0.5 mg / 2.5 mg per 2.5 ml nebuliser solution , single dose
ipratropium bromide / salbutamol container
What Sapimol is and what it is used for
Sapimol belongs to a class of medicines called bronchodilators that facilitate breathing by opening up the airways.
Sapimol is used to treat breathing problems in people who have long-term breathing difficulties.
Ipratropium bromide and salbutamol contained in Sapimol may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Sapimol
Do not use Sapimol
- if you are allergic to ipratropium bromide, salbutamol sulfate, atropine, or any of the other ingredients of this medicine (see section 6).
- if you have a heart condition called cardiomyopathy (ie heart rhythm disorders caused by inflammation of the heart muscle)
- if you have a fast and irregular heart rhythm (so-called tachyarrhythmia)
Warnings and cautions
Talk to your doctor or pharmacist before using Sapimol:
- if you are pregnant, planning to become pregnant, or if you are breast-feeding
- if you have diabetes
- if you have or have had a heart condition or have recently had a heart attack
- if you have high blood pressure, irregular heartbeat, or angina
- if you have an overactive thyroid gland
- if you have cystic fibrosis
- if you have problems emptying your bladder
- if you have or think you may have an eye disease called glaucoma (increased pressure in the eyes)
- if you have or have had liver or kidney disease
- if you have been informed that you have pheochromocytoma. This is a rare tumor that can cause restlessness, and high blood pressure and make the heart beat faster.
A condition called lactic acidosis (increased acidity ( lactic acid ) in the blood) has been reported in association with high doses of salbutamol, especially in patients being treated for acute bronchospasm (spasm of the trachea) (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.
Good oral hygiene and regular dental check-ups are recommended, especially for children.
Other medicines and Sapimol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any of the following medicines, which may or may not be affected by Sapimol:
- Steroids include prednisolone
- Xanthines such as theophylline
- Beta-blockers such as propranolol or timolol as may reduce the effect of your medicine
- Diuretics (“diuretics”) including non-potassium -sparing diuretics such as furosemide or indapamide.
- Digoxin (used in heart failure )
- Other drugs that facilitate breathing such as terbutaline
- Anticholinergic drugs (for asthma, gastrointestinal irritation, Parkinson’s disease, and incontinence (involuntary bladder emptying))
- Some medicines are used to treat depression (so-called monoamine oxidase inhibitors and tricyclic antidepressants ).
Some anesthetic gases may interact with your medicine. If you are going to have surgery under anesthesia, tell your anesthetist that you are taking Sapimol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. If you are breastfeeding, do not use Sapimol unless your doctor tells you to. If you become pregnant while you are being treated with this medicine, tell your doctor as soon as possible.
Driving and using machines
Sapimol has no known effect on the ability to drive and 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.
How to use Sapimol
Always use Sapimol exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will probably tell you that you should use the nebulizer at regular times each day and you should always follow your doctor’s instructions.
The usual dose for adults (including the elderly) and children over the age of 12 is 1 single dose 3-4 times daily.
Sapimol is not recommended for use in children under 12 years of age.
Open one foil package at a time and use all the single-dose containers in it before opening the next foil package. After use, the remaining single-dose container should always be returned to the foil package and the foil package should be returned to the carton. As single-dose containers do not contain preservatives, they must be used immediately after opening.
Instructions for use
- Prepare the nebulizer according to the manufacturer’s and physician’s dosing instructions.
- Remove the single-dose containers from the foil package. Remove a single-dose container from the card single-dose container and put the rest back in the foil package, which in turn is put back in the box (see figure A). Never use medicines from a single-dose container that has been opened before or if the solution is discolored.
- Hold the single-dose container upright and turn off the top (see figure B).
- Unless your doctor recommends otherwise, squeeze the entire contents into the nebulizer chamber (see Figure C).
- Discard the used single-dose container.
- Turn on the nebulizer and inhale the “steam” deeply and calmly using the face mask and mouthpiece. If you use a face mask, make sure that it closes tightly. Protect your eyes from the steam as it may otherwise cause pain or discomfort. This is especially important if you have glaucoma.
- How long it takes for the nebulizer to convert your medicine to steam depends on the type of equipment you use. When steam no longer comes out of the face mask, your treatment is complete.
- Wash the nebulizer, face mask, and/or your mouthpiece with warm soap solution after each use and rinse well.
Sapimol should only be used in a nebulizer approved by your doctor and should not be mixed with other medicines in the same nebulizer.
Contact a doctor immediately if:
• The current dosage does not improve
• Your breathing difficulties get worse
• You experience pressure over the chest
The above are signs that your symptoms are not adequately controlled by the treatment and that you may need another or additional treatment.
If you use more Sapimol than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital immediately for an assessment of the risk and advice.
If you have taken a slightly larger dose than usual, you may have hot flashes, feel shaky, feel weak, feel restless and/or dizzy, have an abnormal heart rhythm, have chest pain, feel your heart beat faster than normal, and get loud or low blood pressure. If you have taken more medicine than you should, tell your doctor immediately or go to the nearest hospital. If you feel shaky, do not drive. Take this leaflet and a single-dose container of your medicine with you so that they know at the hospital which medicine you have taken.
If you forget to use Sapimol
If you forget to take a dose at the right time, take it instead when it is time for the next dose or before you get wheezing. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although severe allergic reactions are very rare. Contact a doctor immediately if you suddenly experience wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash, or itching (especially if it occurs all over the body.)
In rare cases, inhaled medicines such as Sapimol may cause acute wheezing and/or shortness of breath. If this happens, stop using the medicine immediately and contact a doctor.
The following side effects have been reported:
Common side effects (may affect up to 1 in 10 people):
- Dry mouth
- Speech difficulties or hoarseness
- Palpitation er (palpitations)
- Feeling sick (nausea)
- Problems focusing the eyes
- Fast pulse
Uncommon side effects (may affect up to 1 in 100 people):
- Difficulty emptying the bladder
- High blood pressure
- Tremors or tremors
- Irregular heartbeat
Rare side effects (may affect up to 1 in 1,000 people):
- Muscle weakness, muscle aches/cramps
- Lowered blood pressure and circulatory problems
- Allergic reactions (see above)
- Mouth and throat irritation
- Breathing difficulties (see above)
- Memory disorders
- Anxiety and depression
- Hyperactivity in children
- Eye problems, including eye pain and glaucoma (increased pressure in the eyes)
Has been reported (occurs 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), and cold hands and feet, irregular heartbeat, or thirst.
If the solution or vapor enters the eyes, you may have pain or irritation in the eyes, blurred vision, or see light rings (halo phenomena) or colored dots. Therefore, you must be careful and protect your eyes when using your medicine.
Sometimes your medicine can cause a decrease in the level of potassium in your blood, which can make you nauseous. If you get nausea, tell your doctor so any blood tests can be taken.
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/nurse if you get these symptoms while you are being treated with Sapimol, but do not stop treatment unless your doctor recommends it.
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 (see details below). By reporting side effects, you can help increase the safety of medicines.
751 03 Uppsala
How to store Sapimol
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Store the single-dose containers in the foil package in the original packaging. Sensitive to light. Do not freeze.
Do not use this medicine after the expiry date / EXP which is stated on the carton after “EXP” / EXP. The expiration date is the last day of the specified month.
Do not use this medicine if the packaging is damaged or if the solution is discolored or cloudy.
The medicine 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.
Contents of the packaging and other information
The active substances are: ipratropium bromide (0.5 mg / 2.5 ml) and salbutamol (as sulphate (2.5 mg / 2.5 ml)
The other ingredients are sodium chloride, hydrochloric acid, and water for injections.
Each 2.5 ml Sapimol single-dose container contains 0.5 mg ipratropium bromide and 2.5 mg salbutamol ( as sulfate).
What the medicine looks like and the contents of the pack
Sapimol is a nebulizer solution .
Your medicine is contained in single-dose plastic containers containing 2.5 ml in a clear solution intended for nebulization (conversion to vapor for inhalation ). Cards with 10 single-dose containers are packed in foil bags, which in turn are packed in cardboard boxes containing 10, 20, 40, 60, 80, 100, or 120 ampoules of Sapimol.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
17 Corrig Road
Sandyford, Dublin 18
Espace Industriel Nord, 151 rue Adré Durouchez- CS 28028
80084 Amiens, Cedex 2,