OSSIBUTININA 5 mg Коированная Таблетка

Содержание инструкции

1. Oxibutynin Hydrochloride Mylan Generics 5 mg tablets
   1. What is Ossibutinina Cloridrato Mylan Generics and what is it used for
   2. What you need to know before taking Ossibutinina Cloridrato Mylan Generics
   3. How to take Ossibutinina Cloridrato Mylan Generics
   4. Possible side effects
   5. How to store Ossibutinina Cloridrato Mylan Generics
   6. Contents of the pack and other information

Oxibutynin Hydrochloride Mylan Generics 5 mg tablets

oxibutynin hydrochloride

Generic medicine

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ossibutinina Cloridrato Mylan Generics and what is it used for

Ossibutinina cloridrato belongs to two groups of medicines called “antispasmodics” and
“anticholinergics”.
Ossibutinina cloridrato works by helping to reduce the spasms of the bladder muscles. It is
these spasms that make you feel the need to urinate frequently. Therefore, ossibutinina has
the effect of relaxing the bladder muscles, so the bladder can hold more urine and the
frequent urge to urinate is reduced. Therefore, ossibutinina cloridrato tablets can be used to
treat conditions in which you are unable to normally control your bladder. The reason for
this may not be known or may be caused by a disorder affecting the
nerves of the bladder.
Ossibutinina cloridrato can be used in adults and children 5 years of age and older, to
treat:

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

2. What you need to know before taking Ossibutinina Cloridrato Mylan Generics

Do not take Ossibutinina Cloridrato Mylan Generics

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Ossibutinina Cloridrato Mylan Generics:

• if you are elderly (65 years or older), because you may be more sensitive to the effects of Ossibutinina Cloridrato Mylan Generics
• if the person taking the medicine is a child (use is not recommended for under 5 years of age)
• if you suffer from a chronic illness
• if you have a heart or blood vessel disease or if you suffer from high blood pressure
• if you have an irregular heartbeat and/or an increased or rapid heartbeat
• if you suffer from a liver, kidney or intestinal disease
• if you suffer from a condition that affects the nervous system
• if you have an overactive thyroid (hyperthyroidism)
• if you have a fever or live in a hot environment, because 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 must be treated before starting treatment with oxybutynin.

Inform your doctor if any of these conditions apply to you.

Other medicines and Ossibutinina Cloridrato 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 to relieve allergy symptoms
• other medicines called anticholinergics or antimuscarinics, such as some medicines to treat irritable bowel syndrome, asthma or incontinence, mobility diseases or movement disorders associated with Parkinson's disease
• medicines to treat depression, e.g. amitriptyline, imipramine or dosulepine (tricyclic antidepressants)
• medicines to treat mental illnesses, e.g. clozapine, phenothiazines, butyrophenones
• medicines against 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 to prevent some viral infections or to treat Parkinson's disease, e.g. levodopa, biperiden, procyclidine, amantadine
• medicines that dissolve on the tongue, e.g. glyceryl trinitrate (GTN) tablets for angina, because oxybutynin hydrochloride may cause dry mouth so the tablets may not dissolve properly
• digoxin, used to treat heart problems
• medicines to treat myasthenia gravis, e.g. neostigmine or pyridostigmine
• medicines 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 Ossibutinina Cloridrato Mylan Generics with food, drinks and alcohol
Ossibutinina Cloridrato Mylan Generics can be taken on an empty stomach but it is advisable to take it
with food or with milk if it causes stomach problems.
Drinking alcohol may increase the drowsiness caused by oxybutynin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Oxybutynin should only be used during pregnancy if the benefits to the mother outweigh the risks
to the baby. Talk to your doctor first. You should not breastfeed while taking oxybutynin
because small amounts of oxybutynin hydrochloride may pass into breast milk.

Driving and using machines
Donot drive or use machines if you experience dizziness or blurred vision while using Ossibutinina Cloridrato Mylan Generics tablets.

Ossibutinina Cloridrato Mylan Generics tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Ossibutinina Cloridrato Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask 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 problems,
take them during meals or with milk. Have regular check-ups with your dentist because
oxybutynin causes dry mouth which can increase the risk of tooth decay.

Adults
The initial dose is one Ossibutinina Cloridrato Mylan Generics 2.5 mgtablet two or three
times a day. The recommended dose is one Ossibutinina Cloridrato Mylan Generics

5 mgtwo or three times a day.
The doctor may increase this dose up to a maximum of 5 mg four times a day.

Elderly patients
Initially use a lower dose of Ossibutinina Cloridrato Mylan Generics, 2.5 mgtwo
times a day, because the elderly and debilitated patients may be more sensitive to the effects of
this medicine.
The doctor may increase this dose up to a maximum of one Ossibutinina
Cloridrato Mylan Generics 5 mgtablet two times a day.

Use in children and adolescents
Do not give this medicine to children under 5 years of age.
For children over 5 years of age, the recommended initial dose is 2.5 mgof Ossibutinina Cloridrato
Mylan Generics two times a day.
The doctor may increase this dose up to a maximum of one Ossibutinina
Cloridrato Mylan Generics 5 mgtablet two or three times a day. Give the child the last dose just
before bedtime.
If efficacy is insufficient, the doctor may increase the dose, depending on 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 directly to the emergency room of a hospital. Bring the medicine with you.
Taking too many Ossibutinina Cloridrato Mylan Generics tablets can be very dangerous.
You may become very restless or agitated, flushed or have dizziness or feel faint. Your heartbeat
may become very rapid, irregular or forceful. You may have breathing problems or
numbness or go into a coma.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In some cases these effects may disappear if your doctor reduces the dose.
If you get any of these serious side effects, stop taking this medicine immediately and seek medical attention immediately:

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 can cause difficulty swallowing or breathing (angioedema)
• if you sweat little, this can cause hyperthermia (overheating) in hot environments and this can cause heatstroke.
• if you have an increase in pressure inside the eye (glaucoma). If you notice a sudden change in vision, see an eye doctor immediately
• if you have urinary tract infections (symptoms may include pain or burning when urinating)
• seizures
• partial blockage of the intestine - stools pass with difficulty or may not be able to pass, or you have a painful and bloated 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)
Feeling confused, dry eyes, facial flushing (more common in children than in
adults), diarrhea, 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)
Feeling restless, delirium, agitation, depression, nightmares, feeling anxious, paranoia or
experiencing hallucinations (seeing, feeling or hearing things that are not real), difficulty
learning, nosebleeds (epistaxis), muscle weakness, myalgia and/or muscle spasms,
perception and logic, 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, fast or irregular heartbeat, disorientation, gastric disturbances and heartburn which usually occurs after
meals or during the night and which may worsen when bending over (reflux
gastroesophageal), impotence, skin allergic reactions such as rashes, itching or
increased sensitivity of the skin to sunlight (photosensitivity).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
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 at a temperature above 25°C.

Blisters: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 which is stated on the label and on the packaging
after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ossibutinina Cloridrato Mylan Generics contains

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

Description of the appearance of Ossibutinina Cloridrato Mylan Generics and contents of the pack
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 can be divided into two equal doses.
Ossibutinina Cloridrato Mylan Generics tablets are available in plastic bottles or in
blister packs of 20, 30, 50, 60, 84, 90, 100, 250 (bottles only) and 500 (bottles only)
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
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 authorised in the Member States of the European Economic
Area under the following denominations:
France - Oxybutynine Viatris 5 mg comprimé sécable
Italy – Ossibutinina Cloridrato Mylan Generics (5 mg tablets)
Netherlands - Oxybutynine HCl Viatris 2.5 mg and 5 mg Tablets
United Kingdom – Oxybutynin Hydrochloride Tablets 2.5 mg and 5 mg