0.5 mg / 2.5 mg solution nebulizer 
ipratropium bromide / salbutamol

1. What Combivent is and what it is used for

Combivent dilates the trachea. Combivent is used as maintenance treatment for treatable airway contraction.

Ipratropium bromide and salbutamol contained in Combivent 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.

2. What you need to know before using Combivent

Do not use Combivent

  • if you are allergic to ipratropium bromide, salbutamol, substances related to atropine, or any of the other ingredients of this medicine (listed in section 6).
  • if you have certain types of heart muscle disease or heart rhythm disorders.

Warnings and cautions

Stop taking Combivent and contact a doctor immediately

  • you get a hypersensitivity reaction (swelling in or around the mouth and airways, difficulty breathing, skin rash, hives ).
  • after inhalation of the drug you get sudden, acute wheezing or shortness of breath.

Contact a doctor immediately if you experience acute or rapidly increasing shortness of breath.

If you have any of the following conditions, you should consult a doctor before starting treatment with Combivent:

  • recent heart attack
  • heart disease or angina
  • another serious cardiovascular disease
  • hyperfunction of the thyroid gland
  • very high blood pressure due to overproduction of adrenaline and norepinephrine
  • predisposition for glaucoma with narrow ventricular angle
  • difficulty urinating
  • diabetes
  • cystic fibrosis
  • hepatic impairment
  • renal impairment

It is important to avoid getting Combivent in your eyes. This is especially true for people who suffer from glaucoma. In rare cases, eye problems (pupillary enlargement, the pressure increase in the eye, glaucoma with a narrow ventricular angle, eye pain) have been reported when Combivent comes into contact with the eyes. Seek an ophthalmologist immediately if eye irritation and pain, visual phenomena and red, irritated eyes occur, as this may be a sign of acute glaucoma with a narrow ventricular angle.

It is important to take good care of your oral hygiene as Combivent can cause dry mouth, which increases the risk of caries.

Combivent can give a positive result in doping tests.

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 (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.

If the effect of Combivent worsens, contact a doctor immediately for further instruction. Repeated inhalation without effect means that another treatment is required.

Other medicines and Combivent

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of Combivent can be enhanced by other medicines for respiratory diseases, certain antidepressants, and certain anesthetics. A certain type of blood pressure medication, so-called beta – receptor blockers, can counteract the effects of Combivent. Treatment with Combivent can lead to low blood potassium levels. Some other medicines, especially diuretics, may aggravate this effect.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Limited experience of use during pregnancy. Therefore, always consult a doctor if more than temporary use of Combivent during pregnancy.

It is not known whether the ingredients in Combivent pass into breast milk. Therefore, consult a physician before regular use during breast-feeding.

Driving and using machines

Dizziness is a less common side effect of Combivent. Also, Combivent may in rare cases cause visual disturbances. You should keep this in mind when driving or using 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.

3. How to use Combivent

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults and children over 12 years is 1 single-dose container 3-4 times daily.

Instructions for use 

Read the operating instructions carefully and follow the instructions.
Show larger

1. 2. 3.  1. Tear off a container.
2. Open the container by turning off the top.
Squeeze out the contents of the nebulizer. Inhale calmly evenly through the nozzle/nebulizer mask.

The inhalation liquid is ready to use, it should not be diluted. The liquid is inhaled with the help of a so-called nebulizer. The liquid is not intended to be drunk or supplied to the body using a syringe.

If you use more Combivent than you should 

If you take too large a dose of Combivent you can for example get chest pains and palpitations.

If you forget to take Combivent

Do not take a double dose to make up for a forgotten dose.

If you stop using Combivent

Contact your doctor to get another medicine for your airways.

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.

Stop taking Combivent and contact your doctor immediately if you get any of the following symptoms ( angioedema ):

swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing. This may in rare cases occur with the use of Combivent.

Stop taking Combivent and contact your doctor immediately if you experience sudden, acute wheezing or shortness of breath after inhaling the medicine. This may in rare cases occur after the use of inhaled medicines such as Combivent.

In very rare cases, some people may develop chest pain (as a sign of angina) when using Combivent. If this happens, talk to your doctor as soon as possible. However, do not interrupt the treatment on your own.

Other possible side effects:

Uncommon (may affect up to 1 in 100 people): Nervousness, dizziness, headache, tremors, palpitations, fast heart rate, cough, hearing loss, nausea, dry mouth, throat irritation, weakness, skin reactions (such as skin rash, itching, and hives ), increase in blood pressure.

Rare (may affect up to 1 in 1,000 people): Severe allergic reaction, hypersensitivity, decreased potassium in the blood, psychological effects (eg anxiety, memory disorders, anxiety, depression), effects on the eyes (eg glaucoma, visual disturbances, eye pain), fits in the larynx, dry throat, diarrhea, constipation, disorders of bowel function, vomiting, inflammation or swelling of the mouth, sweating, hives, muscle cramp, muscle weakness, muscle, blood pressure, bladder emptying problems, cardiac arrhythmias, cardiac fibrillation.

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 includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Combivent

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 after “EXP”. 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.

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

Content declaration

The active substances are ipratropium bromide monohydrate corresponding to 0.5 mg anhydrous ipratropium bromide and salbutamol sulfate corresponding to 2.5 mg salbutamol.

The other ingredients are: sodium chloride, dilute hydrochloric acid (for adjustment), purified water.

A single-dose container contains 2.5 ml of inhalation fluid.

What the medicine looks like and the contents of the pack

Unstained inhalation liquid.

Package with a single-dose container of polyethylene 60 pcs x 2.5 ml.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim, Germany.

Manufacturer

Laboratory UNITHER, Espace Industriel Nord, 151 rue André Durouchez – CS 28028, 80084 Amiens Cedex 2, France.

Information is provided by

Email: info.sto@boehringer-ingelheim.com

Muhammad Nadeem

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