40 mg modified-release capsules, hard
doxycycline
What Oracea is and what it is used for
Oracea is a medicine that contains the active substance doxycycline for use in adults to reduce pimples and redness on the face caused by a condition called rosacea.
Doxycycline contained in Oracea may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Oracea
Do not use Oracea
- if you are allergic to any drug in the tetracycline family, e.g. doxycycline or minocycline or against any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant, Oracea should not be used from the 4th month, as it may harm the unborn baby. If you suspect or find out you are pregnant while taking Oracea, contact your doctor immediately.
- in combination with retinoids ( medicines prescribed to treat certain skin conditions, such as severe acne ) when administered orally (see section: Other medicines and Oracea).
- if you have a condition that causes a lack of acid in the stomach (chlorohydria) or if you have undergone an operation in the upper part of the intestine (called the duodenum ).
Oracea should not be taken by infants or children under 12 years of age, as it may lead to permanent discoloration of the teeth or problems with tooth development.
Warnings and cautions
Oracea must not be used to treat infections caused by bacteria.
Talk to your doctor or pharmacist before using Oracea if:
- you have a liver disease
- you have previously had a fungal infection or currently have an oral or vaginal yeast or fungal infection
- You have a muscle disease called myasthenia gravis
- you have colitis ( inflammation of the colon)
- you have irritation or sores in the esophagus
- You have the type of rosacea that affects the eyes
- you are exposing your skin to strong sunlight or artificial sunlight, as severe sunburn can occur in some people taking doxycycline . You should consider using sunscreen with a sun protection factor to reduce the risk of sunburn and you should stop using Oracea if your skin gets sunburned.
- Your doctor has told you that you are hypersensitive to certain sugars.
Oracea can cause permanent discoloration of the teeth.
During treatment with Oracea, talk to your doctor or pharmacist about:
- you develop severe or prolonged or bloody diarrhea during or after using Oracea. Contact your doctor immediately as it may be necessary to discontinue treatment. This may be a sign of inflammation in the gut (pseudomembranous colitis ) which may occur after treatment with antibiotics .
Always take Oracea exactly as your doctor has told you. Taking more than the prescribed dose can increase the risk of intestinal bacteria becoming resistant to Oracea.
Other medicines and Oracea
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Oracea and some other medicines may not work very well when taken together. Tell your doctor or pharmacist which medicines you are taking, or plan to take, while you are taking Oracea.
- Oracea should not be used at the same time as the drug isotretinoin due to the risk of increased pressure in the brain. Isotretinoin is prescribed to patients with severe acne.
- Do not take antacids (for acid stomach), multivitamins or other products that contain calcium (eg milk and dairy products and fruit juices that contain calcium ), aluminum, magnesium (including chinapril tablets, which are taken for high blood pressure ), iron or bismuth or cholestyramine , activated carbon or sucralfate until 2 to 3 hours after ingestion of Oracea. These medicines can reduce the effect of Oracea if taken at the same time.
- Other treatments for stomach ulcers or heartburn can also reduce the effect of Oracea and should not be taken until at least 2 hours after Oracea.
- If you are taking blood thinners, your doctor may need to change the dosage of one of the blood thinners.
- If you are taking certain treatments for diabetes , your doctor may need to check if the dose of the diabetes medicine needs to be changed.
- Oracea may make certain antibiotics , including penicillins , less effective.
- Taking barbiturates (sleeping pills or short-acting painkillers), rifampicin ( tuberculosis ), carbamazepine ( epilepsy ), diphenylhydantoin and phenytoin (epileptic seizures), primidone ( antiepileptic drugs ) or cyclosporine (organ transplantation) may reduce the time the body is active.
- Use of Oracea with the anesthetic methoxyfluorane can cause serious damage to the kidneys.
Oracea with food and drink
Always take Oracea with a sufficient amount of water to rinse the capsule, as this reduces the risk of irritation or sores in the throat or esophagus.
Avoid milk or dairy products at the same time as Oracea as these products contain calcium which may reduce the effect of Oracea. Allow 2 to 3 hours to pass after your daily dose of Oracea before eating or drinking dairy products.
Pregnancy and breastfeeding
Oracea should not be used during pregnancy as it may cause permanent discoloration of the teeth of the unborn baby.
Oracea should not be used during prolonged periods by breastfeeding mothers as it may discolor the teeth and reduce bone growth in the breastfed baby.
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.
Driving and using machines
Oracea has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Oracea contains sugar (sucrose) and allura red AC-aluminum lacquer (E129)
If you have been told by your doctor that you have an allergy to certain sugars, contact your doctor before taking this medicine.
The ink used to press the capsule contains Alluraröd AC aluminum lacquer (E129) which can cause allergic reactions.
How to use Oracea
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 capsule of Oracea taken daily in the morning, on an empty stomach, preferably at least one hour before or two hours after a meal. Swallow the capsule whole, do not chew it.
You should take Oracea with a full glass of water when sitting or standing up to avoid throat irritation.
If you take more Oracea than you should
If you take more Oracea than you should, there is a risk of damage to the liver, kidneys, or pancreas.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital by mistake for assessment of the risk and advice.
If you forget to take Oracea
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Oracea
Keep taking 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor as soon as possible if any of the following symptoms occur:
- Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle aches and rash. These symptoms are usually self-limiting. This occurs shortly after starting doxycycline treatment of infections caused by spirochete such as Lyme disease infection .
Common side effects are
The following side effects can often occur (affecting 1 to 10 users in 100) during treatment with Oracea:
- Inflammation of the nose and throat
- Inflammation of the sinuses
- Fungal infection
- Concern
- Headache
- High or high blood pressure
- Diarrhea
- Pain in the upper abdomen
- Dry mouth
- Back pain
- Pain
- Changes in certain blood tests (the amount of glucose in the blood or tests of liver function).
Adverse reactions with an unknown frequency (not estimated from available data).
The following side effects may occur during treatment with Oracea:
- Increased pressure in the brain
- Headache
Rare side effects
The following side effects may sometimes occur (affecting 1 to 10 users in 10,000) during treatment with the drug class to which Oracea belongs ( tetracyclines ):
- Allergy (hypersensitivity) throughout the body *
- Changes in the number or type of certain blood cells
- Increased pressure in the brain
- Inflammation of the membrane one that surrounds the heart
- Nausea, vomiting, diarrhea, anorexia
- Liver damage
- Skin irritation or hives
- Abnormal reaction in the skin to sunlight
- Elevated amount of urea ( urea ) in the blood
Very rare side effects
The following side effects may occur in rare cases (affecting less than 1 user in 10,000) during treatment with the class of medicines to which Oracea belongs ( tetracyclines ):
- Allergic reaction that causes swelling of the eyes, lips or tongue *
- Yeast infection around the rectum or genitals
- Damage to the red blood cells ( haemolytic anemia )
- Brown-black microscopic discoloration of thyroid tissue has been reported with long-term use of tetracyclines . Thyroid function is normal
- Increased pressure in the brain of infants
- Inflammation of the tongue
- Difficulty swallowing
- Inflammation of the intestine
- Inflammation or ulceration of the esophagus
- Inflammation of the skin so that it scales
- Deterioration of the immune system disease systemic lupus erythematosus ( SLE )
Side effects with unknown frequency (can not be calculated from the available data)
The following side effects may occur during treatment with the class of medicines to which Oracea belongs ( tetracyclines ):
- Nail detachment from nail bed one after exposure to the sun
* See a doctor or emergency department immediately if you experience side effects such as swelling of the face, lips, tongue, and throat, difficulty breathing, hives, skin or eye irritation or palpitations, and fainting sensations. These side effects may be symptoms of a severe allergic reaction (hypersensitivity).
How to store 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 outer carton and blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to 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 to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is doxycycline. Each capsule contains 40 mg of doxycycline (as monohydrate).
Other ingredients are:
Hypromellose, methacrylic acid ethyl acrylate copolymer (1: 1), triethyl citrate, talc, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80, sugar beads (corn starch, sucrose).
Capsules: gelatin, black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide.
Ink printing: shellac, propylene glycol, black iron oxide, indigo carmine aluminum lacquer, Allura red AC aluminum lacquer (E129), brilliant blue FCF aluminum lacquer, quinoline yellow aluminum lacquer.
See the end of section 2 for information on sugar (sucrose) and all-red AC-aluminum lacquer (E129).
What the medicine looks like and contents of the pack
Oracea is a hard capsule with modified release
The capsules are beige and are marked “GLD 40”.
Oracea is available in packs of 14, 28, and 56 capsules (not all pack sizes may be marketed).
Marketing Authorization Holder and Manufacturer
Manufacturer:
Patheon France, 40 Boulevard de Champaret
38300 BOURGOIN JALLIEU
France
or
GALDERMA Laboratories, Montdésir Industrial Zone
74540 Alby sur Chéran, France
This medicinal product is authorized under the European Economic Area under the names:
DK, EL, ES, FI, IS, SE, NO – Oracea 40 mg modified-release hard capsules
DE, AT – Oraycea 40 mg modified-release hard capsules
BE, FR, NL, UK, IE, IT, PL, PT, LU – Efracea 40 mg modified-release hard capsules