PRODUCT INFORMATION

Product Information: Information for the User

Recto Menaderm 0.125 mg/g rectal ointment

Beclometasone dipropionate

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

- Keep this product information, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to other people even if they have the same symptoms as 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 product information. See section 4.

1.What is Recto Menaderm and how is it used

2.What you need to know before starting to use Recto Menaderm

3.How to use Recto Menaderm

4.Possible side effects

5Storage of Recto Menaderm

6.Contents of the pack and additional information

Contains as active ingredientbeclometasona dipropionato,a corticosteroid,andbelongs to a group of local medicationfor some symptoms of hemorrhoids, as the active ingredient hasanti-inflammatory activity andeliminatesitching.

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

No use Recto Menaderm:

• if you are allergic to beclometasona or any of the other components of this medication (listed in section 6).
• if you have an infection caused by bacteria, fungi, or viruses in the area to be treated.

• if you have bleeding hemorrhoids.
• do not administer in children under 12 years old.

Advertencias and precautions

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

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

- Avoid contact with the eyes and nearby areas, as well as other areas not indicated.

- Elderly patients and debilitated patients in an 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, beclometasona, which may produce a positive result in doping control tests.

Children and adolescents

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

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

Other medications and Recto Menaderm

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

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

Do not apply other preparations to the area to be treated at the same time.

Pregnancy,breastfeedingand fertility

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

Do not recommend using Recto Menaderm during pregnancy.

You should not use it during pregnancy unless your doctor considers it clearly necessary and the potential benefit outweighs the potential risk to the fetus/child.

In any case, do not use it in large quantities or for long periods of time.

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

Driving and operating machinery

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

Recto Menaderm containsparahidroxibenzoate of methyl (E-218), parahidroxibenzoate of propyl, lanolin, cetyl alcohol, and stearic alcohol.

It may cause allergic reactions (possibly delayed) because it contains parahidroxibenzoate of methyl and parahidroxibenzoate of propyl.

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

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

The recommended dose is:

- Adults and children 12 years of age and older: 1 to 2 applications per day on the affected area with an amount of ointment equivalent to2 cm.

Anal and/or rectal use.

It is recommended to apply the medication after bowel evacuation and to clean and dry the area to be treated beforehand.

In case of internal hemorrhoids, it may be applied using the cannula provided in the packaging.

If symptoms worsen or do not improve within 7 days of treatment, discontinue use and consult your doctor.

Use in children and adolescents

Recto Menaderm should not be used in children under12 years of age.

If you use more Recto Menaderm than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or seek medical attention, or call the Toxicological Information Service, Teléfono 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Recto Menaderm

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

If you forgot a dose, continue with your regular schedule according to your doctor's instructions or the instructions in this prospectus.

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 will experience them.

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

• Skin thinning (atrophy)
• Dermatological striations
• Redness (erythema)
• Acne
• Small blood vessels in the skin (telangiectasia)
• Skin hypersensitivity reaction (allergic contact dermatitis)
• Fungal, viral, or bacterial infections
• Bruises (ecchymoses)
• Burning, itching, irritation, and dryness at the application site
• Maceration
• Folliculitis (inflammation of hair follicles)
• Hair loss
• Blurred vision.

Adverse 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 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 theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medicationout of the sight andreach of children.

No special storage conditions are required.

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

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubtask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Recto Menaderm0.125 mg/g rectal ointment

• The active ingredient is beclometasone dipropionate.Eachg of ointment contains 0.125 mg ofbeclometasone dipropionate (0.0125%).
• The other components(excipients)are: solid paraffin, light liquid paraffin, cod liver oil, cetyl alcohol, stearic acid, stearyl alcohol, lanolin, cetomacrogol 700, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, beeswax, purified water.

Appearance of the product and contents of the packaging

Recto Menaderm is a uniform, yellowish-colored rectal ointment.

It is presented in an aluminum tube. Each package 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 commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

LABORATORIOS FERMON, S.L.U.

AlfonsXII, 587 – E 08918 Badalona (Barcelona) Spain

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

Responsible manufacturer:

LABORATORIOS MENARINI, S.A.

Alfonso XII, 587. Badalona (Barcelona) SPAIN

For further information about this medicine, please contact the local representative of the marketing authorization holder:

LABORATORIOS MENARINI, S.A.

AlfonsoXII, 587 – E 08918 Badalona (Barcelona) Spain

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

Last revision date ofethisleaflet:November 2017

Further detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/