200 micrograms/ml injection solution
What Glycopyrronium Bromide Accord is and what it is used for
Glycopyrronium bromide belongs to a group of medicines called anticholinergics. The purpose is to wipe up the secretions in the mouth and airways and to reduce the acid in the stomach before surgery. It is also used to block some of the side effects that may occur during surgery or from other drugs that may be used, e.g. to reduce heart rate or heavy saliva production.
Glycopyrronium bromide contained in Glycopyrronium Bromide Accord may also be approved for the treatment of other diseases 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 Glycopyrronium Bromide Accord
Do not use Glycopyrronium Bromide Accord
- if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6).
Make sure your doctor knows if you have any of the following:
- if you have glaucoma (increased pressure in the eye)
- if you have myasthenia gravis (a disease that causes extreme muscle weakness and fatigue)
- if you have stomach or intestinal problems, e.g. narrowing of the stomach (pyloric stenosis) or bowel leading to vomiting, abdominal pain and swelling (paralytic ileus )
- if you have prolonged the QT interval (and have also been given a medicine with antimuscarinic effect, such as neostigmine)
- if you have an enlarged prostate .
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Glycopyrronium Bromide Accord
- if you are over 60 years old
- if you are a child
- if you have just had a heart attack
- if you have cardiac arrhythmias (irregular heartbeat) or slow heart rate
- if you have a condition characterized by rapid heartbeat (including overactive thyroid , heart failure or heart surgery)
- if you have had high blood pressure , coronary heart disease or irregular heartbeat
- if you have a high temperature (because the medicine inhibits sweating)
- if you receive anesthesia that is inhaled (to put you to sleep before an operation with medicines such as cyclopropane or halothane) as it may lead to a change in your normal heart rhythm
- if you have reflux from the stomach (a condition that means that the contents of the stomach come back up into the esophagus)
- if you have diarrhea
- if you have ulcerative colitis (a chronic inflammation of the colon [colon] that can lead to abdominal pain, diarrhea, and bleeding from the bowel)
- if you have recently undergone bowel surgery
- if you are pregnant or breastfeeding
- if you have kidney disease.
Always tell your doctor or nurse if you have any of these conditions before receiving your injection.
Other medicines and Glycopyrronium bromide Accord
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
A large number of drugs can interact with Glycopyrronium Bromide Accord and this can greatly alter their effects.
These medicines include:
- Antidepressants called tricyclic antidepressants and monoamine oxidase inhibitors ( MAOIs )
- Clozapine used to treat mental disorders
- Nefopam used as an analgesic
- Amantadine used to treat Parkinson’s disease or viral infection.
Pregnancy and breastfeeding
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.
There are no data on the use of this medicine in pregnant women and. Glycopyrronium bromide Accord should be given during pregnancy only if your doctor considers it necessary.
It is not known if the active substance passes into breast milk.
This medicine should only be taken during breastfeeding if it is considered necessary.
Driving and using machines
Do not drive or use machines as this medicine may cause blurred vision, dizziness, and other effects that may affect your ability to do so.
Do not drive or use machines until these effects have disappeared or your doctor tells you that it is safe to do so.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Glycopyrronium bromide Accord contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free. is next to “sodium-free”.
3. How to use Glycopyrronium Bromide Accord
Method of administration
Glycopyrronium bromide is injected as an injection into a vein or muscle.
Your doctor will decide which dose is right for you based on the circumstances. Dose one can be calculated according to your weight.
Injection one may need to be repeated depending on how you react.
If you take more Glycopyrronium Bromide Accord than you should
This is not likely because the medicine is given by healthcare professionals.
If you suspect you have received too much, tell your doctor immediately.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you experience any of the following symptoms, as you may then need emergency care:
Swelling mainly of the face, lips, or throat, which may make it difficult to swallow or breathe, itching and rash. This may be a sign of a severe allergic reaction or angioedema (no known frequency, can not be calculated from the available data).
The following side effects have been reported very rarely (may affect up to 1 in 10,000 people):
- glaucoma (increased pressure in the eyes)
The following side effects have also been reported but it is unknown how often they occur (cannot be calculated from the available data):
- dry mouth
- impaired ability to sweat
- palpitations (be aware of strong, throbbing heartbeats)
- fear of bright light
- difficulty urinating
- faster heart rate than normal
- difficulty emptying the bowel (constipation)
- reduced amount of secretions from the lungs
- red and dry skin
- feeling sick
- slower than normal heart rate that persists for a short period
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 Glycopyrronium Bromide Accord
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 label and carton. The expiration date is the last day of the specified month.
For single use only. Once the medicine has been opened, it should be used immediately and any remaining contents should be discarded.
No special storage instructions.
Injection one should not be used if there are particles. Do not use this medicine if you notice that the ampoule is damaged or if the contents are discolored
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 substance is glycopyrronium bromide.
The other ingredients are sodium chloride, hydrochloric acid, and water for injections.
What the medicine looks like and contents of the pack
Glycopyrronium bromide Accord is a clear, colorless solution for injection.
1 ml sterile solution for injection contains 200 micrograms of glycopyrronium bromide (200 micrograms/ml)
3 ml sterile solution for injection contains 600 micrograms glycopyrronium bromide (200 micrograms/ml).
Pack sizes: Glass ampoule of 1 ml glass in packs of 5 or 10 and glass ampoule of 3 ml in packs of 3 or 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Marketing Authorisation Holder
Accord Healthcare BV
3526 KV Utrecht
Accord Healthcare Limited
319, Pinner Road
Middlesex HA1 4 HF
Accord Healthcare BV
3526 KV Utrecht
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland