OXYBUTYNIN HYDROCHLORIDE 5 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - OXYBUTYNIN HYDROCHLORIDE 5 MG TABLETS

Oxybutynin hydrochloride

2.5 mg/ 3 mg/5 mg tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illnessare 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.

What is in this leaflet:

1. What Oxybutynin 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 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 (hypersensitive) 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 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 Tablets.

Warnings and precautions Talk to your doctor or pharmacist before taking Oxybutynin hydrochloride tablets

if you have kidney or liver problems if you are 65 years of age or older if the person taking the medicine is a child (use is not recommended under 5 years of age)
if you have an illness affecting the nerves called ‘autonomic neuropathy’
if you have an overactive thyroid gland (‘Hyperthyroidism’)
if you have heart disease or high blood pressure
if you have an irregular heart beat (palpitations) and/or increased or rapid heart beat
if you have an enlarged prostate gland
if you have indigestion or heart burn caused by a “hiatus hernia” (where part of your stomach pushes through the diaphragm
if you have a raised body temperature or fever
if you will be taking this medicine in a hot climate

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 may reduce the amount of saliva resulting in tooth decay or fungal infection of the mouth.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Oxybutynin Tablets.

Children

Oxybutynin hydrochloride tablets should not be used in children under the age of 5.

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, including medicines obtained without a prescription, including herbal 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) or if you are feeling sick (nausea) or have vertigo – such as prochlorperazine or chlorpromazine
Medicines used to treat certain mental illnesses such as clozapine, phenothiazines haloperidol or benperidol (butyrophenones)
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 – used to treat Parkinson’s disease
Digoxin – used to treat heart problems
Medicines for stomach and bowel related problems – such as domperidone, metoclopromide or bethanechol

Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as oxybutynin should not be used during pregnancy unless clearly necessary.

Breast-feeding

When oxybutynin is used during breast-feeding, a small amount is excreted in the mother’s milk. Use of oxybutynin while breast-feeding 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.

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 Tablets than you should, tell a doctor or go to a hospital casualty department immediately. Take the medicine pack with you, to inform the doctor what you have taken.

Taking too many Oxybutynin Tablets can be very dangerous.

In cases of overdose the side effects occur to an increased degree. Symptoms include:

Restlessness, agitation,
Flushing, dizziness, lightheadedness
Very fast, uneven or forceful heart beats
Breathing problems or numbness or go into a coma

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.

Do not take a double dose of Oxybutynin hydrochloride tablets 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.

Children are at higher risk of the effects.

Stop taking Oxybutynin Tablets and see a doctor or go to a hospital immediately if:

Frequency unknown

– 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 in10 people)	– Constipation -Drymouth – Feeling sick, being sick – Dry skin – Headache – Somnolence (feeling drowsy or sleepy) – Dizziness – Blurring of vision
Common (may affect up to 1 in 10 people)	– Dry eyes – Diarrhoea – Vomiting – Flushing especially in children – Confusion
Uncommon (may affect up to 1 in 100 people)	– Stomach pain – Loss of appetite (anorexia) – Difficulty in swallowing (dysphagia)
Not known (frequency cannot be estimated from the available data)	– Increased pressure in the eyes, sometimes sudden and painful with blurred vision or loss of vision (glaucoma), enlargement of the pupil of the eye – Indigestion or heartburn (acid reflux) – Urinary tract infection – Increased, rapid or irregular heartbeat (palpitations) – Heat stroke – Difficulty passing water (urine) – Agitation – Anxiety – Becoming dependent on Oxybutynin – Feeling excessively suspicious and distrustful of others (paranoia) – Seeing or hearing things that are not there (hallucinations) – Drowsiness – Nightmares – Fits (convulsions) – Depression – Itchy, lumpy rash (urticaria) – Absence of sweating (hypohidrosis) -Skinthatis more sensitive to the sun (photosensitivity) – Abnormal bloating/ swelling together with pain and feeling or being sick (pseudoobstruction)

measures will help to protect the environment.

6. contents of the pack and other information

What Oxybutynin hydrochloride 2.5mg/3mg/5mgtabletscontain 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.

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

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