Generic Cyclopam ( Dicyclomine/Paracetamol )

Buy Generic Cyclopam (Dicyclomine/Paracetamol) without prescription in Canada

Cyclopam (Dicyclomine 20 mg / Paracetamol 500 mg): Comprehensive Patient Information for Canada

Basic Product Information

Mechanism of Action

In simple terms: Cyclopam is a combination medicine that relaxes the muscles in the gut and relieves pain. Dicyclomine is an antispasmodic that works by blocking the action of acetylcholine, a chemical that causes the intestinal muscles to contract. By blocking this chemical, dicyclomine helps relax the smooth muscles of the stomach and intestines, easing spasms and cramps. Paracetamol (acetaminophen) is a pain reliever and fever reducer that works in the brain to reduce pain signals and lower fever. Together, these ingredients target both the cause of the cramp (the spasm) and the resulting pain.

For specialists: Dicyclomine hydrochloride is a synthetic anticholinergic agent with direct musculotropic and antimuscarinic activity. It acts on the smooth muscle of the gastrointestinal tract to relieve spasm. Dicyclomine blocks acetylcholine at muscarinic receptors, which reduces smooth muscle contraction and decreases gastric and intestinal motility. The drug has both local anesthetic and anticholinergic properties. Paracetamol (acetaminophen) is a centrally acting analgesic and antipyretic with weak peripheral anti-inflammatory effects. Its mechanism of action is not fully understood but is believed to involve inhibition of prostaglandin synthesis in the central nervous system, activation of descending serotonergic pathways, and interaction with the endogenous opioid system. The combination is used to provide symptomatic relief of spasmodic pain in gastrointestinal, biliary, renal, and gynecological conditions.

Pharmacokinetics

• Absorption: Dicyclomine is rapidly absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are reached approximately 60 to 90 minutes after a single oral dose. Paracetamol is rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations occurring 0.5 to 2 hours after oral administration. The rate of absorption of paracetamol may be delayed by the anticholinergic effect of dicyclomine, which slows gastric emptying.
• Metabolism: Dicyclomine is extensively metabolized in the liver. The major metabolic pathways include hydrolysis, oxidation, and conjugation. Paracetamol is metabolized primarily in the liver through glucuronidation and sulfation, with a small fraction metabolized by CYP2E1 to the toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI), which is normally detoxified by glutathione.
• Elimination: Dicyclomine is excreted primarily in the urine and feces. The elimination half-life is approximately 1.8 hours. Paracetamol is excreted primarily in the urine as conjugated metabolites. The elimination half-life is approximately 2 to 3 hours. In overdose, the half-life may be prolonged.
• Onset of Action: Symptomatic relief of abdominal cramps typically begins within 30 to 60 minutes after oral administration.
• Duration of Action: The antispasmodic and analgesic effects typically last for approximately 4 to 6 hours.

Uses in Daily Life and Best Practice Advice

Cyclopam is used in jurisdictions where it is approved for the symptomatic relief of spasmodic pain. In Canada, the combination product is not approved, but your physician may prescribe dicyclomine and acetaminophen separately for similar indications. The information below reflects the use of the combination product for educational and reference purposes.

• Typical Uses: Relief from spasmodic pain and discomfort due to biliary colic, intestinal colic, renal colic, and spasmodic dysmenorrhea (painful menstruation). It is also used for abdominal cramps and stomach pain associated with irritable bowel syndrome (IBS) and other functional gastrointestinal disorders.
• Administration: The usual dose is one tablet up to four times a day. Swallow the tablet whole with water, with or without food. Taking it with food may reduce the chance of stomach upset.
• Monitoring: If symptoms do not improve or worsen, consult your physician. Do not use for more than a few days without medical advice.
• Do Not Exceed Recommended Dose: Do not take more than the prescribed dose. The maximum daily dose of paracetamol should not exceed 4,000 mg per day from all sources.

Morning vs. Evening Dosing

Cyclopam is typically taken up to four times a day, with doses spaced throughout the day. There is no specific clinical recommendation for morning versus evening dosing. The dosing schedule is driven by your symptoms. Always follow the schedule recommended by your physician.

• Divided Dosing: The daily dose is usually divided into three or four doses taken throughout the day.
• Consistency: Take the medication at the same times each day if prescribed on a regular schedule.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
• Professional Guidance: Your healthcare provider will determine the optimal dosing frequency based on your condition and response to treatment.

Administration With or Without Food

Cyclopam can be taken with or without food. However, taking it with food may help reduce the risk of stomach upset. Swallow the tablet whole with a glass of water. Do not chew or crush the tablet.

• Take the tablet with a full glass of water.
• Cyclopam can be taken with or without food.
• Taking it with food may reduce the chance of stomach upset.
• Do not chew or crush the tablet.
• Avoid drinking alcohol while taking this medication, as it can worsen drowsiness and increase the risk of liver toxicity from paracetamol.

Interaction Warnings

Indications for Dicyclomine/Paracetamol

"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence. The combination product is not approved by Health Canada.

Dosing According to Clinical Indication

Doses should always be adjusted according to the advice of your physician and depending on your health condition. Do not exceed the recommended dose. The combination product is not approved in Canada, and the dosing information reflects its use in jurisdictions where it is authorized.

Side Effects and Safety Profile

Guidelines for Correct Use

• Take Cyclopam exactly as prescribed by your physician. Do not change your dose without medical advice.
• Swallow the tablet whole with a full glass of water. Do not chew or crush the tablet.
• Take it with or without food. Taking it with food may reduce the chance of stomach upset.
• Do not exceed the recommended dose. The maximum daily dose of paracetamol should not exceed 4,000 mg per day from all sources.
• Do not take other medicines containing paracetamol while taking Cyclopam.
• Avoid drinking alcohol while taking this medication.
• Do not drive or operate machinery until you know how this medication affects you.
• If you are pregnant, planning to become pregnant, or breastfeeding, consult your physician before use.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double the dose.
• Store at room temperature (10–30°C) in a cool, dry place. Keep out of reach of children.

Alternative Treatment Options

• Dicyclomine (single-agent): Available in Canada as a prescription medication in 10 mg and 20 mg tablets. Used for the relief of spastic conditions of the gastrointestinal tract. May be used alone or in combination with acetaminophen taken separately.
• Acetaminophen (Tylenol): Available over the counter in Canada for pain relief. May be taken with dicyclomine as separate products under the guidance of a healthcare provider.
• Hyoscine butylbromide (Buscopan): An antispasmodic available in Canada by prescription or over the counter in some formulations. Used for abdominal cramps and spasms.
• Peppermint Oil (enteric-coated): A natural antispasmodic that may help relieve IBS-related abdominal pain and bloating. Available over the counter in Canada.
• Mebeverine (Colofac, Colospa): An antispasmodic available in some international markets but not approved in Canada. May be accessible through international pharmacy channels for personal use under specific circumstances.
• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) (e.g., ibuprofen, naproxen): Used for pain and inflammation. Not recommended for long-term use in gastrointestinal conditions due to the risk of stomach irritation.

Comparison: Cyclopam is a combination of dicyclomine and paracetamol that provides both antispasmodic and analgesic effects in a single tablet. In Canada, this combination is not available, but dicyclomine and acetaminophen can be prescribed or purchased separately. Dicyclomine targets the underlying spasm, while paracetamol provides pain relief without the gastrointestinal irritation associated with NSAIDs. For patients with IBS or other functional gastrointestinal disorders, this combination may offer convenient symptomatic relief. However, the anticholinergic side effects of dicyclomine (dry mouth, blurred vision, constipation) may limit its use in some patients. Your physician will determine the best option for your specific condition.

Legal Status, Registration, and Coverage in Canada

• Registration: Cyclopam (dicyclomine 20 mg / paracetamol 500 mg) is not approved by Health Canada. The combination product is manufactured in India by Indoco Remedies Ltd. and is available in other jurisdictions. In Canada, dicyclomine is authorized for sale as a single-agent prescription drug (10 mg and 20 mg tablets) by Health Canada. Acetaminophen is authorized for sale as an over-the-counter product in various strengths.
• Prescription Status: Cyclopam is not available in Canada. Dicyclomine is prescription only in Canada. Acetaminophen is available over the counter.
• Coverage: Not applicable for the combination product, as it is not available in Canada. Dicyclomine is covered by some provincial drug plans under limited use criteria. Acetaminophen is generally not covered by provincial drug plans for over-the-counter use.
• Pharmacovigilance: Adverse reactions to dicyclomine or acetaminophen in Canada should be reported to Health Canada's MedEffect Canada program.

Recent Research and Clinical Guidelines (2022–2026)

• A 2024 study published in the Russian Medical Review evaluated the efficacy and safety of the dicycloverine and paracetamol combination in the treatment of irritable bowel syndrome. The drug containing dicycloverine 20 mg and paracetamol 500 mg was prescribed as 1 tablet 3 times daily for 5 days, and symptoms improved.
• Dicyclomine remains a commonly used antispasmodic in clinical practice for the symptomatic relief of abdominal cramps and spasms associated with functional gastrointestinal disorders and IBS.
• The combination of dicyclomine and paracetamol is widely used in India and other jurisdictions for spasmodic pain and discomfort due to biliary colic, intestinal colic, renal colic, and spasmodic dysmenorrhea.
• Research continues to explore the role of antispasmodics in the management of IBS, with dicyclomine remaining one of the first-line pharmacological options for abdominal pain in IBS in many guidelines.
• In Canada, clinical practice guidelines recommend dicyclomine and other antispasmodics as treatment options for IBS-related abdominal pain and cramps. The combination of dicyclomine and acetaminophen is not standard practice in Canada, but the individual components are used.

Availability and Supply in Canada

Prices and availability may vary by province, territory, and pharmacy. Cyclopam is not available in Canada. Dicyclomine and acetaminophen are available separately and may be prescribed or purchased together under the guidance of a healthcare provider. Check with your local pharmacy for current pricing and availability.

Frequently Asked Questions (FAQ)

1. Is Cyclopam available in Canada?
   No. Cyclopam (dicyclomine 20 mg / paracetamol 500 mg) is not approved by Health Canada and is not commercially available in Canada. However, dicyclomine and acetaminophen are available separately in Canada.
2. What is Cyclopam used for?
   Cyclopam is used for the relief of spasmodic pain and discomfort due to biliary colic, intestinal colic, renal colic, and spasmodic dysmenorrhea. It is also used for abdominal cramps and stomach pain associated with irritable bowel syndrome (IBS) and other functional gastrointestinal disorders.
3. How does Cyclopam work?
   Cyclopam contains two active ingredients. Dicyclomine is an antispasmodic that relaxes the smooth muscles of the gut, easing spasms and cramps. Paracetamol (acetaminophen) is a pain reliever that reduces pain associated with cramping. Together, they target both the spasm and the pain.
4. What is the dose of Cyclopam?
   The usual dose is one tablet (dicyclomine 20 mg + paracetamol 500 mg) up to four times a day. Do not exceed the recommended dose. The maximum daily dose of paracetamol should not exceed 4,000 mg per day from all sources.
5. Can I take Cyclopam with food?
   Yes. Cyclopam can be taken with or without food. Taking it with food may reduce the chance of stomach upset.
6. What should I do if I miss a dose?
   If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
7. What are the serious side effects of Cyclopam?
   Serious side effects include severe cutaneous adverse reactions (SJS, TEN), hepatotoxicity (liver damage from paracetamol), and severe allergic reactions. Seek immediate medical attention if you experience signs of a severe skin reaction, signs of liver problems, or severe allergic reactions.
8. Can I take Cyclopam if I am pregnant?
   Consult your physician before use if you are pregnant, planning to become pregnant, or breastfeeding. Cyclopam should be used during pregnancy only if clearly needed.
9. Can I drink alcohol while taking Cyclopam?
   No. Alcohol should not be consumed while taking Cyclopam because it can worsen drowsiness and increase the risk of liver toxicity from paracetamol.
10. What are the alternatives to Cyclopam in Canada?
    In Canada, dicyclomine (as a single agent) and acetaminophen (as a single agent) can be prescribed or purchased separately. Other antispasmodics such as hyoscine butylbromide and peppermint oil are also available. Your physician will determine the best option for your specific condition.