ASACOL 1 G SUPPOSITORIES

2. What you need to know before you use Asacol 1 g Suppositories

Do not use Asacol 1g Suppositories

• if you are allergic to salicylic acid, salicylates such as acetylsalicylic acid (aspirin) or any of the other components of this medicine (listed in section 6),
• if you have severe liver or kidney disease.

Warnings and Precautions

Consult your doctor before starting to use Asacol 1g Suppositories

• If you have a history of or suffer from lung problems, particularly if you suffer from bronchial asthma.
• If you have a history of allergy to sulfasalazine, a substance related to mesalazine.
• If you have liver problems.
• If you have kidney problems.
• If you have ever suffered from a severe skin rash, skin peeling, or blisters in the mouth after using mesalazine.

If you experience severe or recurrent headache, vision disturbances, or ringing in the ears, contact your doctor immediately.

Additional Precautions

During treatment, your doctor may want to keep you under close medical supervision, and it may be necessary to perform regular blood and urine tests.

Kidney stones can occur with the use of mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Make sure to drink enough fluids during treatment with mesalazine.

Severe skin reactions, 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 notice any of the symptoms related to these severe skin reactions described in section 4.

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.

Other Medicines and Asacol 1g Suppositories

Tell your doctor if you are taking or using any of the following medicines, as their effects may change (interactions):

• Azathioprine, 6-mercaptopurine, or thioguanine(medicines used to treat immune system disorders).
• Certain medicines that inhibit blood clotting(medicines for thrombosis or to thin the blood, e.g., warfarin).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Even so, it may be correct for you to use this medicine, and your doctor will decide what is suitable for you.

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 using this medicine.

You should only use this medicine during pregnancy if your doctor tells you to.

You should only use this medicine during breastfeeding if your doctor tells you to, as the medicine may be excreted in breast milk.

Driving and Using Machines

This medicine is not expected to affect your ability to drive or use machines.

3. How to Use Asacol 1 g Suppositories

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

Method of Administration

This medicine can only be used rectally, so it must be inserted into the anus. DO NOT swallow it.

Dosage

Adults and Elderly

For the treatment of acute ulcerative proctitis, the recommended dose is one mesalazine suppository once daily, at bedtime.

The dose will be adjusted by your doctor according to your disease.

Use in Children

There is limited experience and documentation of the effect in children.

Duration of Treatment

Your doctor will decide how long you need to continue treatment with this medicine. This will depend on your disease.

To get the most benefit from this medicine, you should use mesalazine regularly and constantly, as indicated.

If you think this medicine is too strong or too weak, talk to your doctor.

If you use more Asacol 1 g Suppositories than you should

Contact your doctor if you have any doubts so that they can decide what to do.

If you use too much mesalazine at one time, just take the next dose as prescribed.

Do not use a smaller amount.

If you forget to use Asacol 1g Suppositories

If you forget to use this medicine, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Use the next dose at the usual time. Do not use a double dose to make up for forgotten doses.

If you stop using Asacol 1g Suppositories

Do not stop using this medicine until you talk to your doctor.

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

4. Possible Side Effects

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

All medicines can cause allergic reactions, although serious allergic reactions are very rare. If you get any of the following symptoms after using this medicine, you should contact your doctor immediately:

• Allergic skin rash
• 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
• Fever
• Difficulty breathing

Tell your doctor immediatelyif you experience severe or recurrent headache, vision disturbances, or ringing 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]).

If you experience a marked worsening of your general health, especially if accompanied by fever and/or sore throat and mouth, stop using these suppositories andcontact your doctor immediately. These symptoms could, very rarely, be due to a reduction in the number of white blood cells in the blood (a disease called agranulocytosis), which can make you more prone to developing a serious infection. A blood test can confirm if your symptoms are due to an effect of this medicine on your blood.

The following side effects have also been reported by patients using mesalazine:

Rare side effects (may affect up to 1 in 100 patients):

• Abdominal pain, diarrhea, flatulence, nausea, and vomiting, constipation
• Headache, dizziness
• Chest pain, difficulty breathing, or swelling of the limbs due to an effect on the heart
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

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

• Changes in kidney function, sometimes with swelling of the limbs or pain in the side
• Severe abdominal pain due to acute inflammation of the pancreas
• Fever, sore throat, or malaise due to changes in the blood count
• Shortness of breath, cough, wheezing, spots on the lungs visible on X-rays due to allergic and/or inflammatory lung diseases
• Severe diarrhea and abdominal pain due to an allergic reaction to this medicine in the intestine
• Skin rash or inflammation
• Muscle and joint pain
• Jaundice or abdominal pain due to liver and bile duct disorders
• Hair loss and development of baldness
• Numbness and tingling in hands and feet (peripheral neuropathy)
• Reversible decrease in semen production

Unknown frequency side effects(frequency cannot be estimated from the available data)

• 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Asacol 1 g Suppositories

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 blister and on the carton after 'EXP'. The expiry date is the last day of the month stated.

Store below 30°C.

Store in the original package to protect from light.

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 further information

Composition of Asacol 1g Suppositories

• The active substance is mesalazine, and one suppository of this medicine contains 1 g of mesalazine.
• The other component is hard fat.

Appearance of the product and pack contents

This medicine is suppositories in the shape of a torpedo, light beige in color.

This medicine is available in boxes of 10, 20, 30, 60, or 90 suppositories.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Tillotts Pharma Spain, S.L.U.

Travessera de Gràcia 58, 5º 3ª

08006 Barcelona

Spain

Manufacturer:

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Czech Republic, Denmark, Finland, Germany, Iceland, Norway, Spain, Sweden: Asacol.

Estonia, Latvia, Lithuania: Yaldigo

France: Fivasa

Ireland: Asacolon

Greece, Netherlands: Kiudro

Date of last revision of this leaflet:May 2025

Other sources of information

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