Colpep Spas Tablet 10'S

Introduction About COLPEP SPAS TABLET

COLPEP SPAS TABLET is a combination of Aceclofenac and Drotaverine which belongs
to the group of medicines called Antispasmodics. It is used to manage
dysmenorrhea (menstrual pain), abdominal pain and cramps.

Do not use COLPEP SPAS TABLET if you are allergic to other NSAIDs like ibuprofen
or aspirin. Before taking COLPEP SPAS TABLET, inform your doctor if you have a
history of stomach ulcer, have vomited blood, passed blood in faeces, have any
kidney, heart, liver, bowel or blood clotting problems, porphyria, diabetes,
chicken pox or if you have undergone any bypass surgery.

COLPEP SPAS TABLET is not recommended for use in pregnant and breastfeeding
women unless considered necessary by your doctor. COLPEP SPAS TABLET is not
recommended for use in children and adolescents (under 18 years of age) so,
consult your child’s doctor for advice.

Avoid smoking while taking COLPEP SPAS TABLET. The most common side effects of
taking COLPEP SPAS TABLET are dizziness, dry mouth, nausea, sleepiness, blurred
vision and weakness. Contact your doctor if any of the symptoms worsen over
time.

Uses Of COLPEP SPAS TABLET

Manages,

• dysmenorrhea
• abdominal pain
• cramps

How COLPEP SPAS TABLET Works

COLPEP SPAS TABLET relieves abdominal pain and cramps where Drotaverine relieves
contractions in the abdomen by inhibiting phosphodiesterase-IV (a substance
specific for smooth muscles) and Aceclofenac blocks the release of
prostaglandins (certain chemicals) responsible for causing pain and
inflammation.

How to use COLPEP SPAS TABLET

Always take COLPEP SPAS TABLET as directed by your physician. Swallow the
medicine with a glass of water and do not crush or chew the medicine. Your
doctor will decide the correct dose and duration of COLPEP SPAS TABLET
management depending upon your age, body weight and disease condition. Do not
stop taking COLPEP SPAS TABLET unless your doctor advises you to stop.

Side Effects Of COLPEP SPAS TABLET

Common

• dizziness, weakness
• dry mouth, nausea
• sleepiness
• blurred vision

Uncommon

• mouth ulcers
• inflammation or irritation of stomach lining
• itching, rash, hives, skin inflammation
• increase in blood urea and creatinine levels
• constipation, gas

Rare

• allergic reaction
• problems with eyesight
• heart failure, high blood pressure, breathlessness
• stomach or bowel bleeding or ulceration

Stop taking this medicine and contact your doctor immediately if you experience
any of the following side effects:

• severe allergic reaction like anaphylactic shock (fever, difficulty breathing, wheezing, abdominal pain, vomiting, swollen face and throat)
• frequent infections, such as a sore throat, fever or mouth ulcers
• bruising or bleeding
• severe skin rashes such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (large blisters and the skin peeling away, rash appearing in the mouth, throat or eyes, fever, headache and joint pain)
• meningitis (high fever, headache, vomiting, red rashes, neck stiffness, sensitivity to light)
• blood in faeces or black tarry stools, vomit with blood or dark particles
• kidney failure
• indigestion, heartburn, stomach pain
• blood disorders (extreme tiredness, breathlessness, aching of the joints and becoming prone to repeated infections and bruising)

How To Manage Side Effects

Nausea:

Take COLPEP SPAS TABLET with or just after meals. Stick to simple meals. Avoid
eating oily or spicy foods. If symptom persists, contact your doctor.

Headache:

Take some rest, in a quiet place. Avoid using mobile phones and other electronic
devices for a while. Drink water as inadequate hydration may lead you to develop
a headache. If the symptom persists, contact your doctor.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or
machines while you are feeling dizzy. If the symptom persists, contact your
doctor.

Dry mouth:

Sip water regularly and other sugar free liquids. Do not use alcoholic
mouthwashes because they can make your mouth dry, use the one that is used only
for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco
products. If dryness persists, consult your doctor.

Warning & Precautions

!### Pregnancy

COLPEP SPAS TABLET is not recommended for use in pregnant women unless
considered clearly necessary (especially in last 3 months). Consult your doctor
before taking it.

!### Breastfeeding

COLPEP SPAS TABLET is not recommended for use in breastfeeding women unless
considered clearly necessary. Consult your doctor before taking it.

!### Driving and Using Machines

Do not drive or operate any machines if you experience dizziness, spinning
sensation, drowsiness, tiredness or any difficulty with your eyesight after
taking COLPEP SPAS TABLET.

!### Kidney

COLPEP SPAS TABLET is not recommended for use in patients with severe kidney
disease.

COLPEP SPAS TABLET should be used with caution in patients having other kidney
diseases. Consult your doctor before taking it.

!### Liver

COLPEP SPAS TABLET is not recommended for use in patients who have or suspect
they have severe liver failure.

COLPEP SPAS TABLET should be used with caution in patients with other liver
diseases. Consult your doctor before taking it.

!### Allergy

Do not take COLPEP SPAS TABLET if you are allergic to Aceclofenac, Drotaverine,
aspirin, any other NSAIDs (Ex. ibuprofen, naproxen or diclofenac) or any of the
other ingredients of this medicine.

!### Lungs

COLPEP SPAS TABLET should be used with caution in patients having asthma or any
other breathing problems. Consult your doctor before taking it.

!### Heart Disease

COLPEP SPAS TABLET is not recommended for use in patients having heart diseases
like heart attack and cerebrovascular diseases like stroke or mini stroke or
those who have undergone a surgery to clear or bypass blockages.

COLPEP SPAS TABLET should be used with caution in patients with angina, blood
clots, high blood pressure, cholesterol or other body fats such as
triglycerides. Consult your doctor before taking it.

Others

COLPEP SPAS TABLET is not recommended for use if you:

• had, have or suspect that you have a stomach ulcer
• have vomited blood or passed black tarry stools
• have blood circulation problems
• have bleeding or blood clotting disorders
• glaucoma (increased eye pressure)

Before taking COLPEP SPAS TABLET inform your doctor if you:

• have stomach or bowel disorders (Ex. ulcerative colitis, Crohn’s disease, ulceration, bleeding or holes in the stomach or bowel)
• have or had blood circulation problems to your brain
• have porphyria (rare genetic disorder)
• smoke
• have diabetes
• have systemic lupus erythematosus (an autoimmune condition)
• have connective tissue disorders
• have chicken pox
• are recovering from any major surgery

Use in paediatrics:

COLPEP SPAS TABLET is not recommended for use in children and adolescents (below
18 years of age). Consult your child’s doctor for advice.

Use in geriatrics:

COLPEP SPAS TABLET should be used with caution in elderly people. Consult your
doctor before taking it.

Interactions

A. Drug - Drug interactions:

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

• medicines used for mental health problems (Ex. fluoxetine, fluvoxamine, citalopram, escitalopram, paroxetine, sertraline, lithium)
• medicines used to manage heart failure, irregular heartbeats, high blood pressure and other heart problems (Ex. digoxin, enalapril, lisinopril, losartan, candesartan, hydralazine, methyldopa, clonidine, moxonidine, propranolol, quinidine, procainamide)
• medicines used to manage infection (ciprofloxacin, ofloxacin, levofloxacin, moxifloxacin)
• medicines used to manage fluid retention (Ex. hydrochlorothiazide, furosemide, amiloride)
• medicines that stop blood clotting (Ex. warfarin, heparin)
• methotrexate (used to manage cancer and autoimmune disorders like arthritis and skin conditions)
• mifepristone (used to terminate pregnancy)
• medicines used to manage swelling and inflammation (Ex. hydrocortisone, prednisolone)
• medicines used to suppress the immune system after transplant (Ex. ciclosporin, tacrolimus)
• zidovudine (used to manage HIV)
• medicines used to reduce blood sugar levels in diabetes (Ex. glibenclamide, gliclazide, tolbutamide)
• other medicines used to reduce pain (Ex. aspirin, ibuprofen, naproxen, celecoxib, etoricoxib)
• clopidogrel (used to dissolve blood clots)
• phenobarbital (used to control fits)
• levodopa (used in Parkinsons’ management)
• morphine (used to manage severe pain)

Overdosage:

If you or anyone else accidentally took too much of COLPEP SPAS TABLET, consult
your doctor immediately.Symptoms of COLPEP SPAS TABLET overdose include heart
problems or paralysis of breathing center.

Synopsis

Drug	:	Aceclofenac, Drotaverine
Pharmacological Category	:	Non-steroidal anti-inflammatory drugs (NSAIDs), Antispasmodics
Therapeutic Indication	:	Dysmenorrhea, Abdominal pain, Cramps
Dosage Forms	:	Tablet, Injection

More Information

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

FAQs About COLPEP SPAS TABLET

Can I take paracetamol along with COLPEP SPAS TABLET?

No, if you take paracetamol along with COLPEP SPAS TABLET, it will result in
overdosing of NSAIDs, affecting the liver. Avoid taking any other painkillers
along with COLPEP SPAS TABLET without your doctor’s advice.

Can COLPEP SPAS TABLET cause dizziness?

Yes, dizziness is a common side effect caused by COLPEP SPAS TABLET. Try to rest
and relax. Get enough sleep. Avoid driving or operating any tools or machines if
you feel dizzy. Contact your doctor if dizziness persists.

Can I take additional doses of COLPEP SPAS TABLET if my pain does not
reduce?

No, you are not advised to take additional doses of COLPEP SPAS TABLET without
doctor’s advice as it may cause seriously harmful effects. If you or anyone else
accidentally took too much of COLPEP SPAS TABLET, consult your doctor
immediately.

What if I miss a dose of COLPEP SPAS TABLET?

If you miss a dose of COLPEP SPAS TABLET, take it as soon as you remember.
However, skip that dose if it's almost time to take the next dose. Do not take
COLPEP SPAS TABLET two times to make up for the missed dose.

Can I stop taking COLPEP SPAS TABLET if I feel better?

Keep taking COLPEP SPAS TABLET until your doctor tells you to stop, unless you
experience any unusual effects, worsening of your condition or any new symptoms.
Contact your doctor in such situation.

Can COLPEP SPAS TABLET be taken in pregnancy?

COLPEP SPAS TABLET is not recommended for use in pregnancy unless your doctor
finds it necessary (especially in last 3 months). If you are pregnant, think you
may be pregnant or are planning to have a baby, consult your doctor before
taking COLPEP SPAS TABLET.