ORACEA 40 mg EXTENDED-RELEASE HARD CAPSULES

2. What you need to know before you take Oracea

Do not take Oracea

• if you are allergic (hypersensitive) to any tetracycline antibiotic, including doxycycline or minocycline, or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant, as Oracea may harm the unborn child. If you become pregnant while taking Oracea, contact your doctor immediately.
• in combination with oral retinoids (medicines used to treat certain skin conditions such as severe acne)
• if you have a condition that causes a lack of acid in the stomach (achlorhydria) or if you have had surgery on the upper part of the small intestine (called the duodenum)

Oracea should not be given to babies or children under 12 years of age, as it may cause permanent tooth discolouration or affect tooth development.

Warnings and precautions

Oracea should not be used to treat bacterial infections.

Tell your doctor or pharmacist before taking Oracea if:

• you have liver disease
• you have or have had a tendency to develop thrush or are currently suffering from a fungal or yeast infection
• you have a muscle disease called myasthenia gravis
• you have colitis
• you have irritation or ulcers of the oesophagus
• you have a type of rosacea that affects the eyes
• you are exposed to strong sunlight or ultraviolet light, as some people taking doxycycline may be more likely to get sunburn
• your doctor has told you that you have an intolerance to some sugars

Oracea may cause permanent tooth discolouration.

Tell your doctor or pharmacist if you:

• develop severe or prolonged diarrhoea or diarrhoea containing blood during or after taking Oracea. Contact your doctor immediately, as this may be a sign of a bowel inflammation (pseudomembranous colitis) that can occur after antibiotic treatment

Take Oracea exactly as your doctor has told you. Taking more than the prescribed dose may increase the risk of bacteria in your gut becoming resistant to Oracea.

Taking Oracea with other medicines

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

Oracea and certain other medicines may not work properly if taken at the same time. Tell your doctor about any medicines you are taking or plan to take during treatment with Oracea

• Oracea should not be taken at the same time as isotretinoin, due to the risk of increased pressure in the brain. Isotretinoin is prescribed for severe acne.
• Do not take antacids, multivitamins or other products containing calcium (such as milk and dairy products), aluminium, magnesium (including quinapril tablets, which are taken for high blood pressure), iron, bismuth or cholestyramine, activated charcoal or sucralfate until 2 or 3 hours after taking Oracea. These medicines may reduce the effectiveness of Oracea if taken at the same time.
• Other treatments for ulcers or acid reflux may also reduce the effectiveness of Oracea and should not be taken until at least 2 hours after taking Oracea.
• If you are taking anticoagulants, your doctor may need to adjust the dose.
• If you are taking certain treatments for diabetes, your doctor may need to consider whether to change the dose of your diabetes treatment.
• Oracea may make some antibiotics, including penicillins, less effective.
• Taking barbiturates (sleeping pills or fast-acting painkillers), rifampicin (for tuberculosis), carbamazepine (for epilepsy), phenytoin or phenobarbital (for fits), primidone (anti-convulsants) or ciclosporin (after organ transplantation) may reduce the time that Oracea stays active in your body.
• Taking Oracea with the general anaesthetic methoxyflurane may cause serious kidney damage.

Taking Oracea with food and drink

Take Oracea with a full glass of water, while sitting or standing, to reduce the risk of irritation or ulcers in the throat or oesophagus.

Do not take milk or dairy products at the same time as Oracea, as they contain calcium which may reduce the effectiveness of Oracea. Wait for 2 to 3 hours after taking your daily dose of Oracea before drinking or eating dairy products.

Pregnancy, breast-feeding and fertility

Oracea should not be taken during pregnancy, as it may cause permanent tooth discolouration in the unborn child.

Oracea should not be taken for prolonged periods by breast-feeding mothers, as it may cause tooth discolouration and affect bone growth in the breast-fed child.

Driving and using machines

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

Important information about some of the ingredients of Oracea

Oracea contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

The ink used to print on the capsule contains aluminium lake red Allura AC (E129), which may cause allergic reactions. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Oracea

Follow exactly the instructions of your doctor to take this medicine. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is one Oracea 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 and do not chew it.

Take the Oracea capsule with a full glass of water, while sitting or standing, to avoid throat irritation.

If you take more Oracea than you should

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

If you take more Oracea capsules than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Oracea

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

If you stop taking Oracea

Continue to take Oracea until your doctor tells you to stop.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following side effects occur, contact your doctor as soon as possible:

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

Common side effects

The following side effects may occur frequently (affect 1 to 10 users in 100):

• Nasal and throat inflammation
• Sinusitis (inflammation of the facial sinuses)
• Fungal infections
• Anxiety
• Headache caused by sinusitis
• Hypertension or increased blood pressure
• Diarrhoea
• Pain in the upper abdomen
• Dry mouth
• Back pain
• Pain
• Changes in some blood test parameters (blood glucose or liver function tests).

Uncommon side effects(frequency cannot be estimated from the available data).

The following side effects may occur:

• Increased pressure in the brain
• Headache

Rare side effects

The following side effects may occur rarely (affect 1 to 10 users in 10,000):

• Allergic reactions (hypersensitivity) anywhere in the body
• Changes in the number or type of certain blood cells
• Increased pressure in the brain
• Inflammation of the membrane surrounding the heart
• Nausea, vomiting, diarrhoea, loss of appetite
• Liver damage
• Skin rash or hives
• Abnormal skin reaction to sunlight
• Increased blood urea levels

Very rare side effects

The following side effects may occur very rarely (affect less than 1 user in 10,000):

• Allergic reactions that cause inflammation of the eyes, lips or tongue
• Fungal infections around the anus or genitals
• Changes in red blood cells (haemolytic anaemia)
• After prolonged administration, tetracyclines have been reported to cause brown-black microscopic discoloration of the thyroid gland. Thyroid function is normal.
• Inflammation of the tongue
• Difficulty swallowing
• Inflammation of the intestine
• Inflammation or ulcers of the throat
• Inflammation of the skin that causes scaling
• Worsening of the immune system condition known as systemic lupus erythematosus (SLE)

Side effects of unknown frequency(cannot be estimated from the available data).

The following side effects may occur:

• Separation of the nail from the nail bed after sun exposure

• Tell your doctor immediately or stop taking Oracea if you experience side effects such as swollen face, lips, tongue or throat, difficulty breathing, hives, or itching of the skin and eyes, or rapid heartbeat and feeling of fainting. These may be symptoms of severe allergic reactions (hypersensitivity).

Reporting of side effects

If you experience 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 Spanish Medicines Information System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oracea

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 after EXP:. The expiry date refers to the last day of that month.

Store in the original package 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 further information

Composition of Oracea

The active substance is doxycycline. Each capsule contains 40 mg of doxycycline (as monohydrate).

The other ingredients are:

Hypromellose (E464), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc (E553b), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), red iron oxide (E172), polysorbate 80 (E433), sugar spheres (maize starch, sucrose).

Capsules: gelatin, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171)

Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), aluminium lake red Allura AC (E129), aluminium lake blue brilliant FCF, aluminium lake yellow D & C No. 10

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

Appearance and packaging of Oracea

Oracea is presented as modified-release hard capsules.

The capsules are beige and marked with “GLD 40”.

Oracea is available in packs of 56, 28 or 14 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

LABORATOIRES GALDERMA Zone Industrielle - Montdesir (Alby Sur Cheran) - F-74540 – France

CATALENT UK SWINDON ZYDIS LTD.

Frankland Road. Blagrove, Swindon (Wiltshire) - SN5 8RU - United Kingdom

GALDERMA LABORATORIUM GMBH,

Toulouser Allee 23a

40211 Düsseldorf

Germany

PATHEON FRANCE

40 Boulevard de Champaret

38300 Bourgoin Jallieu

France

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark, Greece, Finland, Iceland, Norway, Sweden: Oracea 40 mg modified release hard capsules

Austria, Germany: ORAYCEA 40 mg modified release hard capsules

Belgium, France, Ireland, Italy, Netherlands, Poland, Portugal, United Kingdom, Luxembourg: EFRACEA 40 mg modified release hard capsules

Spain: Oracea 40 mg modified-release hard capsules

This leaflet was approved in June 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es