Sebomin 100mg Mr Capsules
^actavis
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
T| What Minocycline tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects ^5j How to store
4 Further information
_T| 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.
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.
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.
Colourant warning
Minocycline tablets (100mg only) contain sunset yellow (E110) which may cause allergic reactions.
This leaflet was last revised in February 2016
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.
| 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
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• 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
^actavis
Actavis, Barnstaple, EX32 8NS, UK