EMTROC Film-coated tablet (2015)
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Περιεχόμενα
1. Name of the medicinal product
EMTROC TABLETS (film-coated tablet).
2. Qualitative and quantitative composition
Each film coated tablet contains 200 mg emtricitabine and 300 mg of tenofovir disoproxil fumarate. Contains lactose.
3. Pharmaceutical form
Film-coated tablet. Blue coloured capsule shaped, biconvex, film coated tablets debossed L 24 on one side of the tablet and plain on other surface.
4.1. Therapeutic indications
EMTROC TABLETS is contraindicated: In patients with previously demonstrated hypersensitivity to emtricitabine, tenofovir or to any of the components of the product. Moderate to severe uncontrolled renal ...
4.2. Posology and method of administration
The dose of EMTROC TABLETS is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food. Dose Adjustment for Renal Impairment ...
4.4. Special warnings and precautions for use
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 WARNINGS ...
4.5. Interaction with other medicinal products and other forms of interaction
As EMTROC TABLETS contains emtricitabine and tenofovir disoproxil fumarate, any interactions that have been identified with these agents individually may occur with EMTROC TABLETS. The steady-state pharmacokinetics ...
4.6. Pregnancy and lactation
Safety and use in pregnancy and lactation has not been established. It is not known whether EMTROC TABLETSis excreted in human milk. Breast-feeding Mothers: HIV-1 infected mothers should not breast-feed ...
4.7. Effects on ability to drive and use machines
EMTROC TABLETS may cause dizziness, impaired concentration, and/or drowsiness. Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as ...
4.8. Undesirable effects
EMTRICITABINE (200 mg) Nervous system disorders <u>Frequent:</u> Headache <u>Frequency not known:</u> Asthenia, dizziness, neuropathy, peripheral neuritis, paraesthesia. Psychiatric disorders <u>Frequency ...
4.9. Overdose
If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Emtricitabine Haemodialysis treatment removes approximately 30% of the ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 20.2.8 Antimicrobial (Chemotherapeutic) Agents, Antiviral agents Emtricitabine Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI). Emtricitabine, ...
5.2. Pharmacokinetic properties
Pharmacokinetics in Adults Emtricitabine The pharmacokinetic properties of emtricitabine are summarised in Table 1. Absorption Following oral administration of emtricitabine (200 mg), emtricitabine is ...
6.1. List of excipients
Lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry II Blue 30K505002 coating containing lactose monohydrate, ...
6.4. Special precautions for storage
Store at or below 25°C. Protect from light. Keep the blisters in the carton until required for use. Keep the containers tightly closed. KEEP OUT OF REACH OF CHILDREN.
6.5. Nature and contents of container
<u>HDPE Container. Pack of 28 or 30 tablets:</u> 75 ml white, heavy weight, round white HDPE bottle with 38-400 neck finish with a 38 mm white child resistant closure with pulp and heat seal liner containing ...
7. Marketing authorization holder
Macleods Pharmaceuticals SA (Pty) Ltd, Stand 6 D & E, Growthpoint Business Park, Halfway House, Midrand, South Africa
8. Marketing authorization number(s)
47/20.2.8/0188
9. Date of first authorization / renewal of the authorization
Date of registration: 7 December 2012
10. Date of revision of the text
13 August 2015
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