This rectal ointment is indicated for:

• Internal and external hemorrhoids
• Anal itching (pruritus)
• Anal eczema
• Inflammation of the anal region (anitis)
• Perianal inflammation
• Acute hemorrhoidal thrombosis
• Anal fissure
• Preoperative and postoperative management in hemorrhoidectomy

Long-term use is not recommended.

Each gram of rectal ointment contains:

• Calcium Dobesilate BP 40 mg
• Lidocaine Hydrochloride USP 20 mg
• Dexamethasone Acetate BP 0.25 mg

Calcium Dobesilate acts on capillary walls by improving their altered physiological functions, such as increased permeability and reduced resistance, and helps reduce signs of inflammation. It also exhibits antithrombotic activity. Lidocaine Hydrochloride, a local anesthetic, provides relief from pain. Dexamethasone Acetate, a topical corticosteroid, exerts anti-inflammatory and antipruritic effects.

2-3 times daily. Apply in the morning and bedtime and if possible after defecation. If the ointment is preferred, use the applicator by screwing it to the tube. Insert the applicator as deep as possible in the anus then press the tube gently while withdrawing it. In this case, the tube is sufficient for 8 applications. In case of external hemorrhoids or anal pruritus, apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The doctor must be informed if, after 1 to 2 weeks of treatment, the symptomatology has not improved or has worsened.

Calcium Dobesilate, Lidocaine HCl & Dexamethasone Acetate Ointment should be applied 2-3 times daily preferably in the morning and at bedtime, if possible apply after defecation. In the case of internal hemorrhoids apply the ointment by the applicator. In cases of external hemorrhoids and anal pruritus, apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The physician must be informed if, after 1 to 2 weeks of treatment the symptomatology has not improved or has worsened.

Method of use of this ointment:

For internal use-

• Before use remove the cap from the tube.
• Pierce the tube membrane by inverting the cap.
• Attach the applicator (supplied) to the tube.
• Squeeze the tube to fill the applicator and lubricate the tip with ointment for smooth insertion.
• Insert the applicator gently and to full extend into the anus and squeeze once again from the end of the tube to force the required amount of ointment into the anal canal.
• Remove the applicator after application and discard it.
• Try not to have defecation for a couple of hours after an internal application.

For external use-

• Squeeze the tube of ointment and apply a small amount to the finger.
• Apply the ointment around the outside of the anus with a finger.
• Wash the hands thoroughly with warm water and soap after each application.
• Reattach the cap to tube.

This preparation is contraindicated in patients with hypersensitivity to any of its components.

Very rare cases may include changes in intestinal motility, temporary burning sensation, and local pain. Hypersensitivity reactions, including skin reactions and fever, may occur. These may be allergic in nature, and in such cases, treatment should be discontinued.

Pregnancy Category C. There are no adequate studies in pregnant women or animals. It is not known whether Calcium Dobesilate crosses the placental barrier. However, Lidocaine Hydrochloride and Dexamethasone Acetate may be systemically absorbed after topical application and can cross the placenta. Therefore, this medication should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus. After oral administration, Calcium Dobesilate is excreted in breast milk in small amounts, but data for topical use are limited. Lidocaine Hydrochloride and Dexamethasone Acetate may also pass into breast milk after topical use. As a precaution, a decision should be made whether to discontinue breastfeeding or stop treatment.

In patients with renal insufficiency, prolonged use of this rectal ointment should be avoided. Long-term treatment is not recommended.

No specific information on overdose is available.

Drugs used in the ano-rectal region

Store below 30°C and protect from heat.