PROCTASACOL 500 mg Rectal Gel

Зміст інструкції

1. PROCTASACOL 500 mg
   1. What is PROCTASACOL and what is it 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

PROCTASACOL 500 mg

Rectal gel
mesalazine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even 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 you use 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 is PROCTASACOL and what is it used for?

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

2. What you need to 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 impairment of kidney function, severe nephropathy), damage to the inner lining, mucosa, of the stomach or intestine (gastric or duodenal ulcer, active peptic ulcer).
• if you have severe impairment of liver function.
• if you have a predisposition to the development of bleeding.
• in children under the age of 2 years (see section “Children”).
• in the last weeks of pregnancy and during breastfeeding. During other phases of pregnancy, the doctor will carefully assess the need for treatment with this medicine (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using PROCTASACOL.
Before starting treatment with PROCTASACOL, you will need to undergo the clinical investigations
necessary to define the diagnosis and therapeutic indications.
Before and during treatment with PROCTASACOL, at the doctor's discretion, blood and urine tests must be
performed. The doctor himself will decide how often to repeat the tests.
Before starting treatment with PROCTASACOL, tell your doctor if you have ever experienced
allergic reactions to medicines called sulfasalazine.
In particular, talk to your doctor:

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

Pay particular attention with mesalazine:
Serious skin 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 treatment with mesalazine. Stop using mesalazine and
consult your doctor immediately if you notice any of the symptoms related to these serious
skin reactions described in section 4.
After stopping treatment and during inadequate maintenance treatment, a recurrence of the disease symptoms may occur.
In the most severe cases of intestinal inflammation, your doctor may also prescribe treatment with corticosteroids (cortisone) (see section “Other medicines and PROCTASACOL”).
Stop treatment (see also section “Possible side effects”) and inform your
doctor:

• if, following treatment with PROCTASACOL, you experience bleeding, bruising, red spots on the skin

due to leakage of superficial blood vessels (purpura), decreased hemoglobin levels
in the blood (anemia), fever or sore throat.

• In the case of suspected acute intolerance syndrome which can manifest with symptoms such as, cramps, acute abdominal pain and bloody diarrhea, sometimes 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”).
The use of mesalazine can cause the formation of kidney stones. Symptoms may include
pain on the sides of the abdomen and blood in the urine. It is recommended to drink a sufficient amount of
liquids during treatment with mesalazine.
Mesalazine can cause a reddish-brown discoloration of the urine after contact with
sodium hypochlorite contained in the bleach present in the toilet water. This is caused by a
harmless chemical reaction that occurs between mesalazine and bleach.

Children
PROCTASACOL is contraindicated in children under the age of 2 years (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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Use with caution the medicine together with:

• Azathioprine (medicine used for diseases of the immune system)
• 6-mercaptopurine and thioguanine (medicines used for the treatment of blood cancers)
• Sulfonylureas (used for the treatment of diabetes) whose hypoglycemic effect (reduction of blood sugar levels) may be potentiated.
• Medicines to reduce blood clotting (anticoagulants belonging to the coumarin family such as warfarin).
• Methotrexate (medicine used in subjects with psoriasis, Crohn's disease, rheumatoid arthritis and in the treatment of some forms of cancer).
• Probenecid (medicine used to decrease the concentration of uric acid in the blood).
• Sulfinpyrazone (medicine used in prevention following a heart attack).
• Spironolactone (potassium-sparing diuretic).
• Furosemide (diuretic medicine, which increases urine production, used in case of fluid retention).
• Rifampicin (antibiotic).
• Non-steroidal anti-inflammatory drugs (NSAIDs)

The use of PROCTASACOL together with corticosteroids, may potentiate the undesirable effects of these
latter on the stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
If pregnancy is confirmed or suspected, take the medicine only if absolutely necessary
and under strict medical supervision.
Do not use PROCTASACOL in the last weeks of pregnancy and during breastfeeding (see
section “Do not use PROCTASACOL”).
PROCTASACOL should be used during breastfeeding only if absolutely necessary and
under strict medical supervision. If the newborn experiences diarrhea, breastfeeding should be discontinued.

Driving and operating machinery
PROCTASACOL does not alter or alters negligibly the ability to drive vehicles and operate
machinery.

PROCTASACOL contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate
May cause allergic reactions (including delayed reactions).

PROCTASACOL contains glycerol
May have a mild laxative effect.

3. How to use PROCTASACOL

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The doctor will decide the right dose for you based on the extent and severity of the disease.
The average daily dose recommended 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 try to evacuate, to have the intestinal canal
free from stool. For application, follow the following instructions:

• 1- Remove the rectal cannula from the cannula cover (guarantee seal).
• 2- Insert the cannula into the anus to its full 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, in the active phase, is 4-6 weeks.
In long-term treatments to prevent relapses, the daily dosage and duration of
treatment must be established by the doctor according to the patient's condition or the evolution
of the disease.

If you use more PROCTASACOL than you should
Following the assumption of an excessive dose of the medicine, by rectal administration,
no particular consequences are known.

If you forget to use PROCTASACOL
Do not use a double dose to compensate for the forgotten dose, but resume the normal dosage of
administration as indicated.

If you stop using PROCTASACOL
After stopping treatment, a recurrence of symptoms may occur. (see paragraph
“Warnings and precautions”).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Serious side effects
Immediately inform your doctor

• In case of severe or recurring headache, visual disturbances, ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension). [Not known (frequency cannot be estimated based on available data)]

Stop treatment with mesalazine and immediately consult your doctor if you observe any of the
following symptoms:
reddish-purple blotches that are not raised, target-shaped or circular on the trunk, often with blisters
in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, widespread
skin rash, fever and swollen lymph nodes.
These severe skin rashes may be preceded by fever and flu-like symptoms.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following side effects, stop treatment and immediately contact
your doctor:

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

With the use of PROCTASACOL, the following side effects have been reported:

Common (may affect up to 1 in 10 people):

• nausea;
• diarrhea;
• tense abdomen;
• skin lesions (skin rashes);
• 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 diarrhea);
• pain in the upper abdomen;
• itching;
• drowsiness;
• tremor;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

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

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

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

• decreased number of white blood cells in the blood (leukopenia, neutropenia), decreased number of platelets in the blood (thrombocytopenia), a form of anemia characterized by insufficient production in the bone marrow of all types of blood cells (aplastic anemia), severe decrease in the number of blood cells called granulocytes (agranulocytosis), reduction in the number of all cells present in the blood (pancytopenia);
• loss of hair and hair in a circumscribed or widespread area (alopecia);
• abnormality or damage to the nerves causing a sensation of numbness and tingling (peripheral neuropathy);
• kidney disease (impaired renal 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 rash with the appearance of red spots and/or pustules, blisters, bubbles), drug fever, skin manifestations similar to those of lupus erythematosus (lupoid-like syndrome), inflammation of the colon (pancolitis);
• decreased number of sperm in semen (oligospermia);
• inflammation of the membrane lining the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic reactions and inflammation of the lungs (including difficulty breathing, bronchospasm, cough, alveolitis, eosinophilic pneumonia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, also acute);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary changes in tests to assess liver function;
• gallstones (cholelithiasis);
• high fever (hyperpyrexia).

Not known (frequency cannot be defined based on available data)

• swelling (edema) of the skin, mucous membranes and submucosal tissues (angioedema);
• kidney stones and associated kidney pain (see also paragraph 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Avoid direct exposure of the medicine to light and heat sources.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PROCTASACOL contains

• The active ingredient is mesalazine (5-aminosalicylic acid or 5-ASA). One single-dose container contains 500 mg of mesalazine.
• The other ingredients are: Glycerol, triethanolamine, carboxypolymethylene, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water. Description of the appearance of PROCTASACOL and contents of the packPROCTASACOL is presented as a rectal gel and is available in packs of 20 single-dose containers of 500 mg with a tube container with cap and cannula for rectal administration. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
GIULIANI S.p.A. – Via Palagi, 2 – 20129 Milan.

Manufacturer
Laboratorio Chimico Farmaceutico A. Sella S.r.l. - via Vicenza n. 67- 36015 Schio (VI).