Each gram of Proctomed cream contains:

active ingredients: phenylephrine hydrochloride – 2.5 mg, cinchocaine HCl (Dibucaine) – 10 mg, shark liver oil – 30 mg;
excipients: cetyl alcohol, glyceryl monostearate, white hard paraffin, propylene glycol (15%), polysorbate 60, methylparaben, propylparaben, water purified.

Combined preparation for the topical treatment of hemorrhoids. Proctomed cream contains shark liver oil, a natural source of vitamin A, which promotes wound healing and tissue repair thus relieving symptom accompanying the healing process. Shark liver oil acts also as an emollient and protectant that provides a physical barrier to irritation by foaming a protective layer over the mucous membranes and the skin of the anal region, thereby preventing excessive water loss from the tissues. Shark liver oil has anti-inflammatory, hemostatic, wound healing, immunomodulatory and anti-cancer effect due to its composition; fat-soluble vitamins and alkoxy glycerol.

Phenylephrine is adrenomimetic, has a local vasoconstrictor effect, which helps to reduce exudation and reduce swelling, itching, serous discharge with hemorrhoids and other anorectal diseases zone. Phenylephrine is used to provide temporary symptomatic relief of external or internal hemorrhoids. When applied rectally to the anorectal area, phenylephrine stimulate α-adrenergic receptors in the vascular beds with a resultant temporary constriction of arterioles and a modest and transient reduction in congestion (swelling) of hemorrhoidal tissues. Phenylephrine also may relieve anorectal pruritus, discomfort, and irritation, possibly in part secondary to some weak local anesthetic action; the mechanism of this local anesthetic effect is unknown. Phenylephrine also helps to prolong the duration of dibucaine-induced local and regional anesthesia. Phenylephrine also may relieve pruritus associated with histamine release. However, Phenylephrine is expected to provide only partial relief of pruritus associated with hemorrhoids, and there are more effective agents for relief of anorectal itching. The presence of other ingredients in the formulation (e.g., dibucaine, shark liver oil) may provide additional relief of these and other anorectal symptoms (e.g., discomfort, pain, burning) associated with hemorrhoids.

Dibucaine is one of the most potent and long-acting local anesthetics. Dibucaine causes rapid relief of pain and itching associated with painful hemorrhiods and other anal conditions.

• External and internal hemorrhoids,
• anal fissures,
• anal itching,
• pain relief after proctologic operations.

Adults and children over 12 years: before using the medication to the affected area carry out hygiene, namely, clean the affected area by gently patting with a cleaning tissue. Dry the area by gently patting with a piece of dry tissue or clean cloth. Remove the protective cover from the applicator tip, attach the applicator tip to the medication tube, and lubricate the applicator tip. Gently insert the applicator tip into the rectum and apply a small amount of this medication morning and evening. Apply some medication to the external area around the rectum as well. Apply the preparation to the affected area two times a day, morning and night. After each use, clean the applicator tip well and replace the protective cover. In conditions with severe pain, the cream may be applied up to 4 times daily.

Patients should be advised to consult a clinician if the anorectal condition worsens or does not improve within 4 weeks of treatment, or if bleeding occurs.

Local reactions: redness, itching, swelling.

Allergic reactions are possible.

No side effects are expected to occur. If side effects occur, notify your doctor promptly. If you notice any of the following unlikely but very serious side effects, stop using this medication and consult your doctor or pharmacist immediately: bleeding from the rectum, increased pain (after inserting the applicator tip). If you notice other effects not listed above, contact your doctor or pharmacist.

Phenylephrine

When used in recommended dosages for local effect in anorectal disorders (e.g., hemorrhoids), adverse systemic effects of vasoconstrictors such as phenylephrine generally are minimal. Such effects, although unlikely, can include blood pressure elevation, cardiac arrhythmia or irregular heart rate, CNS disturbance or nervousness, tremor, sleeplessness, and aggravation of hyperthyroid symptoms.

Based on observations with local use for nasal congestion, prolonged local use of excessive anorectal dosages of vasoconstrictors will likely lead to rebound vasodilation and congestion. Less commonly, prolonged local use of excessive anorectal dosages of vasoconstrictors can lead to anxiety and paranoia.

Phenylephrine reportedly is less likely than other topical vasoconstrictors (e.g., ephedrine, epinephrine) to cause local irritation. Contact dermatitis has been reported following topical application of certain formulations of vasoconstrictors.

The possibility that topical anorectal application of vasoconstrictors if absorbed systemically in adequate amounts could interact with monoamine oxidase (MAO) inhibitors resulting in potentiated hypertensive effects should be considered. Such hypertensive potentiation could result in serious, potentially fatal effects such as cerebral hemorrhage or stroke.

• Proctomed cream should not be used in individuals with known hypersensitivity to each ingredient.
• Children up to age 12 years.
• Thromboembolic disease.
• Granulocytopenia.

Unless otherwise directed by a clinician, patients should not receive Proctomed cream for self-medication of hemorrhoidal symptoms if they have cardiac disease, high blood pressure, thyroid disease, diabetes mellitus, or difficulty in urination secondary to prostatic hyperplasia. Patients also should be advised to consult a clinician before initiating self-medication with an anorectal preparation of the preparation if they currently are receiving an antihypertensive agent or antidepressant (e.g., monoamine oxidase inhibitor [MAO] inhibitor).

If rectal bleeding occurs during use of Proctomed cream for pain, itching, and burning of hemorrhoids or if rash, irritation, swelling, pain, bleeding, or other symptoms develop or increase during use of Proctomed cream, the preparation should be discontinued and a physician consulted.

Tell your doctor if you are pregnant before using this medication. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Treatment: in case of methemoglobinemia – i/v of methylene blue.

Tell your doctor of all prescription and nonprescription medication you may use, especially: high blood pressure medicine, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), antidepressants (e.g., fluoxetine, sertraline).

With simultaneous use of the preparation reduces the effect of antihypertensive drugs. Hypertensive crisis may develop when concomitant administration with antidepressants (e.g., fluoxetine, sertraline) and MAO inhibitors

Do not start or stop any medicine without doctor or pharmacist approval

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Bleeding from your rectum.
• No improvement, or worsened symptoms after using the medicine for 4 weeks.
• Pain in your rectum when using the medicine applicator.

White to off white homogenous cream.

20 g of cream is filled into aluminum tubes (inside package).
The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).

3 years. Do not use after the expiration date.

To be dispensed without prescription.

Store at a room temperature, in a dry place, out of the reach of children. Protect from light.