Proctasacol

Package leaflet: Information for the user

PROCTASACOL 500 mg

Rectal gel
mesalazine
Please read all of this 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 other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PROCTASACOL is and what it is used for
2. What you need to know before using PROCTASACOL
3. How to use PROCTASACOL
4. Possible side effects
5. How to store PROCTASACOL
6. Contents of the pack and other information

1. What PROCTASACOL is and what it is used for

PROCTASACOL contains the active substance mesalazine, which belongs to the group of intestinal anti-inflammatory drugs.
This medicine is used in adults and children over the age of 2 for the treatment of certain chronic inflammatory bowel diseases (ulcerative proctitis and Crohn's disease) and other acute or chronic idiopathic inflammations localized in the terminal part of the intestine or in the perianal area.
The medicine is indicated both for the treatment of active disease phases and for the prevention of relapses.
In more severe cases of intestinal inflammation, your doctor may also prescribe treatment with corticosteroids (cortisone).
Consult your doctor if you do not feel better or if you feel worse after the prescribed treatment period.

2. What you should know before using PROCTASACOL

Do not use PROCTASACOL

• if you are allergic to mesalazine, to other related medicines (such as salicylates), or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems (severe renal impairment, severe nephropathy), or injury to the inner lining, mucosa, of the stomach or intestine (gastric or duodenal ulcer, active peptic ulcer).
• if you have severe liver function impairment.
• if you have a tendency to develop bleeding.
• in children under 2 years of age (see section “Children”).
• during the last weeks of pregnancy and while breastfeeding. During other stages of pregnancy, your doctor will carefully evaluate whether treatment with this medicine is necessary (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using PROCTASACOL.
Before starting treatment with PROCTASACOL, you should undergo the necessary clinical investigations to establish diagnosis and therapeutic indications.
Before starting and during treatment with PROCTASACOL, blood and urine tests may be performed at your doctor’s discretion. Your doctor will decide how often these tests should be repeated.
Before starting treatment with PROCTASACOL, inform your doctor if you have ever had allergic reactions to medicines called sulfasalazine.
In particular, contact your doctor:

• if you experience severe or recurrent headache, vision disturbances, ringing or buzzing in the ears, contact your doctor immediately.
• if you have kidney problems. If you have known renal dysfunction, your doctor will carefully evaluate the need for treatment with mesalazine. Your doctor will assess renal function in all patients before starting therapy and periodically during treatment, especially if kidney disease is present.
• if you have liver disorders.
• if you are taking one or more of the following medicines:
  • oral medicines to lower blood sugar levels (oral hypoglycemics)
  • medicines to increase urine production (diuretics)
  • medicines to reduce blood clotting (coumarins)
  • medicines to treat inflammation (corticosteroids)
• if you have lung problems (especially asthma).
• if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after using mesalazine.

Exercise particular caution with mesalazine:
serious cutaneous adverse reactions (SCAR), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine therapy. Discontinue use of mesalazine and consult a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
After stopping treatment or during inadequate maintenance therapy, symptoms of the disease may reappear.
In severe cases of intestinal inflammation, your doctor may prescribe corticosteroid treatment (cortisone) in addition (see section “Other medicines and PROCTASACOL”).
Stop treatment (also see section “Possible side effects”) and inform your doctor:

• if, following treatment with PROCTASACOL, you develop bleeding, bruising, red spots on the skin due to leakage from superficial blood vessels (purpura), decreased hemoglobin levels in the blood (anemia), fever, or sore throat.

• In case of suspected acute intolerance syndrome, which may present with symptoms such as cramps, acute abdominal pain and bloody diarrhea, sometimes accompanied by fever, headache, and erythema.

Prolonged use of the medicine may lead to sensitization phenomena (exaggerated reactivity).
If you experience allergic reactions, stop treatment and contact your doctor immediately (see section 4 “Possible side effects”).
Mesalazine use may cause kidney stone formation. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink sufficient fluids during treatment with mesalazine.
Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite contained in bleach present in toilet water. This is due to a harmless chemical reaction between mesalazine and bleach.

Children
PROCTASACOL is contraindicated in children under 2 years of age (see section “Do not use PROCTASACOL”). The medicine is not recommended for use in children over 2 years of age unless the doctor considers it strictly necessary.

Other medicines and PROCTASACOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use this medicine with caution together with:

• Azathioprine (a medicine used for immune system disorders)
• 6-mercaptopurine and thioguanine (medicines used to treat blood cancers)
• Sulfonylureas (used in diabetes treatment), whose hypoglycemic effect (reduction of blood sugar levels) may be enhanced.
• Medicines to reduce blood clotting (anticoagulants belonging to the coumarin family, such as warfarin).
• Methotrexate (a medicine used in psoriasis, Crohn’s disease, rheumatoid arthritis, and in the treatment of certain cancers).
• Probenecid (a medicine used to reduce blood uric acid levels).
• Sulfinpyrazone (a medicine used for prevention after myocardial infarction).
• Spironolactone (a potassium-sparing diuretic).
• Furosemide (a diuretic medicine that increases urine production, used in fluid retention).
• Rifampicin (an antibiotic).
• Non-steroidal anti-inflammatory drugs (NSAIDs)

The use of PROCTASACOL together with corticosteroids may enhance the undesirable effects of corticosteroids on the stomach.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If pregnancy is confirmed or suspected, take the medicine only if clearly needed and under strict medical supervision.
Do not use PROCTASACOL during the last weeks of pregnancy and while breastfeeding (see section “Do not use PROCTASACOL”).
PROCTASACOL should be used during breastfeeding only if clearly necessary and under strict medical supervision. If the newborn develops diarrhea, breastfeeding should be discontinued.

Driving and using machines
PROCTASACOL does not affect or has negligible influence on the ability to drive vehicles or operate machinery.

PROCTASACOL contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).

PROCTASACOL contains glycerol
It may have a mild laxative effect.

3. How to use PROCTASACOL

Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you based on the extent and severity of the disease.
The recommended daily dose in adults during the active phase of the disease is 1.5 g
of mesalazine, equivalent to 3 single-dose containers of gel.
Use in children and adolescents
Children over 2 years: the dose will be proportionally reduced at the doctor's discretion.
Before using PROCTASACOL, it is advisable to empty the bowels, in order to have a clear intestinal canal.
For application, follow the instructions below:
1- Remove the rectal cannula from the cannula cover (tamper-evident seal).
2- Insert the cannula into the anus fully along its entire length.
3- Press the bottom of the tube to allow the gel to flow out.
4- Spread around the perianal area (around the anus).
The duration of treatment during the active phase is 4-6 weeks.
For long-term treatment to prevent relapses, the daily dosage and duration of treatment must be determined by the doctor according to the patient's condition or the progression of the disease.
If you use more PROCTASACOL than you should
Following an overdose of the medicine administered rectally, no particular consequences are known.
If you forget to use PROCTASACOL
Do not use a double dose to make up for the missed dose; instead, resume the normal dosing schedule as indicated.
If you stop using PROCTASACOL
After stopping treatment, symptoms may reappear. (See section "Warnings and precautions").
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Serious side effects
Inform your doctor immediately

• If you experience severe or recurrent headache, visual disturbances, ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension). [Frequency not known (frequency cannot be estimated from the available data)]

Stop treatment with mesalazine and contact your doctor immediately if you notice any of the
following symptoms:
reddish, non-elevated, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes.
These serious skin reactions may be preceded by fever and flu-like symptoms.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop treatment and contact your doctor immediately:

• allergic reactions (skin rash, itching).
• episodes of acute intestinal intolerance with abdominal pain.
• presence of blood in liquid stools (bloody diarrhoea).
• cramps.
• headache.
• fever.
• skin rash.

The following side effects have been reported with the use of PROCTASACOL:
Common (may affect up to 1 in 10 people):

• nausea;
• diarrhoea;
• abdominal distension;
• skin lesions (rash);
• headache;
• high blood pressure (hypertension);
• general weakness (asthenia);
• fever (pyrexia).

Uncommon (may affect up to 1 in 100 people):

• cramps and abdominal pain;
• presence of blood in liquid stools (bloody diarrhoea);
• upper abdominal pain;
• itching;
• somnolence;
• tremor;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

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

• dizziness;
• vomiting;
• passage of gas from the intestine (flatulence);
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

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

• decrease in the number of white blood cells in the blood (leucopenia, neutropenia), decrease in the number of platelets in the blood (thrombocytopenia), a form of anaemia characterised by insufficient production in the bone marrow of all types of blood cells (aplastic anaemia), severe decrease in the number of blood cells called granulocytes (agranulocytosis), reduction in the number of all blood cells (pancytopenia);
• decrease in the number of hairs and body hair in a localized or widespread area (alopecia);
• nerve disorder or damage causing numbness and tingling sensations (peripheral neuropathy);
• kidney disease (impaired kidney function including acute and chronic interstitial nephritis, nephrotic syndrome and renal failure);
• muscle pain (myalgia) and joint pain (arthralgia);
• allergic reactions such as allergic rash (skin eruption with red spots and/or pustules, blisters, bullae), drug fever, skin manifestations similar to those of systemic lupus erythematosus (lupus-like syndrome), inflammation of the colon (pancolitis);
• decrease in the number of spermatozoa in semen (oligospermia);
• inflammation of the membrane lining the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory reactions in the lungs (including breathing difficulty, bronchospasm, cough, alveolitis, eosinophilic pneumonia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary changes in liver function tests;
• gallstones (cholelithiasis);
• high fever (hyperpyrexia).

Not known (frequency cannot be estimated from the available data)

• swelling (edema) of the skin, mucosa and submucosal tissues (angioedema);
• kidney stones and associated renal pain (see also section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PROCTASACOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and to the product in its original packaging,
intact and properly stored.
Avoid direct exposure of the medicine to light and sources of heat.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PROCTASACOL contains

• The active substance is mesalazine (5-aminosalicylic acid or 5-ASA). Each single-dose container contains 500 mg of mesalazine.
• The other components are: Glycerin, triethanolamine, carbopol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

Description of the appearance of PROCTASACOL and pack contents

PROCTASACOL is a rectal gel and is available in packs of 20 single-dose containers of 500 mg, together with one tube container with cap and cannula for rectal administration.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
GIULIANI S.p.A. – Via Palagi, 2 – 20129 Milan, Italy.
Manufacturer
Laboratorio Chimico Farmaceutico A. Sella S.r.l. - Via Vicenza n. 67 - 36015 Schio (VI), Italy.