SEBOMIN 100 MG MR CAPSULES - patient leaflet, side effects, dosage

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

1. 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 moderate to severe acne.

2. Before you take

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:

• suffer from myasthenia gravis a condition characterised by muscle weakness, difficulty chewing and swallowing and slurred speech
• 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
• suffer from increased pressure in the skull (intercranial hypertension).

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 Sebomin MR capsules, as absorption of minocycline may be reduced
• atovaquone (to treat pneumonia)
• medicines containing iron e.g. ferrous sulphate (to treat anaemia)
• colestipol or colestyramine (to treat high cholesterol)
• typhoid vaccines taken by mouth

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, disturbed vision, ringing or buzzing in the ears, dizziness, a feeling of dizziness or spinning (vertigo) and impaired hearing. Make sure you are not affected before you drive, operate machinery or take part in any activity that could put you or others at risk.

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.

3. 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 have impaired kidney function your doctor may give you a lower dose.

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.

4. possible side effects

Like all medicines, Sebomin MR capsules can cause side effects, although not everybody gets them. Stop taking the capsules immediately and seek urgent medical advice if the following allergic reactions occur.

• swelling of the face, lips, tongue or throat, difficulty breathing, wheezing, tightness in the chest, a drop in blood pressure causing fainting or loss or consciousness (this may be due to an increase in blood cells called eosinophils)
• rash, hives or itchy, red, flaky skin (exfoliative dermatitis), blood spots or bruising and discolouring of the skin (anaphylactoid purpura)
• pain, stiffness or swelling in your joints
• inflammation of the heart (pain in the chest, irregular or fast heartbeat, shortness of breath)
• inflammation of the liver (yellowing of the skin or eyes,tiredness, pain in abdomen, joint or muscles)
• viral infection of the lungs (cough, shortness of breath, high temperature) or fluid in the lungs causing difficulty breathing, coughing up blood or pink frothy phlegm, excessive sweating, anxiety, pale skin
• lymph node disease (enlargement of glands in the neck, armpits or groin)
• inflamed blood vessels causing muscle pain, cramps, unusual tiredness (vasculitis)
• Drug-induced hypersensitivity reaction that includes fever, rash, and blood abnormalities (Drug rash with eosinophilia and systemic symptoms – DRESS).

Contact your doctor immediately if any of the following occur:

• increased pressure in the brain causing headaches, feeling sick and changes in vision
• changes in the amount or need to urinate, pain in the upper back, blood in the urine
• cases of or worsening of inflammation of tissues in the body causing large areas of red scaly patches on the face, hair loss, weight loss, painful joints and fever (Systemic Lupus Erythematosus)
• severe form of skin rash with flushing, fever (rise in body temperature with shivering, headache, nausea), blisters or ulcers (Stevens Johnson syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis)

Tell your doctor if any of the following side effects occur:

Common (affects 1 to 10 users in 10)

• increased values in liver function tests
• dizziness
• blotchy, red, lumpy rashes

Rare (affects 1 to 10 users in 10,000)

• difficulty hearing, ‘ringing’ in the ears, headache, ‘spinning’ sensation
• diarrhoea, feeling or being sick, inflammation in the mouth, loss of appetite
• increased liver enzymes seen in tests, blockages in the liver which may cause itchiness, dark urine or pale stools
• autoimmune system disorders causing inflammation, pain and dysfunction in the bodies organs, blood vessels or muscle
• increase in white blood cells (seen in a blood test)
• hair loss, discolouration of the skin or teeth, increased skin sensitivity to sunlight
• numbness, ‘pins and needles’ or tingling sensation
• circular, irregular red patches on the skin of the hands and arms (erythema multiforme), itchy skin (pruritis)
• shock (cold sweaty skin, weak pulse, irregular breathing, dry mouth, dilated pupils)
• inflammation of the kidneys (swollen ankles, high blood pressure)

Very rare (affects less than 1 user in 10,000)

• abnormal thyroid function (seen in blood tests), discolouration of thyroid tissue (does not affect thyroid function), colour changes seen in the nails, bone or bodily secretions (e.g. sweat, tears, breast milk)
• reduction in amount of red blood cells may cause tiredness or pale skin (anaemia)
• indigestion, inflammation of the small intestine (abdominal pain, diarrhoea), throat or tongue
• ulcers in the throat, white patches in the in the mouth or genitals (thrush), cough
• difficulty speaking, pitted, small or misshapen teeth prone to decay
• swelling of the pancreas causing pain and tenderness in the abdomen or back (pancreatitis)
• worsening of asthma
• vaginal inflammation which may cause pain on urinating
• arthritis
• increased serum urea (seen in blood tests)

Other

fits, sleepiness, presence of antinuclear antibodies in the blood (seen in a blood test), in some cases, death has been reported. A disease in which the body's immune system attacks liver cells, causing inflammation of the liver (autoimmune hepatitis).

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

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 internet at Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store

Keep out of the sight and reach 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.

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

Accord, Barnstaple, EX32 8NS, UK

This leaflet was last revised in September 2019