Skip to Content

EFRACEA 40 MG MODIFIED RELEASE HARD CAPSULES

Active substance(s): DOXYCYCLINE / DOXYCYCLINE

View full screen / Print PDF » Download PDF ⇩
Transcript
FRONT PAGE
T06003

Efracea® 40 mg modified release hard capsules
(doxycycline)

This medicine is available using the above name but will be referred to as Efracea
throughout the Patient Information Leaflet.

Patient Information Leaflet






Read all of this leaflet carefully before you start taking this medicine because
it contains important information for you.
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.

What is in this leaflet
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

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 the pimples or red bumps on the face caused by a condition called rosacea.

2. What you need to know before you take Efracea
Do not take Efracea
• 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.
Warnings and precautions
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.
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 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.
• There is a possibility that Efracea reduces the effectiveness of oral contraceptives,
resulting in pregnancy.
• 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.
Efracea with food and drink
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.
Pregnancy and breast-feeding
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.
Driving and using machines
Efracea has no or negligible influence on the ability to drive and use machines.
Efracea contains sugar (sucrose) and allura red AC aluminium lake (E129).
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.

3. How to take Efracea
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is one capsule of Efracea each day in the morning.
Swallow the capsule whole and do not chew it.
You should take Efracea with a full glass of water whilst sitting or standing to avoid any
irritation to the throat.
If you take more Efracea than you should
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.
If you forget to take Efracea
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Efracea
You should continue to take Efracea until your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects
The following side effects may occur commonly (affects 1 to 10 users in 100) during
treatment with Efracea:
• Inflammation of the nose and throat
• Inflammation of the sinuses
• Fungal infection
• Anxiety
• Sinus headache
• High or increased blood pressure
• Diarrhoea
• Pain in the upper part of the abdomen

BACK PAGE





Dry mouth
Back pain
Pain
Changes in some blood tests (amount of glucose in blood or tests of liver function).

Side effects of unknown frequency (cannot be estimated from the available data)
The following side effects may occur during treatment with Efracea:
• Increased pressure in the brain
• Headache
Rare side effects
The following side effects may occur rarely (affects 1 to 10 users in 10,000) during treatment
with the class of medicines to which Efracea belongs (the tetracyclines):
• Allergic (hypersensitivity) reaction throughout 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, anorexia
• Liver damage
• Skin rashes or hives
• Abnormal reaction of the skin to sunlight
• Increased level of urea in the blood
Very rare side effects
The following side effects may occur very rarely (affects less than 1 user in 10,000) 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
• Damage to red blood cells (haemolytic anaemia)
• Brown-black microscopic discolouration of thyroid tissue has been reported with
long-term use of tetracyclines. Thyroid function is normal.
• Increased pressure in the brain in infants
• Inflammation of the tongue
• Difficulty in swallowing
• Inflammation of the intestine
• Inflammation or ulceration of the gullet
• Inflammation of the skin causing flakiness
• Worsening of the immune system disease known as systemic lupus erythematosus
(SLE)

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.
For information about sugar (sucrose) and allura red AC aluminium lake (E129), see end of
section 2.
What Efracea looks like and contents of the pack
Efracea is a modified release hard capsule, the capsule are beige with the mark “GLD 40”.
Efracea is available in packs containing 56 capsules.
Manufacturer and Product Licence Holder
This product is manufactured by Catalent UK Packaging Limited, Lancaster Way, Wingates
Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX, UK. It is procured from
within the EU by the Product Licence Holder: Swinghope Limited, Brandon House, Marlowe
Way, Croydon CR0 4XS UK. Repackaged by Interport Limited, Brandon House, Marlowe
Way, Croydon CR0 4XS UK.
POM

PL No: 10380/1601
Leaflet revision date: 03/11/2015
Efracea® is registered trademark of GALDERMA, S.A., Switzerland.

Side effects of unknown frequency (cannot be estimated from the available data)
The following side effects may occur during treatment with the class of medicines to which
Efracea belongs (the tetracyclines):
• Loosening of the nail from the nail bed after exposure to the sun
* Tell your doctor immediately or go to casualty if you suffer side effects such as swollen
face, lips, tongue and throat, difficulty in breathing, hives or itchy skin and eyes, or rapid
heartbeat (palpitations) and feeling faint. These effects may be symptoms of a severe
allergic (hypersensitivity) reaction.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme via: www.mhra.gov.uk/yellowcard. 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 which is stated on the outer pack and blister
after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Efracea contains
Each capsule contains 40 mg of the active substance 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.
T06003

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide