MEDOMYCIN Hard capsule (2018)
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Περιεχόμενα
1. Name of the medicinal product
Medomycin 100mg hard gelatin capsules.
2. Qualitative and quantitative composition
Each Medomycin capsule contains 100mg of doxycycline as doxycycline hyclate. <u>Excipient with known effect:</u> lactose. Each capsule contains 145.mg mg lactose (as monohydrate). For the full list of ...
3. Pharmaceutical form
Hard gelatin capsule. Medomycin hard gelatin capsules are green-blue printed with Medochemie.
4.1. Therapeutic indications
Medomycin has been found clinically effective in the treatment of a variety of infections caused by susceptible strains of Gram positive and Gram negative bacteria and certain other micro-organisms. <u> ...
4.2. Posology and method of administration
Posology Adults and children aged 12 years to less than 18 years The usual dose of Medomycin for the treatment of acute infections in adults and children aged 12 years to less than 18 years is 200 mg on ...
4.3. Contraindications
Hypersensitivity to the active substance or or to any other tetracyclines, or to any of the excipients listed in section 6.1 Obstructive oesophageal disorders, such as stricture or achalasia. Pregnancy: ...
4.4. Special warnings and precautions for use
<u>Use in patients with impaired hepatic function:</u> Medomycin should be administered with caution to patients with hepatic impairment or those receiving potentially hepatotoxic drugs. Abnormal hepatic ...
4.5. Interaction with other medicinal products and other forms of interaction
There have been reports of prolonged prothrombin time in patients taking warfarin and doxycycline. Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on ...
4.6. Pregnancy and lactation
Pregnancy Doxycycline has not been studied in pregnant patients. It should not be used in pregnancy unless, in the judgement of the physician, it is essential for the welfare of the patient. (See section ...
4.7. Effects on ability to drive and use machines
The effect of doxycycline on the ability to drive or operate heavy machinery has not been studied. There is no evidence to suggest that doxycycline may affect these abilities.
4.8. Undesirable effects
The following adverse reactions have been observed in patients receiving tetracyclines, including doxycycline. <b>Adverse Reactions Table:</b> System Organ <br />Class Very Common<br /> ≥1/10 Common<br ...
4.9. Overdose
Management Acute overdosage with antibiotics is rare. In the event of overdosage discontinue medication. Gastric lavage plus appropriate supportive treatment is indicated. Dialysis does not alter serum ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Tetracyclines <b>ATC Code:</b> J01 AA02. Doxycycline is primarily bacteriostatic and is believed to exert its antimicrobial effect by the inhibition of protein synthesis. ...
5.2. Pharmacokinetic properties
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and faeces at high concentrations and in ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
Lactose monohydrate, starch maize pregelatinised, magnesium stearate. Capsule shells contain gelatin, titanium dioxide (E171), iron oxide Yellow (E172), quinoline yellow (E104), brilliant blue (E133) and ...
6.2. Incompatibilities
None known.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
Store 25°C in the original package, in order to protect form light and moisture.
6.5. Nature and contents of container
PVC-Al blisters in cartons of 10, 20, 100 and 1000 capsules. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
19936
9. Date of first authorization / renewal of the authorization
22/12/2005
10. Date of revision of the text
11/2018
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