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MINOCYCLINE 100MG FILM- COATED TABLETS

Active substance(s): MINOCYCLINE / MINOCYCLINE / MINOCYCLINE

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Package leaflet: Information for the patient

Minocycline 50 mg
Film-coated Tablets
Minocycline 100 mg
Film-coated Tablets
(minocycline hydrochloride)
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 Minocycline is and what it is used for
2. What you need to know before you take
Minocycline
3. How to take Minocycline
4. Possible side effects
5. How to store Minocycline
6. Contents of the pack and other information.

1. What Minocycline is and what it is
used for
Minocycline belongs to the tetracycline group
of antibiotics. Minocycline can be used to treat a
variety of infections, including bacterial infections
that affect the eyes, ears, nose, throat and
respiratory system (chest infections), skin infections
(acne), gonorrhoea or pelvic, prostate and urinary
tract infections. It can also be used to treat
meningitis carriers. Minocycline can also be given
to prevent infection before and after an operation.

2. What you need to know before you
take Minocycline
Do not take Minocycline if you:

• are allergic to minocycline, other tetracyclines
or any of the other ingredients of this medicine
(listed in section 6)
• have a condition called systemic lupus
erythematosus (SLE)
• need dialysis treatment
• are pregnant or breast-feeding
• are a child under 12 years old; as Minocycline can
affect growing bones and teeth causing staining
and reduce the amount of enamel in the teeth.

Warnings and precautions

Talk to your doctor before taking Minocycline:
• if you have problems with your liver or are taking
medicines which can affect the liver (see ‘Other
medicines and Minocycline’ below)
• if you have serious kidney problems
• if you suffer from myasthenia gravis (a disease
causing muscle weakness)

During treatment

If you notice any of the following during treatment,
stop taking this medicine and immediately contact
your doctor or, if serious, go to your nearest
hospital emergency department:
• difficulty breathing
• signs of SLE which you may see as a rash
(especially on the face), hair loss, fever, a general
feeling of being unwell and joint pain
• signs of liver damage which you may see as
yellowing of the skin or whites of the eyes, loss of
appetite and stomach pain
• growth of tetracycline-resistant bacteria, which
you may see as inflammation of the tongue,
mouth or vagina, inflammation of the intestines
causing severe nausea and vomiting, stomach
cramps or persistent diarrhoea or itching of
the anus
• increased pressure in the head which you may
see as headache or problems with your vision
• patches of darker skin colour.
Avoid strong sunlight or ultra violet light as
Minocycline can make the skin more sensitive. If
your skin becomes red and patchy, tell your doctor
as he may need to stop treatment

Urine tests

Tell your doctor or nurse that you are taking
Minocycline before you take a urine test as
minocycline may affect the results.
If your treatment lasts for longer than 6 months
your doctor will give you a blood test every 3
months to check for the presence of SLE and that
your liver is working properly.

Other medicines and Minocycline

Talk to your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines including medicines obtained
without a prescription, herbal medicines or any of
the following:
• any medicine that can affect how the liver works
(hepatotoxic medicine)
• anticoagulants to thin the blood e.g. warfarin

• antacids, used for indigestion
• ulcer healing medicine, such as sucralfate,
bismuth salts
• medicines containing zinc salts, iron, calcium,
aluminium or magnesium
• kaolin, a medicine used to treat diarrhoea
• quinapril an ACE inhibitor, used to treat high
blood pressure
• a penicillin antibiotic
• diuretics (‘water’ tablets)
• retinoids such as isotretinoid (often used to treat
acne) or retinol
• ergotamine, a medicine used to treat migraines
• ergometrine, a medicine used to induce abortion
or labour

Minocycline with food, drink and alcohol

Do not drink alcohol during treatment. The
absorption of minocycline can be reduced by food,
milk or milk products.

Pregnancy and breast-feeding

Do not take minocycline if you are pregnant or
plan to become pregnant, as it can affect the
development of your unborn baby.
Do not breast-feed if you are taking minocycline as
it can pass into breast milk.
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

Do not drive or use machines if you suffer from
dizziness, headaches, a spinning sensation when
standing still (vertigo), light-headedness, problems
with your sight, hearing problems or ringing in the
ears (tinnitus) while taking minocycline.
Minocycline contains lactose and sunset
yellow (E110)
If you have been told by your doctor that you have
an intolerance to some sugars, such as lactose,
contact your doctor before taking this medicine.
This medicine also contain sunset yellow (E110)
which may cause allergic reactions.

3. How to take Minocycline
Always take this medicine exactly as your doctor or
pharmacist have told you. Check with your doctor
or pharmacist if you are not sure.
It is important that you complete the course of
treatment as directed by your doctor, even if you
feel better.
• Swallow the tablets whole with plenty of fluid
• Avoid taking at the same time as food, milk or
milk products as these can reduce the absorption
of Minocycline.
• Take whilst sitting or standing upright: this
medicine should not be taken immediately
before bedtime or if lying down.
Patients being treated for certain diseases may
need monthly blood tests to check the infection is
clearing up.
Use in adults and the elderly: The recommended
dose is 200 mg daily in divided doses.
The following doses may be given to treat the
specific infection:
Acne: 50 mg twice daily for at least 6 weeks.
Gonorrhoea: For men, take a single starting dose
of 200 mg followed by 100 mg every 12 hours for
at least 4 days. Females may need to be treated
for longer.
To prevent meningitis infection: 100 mg twice
daily for 5 days. Your doctor will then give you
another antibiotic to take, called rifampicin.

Use in children and adolescents

Minocycline must not be given to children under
12 years of age.
Only the 50 mg strength tablets are recommended
in children over 12 years. The recommended dose
is 50 mg every 12 hours.
If you have kidney disease your doctor may give
you a lower dose.

Directions for use

Swallow the tablets whole with plenty of liquid
while standing or sitting down

If you take more Minocycline than
you should

Contact your doctor or hospital emergency
department immediately. You may be sick
(vomiting), have dizziness or nausea (feel sick).

If you forget to take Minocycline

Take your dose as soon as you remember unless
it is nearly time for your next dose. Do not take a
double dose to make up for a forgotten dose.

If you stop taking Minocycline

Do not stop taking Minocycline without talking to
your doctor first. It is important to finish the course
of antibiotic as instructed by your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

LT1318AG

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happen, stop taking
Minocycline and tell your doctor immediately or,
if serious, go to your nearest hospital emergency
department:
Rare (may affect up to 1 in 1,000 people)
• allergic reactions such as severe skin rashes, red
itchy swollen skin, joint pain, swelling of the
face, lips, mouth, tongue or throat resulting in
difficulty breathing. This may also occur with
high levels of white blood cells, and one or
more of the following: inflammation of the liver
(hepatitis), lungs (pneumonitis), kidneys, heart
muscle (myocarditis) and membrane around the
heart (pericarditis). You may also have a fever
and swollen glands
• severe headaches with changes in eyesight such
as loss of vision, blurred or double vision
• frequent or recurrent infections causing fever,
severe chills, mouth ulcers or chest infections.
These may be signs of low levels of white blood
cells (leucopenia)
• shortness of breath during exercise, fatigue,
chest pain or pressure. These may be signs of an
inflamed heart muscle (myocarditis)
• sudden sharp chest pain made worse by
coughing or deep breathing. This may be a sign
of inflammation of the membrane around the
heart (pericarditis)
• yellowing of skin or whites of eyes, dark urine,
pale stools, loss of appetite and stomach pain.
These may be signs of serious problems with
your liver
• pain, inflammation, stiffness or swelling of the
joints with fever, muscle pain, inflammation
of the liver (hepatitis), rash or inflammation of
blood vessels
• producing little or no urine, pain or discomfort
passing urine, producing cloudy or dark urine
with lower back pain. These may be signs of
serious problems with your kidneys
• inflammation of the tongue, mouth or vagina,
inflammation of the intestines causing severe
nausea and vomiting, stomach cramps or
diarrhoea, itching of the anus. These may
be signs of the growth of tetracyclineresistant bacteria
• painful purple lumps on the skin (erythema
nodosum)
• patches of darker skin colour
• sensitivity to sunlight or artificial light (sunbeds).
You may have tingling, burning or redness of
the skin. If this occurs avoid direct exposure to
sunlight or artificial light
Very rare (may affect up to 1 in 10,000 people)
• a reduction in all types of blood cells resulting in
frequent or recurrent infections (see leucopenia
above), unexplained bruising or bleeding for
longer than usual (thrombocytopenia) and
tiredness, weakness or pale skin (anaemia)
• other breathing problems such as shortness of
breath at rest, wheezing, coughing with chest
tightness or worsening of asthma
• watery diarrhoea possibly with blood, loss
of appetite, stomach cramps and feeling sick
(nausea) or being sick (vomiting). These may be
signs of inflammation in your intestines
• severe stomach pain which radiates to your back.
This may be a sign of an inflamed pancreas
• severe skin reactions, blistering of the skin,
mouth, eyes and genitals, flaking or peeling of
the skin
• rash (especially on the face), hair loss, weight
loss, fever, a general feeling of being unwell and
joint pain. These may be signs of systemic lupus
erythematosus (SLE)
Not known (cannot be estimated from the
available data)
• fits
• a drug induced allergic reaction the includes
a skin rash, high fever, changes in the levels of
blood cells (drug reaction with eosinophilia and
systemic symptoms – DRESS)
• fever, itchy rash, pain, inflammation, stiffness or
swelling of the joints, increase in the number of
white blood cells. These may be signs of a serum
sickness like syndrome

Other possible side effects include:
Common (may affect up to 1 in 10 people)
• dizziness
Uncommon (may affect up to 1 in 100 people)
• fever
Rare (may affect up to 1 in 1,000 people)
• an increase in the number of a specific type
of white blood cell which can be seen in a
blood test
• unexplained bruising or bleeding for longer
than normal. This may be a sign of low levels of
blood platelets
• a feeling of spinning when standing or
sitting still (vertigo), ringing in ears, other
hearing problems
• loss of appetite, diarrhoea, feeling or being sick
• headache
• pins and needles in the hands or feet or a
reduction in the sense of touch
• cough

• a change in the colour of your teeth
• an increase in levels of liver enzymes or urea
which can be seen in a blood test
• hair loss
• red round lumps under the skin usually below
the knee
• a skin reaction that keeps appearing in the same
area every time you take the medicine
• skin itching, skin rash, nettle rash, redness or
pain, swelling or tenderness around a vein
(vasculitis)
• joint pain, muscle pain
Very rare (may affect up to 1 in 10,000 people)
• bulging fontanelle (soft spot on head) of babies
• fungal infection in the mouth or genital
area (thrush)
• abnormal thyroid function
• indigestion, difficulty swallowing
• problems with the surface of your teeth
• inflammation of your food pipe or ulcers in your
food pipe
• high levels of bilirubin which can be seen in a
blood test
• flaky skin
• a change in the colour of finger or toe nails,
inside the mouth, bone, eyes, thyroid, secretions
such as breast milk, tears or sweat to blue, black,
grey or muddy brown
• swelling or stiffness of joints
• inflammation of joints (arthritis)
• inflammation of the head of the penis
Not known (cannot be estimated from the
available data)
• a rash of small red or purple spots
• an increase of substances in the lungs which can
be seen in an x-ray
• drowsiness

Reporting of side effects

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
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 Minocycline
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 blister, label or carton
after EXP. The expiry date refers to the last day of
that month.
Store below 25°C. 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 Minocycline contains

The active substance is minocycline hydrochloride.
The other ingredients are lactose (see ‘Minocycline
contain lactose and sunset yellow (E110)’), sodium
starch glycolate, povidone, microcrystalline
cellulose, sodium laurilsulfate and magnesium
stearate. The tablet coating contains carnauba wax.
The printing ink contains hypromellose, titanium
dioxide, macrogol 400, quinoline yellow (E104),
sunset yellow (E110) (see ‘Minocycline contain
lactose and sunset yellow (E110)’) and indigo
carmine (E132).

What Minocycline looks like and contents of
the pack
Minocycline 50 mg film-coated tablets are
round, orange/brown with two sides that curve
out, marked with ‘MN50’ on one side and ‘G’ on
the other.

Minocycline 100 mg film-coated tablets are
round, orange/brown with two sides that curve
out, marked with ‘MN100’ on one side and ‘G’ on
the other.
Minocycline is available in plastic bottles with a
plastic cap of 10 (100 mg only), 50, 100, 250 and
500 tablets or blister packs of 10 (100 mg only), 20
(50 mg only) 28, 50 and 84 (50 mg only) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.

Manufacturer
Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
This leaflet was last revised in 06/2016.

922809
LT1318AG

Expand Transcript

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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