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MINOCYCLINE TABLETS BP 50MG

Active substance(s): MINOCYCLINE HYDROCHLORIDE

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Minocycline 50mg and
100mg tablets
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.

Index
1 What Minocycline tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Minocycline tablets are and what they are
used for

Minocycline belongs to a group of medicines called tetracycline
antibiotics. It is also known as a broad-spectrum antibiotic and
may be used to treat a wide range of infections caused by bacteria.
Minocycline may be used for:
• respiratory tract infections such as pneumonia, bronchiectasis, lung
abscess or bronchitis
• urinary tract infections
• gonorrhoea (a sexually transmitted disease)
• skin infections such as moderate to severe acne
• infections of the eye
• prostate infections
• ear, nose and throat infections
• nocardiosis (an infection often affecting the lungs)
• pelvic inflammatory disease (e.g. salpingitis, oophoritis)
• preventative treatment for meningitis carriers
• preventative treatment before and after surgery.

2 Before you take

Do not take Minocycline tablets and tell your doctor if you:

• are allergic (hypersensitive) to minocycline hydrochloride, other
similar antibiotics (such as tetracycline or doxycycline) or any other
ingredient in Minocycline tablets (see section 6)
• have had complete kidney failure
• are pregnant or breast-feeding
• are giving it to a child under 12 years old.

Take special care with Minocycline tablets and tell your
doctor if you:

• suffer from myasthenia gravis, a condition characterised by
muscle weakness, difficulty chewing and swallowing and slurred
speech
• have impaired liver or kidney function
• have systemic lupus erythematosus (SLE), a condition
characterised by a rash (especially on the face), hair loss, fever, a
feeling of general discomfort and illness and joint pain
• suffer from increased pressure in the skull (intercranial
hypertension)
• are sensitive to sunlight or artifical light (e.g. sunbeds).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. Especially:
• penicillins e.g. phenoxymethylpenicillin (to treat infections)
• medicines which can damage the liver (check with your doctor or
pharmacist to see if this applies to any medicines you are taking)
• retinoids such as isotretinoin (to treat acne)
• ACE inhibitors such as quinopril (to treat heart conditions)
• anticoagulants (to stop the blood clotting)
• ergotamine (to treat migraines)
• ergometrine (to induce abortion or labour)
• diuretics (‘water tablets’) e.g. furosemide
• kaolin (to treat diarrhoea)
• sucralfate and bismuth salts (to treat ulcers)
• medicines such as antacids or other medicines containing
aluminium, calcium, iron, magnesium or zinc salts. Do not take at
the same time as Minocycline tablets, as absorption of Minocycline
may be reduced.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breastfeeding tell your doctor or pharmacist before taking any medicine
as minocycline could cause permanent discolouration and
underdevelopment of tooth enamel.

Driving and using machines

Minocycline tablets can cause lightheadedness, visual disturbances,
dizziness, ringing in the ears, a feeling of dizziness or spinning
(vertigo). Make sure you are not affected before driving or operating
machinery.

Colourant warning

Minocycline tablets (100mg only) contain sunset yellow (E110) which
may cause allergic reactions.

Sugar intolerance

If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine, as it
contains lactose.

Tests

During long term treatment blood, kidney and liver tests will be
carried out.

3 How to take

Always take Minocycline tablets exactly as your doctor has told you.
If you are not sure, check with your doctor or pharmacist.
Swallow the tablets whole with a glass of water, while standing or
sitting down.

Alcohol

Speak to your doctor before taking Minocycline tablets with alcohol.
• Adults (including the elderly):
General infections: 200mg a day to be taken in divided doses.
Acne: 50mg twice a day for a minimum of six weeks.
Gonorrhoea: initially 200mg, then 100mg every twelve hours for a
minimum of four days. Females may require longer-term therapy.
Preventative treatment in meningitis carriers: 100mg twice a
day for five days.
• Children over 12 years old: 50mg every twelve hours.
• Children under 12 years old: Minocycline tablets are not
recommended for use in children under 12 years of age, as they can
cause permanent discolouration and underdevelopment of tooth
enamel.
If you have impaired kidney function your doctor may give you a lower
dose.

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Minocycline 50, 100mg x 28’s (UK)

Minocycline BP 50mg & 100mg 28 Film-coated Tablets PIL - UK
item no: AAAI7815

dimensions: 148 x 210

print proof no: 1

pharmacode:

origination date: 16.02.16

min pt size: 7

1. Black
2.

revision date:

Technical Approval

revised by:

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

JDE No.:

50889696

4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 7936

3.

6.

originated by: S.Anson
approved for print/date

colours/plates:

Non Printing Colours
1.
2.
3.

Date Sent:
12/02/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you
think a child may have swallowed any contact your nearest hospital casualty
department or tell your doctor immediately. Symptoms of an overdose
include dizziness and feeling and being sick.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to
take a dose take it as soon as you remember it and then take the next dose
at the right time.

If you stop taking the tablets

Talk to your doctor before you stop taking the tablets and follow their advice.

4 Possible side effects

Like all medicines, Minocycline tablets can cause side effects, although not
everybody gets them.
Stop taking the tablets immediately and seek urgent medical advice if the
following occur:
• allergic reactions (anaphylaxis, hypersensitivity): rash, blood spots,
bruising and discolouring to the skin (purpura), shock, death, flaky skin
(exfoliative dermatitis), increase in the number of white blood cells and one
or more of the following: inflammation of the liver (hepatitis), inflammation
of the lungs caused by an infection (pneumonitis), inflammation of the
kidneys, inflammation of the heart muscle (myocarditis) or membrane
around the heart (pericarditis). Fever, swelling of the lymph nodes, swelling
of the face, lips, tongue or throat.
• Lupus-like syndrome: presence of antinuclear antibodies in the blood,
joint pain (arthralgia), inflammation (arthritis) stiffness or swelling of
joints and one or more of the following: fever, muscle pain (myalgia),
inflammation of the liver (hepatitis), skin rash, inflammation of blood
vessels.
• Serum sickness-like syndrome: fever, itchy skin rash, rash, joint pain
(arthralgia), inflammation (arthritis) stiffness or swelling of joints, increase in
the number of white blood cells.
• raised pressure in the skull: headache, visual problems including blurred
vision, “blind” spots, double vision, permanent loss of vision. Bulging of the
skull can occur in infants.
• growth of bacteria resistant to tetracyclines: inflammation of the
intestines, inflammation of the tongue and mouth, inflammation of
the female genitals causing itching, discharge or pain on passing urine,
irritation around your bottom, stomach upset.
• sensitivity to sunlight or artificial light (e.g. sunbeds). Symptoms include
tingling, burning or redness of the skin. If symptoms occur avoid direct
exposure to sunlight or artificial light.
• development or worsening of existing systemic lupus erythematosus
(SLE), symptoms include large areas of red scaly patches on the face, hair
loss, weight loss, painful joints and fever.
• symptoms of liver damage: fatigue, weakness, loss of appetite, weight
loss, abdominal pain, fever.
• a change in colour of the skin, nails, teeth, mucous membrane of the
mouth, bones, thyroid, eyes, secretions including breast milk, tears or sweat
(hyperpigmentation).
• difficulty breathing including wheezing or worsening of asthma.
• Drug-induced hypersensitivity reaction that includes fever, rash and blood
abnormalities (Drug rash with eosinophilia and systemic symptoms DRESS)
Tell your doctor if the following side effects occur:
• Effects on the stomach and gastrointestinal tract: feeling or being
sick, diarrhoea, loss of appetite, underdevelopment of tooth enamel,
inflammation of the tongue, mouth or intestines, difficulty swallowing,
inflammation or ulceration of the gullet, indigestion, pseudomembranous
colitis (watery diarrhoea, fever and cramps).
• Effects on the liver and kidneys: inflammation of the liver (hepatitis),
kidneys or pancreas (pancreatitis), liver failure, jaundice (yellowing of the
skin or whites of the eyes), abnormal liver function test results,
acute kidney failure.
• Effects on the blood: increased levels of urea in the blood, blood vessel
inflammation, changes in the numbers and types of your blood cells. If you
notice increased bruising, nosebleeds, sore throats, infections, excessive
tiredness, breathlessness on exertion or abnormal paleness of the skin, you
should tell your doctor who may want you to have a blood test

• Effects on the immune system: inflammation and weakening of blood
vessels (polyarteritis nodosa).
• Effects on the nervous system: dizziness, headache, tingling or pins and
needles in the hands and feet, feeling of dizziness or spinning (vertigo),
decreased sensitivity to touch, fits, drowsiness.
• Effects on the skin: hair loss, skin reactions including red patches
(erythema multiforme), skin rash which may be itchy with or without pale
or red raised patches, severe skin rash with flushing, fever, blisters or ulcers
(Stevens-Johnson syndrome), a severe rash with reddening, peeling and
swelling of the skin that resembles burns (toxic epidermal necrolysis), red
lumps on the legs (erythema nodosum), flaky skin (exfoliative dermatitis).
• Effects on breathing: inflammation of the lungs caused by an infection
(pneumonitis), cough, increase in the number of white blood cells in the
lungs.
• Effects on muscles and bones: joint pain (arthralgia), inflammation
(arthritis) stiffness or swelling of joints, muscle pain (myalgia).
• Other: fever, inflammation of the heart muscle (myocarditis) or membrane
around the heart (pericarditis), impaired hearing, ringing in the ears, thrush
around your bottom, genital area or mouth, inflammation of male genitals,
changes in thyroid function, systemic lupus erythematosus (SLE), if you
already suffer from SLE Minocycline tablets may make your condition
worse.
A disease in which the body’s immune system attacks liver cells, causing
inflammation of the liver (autoimmune hepatitis).
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

Keep out of the reach and sight of children.
Store below 25°C in a dry place.
Protect from light.
Do not use Minocycline tablets after the expiry date stated on the label/
carton/bottle. The expiry date refers to the last day of that month.
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 tablets contain

• Each tablet contains the active substance (the ingredient that
makes the tablets work) minocycline hydrochloride PhEur
equivalent to 50mg or 100mg anhydrous minocycline.
• 50mg tablets contain: hydroxypropylcellulose (E463), maize
starch, magnesium stearate, lactose and methylated spirits.
The tablet coating contains hypromellose (E464), propylene
glycol, purified talc, methylated spirits, titanium dioxide
(E171), iron oxides (E172).
• 100mg tablets contain: hydroxypropylcellulose (E463), maize
starch, magnesium stearate, lactose and methylated spirits.
The tablet coating contains hypromellose (E464), propylene
glycol, purified talc, methylated spirits, titanium dioxide
(E171), sunset yellow (E110) and quinoline yellow (E104).

What Minocycline tablets look like and contents of
the pack

50mg tablets are beige, circular, biconvex, film-coated tablets.
100mg tablets are orange, circular, biconvex, film-coated tablets.
Pack size is 28.

Marketing Authorisation Holder and manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in
February 2016

Continued top of next column
50889696 AAAI7815

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Minocycline 50, 100mg x 28’s (UK)

Minocycline BP 50mg & 100mg 28 Film-coated Tablets PIL - UK
item no: AAAI7815

dimensions: 148 x 210

print proof no: 1

pharmacode:

origination date: 16.02.16

min pt size: 7

1. Black
2.

revision date:

Technical Approval

revised by:

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

JDE No.:

50889696

4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 7936

3.

6.

originated by: S.Anson
approved for print/date

colours/plates:

Non Printing Colours
1.
2.
3.

Date Sent:
12/02/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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.

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