• 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.

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

• 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 discolouration of the teeth or problems with tooth development.

Efracea must not be used to treat infections caused by bacteria.

Talk to your doctor or pharmacist before taking Efracea if:

• you have liver disease
• you have a history of predisposition to candidiasis overgrowth or are currently experiencing an oral or vaginal yeast or fungal infection
• you suffer from the muscle disease called myasthenia gravis
• you suffer from colitis
• you suffer from oesophageal irritation or ulceration
• you have the type of rosacea which affects the eyes
• you expose your skin to strong sunlight or artificial sunlight, because more severe sunburn may occur in some people taking doxycycline.
  You should consider using a sunscreen or sunblock to reduce the risk of sunburn and you should stop using Efracea if your skin becomes sunburned.
• you have been told by your doctor that you have an intolerance to some sugars

Efracea may cause permanent discolouration of the teeth.

During your treatment with Efracea talk to your doctor or pharmacist if:

• you develop severe or prolonged or bloody diarrhoea during or after using Efracea tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.

Take Efraea exactly as prescriped by your doctor. Taking more than your prescribed dose may increase the chance that intestinal bacteria will become resistant to Efracea.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Efracea and certain other medications may not work properly when taken together. Tell your doctor about medications that you are taking or plan to take whilst you are taking Efracea.

• Efracea should not be used at the same time as the medicine isotretinoin because of the risk of increased pressure in the brain. Isotretinoin is prescribed to patients with a severe case of acne.
• Do not take antacids, multi-vitamins or other products that contain calcium (such as milk and dairy products and calcium-containing fruit juices), aluminium, magnesium (including quinapril tablets, which are taken for high blood pressure), iron or bismuth, or cholestyramine, activated charcoal or sucralfate until 2 to 3 hours after taking Efracea. These medicines may 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 blood thinners, your doctor may need to make changes to the dose of your blood thinner.
• If you are taking certain treatments for diabetes, your doctor may need to check whether the dose of the diabetes treatment has to be changed.
• Efracea may make certain antibiotics, including penicillins, less effective.
• Taking barbiturates (sleeping pills or short-term pain-killers), rifampicin (tuberculosis), carbamazepine (epilepsy), diphenylhydantoin and phenytoin (seizures of the brain), primidone (anti-convulsant) or cyclosporin (organ transplant) may reduce the time that Efracea stays active in your system.
• Using Efracea with the general anaesthetic methoxyfluorane may cause serious harm to the kidneys.

Always take Efracea with an adequate amount of water to wash down the capsule, since this reduces the risk of irritation or ulcer in the throat or gullet.

Do not take milk or dairy products at the same time as Efracea since these products contain calcium which may reduce the effectiveness of Efracea.

Leave 2 to 3 hours after your daily dose of Efracea before drinking or eating dairy products.

Efracea must not be used during pregnancy since it may cause permanent discolouration of the teeth in the unborn child.

Efracea should not be used for long periods by breastfeeding mothers since it may cause tooth discolouration and reduced bone growth in the suckling child.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The ink used to print on the capsule contains Allura red AC aluminium lake (E129) which may cause allergic reactions.

If you take an overdose of Efracea, there is a risk of damage to the liver, kidneys or pancreas.

If you take more Efracea capsules than you should, ask your doctor immediately for advice.

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

You should continue to take Efracea until your doctor tells you to stop.

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

• The active substance is doxycycline. Each capsule contains 40 mg doxycycline (as monohydrate).
• The other ingredients are:
  hypromellose, methacrylic acid-ethyl acrylate copolymer (1 :1), triethyl citrate, talc, hypromellose, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80, sugar spheres (maize 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 aluminium lake, allura red AC aluminium lake (E129), brilliant blue FCF aluminium lake, D & C yellow no. 10 aluminium lake.

See end of section 2 for information on sugar (sucrose) and allura red AC aluminium lake (E129).

Efracea is a modified-release hard capsule.

The capsules are beige in colour and bear the marking "GLD 40".

Efracea is available in packs containing 56, 28, or 14 capsules (not all pack sizes may be marketed).

Marketing Authorisation Holder:

United Kingdom

Ireland

Product Licence Number: PL 10590/0056 (UK) & PA22743/006/001 (IRE)

Or

This medicinal product is authorised in the Member States of the EEA under the following names:

CZ, DK, EL, ES, FI, IS, SE, NO - ORACEA 40 mg modified release hard capsules

DE, AT - ORAYCEA 40 mg modified release hard capsules

BE, HU, FR, NL, UK (NI), IE, IT, PL, PT, SK, LU - Efracea 40 mg modified release hard capsules