ARTHREXIN Capsule (2022)
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Περιεχόμενα
1. Name of the medicinal product
ARTHREXIN 25 mg capsules. ARTHREXIN-50 mg capsules.
2. Qualitative and quantitative composition
<u>ARTHREXIN 25:</u> Each capsule of ARTHREXIN 25 contains 25 mg indomethacin. Contains sugar: Lactose 177,6 mg For full list of excipients, see section 6.1. <u>ARTHREXIN-50:</u> Each capsule of ARTHREXIN-50 ...
3. Pharmaceutical form
Capsules. ARTHREXIN 25 is a yellow No. 3 opaque capsule imprinted in black ink with a Lennon logo and LENNON on one side of capsule and ARTHREXIN 25 on the other side, containing a white powder. ARTHREXIN-50 ...
4.1. Therapeutic indications
ARTHREXIN is indicated for: The relief of painful symptoms of ankylosing spondylitis and osteoarthritis. The relief of pain and swelling in gout, acute gouty arthritis and rheumatoid arthritis. The relief ...
4.2. Posology and method of administration
Posology Adults The recommended dosage of ARTHREXIN is 50 mg to 200 mg daily in divided doses, individually adjusted to the patients response and tolerability to the medicine. Undesirable effects may be ...
4.3. Contraindications
ARTHREXIN is contraindicated in: Patients with hypersensitivity to indomethacin or to any excipients in ARTHREXIN (see section 6.1). Patients with severe hepatic failure and renal failure (see section ...
4.4. Special warnings and precautions for use
<b>ARTHREXIN may predispose to cardiovascular events, gastrointestinal events, or cutaneous reactions which may be fatal.</b> Hypersensitivity Serious skin reactions, some of them fatal, including drug ...
4.5. Interaction with other medicinal products and other forms of interaction
Diflunisal When diflunisal and ARTHREXIN are given together, the renal clearance of ARTHREXIN decreases and the plasma concentration increases, and the combined use can result in fatal gastrointestinal ...
4.6. Fertility, pregnancy and lactation
The use of ARTHREXIN is contraindicated in pregnancy and lactation (see section 4.3). Pregnancy First trimester Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal ...
4.7. Effects on ability to drive and use machines
ARTHREXIN has major influence on the ability to drive or operate machinery. ARTHREXIN may interfere with driving and the operation of machines, as it may cause dizziness, drowsiness, visual disturbances ...
4.8. Undesirable effects
a) Summary of the safety profile The most common side effects are gastrointestinal disturbances, headache and dizziness. Gastrointestinal perforation, ulceration and bleeding, sometimes fatal, may occur. ...
4.9. Overdose
Symptoms Symptoms include headache, nausea, vomiting, dyspepsia, epigastric pain, ulceration and/or gastrointestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, ...
5.1. Pharmacodynamic properties
<b>Category and Class:</b> A 3.1 Antirheumatics (anti-inflammatory agents) Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, nonsteroids, acetic acid derivatives and related substances. ...
5.2. Pharmacokinetic properties
Absorption Following a single oral dose, indomethacin is readily absorbed from the gastrointestinal tract, attaining peak plasma concentrations of approximately 1 and 2 mcg/mL, respectively, at about 2 ...
6.1. List of excipients
ARTHREXIN 25: Gelatin, lactose, magnesium stearate, quinoline yellow (C.I. 47005), sodium lauryl sulphate, sodium starch glycollate, sunset yellow (C.I. 15985), titanium dioxide (C.I. 77891) ARTHREXIN-50: ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
ARTHREXIN 25: 60 months in securitainers, amber PVC Xactics, PVC blisters, Tins and in PP Hinge-lid vials. 24 month shelf life is inferred for the product packed in polyethylene minigrip and metallised ...
6.4. Special precautions for storage
Store at or below 25°C. Protect from light and moisture. Keep in original packaging until required for use.
6.5. Nature and contents of container
ARTHREXIN 25 100 capsules are packed in a white cylindrical polypropylene container and sealed with a white round, flat topped linear low density polyethylene snap-on cap with a tamper evident seal. 500 ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191
8. Marketing authorization number(s)
ARTHREXIN 25: K/3.1/285 ARTHREXIN-50: K/3.1/286
9. Date of first authorization / renewal of the authorization
ARTHREXIN 25: 01 May 1978 ARTHREXIN-50: 01 May 1978
10. Date of revision of the text
23 August 2022
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