INTRODUCTION ABOUT ACISPAS TABLET

ACISPAS TABLET is a combination of Dicylcomine 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.

ACISPAS TABLET is not recommended for use in patients with preexisting 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).

ACISPAS 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.

ACISPAS 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.

ACISPAS 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 ACISPAS TABLET are diarrhea, nausea, vomiting, abdominal pain and constipation. Consult your doctor if any of the side effects worsens.

USES OF ACISPAS TABLET

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

HOW ACISPAS TABLET WORKS

ACISPAS TABLET has contains Dicyclomine and Mefenamic acid. Dicyclomine is an anti-spasmodic and anti-cholinergic drug. It 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 is non-steroidal anti-inflammatory drug which has anti-inflammatory, pain relieving and fever reducing action. It 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.

DIRECTIONS FOR USE

Take ACISPAS 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 ACISPAS TABLET after feeling better without consulting your doctor. Your doctor will decide the correct dose and duration of ACISPAS TABLET for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF ACISPAS TABLET

COMMON

diarrhea
nausea, vomiting
flatulence
constipation
abdominal pain
ulcerative stomatitis
peptic ulcers, perforation or gastrointestinal bleeding (in elderly)
blood vomit

UNCOMMON

gastritis

RARE

confusion
depression
hallucination
nervousness

Stop taking ACISPAS 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, aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, blurred vision, convulsions, insomnia
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.

Diarrhoea:

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.

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.

Nausea or vomiting:

Try to take ACISPAS 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.

WARNING & PRECAUTIONS

PREGNANCY

ACISPAS TABLET should be used with caution in first and second trimester of pregnancy only if considered clearly necessary. ACISPAS 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 ACISPAS TABLET.

BREASTFEEDING

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

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience dizziness, drowsiness, fatigue, visual disturbances or blurred vision after taking ACISPAS TABLET.

ALCOHOL

Avoid consumption of alcohol while taking ACISPAS TABLET because it might increase gastrointestinal bleeding, ulceration and perforation.

KIDNEY

ACISPAS 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 ACISPAS TABLET.

LIVER

ACISPAS TABLET should be taken with caution in patients with impaired liver function. Consult your doctor before taking ACISPAS TABLET.

ALLERGY

Do not take ACISPAS TABLET if you are allergic to dicyclomine or to mefenamic acid.

LUNGS

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

HEART DISEASE

ACISPAS TABLET must 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. ACISPAS 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 ACISPAS TABLET.

OTHERS

ACISPAS 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 ACISPAS TABLET, inform your doctor if you:

have a prior history of ulcer disease or gastro-intestinal bleeding
have fever
have fluid retention (edema)
are taking oral anticoagulant therapy (such as warfarin, aspirin or clopidogrel)
have prostate enlargement

Use in Pediatrics:

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

Use in Geriatrics:

ACISPAS 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 ACISPAS TABLET.

INTERACTIONS

A. Drug-Drug interactions:

Before taking ACISPAS 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, tacromilus)
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 ACISPAS 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 paralysis and coma.

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

Keep ACISPAS TABLET out of reach of children
Store at room temperature

FAQs ABOUT ACISPAS TABLET

Can ACISPAS TABLET relieve period pain?

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

Can I consume alcohol after taking ACISPAS TABLET?

No, avoid consumption of alcohol while taking ACISPAS TABLET because it might lead to complications such as increased gastrointestinal bleeding, ulceration and perforation.

Is ACISPAS TABLET safe to use in pregnant women?

Can I take antacid along with ACISPAS TABLET for stomach pain?

No, antacids (such as magnesium hydroxide) can interfere with absorption of ACISPAS TABLET. Hence its advisable not take both medicines together. Consult your doctor before taking it.

Can ACISPAS TABLET be used in patients with kidney problems?

REFERENCES

1. KD. Tripathi. Dicyclomine. Anticholinergic Drugs and Drugs Acting on Autonomic Ganglia. Essentials of medical pharmacology. Seventh edition. 2013. Page – 134.

2. Janczura M, Kobus-Moryson M, Sip S, Zarowski M, Warenczak A, Cielecka-Piontek J. Fixed-Dose Combination of NSAIDs and Spasmolytic Agents in the Treatment of Different Types of Pain—A Practical Review. Journal of Clinical Medicine. National Library of Medicine, National Institute of Health. 2021 [Accessed on 24th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8306558/

3. Bluecross Laboratories. Prescribing Information. [Revised in February 2020] [Accessed on 24th May 2022] https://www.bluecrosslabs.com/img/sections/MEFTAL-SPAS_DS_Tablets.pdf

4. Chemidex Pharma Limited. Medicines and Healthcare Regulatory Agency. [Revised in April 2020] [Accessed on 24th May 2022] https://mhraproducts4853.blob.core.windows.net/docs/d4501ba7a32f3ec237a13651b3b0caa0d2f25384

5. Axcan Scandipharm Inc. U.S. Food & Drug Administration. [Revised in July 2006] [Accessed on 24th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf

6. Lelypharma B.V. Electronic Medicines Compendium (EMC). [Revised in April 2020] [Accessed on 24th May 2022] https://www.medicines.org.uk/emc/files/pil.12891.pdf

USEFUL DIAGNOSTIC TESTS

Liver Function Test
Kidney Function Test

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 16 Nov 2022 | 01:38 PM(IST)