5 mg tablets 
oxybutynin

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Ditropan is and what it is used for 
2. What you need to know before taking Ditropan 
3. How to take Ditropan 
4. Possible side effects 
5. How to store Ditropan 
6. Contents of the packaging and other information 

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.

Children

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

Content declaration

  • 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

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

Sanofi Winthrop Industry

30 at 36 avenue Gustave Eiffel

FR-37071 TOURS CEDEX 2

France

Muhammad Nadeem

Leave a Reply