AZZAVIX 1000 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Azzavix 1000 mg Gastro-Resistant Tablets

Do not take Azzavix

• if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid or any other salicylate
• if you have a medical condition that may make you prone to bleeding
• if you have severe kidney and/or liver impairment

Warnings and precautions

Consult your doctor before starting treatment with Azzavix

• if you are or plan to become pregnant
• if you are breast-feeding
• if you have liver or kidney problems
• if you suffer from any lung disease, for example, asthma
• if you have had an allergy to sulfasalazine in the past
• if you have a stomach or intestinal ulcer
• if you have previously had inflammation of the heart (which could be a consequence of a heart infection)
• if you have ever suffered from severe skin rash, skin peeling, blisters, or sores in the mouth after using mesalazine.

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

In case of appearance of any allergic manifestation (e.g., skin rash, itching) or cramps, abdominal pain, severe headache, and fever during the course of treatment, do not take any more tablets and inform your doctor immediately.

Before and during treatment, your doctor may want to perform regular blood and urine tests to check the functioning of your liver, kidneys, blood, and lungs.

Kidney stones may occur with the use of mesalazine. The symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink a sufficient amount of liquid during treatment with mesalazine.

Severe skin rashes, 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 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.

Children and adolescents

Information on safety in the use of this medicine in children and adolescents is limited.

Do not administer to children under 5 years of age.

Other medicines and Azzavix 1000 mg Gastro-Resistant Tablets

In general, you can continue treatment with other medicines while taking Azzavix. However, inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

Azzavix may interact with some medicines if taken at the same time.

In particular:

• medicines to lower blood sugar levels (antidiabetics)
• medicines to lower blood pressure (antihypertensives/diuretics)
• medicines for the treatment or prevention of gout attacks
• medicines that help with bowel movements (laxatives containing lactulose)
• medicines to prevent blood clotting (anticoagulants)
• medicines to reduce the activity of the immune system (e.g., azathioprine, 6-mercaptopurine, or thioguanine)
• medicines to treat pain and inflammation (anti-inflammatory agents)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is limited experience with the use of mesalazine during pregnancy and breast-feeding. The newborn may develop allergic reactions after breast-feeding, such as diarrhea. If the newborn develops diarrhea, breast-feeding should be discontinued.

The use of Azzavix is not recommended during pregnancy or breast-feeding unless your doctor advises you otherwise.

Driving and using machines

No adverse effects of Azzavix on the ability to drive or use machines have been reported.

Azzavix 1000 mg Gastro-Resistant Tablets contain sodium

This medicine contains 98 mg of sodium (main component of table/cooking salt) in each gastro-resistant tablet. This is equivalent to 5% of the maximum daily recommended sodium intake for an adult.

Consult your doctor or pharmacist if you need to take 4 or more gastro-resistant tablets daily for a prolonged period, especially if you have been advised to follow a low-salt diet.

3. How to take Azzavix 1000 mg Gastro-Resistant Tablets

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment before, even if you feel better, as symptoms may return if treatment is stopped too soon.

Strictly follow the treatment according to your doctor's instructions, both in the acute inflammatory phase and in the maintenance time established.

The recommended dose in adults is:

To treat an acute episode of colitis,your doctor will normally prescribe a dose between 1.5 (one 1000 mg tablet and one 500 mg tablet) and 4 grams (four 1000 mg tablets) of mesalazine per day, which can be administered in one or several doses.

To help prevent further episodes,your doctor may prescribe a dose between 1.5 (one 1000 mg tablet and one 500 mg tablet) and 3 grams (three 1000 mg tablets) of mesalazine per day, which can be administered in one or several doses.

Azzavix 1000 mg Gastro-Resistant Tablets should be taken orally.

The gastro-resistant tablets should be taken before meals, swallowing the tablet whole with the help of liquid. Do not divide, chew, or crush.

In both cases, it may be necessary to use the 500 mg tablets of Azzavix to provide the dose that best suits you.

Use in children and adolescents

The administration of Azzavix is not recommended for children and adolescents under 18 years of age due to the lack of data on its safety and efficacy. Do not administer to children under 5 years of age.

Use in elderly patients

The use of Azzavix in elderly patients should be done with caution and limited to those patients with normal renal function.

If you take more Azzavix 1000 mg Gastro-Resistant Tablets than you should

Consult your doctor if you have taken more than prescribed. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

Consult your doctor if you have taken more than prescribed.

If you forget to take Azzavix 1000 mg Gastro-Resistant Tablets

Do not take a double dose to make up for the forgotten dose.

If you stop taking Azzavix 1000 mg Gastro-Resistant Tablets

It is important that you take Azzavix gastro-resistant tablets every day, even when you do not have symptoms of ulcerative colitis. Always finish the treatment that has been prescribed to you.

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 taking this medicine, stop taking this medicine and contact your doctor immediately:

• allergic skin rash;
• fever;
• difficulty breathing.

If you experience fever or irritation of the throat or mouth, stop using this medicine and contact your doctor immediately. These symptoms may be due, very rarely, to a decrease in the number of white blood cells in the blood (a condition called agranulocytosis).

Serious side effects:

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

• 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.
• if you experience severe headache or recurrent headache, vision changes, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

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

Rare side effects(may affect up to 1 in 1,000 people)

• abdominal pain, diarrhea, flatulence, nausea, and vomiting;
• headache, dizziness;
• chest pain, difficulty breathing, or swollen 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 less than 1 in 10,000 people)

• kidney problems, sometimes with swollen limbs or side pain;

• severe abdominal pain due to acute pancreatitis;
• worsening of colitis symptoms;
• fever, sore throat, or nausea due to changes in blood count;

• difficulty breathing, cough, wheezing, spots on the lung X-ray due to allergic and/or inflammatory conditions in the lungs;
• diarrhea and severe abdominal pain due to an allergic reaction to the medicine at the intestinal level;

• skin rash or inflammation;
• muscle and joint pain;
• jaundice or abdominal pain due to liver or biliary disorders;
• hair loss and development of baldness;
• erythema multiforme;
• numbness and tingling of the fingers of the hands and feet (peripheral neuropathy)
• reversible decrease in semen production;
• blood count disorders.

Side effects of unknown frequency(cannot be estimated from the available data).

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

severe skin reactions: drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN).

• increased pressure inside the skull (idiopathic intracranial hypertension)

Photosensitivity

More severe reactions have been reported in patients with pre-existing skin conditions, such as atopic dermatitis and atopic eczema.

If these symptoms continue or become more severe, consult your doctor.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any 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 Azzavix 1000 mg Gastro-Resistant Tablets

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azzavix 1000 mg Gastro-Resistant Tablets

• Each gastro-resistant tablet contains 1000 mg of mesalazine.
• The other ingredients are anhydrous sodium carbonate, glycine, povidone, microcrystalline cellulose, sodium carboxymethylcellulose, colloidal silicon dioxide, calcium stearate, methacrylic acid-ethyl acrylate copolymer, methacrylic acid-methyl methacrylate copolymer, dibutyl sebacate, talc, titanium dioxide (E-171), polyethylene glycol 6000, yellow iron oxide (E-172), red iron oxide (E-172), isopropyl alcohol.

Appearance and packaging of the product

This medicine is marketed in PVC/PVDC-Aluminum blisters packaged in cardboard boxes containing 60 or 100 tablets.

Only some pack sizes may be marketed.

The tablets are oblong, orange-colored, film-coated tablets.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Date of last revision of this leaflet: January 2023