Oxybutynin Hydrochloride 2.5 Mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxybutynin hydrochloride 2.5 mg tablets Oxybutynin hydrochloride 5 mg tablets
Oxybutynin hydrochloride
Read all of this leaflet carefully before you
start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Oxybutynin Tablets are and what they are used for
2. Before you take Oxybutynin Tablets
3. How to take Oxybutynin Tablets
4. Possible side effects
5. How to store Oxybutynin Tablets
6. Further information
1. What Oxybutynin Tablets are and what they are used for
Oxybutynin Tablets contains a medicine called Oxybutynin hydrochloride. This belongs to two groups of medicines called “anticholinergics and “antispasmodics”. It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps control the release of water (urine).
Oxybutynin Tablets can be used to treat:
Adults:
Frequent and severe urinary urgency or Loss of
control in passing urine (urge incontinence).
Children over 5 years:
- Loss of control in passing water (urinary incontinence).
- Increased need or urgency to pass urine (frequent and excessive urination).
- Night time bedwetting in children when other treatments have not worked.
2. Before you take Oxybutynin Tablets
Do not take Oxybutynin Tablets and tell your
doctor if:
- You are allergic (hypersensitive) to Oxybutynin Tablets hydrochloride or any of the other ingredients of Oxybutynin Tablets (listed in Section 6 Further information).
- You have a rare condition called “Myasthenia gravis” that makes the muscles in the body become weak and tire easily.
- You have increased pressure in the eye (glaucoma).
- Your gut (stomach or intestine) is blocked, perforated or not working properly
- You have a severe form of a condition known as “ulcerative colitis (inflammatory disease of the large intestine)”.
- 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
apply to you. If you are not sure, talk to your doctor
or pharmacist before taking Oxybutynin Tablets.
Take special care with Oxybutynin Tablets
Check with your doctor or pharmacist before taking your medicine if:
- You have kidney or liver problems
- You are 65 years of age or older
- The person taking the medicine is a child
- You have an illness affecting the nerves called “autonomic neuropathy”
- You have an overactive thyroid gland (Hyperthyroidism)
- You have heart disease or high blood pressure
- You have an irregular heart beat (palpitations) and/or increased or rapid heart beat
- You have an enlarged prostate gland
- You have indigestion or heart burn caused by a “ hiatus hernia” (where part of your stomach pushes through the diaphragm
- You have raised body temperature or fever
- You will be taking this medicine in hot climate
Prolonged use may result in an increase in dental caries, as a consequence of reduced or suppressed salivary secretions. Regular dental check-ups are therefore advisable during long-term treatment.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Oxybutynin Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, including herbal medicines.
Oxybutynin Tablets may slow the digestive tract and thereby influence the effect of other medicines, or the use of this medicine together with other medicines may increase the effect of oxybutynin. In particular, tell your doctor if you are taking any one of the following:
- Atropine and other anticholinergic medicines (used for treatment in stomach disorders such as irritable bowel syndrome)
- Prochlorperazine or chlorpromazine (phenothiazines), Clozapine or other antipsychotics (Medicines used to treat psychosis).
- haloperidol or beneridol (butyrophenones) (Medicines used to treat certain mental illness)
- amitriptyline, imipramine or dosulepin or tricyclic anti depressants (Medicines used to treat depression)
- 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)
- Dipyridamole (used to treat blood clotting problems).
- Ketoconasole, itraconazole or fluconazole (used for the treatment of fungal infections).
- Erythromycin a macrolide antibiotic (used to treat bacterial infections).
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine if you are pregnant or breast feeding. This medicine should not be used during pregnancy unless clearly necessary.
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. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Oxybutynin Tablets
Oxybutynin Tablets contains lactose. If you have intolerance to some sugars, consult your doctor before taking this medicine.
3. How to take Oxybutynin Tablets
Always take Oxybutynin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablet with glass of water.
Do not change the dose yourself, inform your doctor if you feel the effect of your medicine too weak or too strong.
Using Oxybutynin Tablets with food and drink
Oxybutynin Tablets may cause drowsiness or blurred vision. Drowsiness may be increased by consumption of alcohol.
Adults
- An initial dose of 2.5 mg three times daily.
- Your doctor may decide to increase to the maximum dose of 5mg four times daily
Elderly
- An initial dose is 2.5mg twice daily
- Your doctor may decide to increase this 5mg twice daily
Children (over 5 years)
- An initial dose is 2.5mg twice daily
- Your doctor may decide to increase this to 5mg two or three times daily
- If you are giving it to a child to prevent bedwetting, give the last dose just before bedtime
If you take more Oxybutynin 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. You may become very restless or excited, flushed or get dizzy or light -headed. Your heart beat may become very fast, uneven or forceful. You may get breathing problems or numbness or go into a coma.
If you forget to take Oxybutynin 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 Tablets
Keep taking Oxybutynin Tablets until your doctor tells you to stop. Do not stop taking Oxybutynin Tablets just because you feel better
4. Possible Side Effect
Like all medicines, Oxybutynin Tablets can cause side effects, although not everybody gets them.
Stop taking Oxybutynin Tablets and see a doctor or go to a hospital immediately if:
- You have an allergic reaction, the signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Tel your doctor or pharmacist if any of the following side effects get serious or lasts
Dry mouth
Blurring of vision nausea, stomach pain, indigestion, flushing, and constipation. Diarrhea, vomiting, loss of appetite, difficulty urinating, heart palpitations, irregular heartbeat, headache, dizziness, fatigue, drowsiness, light hypersensitivity.
Rare (affects hallucinations,
1 : to10 users in 10 000): excitation / agitation,
nightmares, confusion, anxiety, restlessness, convulsions, allergic reactions such as rash, urticaria and angioedema, erectile dysfunction, disorientation, difficulties in concentration, heat stroke, phototoxicity.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. How to store Oxybutynin Tablets
- Keep out of the reach and sight of children. Do not use Oxybutynin Tablets after the expiry date which is stated on the blister or carton. The expiry date refers to the last day of that month.
- Do not store above 30°C. Store in the original package in order to protect from moisture.
- M edicines 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. Further information
What Oxybutynin Tablets contain
The Active substance is Oxybutynin hydrochloride.
Each tablet contains either 2.5mg or 5mg of the Oxybutynin hydrochloride.
The other ingredients are powdered cellulose, lactose monohydrate, talc and magnesium stearate (E572).
What Oxybutynin Tablets looks like and contents of the pack
Oxybutynin 2.5mg Tablets are white to off white, odourless, 5mm round biconvex, uncoated with inscription “BS” on one side and plain on the other side.
Oxybutynin 5mg Tablets are white to off white, odourless, 7.9mm round biconvex, uncoated with inscription “B” and “R” on either side of score line on one side and plain on the other side.
The 5mg can be divided into equal halves.
Oxybutynin 2.5 and 5mg Tablets are packed in blisters and further packed in a carton.
The carton contains 6, 20, 21, 28, 30, 50, 56, 60, 84 and 100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Accord Healthcare Limited Sage House, 319, Pinner Road North Harrow Middlesex HA1 4 HF United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow,
HA1 4HF, Middlesex,
United Kingdom.
The medicinal product is authorized in the Member States of the EEA under the following names:
Name of medicinal product
Oxybutynin hydrochloride Accord Healthcare 5mg comprimes Oxybutynin hydrochloride Accord 5mg tablety Oxybutynin hydrochloride Accord 2.5mg/5mg tabletten Oxybutynin hydrochloride Accord 5mg comprime pellicule.
Oxybutynin hydrochloride 2.5mg/5mg OXIBUTININA ACCORD 5 mg compresse Oxybutynin Accord 5mg tablets Oxybutynin hydrochloride Accord 5mg tabletes Oxybutynin hydrochloride Accord Clorhidrat de Oxibutinina Accord 5mg comprimat Oxybutynin Accord 2.5mg/5mg tabletter Oxybutynin hydrochloride 2.5mg/5mg tablets
This leaflet was last updated in 08/2012.