0.5 mg / ml intravesical solution
oxybutynin hydrochloride
What Oxybutynin Unimedic is and what it is used for
Oxybutynin Unimedic is used to control an overactive bladder that causes you to urinate unusually often or have urinary incontinence (urine leakage). This can, for example, be caused by a spinal hernia or spinal cord injury.
Oxybutynin Unimedic contains the active substance oxybutynin hydrochloride which works by increasing the ability of the bladder to dilate and hold more urine before urinating. This also reduces the risk of involuntary urine leakage.
Oxybutynin Unimedic is given via catheter directly into the bladder, to patients who experience severe, so-called anticholinergic side effects from taking oxybutynin as tablets (see section 4) and who already use a catheter to empty the bladder, so-called Pure Intermittent Catheterization (RIK).
Oxybutynin Unimedic is intended for adults and children over 5 years of age.
Oxybutynin contained in Oxybutynin Unimedic 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 Oxybutynin Unimedic
Do not use Oxybutynin Unimedic
- if you are allergic to oxybutynin or any of the other ingredients of this medicine (listed in section 6).
- if you have an unusual disease that makes the muscles easily weak or tired ( myasthenia gravis )
- if you have glaucoma ( narrow-angle glaucoma ) or shallow posterior eye chamber
- if your intestines are blocked, stagnant, or not working well
- if you have a severe form of ulcerative colitis ( inflammatory bowel disease), ileostomy (surgical opening from the small intestine through the skin) colostomy (surgical opening from the large intestine through the skin), or toxic megacolon (enlarged colon)
- if you have difficulty urinating / the bladder is not emptied properly ( urine retention )
- if you urinate frequently at night due to heart or kidney disease
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Oxybutynin Unimedic. Elderly people and children may be more sensitive to the effects of the medicine.
The drug should be used with caution in
- nerve diseases (eg Parkinson’s disease )
- severe gastrointestinal diseases such as diaphragmatic hernia
- liver or kidney disease
Oxybutynin may worsen the symptoms if you have
- overactive thyroid gland (hyperthyroidism)
- certain cardiovascular diseases
- high blood pressure
- enlarged prostate gland
- irregular or increased heart rate
The ability to sweat can be impaired, which can lead to you overheating in high-temperature environments.
Oxybutynin can cause a certain type of glaucoma. You should contact a doctor immediately in case of eye pain or if the visual acuity suddenly disappears.
With long-term use, the risk of urinary tract infections increases. If you get a urinary tract infection during treatment with oxybutynin, you should be treated with antibiotics.
You must take good care of your teeth during treatment with oxybutynin, as the risk of caries increases due to dry mouth.
There is a risk that this type of medicine reduces the movement in the gastrointestinal tract, affects attention, and causes symptoms such as anxiety, restlessness, and difficulty sleeping. The risk is lower when oxybutynin is given via catheter directly into the bladder compared to when taken orally.
Children and young people
Oxybutynin Unimedic should not be used in children under 5 years of age.
There has been some increased risk of urinary tract infections in children who have been receiving the drug through a catheter into the bladder for a long time.
Other medicines and Oxybutynin Unimedic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Oxybutynin may reduce gastrointestinal motility and thereby affect the effects of other medicines. Use with other medicines may also increase the effect of oxybutynin, especially if you are taking other medicines with similar effects or medicines that inhibit the breakdown of oxybutynin.
This can increase the risk of, for example, dry mouth, constipation, and drowsiness.
In particular, tell your doctor if you are taking any of the following medicines:
- phenothiazines, butyrophenones, and clozapine (groups of drugs used in psychosis )
- amantadine, biperiden, and levodopa (in Parkinson’s disease )
- tricyclic antidepressants (for depression)
- quinine (against malaria )
- atropine (dilates pupil one in the eye, muscle relaxing)
- dipyridamole (reduces the risk of blood clots)
- antihistamine is (against allergies is)
- itraconazole (against fungal infections)
- erythromycin (against bacterial infections)
- cholinesterase inhibitors (for dementia or certain muscle diseases)
Medicines for angina that should melt under the tongue may be more difficult to digest due to dry mouth. Therefore, moisten your mouth before taking such a tablet.
Oxybutynin Unimedic with food, drink, and alcohol
Avoid drinking grapefruit juice as it may affect the breakdown of oxybutynin.
Alcohol in combination with this medicine may aggravate drowsiness.
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 for advice before taking this medicine.
Oxybutynin Unimedic is not recommended for pregnant women.
Oxybutynin Unimedic is not recommended during breastfeeding. Small amounts of oxybutynin hydrochloride may pass into breast milk.
Driving and using machines
You may feel drowsy, dizzy, or have blurred vision when using this medicine. If this happens, do not drive or use any tools or machines.
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.
How to use Oxybutynin Unimedic
This medicine is given to you by healthcare professionals, but if you or a relative/caregiver has received proper training from a qualified healthcare professional, you or a relative/caregiver can give the medicine in a home environment.
The bladder is emptied of urine with the help of a catheter tube that is inserted via the urethra, the so-called Pure Intermittent Catheterization (RIK). When the bladder is empty, the oxybutynin solution and then saline solution are injected into the bladder via the catheter while it is still in place. The catheter is then removed. The bladder should be emptied every 4 hours via RIK.
Dosage is adapted to each individual and depends on the medical condition and how well you respond to the medicine. To make sure that the full dose reaches the bladder, your doctor will prescribe a certain amount of saline solution to be injected through the catheter after the medicine.
Adults
Dosage one is individual and determined by your doctor.
The starting dose is 5 mg (10 ml) in the bladder morning and evening.
As long as you do not feel bad from side effects, the dose can be increased to between 5 mg (10ml) 3 times daily and 10 mg (20ml) 2 times daily to get a better effect.
Use for children and adolescents
Children over 5 years of age: Dosage one is individual and determined by the attending physician.
The starting dose is 0.1 mg/kg in the bladder morning and evening. As long as the child does not feel bad from side effects, the dose can be increased up to 0.15 mg/kg twice daily to give a better effect. More than 5 mg in total should not be given at one dose.
Special groups
Elderly and people with impaired liver or kidney function should be treated with caution and a lower dose may be given.
If you use more Oxybutynin Unimedic then you should
If you have used too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. The bladder should also be emptied if too much has been used.
Too much of the drug can cause symptoms such as anxiety, restlessness, confusion, hallucinations, drowsiness, palpitations, stomach upset, cramps, difficulty urinating, fever, and dehydration.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should contact a doctor immediately in case of eye pain or if the visual acuity suddenly disappears. These symptoms may be signs of narrow-angle glaucoma (a specific type of glaucoma ).
In case of urinary tract infection, a doctor should be consulted and antibiotics are given.
The side effects are significantly milder when the drug is given directly into the bladder compared to if it is taken by mouth. The side effects occur in an unknown number of users when the drug is given directly into the bladder.
Dose dependence, so-called anticholinergic side effects, may occur.
The following side effects may occur in an unknown number of users:
- flushing
- headache, dizziness, drowsiness, drowsiness
- increased heart rate
- dry skin
- dry mouth , constipation, stomach discomfort, diarrhea
- difficulty urinating
- anxiety, confusion, restlessness, difficulty orienting oneself, agitation
- heatstroke due to reduced ability to sweat
- dry eyes, blurred vision, narrow-angle glaucoma , photosensitivity
- urinary tract infection
How to store Oxybutynin Unimedic
Do not store above 25 ° C
Keep this medicine out of the sight and reach of children.
Opened packaging should be used immediately.
Do not use this medicine after the expiry date which is stated on the label after EXP. day.
The expiration date is the last day of the specified month.
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 pack and other information
Content declaration
1 ml solution contains 0.5 mg of the active substance oxybutynin hydrochloride.
The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Clear colorless solution in a glass vial sealed with a bromobutyl stopper and an aluminum seal .
Pack size 10 x 20 ml.
Marketing Authorization Holder and Manufacturer
Unimedic Pharma AB
Box 6216
102 34 Stockholm
Manufacturer
Unimedic AB
Box 91
864 21 Matfors