Recto Menaderm 0.125 mg/g rectal ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET
Package leaflet: Information for the user
Recto Menaderm 0.125 mg/g rectal ointment
Beclometasone dipropionate
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, 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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
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What Recto Menaderm is and what it is used for
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What you need to know before using Recto Menaderm
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How to use Recto Menaderm
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Possible side effects
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How to store Recto Menaderm
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Contents of the pack and other information
1. What Recto Menaderm is and what it is used for
It contains as its active substance beclometasone dipropionate, a corticosteroid, and belongs to a group of locally applied medications used for certain symptoms of hemorrhoids, as the active substance has anti-inflammatory activity and relieves 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:
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if you are allergic to beclometasone or to any of the other ingredients of this medicine (listed in section 6).
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if you have a bacterial, fungal, or viral infection in the area to be treated.
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if you have bleeding hemorrhoids.
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it must not be administered to children under 12 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Recto Menaderm.
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The use of corticosteroids, such as beclometasone, applied locally, in excessive doses or for prolonged periods, especially under occlusive dressings or diapers, significantly increases the risk of adverse effects.
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If you develop sensitization (an allergic reaction), you must stop treatment and consult your doctor.
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If you develop an infection during treatment with this medicine, consult your doctor for appropriate management and advice on whether to discontinue treatment with Recto Menaderm.
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Avoid contact with the eyes and surrounding areas, as well as other areas not specified.
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Elderly patients and those who are acutely ill or debilitated should exercise caution, as they may be more sensitive to the effects of the medicine.
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Contact your doctor if you experience blurred vision or other visual disturbances.
Use in athletes
This medicine contains a component, beclometasone, which may cause a positive result in doping control tests.
Children and adolescents
Recto Menaderm must not be used in children under 12 years of age for safety reasons.
In children, corticosteroids are more likely to produce adverse systemic effects.
Other medicines and Recto Menaderm
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Some medicines may increase the effects of Recto Menaderm, so your doctor will perform careful monitoring if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).
Other topical preparations must not be applied simultaneously to the same treated area.
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 medicine.
The use of Recto Menaderm is not recommended during pregnancy.
It should not be used during pregnancy unless clearly considered necessary by your doctor and the potential benefit outweighs the potential risk to the fetus/child. In any case, it should not be used in large amounts or for prolonged periods.
Your doctor must decide whether to interrupt breastfeeding or discontinue treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and using machines
The use of this medicine does not affect the ability to drive or operate machinery.
Recto Menaderm contains methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate, lanolin, cetyl alcohol, and stearyl alcohol.
It may cause allergic reactions (possibly delayed) due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate.
This medicine may cause local skin reactions (such as contact dermatitis) due to lanolin, cetyl alcohol, and stearyl alcohol.
3. How to use Recto Menaderm
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
- Adults and children aged 12 years and older: 1 to 2 applications per day on the affected area, using an amount of ointment equivalent to 2 cm.
Anal and/or rectal use.
It is advisable to apply the ointment after bowel movement, previously washing and drying the area to be treated.
In case of internal haemorrhoids, it may be applied using the applicator nozzle provided in the package.
If symptoms worsen or do not improve within 7 days of treatment, treatment must be discontinued and medical advice sought.
Use in children and adolescents
Recto Menaderm must not be used in children under 12 years of age.
If you use more Recto Menaderm than you should
Excessive use of topical corticosteroids (repeated overdosing) may cause adverse effects (see section 4).
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical centre, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 missed a dose, continue with your usual schedule according to your doctor's instructions or as described in this leaflet.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported with the use of topical corticosteroids, especially after prolonged use, application over large areas, or under occlusive dressings. The frequency cannot be estimated from the available data. The adverse effects reported are listed below:
- Skin thinning (atrophy)
- Skin striae
- Redness (erythema)
- Acne
- Small blood vessels visible in the skin (telangiectasia)
- Hypersensitivity (allergic) skin reactions, such as contact dermatitis
- Fungal, viral, or bacterial infections
- Bruising (contusions)
- Burning, itching, irritation, and dryness at the application site
- Maceration
- Inflammation of hair follicles (folliculitis)
- Hair loss
- Blurred vision
Adverse effects may occur not only in the treated area but also in completely different parts of the body, particularly with prolonged use of corticosteroids or treatment of large skin areas. One of these effects is reversible suppression of the hypothalamic-pituitary-adrenal axis, leading to manifestations of Cushing's syndrome, characterized, among other symptoms, by a rounded face, fat accumulation, delayed wound healing, and psychiatric symptoms. Other possible effects include: cataracts (subcapsular), hypertension, or edema (fluid retention).
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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Recto Menaderm
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Do not use Recto Menaderm if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Recto Menaderm 0.125 mg/g rectal ointment
- The active substance is beclometasone dipropionate. Each g 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, stearyl alcohol, lanolin, cetomacrogol 700, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, white beeswax, purified water.
Appearance of the product and contents of the pack
Recto Menaderm is a rectal ointment with a uniform, yellowish appearance.
It is presented in an aluminum tube. Each pack contains a polyethylene applicator.
Pack sizes:
Tube containing 30 g of rectal ointment.
Tube containing 60 g of rectal ointment.
Only certain pack sizes may be commercially available.
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 further information about this medicinal product 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 most recent revision of this leaflet: November 2017
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/