Oxybutynin Hydrochloride 5 Mg Tablets
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Package leaflet: Information for the user
Oxybutynin hydrochloride 2.5 mg tablets Oxybutynin hydrochloride 3 mg tablets Oxybutynin hydrochloride 5 mg tablets
Oxybutynin hydrochloride
Read all of this leaflet carefully before you start
taking this medicine because it contains important
informationforyou.
• Keep this leaflet. You may need to read it again.
• If you haveanyfurtherquestions, askyourdoctoror pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Oybutynin hydrochloride tablets are and what they are used for
2. What you need to know before you take Oxybutynin hydrochloride tablets
3. How to take Oxybutynin hydrochloride tablets
4. Possible side effects
5. How to store Oxybutynin hydrochloride tablets
6. Contents of the pack and other information
1. What Oybutynin 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 ofan unstable orover-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).
• if you have an eye condition with raised eyeball pressure (narrow angle glaucoma) or a shallow anterior eye chamber.
• if you have a tendency to muscle weakness (myastheniagravis).
• if you have constriction in the gastrointestinal tract, sluggish bowel movements or constipation as a result of the complete absence of bowel peristalsis (paralytic ileus) or as a result of weakness of the bowel muscles (intestinal atony).
• if you have difficulty in urinating as a result of obstruction of the urinary tract or as a result of enlargement of the prostate (prostatic hypertrophy).
• if you have severe inflammation of the large bowel that is accompanied by ulcers (severe ulcerative colitis).
• if you have acute inflammation of the wall of the large bowel with dilatation and ulcerformation in the mucous membrane (toxic megacolon).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Oxybutynin hydrochloride tablets
• in debilitated, elderly persons because there may be greater sensitivity to the effects of oxybutynin.
• if you suffer from certain nerve diseases (autonomous neuropathy), reduced liver or kidney function, a rupture of the diaphragm with regurgitating gastric acid (hiatus hernia with reflux oesophagitis) or other severe gastrointestinal disorders.
• if you have the symptoms of an overactive thyroid gland (hyperthyroidism), cardiovasculardiseases, heart failure, disturbances of heart rhythm, raised blood pressure (hypertension) and enlarged prostate (prostatic hypertrophy), these symptoms may be intensified by the use ofoxybutynin.
• in the case of treatment of patients subject to a high environmental temperature or in cases offever, there is the risk of a greatly increased body temperature (hyperpyrexia) due to a decrease in sweat production as a result of the use of oxybutynin.
• because oxybutynin can cause a dry mouth. In cases of long-term use this can lead to an increased risk of the development of dental cavities (caries) or to abnormalities of the tooth pockets, oral Candida (a fungal infection) in the oral cavity or general discomfort caused by the reduced salivation. Careful oral hygiene is necessary.
• in the case of a urinary tract infection during treatment an adequate therapy with antibiotics has to be started.
• if you sufferfrom frequent urination (pollakiuria), in the daytime orat night (nocturia), caused by a heart or kidney disease.
If any of the above warnings applies to you, or has done in the past, please askyourdoctorforadvice.
Oxybutynin hydrochloride tablets should not be used in children underthe age of5.
Other medicines and Oxybutynin hydrochloride tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
An interaction with other medicines can occur when oxybutynin is used with the following medicines:
• The effect may be potentiated by administration of other anticholinergic agents (a group of medicines to which oxybutynin belongs) oratropine and other parasympatholytic agents (medicines in eye drops for dilating the pupils, among other things).
• By reducing the motility of the gastrointestinal tract, oxybutynin can influence the uptake of other medicines into the blood.
• Anticholinergics and phenothiazines (medicines for mental disorders), amantadine (medicine for Parkinson's disease), butyrophenones (medicines for mental disorders), levodopa (medicine for Parkinson's disease), digitalis (medicine for heart failure), quinidine (medicine for disturbances of heart rhythm), and tricyclic antidepressants (medicines for severe depression). Caution should be exercised in cases of concomitant use of these agents with oxybutynin.
• Certain anti-fungal agents (antimycotics) such as e.g. ketoconazole or itraconazole, and macrolide antibiotics, e.g. erythromycin. The effect of oxybutynin may increase.
• Agents for nausea (metoclopramide and domperidone); the effect ofoxybutynin may be reduced by these agents.
In this section, medicines are indicated with the name of the active substance or the group to which the substance belongs. Usually you know a medicine by its trade name. Therefore, check the pack or the package leaflet of the medicine that you are using in order to establish which substances are present, or ask your doctor or pharmacist for advice.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
During pregnancy, only take the product after consulting yourdoctor. Oxybutynin may only be used during pregnancy if the expected positive effect outweighs the risks of treatment.
Breast-feeding
Oxybutynin is excreted into the breast-milk in animals (rats). It is not known if the active substance is excreted into the breast-milk in humans. Oxybutynin hydrochloride tablets may only be used during lactation under the supervision of your doctor, if the expected positive effect outweighs the risks of treatment.
Driving and using machines
Oxybutynin hydrochloride tablets can cause drowsiness, dizziness and blurred vision, especially in combination with alcohol. You should take account of this when driving vehicles or operating machines.
Oxybutynin hydrochloride tablets contain lactose
If you have been told byyour doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Pharma code 58
Age
5 - 9 years 9-12 years older than 12years
r i
3. How to take Oxybutynin hydrochloride tablets
- .
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 10and15mg per day, possibly to a maximum of 20 mg, to be taken in2to3 (maximum 4) doses.
Elderly
The dose must be determined individually for each patient by starting with an initial dosage of2.5 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:
Dosage
2.5 mg three times daily 5 mg twice daily 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 4to6 weeks, because normal bladder function may have returned.
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 orwith some milk.
If you take more Oxybutynin hydrochloride tablets than you should
If you have used ortaken more Oxybutynin hydrochloride tablets than you should, contact your doctor or pharmacist immediately.
In cases of overdose the side effects occur to an increased degree.
Symptoms include:
• Restlessness, agitation,
• Mental disturbances,
• Redness of the (facial) skin,
• Fall in blood pressure,
• Disturbances in the blood circulation and the airways,
• Paralysis,
• Lossofconsciousness.
You must consult your doctor immediately.
The treatment consists of immediate stomach washout and, depending on the severity of the clinical picture, further treatment in hospital.
If you forget to take Oxybutynin hydrochloride tablets
If you accidentally forget a dose, take it as soon as you remember unless it is almost time for the next dose according to the instructions. In that case take the next dose as normal in accordance with the instructions.
Never take a double dose of Oxybutynin hydrochloride tablets to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possiblesideeffects
Like all medicines, this medicine can cause side effects, although not everyone gets them. A list of side effects is given below.
The following side effects may occur during use of Oxybutynin hydrochloride tablets:
Very Common side effects (>1/10)
Dry mouth.
Common side effects (>1/100, <1/10)
Blurred vision, dilatation of the pupils (mydriasis), facial flushing, constipation, nausea, abdominal discomfort/pain, dizziness, drowsiness.
Uncommon side effects (>1/1000, <1/100)
Restlessness, disorientation, confusion, headache, reduced tear secretion /dry eyes, lack of appetite (anorexia), diarrhoea, vomiting, reduced sweating/dry skin, problems with urination, fatigue.
Rare side effects (>1/10000, <1/1000)
Accelerated heartbeat (tachycardia), disturbances of heart rhythm (palpitations, arrhythmias), skin reactions including rash, problems with urine remaining in the bladder on account of disturbed bladder emptying.
Very rare side effects (<1/10000)
Impotence, convulsions (children can be more susceptible to this type of side effect), increased eyeball pressure (narrow angle glaucoma), repeated episodes of transient itchy oedema of the skin and/or mucous membranes (angioedema), photosensitivity, heatstroke.
Frequency unknown
Agitation, anxiety, seeing or hearing things that are not there (hallucinations), nightmares, feeling excessively suspicious and distrustful ofothers (paranoia), elderly patients mayfeel confused, depression, becoming dependent on Oxybutynin hydrochloride tablets, indigestion or heartburn (acid reflux) and abdominal discomfort in elderly patients.
The experience of the above side effects may be reduced by administering a lower dose of Oxybutynin hydrochloride tablets.
Reporting of side effects
If you get any side effects, talk to yourdoctoror 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.aov.uk/vellowcard. 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 Oxybutynin hydrochloride tablets after the expiry date which is stated on the outer packaging after “do not use after” and on the blister strips after the term “Exp.” (month and year). 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 through 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 ofthe pack and other information
What Oxybutynin hydrochloride 2.5 mg/3mg/5mg 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/3mg/5mg 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 breakline line on the other side.
The tablets are supplied in blister packs of7,28,56 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd 115 Narborough Road,
Leicester, LE3 0PA,
UK
Manufacturer
FAL Duiven Dijkgraaf, 6921,
RK Duiven,
The Netherlands
This leaflet was last revised in April 2015.