Registered Rwanda · Rwanda FDA

XALME SPAS

Mephenamic Acid BP 250mg and Dicyclomino Hydrochloride USP 10mg

Rwanda FDA-HMP-MA-1457 Tablets 250mg and 10mg

What it does

Dicyclomine is a medication that helps relieve stomach and bowel discomfort.

Commonly used for: irritable bowel syndrome (IBS), stomach cramps, intestinal spasms

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1457
Registration date
20/07/2024
Expiry date
19/07/2029
Status
Registered
Active ingredient
Mephenamic Acid BP 250mg and Dicyclomino Hydrochloride USP 10mg
Dosage form
Tablets
Strength
250mg and 10mg
Pack size
10 tablets
Therapeutic class
-
Manufacturer / MAH
Bliss Gvs Pharma
Applicant / LTR
BLISS GVS PHARMA LTD
Country of origin
INDIA
Manufacturer location
102, Hyde Park, Saki Vihar Rd, Ganesh Nagar, Marol, Andheri East, Mumbai, Maharashtra 400072, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:12 · updated 2026-09-21 02:30:20

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About dicyclomino

Dicyclomine is a medication that helps relieve stomach and bowel discomfort.

What it treats

  • irritable bowel syndrome (IBS)
  • stomach cramps
  • intestinal spasms

How it works

Dicyclomine works by relaxing the muscles in the stomach and intestines, which helps reduce pain and discomfort.

Who it's for

It is suitable for adults who experience muscle spasms in the gut.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About mephenamic

Mephenamic acid is a pain-relieving medicine often used to help with various types of pain.

What it treats

  • pain relief
  • menstrual pain (dysmenorrhea)
  • mild to moderate pain from conditions like arthritis or injuries

How it works

It reduces pain and inflammation in the body by blocking substances that cause these feelings.

Who it's for

It is suitable for adults and children over a certain age who need relief from pain.

Cautions

  • • Not suitable for people with certain heart, kidney, or liver problems.
  • • Should be used with care in those who have asthma or allergies.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: dicyclomino

Dicyclomine is an anticholinergic medication primarily used to relieve muscle spasms in the gastrointestinal tract. It works by decreasing the activity of the smooth muscle in the gut, thereby alleviating discomfort associated with conditions such as irritable bowel syndrome. Dicyclomine is commonly prescribed for its ability to reduce spasms and cramping in the intestines, leading to improved digestive comfort.

Indications

  • Irritable bowel syndrome
  • Functional bowel disorders
  • Abdominal cramps
  • Spastic colon

Dosage

Children: Refer to established dosing guidelines; consult a healthcare professional for individual recommendations based on specific clinical conditions.

Adults: Refer to established dosing guidelines; consult a healthcare professional for individual recommendations based on specific clinical conditions.

Mechanism of action

Dicyclomine acts as a competitive antagonist at muscarinic acetylcholine receptors. By blocking these receptors, it inhibits the action of acetylcholine, which is responsible for promoting gut motility. This leads to a reduction in gastrointestinal motility and secretions, providing symptomatic relief from abdominal pain and cramping.

Pharmacodynamics

Dicyclomine exhibits antispasmodic properties, primarily affecting the smooth muscle of the gastrointestinal tract. Its anticholinergic effects result in relaxation of the smooth muscle, thereby decreasing motility and secretions. This is particularly beneficial in conditions characterized by increased gastrointestinal activity.

Pharmacokinetics

Dicyclomine is well absorbed from the gastrointestinal tract after oral administration. It undergoes hepatic metabolism, and its metabolites are excreted primarily through the kidneys. The elimination half-life of dicyclomine is approximately 1 to 2 hours, but the duration of action may be longer due to its effects on smooth muscle. Dicyclomine's distribution is influenced by its lipophilicity, allowing it to cross the blood-brain barrier and potentially cause central nervous system side effects.

Contra-indications

  • Myasthenia gravis
  • Severe ulcerative colitis
  • Glaucoma
  • Prostatic hypertrophy
  • Tachyarrhythmias
  • Hypersensitivity to dicyclomine or any component of the formulation

Adverse effects

  • Dry mouth
  • Dizziness
  • Nausea
  • Blurred vision
  • Constipation
  • Tachycardia
  • Urinary retention
  • Confusion or agitation (especially in elderly patients)

Interactions

  • Anticholinergic agents may enhance the effects
  • Antidepressants (tricyclics) may have additive anticholinergic effects
  • Antihistamines may increase drowsiness
  • Alcohol may increase sedation
  • Neuromuscular blockers may have enhanced effects

Precautions

  • Caution in patients with gastrointestinal obstruction
  • Use with care in elderly patients due to increased sensitivity
  • Monitor for signs of urinary retention
  • Caution in patients with cardiovascular disease
  • May cause drowsiness; avoid driving or operating heavy machinery

Pregnancy

Dicyclomine is classified as a Category C drug. Risk cannot be ruled out; use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Dicyclomine is excreted in breast milk. Caution is advised when administering to nursing mothers, as there is potential for adverse effects in the infant.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Oral tablets
  • Oral syrup
  • Injection

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: mephenamic

Mephenamic acid is a non-steroidal anti-inflammatory drug (NSAID) belonging to the anthranilic acid derivative class. It is primarily used for its analgesic and anti-inflammatory properties, often indicated for the treatment of mild to moderate pain, including dysmenorrhea. It works by inhibiting the synthesis of prostaglandins, which are mediators of pain and inflammation.

Indications

  • Mild to moderate pain
  • Dysmenorrhea
  • Osteoarthritis
  • Rheumatoid arthritis

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations in paediatric patients.

Adults: The adult dosage typically ranges from 500 mg to 1000 mg taken orally, with a maximum daily limit of 3000 mg. Dosing frequency may vary based on the condition being treated and clinical response.

Mechanism of action

Mephenamic acid functions by inhibiting cyclooxygenase (COX) enzymes, particularly COX-1 and COX-2, which are critical in the conversion of arachidonic acid to prostaglandins. By reducing prostaglandin levels, mephenamic acid effectively decreases inflammation, pain, and fever.

Pharmacodynamics

The analgesic effect of mephenamic acid is attributed to its ability to reduce the levels of prostaglandins, which sensitize pain receptors and contribute to the inflammatory response. Additionally, mephenamic acid exhibits antipyretic properties, helping to lower fever. Its anti-inflammatory effects are beneficial in conditions characterized by inflammation and pain.

Pharmacokinetics

Mephenamic acid is rapidly absorbed after oral administration, with peak plasma concentrations typically occurring within 1 to 2 hours. It is extensively metabolized in the liver, primarily through glucuronidation, and has a half-life of approximately 2 hours. The drug is eliminated via urine, mainly as metabolites. Food can alter its absorption but does not significantly affect its overall bioavailability.

Contra-indications

  • Hypersensitivity to mephenamic acid or any of its excipients
  • Active or history of peptic ulcer disease
  • Severe renal impairment
  • Severe hepatic impairment
  • History of gastrointestinal bleeding
  • Pregnancy (particularly in the third trimester)

Adverse effects

  • Gastrointestinal disturbances (nausea, vomiting, diarrhea, constipation)
  • Dizziness
  • Headache
  • Rash
  • Elevated liver enzymes
  • Renal impairment
  • Rarely, hypersensitivity reactions (anaphylaxis, skin reactions)

Interactions

  • Increased risk of gastrointestinal bleeding with other NSAIDs or anticoagulants
  • May reduce the effectiveness of antihypertensive medications
  • Caution with diuretics due to potential renal impairment
  • May enhance effects of methotrexate

Precautions

  • Use with caution in patients with a history of asthma, as it may induce bronchospasm
  • Monitor renal function in patients with existing renal impairment
  • Caution in patients with cardiovascular disease due to potential fluid retention and hypertension

Pregnancy

Mephenamic acid is contraindicated during pregnancy, especially in the third trimester, due to potential risks to the fetus, including cardiovascular effects and premature closure of the ductus arteriosus.

Breast-feeding

Mephenamic acid is excreted in breast milk; caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Tablets (e.g., 250 mg, 500 mg)
  • Capsules

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.