Prospecto: information for the user

ORACEA40mg hard capsules of modified release

Doxiciclina

Read this prospectus carefully before starting to take this medication, because it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Oracea and for what it is used

2.What you need to know before starting to take Oracea

3.How to take Oracea

4.Possible adverse effects

5.Storage of Oracea

6.Contents of the package and additional information

Oracea is a medication that contains doxycycline as its active ingredient, used in adults to reduce red bumps and pimples on the face caused by a condition called rosacea.

Do not take Oracea

• if you are allergic (hypersensitive) to any medication in the tetracycline group, including doxycycline or minocycline, or to any of the other components of this medication (listed in section 6)
• if you are pregnant, do not use Oracea from the 4th month of pregnancy, as it may harm the fetus. If you suspect or learn that you are pregnant while taking Oracea, contact your doctor immediately.
• in combination with retinoids (medications used in the treatment of certain skin conditions such as severe acne) administered orally (see section Use of other medications)
• if you have a disease that produces a lack of acid in the stomach (achlorhydria) or if you have been operated on the upper part of the intestine (called the duodenum)

Oracea should not be administered to babies or children under 12 years old, as it may produce permanent changes in the color of the teeth or problems in their development.

Warnings and precautions

Oracea should not be used to treat infections caused by bacteria.

Consult your doctor or pharmacist before starting to take Oracea if:

• you have liver disease
• you have or have had a predisposition to having candidiasis or are currently suffering from an infection, oral or vaginal, by fungi or yeast.
• you suffer from a muscle disease called myasthenia gravis
• you suffer from colitis
• you have irritation or ulceration of the esophagus
• you have a type of rosacea that affects the eyes
• you expose your skin to intense sunlight or artificial light, as some people taking doxycycline may have more severe sunburns. You should use a cream or sunscreen to reduce the risk of sunburn and discontinue Oracea treatment if your skin starts to burn.
• your doctor has told you that you have intolerance to some sugars

Oracea may cause permanent discoloration of the teeth.

During your treatment with Oracea, consult your doctor or pharmacist if:

• you develop severe or prolonged diarrhea or with blood during or after using Oracea, speak with your doctor immediately, as it may be necessary to discontinue treatment. This may be a sign of intestinal inflammation (pseudomembranous colitis) that can occur after antibiotic treatment.

Take Oracea exactly as prescribed by your doctor. Taking more than the prescribed dose may increase the likelihood of an intestinal bacterium becoming resistant to Oracea.

Oracea use with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Oracea and certain medications may not work properly if taken at the same time. Inform your doctor about the medications you are taking or plan to take during Oracea treatment.

• Oracea should not be used at the same time as isotretinoin due to the risk of increased intracranial pressure. Isotretinoin is prescribed to patients with severe acne.
• Do not take antacids, multivitamins, or other products containing calcium (such as milk and dairy products, or fruit juices containing calcium), aluminum, magnesium (including quinapril tablets taken for high blood pressure), iron, bismuth, or cholestyramine, carbon active, or sucralfate, until 2 or 3 hours after taking your daily dose of Oracea.These medications 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 of these medications.
• If you are taking certain diabetes treatments, your doctor may need to consider changing the dose of that diabetes treatment.
• Oracea may make some antibiotics, including penicillins, less effective.
• The use of barbiturates (sleeping pills or rapid-acting analgesics), rifampicin (tuberculosis), carbamazepine (epilepsy), diphenylhydantoin, and phenytoin (seizures), primidone (anticonvulsants), or cyclosporine (organ transplant) may reduce the time Oracea remains active in your body.
• The use of Oracea with the general anesthetic methoxiflurane may cause severe kidney damage.

Oracea use with food and beverages

Take Oracea always with a sufficient amount of water to swallow the capsule, as this reduces the risk of irritation or ulceration in the throat or esophagus.

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

Pregnancy, breastfeeding, and fertility

Oracea should not be used during pregnancy, as it may produce permanent changes in the color of the teeth in the fetus.

Oracea should not be used for prolonged periods by breastfeeding mothers, as it may cause discoloration of the teeth and reduce bone growth in the infant.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Oracea has no influence, or is insignificant, on the ability to drive and operate machinery.

Important information about some of the components of Oracea

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult 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 eating. 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 irritating the throat.

If you take more Oracea than you should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Oracea

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Oracea

You must continue taking Oracea until your doctor tells you to stop.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Frequent side effects

The following side effects may appear frequently (affecting 1 to 10 of every 100 patients) during treatment with Oracea:

• Pharyngitis and nasal inflammation
• Sinusitis (inflammation of the facial sinuses)
• Fungal infection
• Anxiety
• Headache caused by sinusitis
• Hypertension or increased blood pressure
• Diarrhea
• Upper abdominal pain
• Dry mouth
• Back pain
• Pain
• Changes in some blood test parameters (blood glucose levels or liver function tests).

Side effects of unknown frequency(cannot be estimated with available data). The following side effects may appear during treatment with Oracea:

• Increased intracranial pressure
• Headache

Rare side effects

The following side effects may appear rarely (affecting 1 to 10 of every 10,000 patients) during treatment with the type of medications to which Oracea belongs (tetracyclines):

• Allergic reactions (hypersensitivity) anywhere in the body*
• Changes in the number or type of certain blood cells
• Increased intracranial pressure
• Pericarditis (inflammation of the membrane surrounding the heart)
• Nausea, vomiting, diarrhea, anorexia
• Liver damage
• Rash or urticaria
• Abnormal skin reaction to sunlight
• Elevated blood urea levels

Very rare side effects

The following side effects may appear very rarely (affecting fewer than 1 in 10,000 patients) during treatment with the type of medications to which Oracea belongs (tetracyclines):

• Allergic reactions that cause inflammation of the eyes, lips, or tongue*
• Candidiasis around the anus or genitals
• Alterations in red blood cells (hemolytic anemia)
• After prolonged administration, it has been reported that tetracyclines produce brown-black microscopic staining of the thyroid gland. Thyroid function is normal.
• Pharyngitis
• Dysphagia
• Enteritis
• Pharyngitis or esophagitis
• Dermatitis with desquamation
• Worsening of the immune system known as systemic lupus erythematosus (SLE)

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

The following side effects may appear during treatment with the type of medications to which Oracea belongs (tetracyclines):

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

* Inform your doctor immediately or take a break if you experience side effects such as swollen face, lips, tongue, or throat, difficulty breathing, urticaria, or skin and eye itching, or rapid heartbeat and dizziness. These effects may be symptoms of severe allergic reactions (hypersensitivity).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after EXP:. The expiration date is the last day of the month indicated.

Store it in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofOracea

The active ingredient isdoxycycline. Each capsule contains40mg of doxycycline (as monohydrate).

The other components are:

Hypromellose (E464), copolymer of methacrylic acid-acrylate of ethyl(1:1),trietil citrate, talc (E553b), titanium dioxide (E171), macrogol400, yellow iron oxide (E172), red iron oxide (E172), polisorbate 80 (E433), sugar spheres(cornstarch, 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 of indigo carmine, aluminium lake of red Allura AC (E129),aluminium lake of brilliant blue FCF, aluminium lake of D & C yellow No. 10

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

Appearance of the product and contents of the pack

Oraceais presented as modified release hard capsules.

The capsules are beige in color and bear the inscription “GLD40”.

Oraceais available in packs containing 56, 28 or 14 capsules

Only some pack sizes may be marketed

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Galderma Laboratories, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible:

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

CATALENT UK SWINDON ZYDIS LTD.

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

GALDERMA LABORATORIUM GMBH,

Toulouser Allee 23a

40211 Düsseldorf

Germany

PATHEON FRANCE

40 Boulevard de Champaret

38300 Bourgoin Jallieu

France

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Denmark, Greece, Finland, Iceland, Norway, Sweden: Oracea40mg modified release hard capsules

Austria, Germany: ORAYCEA40mg modified release hard capsules

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

Spain:Oracea40mg modified release hard capsules

This leaflet was approved in June 2019

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es