Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets)

1. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) © The Swiss Pharmacy

2. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Dicyclomine Hydrochloride and Acetaminophen tablets is a combination medication primarily used in the treatment of spasmodic pain and discomfort due to biliary colic, intestinal colic, renal colic and spasmodic dysmenorrhea (painful irregular periods). It also helps alleviate the symptoms of irritable bowel syndrome (IBS). © The Swiss Pharmacy

3. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) are manufactured by Wallace Pharmaceuticals Private Limited, India in the strengths of Dicyclomine Hydrochloride 20 mg and Paracetamol (Acetaminophen) 500 mg. © The Swiss Pharmacy

4. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Chemical Structure - Dicyclomine Hydrochloride © The Swiss Pharmacy

5. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Chemical Structure - Acetaminophen © The Swiss Pharmacy

6. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) The active ingredient contained in Colimex tablets are Dicyclomine Hydrochloride and Acetaminophen (Paracetamol). Each uncoated Colimex tablet contains of 20 mg of Dicyclomine Hydrochloride and 500 mg of Acetaminophen (Paracetamol). © The Swiss Pharmacy

7. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Uses of Colimex tablets: Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) is used for relief from spasmodic pain and discomfort due to biliary colic, relieving spasmodic pain associated with stones in the kidney or gallbladder, pain in the stomach during or before intestinal colic, renal colic and spasmodic dysmenorrhea. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

8. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Uses of Colimex tablets: Dicyclomine Hydrochloride is used for the treatment of functional gastrointestinal tract conditions involving smooth muscle spasm such as irritable colon (mucous colitis, spastic colon, irritable bowel syndrome) and spastic constipation. It can also be used as adjunctive therapy in organic gastrointestinal conditions to relieve associated smooth muscle spasm such as in colitis, diverticulitis, regional enteritis, gastritis, and peptic ulcer. Acetaminophen (Paracetamol) temporarily relieves minor aches and pains due to headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache and premenstrual and menstrual cramps. This medicine also temporarily reduces fever. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

9. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Recommended Dosage The dosage of Colimex Tablets Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) is given below: Adults Including The Elderly And Children 13 Years and Above: Adults Including The Elderly And Children 13 Years and Above: One tablet every 8 hours as required, to a maximum of 3 tablets daily. This product is not to be used in children below 12 years of age URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

10. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Contraindications ➔Colimex tablets are contraindicated in patients with a known hypersensitivity to Dicyclomine Hydrochloride, Acetaminophen (Paracetamol) or any other component of the tablet. ➔Administration of Colimex is contraindicated in patients with severe hepatic impairment or severe active liver disease. ➔Also contraindicated in a small fraction of patients that show untoward reactions to Dicyclomine Hydrochloride. ➔Other contraindications include unstable cardiovascular status in acute hemorrhage, myasthenia gravis, glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, severe ulcerative colitis and reflux esophagitis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

11. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Storage Instructions Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

12. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Warnings Administration of Acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Acetaminophen. Use caution when administering Acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance 30 mL/min or less). Discontinue Colimex tablets immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with Acetaminophen or Dicyclomine Hydrochloride allergy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

13. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Warnings Severe liver damage may occur if you take more than 4,000 mg of Acetaminophen (Paracetamol) in 24 hours which is the maximum daily amount. However it is highly recommended to keep your dosage under 3,250 mg in any 24-hour period. Severe liver damage may occur if you take this medicine with other drugs containing Acetaminophen (Paracetamol). Severe liver damage may occur if you take 3 or more alcoholic drinks every day while using Colimex tablets. Acetaminophen may cause severe skin reactions. Symptoms may include skin reddening, blisters and rash. In case a skin reaction occurs, stop use and seek medical help right away. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

14. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Warnings Do not use with any other drug containing Acetaminophen (Paracetamol) (prescription or nonprescription). If you are not sure whether a drug contains Acetaminophen (Paracetamol), ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug Warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, new symptoms occur or redness or swelling is present. These could be signs of a serious condition. In case you are pregnant or breast-feeding, ask a health professional before use. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

15. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Warnings Dicyclomine Hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation. With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

16. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Warnings Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery. Caution should be taken in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon. Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis. Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention Dicyclomine Hydrochloride should be used with caution in patients with known hepatic and renal impairment. Dicyclomine Hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

17. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Possible Side Effects The most serious possible side effects due to Dicyclomine Hydrochloride include cardiovascular and central nervous system symptoms. The most common side effects (with an incidence rate of 5% or greater of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

18. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Possible Side Effects Side effects of Acetaminophen tablets (Paracetamol) are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia, neutropenia, pancytopenia, leukopenia and agranulocytosis but these were not necessarily causality related to Paracetamol. Very rare cases of serious skin reactions have been reported. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

19. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Colimex Overdosage The signs and symptoms of Dicyclomine Hydrochloride overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

20. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Colimex Overdosage Toxic symptoms due to Acetaminophen overdose include vomiting, abdominal pain, hypotension and sweating. The most serious adverse effect of acute overdose of Acetaminophen tablets (Paracetamol) is a dose-dependent, potentially fatal hepatic necrosis. Clinical and laboratory evidence of hepatoxicity may be delayed for up to one week. Major manifestations of liver failure such as jaundice, hypoglycemia and metabolic acidosis may take at least 3 days to develop. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

21. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Treatment of Colimex Overdosage In cases of overdose, methods of reducing the absorption of ingested drug are important. Gastric lavage is essential even if several hours have elapsed. Prompt administration of 50g activated charcoal and 500ml iced Mannitol 20% by mouth, may reduce absorption. If the history suggests that 15g Acetaminophen (Paracetamol) or more has been ingested, administer one of the antidotes. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote for Dicyclomine Hydrochloride. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

22. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Colimex Tablets During Pregnancy Colimex is a combination medication containing Dicyclomine Hydrochloride and Acetaminophen (Paracetamol). Acetaminophen (Paractamol) has been classified by the US FDA as Pregnancy Category C. This medicine is considered to be the analgesic of choice in pregnant patients. However Acetaminophen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

23. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Colimex Tablets During Pregnancy Dicyclomine Hydrochloride has been classified by the US FDA as Pregnancy Category B. Adequate and well-controlled studies have not been conducted with Dicyclomine Hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy

24. Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) Colimex Tablets Colimex Tablets (Generic Dicyclomine Hydrochloride and Acetaminophen Tablets) are manufactured by Wallace Pharmaceuticals Private Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9752_Colimex-Tablets.html © The Swiss Pharmacy