Salipra 0.5 mg/2.5 mg solution for Nebulizer Ipratropium Bromide and Salbutamol
What Salipra Is And What Salipra Used For
This medicine is called Salipra. The active substances are ipratropium bromide and salbutamol . Ipratropium bromide and salbutamol both belong to the group of bronchodilators and 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 works by stimulating beta 2 receptors in the muscles.
Salipra is used to treat breathing problems in people with long-term breathing difficulties (eg chronic bronchitis or emphysema ). Salipra provides relief from
- Wheezing
- Shortness of breath
- Tightness in the chest
Ipratropium bromide and salbutamol contained in Salipra 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 Using Salipra
Do Not Use Salipra
- If you have a fast heartbeat
- If you know that your heart is enlarged or that you have hypertrophic obstructive cardiomyopathy (HOCM)
- If you are allergic to salbutamol, ipratropium bromide, or atropine (including medicines similar to atropine) or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before using Salipra if:
- You have or think you may have an eye disease called glaucoma (increased pressure in the eyes) or if you have another eye disease. Your doctor may recommend that you protect your eyes while using Salipra.
- You know that you (if you are a man) have an enlarged prostate or if you have problems emptying your bladder.
- You have recently had a heart attack.
- You have problems with the arteries or get sore legs when you walk.
- You have previously had any heart disease, irregular heartbeat, or angina (tell your doctor before taking this medicine).
- You have diabetes.
- You have an overactive thyroid gland.
- You have cystic fibrosis.
- You have been told that you have an adrenal tumor.
Contact a doctor immediately if you experience a hypersensitivity reaction (swelling in or around the mouth and respiratory tract, difficulty breathing, skin rash, hives ) or acute, rapidly increasing shortness of breath. This may in rare cases occur with the use of Salipra.
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. (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.
Salipra can cause tooth decay. It is important to take care of your oral hygiene care and visit the dentist regularly.
Other Medicines And Salipra
Some medicines can be affected by Salipra and may cause more severe side effects or reduce the effect of Salipra. You must always tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:
- Other medicines for asthma such as inhalers and tablets, as well as treatment that relieves the symptoms e.g. salbutamol, or prevents the symptoms e.g. beclomethasone dipropionate. These may increase the effect of Salipra and make the side effects more difficult.
- Beta-blockers, i.e. medicines that are often used for heart problems such as
- Chest pain during exertion (angina or angina pectoris )
- Irregular heartbeat or arrhythmias
- High blood pressure ( hypertension ). This includes drugs such as propranolol, which can cause the potassium level in the blood to drop when given at the same time as Salipra.
- Certain medicines for depression (such as “antidepressants” are medicines that are prescribed to patients suffering from depression and anxiety). 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 Salipra.
- Diuretics (so-called diuretics) can cause an inability to empty the bladder.
- Steroid tablets (medicines used to reduce inflammation in the body, such as prednisolone ), which can aggravate airway obstruction.
- 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 you from taking Salipra if you are having surgery.
If you are going to be anesthetized at the hospital, tell the anesthetist which medicines you are taking.
Salipra With Food And Drink
Salipra is not affected by food and drink.
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.
Pregnancy
Salipra should not be used during pregnancy or breastfeeding unless the doctor considers that the benefits to the mother outweigh the risks to the baby. Always consult a doctor before using Salipra during pregnancy.
Breast-feeding
Always consult a doctor before using Salipra during breastfeeding.
Fertility
There are no data available on the effect on human fertility.
Driving And Using Machines
If you experience side effects such as
- Dizziness
- Difficulty focusing
- Blurred vision
When treated with Salipra, you should avoid doing things that may involve risks, e.g. driving a car or using 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 Take Salipra
- Salipra is intended for inhalation. The Salipra inhalation nebulizer solution is intended for inhalation by mouth after nebulization.
- Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- 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.
- Salipra is not recommended for children under 12 years of age.
- 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.
- Salipra should be used with a suitable nebulizer e.g. a PARI LC PLUS nebulizer or jet nebulizer. Read the complete instructions for the use of the nebulizer 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 nebulizer solution is discolored (Fig. A).
- Hold the single-dose container upright and turn off the lid (Fig. B).
- Squeeze the contents of the reservoir into 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 Salipra inhalation, discard the nebulizer solution remaining in the reservoir. The nebulizer solution remaining in the single-dose container should also be discarded.
- Thoroughly clean the nebulizer according to the manufacturer’s instructions. The nebulizer must be kept clean.
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Do not dilute the nebulizer solution or mix it with other medicines unless your doctor tells you to.
The single-dose containers of Salipra inhalation do not contain preservatives. Therefore, the content must be used immediately after opening. You must take a new container each time you use Salipra 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.
Do not swallow the nebulizer solution or use it for injection.
Do not allow the nebulizer solution or aerosol to enter the eyes.
If You Use More Salipra Inhalation Than You Should
If you have taken a slightly larger dose than usual, you may feel your heart beat faster (palpitations) or start shaking. Other symptoms may include
- Chest pain
- Altered blood pressure
- Redness
- Restlessness
- 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 or hospital for risk assessment and advice. Bring all your medicines to the hospital, even 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 Salipra
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 Taking Salipra
- Do not stop taking Salipra inhalation without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible Side Effects Of Salipra
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and require medical attention.
Serious side effects of Salipra
If your asthma or wheezing worsens immediately after inhaling Salipra, or if it becomes more difficult for you to breathe and you become short of breath, do not take more Salipra but use your fast-acting inhaler immediately (occurs in 1 to 10 out of 10 000 users). Stop using Salipra and contact your doctor immediately. Your doctor may prescribe another treatment for your illness.
If you experience
- Pain or discomfort in your eyes
- See blurred or red eyes
- If you see auras (light rings) or colored dots
Contact a doctor immediately as you may need treatment for these symptoms (occurs in 1 in 10 in 10,000 users).
If you think you may be allergic to Salipra or you may have had an allergic reaction to the nebulizer solution, stop using Salipra immediately and contact a doctor immediately. Symptoms may include
- Sudden rash
- Difficulty breathing
- Fainting (within minutes to hours)
- Hypersensitivity ( anaphylactic reaction ). It May be fatal (affects 1 to 10 users in 10,000).
The salbutamol component of Salipra may decrease the amount of potassium in the blood ( hypokalaemia ) (affects 1 to 10 users in 10,000). This can cause
- Muscle weakness
- Twitching
- Abnormal heart rhythm
This is more likely to happen if you are taking Salipra at the same time as any other asthma treatment, with inhaled steroids or steroid tablets, or with diuretics. Your doctor may need to take blood samples to test your potassium levels from time to time.
Some people may get chest pain (due to angina), but it is not known exactly how often this occurs (occurs in an unknown number of users). Tell your doctor as soon as possible if you get these symptoms while you are being treated with Salipra, but do not stop taking this medicine unless your doctor tells you to.
If you get chest pain, which may radiate to the arm or neck, or shortness of breath due to poor blood supply to the heart muscle, you must contact a doctor immediately (occurs in 1 to 10 out of 10,000 users).
If you get a fast, irregular heartbeat, fast heartbeat, or extra heartbeat, you must contact a doctor immediately (this occurs in 1 to 10 out of 10,000 users).
Side effects can occur with the following frequency:
Common (affects 1 to 10 users in 100) :
- Headache
- Palpitations or rapid heartbeat
- Dry mouth
- Nausea
- Cough
- Speech difficulties
- Problems with blurred vision
Uncommon (affects 1 to 10 users in 1,000) :
- Dizziness
- High blood pressure
- Abnormal or very fast heart rhythm
- Nervousness
- Vomiting
- Shaking
- Difficulty emptying the bladder.
Rare (affects 1 to 10 users in 10,000) :
- Allergic reaction with swelling, which can affect the tongue, lips, and face
- Difficulty breathing and shortness of breath
- Sweating
- Hives
- Low blood pressure
- Irritation of the mouth and throat
- Gastrointestinal problems
- Itching
- Rash
- Muscle pain
- Weakness and cramps
- Restlessness
- Memory disorders
- Anxiety
- Depression
- Hyperactivity in children
- Eye pain or other eye problems, such as
- Blurred vision
- Mydriasis (enlarged pupils )
- Glaucoma (increased pressure in the eyes)
- Dizziness due to low blood pressure
- Shortness of breath
- Difficulty breathing
- Asthma-like attacks
- Sore throat with difficulty breathing
Has been reported (occurs in an unknown number of users) :
- Caries
- A condition called lactic acidosis (increased acidity ( lactic acid )) that can cause
- Abdominal pain
- Hyperventilation (rapid and shallow breathing)
- Difficulty breathing (although other symptoms such as wheezing improve)
- Cold hands and feet
- Irregular heartbeat
- Thirst
How To Store Salipra
- 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 outer carton after EXP. The expiration date is the last day of the specified month.
- No special temperature instructions.
- 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 by local requirements.
- Store the nebulizer solution in the outer bag and carton. Sensitive to light and evaporation.
- Do not use this medicine if you notice that the nebulizer 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.
Contents Of The Packaging And Other Information
Content Declaration
Each 2.5 ml single-dose container of Salipra contains:
- The active substance is 0.52 mg ipratropium bromide monohydrate equivalent to 0.5 mg anhydrousipratropium bromide and 3 mg salbutamol sulfate equivalent to 2.5 mg salbutamol.
- The other ingredients are sodium chloride, water for injections, and sulfuric acid.
What The Medicine Looks Like And The Contents Of The Pack
- Single-dose low-density polyethylene (LDPE) container containing 2.5 ml of nebulizer solution, repackaged in a foil-coated envelope and then in a cardboard box.
- Each package contains 60 single-dose containers.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder:
Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark.
Manufacturer:
Pharma Stulln GmbH, Werksstrasse 3, 92551 Stulln, Germany