PENTASA SLOW RELEASE TABLETS 500 MG

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
MESALAZINE
Available from:
FERRING PHARMACEUTICALS LTD
ATC code:
A07EC02
Pharmaceutical form:
TABLETS SLOW RELEASE
Composition:
MESALAZINE 500 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
FERRING INTERNATIONAL CENTER SA, SWITZERLAND
Therapeutic group:
MESALAZINE
Therapeutic area:
MESALAZINE
Therapeutic indications:
Ulcerative colitis. Crohn's disease.
Authorization number:
064 73 26905 00
Authorization date:
2014-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

18-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

18-05-2020

2. The tablet should be taken whole or split into halves. If you have difficulty swallowing the

tablet, you can disperse it in a small quantity of cold water )approximately 50 ml(, then stir

and drink immediately.

If you have accidentally taken a higher dose. If you have accidentally taken an overdose

or if a child has accidentally swallowed the medicine, immediately refer to a doctor or proceed

to a hospital emergency room and bring the package of the medicine with you.

If you have forgotten to take the medicine. If you have forgotten to take the medicine at

the required time, take a dose as soon as you remember, provided that at least 3 hours still

remain until your next dose; do not take a double dose to make up for the forgotten one.

Adhere to the treatment regimen as recommended by the doctor.

Even if there is an improvement in your health, do not stop treatment with the medicine

without consulting the doctor or pharmacist.

Do not take medicines in the dark! Check the label and the dose each time you take a medicine.

Wear glasses if you need them.

If you have further questions regarding use of this medicine, consult the doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Pentasa tablets may cause side effects in some users. Do not be

alarmed when reading the list of side effects. You may not suffer from any of them.

Stop taking the medicine and consult a doctor immediately if you notice:

itchiness, skin rashes, swelling of the face, lips or throat, breathing difficulties or wheezing

)signs of an allergic reaction(

unexplained bleeding, bruising, skin rashes, fever or sore throat )signs of a blood disorder(

change in the amount or color of urine )signs of kidney impairment(

Additional side effects:

Rare side effects - effects that occur in 1-10 out of 10,000 users:

Vomiting, abdominal pain, nausea, diarrhea, headache, inflammatory heart conditions

)myocarditis, pericarditis(, dizziness, flatulence, increased skin sensitivity to sun and

ultraviolet light

Side effects that occur very rarely - effects that occur in fewer than 1 in 10,000 users:

Elevated liver enzymes, hair loss )reversible(, muscle and joint pain, allergic reactions and

fever, lupus erythematosis )an auto-immune disorder affecting the skin(, reduced sperm count

)reversible(, blood disorders )e.g., reduced red blood cell count(, tingling and numbness in the

hands and feet, allergic and fibrotic lung reactions )including breathing problems(, reduced

kidney function or kidney failure, inflammation of the pancreas.

If one of the side effects worsens, or if you suffer from a side effect not mentioned in the leaflet,

consult with the doctor.

Reporting side effects

Side effects can be reported to the Ministry of Health by clicking on the link "Reporting Side

Effects of Drug Treatment" found on the Ministry of Health homepage )www.health.gov.il( that

directs you to the online form for reporting side effects, or by entering the link:

https://sideeffects.health.gov.il/

5. HOW TO STORE THE MEDICINE?

Avoid poisoning! This medicine as well as any other medicine should be kept in a closed place

out of the reach of children and/or infants in order to avoid poisoning. Do not induce vomiting

unless explicitly instructed to do so by the doctor.

Do not use this medicine after the expiry date )exp. date( which appears on the package. The

expiry date refers to the last day of that month.

Store below 25°C.

6. FURTHER INFORMATION

In addition to the active ingredient, the tablet also contains:

Microcrystalline Cellulose, Povidone, Talc, Ethylcellulose, Magnesium Stearate

What the medicine looks like and the contents of the pack:

PENTASA Slow-Release Tablets 500 mg: White-grey to pale brown colored, round speckled

tablets with a score line and ‘PENTASA’ embossed on one side, and ‘500 mg’ on the other side.

PENTASA Slow-Release Tablets 1 g: White-grey to pale brown colored, oval speckled tablets

with ‘PENTASA’ embossed on both sides.

PENTASA Slow-Release Tablets 500 mg: Available in packs containing 10, 20, 50 or 100

tablets. Not all pack sizes may be available.

PENTASA Slow-Release Tablets 1 g: Available in packs of 60 tablets.

Registration holder and address: Ferring Pharmaceuticals Ltd.,

8 Hashita St., Industrial Park, Caesarea 3088900.

Manufacturer name and address: Ferring, Switzerland.

The format of this leaflet was determined by the Ministry of Health and its content was checked

and approved by the Ministry of Health in November 2014, and was updated in accordance

with Ministry of Health guidelines in October 2019.

Registration number of the medicine in the National Drug Registry of the Ministry of

Health:

PENTASA Slow-Release Tablets 500 mg: 064-73-26905

PENTASA Slow-Release Tablets 1 g:

147-06-33401

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986

The medicine is dispensed with a doctor’s prescription only

PENTASA Slow-Release Tablets 500 mg

PENTASA Slow-Release Tablets 1 g

Composition:

Each 500 mg slow-release tablet contains: Mesalazine 500 mg

Each 1 g slow-release tablet contains: Mesalazine 1 g

Inactive ingredients - see Section 6 ”Additional Information“.

Read this leaflet carefully in its entirety before using the medicine.

This leaflet contains concise information about the medicine. If you have further questions,

refer to the doctor or pharmacist.

This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may

harm them even if it seems to you that their ailment is similar.

1. WHAT IS THE MEDICINE INTENDED FOR?

An anti-inflammatory medicine for the treatment of inflammation of the large intestine

)Ulcerative Colitis( or Crohn’s Disease.

Therapeutic group: An anti-inflammatory drug from the salicylates group.

2. BEFORE USING THE MEDICINE

Do not use this medicine if you:

Are allergic to mesalazine or any of the ingredients of this medicine )see Section 6(.

Are allergic to other salicylates, such as aspirin.

Suffer from severe liver or kidney problems.

Special warnings regarding use of the medicine

While you are being treated with this medicine

- If you experience unexplained bleeding, bruising, skin rashes, fever or sore throat - stop

taking the medicine and refer to the doctor immediately.

- If you feel chest pain, an increased heartbeat and excess tiredness while using this medicine

- stop taking the medicine and refer to the doctor immediately.

- If you suddenly start to suffer from abdominal cramps, abdominal pain, fever, very severe

headache and rash - stop taking the medicine and refer to the doctor immediately.

Tell the doctor before taking the medicine if you:

- have lung problems, in particular asthma.

- currently have, or have previously had liver or kidney disease.

- are taking medicines that may affect kidney function, such as azathioprine.

- have ever had an allergy to a medicine that contains sulfasalazine.

If you suffer from kidney problems you will require regular check ups by the doctor.

Take care to avoid dehydration while taking the medicine. Dehydration may result following

prolonged vomiting and/or diarrhea, elevated fever and heavy sweating. If this occurs, consult

with the doctor or pharmacist as soon as possible.

If you are taking, or have recently taken, other medicines, including non-prescription

medicines and nutritional supplements, tell the doctor or pharmacist; in particular

inform the doctor or pharmacist if you are taking:

- medicines that inhibit blood clotting )e.g., warfarin(.

- azathioprine, 6-mercaptopurine or thioguanine.

Pregnancy and breast-feeding:

If you are pregnant, are planning to become pregnant or are breast-feeding, consult with

the doctor or pharmacist before taking this medicine. There is limited experience with the

use of mesalazine during pregnancy and breast-feeding. The infant may develop allergic

reactions after breast-feeding, e.g., diarrhea. If the infant develops diarrhea, breast-feeding

should be discontinued.

Driving and using machines:

No effect has been observed on driving and use of machines.

3. HOW TO USE THIS MEDICINE?

Always use according to the doctor’s instructions.

Check with the doctor or pharmacist if you are not sure.

The dosage and treatment regimen will be determined by the doctor only. The usual dosage

is generally:

- Inflammation of the large intestine (Ulcerative Colitis(:

To treat an acute attack: Up to 4 g a day, to be taken either once a day or in divided doses.

Long term treatment: 2 g once daily.

- Crohn’s Disease:

To treat an acute attack and for long term treatment: Up to 4 g a day in divided doses.

There is limited information about the effectiveness of the medicine in children )aged 6

to 18 years(.

Do not exceed the recommended dose.

Directions for use:

1. Do not chew or crush the tablet.

ىلإ

لااح هجوت ،ءاودلا نم أطخلاب لفط علب وأ ةطرفم ةعرج أطخلاب تلوانت اذإ .ربكأ ةيئاود ةعرج أطخلاب تلوانت اذإ .ءاودلا ةبلع كعم رضحأو ىفشتسملا يف ئراوطلا ةفرغل وأ بيبطلا نأ طرشب ،كركذت روف ةعرجلا لوانت بجي ،ددحملا تقولا يف ءاودلا اذه لوانت تيسن اذإ .ءاودلا لوانت تيسن اذإ .ةيسنملا ةعرجلا نع ضيوعتلل ةفعاضم ةعرج لوانت زوجي لا ؛ةيلاتلا كتعرج ىتح لقلأا ىلع تاعاس 3 كانه نوكي .بيبطلا هب ىصوأ امك جلاعلا ىلع ةبظاوملا بجي . يلديصلا وأ بيبطلا ةراشتسا نودب ءاودلاب جلاعلا نع فقوتلا زوجي لا ة

يحصلا كتلاح ىلع نسحت أرط ول ىتح تاراظنلا عض .ءاود اهيف لوانتت ةرم لك يف ةيئاودلا ةعرجلا نمو ءاودلا عباط نم ققحت !ةمتعلا يف ةيودلأا لوانتت لا .اهل ةجاحب تنك اذإ ةيبطلا .يلديصلا وأ بيبطلا رشتسا ،ءاودلا اذه لامعتسا لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ ةيبناجلا ضارعلأا .4 ةمئاق ةءارق نم عزجت لا .نيلمعتسملا نم مسق ىدل ةيبناج

اضارعأ صارقأ اساتنپ لامعتسا ببسي دق ،ءاود لك يف امك .اهنم يأ نم يناعت لاأ لمتحملا نم .ةيبناجلا ضارعلأا :لاح يف اروف بيبطلا ىلإ هجوتلاو ءاودلا لامعتسا فاقيإ بجي )يسسحت لعف در تاملاع( ةرخرخ وأ سفنتلا يف تابوعص ،قلحلا وأ نيتفشلا ،هجولا يف خافتنا ،يدلج ج

يهت ،ةكحلا

)مدلا زاهجب ةباصلإ تاملاع( قلح ملأ وأ ىمح ،يدلج ج

يهت ،تامدك ،رربم ريغ فيزن

)ةيولك ةباصلإ تاملاع( لوبلا نول وأ ةيمك يف ريغت

:ةيفاضإ ةيبناج ضارعأ :10,000 لك نم نيلمعتسم 10-1 ىدل رهظت ضارعأ ،ةردان ةيبناج ضارعأ سمشلل ةطرفم دلج ةيساسح ،تازاغ ،راود ،بلقلا ءاشغ وأ بلقلا باهتلا ،عادص ،لاهسإ ،نايثغ ،نطب ملأ ،تاؤيقت

يجسفنب قوفلا ءوضللو :10,000 نم دحاو لمعتسم نم لقأ ىدل رهظت ضارعأ ،

ادج ةردان نايحأ يف رهظت ةيبناج ضارعأ سوبول ،ىمحو ةيسسحت لعف تادر ،لصافملاو تلاضعلاب ملأ ،)سوكع( رعشلا طقاست ،دبكلا تاميزنإب عافترا ليبس ىلع( مدلا زاهجب تابارطضا ،)سوكع( فاطنلا دادعتب ضافخنا ،)دلجلا بيصي ةيتاذ ةعانم ضرم( سيسوتومتيرأ ةئرلاب ة

يفيلتو ةيسسحت لعف تادر ،نيمدقلاو نيديلاب روعشلا نادقفو زخو ،)ءارمحلا مدلا ايلاخ دادعتب ضافخنا لاثملا .سايركنبلاب باهتلا ،يولك لشف وأ ةيولكلا ةفيظولاب ضافخنا ،)سفنتلا تابوعص لمشي( كيلع ،ةرشنلا يف ركذي مل يبناج ضرع نم تيناع لاح يف وأ ،ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ .بيبطلا ةراشتسا ةيبناج ضارعأ نع غيلبتلا بقع ةيبناج ضارعأ نع غيلبتلا" طبارلا ىلع طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا نكمملا نم جذومنلل كهجوي يذلا )www.health.gov.il( ةحصلا ةرازو عقومب ةيسيئرلا ةحفصلا يف دوجوملا "يئاود جلاع :طبارلا حفصت قيرط نع وأ ،ةيبناج ضارعأ نع غيلبتلل رشابملا

https://sideeffects.health.gov.il/

؟ءاودلا نيزخت ةيفيك .5 وأ/و لافطلأا ةيؤر لاجمو يديأ لوانتم نع

اديعب قلغم ناكم يف رخآ ءاود لكو ءاودلا اذه ظفح بجي !ممستلا بنجت .بيبطلا نم ةحيرص تاميلعت نودب ؤيقتلا ببست لا .م

مستلا عنمت لكشلا اذهبو عضرلا مويلا ىلإ ةيحلاصلا خيرات ريشي .ةوبعلا ىلع رهظي يذلا )exp.date( ةيحلاصلا خيرات ءاضقنا دعب ءاودلا لمعتست لا .رهشلا سفن نم ريخلأا .ةيوئم ةجرد 25 ـلا نود نيزختلا بجي ةيفاضإ تامولعم .6 :ىلع كلذك ءاودلا يوتحي ةلاعفلا ةداملل ةفاضإ

Microcrystalline Cellulose, Povidone, Talc, Ethylcellulose, Magnesium Stearate

:ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك عم ،حتاف ينب ىتح يدامر -ضيبأ اهنول ،ةريدتسم ةطقنم صارقأ : غلم 500 ءيطب ريرحت تاذ صارقأ اساتنپ .رخلآا بناجلاب 500 mg و دحاو بناج يف PENTASA ةباتكو رطشلل قش عم ،حتاف ينب ىتح يدامر -ضيبأ اهنول ،ةيوضيب ةطقنم صارقأ : مغ 1 ءيطب ريرحت تاذ صارقأ اساتنپ .نيبناجلا لاك يف PENTASA ةملكلل ةباتك لمتحملا نم .صرق 100 وأ ،50 ،20 ،10 ىلع يوتحت تاوبعب رفوتت :غلم 500 ءيطب ريرحت تاذ صارقأ اساتنپ .تاوبعلا ماجحأ ةفاك ق

وست لاأ .صرق 60 ةوبعب رفوتت : مغ 1 ءيطب ريرحت تاذ صارقأ اساتنپ :هناونعو زايتملاا بحاص ،ض.م لاكيتويسامراف چنيريف .3088900 ايراسيق ،ةيعانصلا ةقطنملا ،8 اطيشه عراش :هناونعو ج

ِ

تنملا مسا .ارسيوس ،چنيريف خيراتب ةحصلا ةرازو لبق نم هيلع ةقفاوملاو اهاوتحم صحف متو ةحصلا ةرازو لبق نم ةرشنلا هذه ةغيص ديدحت مت .2019 لوأ نيرشت خيرات يف ةحصلا ةرازو تاميلعتل

اقفو هليدعت متو ،2014 يناث نيرشت :ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا ليجست مقر

064-73-26905

:غلم 500 ءيطب ريرحت تاذ صارقأ اساتنپ

147-06-33401

:مغ 1 ءيطب ريرحت تاذ صارقأ اساتنپ .نيسنجلا لاكل صصخ

م ءاودلا ،كلذ نم مغرلاب .ركذملا ةغيصب ةرشنلا هذه ةغايص تمت ،ةءارقلا ليهستو طيسبتلل

1.

NAME OF THE MEDICINAL PRODUCT

Pentasa® Suppositories

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Pentasa suppository contains: 1g mesalazine

For full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Suppositories. Oblong, compressed white to light tan, speckled suppositories

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Treatment of Ulcerative Proctitis.

4.2

Posology and method of administration

1 suppository 1-2 times daily.

4.3

Contraindications

PENTASA is contraindicated in:

- patients with known hypersensitivity to to salicylates or any of the excipients

- patients with severe liver and/or renal impairment

4.4

Special warnings and precautions for use

Blood tests ( differential blood count; liver function parameters such as ALT or AST; serum

creatinine) and urinary status (dip sticks) should be determined prior to and during treatment,

at the discretion of the treating physician. As a guideline, follow-up tests are recommended

14 days after commencement of treatment, then a further two to three tests at intervals of 4

weeks.

If the findings are normal, follow-up tests should be carried out every three months. If

additional symptoms occur, these tests should be performed immediately.

Caution is recommended in patients with impaired liver function.

PENTASA should not be used in patients with impaired renal function. Mesalazine-induced

renal toxicity should be considered, if renal function deteriorates during treatment.

Patients with pulmonary disease, in particular asthma, should be very carefully monitored

during a course of treatment with Pentasa.

Patients with a history of adverse drug reactions to preparations containing sulphasalazine

(risk of allergy to salicylates) should be kept under close medical surveillance on

commencement of a course of treatment with PENTASA. Should PENTASA cause acute

intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache

and rash, the treatment should be discontinued immediately.

If a patient develops dehydration while on treatment with meclizine, normal electrolyte levels

and fluid balance should be restored as soon as possible.

Mesalazine induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have

been reported rarely. Treatment should be discontinued on suspicion or evidence of these

reactions.

Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a

100% mesalazine content. It is recommended to ensure adequate fluid intake during

treatment.

4.5

Interaction with other medicinal products and other forms of interaction

In patients who are concomitantly treated with azathioprine, or 6-mercaptopurine, or

thioguanine, a possible increase in the myelosuppressive effects of azathioprine, or 6-

mercaptopurine, or thioguanine should be taken into account.

There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.

4.6

Fertility, pregnancy and lactation

Pentasa should be used with caution during pregnancy and lactation only if the potential

benefit outweighs the possible risks in the opinion of the physician.

Pregnancy: Mesalazine is known to cross the placental barrier. There is no adequate data on

the use of PENTASA in pregnant women. However, data on a limited number of exposed

pregnancies indicate no adverse effect of mesalazine on the pregnancy or on the health of the

fetus/newborn child. To date no other relevant epidemiologic data are available

In one single case after long-term use of a high dose of mesalazine (2-4 g, orally)

during pregnancy, renal failure in a neonate was reported.

Animal studies on oral mesalazine do not indicate direct or indirect harmful effects

with respect to pregnancy, embryonic/fetal development, parturition or postnatal

development.

Blood disorders (leucopenia, thrombocytopenia, anaemia) have been reported in new-

borns of mothers being treated with PENTASA.

PENTASA should only be used during pregnancy if the potential benefit outweighs

the possible risk

Breast-feeding: N-acetyl-5-aminosalicylic acid and to a lesser degree

mesalazine is excreted

in breast milk. The mesalazine concentration in breast milk is lower than in maternal blood,

whereas the metabolite, acetyl-mesalazine appears in similar or increased concentrations.

There is limited experience of the use of oral mesalazine in lactating women available to date.

No controlled studies with PENTASA during breast-feeding have been carried out.

Hypersensitivity reactions such as diarrhoea in the infant cannot be excluded. Therefore,

PENTASA should only be used during breast-feeding, if the potential benefit outweighs the

possible risk. If the infant develops diarrhoea, breast-feeding should be discontinued.

4.7

Effects on ability to drive and use machines

No effects on the ability to drive and use machines have been observed.

4.8

Undesirable effects

Following rectal administration local reactions such as pruritis, rectal discomfort and urge

may occur.

Frequency of adverse effects, based on clinical trials and reports from post-marketing

surveillance

SOC

Common

≥1/100 to < 1/10

Rare

≥1/10,000 to ≤ 1/1,000

Very rare

≤ 1/10,000

Blood and the

lymphatic system

disorders

altered blood counts (anaemia,

aplastic anaemia,

agranulocytosis,

neutropenia, leukopenia

pancytopenia,

thrombocytopenia, and

eosinophilia (as part of an

allergic reaction),

Nervous system

disorders

Headache , dizziness

Peripheral neuropathy

Cardiac disorders

Myocarditis*

Pericarditis*

Respiratory,

thoracic and

mediastinal

disorders

allergic and fibrotic lung

reactions (incl. dyspnoea,

cough, bronchospasm,

alveolitis, pulmonary

eosinophilia, pulmonary

infiltration, pneumonitis)

Gastrointestinal

disorders

Diarrhoea,

Abdominal pain, Nausea,

Vomiting

Flatulence

Increased amylase

acute pancreatitis*

Renal and urinary

disorders (***)

impairment of renal

function**** (incl. acute and

chronic interstitial nephritis)*,

nephrotic syndrome, renal

insufficiency and urine

discolouration

Skin and

subcutaneous

tissue disorders

Rash (incl.

urticaria,

erythematous

rash)

Photosensitivity**

Alopecia (Reversible)

Erythema multiform, and

Stevens-Johnson Syndrome

(SJS)

Musculoskeletal

connective tissue

and bone

disorders

Myalgia, Arthralgia

Immune system

disorders

Hypersensitivity reactions

such as allergic exanthema,

drug fever

lupus erythematosus

syndrome,

pancolitis

Hepato-biliary

disorders

Changes in liver function

parameters (increase in

transaminases, and cholestasis

parameters), hepatitis*,

cholestatic hepatitis, cirrhosis,

hepatic failure

Reproductive

system disorders

Oligospermia (reversible)

* The mechanism of mesalazine induced myocarditis, pericarditis, pancreatitis, nephritis

and hepatitis is unknown, but it might be of allergic origin.

** Photosensitivity: More severe reactions are reported in patients with pre-existing

skin conditions such as atopic dermatitis and atopic eczema.

(***) Not known: Nephrolithiasis; see section 4.4 for further information.

**** Renal

failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in

patients developing renal dysfunction during treatment.

It is important to note that several of these disorders can also be attributed to be the

inflammatory bowel disease itself.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions to the Ministry

of Health according to the National Regulation by using an online form

https://sideeffects.health.gov.il/

4.9

Overdose

Acute experience in animals:

Single oral doses of mesalazine of up to 5g/kg in pigs or a single intravenous dose of

mesalazine at 920mg/kg in rats were not lethal.

Human experience:

There are rare data on overdosage (e.g. intended suicide with high oral doses of

mesalazine), which do not indicate renal or hepatic toxicity.

Management of overdose

There is no specific antidote and treatment is symptomatic and supportive. The

treatment at hospital includes close monitoring of renal function.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties

Pharmacotherapeutic group: Intestinal anti-inflammatory agents.

ATC Code: A07 EC02

Mechanism of action and pharmacodynamic effects:

Mesalazine is recognised as the active moiety of sulphasalazine in the treatment of

ulcerative colitis

It is thought to act locally on the gut wall in inflammatory bowel disease, although its precise

mechanism of action has not been fully elucidated.

Increased leucocyte migration, abnormal cytokine production, increased production of

arachidonic acid metabolites, particularly leukotriene B4 and increased free radical formation

in the inflamed intestinal tissue are all present in patients with inflammatory bowel disease.

Mesalazine has in-vitro and in-vivo pharmacological effects that inhibit leucocyte

chemotaxis, decrease cytokine and leukotriene production and scavenge for free radicals. It is

currently unknown which, if any of these mechanisms play a predominant role in the clinical

efficacy of mesalazine.

5.2

Pharmacokinetic Properties

General characteristics of the active substance:

Disposition and local availability:

PENTASA suppositories

are designed to provide the distal part of the intestinal tract

with high concentrations of mesalazine and a low systemic absorption. Suppositories

are used to treat the rectum,

Biotransformation: Mesalazine is metabolised both pre-systemically by the intestinal mucosa

and systemically in the liver to N-acetyl mesalazine (acetyl mesalazine). The acetylation

seems to be independent of the acetylator phenotype of the patient. Some acetylation also

occurs through the action of colonic bacteria.

Acetyl mesalazine is thought to be clinically as well as toxicologically inactive, although this

remains to be confirmed.

Absorption:

The absorption following rectal administration is low, but depends on the

dose, the formulation and the extent of spread. Based on urine recoveries in

healthy volunteers under steady-state conditions given a daily dose of 2g (1g

x 2), approximately 10% of the dose is absorbed after administration of

suppositories.

Distribution: Mesalazine and acetyl mesalazine do not cross the blood-brain barrier. Protein

binding of mesalazine is approximately 50% and of acetyl mesalazine about 80%.

Elimination:

The plasma half-life of pure mesalazine is approximately 40 minutes and for acetyl

mesalazine approximately 70 minutes. Both substances are excreted in urine and

faeces. The urinary excretion consists mainly of acetyl mesalazine.

Characteristics in patients:

In patients with impaired liver and kidney functions, the resultant decrease in the rate of

elimination and increased systemic concentration of mesalazine may constitute an increased

risk of nephrotoxic adverse reactions.

5.3

Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that

already included in other sections of the SPC.

Pharmaceutical Particulars

List of excipients

Magnesium stearate, talc, povidone, macrogol 6000

Incompatibilities:

Not applicable

Shelf Life:

The expiry date of the product is indicated on the packaging

materials

Storage Conditions

Store bellow 25°C.

Nature and Contents of Container

Double aluminium foil blister strips of 7 suppositories each. Pack size: 28

Instructions for use/handling

No special requirements.

License Number

062 73 26904

Manufacturer:

Ferring, St-Prex ,Switzerland

License Holder

Ferring Pharmaceuticals Ltd 8, Hashita Street, Industrial Park Caesarea 38900

ISRAEL

Revised on May 2020

רבמצד

אפור

חקור

דבכנ

לש אפורלו ןכרצל םינולע יכ ךתעידיל איבהל םיצור ונא

םירישכת

Pentasa slow release tablets 500mg; 1g

םאתהב ונכדוע םירישכת םושירל הקלחמה רזוחל אשונב לש םינולעב תורמחהו םינולע ןוכדעל (היצקיפיטונ) העדוה לולסמ"

לש הבחרהו הכראה םירישכת ךיראתל דע העשה תארוה

31.12.2020

."

רישכת םש

Pentasa slow release tablets 500 mg

Pentasa slow release tablets 1g

:ליעפ רמוח

Each tablet of Pentasa slow release tablet 500 mg contains

Mesalazine

500 mg

Each tablet of Pentasa slow release tablet 1g contains

Mesalazine

:היוותה

Ulcerative colitis. Crohn`s disease

רוצמ םיפ

ולע םינ

.םינכדועמ

.םינמוסמ ונכדועש םיקלחה

בושח .הטמ תואלבטב םיטרופמ תורמחה םיווהמה םיירקיע םינוכדע תא תוליכמ ןניא תואלבטהש שיגדהל .םיפרוצמה םינולעב ןייעל שי םינוכדעה לכל .םינוכדעה לכ

הטמ הלבטב םיטרופמ םיירקיעה םינוכדעה

ל ןולעב אפור

ןוכדעה

קרפ

The drug is not recommended for use in patients with impaired renal function

and in patients with haemorrhagic diathesis. The renal function should be

monitored regularly (e.g. serum creatinine), especially during the initial phase

of treatment. Urinary status (dip sticks) should be determined prior to and

during treatment at the discretion of the treating physician. Mesalazine induced

nephrotoxicity should be suspected in patients developing renal dysfunction

such

during treatment. The concurrent use of other known nephrotoxic agents,

tions.

, may increase of the risk of renal reac

as NSAIDs and azathioprine

Caution is recommended in patients with active peptic ulcer.

4.4 Special

warnings and

precautions for

use

Pregnancy: Mesalazine is known to cross the placental barrier, and its

concentration in umbilical cord plasma is lower than the concentration

in maternal plasma. The metabolite acetyl-mesalazine is found in the

same concentration in umbilical cord and maternal plasma. . Animal

studies on oral mesalazine do not indicate direct or indirect harmful

effects with respect to pregnancy, embryonic/foetal development,

parturition or postnatal development. There are no adequate data on

the use of PENTASA in pregnant women. Limited published human

data on mesalazine show no increase in the overall rate of congenital

malformations. Some data show an increased rate of preterm birth,

stillbirth and low birth weight; however, these adverse pregnancy

outcomes are also associated with active inflammatory bowel disease.

4.6 Fertility,

pregnancy and

lactation

Gastrointestinal disorders.

Common: >1/100 to < 1/10:

Diarrhea, abdominal pain, nausea, vomiting,

flatulence

Skin and subcutaneous tissue disorders

Rare >1/10,000 to <1/1,000:

Photosensitivity**

Very rare <1/10,000

: Alopecia (Reversible)

Quincke's oedema, dermatitis allergic, Erythema multiforme Stevens Johnson

Syndrome (SJS)

(**) Photosensitivity: More severe reactions are reported in patients with pre-

existing skin conditions such as atopic dermatitis and atopic eczema.

4.8 Undesirable

effects

ןולעב

ןכרצ

ןוכדעה

קרפ הפורתב לופיטה ךלהמב

ןורג באכ וא םוח ,תירוע החירפ ,תורובח ,רבסומ יתלב םומיד הווח התא םא

תליטנ תא קיספה .דימ אפורל הנפו הפורתה

באכ שיגרמ התא םא הפורתב שומישה ןמזב ,תרבגומ תופייעו תוצאומ בל תוקיפד ,הזחב

קיספה דימ אפורל הנפו הפורתה תליטנ תא

החירפו דאמ קזח שאר באכ ,םוח ,ןטב באכ ,ןטבב תותיוועמ ימואתפ ןפואב לובסל ליחתמ ךנה םא

דימ אפורל הנפו הפורתה תליטנ תא קיספה

םא אפורל רפס הפורתב לופיטה ינפל :התא

המטסא דחוימב ,תויארב היעבמ לבוס

.הילכ וא דבכ תלחממ רבעב תלבס וא לבוס

ןירפויטוזא ןוגכ הילכה תוליעפ לע עיפשהל תולולעה תופורת לטונ היגרלאמ םעפ יא תלבס ןיזאלאסאפלוס הליכמה הפורתל

אפורה לש תיתפוקת הקידבל קקדזת הילכ תויעבמ לבוס ךנה םא

תודחוימ תורהזא שומישל תועגונה הפורתב

םא

ךנה

ןוירה תננכתמ ,ןוירהב

וא

הקינמ

שי

ץעוויהל

אפורב

וא

חקורב

ינפל

שומישה

הפורתב

ונשי .הקנהו ןוירה ןמזב ןיזלסמב שומישב לבגומ ןויסינ רחאל תויגרלא תועפות חתפל לולע קוניתה הקנהה תא קיספהל שי לושלש חתפמ קוניתה םא .לושלש המגודל ,הקנה

ןוירה

הקנהו

:

שי

קיספהל

תא

הפורתב שומישה

תונפלו

דימ

אפורל

לש הרקמב

,דרג

,תירוע החירפ תוחיפנ םינפב וא םייתפשב , המישנ יישק .ןורגב םירוחרח וא

ולא תיגרלא הבוגת לש םינימסת

,תורובח ,רבסומ יתלב םומיד

,תירוע החירפ ןורג באכ וא םוח

העיגפ לש םינימסת ולא םדה תכרעמב

ןתשה לש עבצ וא תומכב יוניש

תיתיילכ העיגפל םינימסת

תועפות

יאוול

תופסונ

:

ב תועיפומש תועפות ,תורידנ יאוול תועפו

1-10

ךותמ םישמתשמ

10,000

,תרוחרחס ,בלה םורקב וא בלב תקלד ,שאר באכ ,לושלש ,תוליחב ,ןטב באכ ,תואקה ,םיזג הרטלוא רואלו שמשל רועה לש תרבגומ תושיגר

לוגס

תועפות

יאוול

תועיפומש

םיתיעל

דחא שמתשממ תוחפב תועיפומש תועפות ,דאמ תורידנ ךותמ

10,000

:

דבכ ימיזנאב הילע תרישנ ,

רעיש

ךיפה

,םוחו תויגרלא תובוגת ,םיקרפמבו םירירשב באכ , סופול ב תעגופה תינומיאוטוא הלחמ) סיסוטמטירא (רוע תכרעמב תוערפה ,(ךיפה) ערז תריפסב הדירי , תובוגת ,םיילגרבו םיידיב השוחת רסוחו ץוצקע ,(םימודא םד יאת תריפסב הדירי המגודל) םדה בלבלב תקלד ,יתיילכ לשכ וא יתיילכ דוקפתב הדרי ,(המישנ ישק ללוכ) היארב תויטורבפו תויגרלא

תועפות :יאוול

ה םינולעה כדועמ םינ

חלשנ

.תוחקורה ףגא לש טנרטניאה רתאב םוסרפל

ןתינ

ולעה תא לבקל םג םינ

קתועב

חישק

"

הינפ

לעבל

םושירה

תרבח

גנירפ

סלקיטואצמרפ

עב

"

בוחר

הטישה

הירסיק

,הכרבב

רוא

טוזוז ת

היצלוגר תלהנמ תוכיאו

גנירפ

סלקיטואצמרפ

עב

"

Similar products

Search alerts related to this product

View documents history

Share this information