ASACOL 400 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Asacol 400 mg Gastro-Resistant Tablets

Mesalazine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet:

1. What is ASACOL and what is it used for
2. Before taking ASACOL
3. How to take ASACOL
4. Possible side effects
5. Storage of ASACOL
6. Further information

1. What is ASACOL and what is it used for

ASACOL is indicated for:

• Treatment of acute phase of mild to moderate ulcerative colitis.
• Maintenance treatment of ulcerative colitis remission (including patients who do not tolerate sulfasalazine).
• Treatment of acute phase of Crohn's disease and maintenance treatment of Crohn's disease remission.

2. Before taking ASACOL

Do not take ASACOL if:

• You are allergic (hypersensitive) to salicylic acid, salicylates, or any other components of Asacol.

• You have a duodenal or gastric ulcer.
• You have a bleeding tendency.
• You have coagulation disorders.
• You have severe liver or kidney impairment.

Be cautious when taking ASACOL:

• If you have ever had kidney problems. When you start taking ASACOL, your doctor should regularly check your blood to ensure your kidneys are functioning properly.

• There have been reports of increased liver enzyme levels. Caution is recommended if ASACOL is administered to patients with liver failure.

• If you experience any unexplained bleeding, bruising, purpura, sore throat, fever, or general malaise during treatment, inform your doctor, as treatment may need to be interrupted.

• If you have any lung disease, such as asthma, your doctor should regularly check your breathing.

• If you have ever had adverse reactions to sulfasalazine, a medication used to treat ulcerative colitis and Crohn's disease.

• 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 or recurrent headaches, vision changes, or ringing in the ears, contact your doctor immediately.

Kidney stones may occur with the use of mesalazine. Symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink enough 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 toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

ASACOL tablets should not be administered with lactulose or similar preparations that decrease the pH of the stool and prevent the release of mesalazine.

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

• Medications to prevent blood clotting (anticoagulants, e.g., warfarin).
• Medications to reduce immune system activity (e.g., azathioprine or 6-mercaptopurine or thioguanine).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

There is no adequate data on the use of ASACOL during pregnancy or breastfeeding. Its use is not recommended during pregnancy or breastfeeding, unless the benefit of treatment outweighs the potential risks.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Important information about some of the components of ASACOL

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take ASACOL

Follow the administration instructions of ASACOL indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

ASACOL should be taken orally.

The tablets should be swallowed whole and before meals.

The normal dose is:

Adults

Ulcerative colitis, acute treatment of mild to moderate episodes: 2 tablets three times a day.

Maintenance treatment of ulcerative colitis: 2 to 4 tablets.

Crohn's disease: maintenance treatment: 3 to 6 tablets distributed in 3 doses per day.

Elderly

Administration of ASACOL in the elderly should be done with caution and always limited to those patients with normal renal function.

Use in children

The efficacy and safety of ASACOL in children under 5 years of age have not been established.

Information on the effect in children (between 6 and 18 years of age) is limited.

Children from 6 years of age

The general recommendation is that half the adult dose can be administered to children up to 40 kg in weight; and the normal adult dose to children over 40 kg. However, your doctor will indicate the appropriate dose to treat your disease.

If you take more ASACOL than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to the nearest hospital, or call the Toxicology Information Service. Phone 91 562 04 20 (indicating the medication and the amount ingested).

In case of massive ingestion of the tablets, treatment consists of gastric lavage, induction of vomiting, along with symptomatic and supportive measures. There is no specific antidote.

If you forget to take ASACOL

If you have forgotten to take a dose, take it as soon as you remember, and then take the next dose at your usual time.

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

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

4. Possible side effects

Like all medications, ASACOL can cause side effects, although not everyone gets them.

Stop taking mesalazine and seek immediate medical attention 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.

Inform your doctor immediatelyif you experience severe or recurrent headaches, vision changes, or ringing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from the available data]).

The following side effects have been rarely reported:

Rare side effects

• Headache
• Dizziness
• Abdominal pain
• Diarrhea
• Abdominal bloating
• Pancreatitis (inflammation of the pancreas)
• General malaise (nausea)
• Vomiting
• Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart)
• Neuropathy
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

Very rare side effects

• Blood disorders, including:

• Low white blood cell count (leucopenia, neutropenia), which can sometimes be severe (agranulocytosis)
• Low count of all blood cells (pancytopenia)
• Low platelet count (thrombocytopenia)
• Low count of red and white blood cells and platelets (aplastic anemia)

• Abnormal liver function test results (blood tests to check liver function)
• Hepatitis (inflammation of the liver)
• Acute pancreatitis (inflammation of the pancreas)
• Allergic reactions, such as:

• Fever that appears while taking the medication and disappears when it is stopped (drug fever)
• Rash or skin eruption (allergic exanthem) including itching (pruritus) and hives (urticaria)
• Autoimmune disease that can affect organs and joints (lupus erythematosus syndrome)
• Ulcerative colitis, including the entire colon (pancolitis)

• Numbness, tingling, strange sensations, weakness, burning (peripheral neuropathy)
• Muscle pain (myalgia)
• Joint pain (arthralgia)
• Kidney function impairment, including:

• Interstitial nephritis (inflammation of the kidneys)
• Kidney failure
• Renal failure

• Reversible decrease in sperm count (oligospermia) that appears while taking the medication and disappears when it is stopped.
• Pulmonary fibrotic and allergic reactions (hypersensitivity) (the alveoli, small air sacs in the lungs, are damaged and inflamed) including:

• Difficulty breathing (cough, dyspnea, bronchospasm)
• Inflammation of the small air sacs (alveoli) of the lungs (alveolitis)
• Inflammation of the lungs with an increase in eosinophils, a type of white blood cell (pulmonary eosinophilia)
• Inflammation of the lung tissue (pneumonitis)
• Pulmonary edema (fluid accumulates and fills the lungs)

• Hair loss (alopecia)

Side effects of unknown frequency:

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

The assessment of side effects is based on the following frequencies:

Rare: may affect up to 1 in 1,000 people.

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

Frequency not known: cannot be estimated from the available data

If you experience any side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of ASACOL

Store below 25°C. Store in the original packaging.

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

Do not use ASACOL after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Further information

Composition of ASACOL 400 mg Gastro-Resistant Tablets

• The active ingredient is mesalazine. Each tablet contains 400 mg of mesalazine.
• The other ingredients are lactose, potato starch, magnesium stearate, talc, povidone, methacrylic acid copolymer type B, triethyl citrate, yellow iron oxide (E172), red iron oxide (E172), and polyethylene glycol 6000.

Appearance of the product and packaging contents

ASACOL is a red, oblong, gastro-resistant tablet coated with an acrylic resin (Eudragit-S) to ensure the release of the active ingredient in the terminal ileum and colon.

ASACOL is available in packaging containing 100 gastro-resistant tablets.

Marketing Authorization Holder:

Tillotts Pharma Spain, S.L.U.

Travessera de Gràcia 58, 5º 3ª

08006 Barcelona

Manufacturer:

HAUPT PHARMA WULFING GMBH

Bethelner Landstrasse, 18

Gronau D-31028

GERMANY

This leaflet was approved in May 2025

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