Efracea

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Efracea (Oracea)
40 mg, modified-release hard capsules
Doxycyclinum
Efracea and Oracea are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet :

1. What Efracea is and what it is used for
2. Important information before taking 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 intended for use in adults to reduce pimples or red bumps caused by a condition called rosacea.

2. Important information before using Efracea

When not to use Efracea:

• If the patient is allergic (hypersensitive) to any tetracycline-class drug, including doxycycline or minocycline, or to any of the other ingredients of Efracea (listed in section 6).
• If the patient is pregnant, she should not use Efracea from the 4th month of pregnancy onwards, as it may cause harm to the unborn child. If a patient suspects or confirms she is pregnant while taking Efracea, she should contact her doctor immediately.
• Concurrently with retinoids (medicines used in certain skin disorders such as severe acne), when administered orally (see section Efracea with other medicines).
• If the patient has absence of gastric acid (achlorhydria) or has undergone surgery of the upper part of the small intestine (called duodenum).

Do not give Efracea to infants or children under 12 years of age, as it may cause permanent tooth discoloration or disturbances in tooth development.

Warnings and precautions

Efracea must not be used for the treatment of bacterial infections.

Before starting treatment with Efracea, discuss this with your doctor. Inform your doctor if the patient has:

• liver disease,
• a tendency to fungal (yeast) infections or has an existing fungal infection of the mouth or vagina,
• a muscle disorder called myasthenia gravis,
• colitis (inflammation of the colon),
• irritation or ulceration of the oesophagus,
• rosacea affecting the eye area,
• if the patient’s skin is exposed to sunlight or sunbeds, inform the doctor, as people taking doxycycline may sunburn more easily. Consider using protective creams with UV filters or blockers to reduce the risk of sunburn, and discontinue Efracea if excessive sunburn occurs,
• intolerance to certain sugars.

Efracea may cause permanent tooth discoloration.

Contact your doctor or pharmacist during treatment if:

• you experience acute, persistent or bloody diarrhoea during or after treatment with Efracea. Contact your doctor immediately, as treatment may need to be stopped. These symptoms may indicate an inflammatory bowel condition (pseudomembranous colitis), which may require antibiotic treatment.

Use Efracea exactly as prescribed by your doctor. Taking a higher dose than recommended by your doctor may increase the risk of developing bacterial resistance in the gut to Efracea.

Efracea with other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Efracea and certain other medicines may not work properly when taken together. Inform your doctor about all medicines the patient is currently taking or intends to take concurrently with Efracea.

• Do not take Efracea together with medicines containing isotretinoin, due to the risk of increased intracranial pressure. Isotretinoin is prescribed for severe cases of acne.
• Do not take antacids, multivitamin preparations, or other products containing calcium (such as milk, dairy products, and calcium-fortified fruit juices), aluminium, magnesium (including chinapril tablets used for hypertension), iron, bismuth, cholestyramine, activated charcoal, or sucralfate within 2 to 3 hours after taking Efracea, as these may reduce the effectiveness of Efracea.
• Other medicines used for peptic ulcer disease or heartburn may also reduce the effectiveness of Efracea and should not be taken less than 2 hours before taking Efracea.
• If the patient is taking anticoagulant medicines (blood thinners), the doctor may need to adjust the dose of these medicines.
• If the patient is taking certain antidiabetic medicines, the doctor may check whether a dose adjustment is needed.
• Efracea may reduce the effectiveness of certain antibiotics, including penicillin.
• Taking barbiturates (sleeping or short-acting pain medicines), rifampicin (used in tuberculosis), carbamazepine (used in epilepsy), diphenylhydantoin or phenytoin (used in epileptic seizures), primidone (an anticonvulsant), or cyclosporine (used after organ transplantation) may shorten the time Efracea remains active in the patient’s body.
• Taking Efracea with methoxyflurane (a medicine used in general anaesthesia) may cause severe kidney damage.

Efracea with food and drink

Take the Efracea capsule with a full glass of water, as this reduces the risk of irritation or ulceration of the throat and oesophagus.

Do not consume milk or dairy products at the same time as Efracea, as they contain calcium, which may reduce the effectiveness of Efracea. Wait 2 to 3 hours after taking the daily dose of Efracea before consuming dairy products.

Pregnancy and breastfeeding

Do not use Efracea during pregnancy, as it may cause permanent tooth discoloration in the unborn child.

Do not use Efracea long-term during breastfeeding, as it may cause tooth discoloration and reduced bone growth in the breastfed infant.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines

Efracea has no effect or has a negligible effect on the ability to drive and operate machinery.

Efracea contains 102–150 mg of sucrose and 26.6–29.4 μg of Allura Red AC (E 129) per capsule.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The ink used for printing on the capsules contains Allura Red AC (E 129), which may cause allergic reactions.

3. How to take Efracea

This medicine should always be taken exactly as directed by the physician.
If in doubt, consult the doctor or pharmacist.
The recommended dose is one Efracea capsule every morning on an empty stomach, or alternatively one hour before or two hours after a meal. Swallow the capsule whole, without chewing.
Efracea should be taken with a full glass of water, while sitting or standing, to avoid irritation of the throat.

Taking more Efracea than recommended
In case of overdose, there is a risk of liver, kidney, and pancreas damage.
If a patient has taken more Efracea capsules than recommended, they should contact their doctor immediately.

If a dose of Efracea is missed
Do not take a double dose to make up for the missed capsule.

Stopping Efracea
Continue taking Efracea for the duration specified by the doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the adverse reactions listed below occur, contact your doctor as soon as possible:

• Jarisch-Herxheimer reaction, causing fever, chills, headache, muscle pain and skin rash, which is usually self-limiting. It occurs shortly after starting doxycycline treatment for spirochetal infections, such as Lyme disease.

Common adverse reactions
The following adverse reactions are common (occurring in 1 to 10 out of 100 patients) during treatment with Efracea:

• inflammation of the nose and throat
• sinusitis
• fungal infection
• anxiety
• sinus pain
• high or elevated blood pressure
• diarrhoea
• upper abdominal pain
• dryness of the mouth
• back pain
• pain
• changes in results of certain blood tests (blood glucose or liver function tests).

Adverse reactions with unknown frequency (frequency cannot be estimated due to insufficient data)
The following adverse reactions may occur during treatment with Efracea:

• increased intracranial pressure
• headache.

Uncommon adverse reactions
The following adverse reactions are uncommon (occurring in 1 to 10 out of 10,000 patients) during treatment with medicines of the same group as Efracea (tetracyclines):

• systemic allergic (hypersensitivity) reactions*
• changes in the number or types of blood cells
• increased pressure in the brain
• inflammation of the membrane surrounding the heart (pericarditis)
• nausea, vomiting, diarrhoea, loss of appetite
• liver damage
• skin rash or urticaria
• abnormal skin reaction to sunlight
• increased blood urea concentration.

Rare adverse reactions
The following adverse reactions are very rare (occurring in fewer than 1 out of 10,000 patients) during treatment with medicines of the same group as Efracea (tetracyclines):

• allergic reactions causing swelling of the eyes, lips or tongue*
• fungal infections in the anal and genital areas
• breakdown of red blood cells (haemolytic anaemia)
• brown-black microscopic discoloration of thyroid tissue has been reported with long-term use of tetracyclines. No changes in thyroid function have been observed.
• increased intracranial pressure in infants
• inflammation of the tongue
• difficulty swallowing
• inflammation of the intestine
• inflammation or ulceration of the oesophagus
• skin inflammation causing peeling
• immune system weakening, known as systemic lupus erythematosus (SLE).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)
Adverse reactions that may occur during treatment with medicinal products belonging to the same group as Efracea (tetracyclines):

• weakening of the connection between the nail and the nail bed following exposure to sunlight.

* Inform your doctor immediately if you notice adverse reactions such as swelling of the face, lips, tongue or throat, breathing difficulties, tingling or itching of the skin or eyes, rapid heartbeat (palpitations), or tendency to faint. These may be symptoms of a severe allergic (hypersensitivity) reaction.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Efracea

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Efracea contains
The active substance is doxycycline. Each capsule contains 40 mg of doxycycline (as doxycycline monohydrate).
The other ingredients are: hypromellose 2910, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, talc, Opadry Beige YS-1-17274-A comprising: hypromellose 3 cP, hypromellose 6 cP, titanium dioxide, polyethylene glycol 400, yellow iron oxide, red iron oxide, polysorbate 80; sucrose, beads (corn starch, sucrose).
Capsule shell (Hard Gelatin Capsule no 2, beige Opaque) comprising:
black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide, gelatin.
Printing ink comprising:
shellac, propylene glycol, black iron oxide, indigo carmine, Allura Red AC (E 129), brilliant blue FCF, aluminium lake, quinoline yellow.

What Efracea looks like and contents of the pack
Modified-release hard capsules. Beige capsules, size no. 2, marked with "GLD 40".
Efracea is available in packs containing 28 or 56 capsules.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Greece, country of export:
GALDERMA INTERNATIONAL
Tour Europlaza
20 avenue André Prothin - La Défense 4
92 927 Paris La Défense Cedex
France

Manufacturer:
Patheon France
40 boulevard de Champaret
38300 Bourgoin-Jallieu, France
Laboratoires GALDERMA
Zone Industrielle Montdésir
74540 Alby-sur-Chéran, France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation number in Greece, country of export: 109605/19-09-2019
Parallel Import Licence number: 195/25
This medicinal product is authorised in the countries of the European Economic Area under the following names:
ORACEA 40 mg modified release hard capsules - DK, EL, ES, FI, IS, SE, NO
ORAYCEA 40 mg modified release hard capsules - AT, DE
EFRACEA 40 mg modified release hard capsules - BE, FR, IE, IT, LU, NL, PL, PT, UK