Asacol 1 g suppositories

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Asacol 1 g suppositories

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

1. What Asacol 1 g suppositories are and what they are used for
2. What you need to know before using Asacol 1 g suppositories
3. How to use Asacol 1 g suppositories
4. Possible adverse effects
   1. How to store Asacol 1 g suppositories
   2. Contents of the pack and other information

1. What Asacol 1 g suppositories is and what it is used for

This medicinal product contains the active substance mesalazine, an anti-inflammatory drug used for the treatment of inflammatory bowel disease.

This medicinal product is used for the treatment of mild to moderate acute ulcerative colitis limited to the rectum (ulcerative proctitis).

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

Do not use Asacol 1g suppositories

• if you are allergic to salicylic acid, salicylates such as acetylsalicylic acid (aspirin), or to 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 have bronchial asthma.
• If you have a history of allergy to sulfasalazine, a substance related to mesalazine.
• If you suffer from liver problems.
• If you suffer from kidney problems.
• If you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after using mesalazine.

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

Additional precautions

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

Kidney stones may occur with the use of mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Make sure you drink an adequate amount of fluids during treatment with mesalazine.

Serious skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been observed with mesalazine treatment. Stop taking mesalazine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Mesalazine may cause a red-brown discoloration of urine upon 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

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

• Azathioprine, 6-mercaptopurine, or thioguanine (medicines used to treat immunological disorders).
• Certain drugs that inhibit blood clotting (medicines for thrombosis or blood thinning, e.g., warfarin).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Even in such cases, it may still be appropriate 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 become pregnant, consult your doctor or pharmacist before using this medicine.

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

You should only use this medicine while breastfeeding if your doctor tells you to do so, 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 operate machinery.

3. How to use Asacol 1 g suppositories

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist.

Method of administration

This medicine is for rectal use only, so it must be inserted into the anus. DO NOT swallow it orally.

Dosage

Adults and elderly patients

To treat the acute phase of ulcerative proctitis, the recommended dose is one mesalazine suppository once daily at bedtime.

Your doctor will adjust the dose according to your condition.

Use in children

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

Duration of treatment

Your doctor will decide how long you should continue treatment with this medicine. This will depend on your condition.

To obtain the maximum benefit from this medicine, you must use mesalazine regularly and consistently as directed.

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

If you use more Asacol 1 g suppositories than you should

Contact your doctor if you have any doubts so that he or she can decide what action to take.

If you use too much mesalazine at one time, simply continue with the next dose as prescribed.

Do not use a smaller amount.

If you forget to use Asacol 1 g 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. Take the next dose at the usual time. Do not use a double dose to make up for a missed dose.

If you stop using Asacol 1 g suppositories

Do not stop using this medicine until you have spoken with your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Skin allergic rash
• Flat 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, widespread rash, fever and swollen lymph nodes. These serious skin rashes are often preceded by fever or flu-like symptoms
• Fever
• Difficulty breathing

Contact your doctor immediately if you experience severe or recurring headache, changes in vision, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from 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 and contact your doctor immediately. These symptoms could very rarely be due to a reduction in the number of white blood cells in the blood (a condition called agranulocytosis), which may make you more susceptible to developing a serious infection. A blood test can confirm whether your symptoms may be caused by an effect of this medicine on your blood.

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

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Abdominal pain, diarrhoea, flatulence (gas), 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 adverse effects (may affect up to 1 in 10,000 patients):

• Changes in kidney function, sometimes with swelling of the limbs or side pain
• Severe abdominal pain due to acute inflammation of the pancreas
• Fever, sore throat or malaise due to changes in blood count
• Shortness of breath, cough, wheezing, spots in the lungs visible on X-ray due to allergic and/or inflammatory lung diseases
• Severe diarrhoea 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 disorders of the liver and gallbladder
• Hair loss and development of baldness
• Numbness and tingling in hands and feet (peripheral neuropathy)
• Reversible decrease in semen production

Adverse effects not known (frequency cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the blister and on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30°C.

Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Asacol 1 g suppositories

• The active substance is mesalazine; each suppository of this medicine contains 1 g of mesalazine.
• The other component is hard fat.

Appearance of the product and contents of the pack

This medicine consists of beige-colored, torpedo-shaped suppositories.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the European Economic Area member states 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 the most recent review of this leaflet: May 2025

Other sources of information

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