizer more than your doctor has prescribed, talk to a doctor immediately.
Children and young people
Ipramol is not recommended for use in children 12 years of age or 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.
Some medicines can affect Ipramol and aggravate the side effects or weaken the effect of Ipramol. You must tell your doctor if you are taking any of the following medicines:
- other asthma medications, including inhalers and asthma tablets . This applies to both medicines used “as needed”, such as salbutamol , and “preventive medicine”, such as beclomethasone dipropionate. These drugs may increase the effect of Ipramol and aggravate the side effects;
- beta-blockers , ie medicines commonly used for heart problems such as chest pain during exertion (angina pectoris), irregular heartbeat or arrhythmias , and high blood pressure . These medications include drugs such as propranolol. These drugs inhibit Ipramol’s bronchodilator effect;
- certain drugs used to treat depression and anxiety, so-called “antidepressants”. This class of drugs includes medicines such as monoamine oxidase inhibitors (eg phenelzine) and tricyclic antidepressants (eg amitriptyline);
- digoxin (for heart problems) can cause heart rhythm problems when given with Ipramol;
- diuretics (” diuretics “) and steroid tablets(medicines that reduce inflammation such as prednisolone ). These drugs may increase the risk of decreased potassium in the blood;
- Anesthetics can increase the sensitivity to the effect of salbutamol on the heart – you will be closely monitored, and possibly your doctor may decide to discontinue Ipramol if you are having surgery.
If you are going to have an operation under anesthesia, you must tell the anesthetist which medicines you are taking.
Ipramol with food and drink
Intake of food and drink does not affect Ipramol.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ipramol should not be used during pregnancy or breastfeeding unless your doctor decides that the benefits to the mother outweigh the risks to the baby.
Driving and using machines
Ipramol may cause dizziness and you may have difficulty focusing or blurred vision. If this happens to you, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
3. How to use Ipramol
Ipramol is for inhalation after nebulization.
Always take Ipramol exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or nurse.
The recommended dose for adults and children over 12 years of age consists of the contents of one ampoule, three or four times a day.
Elderly patients should take the normal adult dose.
Ipramol is not recommended for children under 12 years of age.
The label says how much you should take and how often.
Never take more medicine than your doctor has prescribed. Tell your doctor if your breathing problems worsen or if the medicine does not alleviate your breathing problems as much as before or if you use your blue short-acting inhaler with “on-demand medicine” more often than usual.
Instructions for use
- Prepare the nebulizer according to the manufacturer’s and physician’s instructions.
- Carefully twist and pull a new ampoule from the ampoule map (Fig. A). Never use medicines from an ampoule that has been opened before or if the solution is discolored.
- Hold the ampoule upright and turn off the top (picture B).
- Squeeze the contents into the nebulizer chamber (Fig. C).
- Prepare and use the nebulizer according to the manufacturer’s and physician’s instructions.
- After using the nebulizer, discard any solution remaining in the chamber. Also discard any solution that may remain in the ampoule .
- Thoroughly clean the nebulizer according to the manufacturer’s instructions. It is important to keep the nebulizer clean.
Do not dilute the solution or mix it with other medicines, unless your doctor tells you to.
Endosampullerna with Ipramol contain no preservatives and therefore it is important to use the contents as soon as the ampoule is opened. Each time you use Ipramol in your nebulizer, you must use a new ampoule.
Partly used, opened, or damaged Ipramol- cartridge you should be discarded. Never use an ampoule that has been opened before.
It is important that you follow these instructions so as not to contaminate the solution in the ampoules.
Swallow is not the solution and uses it for injection.
The solution or mist from the solution must not get into the eyes.
If you use more Ipramol than you should
If you have taken a slightly larger dose than usual, you may experience a faster heartbeat (palpitations) or tremors. Other symptoms may include chest pain, high blood pressure, hot flashes, restlessness, and dizziness. These effects usually go away in a couple of hours. The potassium level in the blood can drop and the doctor may sometimes want to take blood samples to check the potassium level in the blood. Tell your doctor if you are worried about any of these symptoms or if they persist.
If you have taken more medicine than you should, tell your doctor immediately or go to the nearest hospital. If you need to go to a doctor or hospital, take all the medicines you take with you, even those that you have bought without a prescription. If possible, take the medicines in their original packaging. Take this leaflet with you and show it to your doctor.
If you forget to take Ipramol
If you forget to take a dose at the right time, take it as soon as you find that you have forgotten to take a dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Ipramol
You should not stop using Ipramol without first discussing it with your 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, Ipramol can cause side effects, although not everybody gets them. Some of the side effects can be serious and require medical attention.
Serious side effects are
, if your asthma or wheezing gets worse immediately after you have inhaled Ipramol, or if you find it harder to breathe and get short of breath, you should not take more Ipramol. Use your short-acting inhaler with “on-demand medicine” immediately. You should stop using Ipramol and contact your doctor immediately. Your doctor may prescribe another treatment for your condition.
If you get pain or irritation in your eyes, blurred vision, or red eyes, or if you see light rings (halophenomas) or colored dots, you should contact a doctor immediately as these symptoms may need to be treated.
If you think you may be allergic to Ipramol or if you think you may have had an allergic reaction to the solution, stop taking Ipramol immediately and contact your doctor.
Ipramol contains salbutamol, which can lower the level of potassium in the blood ( hypokalaemia ) – and this can cause muscle weakness, twitching, or abnormal heart rhythm. This is more likely to happen if you use Ipramol with another asthma treatment, inhaled steroids, steroid tablets, or diuretics (” diuretics “). Your doctor may sometimes need to take a blood test to check your potassium levels.
Frequency of side effects
Uncommon side effects (may affect up to 1 in 100 people):
- palpitations or fast pulse
- dry mouth
- mouth and throat irritation
- speech difficulties
- high blood pressure
- difficulty emptying the bladder (urination)
Rare side effects (may affect up to 1 in 1,000 people):
- allergic reactions including swelling of the tongue, lips and face
- difficulty breathing and shortness of breath
- hot flashes
- lowered blood pressure
- irregular heartbeat
- chest pain (due to heart problems)
- stomach upset / upset stomach (including intestinal obstruction)
- muscle pain, muscle weakness and muscle cramps
- memory disorders
- hyperactivity in children
- eye pain or other eye problems, including blurred vision, severe pupillary enlargement and glaucoma (increased pressure in the eyes)
- low potassium levels in the blood
Although it is not known exactly how often it occurs, some people can sometimes experience chest pain (caused by heart problems such as angina). Tell your doctor as soon as possible if you get these symptoms while you are being treated with Ipramol, but do not stop the treatment unless your doctor recommends it.
The following side effects have also been reported and occur in an unknown number of users:
A condition called lactic acidosis (increased acidity ( lactic acid )) can cause abdominal pain, hyperventilation (rapid and shallow breathing), difficulty breathing (although other symptoms such as wheezing improve), cold hands and feet, irregular heartbeat, or thirst.
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 Ipramol
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 carton. The expiration date is the last day of the specified month.
Store in the outer carton. Sensitive to light. Do not store above 25 ° C. Do not freeze.
Do not use this medicine if the solution is discolored or 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: 0.5 mg ipratropium bromide (as monohydrate) and 2.5 mg salbutamol (as sulphate);
- The other ingredients are: sodium chloride, water for injections and dilute hydrochloric acid .
What the medicine looks like and contents of the pack
Each plastic ampoule of Ipramol contains a clear solution. Cards with 5 ampoules are packed in foil bags, which in turn are packed in cardboard boxes containing 5, 10, 15, 20, 25, 30, 40, 50, 60, or 60 (2 cartons of 30 ampoules ) ampoules with Ipramol.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
IVAX Pharmaceuticals UK, Preston Brook, Runcorn, Cheshire, WA7 3FA, UK
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany