ASACOL 1600 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Asacol

Do not take Asacol if:

• you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• you are allergic to salicylates (salicylic acid)

• you have severe liver damage
• you have severe kidney damage

Warnings and precautions

Consult your doctor or pharmacist before starting to take Asacol if you have any medical problem or disease, especially if:

• you suffer from any lung disease, such as asthma
• you have ever had kidney or lung failure
• you have had an allergic reaction to sulfasalazine in the past
• you have had a heart allergic reaction, such as inflammation of the heart muscle. If you have had heart allergic reactions induced by mesalazine, then Asacol should not be used. Asacol should be used with caution if you have had a previous heart allergic reaction not caused by mesalazine
• you have a stomach or intestinal ulcer, you should take Asacol with caution
• if you have ever had a severe skin rash or skin peeling or 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.

Severe skin rashes, 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 medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

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 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 the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Assessment of your liver, kidneys, and blood

Before and during treatment with Asacol, your doctor may want to assess you from time to time to check that your liver, kidneys, blood, and lungs are in good condition.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as Asacol has not been tested in this age group.

Other medicines and Asacol

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• Medicines to prevent blood clotting (anticoagulants, e.g., warfarin). The effects of these medicines may be increased or decreased, the effects this may have on you are unknown.
• Medicines to reduce the activity of the immune system (e.g., azathioprine or 6-mercaptopurine or thioguanine). Used together with Asacol, these medicines may cause life-threatening infections (see section 4).
• Non-steroidal anti-inflammatory medicines (e.g., medicines containing acetylsalicylic acid, ibuprofen, or diclofenac).

Using Asacol with food and drinks

Consumption of food, drinks, or alcohol does not interfere with the consumption of Asacol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Mesalazine is excreted in breast milk in small amounts, so special caution is recommended if Asacol is used during breastfeeding. If the baby develops diarrhea, breastfeeding should be discontinued.

Driving and using machines

Asacol has no or negligible influence on the ability to drive and use machines. However, if you feel affected, you should not drive or use machines.

Asacol contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free"

3. How to take Asacol

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

Your doctor will inform you about the dose you should take.

The recommended dose is:

Adults

Active phase of the disease:When the disease is worsening, the dose may be increased up to 4800 mg (3 tablets) per day, taken in one dose or divided into 2-3 doses per day.

Maintenance treatment:1600 mg once a day.

Use in children and adolescents:

The efficacy and safety of Asacol in children and adolescents under 18 years of age have not been established.

Asacol is not recommended for use in children and adolescents.

The tablets should be swallowed whole with a glass of water. Do not chew, crush, or break the tablets before swallowing. The tablets have a modified release in time, so if not taken correctly, they may not exert the necessary action.

Asacol can be taken with or without food.

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

The symptoms of overdose of this medicine are: ringing in the ears, dizziness, headache, confusion, drowsiness, excess fluid in the lungs, dehydration due to sweating, diarrhea, and vomiting, low blood sugar levels, rapid and deep breathing, changes in body water or electrolyte content and blood pH, and abnormally high body temperature.

Your doctor will treat the symptoms of overdose of this medicine.

If you forget to take Asacol

If you have forgotten to take a dose, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Asacol

Take Asacol until your doctor has prescribed it. Inform your doctor before changing or stopping treatment.

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

4. Possible side effects

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

Stop taking Asacol immediately and consult your doctor if

you develop one or more of the following symptoms:

• unexplained appearance of bruises (without having suffered blows), bleeding under the skin, spots or purple patches under the skin, anemia (feeling of tiredness, weakness, and paleness, especially in the lips and nails), fever (high temperature), severe stomach pain, sore throat, or unusual bleeding (e.g., nosebleeds).

• reddish 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.

Tell your doctor immediately ifyou 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) (frequency not known [cannot be estimated from the available data]).

Asacol may, in very rare cases, affect the white blood cells, so your immune system may worsen. If you contract an infection with symptoms such as fever with severe worsening of your general condition or fever with local symptoms of infection such as sore throat/pharynx/mouth or urinary problems, you should consult your doctor immediately. Blood tests may be performed to check for the absence of white blood cells (agranulocytosis). It is important that you inform your doctor about all your medicines.

Other side effects:

Common: may affect up to 1 in 10 people

• rash
• indigestion

Uncommon: may affect up to 1 in 100 people

• increased number of white blood cells called eosinophils
• tingling sensation, pins and needles, and numbness
• itching of the skin, hives
• chest pain

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

• headache
• dizziness
• inflammation of the heart muscle accompanied by signs of chest pain or palpitations
• diarrhea, stomach pain, abdominal bloating, feeling of discomfort and nausea with 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 the number of blood cells that can cause weakness, bruising, or more frequent infections, low blood cell count: reduction in platelets which increases the risk of bleeding
• allergic reactions such as hives
• fever that appears while taking the medicine and disappears when it is stopped (drug fever)
• autoimmune disease that can affect organs and joints
• ulcerative colitis that can affect the entire large intestine
• nerves that are abnormal or damaged, which can cause tingling, numbness
• lung disease (scarring of lung tissue, allergic reactions) resulting in: difficulty breathing, cough, wheezing, and fluid accumulation in the lungs, pneumonia
• inflammation of the pancreas (associated with pain in the upper abdomen and back and feeling of discomfort)
• abnormal liver function test results, hepatitis (inflammation of the liver that produces flu-like symptoms and jaundice)
• hair loss
• muscle and joint pain
• kidney problems (such as inflammation, scarring), kidney failure, which can be reversible if treatment is stopped early
• reversible decrease in sperm production

Frequency not known: frequency cannot be estimated from the available data

• immune system disorder (lupus-like syndrome) that can cause inflammation of the pericardium or the membranes surrounding the lungs and heart, hives, and/or joint pain
• weight loss
• abnormal laboratory test results
• severe skin diseases (Erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis)
• sharp chest pain and dry cough (inflammation of the membrane that covers the lungs) and the thoracic cavity ((pleurisy))
• intolerance to mesalazine and/or exacerbation of the disease
• kidney stones and associated kidney pain (see also section 2)

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 via the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Asacol

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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 of Asacol 1600 mg Gastro-Resistant Tablets

• The active substance is mesalazine. Each tablet contains 1600 mg of mesalazine.
• The other ingredients are:

magnesium stearate (E 470B)

methacrylic acid - methyl methacrylate copolymer (1:2)

trietin

yellow iron oxide (E 172)

red iron oxide (E 172)

macrogol

microcrystalline cellulose

glycerol monostearate 40-55

hypromellose

corn starch

polysorbate 80

potassium dihydrogen phosphate

colloidal anhydrous silica

sodium carboxymethyl starch (type A).

Appearance and packaging

Asacol 1600 mg Gastro-Resistant Tablets are reddish-brown in color. The tablets are oblong in shape and have an approximate length of 2.3 cm and a thickness of 1.1 cm.

The tablets are available in boxes and blister packs. The blister packs are packaged in cardboard boxes of 30 tablets, 60 tablets, or 90 tablets.

Not all pack sizes may be marketed.

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

Or

Tillotts Pharma GmbH

Warmbacher Str. 80

Rheinfelden DE - 79618

GERMANY

Date of last revision of this leaflet:May 2025

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