RECTO MENADERM 0.125 mg/g RECTAL OINTMENT

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the User

Recto Menaderm 0.125 mg/g Rectal Ointment

Beclometasone dipropionate

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

• Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you, 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Recto Menaderm and what is it used for
2. What you need to know before using Recto Menaderm
3. How to use Recto Menaderm
4. Possible side effects

5 Conservation of Recto Menaderm

1. Contents of the packaging and additional information

1. What is Recto Menaderm and what is it used for

It contains beclometasone dipropionate as the active ingredient, a corticosteroid, and belongs to a group of locally applied medications for some symptoms of hemorrhoids, as the active ingredient has anti-inflammatory activity and eliminates itching.

Recto Menaderm is indicated for the local symptomatic treatment of inflammatory anorectal manifestations and anal pruritus (itching) associated with hemorrhoids.

2. What you need to know before using Recto Menaderm

Do not use Recto Menaderm:

• if you are allergic to beclometasone or any of the other components of this medication (listed in section 6).
• if you have a bacterial, fungal, or viral infection in the area to be treated.

• if you have bleeding hemorrhoids.
• it should not be administered to children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Recto Menaderm.

• The use of corticosteroids, such as beclometasone, in local use, in excessive doses or for prolonged periods, with occlusive dressings or diapers, significantly increases the risk of side effects.
• If you experience sensitization (an allergic reaction), you should discontinue treatment and consult your doctor.
• If you develop an infection during the use of this medication, you should consult your doctor about your treatment and they will indicate whether you should discontinue treatment with Recto Menaderm.

• Avoid contact with the eyes and areas near them, as well as other areas not indicated.
• Elderly patients and debilitated patients in the acute phase should be cautious, as they may be more sensitive to the effects of the medication.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

This medication contains a component, beclometasone, which may produce a positive result in doping tests.

Children and adolescents

Recto Menaderm should not be used in children under 12 years of age for safety reasons.

In children, it is more likely that the corticosteroid may have side effects in other areas of the body.

Other medications and Recto Menaderm

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

Some medications may increase the effects of Recto Menaderm, so your doctor will monitor you closely if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Other preparations should not be applied to the area to be treated at the same time.

Pregnancy, breastfeeding, and fertility

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.

Recto Menaderm is not recommended during pregnancy.

It should not be used during pregnancy unless your doctor considers it clearly necessary and the potential benefit outweighs the potential risk to the fetus/child. In any case, it should not be used in large quantities or for long periods of time.

The doctor must decide whether to interrupt breastfeeding or treatment after considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

The use of this medication does not affect the ability to drive or use machines.

Recto Menaderm containsmethylparaben (E-218), propylparaben, lanolin, cetyl alcohol, and stearic alcohol.

It may cause allergic reactions (possibly delayed) because it contains methylparaben and propylparaben.

This medication may cause local skin reactions (such as contact dermatitis) because it contains lanolin, cetyl alcohol, and stearic alcohol.

3. How to use Recto Menaderm

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and children from 12 years: 1 to 2 applications per day on the affected area with an amount of ointment equivalent to 2 cm.

Anal and/or rectal use.

It is recommended to apply after intestinal evacuation and to wash and dry the area to be treated beforehand.

In case of internal hemorrhoids, it can be applied using the cannula attached to the packaging.

If the symptoms worsen or do not improve after 7 days of treatment, you should discontinue it and consult your doctor.

Use in children and adolescents

Recto Menaderm should not be used in children under 12 years of age.

If you use more Recto Menaderm than you should

The excessive use of topical corticosteroids (repeated overdoses) may produce side effects (see section 4).

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

If you forget to use Recto Menaderm

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

If you have forgotten a dose, continue with your usual schedule as indicated by your doctor or as described in this package leaflet.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

With the application of topical corticosteroids, the following effects have been reported, especially after prolonged application or in extensive areas or with occlusive dressings. The frequency cannot be estimated from the available data. The following side effects have been reported:

• Thinning of the skin (atrophy)
• Stretch marks
• Redness (erythema)
• Acne
• Small blood vessels in the skin (telangiectasia)
• Hypersensitivity reaction (allergic) of the skin, such as contact dermatitis
• Infections by fungi, viruses, or bacteria
• Bruises (bruises)
• Burning, itching, irritation, and dryness at the application site
• Macération
• Inflammation of hair follicles (folliculitis)
• Hair loss
• Blurred vision.

Side effects may occur not only in the treated area but also in completely different areas of the body, especially with prolonged use of corticosteroids or treatment of extensive areas. One of these effects is reversible suppression of the hypothalamic-pituitary-adrenal axis with manifestations of Cushing's syndrome, characterized, among other symptoms, by a rounded face, fat accumulation, delayed wound healing, psychiatric symptoms, etc. Other effects that may occur are: cataracts (subcapsular), hypertension, or edema (fluid accumulation).

Reporting side effects

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

5. Conservation of Recto Menaderm

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

No special storage conditions are required.

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

Do not use Recto Menaderm if you notice visible signs of deterioration.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Recto Menaderm 0.125 mg/g Rectal Ointment

• The active ingredient is beclometasone dipropionate. Each gram of ointment contains 0.125 mg of beclometasone dipropionate (0.0125%).
• The other components (excipients) are: solid paraffin, light liquid paraffin, cod liver oil, cetyl alcohol, stearic acid, stearic alcohol, lanolin, cetomacrogol 700, methylparaben (E 218), propylparaben, white beeswax, purified water.

Appearance of the product and contents of the packaging

Recto Menaderm is a rectal ointment with a uniform appearance and yellowish color.

It is presented in an aluminum tube. Each packaging contains a polyethylene cannula.

Packaging sizes:

Tube with 30 g of rectal ointment.

Tube with 60 g of rectal ointment.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LABORATORIOS FERMON, S.L.U.

Alfonso XII, 587 – E 08918 Badalona (Barcelona) Spain

• +34 934 628 800 – e-mail: [email protected]

Manufacturer:

LABORATORIOS MENARINI, S.A.

Alfonso XII, 587. Badalona (Barcelona) SPAIN

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

LABORATORIOS MENARINI, S.A.

Alfonso XII, 587 – E 08918 Badalona (Barcelona) Spain

• +34 934 628 800 – e-mail: [email protected]

Date of the last revision of this package leaflet:November 2017

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