DRIPTANE 5 mg. 60 tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Oxybutynin (INN) hydrochloride / Oxybutynin hndrohlorid - 5,00 mg
Excipients (pomoshni substances: microcrystalline cellulose (17,80 mg), calcium stearate (1,90 mg), anhydrous lactose (153,30 mg).
3. PHARMACEUTICAL FORM
6. THERAPEUTIC CLASS:
Medicinal products for urology / Other urological drugs including antispasmodics / antispasmodics Urinary tract (G 04 BD04: Genitourinary system and sex hormones)
This medicine is recommended in the following cases:
- Urinary Incontinence (involuntary daily or nocturnal enuresis);
- Urinary urgency (the need to urinate immediately) and excessive frequency of urination in unstable bladder, which may be due to idiopathic detrusor instability (instability of unknown origin bladder bladder-related), or neurogenic vesical disorders (disorders bladder certain diseases of the nervous system).
8. INFORMATION REQUIRED BEFORE medicinal use
This medicine should not be used in cases of:
- Allergy to any component of this medication;
- Risk of urinary retention (discomfort in emptying the bladder) associated with urethra-prostate disorders;
- Intestinal obstruction (blocked passage of material or gas contained in a segment of the intestine);
- Toxic megacolon (extension of part of the intestine);
- Intestinal atony (excessive reduction of intestinal tone);
- Severe ulcerative colitis (inflammation of the colon);
- Myasthenia (illness with muscle fatigue);
- Narrow-angle glaucoma or shallow anterior chamber;
IF YOU HAVE ANY DOUBTS, consulted with your doctor or pharmacist.
b) Special precautions for use
Your doctor will see you again after 4 to 6 weeks to reassess your treatment.
Oxybutynin should not be used to treat urinary incontinence, caused by stress or effort.
Oxybutynin hydrochloride should be used with caution in elderly patients and in children who may be more sensitive to the effects of oxybutynin, and in patients with autonomic neuropathy, hiatus hernia or other severe gastrointestinal symptoms, liver and kidney disorders, tachyarrhythmia or cerebrovascular insufficiency.
After administration of oxybutynin is a possible increase in the complaints in patients with hyperthyroidism (overactive thyroid), certain heart problems (coronary artery disease, congestive heart failure, cardiac arrhythmias, tachycardia) and prostatic hypertrophy (enlarged prostate volume). If you suffer from any of these diseases, contact your doctor.
Chronic administration of oxybutynin may lead to discomfort due to salivary failure which can cause the occurrence of caries, periodontoklaziya (damage to the tissues that support the teeth) or candidiasis of the oral cavity (infection in the mouth, due to the microscopic fungi). In urinary tract infections should be given appropriate antimicrobial therapy.
Under conditions of high ambient temperature, treatment with oxybutynin may cause decreased sweating and result in insufficient and unacceptable response by the mechanisms regulating the temperature by reflecting the emergence of heatstroke. This risk is increased by:
- Elderly or very young (the elderly, infants and children)
- The presence of chronic disease (in particular cardiovascular, renal or psychiatric).
Due to the presence of lactose this drug is contraindicated in congenital galactose intolerance, poor absorption of glucose and galactose, or deficiency syndrome lactose (rare metabolic diseases).
Tell your doctor if:
- Neurological symptoms;
- Hiatus hernia shi other gastrointestinal diseases;
- Hepatic shi kidney disease;
- Urinary tract infection;
- Known abnormalities in heart rhythm;
- Known diseases of the brain.
IF YOU HAVE ANY DOUBTS, consulted with your doctor or pharmacist.
To avoid possible reactions with other medicines Please let your doctor or pharmacist about any other medicines PRODUCTS THAT TAKE IN THIS MOMENT, and all unusual symptoms occurred during treatment.
Medicinal products that must take precautions for parallel application; + Lisuride
Risk of mental confusion. Regular clinical monitoring.
Medicinal products which should be exercised when co-administration:
- Atropine and other preparations containing atropine
Imapriminovi antidepressants, sedative antihistamines HI, atropinic antispasmodic medicines antkholinergichni other anti-Parkinsonian drugs, disopyramide, phenothiazine neuroleptics. Additional atropine side effects such as urinary retention, constipation, dry mouth.
d) Pregnancy and lactation
This drug should not be used during pregnancy unless clearly necessary, judged by your doctor. It should not be used during breastfeeding.
IN ALL CASES, IT IS IMPORTANT TO ALWAYS tell your doctor or pharmacist before you start taking ANY drugs during pregnancy and lactation.
e) Effects on ability to drive and use machines
This medicine may cause drowsiness or blurred vision. Not recommended driving, operating machinery or performing hazardous activities.
Excipients with well known effect
INFORMATION FOR PROPER USE
The dosage and duration of treatment is determined by a doctor. If your doctor advises otherwise, the most common dose following:
The starting dose is half a tablet 3 times daily. The usual dosage is 1 tablet 2 or 3 times daily.
Your doctor may increase the dose to a maximum of one tablet four times a day. If you are an elderly patient, the initial dose is half a tablet twice a day. The usual dose is one tablet twice daily.
Children over 5 years: starting dose is half a tablet twice a day.
The usual dose is:
- 1/2 tablet 3 times a day - for children from 5 to 9 years; -1 Tablet twice a day - for children 9 to 12 years; -1 Tablet 3 times a day - for children over 12 years.
Not recommended use of this medicine in children up to age 5. IN ALL CASES strictly follow your doctor's instructions.
b) Method and route of administration
c) How often and when to take medicine
Tablets should be taken before meals with a glass of water. They can be taken during a meal or a glass of milk in case of stomach pain.
d) Duration of treatment
Followed exactly the doctor's prescription.
Overdose can occur following effects:
- Signs of intoxication typical of other anticholinergic agents (mydriasis, agitation, greatly reduced secretion, tachycardia, flushing).
- Circulatory changes (drop in blood pressure, circulatory collapse, etc.) respiratory collapse, coma and paralysis.
f) Arrangements missed dose
If you forget to take a dose, take it as soon as you remember, and then continue in the normal way.
10. SIDE EFFECTS
Like all medicines, USE OF DRIPTAN CAN cause some side effects, meant as an adverse reaction.
The most commonly reported side effects are dry mouth, constipation, blurred vision, mydriasis (widening of the pupil), tachycardia (rapid heartbeat), nausea, stomach pain, flushing, agitation, difficulty in urinating (dysuria).
The occurrence of these side effects can be reduced by reducing the dose. Gastrointestinal disorders:
Nausea, constipation, dry mouth, stomach discomfort, diarrhea and gastroesophageal reflux zofagealen.
Psychiatric disorders and CNS disorders:
Agitation, headache, dizziness, drowsiness, hallucinations, nightmares, cognitive disorders (confusion, agitation, delirium) and convulsions. Cardiovascular disorders: tachycardia and cardiac arrhythmias Visual disorders:
Blurred vision, mydriasis, increased intraocular pressure, development of narrow-angle glaucoma, dry eye.
Disorders in the kidney and ureter
Difficulty in micturition and urinary retention.
Disorders in the skin and subcutaneous tissue
Flushing more often in children than in adults), dry skin, allergic reactions such as skin rashes, urticaria and angioedema.
11. SPECIAL STORAGE
The medicine should be stored below 30 ° C. Keep out of reach of children.
12. Do not use after the expiry date stated OUTSIDE THE PACKAGE