RAZTROL Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
RAZTROL (Tablets 10 mg).
2. Qualitative and quantitative composition
Each tablet contains: Rupatadine fumarate 12,79 mg equivalent to rupatadine 10 mg. For full list of excipients, see section 6.1. Contains sugar: lactose monohydrate 60 mg per tablet.
3. Pharmaceutical form
Tablet. RAZTROL is a salmon coloured, 6,35 mm ± 0.1 mm round, biconvex, uncoated tablets, plain on both sides.
4.1. Therapeutic indications
Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age).
4.2. Posology and method of administration
Posology Adults and adolescents (over 12 years of age) The recommended dose is 10 mg (one tablet) once a day, with or without food. Method of Administration For oral use.
4.3. Contraindications
Hypersensitivity to rupatadine or to any of the excipients of RAZTROL listed in section 6.1. RAZTROL tablets are not recommended for use in children below 12 years of age. Pregnancy and lactation.
4.4. Special warnings and precautions for use
<u>Renal and hepatic impairment:</u> As there is no clinical experience reported in patients with impaired kidney or liver functions, the use of RAZTROL is not recommended in these patients. <u>Paediatric ...
4.5. Interaction with other medicinal products and other forms of interaction
<u>Interaction with alcohol:</u> RAZTROL should be used with caution when administered with alcohol. <u>Interaction with grapefruit:</u> The concomitant administration of grapefruit juice with rupatadine ...
4.6. Fertility, pregnancy and lactation
Pregnancy RAZTROL is contraindicated in pregnancy. Lactation Rupatadine is excreted in animal milk. Due to potential harmful effects in neonates, the use of rupatadine should be avoided during breastfeeding. ...
4.7. Effects on ability to drive and use machines
At the recommended dosage, RAZTROL is not expected to influence the ability to drive or use machinery. Nevertheless, care should be taken before driving or using machinery until the patients individual ...
4.8. Undesirable effects
System Organ Class Frequent Less frequent <b>Infections and infestations</b> - Pharyngitis, Rhinitis <b>Immune system disorders</b> - Hypersensitivity reactions (including anaphylactic reactions, ...
4.9. Overdose
Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> A.5.7.1 Antihistaminics other antihistamines for systemic use <b>ATC code:</b> R06AX28 Mechanism of Action Rupatadine is a non-sedating, long-acting histamine antagonist, ...
5.2. Pharmacokinetic properties
Absorption and bioavailability Rupatadine is reported to be rapidly absorbed after oral administration, with a T<sub>max</sub> of approximately 0,75 hours after intake. The mean C<sub>max</sub> was 2,6 ...
6.1. List of excipients
Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Pre-gelatinised starch Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 Months.
6.4. Special precautions for storage
Store at or below 30⁰C. Keep the blister in the outer carton in order to protect from light. KEEP OUT OF THE REACH OF CHILDREN.
6.5. Nature and contents of container
RAZTROL tablets are packed in blister packs consisting of PVC/PVDC foil as a forming material and pre-printed aluminium foil as a lidding material. Each blister will contain 10 tablets. Blisters are packed ...
6.6. Special precautions for disposal and other handling
No special requirement for disposal.
7. Marketing authorization holder
RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa
8. Marketing authorization number(s)
55/5.7.1/0293
9. Date of first authorization / renewal of the authorization
7 December 2021
10. Date of revision of the text
7 December 2021
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