REYDIN Film-coated tablet (2023)
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Περιεχόμενα
BOXED WARNING SECTION
<b>WARNING LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE ...
1. Name of the medicinal product
REYDIN (Film-coated tablets).
2. Qualitative and quantitative composition
<u>Each REYDIN film-coated tablet contains:</u> Lamivudine 300 mg. Tenofovir disoproxil 300 mg (equivalent to tenofovir disoproxil fumarate). Dolutegravir 50 mg (as dolutegravir sodium). Excipients: croscarmellose ...
3. Pharmaceutical form
Blue coloured, capsule shaped biconvex film coated tablet, debossed with C on one side and plain on other side.
4.1. Therapeutic indications
REYDIN is indicated for the treatment of HIV-1 infection in adults aged 18 years and older.
4.2. Posology and method of administration
Posology Therapy should be initiated by a medical practitioner experienced in the management of HIV infection. Adults The dose of REYDIN is one tablet taken orally, once daily, without regard to food. ...
4.3. Contraindications
REYDIN is contraindicated in patients with known hypersensitivity to dolutegravir, lamivudine, tenofovir disoproxil fumarate or any of the components of REYDIN. Uncontrolled renal failure (see 4.4 Special ...
4.4. Special warnings and precautions for use
Safety and efficacy of the individual active ingredients in various antiretroviral combination regimens with similar dosages as contained in REYDIN have been established in clinical studies for the treatment ...
4.5. Interaction with other medicinal products and other forms of interaction
The likelihood of interactions is low due to the limited metabolism as plasma protein binding and almost complete renal clearance. Zidovudine plasma levels are not significantly altered when co-administered ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should be counselled about the potential risk of neural tube defects with dolutegravir (see below), including consideration of using effective ...
4.7. Effects on ability to drive and use machines
REYDIN cause dizziness, impaired concentration and/or drowsiness and may affect the ability to drive and use machines. Patients should ensure that they do not engage in driving or using machines until ...
4.8. Undesirable effects
REYDIN can have side effects. <b>Dolutegravir:</b> Immune system disorders <u>Less frequent:</u> Hypersensitivity, Immune Reconstitution Syndrome. Psychiatric disorders <u>Frequent:</u> Insomnia. Nervous ...
4.9. Overdose
If overdose occurs the patients must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Dolutegravir Management should be as clinically indicated or as recommended ...
5.1. Pharmacodynamic properties
A 20.2.8 – Antimicrobial (Chemotherapeutic) Medicine. Other than antibiotics. Antiviral Medicine. Dolutegravir Dolutegravir inhibits HIV integrase by binding to the integrase active sites and blocking ...
5.2. Pharmacokinetic properties
Dolutegravir Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects. The PK variability of dolutegravir is between low to moderate. In Phase 1 studies in healthy subjects, ...
6.1. List of excipients
Croscarmellose sodium Hydroxypropyl methyl cellulose Magnesium stearate Mannitol Microcrystalline cellulose Opadry blue (containing polyvinyl alcohol, talc, titanium dioxide, indigo carmine, glycerol esters ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store at or below 30°C. Keep the container tightly closed. Keep in the original container until required for use. KEEP OUT OF REACH OF CHILDREN.
6.5. Nature and contents of container
<u>Containers of 28s:</u> REYDIN is packed in a 85 cc white HDPE bottle with 38 mm Non Child Resistant Cap containing 28 tablets and two silica gel bags of 2 g each, packed in a cardboard carton. <u>Containers ...
7. Marketing authorization holder
CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA
8. Marketing authorization number(s)
REYDIN: 52/20.2.8/0451.450
9. Date of first authorization / renewal of the authorization
31 August 2018
10. Date of revision of the text
November
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