Label: information for the user

Antihemorroidal Cinfa rectal cream

Read this label carefully before starting to use this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you must not give it to other people even if they have the same symptomsas you, as it may harm them.

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

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

2.What you need to knowbeforestarting touse Antihemorroidal Cinfa

3.How to use Antihemorroidal Cinfa

4.Possible side effects

5Storage of Antihemorroidal Cinfa

6.Contents of the package and additional information

It is a rectal cream (anorectal use) that contains as active principles neomycin sulfate (aminoglycoside antibiotic), hydrocortisone acetate (corticosteroid anti-inflammatory), benzocaine (topical anesthetic) and tannic acid (astringent). This association relieves pain, inflammation, itching or stinging and exudate of some anorectal diseases.

Antihemorroidal Cinfa is indicated for the local symptomatic treatment of anorectal inflammation and anal itching associated with diseasessuch as hemorrhoids, anal fissure, anal eczema or proctitis (inflammation of the rectal lining).

No use Antihemorroidal Cinfa

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

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 suspended, and appropriate treatment should be initiated.
• Caution is required in case of asthma.
• If an associated infection occurs, it is advisable to incorporate specific complementary treatment.
• It is reported to athletes that this medication contains a component (hydrocortisone) that may result in a positive analytical control test for doping.
• Avoid contact with Antihemorroidal Cinfa and the eyes.
• Do not administer in severe burns or deep wounds, or for prolonged use, mainly in occlusive dressings and extensive skin areas.
• The prolonged use of antibiotics/corticosteroids on the skin may occasionally lead to the proliferation of non-susceptible organisms, including fungi. In these cases, treatment should be suspended, and the doctor should be consulted.
• The concurrent 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 concurrently with cholinesterase inhibitors (for Alzheimer's disease, such as donepezil, galantamine, and 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 old.

In case of use, it is recommended to use the minimum possible dose and for the shortest possible time, under medical supervision.

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

Use in elderly individuals

Elderly individuals are more prone to adverse effects, so a dose adjustment may be necessary.

Maintain normal intestinal function through an appropriate diet (fruits, vegetables, adequate fluid intake, and regular exercise). Taking a laxative, volume expander, or stool softener simultaneously may be helpful.

Other medications and Antihemorroidal Cinfa

Inform your doctor or pharmacist if you are using, have used recently, 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 the risk of adverse 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. Avoid applying in the same area as other local anesthetics, due to additive effect.

Pregnancy and lactation

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

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

Driving and operating machinery

The influence of Antihemorroidal Cinfa on the ability to drive or operate machinery is negligible or insignificant.

Antihemorroidal Cinfa contains parahydroxybenzoate methyl (E218) and parahydroxybenzoate butyl

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate methyl (E-218) and parahydroxybenzoate butyl.

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

Rectal route (anorectal 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 while applying 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 anorectal diseases, as well as a diet rich in fiber to help combat constipation. It is recommended to wash the area after each bowel movement, with a 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 prevent infections, the cannula should only be used by one patient.

Use in children

Do not administer to children under 2 years.

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

If you use more Antihemorroidal Cinfa than you should

Considering the administration route of this medication, it is unlikely to cause intoxication, following the instructions correctly.

The use of amounts greater than recommended corticosteroids increases the risk of adverse effects.

In case of chronic overdose or improper use, topically applied corticosteroids could absorb sufficient amounts to produce systemic effects. They may suppress pituitary-adrenal function, producing secondary adrenal insufficiency and manifestations of hypercorticism, including Cushing's syndrome.

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 overdoseor accidental ingestion, consult your doctor or pharmacist immediately or callthe Toxicological Information Service, phone 91 562 04 20,indicating the medication and the amount ingested.

If you forgot to use AntihemorroidalCinfa

Do not use a double dose to compensate for the missed doses.

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Infrequently, based on available data, adverse reactions of a local nature may appear, such as contact allergic dermatitis, mainly due to hypersensitivity to the preparation. Redness, burning, or itching of the skin, blurred vision may appear.

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

A rare but serious 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 areas or with occlusive treatment or prolonged use, atrophy of the skin, acneiform eruptions, skin maceration, and striae may also occur.

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

Prolonged use of benzocaine in mucous membranes may cause dehydration of the epithelium or caustic effect.

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

Reporting of Adverse Effects

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

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at theSIGREcollection point at the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Antihemorroidal Cinfa

The active principles 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 petrolatum, microcrystalline wax, cholesterol, methyl parahydroxybenzoate (E-218), butyl parahydroxybenzoate.

Appearance of the product and contents of the packaging

Antihemorroidal Cinfa is a rectal ointment; it has a greasy consistency, is homogeneous, yellowish in color and odorless or has a faint greasy odor.

Antihemorroidal Cinfa is presented in aluminum tubes with a polyethylene plug, white in color, and provided with a dispensing nozzle.

Carton boxes:

Tube of 10 g of ointment

Tube of 30 g of ointment

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:April 2022.

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