Patient Information Leaflet

Asacol 1g suppositories

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Asacol 1g suppositories are and what they are used for

2.What you need to know before you start taking Asacol 1g suppositories

3.How to use Asacol 1g suppositories

4.Possible side effects

1. Storage of Asacol 1g suppositories
2. Contents of the pack and additional information

This medication contains the active ingredient mesalazine, an anti-inflammatory drug used for the treatment of inflammatory bowel disease.

This medication is used for the treatment of mild to moderate acute limited ulcerative proctitis.

No use Asacol 1g supositorios

-if you are allergic to salicylic acid, salicylates such as acetylsalicylic acid (aspirin) or any of the other components of this medication (listed in section 6),

-if you have severe liver or kidney disease.

Advertencias y precauciones

Consulte a su médico antes de empezar a utilizar Asacol 1g supositorios

• if you have a history or suffer from respiratory problems,particularly if you suffer frombronchial asthma.
• if you have a history of allergy to sulfasalazine,a related substance tomesalazine.
• if you sufferfrom liver problems.
• if you sufferfrom kidney problems.
• if you have ever experienced a severe skin rash or peeling of the skin, blisters or mouth sores after using mesalazine.

Precauciones adicionales

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

Renal calculi may occur with the use of mesalazine. Symptoms may include abdominal pain on the sides and blood in the urine. Make sure to drink enough liquids 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 observe any of the symptoms related to these severe skin reactions described in section 4.

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

Otros medicamentos y Asacol 1g supositorios

Inform your doctor if you take or use any of the medications listed below, as the effects of these medications may change (interactions):

• Azathioprine, 6-mercaptopurine or thioguanine(medications used to treat immunological disorders).
• Certain anticoagulant medications(medications for thrombosis or to dilute the blood, e.g., warfarin).

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. Even in such cases, it may be correct to use this medication, and your doctor will be able to decide what is suitable for you.

Embarazo y lactancia

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

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

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

Conducción y uso de máquinas

This medication is not expected to affect your ability to drive and use machines.

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

Administration form

This medication can only be used rectally, so you must insert it through the anus. DO NOT ingest it by mouth.

Dosage

Adults and elderly people

For the treatment of the acute phase of proctitis ulcerosa, the recommended dose is one mesalazine suppository once a day, at bedtime.

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

Use in children

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

Treatment duration

Your doctor will decide for how long you should continue treatment with this medication. This will depend on your disease.

To get the maximum benefit from this medication, you should use mesalazine regularly and consistently, as indicated.

If you think this medication is too strong or too weak, consult with your doctor.

If you use more Asacol 1 g suppositories than you should

Contact your doctor if you are unsure, so they can decide what to do.

If you take too much mesalazine at one time, limit yourself to taking the next dose as prescribed.

Do not use a smaller dose.

If you forgot to use Asacol 1g suppositories

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

If you interrupt treatment with Asacol 1g suppositories

Do not stop using this medication until you speak with your doctor.

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

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

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

• Allergic skin eruption
• Rash, flat, non-elevated patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, generalized eruption, fever, and lymph node enlargement. These severe skin eruptions are often preceded by fever or flu-like symptoms
• Fever
• Difficulty breathing

If you experience a significant worsening of your overall health, especially if accompanied by fever and/or throat and mouth pain,stop using these suppositories andimmediately contact your doctor. These symptoms may, very rarely, be due to a decrease in the number of white blood cells in the blood (a disease called agranulocytosis), which may make you more prone to developing a severe 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:

Side effects rare (may affect up to 1 in 1,000 patients):

• Abdominal pain, diarrhea, flatulence (gas), nausea, and vomiting, constipation
• Headache, dizziness
• Chest pain, difficulty breathing, or swelling of the extremities due to an effect on your heart
• Increased skin sensitivity 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 extremities or side pain
• Intense abdominal pain due to acute pancreatitis inflammation
• Fever, sore throat, or discomfort due to changes in blood counts
• Shortness of breath, cough, wheezing, lung spots visible on X-rays due to allergic and/or inflammatory lung diseases
• Intense diarrhea and abdominal pain due to an allergic reaction to this medicine in the intestine
• Skin eruption or inflammation
• Muscle and joint pain
• Jaundice or abdominal pain due to liver and gallbladder disorders
• Hair loss and development of baldness
• Numbness and tingling in hands and feet (peripheral neuropathy)
• Reversible decrease in semen production

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

-Renal calculi and associated renal pain (see also 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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store below 30°C.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Asacol 1g suppositories

• The active ingredient is mesalazine and a suppository of this medication contains 1 g of mesalazine.
• The other component is hard fat.

Appearance of the product and contents of the packaging

This medication are suppositories in the form of a torpedo of a light beige color.

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tillotts Pharma Spain,, S.L.U.

Gran Via de les Corts Catalanes 680, 1st floor

08010 Barcelona

Responsible for manufacturing:

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden

Germany

This medication is authorized in the member states of the European Economic Area with the following names:

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

Austria, Estonia, Latvia, Lithuania: Yaldigo

France: Fivasa

Ireland: Asacolon

Greece, Netherlands: Kiudro

Date of the last review of this leaflet:January 2023

Other sources of information

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