COLINOL SPAS Tablet 10's

Introduction About COLINOL SPAS TABLET

COLINOL SPAS TABLET is a combination of Dicyclomine and Mefenamic Acid which
belongs to the group of medicines called Anticholinergics and Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) respectively. It is used for the management of
abdominal (stomach) pain and dysmenorrhea, it is a condition in women who
experience severe and frequent cramps and pain during menses.

COLINOL SPAS TABLET is not recommended for use in patients with pre-existing
renal disease or obstructive uropathy, asthma, increased pressure in eyes
(glaucoma), myasthenia gravis (muscle weakness), gastrointestinal conditions
like inflammatory bowel disease, severe ulcerative colitis, paralysis of
intestine (paralytic ileus), chronic constipation (intestinal atony) and toxic
dilatation of intestine (megacolon). COLINOL SPAS TABLET should be used with
caution in patients with heart diseases (heart failure, high blood pressure),
impaired liver function, fluid retention, prior history of ulcer disease or
gastro-intestinal bleeding and prostate enlargement.

COLINOL SPAS TABLET is not recommended for use in third trimester of pregnancy
and should be used with caution in first and second trimester of pregnancy. It
is not recommended for use in breastfeeding women. COLINOL SPAS TABLET is not
recommended for use in infants (below 6 months of age) and it should be used
with caution in elderly patients (aged 65 years and above) as it increases the
risk of gastrointestinal (GI) bleeding and perforation which may be fatal. The
common side effects of taking COLINOL SPAS TABLET are diarrhea, nausea,
vomiting, abdominal pain and constipation. Consult your doctor if any of the
side effects worsens.

Uses Of COLINOL SPAS TABLET

It is used to manage:

• abdominal pain
• dysmenorrhea (severe and frequent menstrual cramps and pain during menses)

How COLINOL SPAS TABLET Works

COLINOL SPAS TABLET contains Dicyclomine and Mefenamic acid. Dicyclomine works
by blocking the effects of a chemical called acetylcholine (responsible for
causing contraction of muscles) at the acetylcholine-receptor sites along with
direct spasmolytic effect upon smooth muscles (musculotropic). This helps to
relieve smooth muscle spasm of the intestine, bile duct, ureters and uterus.
Mefenamic acid works by inhibiting the enzyme cyclooxygenase (COX) which is
responsible for formation of chemical called prostaglandin that is responsible
for inflammatory response in the body.

How to use COLINOL SPAS TABLET

Take COLINOL SPAS TABLET as advised by your doctor. It must be taken preferably
after food. Swallow the medicine with a glass of water. Do not crush or chew the
medicine. Do not alter or discontinue the daily dose of COLINOL SPAS TABLET
after feeling better without consulting your doctor. Your doctor will decide the
correct dose and duration of COLINOL SPAS TABLET for you depending upon your
age, body weight and disease condition.

Side Effects Of COLINOL SPAS TABLET

Common

• diarrhea
• nausea
• vomiting
• flatulence
• constipation
• abdominal pain
• ulcerative stomatitis
• pe
• blood vomiting

Uncommon

• gastritis

Rare

• confusion
• depression
• hallucination
• nervousness

Stop taking COLINOL SPAS TABLET and contact your doctor immediately if you
experience any of the following side effects:

• signs of gastric problems such as ulcers in stomach, perforation or stomach bleeding leading to nausea, loss of taste, vomiting, diarrhea, bloated feeling, constipation, indigestion, stomach pain, blood in vomit and in stools, ulcers in mouth, inflammatory bowel disease (Crohn's disease)
• signs of blood related disorders such as hemolytic anemia (reversible), hypoplastic bone marrow, reduced in red blood cell, platelets, white blood cell count (leukopenia) with an increased risk of infection, sepsis and clotting disordering leading to uncontrollable bleeding
• severe allergic reactions such as asthma, bronchospasm or difficulty in breathing, skin disorders including rashes of various types, redness, extreme itching and rarely exfoliative or bullous skin lesions (including epidermal necrolysis and erythema multiforme)
• glucose intolerance in diabetic patients, low sodium levels in circulation
• confusion, depression, hallucinations, nervousness
• signs of nervous system disorders such as pain with eye movement and temporary vision loss in one eye, headaches, tingling, altered sensation, dizziness, drowsiness, numbness, mental confusion, excitement (especially in elderly persons), loss of sensation, speech disturbance, sleeplessness, ase
• eye irritation, reversible loss of color vision, visual disturbances like blurred vision, double vision, dilation, cycloplegia, increased eye pressure
• ear pain, tinnitus, vertigo
• signs of cardiac disorders such as edema, hypertension, tachycardia and with an increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) along with palpitations and hypotension
• asthma, breathing difficulties, nasal stuffiness or congestion, sneezing, throat congestion
• signs of skin disorders such as swelling (edema) of face and body, skin reactions, including Lyell's syndrome (toxic epidermal necrolysis) and stevens-johnson syndrome, excessive sweating, rash, photosensitivity reaction, itching and redness
• renal disorders such as allergic glomerulonephritis, acute interstitial nephritis, reduced or blood in urine, nephrotic syndrome, non-oliguric renal failure (particularly in dehydration), proteinuria, renal failure including renal papillary necrosis, urinary hesitancy, retention of urine
• fatigue, malaise, multi-organ failure, fever
• decreased sweating
• impotence (inability to keep erection)
• suppression of lactation

How To Manage Side Effects

!### Constipation

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole
grain cereals, and drink plenty of fluids. Exercise more regularly and stay
active. Consult your doctor if the symptom does not improve.

!### 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.

!### Nausea And Vomiting

Try to take COLINOL SPAS TABLET with or just after a meal or a snack. Stick to
simple meals. Avoid eating oil rich, fried or spicy foods. Consult your doctor
if the symptom does not improve.

!### Stomach Pain

Try to take rest and relax. Eat and drink slowly or try to have smaller and
frequent meals. Keep a heat pad on your stomach. If the symptom does not
improve, contact your doctor.

Warning & Precautions

!### Pregnancy

Consult your doctorCOLINOL SPAS TABLET should be used with caution in first and second trimester of
pregnancy only if considered clearly necessary. COLINOL SPAS TABLET is strictly
not recommended for use in third trimester of pregnancy as it can cause heart
defects in the fetus (premature closure of heart duct), delay in onset of labour
and increased bleeding tendency in mother. Consult your doctor before taking
COLINOL SPAS TABLET.

!### Breastfeeding

ContraindicatedCOLINOL SPAS TABLET is not recommended for use in breastfeeding women due to
increased risk of serious adverse reactions in nursing infants. If COLINOL SPAS
TABLET therapy is essential to mother, breast-feeding must be discontinued
during management period. Consult your doctor before taking COLINOL SPAS TABLET.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines if you experience dizziness, drowsiness,
fatigue, visual disturbances or blurred vision after taking COLINOL SPAS TABLET.

!### Alcohol

Consult your doctorAvoid consum
increase gastrointestinal bleeding, ulceration and perforation.

!### Kidney

ContraindicatedCOLINOL SPAS TABLET is not recommended for use in patients with pre-existing
renal disease or obstructive uropathy or in patients with significantly impaired
renal function. Consult your doctor before taking COLINOL SPAS TABLET.

!### Liver

Use with CautionCOLINOL SPAS TABLET should be taken with caution in patients with impaired liver
function.Consult your doctor before taking COLINOL SPAS TABLET.

!### Allergy

ContraindicatedDo not take COLINOL SPAS TABLET if you are allergic to Dicyclomine or Mefenamic
acid or any other ingredients of this medicine.

!### Lungs

ContraindicatedCOLINOL SPAS TABLET is not recommended for use in patients with pre-existing
asthma and aspirin-sensitive asthma. Consult your doctor before taking COLINOL
SPAS TABLET.

Heart Disease

Consult your doctorCOLINOL SPAS TABLET should be used with caution in patients with heart diseases
(such as heart failure, hypertension) as well as increased heart rate conditions
such as thyrotoxicosis, congestive heart failure and in cardiac surgery. COLINOL
SPAS TABLET is not recommended for use in management of peri-operative pain in
the setting of coronary artery bypass graft (CABG) surgery. Consult your doctor
before taking COLINOL SPAS TABLET.

!### Use In Pediatrics

ContraindicatedGBNKEYWORD is not recommended for use in infants (below 6 months of age). Other
dosage forms of this medicine can be used in children and adolescents (below 12
years of age). Consult your child’s doctor for advice before administration of
COLINOL SPAS TABLET to your child.

![### Use In Geriatrics

Use with CautionCOLINOL SPAS TABLET should be used with caution in elderly patients (65 years
and above) as it increases the risk of gastrointestinal (GI) bleeding and
perforation which may be fatal. Consult your doctor before taking COLINOL SPAS
TABLET.

Others

COLINOL SPAS TABLET is not recommended for use if you have:

• increased pressure in eyes (glaucoma)
• myasthenia gravis (muscle weakness and fatigue)
• gastrointestinal conditions like inflammatory bowel disease, severe ulcerative colitis, paralytic ileus, intestinal atony (chronic constipation), toxic dilatation of intestine (Megacolon)

Before taking COLINOL SPAS TABLET, inform your doctor if you:

• have a prior history of ulcer disease or gastro-intestinal bleeding
• have fever
• have fluid retention (edema)
• have prostate enlargement

Interactions

A. Drug-Drug interactions:

Before taking COLINOL SPAS TABLET, inform your doctor if you are taking any of
the following medicines:

• medicine used to correct heart rhythm (Ex. digoxin)
• medicine used to manage HIV infection (Ex. Zidovudine)
• medicines used to manage high blood pressure such as ACE Inhibitors (Ex. captopril, enalapril, lisinopril, benazepril) and diltiazem
• non-steroidal anti-inflammatory drugs (NSAID) that are used to relieve pain Ex. aspirin, ibuprofen, diclofenac, celecoxib
• erythromycin, fluoroquinolones such as ciprofloxacin, levofloxacin and aminoglycosides such as amikacin, tobramycin, gentamicin (used to manage bacterial infections)
• ketoconazole (used to manage fungal infections)
• colchicine (used to manage gout)
• lithium, isocarboxazid, phenelzine, amitriptyline (used to manage depression)
• immunosuppressant drugs (used to suppress immune activity) (Ex. methotrexate, cyclosporin, tacrolimus)
• medicines used to manage clot formation in blood such as anti-platelet drugs (Ex. warfarin, aspirin or clopidogrel)
• diuretics such as furosemide, hydrochlorothiazide (used to manage edema)
• medicines used to reduce acidity (Ex. magnesium hydroxide)
• oral anti-diabetic drugs used for the management of type 2 Diabetes (Ex. glimepiride, gliclazide, glibenclamide)
• corticosteroid drugs such as prednisone, prednisolone, methylprednisolone, dexamethasone (used to manage inflammatory conditions)
• latanoprost, tafluprost (used to manage glaucoma)
• antihistamines (Ex. chlorpheniramine, hydroxyzine, dimenhydrinate) (used to manage allergy)
• antipsychotic agents such as chlorpromazine, fluphenazine (used to manage psychosis)
• alprazolam, diazepam (used to manage anxiety and induce sleep)
• narcotic analgesics (Ex. meperidine) (used to relieve moderate to severe pain)
• nitroglycerin, isosorbide mononitrate (used to manage chest pain)
• medicines that affect gastrointestinal motility (Ex. metoclopramide)
• medicines used to manage pregnancy (abortion) (Ex. mifepristone)

Overdosage:

If you or anyone else accidentally takes too much of COLINOL SPAS TABLET,
consult your doctor immediately or visit the nearby hospital. Symptoms of
overdose are lethargy, drowsiness, nausea, headache, blurred vision, dilated
pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing,
vomiting, (upper stomach) epigastric pain, tonic-clonic (grand mal) fits,
gastrointestinal bleeding, high blood pressure, acute renal failure, CNS
stimulation (increased alertness, attention, energy and physical activity),
respiratory depression (slow and ineffective breathing), muscular weakness and
paralysis.

Synopsis

Drug	:	Dicyclomine, Mefenamic Acid
Pharmacological Category	:	Anti-cholinergic, Non-Steroidal Anti-Inflammatory Drugs
Therapeutic Indication	:	Abdominal pain, Dysmenorrhea
Dosage Forms	:	Tablet, Injection

More Information

Storage

• Keep COLINOL SPAS TABLET out of reach of children
• Store at room temperature

FAQs About COLINOL SPAS TABLET

Q: Can COLINOL SPAS TABLET relieve period pain?

A: Yes, COLINOL SPAS TABLET is an anti-spasmolytic and analgesic that helps to
relieve pain and cramps during mensuration. Consult your doctor regarding dose
and duration of course of COLINOL SPAS TABLET before taking it.

Q: Can I consume alcohol after taking COLINOL SPAS TABLET?

A: No, avoid consum
might lead to complications such as increased gastrointestinal bleeding,
ulceration and perforation.

Q: Is COLINOL SPAS TABLET safe to use in pregnant women?

A: COLINOL SPAS TABLET should be used with caution in first and second trimester
of pregnancy only if considered clearly necessary. COLINOL SPAS TABLET is
strictly not recommended for use in third trimester of pregnancy as it can cause
heart defects in the fetus (premature closure of heart duct), delay in onset of
labour and increased bleeding tendency in mother. Consult your doctor before
taking it.

Q: Can I take antacid along with COLINOL SPAS TABLET for stomach pain?

A: No, antacids (such as magnesium hydroxide) can interfere with absor
COLINOL SPAS TABLET. Hence its advisable not take both medicines together.
Consult your doctor before taking it.

Q: Can COLINOL SPAS TABLET be used in patients with kidney problems?

A: COLINOL SPAS TABLET is not recommended for use in patients with preexisting
renal disease or obstructive uropathy or in patients with significantly impaired
renal function. Consult your doctor before taking it.

Useful Diagnostic Tests

• Liver Function Test
• Kidney Function Test