EFRACEA 40 mg Модифицированные Капсулы С Контролируемым Высвобождением
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Инструкция по применению EFRAKEA
Содержание инструкции
- Efracea 40 mg modified-release hard capsules
- Efracea should not be used during pregnancy as it may cause
Efracea 40 mg modified-release hard capsules
doxycycline
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of 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 is Efracea and what is it used for
Efracea is a medicine containing the active substance doxycycline. It is used in adults to reduce
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 of the medicines 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 onwards as it may harm the unborn child. If you suspect or find out that you are pregnant while taking Efracea, contact your doctor immediately.
- in combination with retinoids (medicines used to treat certain skin conditions such as severe acne) taken orally (see section “Other medicines and Efracea”).
- if you suffer from a condition that causes a lack of acid in the stomach (achlorhydria) or if you have undergone surgery on the upper part of the small intestine (duodenum).
Efracea should not be taken by newborns or children under 12 years of age, as it may cause
permanent abnormal discoloration of the teeth or problems with dental development.
Warnings and precautions
Efracea should not be used to treat infections caused by bacteria.
Consult your doctor or pharmacist before taking Efracea if:
- you have liver disease
- you have a history of a predisposition to candidiasis or if you are suffering from an oral or vaginal yeast or fungal infection
- you suffer from a muscle disease called myasthenia gravis
- you suffer from colitis
- you suffer from irritation or esophageal ulcer
- you are affected by the type of rosacea that affects the eyes
- you expose your skin to strong sunlight or artificial sunlight, as severe sunburns can occur in some people taking doxycycline. Consider using a protective or full-spectrum sunscreen to reduce the risk of sunburn and stop using Efracea if a sunburn occurs.
- your doctor has told you that you are intolerant to certain sugars
Efracea may cause permanent discoloration of the teeth.
During treatment with Efracea, consult your doctor or pharmacist if:
- you develop severe or prolonged diarrhea or bloody stools during or after using Efracea. Tell your doctor immediately as you may need to stop treatment. This could be a sign of inflammation of the intestine (pseudomembranous colitis) that can occur after antibiotic treatment.
Take Efracea exactly as prescribed by your doctor. Taking a higher dose than
prescribed may increase the likelihood that intestinal bacteria develop
resistance to Efracea.
Other medicines and Efracea
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Efracea and some other medicines may not work properly when taken together. Tell your
doctor about any medicines you are taking or planning to take while taking
Efracea.
- Efracea should not be used at the same time as isotretinoin medicine due to the risk of increased intracranial pressure. Isotretinoin is prescribed to patients with severe acne conditions.
- Do not take antacids ,multivitamins or other products containing calcium (such as milk and dairy products or fruit juices containing calcium), aluminum, magnesium (including quinapril tablets taken for high blood pressure), iron or bismuth, or cholestyramine, activated charcoal or sucralfate until 2-3 hours after taking Efracea. These medicines can reduce the effectiveness of Efracea if taken at the same time.
- Other treatments for ulcers or heartburn may also reduce the effectiveness of Efracea and should not be taken until at least 2 hours after Efracea.
- If you are taking anticoagulants, your doctor may need to adjust the dose of anticoagulant.
- If you are taking certain medicines for diabetes, your doctor may need to check whether the dose of these medicines needs to be changed.
- Efracea may make certain antibiotics, including penicillins, less effective.
- Taking barbiturates (sleeping pills or short-term pain relievers), rifampicin (tuberculosis), carbamazepine (epilepsy), diphenylhydantoin and phenytoin (brain seizures), primidone (anticonvulsant) or cyclosporine (organ transplants) may reduce the duration of Efracea's activity in your body.
- The use of Efracea with the general anesthetic methoxyflurane can cause serious kidney injury.
Efracea with food and drink
Always take Efracea with an adequate amount of water to moisten the capsule, as this
reduces the risk of irritation or ulceration in the throat or esophagus.
Do not take milk or dairy products at the same time as Efracea as these products contain calcium
which can reduce the effectiveness of Efracea. Wait 2-3 hours after taking your daily dose of
Efracea before drinking or eating dairy products.
Pregnancy and breastfeeding
Efracea should not be used during pregnancy as it may cause
abnormal permanent discoloration of the teeth in the unborn child.
Efracea should not be used for prolonged periods by breastfeeding mothers as the
medicine may cause abnormal tooth discoloration and reduce bone growth in the infant.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Efracea does not or negligibly alters the ability to drive vehicles and use machines.
Efracea contains sugar (sucrose) and Allura Red AC - aluminium lake (E129).If your doctor has
diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
The ink used for printing on the capsules contains Allura Red AC - aluminium lake (E129)
which may cause allergic reactions.
3. How to take Efracea
Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one Efracea capsule per day in the morning, on an empty stomach, preferably
at least one hour before or two hours after a meal. Swallow the capsule whole, without chewing.
You must take Efracea with a full glass of water while sitting or standing to avoid
any possible irritation to the throat.
If you take more Efracea than you should
If you take an excessive dose of Efracea, there is a risk of damaging the liver, kidneys or pancreas.
If you take more Efracea capsules than you should, consult your doctor immediately.
If you forget to take Efracea
Do not take a double dose to make up for a missed capsule.
If you stop taking Efracea
You must continue to take Efracea until your doctor decides to stop it.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the side effects listed below, contact your doctor as soon as
possible:
- The Jarisch-Herxheimer reaction, which causes fever, chills, headache, muscle pain and rash, is usually self-limiting. It occurs shortly after starting treatment with doxycycline for infections caused by spirochetes such as Lyme disease.
Common side effects
The following side effects may occur commonly (affecting 1 to 10 patients per 100)
during treatment with Efracea:
- Inflammation of the nose and throat
- Sinus inflammation (sinusitis)
- Fungal infections
- Anxiety
- Sinus headache
- High or increased blood pressure
- Diarrhea
- Upper abdominal pain
- Dry mouth
- Back pain
- Pain
- Changes in some blood tests (blood sugar levels or liver function tests).
Side effects with unknown frequency (cannot be defined on the basis of available
data)
The following side effects may occur during treatment with Efracea:
- Increased intracranial pressure
- Headache
Rare side effects
The following side effects may occur rarely (affecting 1 to 10 patients per 10,000)
during treatment with the class of medicines to which Efracea belongs (tetracyclines):
- Allergic reaction (hypersensitivity) throughout the body*
- Changes in the number or type of certain blood cells
- Increased intracranial pressure
- Inflammation of the membrane surrounding the heart
- Nausea, vomiting, diarrhea, anorexia
- Liver damage
- Skin rashes or hives
- Abnormal skin reaction to sunlight
- Increased urea levels in the blood
Very rare side effects
The following side effects may occur very rarely (affecting less than 1 patient per
- 10,000) during treatment with the class of medicines to which Efracea belongs (tetracyclines):
- Allergic reaction causing swelling of the eyes, lips or tongue*
- Yeast infection around the anus or genitals
- Changes in red blood cells (hemolytic anemia)
- With long-term use of tetracyclines, microscopic brown-black spots of thyroid tissue have been observed. Thyroid function is normal.
- Increased intracranial pressure in newborns
- Inflammation of the tongue
- Difficulty swallowing
- Inflammation of the intestine
- Inflammation or ulceration of the esophagus
- Inflammation of the skin causing peeling
- Worsening of a known autoimmune condition called systemic lupus erythematosus (SLE)
Side effects with unknown frequency(cannot be defined on the basis of available data)
The following side effects may occur during treatment with the class of medicines to which
EFRACEA belongs (tetracyclines):
- Detachment of the nail from the nail bed after exposure to the sun.
* Consult your doctor immediately or go to the nearest emergency room if you notice side
effects such as swelling of the face, lips, tongue and throat, difficulty breathing, hives or skin and eye itching,
or a rapid heartbeat (palpitations) and a feeling of weakness. These effects
may be symptoms of a serious allergic reaction (hypersensitivity).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
adverse .
By reporting side effects you can help provide more information on the safety
of this medicine.
5. How to store Efracea
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
”Exp.”. The expiry date refers to the last day of that month.
Store in the original package to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Efracea contains
- The active ingredient is doxycycline. Each capsule contains 40 mg of doxycycline (as monohydrate).
- The other ingredients are: Hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80, sugar spheres (corn starch, sucrose). Capsules: gelatin, black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide Printing ink: shellac, propylene glycol, black iron oxide, indigo carmine - aluminum lake, allura red AC - aluminum lake (E129), brilliant blue FCF - aluminum lake, D & C yellow
- n. 10 - aluminum lake. See the end of paragraph 2 for information on sugar (sucrose) and allura red AC - aluminum lake (E129).
Description of the appearance of Efracea and package contents
Efracea is a hard, modified-release capsule.
The capsules are beige in color and bear the inscription “GLD 40”.
Efracea is available in packs of 56, 28 or 14 capsules (not all pack sizes may be
marketed).
Marketing Authorisation Holder
GALDERMA ITALIA S.p.A.
Registered office: via dell’Annunciata 21, 20121 Milan
Manufacturer responsible for batch release:
Patheon France, 40 boulevard de Champaret
38300 BOURGOIN JALLIEU
France
or
Laboratoires GALDERMA, Zone Industrielle Montdésir
74540 Alby sur Chéran, France
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
DK, EL, ES, FI, IS, SE, NO - ORACEA modified-release hard capsules 40 mg
DE, AT - ORAYCEA modified-release hard capsules 40 mg
BE, FR, NL, UK, IE, IT, PL, PT, LU - EFRACEA modified-release hard capsules 40 mg
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- Страна регистрации
- Форма выпускаModified-release hard capsule, 40 MG
- Код АТХJ01AA02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги EFRAKEAФорма выпуска: Tablet, 100 MGДействующее вещество: ДоксициклинПроизводитель: PFIZER ITALIA S.R.L.Отпускается по рецептуФорма выпуска: Film-coated tablet, 100 MGДействующее вещество: ДоксициклинПроизводитель: F.I.R.M.A. S.P.A.Отпускается по рецептуФорма выпуска: Tablet, 100 MGДействующее вещество: ДоксициклинПроизводитель: ITALFARMACO S.P.A.Отпускается по рецепту
Аналоги EFRAKEA в других странах
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Аналог EFRAKEA в Испания
Аналог EFRAKEA в Польша
Аналог EFRAKEA в Украина
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Часто задаваемые вопросы
EFRAKEA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество EFRAKEA — Доксициклин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
EFRAKEA производится компанией GALDERMA ITALIA S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения EFRAKEA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить EFRAKEA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Доксициклин) включают BASSADO, DOXYNOR, FARMODOXI. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
