5 mg tablets
1. What Ditropan is and what it is used for
Ditropan reduces the pressure in the bladder and makes the contractions less frequent and at the same time weaker. The ability to hold urine is improved.
Ditropan is used in adults to treat heavy or frequent urination with or without urine leakage. Ditropan is also used for urinary incontinence caused by damage to the nervous system.
Ditropan is used in children aged 5 years or older in:
- Lack of control over urination (urinary incontinence).
- Increased need or frequency of urination.
- Nocturnal bedwetting when another treatment has not given results.
2. What you need to know before taking Ditropan
Do not take Ditropan if you are/have:
- allergic to oxybutynin or any of the other ingredients of this medicine (listed in section 6).
- bladder obstruction (eg enlarged prostate )
- high fluid pressure in the eye ( glaucoma )
- myasthenia gravis (severe muscle weakness)
- impaired emptying of the stomach
- severe ulcerative colitis
- toxic megacolon (enlarged colon)
- frequent night cramps caused by heart and kidney disease
Warnings and cautions
Talk to your doctor or pharmacist or nurse before taking Ditropan.
If you suffer from any of the following conditions, you should consult your doctor before starting treatment:
- high blood pressure,
- heart disease,
- hyperthyroidism (hypothyroidism),
- prostate enlargement,
- autonomic neuropathy (nerve disease such as Parkinson’s disease ),
- severe gastrointestinal disease,
- liver or kidney disease.
Ditropan should be used with caution in elderly patients due to the risk of side effects affecting learning, thinking, and memory.
Dry mouth is a common side effect that can increase the risk of caries (cavities in the teeth), tooth loss, or fungal infection in the mouth. It is therefore important to take extra care of your teeth during the entire time you use Ditropan. If you are using anticonvulsants (so-called nitrates) that are supposed to melt under your tongue, it is also important that you moisten your mouth with your tongue or with a little water before taking such a tablet.
If Ditropan is used in hot climates, there is a risk of fatigue because you sweat less.
Stop taking Ditropan and contact a doctor immediately if you get any of the following symptoms ( angioedema )
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
Contact a doctor immediately if you get any of the following symptoms ( glaucoma )
- sudden loss of visual acuity
- eye pain
Talk to your doctor if you experience symptoms such as hallucinations, upset, confusion, and sleep disturbances.
Ditropan is not recommended for children under 5 years of age. Children are at greater risk of side effects from Ditropan.
Other medicines and Ditropan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Treatment may be affected if Ditropan is taken at the same time as other medicines.
Medicines that can affect or affect Ditropan if taken at the same time as Ditropan:
- Anticholinergic drugs (a class of drugs that block the action of the neurotransmitter acetylcholine in the brain). These drugs are used to treat diseases such as Parkinson’s disease (eg biperiden, levodopa ), allergies ( antihistamines ), mental illnesses (phenothiazines, butyrophenones, clozapine), heart problems (quinine, digitalis ), depression ( tricyclic antidepressants ), seizures ( atropine, pyramidal and more).
- Cholinesterase inhibitors (used to treat Alzheimer’s disease ).
- Drugs that affect bowel movement (increase or decrease), e.g. metoclopramide and domperidone (used to treat nausea) they reduce bowel movements.
- Medicines for fungal infections (eg ketoconazole )
- Medicines for bacterial infections (eg erythromycin or other so-called macrolide antibiotics)
Ditropan with alcohol
If alcohol is consumed in connection with treatment with Ditropan, the drowsiness that some people experience as a side effect of medicines such as Ditropan may increase.
Pregnancy and breastfeeding
Limited experience of use during pregnancy. Therefore, always consult a doctor before using Ditropan during pregnancy.
Oxybutynin passes into breast milk but is unlikely to affect breastfed infants. However, consult a doctor when using Ditropan during breast-feeding.
Driving and using machines
Ditropan can cause drowsiness and visual disturbances. This should be taken into account when sharper attention is required, e.g. when driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Ditropan contains excipients
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Ditropan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor who adapts it individually for you, and you should always follow the doctor’s instructions.
The usual starting dose for adults is 2.5 mg (½ tablet) three times daily and for children over 5 years 2.5 mg (½ tablet) twice daily. The maximum dose for adults is 20 mg (4 tablets) per day divided into 2-3 doses.
The tablets can be taken before meals.
The tablets taste bad and should therefore be swallowed whole or divided with half a glass of water/liquid.
If you take more Ditropan then you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, always contact a doctor, hospital, or the Poison Information Center
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (affects more than 1 in 10 people): Dizziness, headache, dry mouth, nausea, constipation, dry skin, fatigue.
Common (affects more than 1 user in 100): Confusion, dry eyes, flushing, diarrhea, vomiting, difficulty urinating.
Uncommon: Loss of appetite, difficulty swallowing, abdominal discomfort/pain, drowsiness.
Rare (affects less than 1 in 1,000 people ): Irritated state of mind, restlessness, sensitivity to sunlight, impotence.
Have been reported (affecting an unknown number of people): Urinary tract infections, hypersensitivity, nightmares, hallucinations, anxiety, agitation, feeling anxious, restlessness, seizures, mydriasis, high intraocular pressure, glaucoma ( glaucoma ), blurred vision, palpitations, irregular heartbeat, acid reflux, bowel obstruction, skin rash, hives and angioedema (swelling of the face, tongue or throat see To think about before and when using the medicine), heatstroke, decreased sweating, dependence on oxybutynin (in patients with a history of drug abuse), depression.
Contact your doctor immediately if your visual acuity suddenly disappears.
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.
5. How to store Ditropan
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 expiration date is the last day of the specified month.
Do not store above 25 ° C.
The medicine 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. Contents of the packaging and other information
- The active substance is oxybutynin hydrochloride 5 mg
- The other ingredients are anhydrous lactose, microcrystalline cellulose, calcium stearate
What the medicine looks like and the contents of the pack
The tablet is white, round, and cupped with a scoreline on one side and marked with “OXB 5” on the other. Diameter about 8 mm.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Sanofi Winthrop Industry
30 at 36 avenue Gustave Eiffel
FR-37071 TOURS CEDEX 2