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SEBACT MR 100MG CAPSULES

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PATIENT INFORMATION LEAFLET

Sebact MR 100mg Capsules

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(minocycline hydrochloride)
Please read all of this leaflet carefully
before you start taking this medicine. It
is an important source of information
about your medicine and how to take it
safely.
• Keep this leaflet. You may need to read it
again.
• If you have further questions, please ask
your doctor or your pharmacist.
• This medicine has been prescribed for you
personally and you should not pass it on
to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sebact MR is and what it is
used for
2. Before you take Sebact MR
3. How to take Sebact MR
4. Possible side effects
5. How to Store Sebact MR
6. Further information
1. What Sebact MR is and what it is used
for
The name of your medicine is Sebact MR
100mg Capsules (referred to as Sebact MR
throughout this leaflet).
The active ingredient in your medicine is
minocycline.
Minocycline is one of a group of antibiotics
called Tetracyclines.
Sebact MR is used for the treatment of
acne. It is thought that acne is partly due to,
or made worse by, infection with a type of
bacteria called Propionibacterium Acnes.
Treating acne with Sebact MR is intended
to reduce the infection with this bacterium
and so help in the overall treatment of acne.
2. Before you take Sebact MR
Do not take Sebact MR if:
• You are allergic (hypersensitive) to
minocycline or any of the other ingredients
of Sebact MR (these are listed below
in Section 6)
• You are allergic to any medicines from the
group of antibiotics called Tetracyclines
(e.g. oxytetracycline, tetracycline,
doxycycline)
• You have kidney failure
• You are pregnant, think you might be
pregnant or are trying to become pregnant.
Sebact MR may cause harm to the
foetus
• You are breastfeeding. Medicines from the
Tetracycline group (as Sebact MR) passes
through the breast milk
• You are less than 12 years old
The use of Sebact MR during tooth
development (last half of pregnancy, breastfeeding infants and children under the age
of 12 years) may cause dental staining and/or
incomplete development of the hard tooth
surface leading to pitted, small or mis-shaped
sensitive teeth prone to tooth decay (enamel
hypoplasia).
Sebact MR may or may not be suitable
for you if:
• You have liver problems
• You have had, or think you might have,
kidney disease
• You have a condition called Myasthenia
Gravis i.e. serious weakness in the muscles
• You have Systemic Lupus Erythematosus
(SLE) i.e. swelling and tissue damage due
to the immune system attacking the body’s
cells and tissues
Tell your doctor or pharmacist if you have
any of the above conditions before you start
taking Sebact MR.
If you have any questions or are not sure
about anything, ask your doctor before
you start to take Sebact MR.
Take special care with Sebact MR:
If you are having tests on your urine for
substances called Catecholamines
(sometimes measured to look for problems
with the adrenal gland), you should tell the
doctor ordering the test that you are taking
minocycline because it may interfere with
the test and give the wrong result.
Taking Sebact MR with food and drink:
It is advisable not to drink too much alcohol
while taking Sebact MR. Drink alcohol only
in moderation and within the Government’s
recommended limits. Sebact MR can be
taken with food or drink.
Pregnancy and breast-feeding: Do not take
Sebact MR if you are pregnant or beastfeeding. If you become pregnant while taking

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Sebact MR stop taking it immediately and
tell your doctor (For further information see
above 'Do not take Sebact MR if').
Driving and using machines: It is advisable
not to drive or operate machinery if you notice
headaches, dizziness, lightheadedness,
vertigo (a feeling of unsteadiness), tinnitus
(ringing in the ears) or effects on hearing
whilst you are taking Sebact MR.
Taking other medicines: Please inform your
doctor or pharmacist if you are taking or have
recently taken any other medicines, even
those not prescribed, before you start taking
Sebact MR. It is especially important that
you tell your doctor or pharmacist if you are
taking any of the following:
• Quinapril (ACE inhibitor)- a medicine used
to treat heart disease and high blood
pressure
• Ranitidine bismuth citrate, sucralfate and
tripotassium dicitratobismuthate (ulcer
healing drugs)
• Antacids such as calcium carbonate,
sodium bicarbonate, aluminium or
magnesium compounds
• Vitamins or any preparations containing
iron, calcium, aluminium, magnesium,
bismuth or zinc salt
• Kaolin (to treat diarrhoea or stomach upset)
• Strontium ranelate (to treat osteoporosis)
• Ergotamine and methysergide (ergot
alkaloids)- medicines used to treat
migraines.
• Any medicines that can damage your liver
(hepatotoxic drugs). For example:
Nonsteroidal Anti-Inflammatory Drugs
(NSAIDs) such as aspirin, diclofenac and
Ibuprofen (to treat pain, fever and
inflammation); isoniazide (to treat
tuberculosis), phenytoin (to treat epilepsy).
It is imperative that you check with your
doctor or pharmacist first to see if this
applies to any medicine you are taking
• Antibiotics called beta-lactams (to treat
infections). For example, penicillins (e.g.
ampicillin, amoxicillin) and cephalosporins
(e.g. cefalexin, cefaclor, cefadroxil)
• Medicines to thin your blood (e.g. warfarin).
The dose of these medicines may need to
be reduced whilst you are taking Sebact
MR
• Diuretics (to regulate body water content),
for example, thiazides, furosemide or
amiloride.
• Isotretinoin (sometimes used to treat severe
acne) should not be taken shortly before,
during or shortly after a course of Sebact
MR
• Oral contraceptives (the “pill”). Taking
Sebact MR may make oral
contraceptives less effective. It is very
important that you do not become pregnant
while taking Sebact MR and you should
take advice from your doctor on extra
precautions needed to avoid pregnancy
3. How to take Sebact MR
• Always take Sebact MR exactly as your
doctor has instructed you. You should
check with your doctor or pharmacist if you
are unsure.
Dosage and frequency of administration:
• The usual dose for children over the
age of 12 years and for adults is one
capsule of Sebact MR taken at about
the same time each day.
• Some elderly people may need a lower
dose. Your doctor will advise you about
this.
Method of administration:
• Sebact MR capsules should be
swallowed whole with a drink of water.
They should not be sucked or chewed.
The capsules should be taken while you
are sitting upright or standing to prevent
irritation of your gullet.
• It does not matter whether you take
Sebact MR on an empty stomach or
after food. However, the capsules should
not be taken within 3 hours of some types
of antacids, vitamins and other medicines.
• Do not remove a capsule from the pack
until you are due to take it.
Duration of treatment:
Acne responds quite slowly to antibiotics
and it may be several weeks (e.g. six
weeks or more) before you see any
improvement in your acne. If, however,
your acne has not improved after a treatment
period of six months, you should return to
your doctor to have your treatment reviewed.
Your doctor may decide to continue your
treatment with Sebact MR for longer than 6

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months, and will ask to see you on a regular
basis, usually at least once every 3 months.
These regular visits will enable your doctor
to examine you for any possible side effects
related to the liver or unusual skin colouration
or a condition called Systemic Lupus
Erythematosus (SLE) which can include pain
or stiffness of joints, rash or fever.
Your doctor will also take blood tests to
measure your blood count and to assess
how your liver and kidneys are working.
If you take more Sebact MR than you
should: Never take more capsules than the
doctor has told you to, it will not help you get
better any faster and it could be harmful to
you.
If you have accidentally taken too many
capsules of Sebact MR (more capsules than
the doctor has told you to take) you should
get medical help immediately, either by calling
your doctor or by going to the nearest hospital
accident and emergency department. Always
take the labelled medicine container with
you, whether there are any Sebact MR
capsules left or not.
If you forget to take Sebact MR: If you do
miss a dose you should take it as soon as
possible. However, if it is almost time for your
next dose, skip the missed dose and go back
to your regular dosing schedule. Do not take
a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines Sebact MR can cause
side effects.
Do not be alarmed by the list of possible
side effects. You may not experience any
of them. Your doctor has judged the
benefits of Sebact MR outweigh the risk
of side effects.
If any of the following happen, stop taking
Sebact MR and tell your doctor
immediately or go to the emergency
department at your nearest hospital.
• Severe allergic reactions that cause
symptoms such as sudden onset of
wheezing, shortness of breath, tightness
in chest, swelling of the face, eyelids,
mouth, lips, tongue or body and a drop in
blood pressure resulting in loss of
consciousness.These allergic responses
might sometimes be linked to an increase
in blood cells called eosinophils
• Swelling of the heart muscle or area
around the heart resulting in symptoms
such as fever, chest pain or difficulty
breathing
• Swelling of the blood vessels resulting
in symptoms such as muscle pain, cramps,
unusual tiredness or weakness, spitting
blood
• Kidney problems
• Liver problems
• Headaches, occasionally with eyesight
problems including blurred vision, "blind"
spots, permanent loss of vision or double
vision
• Joint pains, stiffness or swelling or other
joint problems together with fever, muscle
pain and/or rashes
• Allergic skin reactions such as:
skin rashes that may blister and peel, often
with involvement of the mouth, eyes and
genital areas (Stevens-Johnson Syndrome)
or redness and scaling of the skin
(exfoliative dermatitis). Sometimes these
types of reactions can occur with
inflammation of one or more major body
organs and with fever and swelling of the
glands
• Severe and/or bloody diarrhoea
• Swelling of the pancreas or pancreatitis, is
very serious condition resulting in symptoms
such as severe upper abdominal pain,
spreading to the back, and often with
nausea and vomiting
Contact your doctor immediately if you
notice any of the following side effects:
• Any staining or discoloration (slight
blue/black/grey or muddy-brown) on your
body or of secretions so that your treatment
can be reviewed. Staining can appear on
your skin, teeth or nails, inside of the mouth,
eyes, in body secretions (e.g. tears, breast
milk or sweat). Staining of some internal
tissues such as the thyroid gland and bones
can also occur
Staining may appear at any time during
treatment with Sebact MR but is more
common during long-term treatment.
Staining usually disappears a few months
after discontinuation of the drug, although
some muddy-brown skin pigmentation may
persist, particularly in areas exposed to
the sun.
• Diarrhoea, sickness or unexpected
bleeding while taking a contraceptive pill.
Your "pill" may not work. You should use
a different or additional means of birth
control (e.g. a condom or diaphragm/cap)
to ensure you are protected. See also
Section 2 of this leaflet.

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Other possible side effects of Sebact MR
are:
Common (more than 1 in every 100
people)
• Dizziness or feeling light-headed
Rare (less than 1 in every 1,000 people
but more than 1 in every 10,000 people)
• Loss of appetite
• Sore mouth
• Hearing problems such as loss of hearing
ringing in the ears or unsteadiness
• Loss of hair
• Increased sensitivity of the skin to sunlight
• Cough
• Numbness or tingling feelings (like pins
and needles)
• Increasing frequency of infections or
unexplained or unusual bruising or bleeding
(as a result of drop in numbers of white
blood cells) or in small cells called platelets)
• Increased sensitivity to stimulation such as
pain etc.
Very rare (less than 1 in every 10,000
people)
• Worsening of asthma
• Incomplete development of the hard tooth
surface leading to pitted, small or missshaped sensitive teeth prone to tooth decay
• Heartburn or difficulty in swallowing,
sometimes due to swelling of the gullet
or ulcers in the gullet
• Itching around the anus
• Anaemia resulting in tiredness, paleness
and blood test showing red blood cells
breaking up
• Swelling of the area around the tip of
the penis
• Abnormal function of the thyroid gland
(show up only in blood test results)
• Sleepiness
• Fits
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
5. How to store Sebact MR
Store the capsules in the original package.
Do not use this medicine after the expiry
date stated on the label.
Keep out of the reach and sight of
children.
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.
6. Further information
What Sebact MR contains
Each capsule contains 100mg of the active
substance minocycline as minocycline
hydrochloride.
Sebact MR also contains the following other
ingredients: microcrystalline cellulose,
croscarmellose sodium, povidone, iron oxide
red (E172), iron oxide yellow (E172), silica
colloidal anhydrous, magnesium stearate,
hypromellose phthalate, triethyl citrate,
carnauba wax, gelatin, Opadry OY-S-24932
pink which contains hypromellose 2910,
macrogol 6000, titanium dioxide (E171), talc,
iron oxide red (E172).
What Sebact MR looks like and content
of the pack
Sebact MR is a modified release brown and
cream coloured, hard gelatin capsule. These
MR capsules are intended to provide
“modified release” of the active substance
minocycline so that some is released in the
stomach and some in the small intestine.
Sebact MR is available in packs of 56
capsules, in foil blister strips.
Marketing authorisation holder and
manufacturer is Dexcel®-Pharma Ltd. 1
Cottesbrooke Park, Heartlands Business
Park, Daventry, Northants NN11 8YL, United
Kingdom.
This leaflet was last approved in 08/2009.
If after reading this leaflet you have any
questions, please ask your doctor or
pharmacist or contact NHS
Direct on 0845 46 47.

1253740110-A/V586

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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.

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