Asacol 1.600 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Asacol 1600 mg gastro-resistant tablets

mesalazine

Read the entire leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions 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 adverse 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 contains the active substance mesalazine. It is an anti-inflammatory drug used for the treatment of ulcerative colitis. Ulcerative colitis is a condition in which the lining of the large intestine (colon) or the final segment of the large intestine (rectum) becomes inflamed (reddened and swollen). This may cause frequent bloody stools along with abdominal cramps.

Asacol is indicated for the treatment of mild to moderate acute episodes of ulcerative colitis and for the maintenance of remission.

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

Do not take Asacol if:

• you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• you are allergic to salicylates (salicylic acid)
• you have severe hepatic impairment
• you have severe renal impairment

Warnings and precautions

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

• you suffer from a lung disease, for example asthma
• you have previously experienced renal or pulmonary failure
• you have previously had an allergic reaction to sulfasalazine
• you have previously had a heart allergic reaction, such as inflammation of the heart muscle. If you have previously had heart allergic reactions induced by mesalazine, then Asacol must not be used. Asacol should be used with caution if you have previously had a heart allergic reaction not caused by mesalazine
• you have a stomach or intestinal ulcer, you should take Asacol with caution
• you 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 tinnitus (ringing or buzzing in the ears), contact your doctor immediately.

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

Kidney stones may occur with the use of mesalazine. Symptoms include pain in the sides of the abdomen and presence of blood in the urine. Make sure to drink an adequate amount of fluid during treatment with mesalazine.

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

Evaluation of your liver, kidneys, and blood

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

Children and adolescents

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

Other medicines and Asacol

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

• Medicines used to prevent blood clotting (anticoagulants, e.g. warfarin). The effects of these medicines may be increased or decreased; the consequences of this are unknown.
• Medicines used to reduce the activity of the immune system (e.g. azathioprine, 6-mercaptopurine, or thioguanine). When used together with Asacol, these medicines may cause fatal infections (see section 4).
• Non-steroidal anti-inflammatory drugs (for example: medicines containing acetylsalicylic acid, ibuprofen, or diclofenac).

Use of Asacol with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Mesalazine is excreted in breast milk in small amounts; therefore, special caution is advised if Asacol is used during breastfeeding. If the infant develops diarrhea, breastfeeding should be discontinued.

Driving and use of machines

The influence of Asacol on the ability to drive and use machines is none or negligible. However, if you feel affected, you should not drive or operate machinery.

Asacol contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., it is essentially "sodium-free".

3. How to take Asacol

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, 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) daily, taken as a single dose or divided into 2–3 doses per day.

Maintenance treatment: 1600 mg once daily.

Use in children and adolescents:

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

The use of Asacol is not recommended in children and adolescents.

The tablets must be swallowed whole with a glass of water. Do not chew, crush, or break the tablets before swallowing. The tablets have a modified-release formulation, so if not taken correctly, they may not exert the required effect.

Asacol may 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 at telephone number 91 562 04 20 (indicating the medicine and the amount ingested). It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Symptoms of overdose with this medicine include: 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, disturbances in body water or electrolyte content and blood pH, and abnormally high body temperature.

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

If you forget to take Asacol

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

If you stop taking Asacol

Take Asacol for as long as your doctor has prescribed. Inform your doctor before changing or stopping the treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 injury), bleeding under the skin, purplish spots or patches under the skin, anaemia (feeling tired, weak, and pale, especially in the lips and nails), fever (high temperature), severe stomach pain, sore throat, or unusual bleeding (e.g., nosebleeds).

• non-elevated reddish patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital or eye sores, widespread rash, fever, and swollen lymph nodes. These serious skin rashes are often preceded by fever or flu-like symptoms.

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

Asacol may, in very rare cases, affect white blood cells, thereby weakening your immune system. If you develop an infection with symptoms such as fever accompanied by a severe worsening of your general condition, or fever with local signs 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 medications.

Other adverse effects:

Common: may affect up to 1 in 10 patients

• rash
• indigestion

Uncommon: may affect up to 1 in 100 patients

• elevated number of white blood cells called eosinophilic granulocytes
• tingling, pricking, and numbness sensations
• itchy skin, urticarial hives
• chest pain

Rare adverse effects: may affect up to 1 in 1,000 patients

• headache
• dizziness
• inflammation of the heart muscle accompanied by chest pain or palpitations
• diarrhoea, stomach pain, abdominal flatulence, feeling of discomfort and uneasiness in the stomach with nausea or vomiting
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

Very rare adverse effects: may affect up to 1 in 10,000 patients

• marked reduction in blood cell counts which may cause weakness, bruising, or increased susceptibility to infections; low blood cell count: reduction in platelets, increasing the risk of bleeding
• allergic reactions such as rash (urticaria)
• fever that appears while taking the medicine and disappears when treatment is stopped (drug fever)
• autoimmune disease that may affect organs and joints
• ulcerative colitis affecting the entire large intestine
• abnormal or damaged nerves causing tingling or 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 unwell)
• abnormal results in liver function tests, hepatitis (liver inflammation causing flu-like symptoms and jaundice)
• hair loss
• muscle and joint pain
• kidney problems (such as inflammation, kidney scarring), kidney failure, which may 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) 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 diseases (Erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis)
• acute chest pain and dry cough (inflammation of the membrane covering the lungs and the chest cavity (pleuritis))
• intolerance to mesalazine and/or exacerbation of the disease
• kidney stones and associated renal 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: http://www.notificaRAM.es.

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

5. Storage of Asacol

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This 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 components are:

magnesium stearate (E 470B)

copolymer of methacrylic acid and methyl methacrylate (1:2)

triethyl citrate

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

anhydrous colloidal silica

sodium carboxymethylstarch (type A).

Appearance of the product and contents of the pack

Asacol 1600 mg gastro-resistant tablets are reddish-brown in colour. The tablets are oblong-shaped, approximately 2.3 cm in length and 1.1 cm in thickness.

The tablets are available in cardboard boxes containing blister strips. Blister strips are packed 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 the most recent review of this leaflet: May 2025

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