Sebomin 100mg MR capsules
(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.
Index
1 What Sebomin MR capsules 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
What Sebomin MR capsules are and what they are used for
Sebomin MR capsules contain a medicine called minocycline hydrochloride. This belongs to a group of medicines called tetracycline antibiotics. Sebomin MR capsules are used to treat acne.
Before you take
Do not take Sebomin MR capsules and tell your doctor if you:
- are allergic (hypersensitive) to minocycline, other similar antibiotics (such as tetracycline or doxycycline) or any other ingredient in Sebomin MR capsules (see section 6)
- are pregnant or breast-feeding
- have had complete kidney failure
- are giving it to a child under 12 years old.
Do not take Sebomin MR capsules if any of the above apply to you. If you are not sure, talk to your doctor before taking Sebomin MR capsules.
Take special care with Sebomin MR capsules and tell your doctor if you:
- have kidney or liver disease
- are sensitive to sunlight or artificial light (e.g. sunbeds)
- 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.
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 (to treat infections) e.g. amoxicillin
anticoagulants (to stop the blood clotting) e.g. warfarin
oral contraceptives (the pill). Sebomin MR capsules may make the oral contraceptive pill less effective. You should use additional contraceptive precautions e.g. a condom, whilst taking Sebomin MR capsules and for 7 days after stopping- medicines which can damage your liver (check with your doctor or pharmacist to see if this applies to any medicines you are taking)
- medicines such as antacids or other medicines containing aluminium, calcium, iron, magnesium or zinc salts. These should be taken at least 3 hours before or after a dose of Sebomin MR capsules.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Sebomin MR capsules.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding tell your doctor or pharmacist before taking any medicine. Minocycline can cause permanent discolouration and underdevelopment of tooth enamel or skeletal growth retardation in the child.
Driving and using machines
Sebomin MR capsules can cause headache, light-headedness, dizziness, a feeling of dizziness or spinning (vertigo) and impaired hearing. Make sure you are not affected before driving or operating machinery.
Important information about some of the ingredients in Sebomin MR capsules
Each capsule contains sunset yellow (E110) which may cause allergic reactions.
Tests
During long term treatment blood, kidney and liver tests will be carried out.
Taking with food or alcohol
Do not take the capsules at the same time as food, as it can make the medicine less effective. Speak to your doctor before taking Sebomin MR capsules with alcohol, they will advise you on how much you can drink.
How to take
Always take Sebomin MR capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the capsules whole, followed by a glass of water when standing or sitting down. Do not take the capsules at the same time as food.
Adults (including elderly): 1 capsule (100mg) every 24 hours
Children over 12 years old: 1 capsule (100mg) every 24 hours
Children under 12 years old: Sebomin MR capsules are not recommended for use in children under 12 years old. Minocycline can cause permanent discolouration and underdevelopment of tooth enamel in children under 12 years old.
If you take more than you should
If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any go to your nearest hospital casualty department immediately or contact your doctor straight away.
If you forget to take the capsules
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. Do not take a double dose to make up for a forgotten dose.
If you stop taking the capsules
Talk to your doctor before you stop taking the capsules and follow their advice.
Sebomin MR Side Effects
Like all medicines, Sebomin MR capsules can cause side effects, although not everybody gets them.
Stop taking Sebomin MR capsules and see a doctor or go to a hospital straight away if you experience any of the following:
- You have an allergic reaction. The signs of an allergic reaction include a rash, swallowing or breathing problems and swelling of your face, lips, tongue or throat.
Symptoms of raised pressure in the skull. These include headache, visual problems including blurred vision, “blind” spots, double vision. Bulging of the skull can occur in infants.
Growth of bacteria resistant to tetracyclines. Symptoms include 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.- 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.
A change in colour of the skin or nails (hyperpigmentation), teeth, mucous membrane of the mouth, eyes, breast milk, tears and sweat.
Symptoms of liver damage. These include fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever.
Tell your doctor if the following side effects occur:
Common: feeling or being sick, loss of appetite, diarrhoea, hair loss, skin reactions including red patches (erythema multiforme), severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome), red lumps on the legs (erythema nodosum), flaky skin (exfoliative dermatitis), skin rashes with areas of altered skin colour, small raised spots or skin redness, allergic reactions (anaphylaxis or hypersensitivity) including a skin rash with pale or red irregular raised patches with severe itching (hives), swelling of the face, lips, throat or tongue, fever, joint pain (arthralgia) or inflammation (arthritis), muscle pain (myalgia), increase in the number of white blood cells in the lungs, wheezing, blood spots, brusing and discolouring of the skin, abnormal liver function test results, discolouration of the thyroid, 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.
Uncommon: inflammation of the pancreas (pancreatitis).
Rare: inflammation of the liver (hepatitis), acute liver failure, skin rashes, inflammation of the heart muscle (myocarditis) or membrane around the heart (pericarditis), inflammation of blood vessels (vasculitis), kidney failure including inflammation of the kidney, a change in the colour of bones.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Do not store above 30°C.
Keep container in the outer carton.
Do not use Sebomin MR capsules 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.
Further information
What Sebomin MR capsules contain
- The active substance (the ingredient that makes the capsules work) is anhydrous minocycline (as the hydrochloride). Each capsule contains 100mg of the active substance.
- The other ingredients in the capsule are glycerol monostearate 40-55, microcrystalline cellulose 101 (E460(i)), povidone K-30 (E1201), purified talc (E553b), gelatin, titanium dioxide (E171), sunset yellow (E110), quinoline yellow (E104), shellac (E904), ethyl alcohol, isopropyl alcohol, propylene glycol, butyl alcohol, povidone (E1201), sodium hydroxide.
What Sebomin MR capsules look like and contents of the pack
Sebomin MR capsules are orange, opaque, hard gelatin capsules.
Pack sizes are 28 and 56.
Marketing Authorisation Holder and manufacturer
This leaflet was last revised in June 2009.
50309920
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