Asacol 800 mg gastro-resistant tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Asacol 800 mg gastro-resistant tablets

mesalazine

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

1 What Asacol is and what it is used for

2 What you need to know before taking Asacol

3 How to take Asacol

4 Possible side effects

5 How to store Asacol

6 Contents of the pack and other information

1. What Asacol is and what it is used for

Asacol is indicated for:

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

2. What you need to know before starting to take Asacol

Do not take Asacol

• If you are allergic to mesalazine or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to salicylates (e.g. aspirin).
• You have severe hepatic impairment.
• You have severe renal impairment.

Warnings and precautions

Consult your doctor before starting to take Asacol, especially if you:

• suffer from a lung disease, such as asthma.
• have previously experienced an allergy to sulfasalazine.
• have ever had allergic reactions affecting the heart, such as inflammation of the heart muscle or pericardium. If you have previously had suspected allergic reactions to mesalazine affecting the heart, you must not take Asacol. Asacol may be used with caution if you have previously had an allergic reaction affecting the heart not caused by mesalazine.
• have a stomach or intestinal ulcer, in which case you should take Asacol with caution.
• have ever experienced severe skin rash, skin peeling, blisters, or mouth sores after taking mesalazine.

If you experience severe or recurrent headache, vision disturbances, or ringing or buzzing 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 an adequate amount of fluid during treatment with mesalazine.

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

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

Evaluation of liver, kidney, and blood function

Before and during treatment with Asacol, your doctor may want to monitor you periodically to check that your liver, kidneys, blood, and lungs are functioning properly.

Tablets in the stools

There have been some reports of intact tablets appearing in the stools. What appears to be an intact tablet may sometimes be just the empty tablet shell. If you frequently notice tablets or their shells in your stools, you should consult your doctor.

Children and adolescents

The use of Asacol is only recommended in children aged 6 years and older.

Elderly patients

Asacol should be used with caution. Your doctor will evaluate your renal and hepatic function before starting treatment.

Other medicines and Asacol

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, such as:

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

Use of Asacol with food, drinks, and alcohol

The consumption of food, drinks, and alcohol does not interfere with the use of Asacol.

Pregnancy and breastfeeding

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.

Experience with the use of mesalazine during pregnancy and breastfeeding is limited.

Newborns may develop allergic reactions while breastfeeding, for example, diarrhea. If the newborn develops diarrhea, breastfeeding should be discontinued.

Driving and using machines

The influence of Asacol on the ability to drive and operate machinery is none or negligible. However, if you are affected in any way, do not drive or operate machinery.

Asacol contains milk sugar (lactose)

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Asacol

Follow exactly the instructions for use of this medicine provided by your doctor. If you are unsure, consult your doctor or pharmacist again.

Asacol should be administered orally.

The tablets should be swallowed whole and taken before meals.

The recommended dose is:

Adults

Ulcerative colitis, acute treatment of mild to moderate episodes: 2.4 g (3 tablets, divided into three daily doses).

Maintenance treatment of ulcerative colitis: 0.8 g (1 tablet) to 1.6 g (2 tablets given in separate doses) per day.

Crohn's disease, maintenance treatment: individualized dose up to a maximum of 2.4 g daily (2 to 3 tablets distributed in several daily doses).

Elderly patients

Administration of Asacol in elderly patients should be carried out with caution and only in patients with normal renal function.

Use in children

The efficacy and safety of Asacol in children under 5 years of age has 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 may be administered to children weighing up to 40 kg; and the full adult dose to children above 40 kg. However, your doctor will indicate the appropriate dose for treating your condition.

If you take more Asacol than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to the nearest hospital, or call the Toxicology Information Service. Telephone number: 91 562 04 20 (specify the medicine and the amount ingested).

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

If you forget to take Asacol

If you forget 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 missed doses.

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.

Adverse effects affecting specific organs such as the heart, lungs, liver, kidneys, pancreas, skin, and subcutaneous tissue have been reported.

Stop taking Asacol immediately and seek urgent medical advice if you develop unexplained bruising (without injury), bleeding, purplish spots or spots under the skin, anaemia (feeling tired, weak, or pale appearance, especially in the lips, nails, and inside the eyelids), fever (high temperature), sore throat, or unusual bleeding (e.g. nosebleeds), non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers, widespread rash, fever, and swollen lymph nodes. These severe skin rashes are often preceded by fever or flu-like symptoms.

Contact your doctor immediately if you experience severe or recurrent headache, vision disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure within the skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from available data]).

The following adverse effects have been reported at the approximate frequencies shown:

Common (may affect up to 1 in 10 people)

• Rash
• Indigestion

Uncommon (may affect up to 1 in 100 people)

• Fever
• High number of white blood cells called eosinophils
• Hives, itching of the skin
• Chest pain

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

• Headache
• Tingling, pricking, or numbness sensations
• Dizziness
• Inflammation of the heart with symptoms such as chest pain and palpitations
• Diarrhoea, nausea, stomach pain, flatulence, feeling of restlessness and discomfort in the stomach, with nausea and vomiting
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

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

• Severe reduction in blood cells which may cause weakness, bruising, increased risk of infections, low white blood cell count, reduced platelets increasing the risk of bleeding
• Allergic reactions such as rashes and skin eruptions
• Fever that appears while taking the medicine and disappears when treatment is stopped (drug fever)
• Ulcerative colitis affecting the entire large intestine
• Damaged or abnormal nerves causing numbness or tingling
• Lung disease (scarring of lung tissue, allergic reaction), resulting in difficulty breathing or wheezing and fluid accumulation in the lungs, pneumonia
• Inflammation of the pancreas (associated with pain in the upper abdomen and back and feeling unwell)
• Abnormal results in liver function tests, hepatitis (inflammation of the liver leading to flu-like symptoms and jaundice)
• Hair loss
• Muscle pain (myalgia) or joint pain (arthralgia)
• Kidney problems (such as inflammation and scarring of the kidney), kidney failure, which may be reversible if treatment is stopped early
• Reversible decrease in sperm production
• Cough

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

• Autoimmune disease (lupus-like syndrome) which may cause inflammation of the pericardium or of the membranes surrounding the lungs and heart, rashes and/or joint pain
• Weight loss
• Abnormal laboratory test results
• Severe skin disorders (Erythema multiforme, Stevens-Johnson syndrome, and Toxic epidermal necrolysis)
• Sharp chest pain and dry cough (inflammation of the membrane covering the lungs)
• Kidney stones and associated kidney pain (see also section 2)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Asacol

This medicine does not require special storage conditions. Store in the original packaging.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Asacol 800 mg gastro-resistant tablets

• The active substance is mesalazine. Each tablet contains 800 mg of mesalazine.
• The other components are lactose, sodium carboxymethyl starch from potato, 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 medicinal product and contents of the pack

Red-brown, oblong gastro-resistant tablets contained in PVC/aluminum blisters.

Available in packs of 60 or 90 gastro-resistant tablets.

Marketing Authorization Holder

TILLOTTS PHARMA SPAIN, S.L.U.

Travessera de Gràcia 58, 5th floor, 3rd door

08006 Barcelona

Spain

Manufacturer

HAUPT PHARMA WULFING GMBH

Bethelner Landstrasse, 18

Gronau D-31028

GERMANY

Date of the most recent revision of this leaflet: May 2025

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