ANTIHEMORROIDAL CINFA RECTAL OINTMENT

Introduction

Leaflet: information for the user

Antihemorroidal Cinfa rectal ointment

Read the entire leaflet carefully before starting to use this medication,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Antihemorroidal Cinfa is and what it is used for
2. What you need to know before starting to use Antihemorroidal Cinfa
3. How to use Antihemorroidal Cinfa
4. Possible side effects

5 Conservation of Antihemorroidal Cinfa

1. Package contents and additional information

1. What Antihemorroidal Cinfa is and what it is used for

It is a rectal ointment (ano-rectal use) that contains as active ingredients neomycin sulfate (aminoglycoside antibiotic), hydrocortisone acetate (corticosteroid anti-inflammatory), benzocaine (topical anesthetic), and tannic acid (astringent). This combination relieves pain, inflammation, itching, or burning and discharge of some ano-rectal diseases.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Antihemorroidal Cinfa is indicated for the local symptomatic treatment of ano-rectal inflammation and anal pruritus associated with diseases such as hemorrhoids, anal fissure, anal eczema, or proctitis (inflammation of the rectal lining).

2. What you need to know before starting to use Antihemorroidal Cinfa

Do not use Antihemorroidal Cinfa

• If you are allergic to hydrocortisone, neomycin, benzocaine, tannic acid, or any other component of this medication (listed in section 6).
• If you have viral, tuberculous, or primary bacterial or fungal infections, as well as in the presence of bleeding.
• If you have pre-existing neurological deafness.
• In large quantities, in occlusive dressings, or on extensive areas for a prolonged period, due to the risk of ear toxicity (ototoxicity), nephrotoxicity, methemoglobinemia (blood disorder), or other adverse reactions.
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Antihemorroidal Cinfa.

• In case of irritation in the application area, the medication should be discontinued, and appropriate treatment should be initiated.
• Caution is required in case of asthma.
• If an associated infection occurs, it is advisable to incorporate complementary specific treatment.
• Athletes are informed that this medication contains a component (hydrocortisone) that may result in a positive doping test.
• Avoid contact of Antihemorroidal Cinfa with the eyes.
• It should not be administered on severe burns or deep wounds, nor for prolonged use, mainly in occlusive dressings and extensive skin areas.
• Prolonged use of antibiotics/corticosteroids on the skin may occasionally lead to the proliferation of non-sensitive organisms, including fungi. In these cases, treatment should be discontinued, and a doctor should be consulted.
• Concomitant use with other antibiotics of the same group as neomycin in the same area or by another route of administration is not recommended.
• Cross-allergic reactions have been described between neomycin and other aminoglycoside antibiotics, and between benzocaine and other local anesthetics of the ester type, and with sulfonamides (antibiotics), thiazides (for hypertension), among others.
• Do not use concomitantly with cholinesterase inhibitors (for Alzheimer's disease, such as donepezil, galantamine, rivastigmine), as they inhibit the metabolism of benzocaine.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Do not administer to children under 2 years of age.

In case of use in pediatric population (children over 2 years and under 12), the minimum possible dose is recommended for the shortest possible time, under medical supervision.

The use of Antihemorroidal Cinfa in children is not recommended due to the higher risk of methemoglobinemia related to benzocaine and because they may absorb proportionally larger amounts of topical corticosteroids and be more sensitive to toxicity inside the body.

Use in elderly people

Elderly people are more prone to experience side effects, so a dose adjustment may be necessary.

Maintaining normal intestinal function through a suitable diet (fruits, vegetables, adequate fluid intake, and regular exercise) is recommended. It may be helpful to take a laxative, bulk-forming agent, or stool softener simultaneously.

Other medications and Antihemorroidal Cinfa

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

If you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment, as they may increase side effects:

1. Cholinesterase inhibitors such as donepezil, galantamine, and rivastigmine, for Alzheimer's disease (see Warnings and Precautions section).
2. Other aminoglycoside antibiotics such as streptomycin and gentamicin.
3. Sulfonamides, as they may inhibit the action of these.
4. It is recommended to avoid applying other local anesthetics to the same area, due to an additive effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The use of Antihemorroidal Cinfa during pregnancy or breastfeeding is not recommended.

Driving and using machines

The influence of Antihemorroidal Cinfa on the ability to drive or use machines is nil or insignificant.

Antihemorroidal Cinfacontains methylparaben (E218) and propylparaben

It may produce allergic reactions (possibly delayed) because it contains methylparaben (E-218) and propylparaben.

3. How to use Antihemorroidal Cinfa

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Rectal route (ano-rectal use).

The recommended dose is: 1 to 3 applications per day.

Apply a thin layer of ointment (approx. 1 cm) to the affected anal area, clean and dry.

To use it inside the rectum (anal canal), screw the cannula onto the tube and carefully insert the tip into the rectum. Then, apply a small amount of ointment by exerting gentle pressure on the tube.

After application, unscrew the cannula from the tube and wash it before storing it.

Personal hygiene is very important to control the symptoms of ano-rectal diseases, as well as a diet rich in fiber to help combat constipation. Keep the area clean; it is recommended to wash it after each bowel movement with mild soap and dry it without rubbing with a clean towel.

If after 7 days of treatment the symptoms do not improve, or bleeding appears, the clinical situation should be reevaluated.

Wash your hands before and after each application. For hygiene reasons and to avoid infections, the cannula should only be used by a single patient.

Use in children

Do not administer to children under 2 years of age.

In case of use in pediatric population (children over 2 years and under 12), the minimum possible dose is recommended for the shortest possible time, under medical supervision.

If you use more Antihemorroidal Cinfa than you should

Taking into account the route of administration of this medication, it is unlikely that intoxication will occur if the instructions are followed correctly.

The use of higher doses of corticosteroids than recommended increases the risk of side effects.

In case of chronic overdose or inadequate use, topical corticosteroids may be absorbed in sufficient quantities to produce systemic effects. They may suppress the hypothalamic-pituitary-adrenal axis function, producing secondary adrenal insufficiency and manifestations of Cushing's syndrome, including glucosuria and hyperglycemia.

The severity of tannic acid intoxication should be based on clinical and laboratory findings. Hepatic necrosis is the most severe manifestation of tannic acid intoxication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Antihemorroidal Cinfa

Do not use a double dose to make up for forgotten doses.

Use the dose as soon as possible, or if it is close to the next dose, use it at the usual time, following the normal course of treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can produce side effects, although not all people experience them.

With unknown frequency from available data, local adverse reactions such as allergic contact dermatitis may appear, mainly due to hypersensitivity to the preparation. Dryness, burning, or itching of the skin, blurred vision may occur.

If sensitivity or irritation occurs in the treated area, the treatment should be discontinued.

A rare but serious adverse drug reaction has been reported: blue discoloration of the skin and mucous membranes (methemoglobinemia).

Due to systemic absorption of corticosteroids, especially with the application of large doses on extensive surfaces or with occlusive treatment or prolonged use, skin atrophy, acneiform eruptions, skin maceration, or striae may also occur.

After systemic absorption of corticosteroids, suppression of the hypothalamic-pituitary-adrenal axis may occur, including manifestations of Cushing's syndrome (round face, fat accumulation in the abdomen, etc.), as well as glucosuria and hyperglycemia.

Prolonged use of benzocaine on the mucous membranes can produce dehydration of the epithelium or a caustic effect.

Prolonged use of antibiotics/corticosteroids on the skin may occasionally lead to the proliferation of non-sensitive organisms, including fungi.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Antihemorroidal Cinfa

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging and carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Antihemorroidal Cinfa

The active ingredients are: hydrocortisone acetate, neomycin sulfate, benzocaine, and tannic acid.

Each gram of rectal ointment contains 25 mg of hydrocortisone acetate (2.5%); 5 mg of neomycin sulfate (0.5%); 15 mg of benzocaine (1.5%); and 10 mg of tannic acid (1%).

The other components are: petrolatum, liquid paraffin, microcrystalline wax, cholesterol, methylparaben (E-218), and propylparaben.

Appearance of the product and package contents

Antihemorroidal Cinfa is a rectal ointment; it has a greasy consistency, is homogeneous, yellowish in color, and has no odor or a slight fatty odor.

Antihemorroidal Cinfa is packaged in aluminum tubes with a white polyethylene cap and comes with an applicator cannula.

Cardboard boxes:

Tube of 10 g of ointment

Tube of 30 g of ointment

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this leaflet:April 2022.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es/