REMYCIN Hard capsule (2019)

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Περιεχόμενα

1. Name of the medicinal product

Remycin 100 mg hard capsules.

2. Qualitative and quantitative composition

Each hard capsule contains doxycycline hyclate equivalent to 100 mg doxycycline. Excipient(s) with known effect: This product contains 102,3 mg lactose. For the full list of excipients, see section ...

3. Pharmaceutical form

Hard capsule. Green / green capsules.

4.1. Therapeutic indications

Remycin 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. Respiratory ...

4.2. Posology and method of administration

Posology Adults and children aged 12 years to less than 18 years The usual dose of Remycin 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 doxycycline, 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 Remycin is ...

4.4. Special warnings and precautions for use

Paediatric population The use of drugs of the tetracycline class during tooth development (last half of pregnancy; infancy and childhood to the age of 8 years) may cause permanent discolouration of the ...

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. Fertility, pregnancy and lactation

Pregnancy Remycin 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 4.3 ...

4.7. Effects on ability to drive and use machines

The effect of doxycycline on the ability to drive and 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. System Organ Class Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 ...

4.9. Overdose

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 half-life ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use; Tetracyclines ATC code: J01AA02 Remycin is primarily bacteriostatic and is believed to exert its antimicrobial effect by the inhibition ...

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

Capsule content: Lactose monohydrate Maize starch Magnesium stearate Talc Cellulose, microcrystalline Povidone Sodium starch glycolate (type A) Silica, colloidal anhydrous Capsule shell: ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack sizes of 10, 100 and 1000 hard capsules. PP containers with PE closures. Pack sizes of 500 and 1000 hard capsules. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

19887

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 13 December 2005 Date of latest renewal: 15 June 2011

10. Date of revision of the text

25/07/2019

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