Driptane

Leaflet attached to the packaging: patient information

Driptane, 5 mg, tablets
Oxybutynin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist .

Table of contents of the leaflet

• 1. What is Driptane and what is it used for
• 2. Important information before taking Driptane
• 3. How to take Driptane
• 4. Possible side effects
• 5. How to store Driptane
• 6. Package contents and other information

1. What is Driptane and what is it used for

Driptane contains oxybutynin hydrochloride as the active substance and is classified as an antispasmodic. It causes relaxation of the urinary bladder detrusor muscle, increases the capacity of the urinary bladder, and delays the onset of urination.
Indications:
The medicine is used to alleviate symptoms of urinary bladder instability, with urinary disorders in patients with a neurogenic bladder - detrusor hyperreflexia (urinary urgency, incontinence, difficulty urinating).
The medicine is used in children aged 5 and older in cases of:

• loss of bladder control (urinary incontinence)
• frequent urination or sudden urge to urinate
• nocturnal enuresis, when other treatment methods have not helped.

2. Important information before taking Driptane

When not to take Driptane

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you have a narrowing of the urinary outflow tract from the bladder, in case urinary retention may occur
• if you have gastrointestinal diseases such as gastric and intestinal obstruction, paralytic ileus, toxic megacolon, severe ulcerative colitis
• if you have a muscle disease called myasthenia
• if you have an eye disease called narrow-angle glaucoma or with a shallow anterior chamber.

Warnings and precautions

Driptane should be used with caution in elderly patients with a frail body and children who may be more sensitive to this medicine, as well as in patients with autonomic nervous system dysfunction (such as patients with Parkinson's disease), liver or kidney dysfunction, severe gastrointestinal dysfunction, and cerebral circulation disorders.
Driptane should be used with caution in elderly patients due to the risk of cognitive impairment.
Driptane may exacerbate symptoms of hyperthyroidism, coronary artery disease, congestive heart failure, prostatic hyperplasia, hypertension, cognitive impairment, and cardiac arrhythmias and tachycardia.
It is recommended to monitor the patient, especially during the first few months of treatment or when increasing the dose. The doctor may consider discontinuing treatment or reducing the dose in case of central nervous system effects (e.g., hallucinations, agitation, confusion, drowsiness).
Since Driptane may cause narrow-angle glaucoma (eye disease), you should immediately contact your doctor in case of sudden vision loss or eye pain.
Chronic use of Driptane may cause tooth decay, periodontal disease, or oral thrush due to reduced or inhibited saliva secretion. During chronic use, regular dental check-ups are recommended.
Driptane should be used with caution in patients with a hiatal hernia, gastroesophageal reflux, and (or) who are currently taking medications (such as bisphosphonates used in osteoporosis and bone diseases) that may cause or exacerbate esophagitis.
Taking Driptane in high ambient temperatures may cause heat stroke due to decreased sweating.
Driptane is considered hazardous in patients with porphyria (a rare genetic disease involving disorders of heme synthesis).

Children and adolescents

Oxybutynin is not recommended for use in children under 5 years of age. The safety of oxybutynin in this age group has not been established.
Caution should be exercised when using Driptane in children aged 5 and older due to possible increased sensitivity to the medicine, especially in terms of central nervous system effects and psychiatric adverse effects.

Driptane and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Inform your doctor about taking:

• other medicines with anticholinergic effects (such as amantadine, other anticholinergic medicines used in Parkinson's disease (e.g., biperiden, levodopa), antihistamines, antipsychotics (e.g., phenothiazine derivatives, butyrophenones, clozapine), quinidine, digitalis preparations, tricyclic antidepressants, atropine and atropine-like substances, such as atropine-like antispasmodics and dipyridamole) as their effects may be enhanced.

By reducing gastrointestinal motility, oxybutynin may affect the absorption of other medicines.
Oxybutynin is metabolized by the cytochrome P450 isoenzyme CYP 3A4. Concurrent use of CYP3A4 inhibitors (e.g., itraconazole - an antifungal medicine) may inhibit oxybutynin metabolism and increase oxybutynin effects. Oxybutynin may reduce the effectiveness of prokinetic medicines.
Concomitant use with cholinesterase inhibitors may decrease the effectiveness of cholinesterase inhibitors.

Driptane with food, drink, and alcohol

Alcohol may enhance the drowsiness caused by taking Driptane.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no adequate data on the safety of Driptane during pregnancy.
Animal studies have shown toxic effects on reproduction at toxic doses for mothers.
The potential risk in humans is not known. Driptane should be avoided during pregnancy unless it is absolutely necessary.
Breastfeeding
Oxybutynin taken during breastfeeding passes into breast milk in small amounts.
Therefore, do not take the medicine while breastfeeding.
Fertility
There are no adequate data in humans. Animal studies have not shown any adverse effects on fertility in males and females.

Driving and using machines

The medicine may cause blurred vision or drowsiness. While taking the medicine, be cautious when performing tasks that require concentration, such as driving, operating machinery, and performing hazardous work.
Driptane contains lactose(a type of sugar). If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Driptane

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults
Typically, the dose for adults is 5 mg (1 tablet) two or three times a day.
The maximum dose for adults is 4 tablets per day.
Elderly patients
In elderly patients, the half-life of the medicine is prolonged, so a dose of 2.5 mg (0.5 tablets) twice a day is sufficient. The dose can be increased to 5 mg (1 tablet) twice a day if the patient tolerates the medicine well.
Children from 5 years old
Neurogenic bladder: the typical dose for children from 5 years old is 2.5 mg (0.5 tablets) twice a day.
The dose can be increased to 5 mg (1 tablet) two or three times a day, provided the child tolerates the medicine well.
Nocturnal enuresis: the typical dose for children from 5 years old is 2.5 mg (0.5 tablets) twice a day.
The dose can be increased to 5 mg (1 tablet) two or three times a day, provided the child tolerates the medicine well.
The last dose on a given day should be taken before bedtime.
The notch on the tablet allows for easy division into two halves of 2.5 mg each to reduce the dose.

Method of administration

Swallow the tablet whole with water.

Taking a higher dose of Driptane than recommended

Symptoms in case of overdose of Driptane are related to the enhancement of usually occurring side effects from the central nervous system (from anxiety, agitation to psychotic behavior). Circulatory disorders (flushing, hypotension, circulatory failure, etc.), respiratory failure, paralysis, coma may occur.
In case of overdose, contact your doctor immediately.

Missing a dose of Driptane

Do not take a double dose to make up for a forgotten dose.
If you miss a dose, take the next scheduled dose of Driptane.

4. Possible side effects

Like all medicines, Driptane can cause side effects, although not everybody gets them.
Very common side effects(may affect more than 1 in 10 people)

• constipation, nausea, dry mouth
• dizziness, headache, drowsiness
• dry skin
• blurred vision

Common side effects(may affect up to 1 in 10 people)

• diarrhea, vomiting
• disorientation
• dry eye
• urinary retention
• flushing
• palpitations, which may be rapid or irregular

Uncommon side effects(may affect up to 1 in 100 people)

• abdominal discomfort, anorexia, decreased appetite, swallowing disorders

Frequency not known(cannot be estimated from the available data)

• urinary tract infections
• gastroesophageal reflux, pseudo-obstruction in patients at risk (elderly patients or patients with constipation and treated with other medicines that reduce intestinal motility)
• agitation, anxiety, hallucinations, nightmares, delusions, cognitive impairment in the elderly, symptoms of depression, dependence (in patients with a history of substance abuse), disorientation, delirium
• cognitive impairment, seizures
• tachycardia, arrhythmias
• heat stroke
• narrow-angle glaucoma, mydriasis, increased intraocular pressure
• urinary disorders
• angioedema, rash, urticaria, decreased sweating, photosensitivity
• hypersensitivity reactions
• epistaxis
• muscle disorders (muscle weakness, pain, cramps)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Driptane

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in a temperature below 30°C.
Medicines 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 protect the environment.

6. Package contents and other information

What Driptane contains

• The active substance is oxybutynin hydrochloride. One tablet contains 5 mg of oxybutynin hydrochloride.
• The excipients are microcrystalline cellulose, calcium stearate, anhydrous lactose.

What Driptane looks like and contents of the pack

Packaging of 30 or 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer:

Astrea Fontaine
Rue des Pres Potets
21121 Fontaine les Dijon
France
To obtain more detailed information, contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 546 64 00
Date of last revision of the leaflet:02/2024