Efracea

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Efracea (Oracea)

40 mg, Modified Release Hard Capsules

Doxycycline
Efracea and Oracea are different trade names for the same medicine.

Read the Leaflet Carefully Before Taking the Medicine, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Efracea and What is it 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 is Efracea and What is it Used For

Efracea is a medicine used in adults to reduce the redness and number of pimples caused by a condition called rosacea.

2. Important Information Before Taking Efracea

When Not to Take Efracea:

• If you are allergic (hypersensitive) to any tetracycline antibiotic, including doxycycline or minocycline, or to any of the other ingredients of Efracea (listed in section 6).
• If you are pregnant, from the 4th month onwards, you should not take Efracea, as it may cause harm to the unborn child. If you become pregnant or think you may be pregnant while taking Efracea, you should immediately consult your doctor.
• If you are taking oral retinoids (medicines used for certain skin disorders, such as severe acne), at the same time (see section "Efracea with Other Medicines").
• If you have a lack of acid in the stomach (achlorhydria) or have had surgery on the upper part of the small intestine (duodenum).

Do not give Efracea to infants or children under 12 years old, as it may cause permanent tooth discolouration or affect tooth development.

Warnings and Precautions

Efracea must not be used to treat infections caused by bacteria.
Before taking Efracea, discuss this with your doctor. Tell your doctor if you have:

• liver disease,
• a tendency to fungal infections or a fungal infection of the mouth or vagina,
• a muscle disease called myasthenia gravis,
• colitis,
• irritation or ulceration of the oesophagus,
• rosacea that affects the area around the eyes,
• if your skin is exposed to sunlight or sunlamps, tell your doctor, as people taking doxycycline may get sunburned more easily. Consider using sunscreens with a sun protection factor (SPF) or UV blockers to reduce the risk of sunburn, and stop taking Efracea if your skin gets too sunburned,
• intolerance to certain sugars.

Efracea may cause permanent tooth discolouration.
Tell your doctor or pharmacist if, during treatment, you:

• notice acute or prolonged or bloody diarrhoea during or after treatment with Efracea. Contact your doctor immediately, as treatment may need to be interrupted. These symptoms may indicate a condition called pseudomembranous colitis, which may require treatment with antibiotics.

Take the medicine as directed by your doctor. Taking a higher dose of Efracea than recommended by your doctor may increase the risk of bacteria in the gut becoming resistant to Efracea.

Efracea with Other Medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Efracea and some other medicines may not work properly if taken together.
Tell your doctor about the medicines you are taking or plan to take at the same time as Efracea.

• Do not take Efracea at the same time as medicines containing isotretinoin, due to the risk of increased pressure in the brain. Isotretinoin is prescribed for severe acne.
• Within 2 to 3 hours after taking Efracea, do not take antacids, multivitamins, or other products containing calcium (such as milk and dairy products and fruit juices containing calcium), aluminium, magnesium (including chinapril tablets used for high blood pressure), iron, bismuth, cholestyramine, activated charcoal, or sucralfate. If these substances are taken at the same time as Efracea, it may reduce its effectiveness.
• Other medicines used for stomach ulcers or heartburn may also reduce the effectiveness of Efracea and should not be taken within 2 hours before or after taking Efracea.
• If you are taking blood-thinning medicines, your doctor may need to adjust the dose of such medicines.
• If you are taking certain anti-diabetic medicines, your doctor may need to check if a change in their dosage is required.
• Efracea may reduce the effectiveness of certain antibiotics, including penicillin.
• Taking barbiturates (sleeping pills or short-acting painkillers), rifampicin (used for tuberculosis), carbamazepine (used for epilepsy), phenytoin, or phenobarbital (used for fits), primidone (an anti-epileptic medicine), or cyclosporin (used after organ transplants) may reduce the time Efracea works in your body.
• Taking Efracea with methoxyflurane (a general anaesthetic) may cause severe kidney damage.

Efracea with Food and Drink

Always take the Efracea capsule with a sufficient amount of water, as this reduces the risk of irritation or ulceration of the throat and oesophagus.
Do not take milk or dairy products at the same time as Efracea, as they contain calcium, which may reduce the effectiveness of Efracea. Wait for 2 to 3 hours after taking your daily dose of Efracea before consuming dairy products.

Pregnancy and Breast-feeding

Do not take Efracea during pregnancy, as it may cause permanent tooth discolouration in the child.
Do not take Efracea for a long time during breast-feeding, as it may cause tooth discolouration and affect bone development in the breast-fed child.
If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

Efracea has no or negligible influence on the ability to drive and use machines.

Efracea Contains 102-150 mg of Sucrose and 26.6-29.4 μg of Allura Red AC (E 129) per Capsule

per capsule.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Efracea.
The ink used to mark the capsules contains Allura Red AC (E 129), which may cause allergic reactions.

3. How to Take Efracea

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose is one Efracea capsule every day in the morning on an empty stomach or, if necessary, 1 hour before or 2 hours after a meal. Swallow it whole, without chewing.
Take Efracea with a full glass of water, sitting or standing upright, to reduce the risk of throat irritation.

What to Do if You Take More Efracea Than You Should

If you take more Efracea than you should, there is a risk of liver, kidney, or pancreas damage.
If you have taken more Efracea capsules than you should, contact your doctor immediately.

What to Do if You Forget to Take Efracea

Do not take a double dose to make up for a forgotten capsule.

What to Do if You Stop Taking Efracea

Continue taking Efracea for as long as your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Efracea can cause side effects, although not everybody gets them.
If you experience any of the following side effects, contact your doctor immediately:

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

Common Side Effects
The following side effects are common (affecting 1 to 10 in every 100 patients) when taking Efracea:

• nasopharyngitis
• sinusitis
• fungal infection
• restlessness
• sinus pain
• high or elevated blood pressure
• diarrhoea
• upper abdominal pain
• dry mouth
• back pain
• pain
• changes in blood test results (blood glucose or liver function tests).

Uncommon Side Effects (frequency cannot be estimated from the available data)
The following side effects may occur when taking Efracea:

• increased intracranial pressure
• headache.

Rare Side Effects
The following side effects are rare (affecting 1 to 10 in every 10,000 patients) when taking tetracycline-class medicines like Efracea:

• allergic reactions (hypersensitivity) affecting the whole body*
• changes in blood cell counts
• increased intracranial pressure
• pericarditis (inflammation of the sac surrounding the heart)
• nausea, vomiting, diarrhoea, loss of appetite
• liver damage
• skin rash or urticaria
• abnormal skin reactions to sunlight
• increased blood urea levels.

Very Rare Side Effects
The following side effects are very rare (affecting less than 1 in every 10,000 patients) when taking tetracycline-class medicines like Efracea:

• allergic reactions causing swelling of the face, lips, tongue, or throat*
• fungal infections in the genital or anal areas
• breakdown of red blood cells (haemolytic anaemia)
• blackish-brown microscopic discolouration 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
• glossitis (inflammation of the tongue)
• difficulty swallowing
• colitis
• oesophagitis or oesophageal ulceration
• skin rash causing peeling
• weakened immune system, known as systemic lupus erythematosus (SLE).

Side Effects with Unknown Frequency (frequency cannot be estimated from the available data)
Side effects that may occur when taking medicines in the same class as Efracea (tetracyclines):

• weakening of the nail bed

* If you notice any of the following side effects, contact your doctor immediately: swelling of the face, lips, tongue, or throat, difficulty breathing, tingling or itching of the skin and eyes, or rapid heartbeat (palpitations) and tendency to faint. These may be signs of a severe allergic reaction (hypersensitivity).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help 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 month.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack 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 - ethyl acrylate copolymer (1:1), triethyl citrate, talc, Opadry Beige, YS-1-17274-A consisting of hypromellose 3cP, hypromellose 6cP, titanium dioxide, macrogol 400, iron oxide yellow, iron oxide red, polysorbate 80; sucrose, pellets (maize starch, sucrose).
The capsule shell (Hard Gelatin Capsule no 2, beige Opaque) consists of: iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, gelatin.
The ink consists of: shellac, propylene glycol, iron oxide black, 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 2, marked "GLD 40".
Efracea is available in packs of 28 or 56 capsules.
For more detailed information, contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Greece, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, the Country of Export:109605/19-09-2019

Parallel Import Authorisation Number: 195/25

This Medicine is Authorised in the Member States 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

Date of Revision of the Leaflet: 05.06.2025

[Information about the Trademark]