MECOLVIX 1000 mg RECTAL FOAM

Introduction

Patient Information Leaflet

Mecolvix 1000 mg Rectal Foam

mesalazine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Mecolvix and what is it used for
2. What you need to know before you use Mecolvix
3. How to use Mecolvix
4. Possible side effects
5. Storage of Mecolvix
6. Contents of the pack and other information

1. What is Mecolvix and what is it used for

Mecolvix rectal foam contains the active substance mesalazine (also known as 5-aminosalicylic acid), which belongs to a group of medicines called intestinal anti-inflammatory agents.

This medicine is indicated for the treatment of ulcerative colitis, an inflammatory disease of the intestine.

2. What you need to know before you use Mecolvix

Do not use Mecolvix

• if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to acetylsalicylic acid or any other salicylate.
• if you have a medical condition that may make you prone to bleeding.
• if you have severe kidney and/or liver impairment.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine

• if you are or plan to become pregnant.
• if you are breast-feeding.
• if you have liver or kidney problems.
• if you have any lung disease, such as asthma.
• if you have been allergic to sulfasalazine in the past.
• if you have a stomach or intestinal ulcer.
• if you have a bleeding tendency (increased propensity to bleeding).
• if you have had inflammation of the heart (which could be a consequence of a heart infection) in the past.
• if you have ever suffered from a severe skin rash, skin peeling, blisters, and/or sores in the mouth after using mesalazine.

If you experience severe headache or recurrent headache, vision disturbances, or ringing or buzzing in the ears, contact your doctor immediately.

In case of appearance of any allergic manifestation (e.g., skin rash, itching) or cramps, abdominal pain, severe headache, and fever during the course of treatment, do not apply this medicine anymore and inform your doctor immediately.

Before and during treatment, your doctor may want to perform regular blood and urine tests to check the functioning of the liver, kidneys, blood, and lungs.

Kidney stones may occur with the use of mesalazine. The symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink a sufficient amount of liquid during treatment with mesalazine.

Severe skin reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN), have been observed with mesalazine treatment. Stop taking mesalazine and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

Mesalazine may cause a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Children and adolescents

Information on safety in the use of this medicine in children and adolescents is limited.

Do not administer to children under 5 years of age.

Other medicines and Mecolvix

In general, you can continue treatment with other medicines while using this medicine. However, inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

This medicine may interact with other medicines if administered at the same time.

In particular:

• medicines to lower blood sugar levels (antidiabetics).
• medicines to lower blood pressure (antihypertensives/diuretics).
• medicines for the treatment or prevention of gout attacks.
• medicines that help with bowel evacuation (laxatives containing lactulose).
• medicines to prevent blood clotting (anticoagulants).
• medicines to reduce the activity of the immune system (e.g., azathioprine, 6-mercaptopurine, or thioguanine).
• medicines to treat pain and inflammation (anti-inflammatory agents).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is limited experience with the use of mesalazine during pregnancy and breast-feeding. The newborn may develop allergic reactions after breast-feeding, such as diarrhea. If the newborn develops diarrhea, breast-feeding should be discontinued.

The use of this medicine is not recommended during pregnancy or breast-feeding, unless your doctor advises you otherwise.

Driving and using machines

No adverse effects of this medicine on the ability to drive or use machines have been reported.

Mecolvix contains glycerol (E-422), methyl parahydroxybenzoate (E-218), and propyl parahydroxybenzoate (E-216)

This medicine may have a mild laxative effect because it contains glycerol (E-422).

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to use Mecolvix

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment before, even if you feel better, as symptoms may return if treatment is stopped too soon.

The recommended dose for an adult is one to two applications per day (1 to 2 g), for four to six weeks.

Use in children and adolescents

The administration of this medicine to children and adolescents under 18 years of age is not recommended due to the lack of data on safety and efficacy. Do not administer to children under 5 years of age.

Use in elderly patients

The use of this medicine in elderly patients should be done with caution and always limited to those patients with normal kidney function.

If you use more Mecolvix than you should

If you use more mesalazine than you should, contact your doctor, pharmacist, or hospital emergency department immediately. Bring the package of this medicine with you.

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 medicine and the amount used. It is recommended to bring the package and leaflet of the medicine to the healthcare professional.

If you forget to use Mecolvix

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

If you stop treatment with Mecolvix

It is important that you use this medicine every day, even when you do not have symptoms of ulcerative colitis. Always finish the treatment that has been prescribed for you.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

All medicines can cause allergic reactions, although serious allergic reactions are very rare. If you experience any of the following symptoms after using this medicine, stop using this medicine and contact your doctor immediately:

• allergic skin rash;
• fever;
• difficulty breathing.

If you experience fever or irritation of the throat or mouth, stop using this medicine and contact your doctor immediately. These symptoms may be due, very rarely, to a decrease in the number of white blood cells in the blood (a condition called agranulocytosis).

Severe side effects:

Stop taking mesalazine and seek medical attention immediately if you experience any of the following symptoms:

• red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and swollen lymph nodes. These severe skin reactions are often preceded by fever or flu-like symptoms.
• if you experience severe headache or recurrent headache, vision disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

The following side effects have also been reported in patients using mesalazine:

Rare(may affect up to 1 in 1,000 people):

• abdominal pain, diarrhea, flatulence, nausea, and vomiting;
• headache, dizziness;
• chest pain, difficulty breathing, or swollen limbs due to an effect on the heart;
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

Very rare(may affect up to 1 in 10,000 people):

• kidney problems, sometimes with swelling of the limbs or pain in the side;
• severe abdominal pain due to acute pancreatitis;
• worsening of ulcerative colitis symptoms;
• fever, sore throat, or malaise due to changes in blood counts;
• difficulty breathing, cough, wheezing, spots on the lung X-ray due to allergic and/or inflammatory conditions in the lungs;
• diarrhea and severe abdominal pain due to an allergic reaction to the medicine at the intestinal level;
• skin rash or inflammation;
• muscle and joint pain;
• jaundice or abdominal pain due to liver or biliary disorders;
• hair loss and development of baldness;
• erythema multiforme;
• numbness and tingling of the fingers and toes (peripheral neuropathy);
• reversible decrease in semen production;
• blood count disorders.

Frequency not known(cannot be estimated from the available data):

• kidney stones and associated kidney pain (see also section 2).
• severe skin reactions: drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN).
• increased pressure inside the skull (idiopathic intracranial hypertension).

Photosensitivity

More severe reactions have been reported in patients with pre-existing skin conditions, such as atopic dermatitis and atopic eczema.

If these symptoms continue or become more severe, consult your doctor.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Information System: https://www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mecolvix

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

This pack is a pressurized aerosol that contains a flammable propellant. It should be kept away from any heat source, flames, or sparks, including cigarettes. It should be protected from direct sunlight and should not be destroyed or burned, even when empty.

Do not use this medicine after the expiry date stated on the label after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mecolvix

• The active substance is mesalazine. Each application (5 g of foam) contains 1000 mg of mesalazine.
• The other ingredients (excipients) are: polysorbate, emulsifying wax, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sorbitan oleate, colloidal anhydrous silica, sodium metabisulfite (E-223), sodium edetate, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, glycerol (E-422), macrogol 300, purified water, isobutane, propane, and n-butane.

Appearance of the product and pack contents

Mecolvix is a white to brownish rectal foam. It is presented in a single-piece aluminum spray can with a dosing valve. Each aerosol dispenses 14 applications.

The box contains, in addition to the aerosol:

• a kit consisting of a base or grid with 14 compartments (containing a small amount of petroleum jelly), and in which 14 disposable applicators are inserted. The purpose of the petroleum jelly is to facilitate the introduction of the applicators into the rectum.
• 14 disposable plastic bags.
• leaflet.

Marketing authorization holder and manufacturer

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

SOFAR S.P.A.

Via Firenze, 40

20060 Trezzano Rosa, Milan

Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Mecolvix 1000 mg rectal foam

Portugal: Azzavix 1000 mg rectal foam

France: Mazalvix 1000 mg rectal mousse

Austria: Azzavix 1000 mg rectal foam

Malta: Mecolzine 1000 mg rectal foam

Cyprus: Mecolzine 1000 mg rectal foam

Date of last revision of this leaflet:December 2024

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