Efracea

Package Leaflet: Information for the Patient

Efracea

40 mg, modified release hard capsules

Doxycycline

Read all of this leaflet carefully before 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.

Contents of the pack and other information:
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 (inflammatory lesions) caused by 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 any of the other ingredients of Efracea (listed in section 6).
• If you are pregnant, from the fourth month onwards, you should not take Efracea as it may cause harm to the unborn child. If you become pregnant or suspect that you are pregnant while taking Efracea, you should contact your doctor immediately.
• At the same time as retinoids (medicines used for certain skin disorders, such as severe acne), taken by mouth (see section "Efracea and 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 (called the 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 should not be used to treat infections caused by bacteria.
Before taking Efracea, you should discuss this with your doctor. You should 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, you should tell your doctor, as people taking doxycycline may get sunburned more easily. You should consider using sunscreens 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.
You should contact your doctor or pharmacist if, during treatment, you

• experience sudden or prolonged or bloody diarrhoea during or after treatment with Efracea. You should contact your doctor immediately, as this may require interruption of treatment. These symptoms may indicate an inflammatory condition of the intestines (pseudomembranous colitis), which may require treatment with antibiotics.

Take the medicine as directed by your doctor. Taking more than the prescribed dose of Efracea may increase the risk of developing resistance to the medicine.

Efracea and other medicines

Tell your doctor about all the medicines you are taking now or plan to take, including those bought without a prescription.
Efracea and some other medicines may not work properly if taken at the same time. You should 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 quinapril tablets used for high blood pressure), iron, bismuth, cholestyramine, activated charcoal, or sucralfate. If these substances are taken at the same time as Efracea, they 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 medicines that thin the blood, your doctor may need to adjust the dose of such a medicine.
• 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 (used for fits), primidone (an anticonvulsant), or cyclosporin (used after organ transplants) may reduce the time during which Efracea works in your body.
• Taking Efracea with methoxyflurane (a general anaesthetic) may cause serious kidney damage.

Efracea with food and drink

Always swallow the Efracea capsule with a sufficient amount of water, as this reduces the risk of irritating or ulcerating 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. You should wait 2 to 3 hours after taking your daily dose of Efracea before consuming dairy products.

Pregnancy and breastfeeding

Do not take Efracea during pregnancy, as it may cause permanent tooth discolouration in the child.
Do not take Efracea for a long time while breastfeeding, as it may cause tooth discolouration and affect the development of the child's bones.
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 (E129) 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 this medicinal product.
The ink used to mark the capsules contains Allura Red AC (E129), 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 morning, on an empty stomach or 1 hour before or 2 hours after a meal. Swallow the capsule whole, without chewing.
Take Efracea with a full glass of water, while sitting or standing upright, to reduce the risk of irritating the throat.

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 to take Efracea for as long as your doctor tells you to.
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 (may affect up to 1 in 10 people)
The following side effects may occur commonly (in between 1 and 10 out of every 100 patients) when taking Efracea:
nasopharyngitis (inflammation of the nose and throat)
sinusitis (inflammation of the sinuses)
fungal infections
anxiety
sinus pain
high or increased blood pressure
diarrhoea
upper abdominal pain
dry mouth
back pain
pain
changes in the results of some blood tests (blood glucose or liver function tests).

Uncommon side effects (may affect up to 1 in 100 people)
The following side effects may occur uncommonly (in between 1 and 100 out of every 1,000 patients) when taking Efracea:
increased pressure in the skull (pseudotumour cerebri)
headache.

Rare side effects (may affect up to 1 in 1,000 people)
The following side effects may occur rarely (in between 1 and 10 out of every 10,000 patients) when taking tetracycline antibiotics like Efracea:
allergic reactions (hypersensitivity) affecting the whole body*
changes in the number or type of blood cells
increased pressure in the skull (pseudotumour cerebri)
inflammation of the tissue surrounding the heart (pericarditis)
nausea, vomiting, diarrhoea, loss of appetite
liver damage
skin rash or urticaria (hives)
abnormal skin reactions to sunlight
increased levels of urea in the blood

Very rare side effects (may affect up to 1 in 10,000 people)
The following side effects may occur very rarely (less than 1 in every 10,000 patients) when taking tetracycline antibiotics like Efracea:

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

Side effects of unknown frequency (frequency cannot be estimated from the available data)
The following side effects may occur when taking tetracycline antibiotics like Efracea:

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

* You should contact your doctor immediately if you experience side effects such as swelling of the face, lips, tongue, or throat, difficulty breathing, tingling or itching of the skin and eyes, or a fast heartbeat (palpitations) and a tendency to faint. These may be signs of a severe allergic reaction (hypersensitivity).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below.
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 carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order 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. These measures 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, copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, talc, Opadry Beige, YS-1-17274-A, which contains hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), red iron oxide (E172), polysorbate 80, sucrose, and maize starch.
The capsule shell (Hard Gelatin Capsule no 2, beige Opaque) contains:
cap:black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin;
body:black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
The ink contains: shellac, propylene glycol, black iron oxide, indigo carmine (E132), Allura Red AC (E129), and other ingredients.

What Efracea looks like and contents of the pack

Modified release hard capsules. Beige capsules, size 2, marked with “GLD 40”.
Efracea is available in packs of 14, 28, or 56 capsules (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warszawa
Polska
tel.: +48 22 331 21 80

Manufacturer:

Patheon France, 40 boulevard de Champaret
38300 BOURGOIN JALLIEU, France
or
Laboratoires GALDERMA, Zone Industrielle Montdésir
74540 Alby sur Chéran, France
or
Galderma Laboratorium GmbH, Toulouser Allee 23a
40211 Düsseldorf, Germany

This medicinal product 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 last revision of the leaflet: