Efracea

Package leaflet: Information for the user

Efracea 40 mg modified-release hard capsules

doxycycline
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Efracea is and what it is used for
2. What you need to know 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 Efracea is and what it is used for

Efracea is a medicine containing the active substance doxycycline. It is used in adults to reduce red pimples and pustules on the face caused by a condition called rosacea.

2. What you need to know before taking Efracea

Do not take Efracea

• if you are allergic (hypersensitive) to any of the medicines 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 must not be used from the 4th month of pregnancy onwards, as it may harm the unborn child. If you suspect or find out that you are pregnant while taking Efracea, contact your doctor immediately.
• in combination with retinoids (medicines used to treat certain skin diseases such as severe acne) taken orally (see section "Other medicines and Efracea").
• if you have a condition causing absence of acid in the stomach (achlorhydria), or if you have undergone surgery on the first part of the intestine (duodenum).

Efracea must not be taken by newborns or children under 12 years of age, as it may cause permanent abnormal discoloration of teeth or problems with dental development.

Warnings and precautions

Efracea must not be used for the treatment of bacterial infections.

Talk to your doctor or pharmacist before taking Efracea if:

• you have liver disease
• you have a history of predisposition to candidiasis, or if you currently have an oral or vaginal fungal or yeast infection
• you have a muscle disease called myasthenia gravis
• you have colitis
• you have irritation or ulceration of the oesophagus
• you have the type of rosacea that affects the eyes
• you expose your skin to strong sunlight or artificial UV light, as severe sunburn may occur in some people taking doxycycline. Consider using a protective sunscreen or total sunblock to reduce the risk of sunburn, and discontinue use of Efracea if sunburn occurs.
• your doctor has told you that you are intolerant to certain sugars

Efracea may cause permanent discoloration of teeth.

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

• you develop severe or prolonged diarrhoea, especially with blood, during or after using Efracea. Inform your doctor immediately, as treatment may need to be stopped. This could be a sign of inflammation of the intestine (pseudomembranous colitis), which may occur after antibiotic treatment.

Take Efracea exactly as prescribed by your doctor. Taking a higher dose than prescribed may increase the likelihood that intestinal bacteria develop resistance to Efracea.

Other medicines and Efracea

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Efracea and certain other medicines may not work properly when taken together. Inform your doctor about any medicines you are taking or plan to take during treatment with Efracea.

• Efracea must not be used at the same time as isotretinoin due to the risk of increased intracranial pressure. Isotretinoin is prescribed for patients with severe acne.
• Do not take antacids, multivitamins, or other products containing calcium (such as milk and dairy products or calcium-fortified fruit juices), aluminium, magnesium (including quinapril tablets used for high blood pressure), iron, or bismuth, or colestyramine, activated charcoal, or sucralfate within 2–3 hours after taking Efracea. These medicines may reduce the effectiveness of Efracea if taken at the same time.
• Other treatments for stomach 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 anticoagulants, your doctor may need to adjust your anticoagulant dose.
• If you are taking certain medicines for diabetes, your doctor may need to check whether the dose of these medicines should be changed.
• Efracea may make certain antibiotics, including penicillins, less effective.
• Taking barbiturates (sleeping pills or short-term painkillers), rifampicin (tuberculosis), carbamazepine (epilepsy), diphenylhydantoin or phenytoin (seizures), primidone (anticonvulsant), or cyclosporine (organ transplants) may reduce the duration of Efracea’s activity in your body.
• The use of Efracea with the general anaesthetic methoxyflurane may cause severe kidney damage.

Efracea with food and drink

Always take Efracea with a sufficient amount of water to wash down the capsule, as this reduces the risk of irritation or ulceration in the throat or oesophagus.

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

Pregnancy and breastfeeding

Efracea must not be used during pregnancy as it may cause permanent abnormal discoloration of the unborn child’s teeth.

Efracea must not be used for prolonged periods by breastfeeding mothers, as the medicine may cause abnormal discoloration of teeth and reduced bone growth in the infant.

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Efracea does not affect or has negligible effect on the ability to drive or use machinery.

Efracea contains sugar (sucrose) and Allura Red AC – aluminium lake (E129). If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
The ink used to print on the capsules contains Allura Red AC – aluminium lake (E129), which may cause allergic reactions.

3. How to take Efracea

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one Efracea capsule daily in the morning, on an empty stomach, preferably at least one hour before or two hours after a meal. Swallow the capsule whole, without chewing it.
Take Efracea with a full glass of water while sitting or standing to help avoid possible irritation of the throat.
If you take more Efracea than you should
If you take too much Efracea, there is a risk of damaging the liver, kidneys, or pancreas.
If you take more capsules than you should, consult your doctor immediately.
If you forget to take Efracea
Do not take a double dose to make up for the forgotten capsule.
If you stop taking Efracea
You must continue taking Efracea until your doctor decides to stop treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the side effects listed below, contact your doctor as soon as possible:

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

Common side effects
The following side effects may commonly occur (affecting from 1 to 10 out of 100 patients) during treatment with Efracea:

• Inflammation of the nose and throat
• Sinus inflammation (sinusitis)
• Fungal infections
• Anxiety
• Sinus headache
• High or increased blood pressure
• Diarrhea
• Upper abdominal pain
• Dry mouth
• Back pain
• Pain
• Changes in certain blood tests (blood sugar levels or liver function tests).

Side effects with unknown frequency (cannot be estimated from available data)
The following side effects may occur during treatment with Efracea:

• Increased intracranial pressure
• Headache

Rare side effects
The following side effects may occur rarely (affecting from 1 to 10 out of 10,000 patients) during treatment with the class of medicines to which Efracea belongs (the tetracyclines):

• Allergic reaction (hypersensitivity) affecting the whole body*
• Changes in the number or type of certain blood cells
• Increased intracranial pressure
• Inflammation of the membrane surrounding the heart
• Nausea, vomiting, diarrhea, loss of appetite
• Liver damage
• Skin rashes or hives
• Abnormal skin reaction to sunlight
• Increased blood urea levels

Very rare side effects
The following side effects may occur very rarely (affecting fewer than 1 out of 10,000 patients) during treatment with the class of medicines to which Efracea belongs (the tetracyclines):

• Allergic reaction causing swelling of the eyes, lips, or tongue*
• Yeast infection around the anus or genitals
• Changes in red blood cells (haemolytic anaemia)
  • With long-term use of tetracyclines, microscopic brown-black pigmentation of thyroid tissue has been observed. Thyroid function remains normal.
  • Increased intracranial pressure in newborns
• Inflammation of the tongue
• Difficulty swallowing
• Inflammation of the intestine
• Inflammation or ulceration of the oesophagus
• Skin inflammation causing peeling
• Worsening of an immune system disorder known as systemic lupus erythematosus (SLE)

Side effects with unknown frequency (cannot be estimated from available data)
The following side effects may occur during treatment with the class of medicines to which EFRACEA belongs (the tetracyclines):

• Nail detachment from the nail bed after sun exposure.

* Consult your doctor immediately or go to the nearest emergency room if you notice side effects such as swelling of the face, lips, tongue, or throat, difficulty breathing, hives, skin or eye itching, rapid heartbeat (palpitations), or a feeling of weakness. These effects could be symptoms of a severe allergic reaction (hypersensitivity).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via avverse.
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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Efracea contains

• The active substance is doxycycline. Each capsule contains 40 mg of doxycycline (as monohydrate).
• The other components 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 spheres (corn starch, sucrose). Capsule shell: 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 the end of section 2 for information on sugar (sucrose) and allura red AC – aluminium lake (E129).

Description of the appearance of Efracea and contents of the pack
Efracea is a modified-release hard capsule.
The capsules are beige in colour and marked with “GLD 40”.
Efracea is available in packs of 56, 28 or 14 capsules (not all pack sizes may be marketed).

Marketing Authorisation Holder
GALDERMA ITALIA S.p.A.
Registered office: via dell’Annunciata 21, 20121 Milano, Italy

Responsible for batch release:
Patheon France, 40 boulevard de Champaret
38300 BOURGOIN JALLIEU
France
or
Laboratoires GALDERMA, Zone Industrielle Montdésir
74540 Alby sur Chéran, France

This medicinal product is authorised in the European Economic Area countries under the following 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