Label: information for the user

Asacol 1600 mg gastro-resistant tablets

mesalazine

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isAsacoland what it is used for

2. What you need to know before starting to takeAsacol

3. How to takeAsacol

4. Possible adverse effects

5. Storage ofAsacol

6. Contents of the pack and additional information

Asacol contains the active ingredient mesalazine. It is an anti-inflammatory medication used for the treatment of ulcerative colitis. Ulcerative colitis is a disease in which the lining of the large intestine (colon) or the final section of the large intestine (rectum) becomes inflamed (red and swollen). This can cause frequent bowel movements with blood along with abdominal cramps.

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

Do not takeAsacolif:

• You are allergic to the active ingredient or to any of the other components of this medication (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 condition or disease, especially if:

• You suffer from any lung disease, for example asthma.
• You have ever had kidney or lung insufficiency.
• You have had an allergic reaction to sulfasalazine in the past.
• You have had a heart allergy, such as myocarditis. If you have had mesalazine-induced allergic reactions of the heart, then Asacol should not be used. Asacol should be used with caution if you have had a previous heart allergy not caused by mesalazine.
• You have a stomach or intestinal ulcer, take Asacol with caution.
• If you have ever had a severe skin rash or skin peeling, blisters, or mouth sores after using 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 medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

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 mesalazine treatment.

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

Liver, kidney, and blood evaluation

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

Children and adolescents

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

Other medications and Asacol

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• Medications to prevent blood clotting (anticoagulants, e.g. warfarin). The effects of these medications may be increased or decreased, and the effects this may cause are unknown.
• Medications to reduce the activity of the immune system (e.g. azathioprine or 6-mercaptopurine or thioguanine). Used together with Asacol, these medications may cause fatal infections (see section 4).
• Nonsteroidal anti-inflammatory medications (e.g. medications containing acetylsalicylic acid, ibuprofen, or diclofenac).

Use of Asacol with food and beverages

The consumption of food, beverages, or alcohol does not interfere with the consumption of Asacol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Mesalazine is excreted in breast milk in small amounts, so special care is recommended if Asacol is used during breastfeeding. If the baby develops diarrhea, discontinue breastfeeding.

Driving and operating machines

The influence of Asacol on the ability to drive and operate machines is negligible or insignificant. However, if you think you may be affected, do not drive or operate machines.

Asacol contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult your doctor again?or?pharmacist.

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

The recommended dose is:

Adults

Active phase of the disease:The dose may be increased up to 4800 mg (3 tablets) per day, distributed in a single dose or in 2-3 doses per day, when the disease is worsening.

Maintenance treatment: 1600 mg once a day.

Use in childrenand adolescents:

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

Asacol use is not recommended 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 formulation, so if they are not taken correctly, they may not exert the necessary action.

Asacolcan 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 Toxicological Information Service. Phone 91 562 04 20 (indicating the medication and the amount ingested). It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The symptoms of overdose of this medication are: ringing in the ears, dizziness, headache, confusion, drowsiness, excessive fluid in the lungs, dehydration due to sweating, diarrhea, and vomiting, low blood sugar levels, rapid and deep breathing, alterations in the body's water and electrolyte content, and blood pH and abnormal body temperature.

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

If you forget to takeAsacol

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

If you interrupt the treatment withAsacol

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

If you have more doubts about the use of this medication, consult your doctor or pharmacist.

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

Stop taking Asacol immediately and consult your doctor if

you develop one or more of the following symptoms:

• unexplained appearance of rashes (without having been hit), bleeding under the skin, purple patches or spots under the skin, anemia (feeling tired, weakness, and paleness, especially on the lips and nails), fever (high temperature), acute stomach pain, 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, and eye ulcers, generalized rash, fever, and swollen lymph nodes. These severe skin eruptions are often preceded by fever or flu-like symptoms.

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

Other side effects:

Frequent: may affect 1 in 10 patients

• rash
• indigestion

Less common: may affect up to 1 in 100 patients

• high number of eosinophilic granulocytes, a type of white blood cell
• tingling, pins and needles, and numbness
• itching, urticarial hives
• chest pain

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

• 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 in the stomach with a desire to vomit or vomiting
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

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

• severe reduction in the number of blood cells, which can cause weakness, rashes, or more frequent infections, low platelet count, which increases the risk of bleeding
• allergic reactions such as: hives (urticaria)
• fever that appears while taking the medication 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
• abnormal or damaged nerves that can cause tingling, numbness
• lung disease (pulmonary fibrosis, allergic reactions) resulting in: difficulty breathing, coughing, wheezing, and fluid accumulation 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 that produces symptoms similar to the flu and jaundice)
• hair loss
• muscle and joint pain
• renal problems (such as inflammation, renal scarring), renal failure, which may be reversible if treatment is stopped in advance
• reversible decrease in sperm production

Unknown frequency: the frequency cannot be estimated from available data

• immunological 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)
• acute chest pain and dry cough (inflammation of the membrane covering the lungs)
• kidney stones and associated renal pain (see section 2)

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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.

This medication does not require special storage conditions

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofAsacol 1600 mg gastro-resistant tablets

• The active ingredient is mesalazine. Each tablet contains 1600 mg of mesalazine.
• The other components are:

magnesium stearate (E 470B)

polymethacrylic acid and methyl methacrylate copolymer (1:2)

triethyl citrate

yellow iron oxide (E 172)

red iron oxide (E 172)

macrogol

microcrystalline cellulose

40-55 mono and diglycerides

hypromellose

cornstarch

polysorbate 80

potassium dihydrogen phosphate

colloidal anhydrous silica

sodium carboxymethylcellulose (type A).

Appearance of the product and content of the container

Asacol 1600 mg gastro-resistant tablets are brownish-red 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 within blister strips. The blister strips are packaged in cardboard boxes containing 30 tablets, 60 tablets, or 90 tablets.

You may not find all packaging sizes on the market.

Marketing Authorization Holder:

Tillotts Pharma Spain, S.L.U.

Gran Via de les Corts Catalanes 680, 1st 1st

08010 Barcelona

Responsible for manufacturing:

HAUPT PHARMA WULFING GMBH

Bethelner Landstrasse, 18

Gronau D-31028

GERMANY

or

Tillotts Pharma GmbH

Warmbacher Str. 80

Rheinfelden DE - 79618

GERMANY

Last review date of this leaflet:January 2023

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