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MINOCYCLINE 50MG FILM- COATED TABLETS

Active substance(s): MINOCYCLINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Minocycline
Tablets BP 50 mg
Minocycline
Tablets BP 100 mg

TBC

(minocycline hydrochloride)
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any side effect gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:

1. What Minocycline is and what it is used for
2. Before you take Minocycline
3. How to take Minocycline
4. Possible side effects
5. How to store Minocycline
6. Further 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. Before you take Minocycline
Do not take Minocycline if you

Take special care with Minocycline

Please tell your doctor if the following applies to you:
• if you have liver disease or are taking medicine which
can affect the liver
• if you have a renal disease
• if you suffer from myasthenia gravis (a disease causing
muscle weakness)
• 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

Taking other medicines

Please tell your doctor if you are taking any other
medicines including medicines obtained without a
prescription, herbal medicines or any of the following:

Taking Minocycline with food and drink

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.
Ask your doctor or pharmacist for advice before taking
any medicine.

Driving and using machines

Do not drive or use machines if you suffer from
dizziness, a headache, light-headedness and in rare
cases hearing loss, while taking Minocycline.

Important information about some of the
ingredients of Minocycline

These tablets contain lactose. If your doctor has told
you that you have an intolerance to some sugars,
such as lactose, contact your doctor before taking
this medicine.
These tablets also contain the colouring sunset
yellow E110 which may cause allergic reactions in
some people.

3. How to take Minocycline

Always take Minocycline exactly as your doctor has told
you. You should 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.
Adults and the elderly: The usual dose is 200mg daily
in divided doses.
The following doses may be given to treat the
specific infection:
Acne: 50mg twice daily for at least 6 weeks.
Gonorrhoea: For men, take a single starting dose of
200mg followed by 100mg every 12 hours for at least
4 days. Females may need to be treated
for longer.
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TBC

• are allergic to minocycline, a similar medicine or any
of the other ingredients of this medicine (listed in
section 6).
• 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.

• any medicine that can affect how the liver works
(hepatotoxic medicine)
• anticoagulants to thin the blood eg. warfarin
• antacids, used for indigestion
• ulcer healing medicine, such as sucralfate,
bismuth salts
• medicine containing zinc salts, iron, calcium,
aluminium or magnesium
• Quinapril an ACE inhibitor, for heart problems
• a penicillin antibiotic
• diuretics (‘water’ tablets)
• retinoids such as isotretinoid (often used to treat
acne) or retinol
• ergotamine, methysergide, used to treat migraine
• strontium ranelate; to treat osteoporosis

To prevent meningitis infection: 100mg twice daily for
5 days. Your doctor will then give you another antibiotic
to take, called rifampicin.

Children

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

If you take more Minocycline than you should

Contact your doctor or hospital emergency department
immediately.

If you forget to take Minocycline

TBC

Take your dose as soon as you remember unless it is
nearly time for your next dose. Never take two doses at
the same time.

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
product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Minocycline can cause side effects,
although not everybody gets them.
If any of the following happen, stop taking Minocycline
and tell your doctor immediately or go to your nearest
hospital emergency department:
• allergic reactions such as severe skin rashes, red
itchy swollen skin, joint pain, fever swelling of
the face or throat, tightening of the chest and
difficulty breathing.
• severe headaches with changes in eyesight, loss of
vision, blurred or double vision.
In a few cases Minocycline may worsen the symptoms
of SLE (lupus) such as joint pain, skin rashes and fever.
Stop taking this medicine and tell your doctor if this
happens to you.
Minocycline can cause staining of the teeth, skin and
nails. Stop taking this medicine and tell your doctor
if this happens to you. It is more likely in patients on
long-term treatment.
• severe diarrhoea with blood in the stools
• liver problems which can cause yellowing of skin
and whites of eyes, dark urine, pale stools – these
are rare side effects may occur several months after
stopping treatment
• severe skin reactions, blistering of the skin, mouth,
eyes and genitals, flaking or peeling of the skin, your
skin becomes sensitive to light.

A few patients may suffer from:

• pain difficulty swallowing – this is less likely to happen
if the tablets are taken with plenty of fluid whilst sat
upright (see section 3)
• a change in the colour of the whites of eyes, tears,
sweat, or breast secretions which usually disappears a
months after the treatment is stopped.
A very few people may suffer from inflammation of the
pancreas which causes severe pain in the abdomen
and back.

• dizziness, a feeling of spinning (more common in
women), ringing in ears
• loss of appetite, diarrhoea, feeling or being sick
• bulging fontanelles (soft spot on head) of babies
• rarely, inflammation of the membrane around the
heart (pericarditis)
• fungal infection in the mouth or genital area, soreness
and itchiness in the genital area
• soreness in the mouth or tongue
• an inflamed stomach or bowel
• discoloration of thyroid tissue.

Your blood tests may show:

• reduction in white blood cells which can cause more
infections e.g. more colds than usual
• reduction in blood platelets which increase risk of
bleeding or bruising
• reduction in red blood cells which can make the skin
pale or yellow and cause weakness or breathlessness
• changes in the way the liver is working
If your treatment lasts for longer than 6 months your
doctor will give you a blood test every 3 months to
check your liver is working properly.

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 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 out of the reach and sight of children.
Do not take Minocycline after the expiry date which is
stated on the label or carton after EXP. The expiry date
refers to the last day of that month.
Store below 25°C. Protect from light.
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 Minocycline contains

The active substance is minocycline hydrochloride,
equivalent to either 50mg or 100 mg of minocycline.
The other ingredients are lactose, sodium starch
glycollate, povidone, microcrystalline cellulose, sodium
lauryl sulphate and magnesium stearate. The tablet
coating contains carnauba wax. The printing ink
contains hypromellose (E464), titanium dioxide (E171),
polyethylene glycol, quinoline yellow (E104), sunset
yellow (E110) and indigo carmine (E132).

Contents of the pack

Minocycline is available in plastic bottles of 10 (100mg
only), 50, 100, 250 and 500 tablets or blister packs of 10
(100mg only), 20 (50mg only) 28, 50 and 84 (50mg 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 03/2016.
828791
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TBC

Tell your doctor if you suffer from any of
the following:

Other side effects include:

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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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