Xelena 7.5mg Tablet 10'S

Introduction About XELENA 7.5MG TABLET

XELENA 7.5MG TABLET contains Darifenacin which belongs to a group of medicines
called Antimuscarinics. XELENA 7.5MG TABLET is used in adults to manage symptoms
of overactive bladder conditions such as a sudden urge to rush to the toilet,
needing to go to the toilet frequently and/or not getting to the toilet in time
and wetting yourself (urge incontinence).

XELENA 7.5MG TABLET is not recommended for use in patients allergic to
Darifenacin. It is also not recommended for use in patients suffering from
urinary retention (inability to empty your bladder), gastric retention,
uncontrolled narrow-angle glaucoma (high pressure in the eyes),  that is not
being adequately manageed), myasthenia gravis (disease characterized by unusual
tiredness and weakness of selective muscles), severe ulcerative colitis/toxic
megacolon (inflammatory bowel disease), and/or severe liver disease.

Before taking XELENA 7.5MG TABLET, inform your doctor if you have autonomic
neuropathy (a condition of nerve damage), difficulties while passing urine,
severe constipation, digestive motility disorder, obstructive gastrointestinal
disorder (any obstruction of the passage of intestinal or gastric contents),
mild to moderate liver problems, and/or kidney problems.

XELENA 7.5MG TABLET is not recommended for use during pregnancy and is advised
to be used with caution in breastfeeding women.

XELENA 7.5MG TABLET is also not recommended for use in children and adolescents
(aged below 18 years) and is advised to be used with caution in elderly patients
(aged 65 years/above) after consulting the doctor.

The most common side effects of taking XELENA 7.5MG TABLET are dry mouth,
constipation, headache, abdominal pain, indigestion, nausea, and/or dry eyes.
Consult your doctor if any of these symptoms worsens.

Uses Of XELENA 7.5MG TABLET

• Manage symptoms of overactive bladder in adults

How XELENA 7.5MG TABLET Works

XELENA 7.5MG TABLET works by blocking certain receptors (M3 muscarinic
acetylcholine receptors, responsible for bladder muscle contractions) which
reduces the muscle spasms of the bladder and urinary tract thereby relaxing the
bladder muscles that results in the  management of urgent, frequent, or
uncontrolled urination.

How to use XELENA 7.5MG TABLET

Tablet:

Take XELENA 7.5MG TABLET as advised by your physician. Swallow XELENA 7.5MG
TABLET with a glass of water and do not chew or crush the medicine. Your doctor
will decide the correct dose and duration for you depending upon your age, body
weight and disease condition.

Side Effects Of XELENA 7.5MG TABLET

Common

• dry mouth
• constipation
• headache
• abdominal pain
• indigestion
• feeling sick
• dry eyes
• nasal dryness

Uncommon

• fatigue
• accidental injury
• facial swelling
• high blood pressure
• diarrhea, flatulence
• ulceration of the mucous membrane of the mouth
• swelling of the hands, ankles or feet
• dizziness, sleeplessness, drowsiness
• abnormal thinking
• runny nose, cough, shortness of breath
• dry skin, itching, rash
• sweating
• blurred vision, taste disturbance
• urinary tract disorder/infection, bladder pain, inability to empty your bladder
• impotence
• discharge and itching in the vagina

Rare

Stop taking XELENA 7.5MG TABLET and contact your doctor if you experience any of
the following side effects:

• signs of angioedema such as swelling of the face, lips, tongue and/or throat

How To Manage Side Effects

Dry mouth:

Try to drink plenty of cold water. Sip on cold unsweetened drinks and use lip
balm if your lips are dry. Try to brush your teeth twice a day and use
mouthwash. Consult your doctor if the symptom gets worse.

Indigestion:

Try to have smaller and more frequent meals and eat and drink slowly. Try to
reduce consum
obese. Avoid smoking and don’t have rich, spicy or fatty foods. Consult your
doctor if the symptom does not improve.

Headache:

If XELENA 7.5MG TABLET causes headache, then take rest and drink plenty of
fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a
painkiller. Paracetamol is safe to be taken with XELENA 7.5MG TABLET. Headaches
should usually go away after the first week of taking XELENA 7.5MG TABLET. If
headaches last more than a week or severe, inform your doctor.

Constipation:

Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals, and
drink plenty of water. Try doing exercise regularly (going for a daily walk or
run). If this does not help, inform your doctor for receiving alternate
managements for constipation.

Diarrhea:

Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid
taking any medicine on your own to manage diarrhea and consult your doctor if
the symptom gets worse.

Dizziness:

Try to rest and relax and get enough sleep. Try to avoid driving or operating
any tools or machines while you are feeling dizzy. Limit your consum
alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom
does not improve.

Warning & Precautions

!### Pregnancy

XELENA 7.5MG TABLET is not recommended for use during pregnancy. Consult your
doctor before taking XELENA 7.5MG TABLET.

!### Breastfeeding

XELENA 7.5MG TABLET should be used with caution in breastfeeding women. Consult
your doctor before taking XELENA 7.5MG TABLET.

!### Driving and Using Machines

Do not drive/operate machines if you experience dizziness, blurred vision,
trouble while sleeping, and/or drowsiness after taking XELENA 7.5MG TABLET.

!### Kidney

XELENA 7.5MG TABLET should be used with caution in patients with urinary tract
infection, and/or other kidney problems. Consult your doctor before taking
XELENA 7.5MG TABLET.

!### Liver

XELENA 7.5MG TABLET is not recommended for use in patients with severe liver
disease. It should be used with caution in patients with mild to moderate liver
problems. Consult your doctor before taking the medicine.

!### Allergy

Do not take XELENA 7.5MG TABLET if you are allergic to Darifenacin, and/or any
other ingredients of this medicine.

!### Heart Disease

XELENA 7.5MG TABLET should be used with caution in patients with heart diseases.
Consult your doctor before taking the medicine.

Others

XELENA 7.5MG TABLET is not recommended for use if you:

• have urinary retention (inability to empty your bladder)
• have gastric retention (difficulties in emptying the contents of the stomach)
• have uncontrolled narrow-angle glaucoma (high pressure in the eyes that is not being adequately manageed)
• have myasthenia gravis (disease characterized by unusual tiredness and weakness of selective muscles)
• have severe ulcerative colitis/toxic megacolon (a type of inflammatory bowel disease).

Before taking XELENA 7.5MG TABLET, inform your doctor if you:

• have autonomic neuropathy (a condition of nerve damage)
• have a condition where one or more organs in your abdomen has moved up into your chest through a hole in your diaphragm, causing you to get heartburn
• have difficulties while passing urine
• have severe constipation
• have digestive motility disorder
• have an obstructive gastrointestinal disorder (any obstruction of the passage of intestinal or gastric contents)
• have an overactive muscle that controls the emptying of the bladder which may cause accidental passing of urine (detrusor hyperreflexia)

Use in Pediatrics:

XELENA 7.5MG TABLET is not recommended for use in children and adolescents (aged
below 18 years). Consult your doctor before taking the medicine.

Use in Geriatrics:

XELENA 7.5MG TABLET should be used with caution in elderly patients (aged 65
years/above).  Consult your doctor before taking the medicine.

Interactions

A. Drug-Drug Interactions:

Before taking XELENA 7.5MG TABLET, inform your doctor, if you are taking any of
the following medicine:

• ciclosporin (medicine used in transplantation to manage organ rejection)
• medicines used to lower blood pressure, to correct heart rhythm or to manage angina pectoris (Ex. verapamil, flecainide, digoxin, quinidine)
• medicines used to manage fungal infections (Ex. ketoconazole, itraconazole, fluconazole, terbinafine)
• oral bisphosphonates (medicines used to manage loss of bone) Ex. risedronate, alendronate, zoledronic acid
• certain antibiotics (medicines used to manage bacterial infections) Ex.. erythromycin, clarithromycin, telithromycin, rifampicin
• medicines used to manage viral infections (Ex. ritonavir)
• medicines used to manage people with psychosis (Ex. thioridazine)
• certain medicines used to manage depression (Ex. imipramine, paroxetine)
• medicines used to manage or manage seizures (Ex. carbamazepine, amobarbital, secobarbital, pentobarbital)
• certain medicines used for the management of stomach problems (Ex. cimetidine)
• other antimuscarinic medicines (used for overactive bladder) (Ex. tolterodine, oxybutynin, flavoxate)
• St. John’s wort (herbal medicine used for depression, menopausal symptoms)

B. Drug-Food Interactions:

Consult your doctor before taking XELENA 7.5MG TABLET if you regularly take
grapefruit juice which may interact with the medicine and alter its effect.

Overdosage:

If you or anyone else accidentally takes too much of XELENA 7.5MG TABLET,
consult your doctor immediately or visit the nearby hospital. Symptoms of
overdose are dry mouth, constipation, headache, indigestion, and/or nasal
dryness.

Synopsis

Drug	:	Darifenacin
Pharmacological Category	:	Antimuscarinics
Therapeutic Indication	:	Manage symptoms of overactive bladder
Dosage Forms	:	Tablet, Orally Disintegrating Tablet

More Information

• Keep XELENA 7.5MG TABLET out of reach in children
• Store XELENA 7.5MG TABLET at room temperature

FAQs About XELENA 7.5MG TABLET

What XELENA 7.5MG TABLET is used for?

XELENA 7.5MG TABLET is used in adults to manage symptoms of overactive bladder
conditions such as sudden urge to rush to the toilet, needing to go to the
toilet frequently and/or not getting to the toilet in time and wetting yourself
(urge incontinence).

How XELENA 7.5MG TABLET works?

XELENA 7.5MG TABLET works by blocking certain receptors (M3 muscarinic
acetylcholine receptors, responsible for bladder muscle contractions) which
reduces the muscle spasms of the bladder and urinary tract thereby relaxing the
bladder muscles that results in the  prevention of urgent, frequent, or
uncontrolled urination.

What happens if you take more XELENA 7.5MG TABLET than your required dose?

If you or anyone else accidentally takes too much of XELENA 7.5MG TABLET,
consult your doctor immediately or visit the nearby hospital. Symptoms of
overdose are dry mouth, constipation, headache, indigestion and/or nasal
dryness.

What are the common side effects of XELENA 7.5MG TABLET?

The most common side effects of taking XELENA 7.5MG TABLET are dry mouth,
constipation, headache, abdominal pain, indigestion, nausea, and/or dry eyes.
Consult your doctor if any of these symptoms worsens.

Is it safe to drive after taking XELENA 7.5MG TABLET?

Do not drive/operate machines if you experience dizziness, blurred vision,
trouble while sleeping, and/or drowsiness after taking XELENA 7.5MG TABLET.

Useful Diagnostic Tests

• Uroflowmetry
• Cystometry