MECOLVIX 500 MG SUPPOSITORIES

Introduction

Package Leaflet: Information for the Patient

Mecolvix 500 mg Suppositories

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 or pharmacist.
• 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 or pharmacist. 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

Mecolvixcontains the active substance mesalazine, which is an anti-inflammatory active substance for the treatment of ulcerative colitis in adults.

Mecolvixis indicated for:

• Distal ulcerative colitis (proctitis), an inflammatory disease of the last region of the colon, for example, the rectum.
• Treatment of mild or moderate acute exacerbations;
• Maintenance of remission.

2. What you need to know before you use Mecolvix

Do not useMecolvix

• 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 severe kidney and/or liver impairment.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Mecolvix

• 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, for example, asthma
• if you have been allergic to sulfasalazine in the past
• if you have a stomach or intestinal ulcer
• if you have previously had an inflammation of the heart (which could be a consequence of a heart infection)
• if you have ever had a severe skin rash or skin peeling, blisters or ulcers in the mouth after using mesalazine.

If you experience severe headache or recurrent headache, vision changes 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 use 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.

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.

Severe skin rashes, 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.

Children and adolescents

The 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 andMecolvix

In general, you can continue treatment with other medicines while using Mecolvix. 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.

Mecolvixmay interact with some medicines if administered at the same time.

In particular:

• medicines to lower blood sugar (antidiabetics)
• medicines to lower blood pressure (antihypertensives/diuretics)
• medicines for the treatment or prevention of gout attacks
• 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)
• mesalazine may delay the excretion of methotrexate

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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, for example, diarrhea. If the newborn develops diarrhea, breast-feeding should be discontinued.

The use of Mecolvixis not recommended in pregnant or breast-feeding women unless your doctor advises you otherwise.

Driving and using machines

Mecolvixhas no or negligible influence on the ability to drive and use machines.

3. How to use Mecolvix

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist before using this medicine.

Your doctor may adjust the dose depending on your characteristics and the characteristics of your disease. The recommended dose in adults is:

• Acute phase treatment: one suppository two or three times a day (corresponding to a daily dose of 1000-1500 mg of mesalazine).
• Remission maintenance: one suppository one or two times a day (corresponding to a daily dose of 500-1000 mg of mesalazine).

Method of administration:

This medicine can only be used rectally, so it must be inserted through the anus. It must not be taken orally.

It is recommended to go to the bathroom and empty the intestine before using the suppository.

It is advisable to insert the suppository while lying on your left side and remain in this position for approximately 1 hour.

The suppositories should be inserted deeply into the anus and should be kept in the rectum for 1 to 3 hours to increase efficacy.

Use in children and adolescents

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

Use in elderly patients

The use of Mecolvixin elderly patients should be done with caution and always limited to those patients with normal renal function.

If you use moreMecolvixthan you should

If you have used more Mecolvixthan you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915620420, indicating the medicine and the amount used. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to useMecolvix

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

It is important that you use Mecolvixevery day, even when you do not have symptoms of ulcerative colitis. Continue treatment as prescribed by your doctor.

If you stop usingMecolvix

Do not stop treatment without consulting your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare. If you get 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 get 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 rashes are often preceded by fever or flu-like symptoms.
  • if you experience severe headache or recurrent headache, vision changes, 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 side effects (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 side effects (may affect less than 1 in 10,000 people)

• kidney problems, sometimes with swollen limbs or side pain;
• severe abdominal pain due to acute pancreatitis;
• worsening of colitis symptoms;
• fever, sore throat, or nausea due to changes in blood count;
• difficulty breathing, cough, wheezing, spots on 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 in the intestine;
• skin rash or skin 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.

Side effects of unknown frequency (cannot be estimated from the available data).

1. Kidney stones and associated kidney pain (see also section 2).

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mecolvix

Do not store above 30°C. Do not refrigerate or freeze.

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

Do not use this medicineafter the expiry date which is stated on the packaging and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofMecolvix

• The active substance is mesalazine. Each suppository contains 500 mg of mesalazine
• The other ingredients are: semi-synthetic solid glycerides.

Appearance of the product and contents of the pack

Mecolvixis presented in the form of torpedo-shaped suppositories, grayish-white to slightly reddish-violet in color.

Mecolvixis available in packs of 12, 24, 30, 60, or 100 suppositories. Not all pack sizes may be marketed.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma Portugal, S.A

Rua Elias Garcia, 28

2700-327 Amadora

Portugal

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

Spain: Mecolvix 500 mg suppositories

France: Mesalazine Mayoly 500 mg suppositories

Ireland: Galtasa 500 mg suppositories

Romania: Azzavix 500 mg suppositories

Czech Republic: Azzavix

Hungary: Salcrozine 500 mg rectal suppositories

Date of last revision of this leaflet: July 2022

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