Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Doxycycline
Galderma International
J01AA02
Doxycycline
40 milligram(s)
Modified-release capsule, hard
doxycycline
Marketed
2009-01-30
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EFRACEA 40 MG MODIFIED RELEASE HARD CAPSULES DOXYCYCLINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Efracea is and what it is used for 2. What you need to know before you take Efracea 3. How to take Efracea 4. Possible side effects 5. How to store Efracea 6. Contents of the pack and other information 1. WHAT EFRACEA IS AND WHAT IT IS USED FOR Efracea is a medicine containing the active substance doxycycline. It is used in adults to reduce the pimples or red bumps on the face caused by a condition called rosacea. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFRACEA DO NOT TAKE EFRACEA - if you are allergic (hypersensitive) to any medicinal product in the tetracycline family, including doxycycline or minocycline, or to any of the other ingredients of this medicine (listed in section 6.) - if you are pregnant Efracea should not be used from the 4th month of pregnancy because it may harm the unborn child. If you suspect or learn that you are pregnant whilst taking Efracea, contact your doctor immediately. - in combination with retinoids (drugs used in the treatment of certain skin disorders such as severe acne) administered by the oral route (see section Other medicines and Efracea). - if you have a condition causing absence of acid in the stomach (achlorhydria) or if you have had surgery on the upper part of the gut (called the duodenum). Efracea must not be taken by infants or children under the age of 12, because it may cause permanent discolouratio Soma hati kamili
Health Products Regulatory Authority 03 November 2022 CRN00D5C9 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT EFRACEA 40 mg modified-release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg doxycycline (as monohydrate). Excipients with known effect: 102 – 150 mg of sucrose and 26.6 - 29.4 microgram of Allura red AC aluminium lake (E129). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release hard capsule Beige capsule, No. 2 size, bear the marking “GLD 40”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Efracea is indicated to reduce papulopustular lesions in adult patients with facial rosacea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, including older people:_ Oral use. The daily dose is 40 mg (1 capsule). It can be taken as monotherapy or as part of combination treatment (see section 5.1). _Patients with renal impairment_ No dosage adjustment is necessary in patients with renal impairment. _Patients with hepatic impairment_ Efracea should be administered with caution to patients with hepatic impairment or to those receiving potentially hepatotoxic medicinal products (see section 4.4) _Paediatric population _ Efracea is contraindicated in children below 12 years of age (see section 4.3). Method of administration THE CAPSULE SHOULD BE TAKEN IN THE MORNING, ON AN EMPTY STOMACH, PREFERABLY AT LEAST ONE HOUR PRIOR TO OR TWO HOURS AFTER THE MEAL. THE CAPSULE SHOULD BE TAKEN WITH ADEQUATE AMOUNTS OF WATER IN ORDER TO REDUCE THE RISK OF OESOPHAGEAL IRRITATION AND ULCERATION (SEE SECTION 4.4). Patients should be evaluated after 6 weeks and, if no effect is seen, consideration should be given to stopping treatment. In clinical trials patients were treated for 16 weeks. Upon discontinuation, lesions tended to reappear at 4 weeks follow-up. Therefore, it is recommended that patients should be assessed 4 weeks after stopping treatment. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substanc Soma hati kamili