ALMIRAL Suppositories (2019)
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Περιεχόμενα
1. Name of the medicinal product
Almiral 50 mg suppositories. Almiral 100 mg suppositories.
2. Qualitative and quantitative composition
Almiral suppositories contain either 50 mg or 100 mg of diclofenac sodium. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suppositories. Almiral suppositories are white, smooth, homogenous, torpedo-shaped suppositories, for rectal administration.
4.1. Therapeutic indications
Relief of all grades of pain and inflammation in a wide range of conditions, including: Arthritic conditions, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout. Acute musculo-skeletal ...
4.2. Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Posology Adults 75-150mg daily, in divided doses (50mg ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active, gastric or intestinal ulcer, bleeding or perforation. History of gastrointestinal bleeding or perforation, ...
4.4. Special warnings and precautions for use
General Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and GI and cardiovascular risks below). The concomitant ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac. <u>Lithium:</u> If used concomitantly, diclofenac may increase ...
4.6. Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and or ...
4.7. Effects on ability to drive and use machines
Patients who experience visual disturbances, dizziness, vertigo, somnolence, central nervous system disturbances, drowsiness or fatigue while taking NSAIDs should refrain from driving or operating machinery. ...
4.8. Undesirable effects
Adverse reactions are ranked under the heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, ...
4.9. Overdose
Symptoms There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiinflammatory and antirheumatic products, Nonsteroids <b>ATC code:</b> M01AB05 Mechanism of action Almiral contains diclofenac sodium which is a nonsteroidal agent ...
5.2. Pharmacokinetic properties
There is limited kinetic data from 6 children aged 6-16 years with juvenile chronic arthritis who received a once daily dose of diclofenac for 2 weeks. When corrected for a body weight of 75kg, kinetic ...
5.3. Preclinical safety data
No further relevant information.
6.1. List of excipients
Hard fat.
6.2. Incompatibilities
None known.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C, in the original package, in order to protect from light and moisture.
6.5. Nature and contents of container
Almiral suppositories 100 mg and 50 mg are presented in aluminium blisters of ten suppositories in an outer carton. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Almiral suppositories are for insertion in the rectum. If required, empty bowels before insertion of suppository. Wash your hands. Open a foil pouch and remove one suppository. Lie on one side. Pull your ...
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Almiral suppositories 50mg: 11763 Almiral suppositories 100mg: 11764
9. Date of first authorization / renewal of the authorization
Almiral suppositories 50mg: 2.7.1988/15.10.2013 Almiral suppositories 100mg: 2.7.1988/19.10.2010
10. Date of revision of the text
05/08/2019
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