Patient leaflet - Oxybutynin Hydrochloride 3 mg tablets
1. What Oxybutynin hydrochloride tablets are and what they are used for
Oxybutynin hydrochloride tablets belong to the group of spasm-relieving agents (a so-called spasmolytic).
Oxybutynin hydrochloride tablets act by reducing the muscle spasms of the bladder. It is these spasms that cause the feeling of having to urinate frequently, which in turn can lead to involuntary loss of urine. Oxybutynin relaxes the bladder muscle, so that the bladder can hold more urine and the frequent urge to urinate is reduced.
Oxybutynin hydrochloride tablets may be prescribed by the doctor for the treatment of the involuntary loss of urine as a result of an unstable or over-active bladder. In other words, when it is not possible to keep the urge to urinate and the frequent need to urinate normally under control.
2. What you need to know before you take Oxybutynin hydrochloride tablets
Do not take Oxybutynin hydrochloride tablets
if you are allergic to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- if you have a rare muscle illness called ‘Myasthenia gravis’
- if you have glaucoma (increased pressure in the eye, sometimes sudden and painful with blurred vision or loss of vision)
- if your gut (stomach or intestine) is blocked, perforated or not working properly
- if you have a severe form of a condition known as ‘ulcerative colitis’ • if you have sudden widening of the colon, which causes abdominal pain, fever or shock known as ‘toxic megacolon’
- if you have a blockage that makes it difficult for you to pass water (urine)
Do not take this medicine if any one of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Oxybutynin hydrochloride tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxybutynin hydrochloride tablets
- if you have kidney or liver problems • if you have an illness affecting the nerves called ‘autonomic neuropathy’ (e.g., Parkinson’s disease)
- if you have an overactive thyroid gland (Hyperthyroidism)
- if you have heart disease or high blood pressure
- if you have an irregular heartbeat (palpitations, arrythmias) and/or increased or rapid heartbeat • if you have an enlarged prostate gland (prostatic hypertrophy) • if you have gastro-intestinal disorders or disease called ulcerative colitis
- if you have indigestion or heart burn caused by a ‘hiatus hernia’ (where part of your stomach pushes through the diaphragm), gastro-oesophageal reflux and/or you are using medicinal products that can cause or worsen oesophagitis
if you have a raised body
temperature or fever
- if you will be taking this medicine in a hot climate
Oxybutynin may reduce the amount of saliva resulting in tooth decay or fungal infection of the mouth.
Oxybutynin can cause glaucoma (increased pressure in the eye). Please contact your doctor immediately if you suffer any blurred vision, loss of vision or have any pain in the eye.
Oxybutynin can cause hallucinations, agitation, confusion or somnolence so that your doctor might consider to monitor you.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Oxybutynin hydrochloride tablets.
Elderly
People 65 years of age or older should take Oxybutynin hydrochloride tablets with caution, because of the risk of cognitive impairment and being at a greater risk of occurrence of adverse reactions.
Children
Children under 5 years of age The use of Oxybutynin hydrochloride tablets is not recommended in children under 5 years of age.
Children 5 years of age or older Oxybutynin hydrochloride tablets should be taken with caution as they may be more sensitive to the effects of the product and at a greater risk of occurrence of adverse reactions.
Other medicines and Oxybutynin hydrochloride tablets
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This is because Oxybutynin can affect the way some other medicines work. Also, some other medicines can affect the way Oxybutynin works.
In particular, tell your doctor if you are taking any one of the following: • Other anticholinergic or
antimuscarinic medicines such as some medicines for irritable bowel syndrome, asthma or incontinence, motion sickness or movement disorders associated with Parkinson’s disease
- Medicines used to make you feel sleepy (sedatives)
- Medicines used to treat nausea and vomiting (prochlorperazine or chlorpromazine)
Medicines used to treat certain mental illnesses such as clozapine, phenothiazines haloperidol or benperidol (butyrophenones) • Medicines used to treat dementia e. g. donepezil, rivastigmine, galantamine or tacrine
(cholinesterase inhibitors)
- Medicines for depression such as amitriptyline, imipramine or dosulepin (‘tricyclic antidepressants’) • Amantadine used in Parkinson’s disease or to treat and prevent some virus infections
- L-dopa or biperidin used to treat Parkinson’s disease
- Digoxin or quinidine used to treat heart problems
- Atropine which is used to treat certain types of poisonings, a slow heart rate, some eye conditions or is given during surgery
- Medicines for stomach and bowel related problems - such as domperidone, metoclopromide, bethanechol
- Medicines to treat allergic symptoms (antihistamines)
- CYP3A inhibitor e. g. ketoconazole, itraconazole or fluconazole used to treat fungal infections or erythromycin or other macrolide antibiotics used to treat bacterial infections
Oxybutynin hydrochloride tablets with alcohol
If you drink alcohol while using Oxybutynin hydrochloride tablets, you may become very drowsy.
Pregnancy and breast-feeding
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.
While breast-feeding, small amounts may pass into mothers’ milk. Breast-feeding while using this medicine is therefore not recommended.
Driving and using machines
You may feel drowsy or have blurred vision while you are taking this medicine, especially in combination with alcohol. If this happens, do not drive or use any tools or machines.
Oxybutynin hydrochloride tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Oxybutynin hydrochloride tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Take this medicine by mouth • Swallow the tablets with a glass of water
- Do not give this medicine to children under 5 years old
- If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
The recommended dose is Adults
You should follow your doctor’s instructions closely. In general the dosage will begin with one Oxybutynin hydrochloride 2.5 mg tablet three times daily, later to be increased to a dosage between 10 and 15 mg per day, possibly to a maximum of 20 mg, to be taken in 2 to 3 (maximum 4) doses.
Elderly
The dose must be determined individually for each patient by starting with an initial dosage of 2.5 mg twice daily. Then the lowest possible effective dose should be chosen.
Children aged 5 years and older
The initial dosage is 2.5 mg twice daily. The maximum dosage adjusted to bodyweight (0.3-0.4 mg/kg per day) is given in the table below:
| Age | Dosage |
| 5 – 9 years | 2.5 mg three times daily |
| 9 – 12 years | 5 mg twice daily |
| older than 12 years | 5 mg three times daily |
If you feel that the effects of
Oxybutynin hydrochloride tablets are too strong or too weak, ask your doctor or pharmacist for advice. Oxybutynin hydrochloride tablets should not be used in children under the age of 5.
Taking Oxybutynin hydrochloride tablets
Your doctor will tell you for how long Oxybutynin hydrochloride tablets must be used. It is recommended that the effect should be re-assessed after 4 to 6 weeks, because normal bladder function may have returned.
M0200LAMUKNA-P1-005 Taking Oxybutynin hydrochloride tablets with food or drink
The tablets should be taken on an empty stomach with plenty of water. If irritation of the stomach occurs, the tablets may be taken during a meal or with some milk.
If you take more Oxybutynin hydrochloride tablets than you should
If you take more Oxybutynin
hydrochloride tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
Taking too much Oxybutynin
hydrochloride tablets can be very dangerous. You may become very restless or excited, flushed or get dizzy or light-headed. Your heartbeat may become very fast, uneven, or forceful or your blood pressure drops. You may get breathing problems or numbness or go into a coma.
If you forget to take Oxybutynin hydrochloride tablets
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Oxybutynin hydrochloride tablets
Keep taking Oxybutynin until your doctor tells you to stop. Do not stop taking Oxybutynin just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Oxybutynin hydrochloride tablets and see a doctor or go to a hospital immediately if:
Frequency not known (frequency cannot be estimated from the available data)
- You have an allergic reaction, the signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- You may feel reduced sweating, leading to overheating in hot environments
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
| Very common (may affect more than 1 in 10 people) |
|
Common (may affect up to 1 in 10 people) |
|
| Uncommon (may affect up to 1 in 100 people) |
|
| Frequency not known (frequency cannot be estimated from the available data) |
|
Additional side effects in children
Children are at higher risk of the effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Oxybutynin hydrochloride tablets
Do not store above 25°C. Store in the original pack.
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 and blister after EXP. The expiry date refers to the last day of that month.
Always hand over any left-over medicine to the pharmacist for safe disposal.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Oxybutynin hydrochloride 2.5 mg / 3 mg / 5 mg tablets contain
- Each Oxybutynin hydrochloride 2.5 mg Tablet contains 2.5 mg oxybutynin hydrochloride.
- Each Oxybutynin hydrochloride 3 mg Tablet contains 3 mg oxybutynin hydrochloride.
- Each Oxybutynin hydrochloride 5 mg Tablet contains 5 mg oxybutynin hydrochloride.
The other ingredients are:
Crospovidone, microcrystalline cellulose, lactose monohydrate and magnesium stearate.
What Oxybutynin hydrochloride
2.5 mg / 3 mg / 5 mg tablets look like and contents of the pack
Oxybutynin hydrochloride is supplied as white circular flat bevelled edge tablets.
Oxybutynin hydrochloride 2.5 mg tablet is marked ‘2.5’ on one side and plain on the other side.
Oxybutynin hydrochloride 3 mg tablet is scored on one side and blank on the other side.
Oxybutynin hydrochloride 5mg tablet is marked ‘5’ on one side and marked with a scoreline on the other side.
The tablets are supplied in blister packs of 7, 28, 56 or 84 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder Morningside Healthcare Ltd
Unit C, Harcourt Way,
Leicester, LE19 1WP, UK
Manufacturer
FAL Duiven
Dijkgraaf, 6921, RK Duiven,
The Netherlands