Aclin
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
19-04-2020
Summary of Product characteristics
(SPC)
19-04-2020
Active ingredient:
Sulindac 100mg; Sulindac 100mg
Available from:
Viatris Limited
INN (International Name):
Sulindac 100 mg
Dosage:
100 mg
Pharmaceutical form:
Tablet
Composition:
Active: Sulindac 100mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified talc Quinoline yellow Sodium starch glycolate Active: Sulindac 100mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified talc Quinoline yellow Sodium starch glycolate
Units in package:
Bottle, plastic, White HDPE bottle with white PP double wadded CRC, 50 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
ZaCh System S.p.A
Therapeutic indications:
ACLIN is indicated for acute or long-term use in the treatment of the following: · Osteoarthritis · Rheumatoid arthritis · Ankylosing spondylitis · Periarticular diseases such as acute painful shoulder (acute subacromial bursitis/supraspinatus tendonitis) and tenosynovitis · Acute gouty arthritis · Painful low back syndrome (low back pain, commonly referred to as lumbago).
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, White HDPE bottle with white PP double wadded CRC - 50 tablets - 36 months from date of manufacture stored at or below 30°C
Authorization date:
1987-09-24
Patient Information leaflet
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ACLIN
_SULINDAC TABLETS 100MG AND 200MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACLIN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ACLIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT ACLIN IS USED
FOR
ACLIN is used to treat:
Osteoarthritis
Rheumatoid arthritis
Ankylosing spondylitis
Joint problems such as acute
painful shoulder
Acute gouty arthritis
Painful low back syndrome (low
back pain, also referred to as
lumbago).
ACLIN contains the active
ingredient sulindac. It belongs to a
group of medicines called non-
steroidal anti-inflammatory drugs
(NSAIDs).
It works by relieving pain,
inflammation and tenderness, and
promotes joint mobility.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
This medicine is not known to be
addictive.
BEFORE YOU TAKE
ACLIN
_WHEN YOU MUST NOT TAKE _
_IT_
YOU MUST NOT TAKE ACLIN:
If you have an active peptic
(stomach) ulcer or
gastrointestinal (stomach or
bowel) bleeding
If you have a history of
repeated gastrointestinal ulcer
or bleeding
If you are vomiting blood or
material that looks like coffee
grounds
If you have bleeding from the
rectum (back passage), have
sticky black stools (bowel
motions), or bloody diarrhoea
If you have had an asthma
attack, hives or itchy rash, or
runny or blocked nose caused
by aspirin or other NSAIDs
If you recently had coronary
artery bypass graft (CABG)
surgery
If you have severe liver
problems
If you have severe heart failure.
Read the complete document
Summary of Product characteristics
Page 1 of 12
NEW ZEALAND DATA SHEET
ACLIN
1. PRODUCT NAME
ACLIN, 100 mg, 200 mg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg or 200 mg of sulindac.
ACLIN tablets contain lactose. For the full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
ACLIN 100 mg tablets: 8 mm flat bevelled edge orange-yellow tablet
marked with “SD” over breakline
“100” on one side and “α” on the other side.
ACLIN 200 mg tablets: 10 mm flat bevelled edge orange-yellow tablet
marked with “SD” over
breakline “200” on one side and “α” on the other side.
The tablet can be divided into equal doses.
Sulindac is a non-steroidal anti-inflammatory indene-type compound.
Sulindac is a yellow crystalline
compound. It is a weak organic acid [pKa (25
C) 4.7]. It is soluble in water as the sodium salt or in
buffers of pH 6 or higher but is practically insoluble in water below
pH 4.5 and sparingly soluble in
alcohol.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
ACLIN is indicated for acute or long-term use in the treatment of the
following:
Osteoarthritis
Rheumatoid arthritis
Ankylosing spondylitis
Periarticular
diseases
such
as
acute
painful
shoulder
(acute
subacromial
bursitis/supraspinatus tendonitis) and tenosynovitis
Acute gouty arthritis
Painful low back syndrome (low back pain, commonly referred to as
lumbago).
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the
shortest possible duration should be used.
Page 2 of 12
DOSE
The usual daily dosage of ACLIN is 400 mg per day. However, the dosage
may be lowered
depending on the response. Dosages above 400 mg per day are not
recommended (see section
4.4).
In acute gouty arthritis, therapy for 7 days is usually adequate.
Patients on long term treatment should be reviewed regularly with
regards to efficacy, risk-factors
and ongoing need for treatment.
METHOD OF ADMINISTRATION
ACLIN should be administere
Read the complete document
