Label: information for the user

Asacol 400 mg gastro-resistant tablets

Mesalazine

Read the entire label carefully before starting to take the medication.

• Keep this label as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist..

1.What isASACOLand for what it is used

2. Before takingASACOL

3. How to takeASACOL

4. Possible adverse effects

5. Storage ofASACOL

6. Additional information

ASACOL is indicated for:

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

Do not take ASACOL if:

• You are allergic (hypersensitive) to salicylic acid, salicylates, or any of the other components of Asacol

• You have a duodenal or gastric ulcer
• You have hemorrhagic diathesis
• You have coagulation abnormalities
• You have severe liver or kidney damage

Be especially careful with ASACOL:

• If you have ever had kidney failure. When you start taking ASACOL, your doctor should check your blood regularly to make sure your kidneys are working properly.

• There have been reports of increased liver enzyme levels. Caution is recommended if ASACOL is administered to patients with liver failure.

• If you experience any unexplained bleeding, bruises, purpura, sore throat, fever, or general discomfort during treatment, tell your doctor if treatment needs to be interrupted.

• If you have any lung disease, for example asthma, your doctor should check your breathing regularly.

• If you have ever had adverse reactions to sulfasalazine, a medication used to treat ulcerative colitis and Crohn's disease.

• If you 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 blood in the urine. Make sure to drink enough liquid during mesalazine treatment.

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.

ASACOL tablets should not be taken with lactulose or similar preparations that reduce stool pH and prevent mesalazine release.

Severe skin eruptions, 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 symptoms related to these severe skin reactions described in section 4.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those obtained without a prescription.

• Blood-thinning medications (anticoagulants, e.g. warfarin)
• Medications to reduce immune system activity (e.g. azathioprine or 6-mercaptopurine or thioguanine)

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

No adequate data is available on the use of ASACOL during pregnancy or breastfeeding. Its use is not recommended during pregnancy or breastfeeding, unless the benefits of treatment outweigh the potential risks.

Driving and operating machinery

No effects have been observed on the ability to drive or operate machinery.

Important information about some of the components of ASACOL

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 ASACOL as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

ASACOL should be administered orally.

The tablets should be swallowed whole and before meals.

The normal dose is:

Adults

Ulcerative colitis, acute treatment of mild to moderate episodes: 2 tablets three times a day.

Maintenance treatment of ulcerative colitis: 2 to 4 tablets.

Crohn's disease: maintenance treatment: 3 to 6 tablets distributed in 3 doses per day.

Seniors

The administration of ASACOL in seniors 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 of weight; and the normal adult dose to children above 40 kg. However, your doctor will indicate the appropriate dose to treat your disease.

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).

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

If you forgot 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 doubts about the use of this product, ask your doctor or pharmacist.

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

Stop taking mesalazine and seek medical help immediately if you experience any of the following symptoms:

Rarely, the following side effects have been described:

Rare side effects

• headache
• dizziness
• abdominal pain
• diarrhea
• abdominal flatulence
• inflammation of the pancreas (pancreatitis)
• general feeling of being unwell (nausea)
• vomiting
• inflammation of the heart muscle (myocarditis) and the membrane surrounding the heart (pericarditis)
• neuropathy
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

Very rare side effects

• blood disorders, including:

• low white blood cell count (leucopenia, neutropenia), which can sometimes be severe (agranulocytosis)
• low count of all blood cells (pancytopenia)
• low platelet count (thrombocytopenia)
• low count of blood cells including red and white blood cells and platelets (aplastic anemia)

• abnormal results from liver function tests (blood tests to check liver function)
• inflammation of the liver (hepatitis)
• acute inflammation of the pancreas (acute pancreatitis)
• allergic reactions such as:

• fever that occurs while taking the medicine and disappears when it is stopped (drug fever)
• rash or skin eruption (allergic exanthema) including itching (pruritus) and hives (urticaria)
• autoimmune disease that can affect organs and joints (lupus erythematosus syndrome)
• ulcerative colitis including the entire colon (pancolitis)

• tingling, numbness, strange sensations, weakness, burning (peripheral neuropathy)
• muscle pain (myalgia)
• joint pain (arthralgia)
• renal insufficiency including:

• inflammation of the kidneys (interstitial nephritis)
• renal insufficiency
• renal failure

• reversible decrease in sperm count (oligospermia) that occurs while taking the medicine and disappears when it is stopped.
• fibrotic and allergic pulmonary reactions (hypersensitivity) (the alveoli, small air sacs in the lungs, that transfer oxygen to the blood, are damaged and inflamed) including:

• difficulty breathing (cough, dyspnea, bronchospasm)
• inflammation of the small air sacs (alveoli) of the lungs (alveolitis)
• inflammation of the lungs with an increase in eosinophils, a type of white blood cell (eosinophilic pneumonia)
• inflammation of the lung tissue (pneumonitis)
• pulmonary edema (fluid accumulates and fills the lungs)

• hair loss (alopecia)

Side effects of unknown frequency:

• kidney stones and associated renal pain (see also section 2)

The assessment of side effects is based on the following frequencies:

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

Very rare: may affect up to 1 in 10,000 people.

Unknown frequency: cannot be estimated from available data

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Store below 25°C. Store in the original packaging.

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

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

Medicines should not be disposed of through drains or in the 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 400 mg gastro-resistant tablets

• The active ingredient is mesalazine. Each tablet contains 400 mg of mesalazine.
• The other components are lactose, carboxymethylstarch, magnesium stearate, talc, polyvinylpyrrolidone, methacrylic acid copolymer type B, triethyl citrate, iron oxide yellow (E172), iron oxide red (E172), and polyethylene glycol 6000.

Appearance of the product and contents of the package

ASACOL are red, oval-shaped, gastro-resistant tablets coated with an acrylic resin base (Eudragit-S) to ensure the release of the active ingredient in the terminal ileum and colon.

ASACOL is presented in packages with 100 gastro-resistant tablets.

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

This leaflet was approved in January 2023

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