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ACNAMINO MR 100MG CAPSULES

Active substance(s): MINOCYCLINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Acnamino 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 Acnamino MR is and what it is used for
2. Before you take Acnamino MR
3. How to take Acnamino MR
4. Possible Side Effects
5. How to Store Acnamino MR
6. Further information
1. What Acnamino MR is and what it is used for
The name of your medicine is Acnamino MR 100mg
Capsules (referred to as Acnamino MR throughout this
leaflet).
The active ingredient in your medicine is minocycline.
Minocycline is one of a group of antibiotics called
Tetracyclines.
Acnamino 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 Acnamino MR is intended to reduce the infection
with this bacterium and so help in the overall treatment of acne
2. Before you take Acnamino MR
Do not take Acnamino MR if:
• You are allergic (hypersensitive) to minocycline or any of
the other ingredients of Acnamino MR (these are listed
below in Section 6).
• You are allergic to any medicines from the group of antibiotics
called Tetracycline (e.g. oxytetracycline, tetracycline,
doxycycline).
• You have kidney failure
• You are pregnant, think you might be pregnant or are trying to
become pregnant. Acnamino MR may cause harm to the foetus
• You are breastfeeding. Medicines from the Tetracycline group
(as Acnamino MR) passes through the breast milk.
• You are less than 12 years old.
The use of Acnamino MR during tooth development (last half of
pregnancy, breast-feeding 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).
Acnamino 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 Acnamino MR.
If you have any questions or are not sure about anything, ask
your doctor before you start to take Acnamino MR.
Take special care with Acnamino 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 Acnamino MR with food and drink:
It is advisable not to drink too much alcohol while taking Acnamino
MR.
Drink alcohol only in moderation and within the Government’s
recommended limits. Acnamino MR can be taken with food or drink.
Pregnancy and breast-feeding:
Do not take Acnamino MR if you are pregnant or breast-feeding.
If you become pregnant while taking Acnamino MR stop taking
it immediately and tell your doctor (For further information see
above 'Do not take Acnamino 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 Acnamino 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 Acnamino 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 salts which can prevent Acnamino
MR from working effectively when taken at the same time.
It is recommended that any indigestion remedies, vitamins
or other supplements containing these are taken at least 3
hours before or after your dose of Acnamino MR
• 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 Acnamino MR
• Diuretics (to regulate body water content), for example,
thiazides, furosemide or amiloride.
• Isotretinoin (sometimes used to treat severe acne) or other
retinoids or retinol should not be taken shortly before, during or
shortly after a course of Acnamino MR
• Oral contraceptives (the “pill”). Taking Acnamino MR may make
oral contraceptives less effective. It is very important that you
do not become pregnant while taking Acnamino MR and you
should take advice from your doctor on extra precautions
needed to avoid pregnancy.
3. How to take Acnamino MR
Always take Acnamino 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 Acnamino 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:
• Acnamino 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 Acnamino 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 Acnamino
MR for longer than 6 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.

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If you take more Acnamino 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 Acnamino
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 Acnamino MR capsules left or not.
If you forget to take Acnamino 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 Acnamino MR can have 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 Acnamino MR outweigh the risk of side effects.
If any of the following happen, stop taking Acnamino MR and tell
your doctor immediately or go to the emergency department
at your nearest hospital.
• Severe allergic reaction 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
Serious side effects:
• Hepatitis (inflammation of the liver), liver damage, liver failure
• Acute kidney failure (rapid loss of your kidneys ability to remove
waste), Interstitial nephritis (kidney condition characterized by
swelling in between the kidney tubules)
• Anaemia resulting in tiredness, paleness and blood test showing
red blood cells breaking up
• A worsening or development of symptoms of SLE (systemic
lupus erythematosus) or a worsening of the symptoms of
myasthenia gravis
• Lupus-like syndrome which includes fatigue, joint pain and
arthritis, and overall feeling of sickness.
• Serum sickness-like syndrome (hypersensitivity reaction)
Contact your doctor immediately if you notice any of the
following side effects:
• Any staining or discoloration (slight blue/black/grey or muddybrown) 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 Acnamino 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.
Other possible side effects of Acnamino MR are:
Common (more than 1 in every 100 people)
• Dizziness or feeling light-headed
Uncommon (more than 1 in every 1000 people)
• Fever

Make sure you know how you react to this medicine before you
drive, use machines or do anything else that could be dangerous
if you are dizzy or not alert.
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
• Skin problems such as rashes most commonly due to increased
sensitivity of the skin to sunlight, itching, redness, scaling
or blistering. You should avoid direct exposure to sunlight or
artificial light. If you experience skin discomfort then stop taking
your capsules and seek advice from your doctor
• Cough
• Numbness or tingling feelings (like pins and needles)
• Increasing frequency or 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.
• Pain in the abdomen or difficulty passing urine
• Sore throat, unexplained bruising or bleeding
• Dyspnoea (shortness of breath)
• Diarrhoea, nausea, vomiting
• Increased liver enzymes (liver problems)
• Increased serum urea (kidney problems)
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 mis-shaped sensitive teeth prone to
tooth decay
• Heartburn or difficulty in swallowing, sometimes due
to swelling of the gullet or ulcers in the gullet, lower
abdominal pain or blood and mucous in stools
• Itching around the anus
• Redness or swelling of the area round the tip of the penis
• Abnormal function of the thyroid gland (show up only in
blood test results)
• Sleepiness
• Fits
• Severe skin rashes, as they may be life threatening
• Swollen, stiff or painful joints or muscle pain. Tender, bruise like
swelling of the shins
• Yellowing of the skin or whites of the eyes, pale stools
• Extreme tiredness
• Lower abdominal pain or blood and mucous in stools
• Convulsions
• Red patches on the skin, white patches in the mouth or itching
around the anus or vagina which may be accompanied by vaginal
discharge. Vaginal inflammation which may be accompanied by
pain on urinating.
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 Acnamino 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
Each capsule contains 100mg of the active substance minocycline
as minocycline hydrochloride.
Acnamino 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 Acnamino MR looks like and content of the pack
Acnamino 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.
Acnamino MR is available in packs of 56 capsules, in foil blister
strips.
Marketing authorization holder and manufacturer is
Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry,
Northamptonshire, NN11 8PB, UK
This leaflet was last revised in August 2014.
If after reading this leaflet you have any questions, please
ask your doctor or pharmacist or contact NHS Direct on 0845
46 47.

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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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