Sebact MR 100mg Capsules

(minocycline hydrochloride)

Please read all of this leaflet carefully before you start taking this medicine. It is an important source of information about your medicine and how to take it safely.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Sebact MR is and what it is used for

2.    Before you take Sebact MR

3.    How to take Sebact MR

4.    Possible side effects

5.    How to Store Sebact MR

6.    Further information

1.    What Sebact MR is and what it is used for

The name of your medicine is Sebact MR 100mg Capsules (referred to as Sebact MR throughout this leaflet).

The active ingredient in your medicine is minocycline.

Minocycline is one of a group of antibiotics called Tetracyclines.

Sebact MR is used for the treatment of acne. It is thought that acne is partly due to, or made worse by, infection with a type of bacteria called Propionibacterium Acnes. Treating acne with Sebact MR is intended to reduce the infection with this bacterium and so help in the overall treatment of acne.

2.    Before you take Sebact MR Do not take Sebact MR if:

•    You are allergic (hypersensitive) to minocycline or any of the other ingredients of Sebact MR (these are listed below

in Section 6)

•    You are allergic to any medicines from the group of antibiotics called Tetracyclines (e.g. oxytetracycline, tetracycline, doxycycline)

•    You have kidney failure

•    You are pregnant, think you might be pregnant or are trying to become pregnant. Sebact MR may cause harm to the foetus

•    You are breastfeeding. Medicines from the Tetracycline group (as Sebact MR) passes through the breast milk

•    You are less than 12 years old The use of Sebact MR during tooth development (last half of pregnancy, breastfeeding infants and children under the age of 12 years) may cause dental staining and/or incomplete development of the hard tooth surface leading to pitted, small or mis-shaped sensitive teeth prone to tooth decay (enamel hypoplasia).

Sebact MR may or may not be suitable for you if:

•    You have liver problems

•    You have had, or think you might have, kidney disease

•    You have a condition called Myasthenia Gravis i.e. serious weakness in the muscles

•    You have Systemic Lupus Erythematosus (SLE) i.e. swelling and tissue damage due to the immune system attacking the body’s cells and tissues

Tell your doctor or pharmacist if you have any of the above conditions before you start taking Sebact MR.

If you have any questions or are not sure about anything, ask your doctor before you start to take Sebact MR.

Take special care with Sebact MR:

If you are having tests on your urine for substances called Catecholamines (sometimes measured to look for problems with the adrenal gland), you should tell the doctor ordering the test that you are taking minocycline because it may interfere with the test and give the wrong result.

Taking Sebact MR with food and drink:

It is advisable not to drink too much alcohol while taking Sebact MR. Drink alcohol only in moderation and within the Government’s recommended limits. Sebact MR can be taken with food or drink.

Pregnancy and breast-feeding: Do not take Sebact MR if you are pregnant or beastfeeding. If you become pregnant while taking

Sebact MR stop taking it immediately and

tell your doctor (For further information see above 'Do not take Sebact MR if').

Driving and using machines: It is advisable not to drive or operate machinery if you notice headaches, dizziness, lightheadedness, vertigo (a feeling of unsteadiness), tinnitus (ringing in the ears) or effects on hearing whilst you are taking Sebact MR.

Taking other medicines: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, before you start taking Sebact MR. It is especially important that you tell your doctor or pharmacist if you are taking any of the following:

•    Quinapril (ACE inhibitor)- a medicine used to treat heart disease and high blood pressure

•    Ranitidine bismuth citrate, sucralfate and tripotassium dicitratobismuthate (ulcer healing drugs)

•    Antacids such as calcium carbonate, sodium bicarbonate, aluminium or magnesium compounds

•    Vitamins or any preparations containing iron, calcium, aluminium, magnesium, bismuth or zinc salt

•    Kaolin (to treat diarrhoea or stomach upset)

•    Strontium ranelate (to treat osteoporosis)

•    Ergotamine and methysergide (ergot alkaloids)- medicines used to treat migraines.

•    Any medicines that can damage your liver (hepatotoxic drugs). For example: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) such as aspirin, diclofenac and Ibuprofen (to treat pain, fever and inflammation); isoniazide (to treat tuberculosis), phenytoin (to treat epilepsy). It is imperative that you check with your doctor or pharmacist first to see if this applies to any medicine you are taking

•    Antibiotics called beta-lactams (to treat infections). For example, penicillins (e.g. ampicillin, amoxicillin) and cephalosporins (e.g. cefalexin, cefaclor, cefadroxil)

•    Medicines to thin your blood (e.g. warfarin). The dose of these medicines may need to be reduced whilst you are taking Sebact MR

•    Diuretics (to regulate body water content), for example, thiazides, furosemide or amiloride.

•    Isotretinoin (sometimes used to treat severe acne) should not be taken shortly before, during or shortly after a course of Sebact MR

•    Oral contraceptives (the “pill”). Taking Sebact MR may make oral contraceptives less effective. It is very important that you do not become pregnant while taking Sebact MR and you should take advice from your doctor on extra precautions needed to avoid pregnancy

3. How to take Sebact MR

•    Always take Sebact MR exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Dosage and frequency of administration:

•    The usual dose for children over the age of 12 years and for adults is one

capsule of Sebact MR taken at about the same time each day.

•    Some elderly people may need a lower dose. Your doctor will advise you about this.

Method of administration:

•    Sebact MR capsules should be swallowed whole with a drink of water. They should not be sucked or chewed. The capsules should be taken while you are sitting upright or standing to prevent irritation of your gullet.

•    It does not matter whether you take Sebact MR on an empty stomach or after food. However, the capsules should not be taken within 3 hours of some types of antacids, vitamins and other medicines.

•    Do not remove a capsule from the pack until you are due to take it.

Duration of treatment:

Acne responds quite slowly to antibiotics and it may be several weeks (e.g. six weeks or more) before you see any improvement in your acne. If, however, your acne has not improved after a treatment period of six months, you should return to your doctor to have your treatment reviewed. Your doctor may decide to continue your treatment with Sebact MR for longer than 6

months, and will ask to see you on a regular basis, usually at least once every 3 months. These regular visits will enable your doctor to examine you for any possible side effects related to the liver or unusual skin colouration or a condition called Systemic Lupus Erythematosus (SLE) which can include pain or stiffness of joints, rash or fever.

Your doctor will also take blood tests to measure your blood count and to assess how your liver and kidneys are working.

If you take more Sebact MR than you should: Never take more capsules than the doctor has told you to, it will not help you get better any faster and it could be harmful to you.

If you have accidentally taken too many capsules of Sebact MR (more capsules than the doctor has told you to take) you should get medical help immediately, either by calling your doctor or by going to the nearest hospital accident and emergency department. Always take the labelled medicine container with you, whether there are any Sebact MR capsules left or not.

If you forget to take Sebact MR: If you do

miss a dose you should take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines Sebact MR can cause side effects.

Do not be alarmed by the list of possible side effects. You may not experience any of them. Your doctor has judged the benefits of Sebact MR outweigh the risk of side effects.

If any of the following happen, stop taking Sebact MR and tell your doctor immediately or go to the emergency department at your nearest hospital.

•    Severe allergic reactions that cause symptoms such as sudden onset of wheezing, shortness of breath, tightness in chest, swelling of the face, eyelids, mouth, lips, tongue or body and a drop in blood pressure resulting in loss of consciousness.These allergic responses might sometimes be linked to an increase in blood cells called eosinophils

•    Swelling of the heart muscle or area around the heart resulting in symptoms such as fever, chest pain or difficulty breathing

•    Swelling of the blood vessels resulting

in symptoms such as muscle pain, cramps, unusual tiredness or weakness, spitting blood

•    Kidney problems

•    Liver problems

•    Headaches, occasionally with eyesight problems including blurred vision, "blind" spots, permanent loss of vision or double vision

•    Joint pains, stiffness or swelling or other joint problems together with fever, muscle pain and/or rashes

•    Allergic skin reactions such as:

skin rashes that may blister and peel, often with involvement of the mouth, eyes and genital areas (Stevens-Johnson Syndrome) or redness and scaling of the skin (exfoliative dermatitis). Sometimes these types of reactions can occur with inflammation of one or more major body organs and with fever and swelling of the glands

•    Severe and/or bloody diarrhoea

•    Swelling of the pancreas or pancreatitis, is very serious condition resulting in symptoms such as severe upper abdominal pain, spreading to the back, and often with nausea and vomiting

Contact your doctor immediately if you notice any of the following side effects:

•    Any staining or discoloration (slight blue/black/grey or muddy-brown) on your body or of secretions so that your treatment can be reviewed. Staining can appear on your skin, teeth or nails, inside of the mouth, eyes, in body secretions (e.g. tears, breast milk or sweat). Staining of some internal tissues such as the thyroid gland and bones can also occur

Staining may appear at any time during treatment with Sebact MR but is more common during long-term treatment. Staining usually disappears a few months after discontinuation of the drug, although some muddy-brown skin pigmentation may persist, particularly in areas exposed to the sun.

•    Diarrhoea, sickness or unexpected bleeding while taking a contraceptive pill. Your "pill" may not work. You should use a different or additional means of birth control (e.g. a condom or diaphragm/cap) to ensure you are protected. See also Section 2 of this leaflet.

Other possible side effects of Sebact MR are:

Common (more than 1 in every 100 people)

•    Dizziness or feeling light-headed

Rare (less than 1 in every 1,000 people but more than 1 in every 10,000 people)

•    Loss of appetite

•    Sore mouth

•    Hearing problems such as loss of hearing ringing in the ears or unsteadiness

•    Loss of hair

•    Increased sensitivity of the skin to sunlight

•    Cough

•    Numbness or tingling feelings (like pins and needles)

•    Increasing frequency of infections or unexplained or unusual bruising or bleeding (as a result of drop in numbers of white blood cells) or in small cells called platelets)

•    Increased sensitivity to stimulation such as pain etc.

Very rare (less than 1 in every 10,000 people)

•    Worsening of asthma

•    Incomplete development of the hard tooth surface leading to pitted, small or miss-shaped sensitive teeth prone to tooth decay

•    Heartburn or difficulty in swallowing, sometimes due to swelling of the gullet or ulcers in the gullet

•    Itching around the anus

•    Anaemia resulting in tiredness, paleness and blood test showing red blood cells breaking up

•    Swelling of the area around the tip of the penis

•    Abnormal function of the thyroid gland (show up only in blood test results)

•    Sleepiness

•    Fits

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Sebact MR

Store the capsules in the original package. Do not use this medicine after the expiry date stated on the label.

Keep out of the reach and sight of children.

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 Sebact MR contains

Each capsule contains 100mg of the active substance minocycline as minocycline hydrochloride.

Sebact MR also contains the following other ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, iron oxide red (E172), iron oxide yellow (E172), silica colloidal anhydrous, magnesium stearate, hypromellose phthalate, triethyl citrate, carnauba wax, gelatin, Opadry OY-S-24932 pink which contains hypromellose 2910, macrogol 6000, titanium dioxide (E171), talc, iron oxide red (E172).

What Sebact MR looks like and content of the pack

Sebact MR is a modified release brown and cream coloured, hard gelatin capsule. These MR capsules are intended to provide “modified release” of the active substance minocycline so that some is released in the stomach and some in the small intestine.

Sebact MR is available in packs of 56 capsules, in foil blister strips.

Marketing authorisation holder and manufacturer is Dexcel®-Pharma Ltd. 1 Cottesbrooke Park, Heartlands Business Park, Daventry, Northants NN11 8YL, United Kingdom.

This leaflet was last approved in 08/2009.

If after reading this leaflet you have any questions, please ask your doctor or pharmacist or contact NHS Direct on 0845 46 47.

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