Label: information for the user

Asacol 800 mg gastro-resistant tablets

mesalazine

1What Asacol is and for what it is used

2What you need to know before starting to take Asacol

3How to take Asacol

4Possible side effects

5Storage of Asacol

6Contents of the pack and additional information

Asacol is indicated for:

•Acute treatment of mild to moderate ulcerative colitis.

•Maintenance treatment of ulcerative colitis remission (including patients who do not tolerate sulfasalazine).

•Maintenance treatment of Crohn's disease remission.

Do not take Asacol

• If you are allergic to mesalazine or any of the other components of this medication (listed in section 6).
• If you are allergic to salicylates (e.g. Aspirin).
• If you have severe liver damage.
• If you have severe kidney damage.

Warnings and precautions

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

• Have any lung disease, for example asthma.
• Have had a past allergy to sulfasalazine.
• Have previously experienced allergic reactions of the heart such as myocarditis or pericarditis. If you have had previous suspicions of mesalazine-induced allergic reactions in the heart, then do not take Asacol. Asacol can be used with caution if you have previously had an allergic reaction in the heart not caused by mesalazine.
• Have a stomach or intestinal ulcer, take Asacol with caution.
• Have ever had intense skin rash or skin peeling, blisters or mouth sores after using mesalazine.

Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain on the sides and presence of blood in the urine. Ensure you drink a sufficient amount of liquid during treatment with mesalazine.

Mesalazine may cause urine discoloration 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.

Severe skin eruptions, 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.

Liver, kidney and blood evaluation

Your doctor may want to evaluate you occasionally before and during Asacol treatment to check that your liver, kidneys, blood and lungs are in good condition.

Tablets in the stool

There have been some reports of intact tablets in the stool. What appears to be the intact tablet sometimes may be the remains of the tablet coating. If you frequently observe tablets or their coatings in the stool, consult your doctor.

Children and adolescents

Asacol use is only recommended for children aged 6 years and above.

Older patients

Use Asacol with caution, your doctor will evaluate both renal and hepatic function before starting treatment.

Other medications and Asacol

Inform your doctor or pharmacist if you are using or have recently used or may need to take any other medication, such as:

• Blood-thinning medications (anticoagulants, e.g. warfarin).
• Medications to reduce the activity of the immune system (e.g. azathioprine or 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, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Newborns may develop allergic reactions after breastfeeding, for example, diarrhea. If the newborn has diarrhea, breastfeeding should be interrupted.

Driving and operating machinery

The influence of Asacol on the ability to drive and operate machinery is negligible or insignificant. However, if it affects you in any way, do not drive or operate machinery.

Asacol contains lactose

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.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Asacol should be taken orally.

The tablets should be swallowed whole and before meals.

The recommended dose is:

Adults

Ulcerative colitis, acute treatment of mild to moderate episodes: 2.4 g (3 tablets, distributed in three doses per day).

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

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

Older adults

The administration of Asacol in older adults should be done with caution and always limited to those patients with normal renal function.

Use in children

The efficacy and safety of Asacol use in children under 5 years has not been established.

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

Children 6 years of age and older

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 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 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 compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Specific side effects have been reported affecting the heart, lungs, liver, kidneys, pancreas, skin, and subcutaneous tissue.

Stop taking Asacol immediately and consult a doctor urgently if you develop unexplained bruising, hematomas, purple spots or patches under the skin, anemia (feeling tired, weak, or pale, especially in the lips, nails, and inside the eyelids), fever (high temperature), sore throat, or unusual bleeding (e.g., nasal bleeding), flat red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, eye ulcers, widespread rash, fever, and swollen lymph nodes. These severe skin eruptions are often preceded by fever or flu-like symptoms.

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

Frequent (can affect up to 1 in 10 patients)

• Urticaria
• Indigestion

Infrequent (can affect up to 1 in 100 patients)

• Fever
• High white blood cell count, called eosinophilic granulocytes
• Urticaria, skin itching
• Chest pain

Rare (can affect up to 1 in 1,000 patients)

• Headache
• Feeling of tingling, pinpricking, and numbness
• Dizziness
• Myocarditis with signs such as chest pain and palpitations
• Diarrhea, nausea, stomach pain, flatulence, feeling of unease and discomfort in the stomach, with a desire to vomit and vomiting.
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)

Very rare (can affect up to 1 in 10,000 patients)

• Severe reduction in blood cells that can cause weakness, bruising, increase the risk of infections, low white blood cell count, reduction in platelets, which increases the risk of bleeding
• Allergic reactions such as urticaria and skin eruptions
• Fever that appears while taking the medication and disappears when stopping it (drug fever)
• Ulcerative colitis that can include the entire large intestine
• Abnormal or damaged nerves causing a feeling of numbness or tingling
• Pulmonary disease (pulmonary fibrosis, allergic reaction), resulting in difficulty breathing or wheezing and accumulation of fluid in the lungs, pneumonia
• Pancreatitis (associated with upper abdominal and back pain and discomfort)
• Abnormal results in liver function tests, hepatitis (inflammation of the liver causing symptoms similar to the flu and jaundice)
• Hair loss
• Muscle pain (myalgia) or joint pain (arthralgia)
• Renal problems (such as inflammation and scarring of the kidney), renal failure, which can be reversible if treatment is stopped in advance
• Reversible decrease in sperm production
• Cough

Unknown frequency (cannot be estimated from available data)

• Autoimmune disease (lupus-like syndrome) that can cause inflammation of the pericardium or the membranes surrounding the lungs and heart, urticaria, 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)
• Renal calculi and associated renal pain (see also section 2)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use.Website:www.notificaRAM.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAsacol 800 mg gastro-resistant tablets

• The active ingredient is mesalazine. Each tablet contains 800 mg of mesalazine.
• The other components are lactose, carboxymethylcellulose sodium from potato, magnesium stearate, talc, povidone, copolymer of methacrylic acid type B, triethyl citrate, yellow iron oxide (E172), red iron oxide (E172), and polyethylene glycol 6000.

Appearance of the product and content of the packaging

Gastro-resistant tablets of reddish-brown color, oblong shape, contained in PVC/aluminum blisters.

It is presented in packaging with 60 or 90 gastro-resistant tablets.

Holder of the marketing authorization

TILLOTTS PHARMA SPAIN, S.L.U.

Gran Via de les Corts Catalanes 680, 1st floor

08010 Barcelona

Spain

Responsible for manufacturing

HAUPT PHARMA WULFING GMBH

Bethelner Landstrasse, 18

Gronau D-31028

GERMANY

Last review date of this leaflet:January 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/