200 micrograms/ml injection solution
glycopyrronium
What Glycopyrronium Martindale is and what it is used for
Glycopyrronium Martindale contains the active substance glycopyrronium bromide and belongs to a group of medicines called anticholinergics.
Glycopyrronium Martindale can be used:
- to protect against some of the side effects that may occur during treatment with drugs such as neostigmine or pyrostigmine, which are used to reverse the effects of certain types of muscle relaxants.
- before surgery to reduce the secretion of saliva and and reduce the acid in the stomach.
- before or during surgery to reduce or prevent a decrease in heart rate during surgery.
Glycopyrronium contained in Glycopyrronium Martindale 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 Martindale
You should not receive Glycopyrronium Martindale if you:
- is allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6)
- have glaucoma (increased pressure in the eye)
- has myasthenia gravis (a disease that causes extreme muscle weakness and fatigue
- has enlarged prostate
- have gastrointestinal problems
- If you have an irregular heartbeat (prolonged QT interval ), the combination of neostigmine and glycopyrronium should be avoided.
Warnings and cautions
Take special care with Glycopyrronium Martindale.
Talk to a doctor if you:
- have Down syndrome
- is over 60 years old
- is a child
- just had a heart attack
- have a condition characterized by rapid heartbeat (including overactive thyroid , heart failure or heart surgery)
- is pregnant or breastfeeding
- have high blood pressure , coronary heart disease or irregular heartbeat
- receiving anesthesia that is inhaled (to be anesthetized before surgery), it may alter the normal heart rhythm
- have acid reflux (the contents of the stomach come back up into the esophagus)
- have diarrhea
- have ulcerative colitis ( chronic inflammation of the colon that can cause abdominal pain, diarrhea and bleeding from the intestine)
- high fever (because the drug inhibits sweating)
- have impaired renal function, as repeated or large doses should be avoided. The doctor may change dose one.
Always tell your doctor or nurse if you have any of these conditions before receiving this medicine.
Other medicines and Glycopyrronium Martindale
Tell your doctor or nurse if you have recently taken or might take any other medicines.
A number of medicines can affect the effect of using Glycopyrronium Martindale:
- antidepressants , so-called tricyclic antidepressants (eg amitriptyline or imipramine) and monoamine oxidase inhibitors ( MAOIs ) (eg phenelzine, tranylcypromine)
- clozapine (for schizophrenia)
- phentiazines used to treat severe mental disorders, nausea, vomiting or dizziness (eg chlorpromazine, flufenazine, proclorperazine, trifluoperazine)
- antihistamines used to treat allergies (eg promethazine)
- nefopam (for the treatment of acute and chronic pain)
- pethidine (for the treatment of mild to severe pain)
- domperidone or metoclopramide (used to treat nausea and vomiting)
- ketoconazole (for the treatment of fungal infections)
- amantadine, levodopa (for the treatment of Parkinson’s disease )
- memantine (for the treatment of Alzheimer’s disease )
- parasympatomimetics (drugs that affect chemical substances in the body that are involved in the transmission of nerve impulses to a muscle (eg carbacol, neostigmine, physostigmine)
- ritodrine (to keep premature labor under control)
- corticosteroids that are used to treat various conditions such as asthma and inflammatory diseases (eg prednisolone )
- slow-dissolving digoxin tablets, disopyramide (for treating heart problems)
- a group of medicines called sympathomimetics , can increase the heart rate when used concomitantly (commonly used in products for coughs and colds and medicines for weight loss).
Glyceryl trinitrate tablets (for angina) may be more difficult to dissolve under the tongue as they should, due to dry mouth caused by glycopyrronium bromide
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
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.
Do not drive or use machines until these symptoms have disappeared.
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 Martindale contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 2 ml, ie essentially ‘sodium-free.
3. How to use Glycopyrronium Martindale
Glycopyrronium Martindale is injected into a muscle or vein.
Recommended dose before surgery
Adults, adolescents over 12 years and older patients:
Injection of 200 to 400 micrograms (0.2 to 0.4 mg) into a vein or muscle before anesthesia is given. Alternatively, you can receive a dose of 4 to 5 micrograms per kg body weight (0.004 to 0.005 mg per kg), up to a maximum dose of 400 micrograms (0.4 mg).
Children:
The child receives 4 to 8 micrograms per kg body weight (0.004 to 0.008 mg per kg) injected into a vein or muscle before anesthesia is given, up to a maximum dose of 200 micrograms (0.2 mg).
Recommended dose during surgery
Adults, adolescents over 12 years and older patients:
The recommended single dose is 200 to 400 micrograms (0.2 to 0.4 mg) in a vein. Alternatively, you can receive a single dose of 4 to 5 micrograms per kg body weight (0.004 to 0.005 mg per kg), up to a maximum dose of 400 micrograms (0.4 mg).
Injection one may need to be repeated.
Children:
The recommended single dose is 200 to 400 micrograms (0.2 mg) in a vein. Alternatively, they may receive an injection of a single dose of 4 to 8 micrograms per kg body weight (0.004 to 0.008 mg per kg) into a vein, up to a maximum dose of 200 micrograms (0.2 mg).
Injection one may need to be repeated.
If you take more Glycopyrronium Martindale then you should
This is unlikely because the medicine is given by healthcare professionals. If you suspect you have received too much, tell your doctor or nurse immediately. If you have any further questions on the use of this product, ask your doctor or nurse.
The recommended dose to remove the effect of muscle relaxants:
Adults, adolescents over 12 years and older patients:
The preferred dose is 200 micrograms (0.2 mg) per 1,000 micrograms (1 mg) neostigmine or an equivalent dose of pyridostigmine vein. Alternatively, you can receive a dose of 10 to 15 micrograms per kg body weight (0.01 to 0.015 mg per kg) in a vein with 50 micrograms per kg (0.05 mg per kg) of neostigmine or the equivalent dose of pyridostigmine.
Glycopyrronium Martindale can be given simultaneously and from the same syringe as neostigmine or pyridostigmine.
Renal impairment :
If you have impaired kidney function, your doctor will decide which dose is appropriate.
Use for children and adolescents
Children:
The recommended dose is 10 micrograms per kg body weight (0.1 mg per kg) in a vein with 50 micrograms per kg (0.05 mg per kg) of neostigmine or the equivalent dose of pyridostigmine. Glycopyrronium Martindale can be given simultaneously and from the same syringe as neostigmine or pyridostigmine.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor or nurse immediately if you experience any of the following symptoms, you may need urgent treatment:
Swelling of the face, lips, or throat that makes it difficult to swallow or breathe, itching, and rash may be signs of a severe allergic reaction or angioedema (has been reported; occurs in an unknown number of users)
Tell your doctor or nurse if you notice any of the following symptoms:
Has been reported (occurs in an unknown number of users):
- slow heart rate
- Confusion can occur in the elderly
- need to urinate more often than usual
- nausea
- vomiting
- dizziness
- redness and dry skin
- enlarged pupil and difficult to focus
- discomfort in bright light
- constipation
- reduced sweating
- reduced amount of secretions from the lungs.
Very common side effects (may affect more than 1 in 10 people):
- dry mouth .
Common (may affect up to 1 in 10 people)
- drowsiness
- visual disturbances
- altered heart rate (fast / irregular heartbeat)
- urgent need to empty the bladder, but inability to cope with it.
Very rare (may affect up to 1 in 10,000 people)
- elevated pressure in the eye ( glaucoma ).
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 Martindale
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. dat. The expiration date is the last day of the specified month.
When the package is opened, the medicine should be used immediately and any remaining contents should be discarded.
Do not use if particles are present in the solution. 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
Content declaration
The active substance is glycopyrronium bromide.
1 ampoule of 1 ml contains 200 micrograms of glycopyrronium bromide.
1 ampoule of 3 ml contains 600 micrograms of glycopyrronium bromide.
The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment ), and water for injections.
Glycopyrronium Martindale is a clear, colorless solution for injection.
Available in glass ampoules with 1 ml or 3 ml solution in packs of 10.
What the medicine looks like and contents of the pack
Glycopyrronium Martindale is a clear, colorless solution for injection.
Available in glass ampoules with 1 ml or 3 ml solution in packs of 10.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Ethypharm
194 Bureaux de la Colline
Building D
92213 Saint-Cloud Cedex
France
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Unimedic Pharma AB
Manufacturer
MacCarthy’s Laboratories Ltd.
T / A Martindale Pharma
Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, UK
ETHYPHARM,
Chemin de la Poudriere, GRAND QUEVILLY,
76120, France
ETHYPHARM,
Industrial Zone of Saint-Arnoult,
CHATEAUNEUF AND THYMERAIS,
28170, France