Senade^® (Tablets) Instructions for Use

Marketing Authorization Holder

Cipla Ltd. (India)

Manufactured By

Cipla Ltd. (India)

Contact Information

Dr. Reddy’s Laboratories Ltd. (India)

ATC Code

A06AB06 (Sennosides A and B)

Active Substance

Sennosides A and B (Grouping name)

Dosage Form

Senade®

Tablets 13.5 mg: 40, 60, or 500 pcs.

Dosage Form, Packaging, and Composition

Tablets from brown to dark brown with specks, flat, round, with beveled edges; on one side of the tablet the word “CIPLA” is embossed, on the other side – a break line.

Excipients : lactose monohydrate – 23.07 mg, corn starch – 43.56 mg, methylparaben – 0.04 mg, microcrystalline cellulose – 15 mg, talc – 11.13 mg, magnesium stearate – 0.93 mg, sodium lauryl sulfate – 0.93 mg, carmellose sodium – 2 mg.

20 pcs. – blisters (2) – carton packs.
20 pcs. – blisters (3) – carton packs.
20 pcs. – blisters (25) – carton packs.

Clinical-Pharmacological Group

Laxative drug that stimulates intestinal peristalsis

Pharmacotherapeutic Group

Laxative of plant origin

Pharmacological Action

Laxative of plant origin. It has a laxative effect, which occurs after 8-10 hours. The laxative effect is due to the effect on the receptors of the large intestine, enhancing peristalsis.

Pharmacokinetics

In accordance with the International Convention (EMEA/HMPWG/11/99), when conducting clinical studies of herbal medicinal products, an isolated study of pharmacokinetic parameters is not required.

Indications

• Constipation caused by hypotension and sluggish peristalsis of the large intestine;
• Regulation of stool in hemorrhoids, proctitis, anal fissures.

ICD codes

Dosage Regimen

The drug is administered orally, usually once a day in the evening before bedtime, with water or some drink.

Adults and children over 12 years old – 1 tab. once a day. If there is no effect, the dose can be increased to 2-3 tablets.

Children aged 6-12 years are prescribed 1/2 tab. once a day and, if necessary, the dose is increased to 1-2 tablets.

During the selection process, the same dose should be taken for several days and gradually increased by 1/2 tab. If defecation does not occur for 3 days after reaching the maximum dose, it is necessary to consult a doctor.

Adverse Reactions

From the digestive system cramping abdominal pain, flatulence are possible; with prolonged use, especially in high doses, deposition of melanin in the intestinal mucosa, nausea, vomiting, diarrhea are possible.

From the metabolism with prolonged use, especially in high doses, disturbances of water-electrolyte balance, deposition of melanin in the intestinal mucosa are possible.

From the urinary system with prolonged use, especially in high doses, albuminuria, hematuria, discoloration of urine are possible.

From the CNS with prolonged use, especially in high doses, convulsions, fatigue, confusion are possible.

Dermatological reactions with prolonged use, especially in high doses, skin rash is possible.

From the cardiovascular system with prolonged use, especially in high doses, vascular collapse is possible.

Contraindications

• Spastic constipation;
• Intestinal obstruction;
• Abdominal pain of unclear origin;
• Strangulated hernia;
• Acute inflammatory diseases of the abdominal cavity;
• Peritonitis;
• Gastrointestinal and uterine bleeding;
• Cystitis;
• Disturbances of water-electrolyte balance;
• Children under 6 years of age;
• Hypersensitivity to the components of the drug.

With caution should be prescribed for liver and/or kidney diseases, during pregnancy, during breastfeeding, in conditions after abdominal surgery.

Use in Pregnancy and Lactation

Senade^® should be used with caution during pregnancy. It is not recommended to use the drug during breastfeeding.

Use in Hepatic Impairment

With caution should be prescribed for liver diseases.

Use in Renal Impairment

With caution should be prescribed for kidney diseases.

Pediatric Use

The drug is used in children aged 6 years and older.

Special Precautions

It is not recommended to use Senade^® for more than 2 weeks.

After taking the drug, urine may turn yellow-brown or red-lilac.

The drug contains lactose.

Use in pediatrics

The drug is used in children aged 6 years and older.

Overdose

Symptoms diarrhea leading to dehydration.

Treatment increasing fluid intake is usually sufficient to compensate for the loss of fluid and electrolytes. In some cases, replenishment of fluid and electrolyte loss with intravenous infusions of plasma substitutes is required.

Drug Interactions

With prolonged use of Senade^® in high doses, it is possible to enhance the effect of cardiac glycosides and influence the effect of antiarrhythmic drugs due to the possibility of hypokalemia development.

With simultaneous use with thiazide diuretics, corticosteroids, licorice root preparations, the risk of hypokalemia development increases.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.