Oxybutynin chloride Mylan Generics

PATIENT INFORMATION LEAFLET

Oxybutynin Chloride Mylan Generics 5 mg tablets

oxybutynin chloride
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Oxybutynin Chloride Mylan Generics is and what it is used for
2. What you need to know before taking Oxybutin Chloride Mylan Generics
3. How to take Oxybutynin Chloride Mylan Generics
4. Possible side effects
5. How to store Oxybutynin Chloride Mylan Generics
6. Contents of the pack and other information

1. What is Oxybutynin Chloride Mylan Generics and what is it used for

Oxybutynin chloride belongs to two groups of medicines known as "antispasmodics" and
"anticholinergics".
Oxybutynin chloride works by helping to reduce muscle spasms of the bladder. These spasms are what cause the frequent need to urinate. Therefore, oxybutynin has the effect of relaxing the bladder muscles, allowing the bladder to hold more urine and reducing the frequent urge to urinate. Thus, oxybutynin chloride tablets can be used to treat conditions in which normal bladder control is impaired. The reason for this may be unknown or may be caused by a disorder affecting the nerves of the bladder.
Oxybutynin chloride can be used in adults and children aged 5 years and older to treat:

• Loss of bladder control (urinary incontinence)
• Increased frequency and urgency to urinate
• Nighttime urine leakage, when other treatments have not been successful.

2. What you need to know before taking Oxybutynin Chloride Mylan Generics

Do not take Oxybutynin Chloride Mylan Generics

• if you are allergic to oxybutynin or to any of the other ingredients of this medicine (listed in section 6)
• if you have difficulty urinating
• if you suffer from a serious condition called ulcerative colitis, or if you have noticed blood or mucus in your stools
• if you suffer from lazy bowel, if you are constipated or have intestinal problems (your bowel is blocked, perforated or not functioning properly)
• if you suffer from a condition causing muscle weakness (myasthenia gravis)
• if you have glaucoma (increased eye pressure)
• if you suffer from a heart condition causing rapid or irregular heartbeat
• if you have been told you have a condition in which brain tissue has hardened (cerebral sclerosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Oxybutynin Chloride Mylan Generics:

• if you are elderly (65 years or older), as you may be more sensitive to the effects of Oxybutynin Chloride Mylan Generics
• if the person taking the medicine is a child (use is not recommended for children under 5 years of age)
• if you suffer from a chronic illness
• if you have a heart or blood vessel disease or suffer from high blood pressure
• if you have an irregular and/or increased or rapid heartbeat
• if you suffer from a liver, kidney or intestinal disease
• if you suffer from a condition affecting the nervous system
• if you have an overactive thyroid (hyperthyroidism)
• if you have a fever or live in a hot environment, as oxybutynin may increase the risk of hyperthermia
• if you have an enlarged prostate
• if you suffer from indigestion or heartburn caused by a condition called "hiatal hernia"
• if you have a urinary tract infection, this should be treated before starting treatment with oxybutynin.

Inform your doctor if any of these conditions apply to you.
Other medicines and Oxybutynin Chloride Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription, herbal remedies, or any of the following medicines:

• antihistamines used to relieve allergy symptoms
• other medicines known as anticholinergics or antimuscarinics, such as certain medicines used to treat irritable bowel syndrome, asthma or incontinence, or movement disorders associated with Parkinson's disease
• medicines used to treat depression, e.g. amitriptyline, imipramine or dosulepin (tricyclic antidepressants)
• medicines used to treat mental illnesses, e.g. clozapine, phenothiazines, butyrophenones
• medicines for nausea and vomiting, e.g. metoclopramide, domperidone
• medicines containing atropine
• disopyramide or quinidine, digitalis used to treat irregular heartbeat
• dipyridamole, used to prevent blood clots and strokes
• medicines used to prevent certain viral infections or to treat Parkinson's disease, e.g. levodopa, biperiden, procyclidine, amantadine
• medicines that dissolve under the tongue, e.g. glyceryl trinitrate (GTN) tablets for angina, because oxybutynin chloride may cause dry mouth, which may prevent the tablets from dissolving properly
• digoxin, used to treat heart problems
• medicines used to treat myasthenia gravis, e.g. neostigmine or pyridostigmine
• medicines used to treat HIV infection, e.g. ritonavir, indinavir or saquinavir
• ketoconazole or itraconazole, used to treat fungal infections
• clarithromycin or telithromycin, used to treat bacterial infections.

Taking Oxybutynin Chloride Mylan Generics with food, drinks and alcohol
Oxybutynin Chloride Mylan Generics may be taken on an empty stomach, but it is advisable to take it with food or milk if it causes stomach problems.
Consumption of alcoholic beverages may increase the drowsiness caused by oxybutynin.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Oxybutynin should be used during pregnancy only if the benefits to the mother outweigh the risks to the baby. Discuss this with your doctor first. You should not breastfeed while taking oxybutynin, as small amounts of oxybutynin chloride may pass into breast milk.
Driving and using machines
Do not drive or operate machinery if you experience dizziness or blurred vision while taking Oxybutynin Chloride Mylan Generics tablets.
Oxybutynin Chloride Mylan Generics tablets contain lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Oxybutynin Hydrochloride Mylan Generics

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Taking this medicine
Swallow the tablets with a glass of water on an empty stomach. Water is also recommended due to the unpleasant taste of the tablets. If the tablets cause you stomach discomfort, take them during meals or with milk. Have regular dental check-ups, as oxybutynin causes dry mouth, which may increase the risk of tooth decay.
Adults
The initial dose is one tablet of Oxybutynin Hydrochloride Mylan Generics 2.5 mg two or three times daily. The recommended dose is one tablet of Oxybutynin Hydrochloride Mylan Generics 5 mg two or three times daily.
Your doctor may increase this dose up to a maximum of 5 mg four times daily.
Elderly patients
Initially use a lower dose of Oxybutynin Hydrochloride Mylan Generics, 2.5 mg twice daily, because elderly and debilitated patients may be more sensitive to the effects of this medicine.
Your doctor may increase this dose up to a maximum of one tablet of Oxybutynin Hydrochloride Mylan Generics 5 mg twice daily.
Use in children and adolescents
Do not give this medicine to children under 5 years of age.
For children over 5 years, the recommended initial dose is 2.5 mg of Oxybutynin Hydrochloride Mylan Generics twice daily.
Your doctor may increase this dose up to a maximum of one tablet of Oxybutynin Hydrochloride Mylan Generics 5 mg two or three times daily. Give the child the last dose just before bedtime.
If the response is inadequate, the doctor may increase the dose according to body weight to 0.3 or 0.4 mg/kg/day. In some cases, the doctor may increase the dose up to a maximum of:

If you take more Ossibutinina Cloridrato Mylan Generics than you should
If you take more Ossibutinina Cloridrato Mylan Generics tablets than you should, contact your
doctor or go immediately to the nearest hospital Emergency Department. Take the medicine with you.
Taking too much Ossibutinina Cloridrato Mylan Generics tablets can be very dangerous.
You may become very restless or agitated, flushed, or experience dizziness or feel faint. Your
heartbeat may become very rapid, irregular, or forceful. You may have difficulty breathing,
numbness, or fall into a coma.

If you forget to take Ossibutinina Cloridrato Mylan Generics
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your
next dose, skip the missed dose. Do not take a double dose to make up for the missed one.

If you stop taking Ossibutinina Cloridrato Mylan Generics
Continue taking Ossibutinina Cloridrato Mylan Generics tablets for as long as your doctor tells you
to. Do not stop taking the medicine just because you feel better.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
In some cases, these side effects may disappear if your doctor reduces your dose.
If you experience any of the following serious side effects, stop taking this medicine immediately and seek medical help right away:

Common (may affect up to 1 in 10 people):

• if you have problems or difficulty urinating

Not known (frequency cannot be estimated from the available data):

• if you have a severe allergic reaction with swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing (angioedema)
• if you sweat less, which may lead to hyperthermia (overheating) in hot environments and could result in heat stroke
• if you develop increased pressure in the eye (glaucoma). If you notice a sudden change in your vision, see an ophthalmologist immediately
• if you develop urinary tract infections (symptoms may include pain or burning during urination)
• seizures
• partial bowel obstruction – stools pass with difficulty or may not pass at all; you may also have a painful, swollen stomach

Other side effects
Very common (may affect more than 1 in 10 people):
Headache, dizziness, drowsiness, blurred vision, dry mouth, dry skin, constipation, feeling unwell
Common (may affect up to 1 in 10 people):
Confusion, dry eyes, facial flushing (more common in children than adults), diarrhoea, feeling unwell.
Uncommon (may affect up to 1 in 100 people):
Decreased appetite, loss of appetite, difficulty swallowing, stomach problems
Not known (frequency cannot be estimated from the available data):
Restlessness, delirium, agitation, depression, nightmares, anxiety, paranoia, or hallucinations (seeing, feeling or hearing things that are not real), learning difficulties, nosebleeds (epistaxis), muscle weakness, myalgia and/or muscle spasms, altered perception and reasoning, dependence on taking this medicine (in patients with a history of drug or substance abuse). Elderly patients are more sensitive to these side effects.
Other possible side effects include changes in vision, rapid or irregular heartbeat, disorientation, gastric disturbances and heartburn that usually occurs after meals or during the night and may worsen when bending forward (gastroesophageal reflux), impotence, skin allergic reactions such as rashes, itching or increased sensitivity of the skin to sunlight (photosensitivity).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ossibutinina Cloridrato Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Blister packs: store in the original packaging to protect from light.
Bottles: keep the container tightly closed to protect from light.
Do not use this medicine after the expiry date stated on the label and the carton after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ossibutinina Cloridrato Mylan Generics Contains

• The active substance is oxybutynin chloride 5 mg.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, calcium stearate, indigo carmine E132.

Description of the Appearance of Ossibutinina Cloridrato Mylan Generics and Pack Sizes
The 5 mg tablets are blue, round, marked on one side with “OB/5” and on the other side with the letter “G”. The 5 mg tablets may be divided into two equal doses.
Ossibutinina Cloridrato Mylan Generics tablets are available in plastic bottles or in blister packs containing 20, 30, 50, 60, 84, 90, 100, 250 (bottles only), and 500 (bottles only) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer:
McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France - Oxybutynine Viatris 5 mg compimé sécable
Italy – Ossibutinina Cloridrato Mylan Generics (5 mg tablets)
Netherlands - Oxybutynine HCl Viatris 2.5 mg and 5 mg Tabletten
United Kingdom – Oxybutynin Hydrochloride Tablets 2.5 mg and 5 mg