Consists of dicyclomine hydrochloride, mefenamic acid
What are the possible side effects of Dicyclomine hydrochloride (Mefcil SPAS-20)?
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth; headache; lightheadedness; loss of taste; nausea; nervousness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing your eyes; difficulty moving; difficulty speaking; difficulty urinating; disorientation; exaggerated sense of well-being; fainting; hallucinations; pounding in the chest, rapid heartbeat; short-term memory loss; unusual weakness; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Side effects of Dicyclomine hydrochloride (Mefcil SPAS-20) in details
The pattern of adverse effects seen with dicylomine is mostly related to its pharmacological actions at muscarinic receptors. They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.
The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg 4 times a day).
In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions (MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo.
| MedDRA Preferred Term | Dicyclomine Hydrochloride (40 mg four times a day) % | Placebo % |
| Dry Mouth | 33 | 5 |
| Dizziness | 40 | 5 |
| Vision Blurred | 27 | 2 |
| Nausea | 14 | 6 |
| Somnolence | 9 | 1 |
| Asthenia | 7 | 1 |
| Nervousness | 6 | 2 |
Nine percent (9%) of patients were discontinued from dicyclomine because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.
Postmarketing Experience
The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- •
- Cardiac Disorders: palpitations, tachyarrhythmias
- •
- Eye Disorders: cycloplegia, mydriasis, vision blurred
- •
- Gastrointestinal Disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting
- •
- General Disorders and Administration Site Conditions: fatigue, malaise
- •
- Immune System Disorders: drug hypersensitivity including face edema, angioedema, anaphylactic shock
- •
- Nervous System Disorders: dizziness, headache, somnolence, syncope
- •
- Psychiatric Disorders: As with the other anticholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of dicyclomine. Nervousness and insomnia have also been reported.
- •
- Reproductive System and Breast Disorders: suppressed lactation
- •
- Respiratory, Thoracic and Mediastinal Disorders: dyspnoea, nasal congestion
- •
- Skin and Subcutaneous Tissue Disorder: dermatitis allergic, erythema, rash
Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action
Gastrointestinal: anorexia
Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia
Peripheral Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis)
Ophthalmologic: diplopia, increased ocular tension
Dermatologic/Allergic: urticaria, itching and other dermal manifestations
Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy
Cardiovascular: hypertension
Respiratory: apnea
Other: decreased sweating, sneezing, throat congestion, impotence
What is the most important information I should know about Dicyclomine hydrochloride (Mefcil SPAS-20)?
- Dicyclomine hydrochloride (Mefcil SPAS-20) may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Dicyclomine hydrochloride (Mefcil SPAS-20) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dicyclomine hydrochloride (Mefcil SPAS-20); it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not become overheated in hot weather or while you are being active; heatstroke may occur.
- Dicyclomine hydrochloride (Mefcil SPAS-20) may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
- Use Dicyclomine hydrochloride (Mefcil SPAS-20) with caution in the ELDERLY; they may be more sensitive to its effects.
- Dicyclomine hydrochloride (Mefcil SPAS-20) should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dicyclomine hydrochloride (Mefcil SPAS-20) while you are pregnant. Dicyclomine hydrochloride (Mefcil SPAS-20) is found in breast milk. Do not breast-feed while taking Dicyclomine hydrochloride (Mefcil SPAS-20).
Dicyclomine hydrochloride (Mefcil SPAS-20) contraindications
Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age, nursing mothers and in patients with:
- •
- unstable cardiovascular status in acute hemorrhage
- •
- myasthenia gravis
- •
- glaucoma
- •
- obstructive uropathy
- •
- obstructive disease of the gastrointestinal tract
- •
- severe ulcerative colitis
- •
- reflux esophagitis
What are the possible side effects of Mefenamic acid (Mefcil SPAS-20)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking Mefenamic acid (Mefcil SPAS-20) and seek medical attention or call your doctor at once if you have any of these serious side effects:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- urinating less than usual or not at all;
- pain, burning, or bleeding when you urinate;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
- bruising, severe tingling, numbness, pain, muscle weakness.
Less serious side effects may include:
- upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
- dizziness, headache, nervousness;
- skin itching or rash;
- dry mouth;
- increased sweating, runny nose;
- blurred vision; or
- ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Mefenamic acid (Mefcil SPAS-20) in details
Applies to Mefenamic acid (Mefcil SPAS-20): oral capsule
As well as its needed effects, Mefenamic acid (Mefcil SPAS-20) (the active ingredient contained in Mefenamic acid (Mefcil SPAS-20)) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Mefenamic acid (Mefcil SPAS-20), check with your doctor immediately:
More common:
- Bloody urine
- bloody, black, or tarry stools
- decreased frequency or amount of urine
- heartburn
- increased bleeding time
- increased blood pressure
- increased thirst
- indigestion
- itching skin
- loss of appetite
- lower back or side pain
- nausea
- pale skin
- rashes
- severe abdominal pain, cramping, or burning
- stomach bloating
- swelling
- swelling of the face, fingers, feet, or lower legs
- trouble breathing with or without exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- vomiting of material that looks like coffee grounds, severe and continuing
- weight gain
- weight loss
- Bleeding gums
- blood in vomit
- blurred vision
- burning feeling in the chest or stomach
- chest pain
- clay-colored stools
- cloudy urine
- confusion
- constipation
- cough or hoarseness
- dark urine
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty in swallowing
- dilated neck veins
- dizziness
- extreme fatigue
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- frequent urge to urinate
- headache
- increased volume of pale, dilute urine
- irregular breathing
- irregular heartbeat
- large, flat, blue, or purplish patches in the skin
- light-colored stools
- lightheadedness
- nervousness
- noisy breathing
- pain or burning throat
- pinpoint red or purple spots on the skin
- pounding in the ears
- rapid, slow breathing
- redness, swelling, or soreness of tongue
- severe or continuing stomach pain
- shortness of breath
- slow heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stomach upset
- swelling or inflammation of the mouth
- swollen glands
- tenderness in the stomach area
- tightness in the chest
- tremors
- unpleasant breath odor
- upper right abdominal pain
- weight changes
- wheezing
- yellow eyes and skin
- Blistering, peeling, or loosening of the skin
- change in consciousness
- chest discomfort
- continuing vomiting
- cracks in the skin
- diarrhea
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- drowsiness
- fever with or without chills
- flushed, dry skin
- fruit-like breath odor
- general body swelling
- general feeling of illness
- high fever
- hives
- increased hunger
- irregular, fast or slow, or shallow breathing
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- leg pain
- loss of consciousness
- loss of heat from the body
- no blood pressure
- no breathing
- no pulse
- nosebleeds
- painful glands
- pain or discomfort in the arms, jaw, back, or neck
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale or blue lips, fingernails, or skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- racing heartbeat or pulse
- red skin lesions, often with a purple center
- red, irritated eyes
- red, swollen skin
- redness or soreness of the skin
- scaly skin
- seeing, hearing, or feeling things that are not there
- seizures
- severe headache
- sneezing
- sores, welting, or blisters
- stiff neck and/or back
- sweating
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- unexplained weight loss
If any of the following symptoms of overdose occur while taking Mefenamic acid (Mefcil SPAS-20), get emergency help immediately:
Symptoms of overdose:
- Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Minor Side Effects
Some Mefenamic acid (Mefcil SPAS-20) side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
More common:
- Acid or sour stomach
- belching
- continuing ringing or buzzing or other unexplained noise in the ears
- excess air or gas in the stomach or intestines
- full feeling
- hearing loss
- passing gas
- stomach discomfort
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- discouragement
- dry mouth
- fear
- feeling of constant movement of self or surroundings
- feeling sad or empty
- hair loss, thinning of the hair
- increased sensitivity of skin to sunlight
- irritability
- lack of appetite
- lack of interest or pleasure
- lack or loss of strength
- redness or other discoloration of the skin
- sensation of spinning
- severe sunburn
- sleepiness
- sleeplessness
- trouble concentrating
- trouble sleeping
- unable to sleep
- Appetite changes
- burning, dry, or itching eyes
- change in hearing
- discharge, excessive tearing
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
What is the most important information I should know about Mefenamic acid (Mefcil SPAS-20)?
- Mefenamic acid (Mefcil SPAS-20) may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Mefenamic acid (Mefcil SPAS-20) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Serious stomach ulcers or bleeding can occur with the use of Mefenamic acid (Mefcil SPAS-20). Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Mefenamic acid (Mefcil SPAS-20) with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Mefenamic acid (Mefcil SPAS-20) is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using Mefenamic acid (Mefcil SPAS-20) unless your doctor tells you to.
- Mefenamic acid (Mefcil SPAS-20) may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Mefenamic acid (Mefcil SPAS-20).
- Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Mefenamic acid (Mefcil SPAS-20). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Mefenamic acid (Mefcil SPAS-20) with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
- Mefenamic acid (Mefcil SPAS-20) should be used with extreme caution in CHILDREN younger than 14 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Mefenamic acid (Mefcil SPAS-20) may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mefenamic acid (Mefcil SPAS-20) while you are pregnant. Mefenamic acid (Mefcil SPAS-20) is found in breast milk. Do not breast-feed while taking Mefenamic acid (Mefcil SPAS-20).
Mefenamic acid (Mefcil SPAS-20) contraindications
Mefenamic acid (Mefcil SPAS-20) (Mefenamic acid (Mefcil SPAS-20)) is contraindicated in patients with known hypersensitivity to Mefenamic acid (Mefcil SPAS-20).
Mefenamic acid (Mefcil SPAS-20) (Mefenamic acid (Mefcil SPAS-20)) should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Mefenamic acid (Mefcil SPAS-20) (Mefenamic acid (Mefcil SPAS-20)) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Mefenamic acid (Mefcil SPAS-20) (Mefenamic acid (Mefcil SPAS-20)) is contraindicated in patients with acute active ulceration or chronic inflammation of either the upper or lower gastrointestinal tract.
Mefenamic acid (Mefcil SPAS-20) (Mefenamic acid (Mefcil SPAS-20)) should not be used in patients with preexisting renal disease.
References
- DailyMed. "MEFENAMIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "mefenamic acid: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- DTP/NCI. "Merbentyl: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Mefcil SPAS-20 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Mefcil SPAS-20. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
