INDOVIS CAPSULES

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

INDOMETHACIN

Tilgængelig fra:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC-kode:

M01AB01

Lægemiddelform:

CAPSULES

Sammensætning:

INDOMETHACIN 25 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Terapeutisk gruppe:

INDOMETACIN

Terapeutisk område:

INDOMETACIN

Terapeutiske indikationer:

Non steroidal anti-inflammatory indicated for the active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative joint disease of the hip, acute muscoloskeletal disorders, low back pain.

Autorisation dato:

2015-02-28

Indlægsseddel

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
INDOVIS CAPSULES 25 MG
Each capsule contains indomethacin 25 mg
Inactive ingredients and allergens in the preparation – see
the section “Important information about some ingredients
of the medicine” and section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information about
the medicine. If you have any other questions, refer to the
doctor or the pharmacist.
This medicine has been prescribed for you. Do not pass it
on to others. It may harm them even if it seems to you that
their medical condition is similar.
The medicine is not intended for children.
1. WHAT IS THE MEDICINE INTENDED FOR?
Non-steroidal anti-inflammatory drug for treatment of
rheumatism, osteoarthritis, spondylitis, hip osteoarthritis,
acute problems in the skeletal muscles system and lower
back pain.
THERAPEUTIC CLASS: Non-steroidal Anti-inflammatory
Drugs (NSAIDs).
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient
(indomethacin) or any of the additional components
the medicine contains (see section 6).
•
You are sensitive to aspirin, ibuprofen or other
NSAIDs, or you have developed signs of asthma
(wheezing), runny nose, swelling of the face, lips,
tongue or throat, or a rash with pale or red irregular
raised patches with severe itching when taking these
medicines.
•
You are in the last three months of pregnancy or are
breastfeeding.
•
You are taking other NSAIDs (e.g. naproxen),
including COX-2 inhibitors (e.g. celecoxib).
•
You have angioneurotic edema (swelling of the face,
lips, tongue or throat).
•
You have or have had two or more episodes
of gastric or intestinal ulcer, or bleeding in your
stomach or intestines. Symptoms may include coffee
ground vomit, black tarry stool and blood in your stool.
•
You have severe liver, kidney or heart problems.
•
You have a n

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Indovis Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Indovis Capsules contain 25 mg of indomethacin
Excipient with known effect: Also contains lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Indovis Capsules are white opaque capsules containing odorless white
powder
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non-steroidal anti-inflammatory indicated for the active stages of
rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis, degenerative joint disease of
the hip, acute
musculoskeletal disorders, low-back pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of Indovis should be carefully adjusted to suit the needs
of the individual patient.
In order to reduce the possibility of gastro-intestinal disturbances,
_Indovis Capsules_ _should _
_always be taken with food or an antacid._
In chronic conditions, starting therapy with a low dosage, increasing
this gradually as
necessary, and continuing a trial of therapy for an adequate period
(in some cases, up to one
month) will give the best results with a minimum of unwanted
reactions.
The recommended oral dosage range is 50 mg to 200 mg daily in divided
doses.
Paediatric dosage not established.
_Use in the elderly_: Indovis should be used with particular care in
older patients who are more
prone to adverse reactions.
4.3 CONTRAINDICATIONS
•
NSAIDs are contra-indicated in patients who have previously shown
hypersensitivity
reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response
to ibuprofen,
aspirin or other non- steroidal anti-inflammatory drugs.
•
Hypersensitivity to indomethacin or any of the excipients listed in
section 6.1.
•
Severe heart failure, hepatic failure and renal failure (See section
4.4).
•
Not to be used in patients who have nasal polyps.
•
During the last trimester of pregnancy or lactation (See section 4.6 )
•
Safety in children has not been established.
•
Active or history of recurrent pepti