Pentasa Mesalazine 1g/100ml enema

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Mesalazine

Предлага се от:

Ferring Pharmaceuticals Ltd

АТС код:

A07EC02

INN (Международно Name):

Mesalazine

дозиране:

10mg/1ml

Лекарствена форма:

Enema

Начин на приложение:

Rectal

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 01050100; GTIN: 5015919736389

Листовка

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
− Keep this leaflet. You may need to read it again
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
− If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET :
1. What Pentasa is and what it is used for
2. Before you use Pentasa
3. How to use Pentasa
4. Possible side effects
5. How to store Pentasa
6. Further Information
1. WHAT PENTASA IS AND WHAT IT IS USED FOR
The name of this medicine is Pentasa Mesalazine Enema in the
form of a suspension. Each bottle contains mesalazine 1g in100ml
of liquid as the active ingredient. Mesalazine belongs to a group of
medicines called salicylates.
Pentasa is used to treat inflammation in the gut caused by
conditions such as active ulcerative colitis where it is affecting the
last part of the colon and rectum (back passage).
The enema releases the active ingredient which then acts locally to
reduce the inflammation and help relieve or stop the pain.
2. BEFORE YOU USE PENTASA
DO NOT USE PENTASA IF YOU :
• are ALLERGIC to mesalazine or any of the other ingredients in
Pentasa (see section 6)
• are ALLERGIC to any other salicylates e.g. Aspirin
• have SEVERE LIVER OR KIDNEY problems
Pentasa is not suitable for use in children
TAKE SPECIAL CARE WITH PENTASA
You should consult your doctor before using these enemas if:
• you currently have, or have previously had liver or kidney
disease
• you are on any medication that may affect kidney function
e.g. azathioprine
• you have ever had an allergy to a medication called
sulphasalazine
• If you have lung problems, in particular asthma.
While you are using Pentasa your doctor may occasionally want to
check your kidney function.
If you suddenly develop abdominal cramps, abdominal pain, fever,

Данни за продукта

OBJECT 1
PENTASA ENEMA (MESALAZINE)
Summary of Product Characteristics Updated 14-Mar-2018 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
PENTASA
®
Mesalazine Enema
2. Qualitative and quantitative composition
Each enema bottle contains mesalazine 1g in 100ml.
3. Pharmaceutical form
Rectal suspension.
Each bottle contains 100ml of a colourless to faint yellow suspension
containing 1g mesalazine
4. Clinical particulars
4.1 Therapeutic indications
PENTASA Mesalazine Enema is indicated for the treatment of ulcerative
colitis affecting the distal colon
and rectum.
4.2 Posology and method of administration
_Adults: _The recommended dosage is one enema at bedtime.
_Children_: Not recommended.
PENTASA Mesalazine Enemas are for rectal administration
4.3 Contraindications
Pentasa is contraindicated in:
- patients with known hypersensitivity 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 hepatic 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 b