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Sebact MR – US: Minocin (Minocycline Hydrochloride) 100mg Tablets

The name of your medicine is Sebact MR [Minocin] 100mg Capsules. Each capsule contains 100mg of the active substance minocycline as minocycline hydrochloride. Sebact MR [Minocin] 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 [Minocin] is and what it is used for

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Sebact MR [Minocin] 100 mg capsules are brown and cream coloured hard capsules that are available in packs of 56 in foil blister strips. These MR capsules are intended to provide “modified release” of minocycline so that some is released in the stomach and some in the small intestine. Minocycline is one of a group of antibiotics called tetracyclines. Sebact MR [Minocin] 100 mg capsules are 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 [Minocin] is intended to reduce the infection with this bacterium and so help in the overall treatment of acne.

Before you take Sebact MR [Minocin]

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Do not take Sebact MR [Minocin] If:

  • You are allergic (hypersensitive) to minocycline or any of the other ingredients in Sebact MR [Minocin] (these are listed above)
  • You are allergic to any medicines called tetracycline antibiotics (e.g. oxytetracycline, tetracycline, doxycycline).
  • You are pregnant, think you might be pregnant or are trying to become pregnant.
  • You are breastfeeding.
  • You are less than 12 years old
  • You have kidney failure.

If you have any questions or are not sure about anything, ask your doctor before you start to take Sebact MR [Minocin] 100 mg capsules. Sebact MR [Minocin] may or may not be suitable for you If:

  • You have liver problems.
  • You have some kidney problems but not kidney failure, in which case you must not take this medicine. In some types of kidney problems, you may still be given Sebact MR [Minocin] 100 mg capsules but at a reduced dose. Your doctor will advise you of the right dose for you.
  • You have a condition called myasthenia gravis
  • You have systemic lupus erythematosus (SLE).

Tell your doctor or pharmacist if you have any of the above conditions before you start taking Sebact MR [Minocin]. Note that during treatment your doctor may perform some routine blood tests to check your blood count and that your liver and kidneys are working normally. This is especially important if your doctor advises you to take the capsules for more than 6 months.

Also, 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 [Minocin] with food and drink:

It is advisable not to drink too much alcohol while taking Sebact MR [Minocin].

Drink alcohol only in moderation and within the Government’s recommended limits. Sebact MR [Minocin] 100 mg capsules can be taken with food or drink.

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 minocycline.

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 [Minocin].

Some medicines should not be taken while taking minocycline while others may be taken but may need special care. It is especially important that you tell your doctor or pharmacist if you are taking any of the following:

  • Any medicines that can affect the way your liver works, either intentionally or as a side effect of their use.
  • Antibiotics called beta-lactams (e.g. penicillins and cephalosporins) because minocycline may prevent them from working.
  • Quinapril (a medicine used to treat heart disease and high blood pressure), indigestion remedies, vitamins, or any preparations containing antacids, iron, calcium, aluminium, magnesium, bismuth or zinc salts. These preparations can prevent Sebact MR [Minocin] from working effectively when taken at the same time. It is recommended that quinapril or any indigestion remedies, vitamins or other supplements containing any of the above salts are taken at least 3 hours before or after your dose of Sebact MR [Minocin]
  • Medicines to thin your blood (e.g. warfarin). The dose of these medicines may need to be reduced while you are taking Sebact MR [Minocin]
  • Diuretics (to regulate body water content) because they may increase the risk of kidney problems while taking minocycline.
  • Isotretinoin (sometimes used to treat severe acne) should not be taken shortly before, during or shortly after a course of minocycline because there is a higher risk of increased pressure on the brain. See section 4 about this side effect.
  • Oral contraceptives (the “pill”). Taking Sebact MR [Minocin] may make oral contraceptives less effective. It is very important that you do not become pregnant while taking minocycline and you should take advice from your doctor on extra precautions needed to avoid pregnancy. See also section 4 of this leaflet on this matter.

How to take Sebact MR [Minocin]

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

The usual dose for children over the age of 12 years and for adults is one Sebact MR [Minocin] 100 mg capsule taken at about the same time each day. Some elderly people may need a lower dose.

Your doctor will advise you about this. Sebact MR [Minocin] 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 or standing to prevent irritation of your gullet. It does not matter whether you take Sebact MR [Minocin] 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.

Please read the advice in section 2 of this leaflet (Taking other medicines) carefully before you start to take the capsules.

Do not remove a capsule from the pack until you are due to take it. 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 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 [Minocin] 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 [Minocin] than you should

If you have accidentally taken too many capsules of Sebact MR [Minocin] (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 [Minocin] capsules left or not.

If you forget to take Sebact MR [Minocin]

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 then carry on as before. Do not take a double dose to make up for a missed dose.

Possible side effects

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Like all medicines Sebact MR [Minocin] can have side effects. The most common side effects (occurring in more than one in a hundred persons) are dizziness or feeling light-headed. If any of the following happen, stop taking Sebact MR [Minocin] and tell your doctor immediately or go to the emergency department at your nearest hospital. These are very serious side effects. If you have them you may have had a serious allergic reaction or other type of reaction to minocycline. You may need urgent medical attention or hospitalisation.

Severe allergic reaction 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.

This type of reaction is rare (in less than one in a thousand but more than one in ten thousand persons). In addition, seek urgent help if you develop any of the following (affecting less than one in ten thousand persons)

  • Yellowing of the skin or whites of the eyes, with or without pale stools.
  • Severe and/or bloody diarrhoea.
  • Severe skin rashes that may blister and peel, often with involvement of the mouth, eyes and genital areas. Sometimes these types of reactions can occur with inflammation of one or more major body organs and with fever and swelling of the glands
  • Symptoms such as joint pains or other joint problems together with fever, muscle pains and/or rashes. Also, contact your doctor immediately if you notice any of the following side effects:
  • 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.
  • Staining of your skin, teeth or nails, slight blue/black/grey color staining of the skin, teeth, nails, inside of the mouth, eyes, tears, breast milk or sweat. Staining may appear at any time during treatment with minocycline but is more common during long-term treatment. Any blue/black/grey staining of the skin or mouth usually disappears a few months after minocycline is stopped. Staining in the other parts of the body, although less common, may persist. A persistent muddy-brown skin stain, particularly in sun-exposed areas of the skin, has also been reported. Inform your doctor without delay if you notice any staining so that your treatment can be reviewed. Although not noticeable, there may also be staining of the thyroid gland, bone and body secretions in addition to those listed above. These effects all occur in less than one in a thousand persons and sometimes less than one in ten thousand persons.
  • A worsening of the symptoms of myasthenia gravis.
  • Fits (these occur in less than one in ten thousand persons) Other possible side effects of Sebact MR [Minocin] are:

Uncommon (in less than one in a hundred but more than one in a thousand persons)

  • Fever.

Rare (in less than one in a thousand but more than one in ten thousand persons)

  • Diarrhoea.
  • Feeling or being sick.
  • Loss of appetite.
  • Sore mouth.
  • Hearing problems such as loss of hearing or as ringing in the ears, unsteadiness
  • Loss of hair.
  • Rashes that may be itchy, including widespread red rashes, rashes that form areas that look like small or large bruises and more local rashes that can form nodules (for example on the shins).
  • Increased sensitivity of the skin to sunlight.
  • Headache, sometimes with vision effects or other problems due to an increased pressure of the fluid within and around the brain
  • Cough, shortness of breath, difficulty breathing.
  • Inflammation of the heart muscle or area around the heart.
  • Numbness or tingling feelings (like pins and needles).
  • Muscle and joint pains, sometimes with associated rashes and other symptoms of generally feeling unwell.
  • Inflammation of the blood vessels resulting of symptoms such as muscle pain, cramps, unusual tiredness or weakness, spitting blood.
  • An increase of urea in the blood due to poor kidney function, inflammation of the kidney or kidney failure.
  • Abnormal results of blood tests that measure how the liver is working, inflammation of the liver.
  • Changes in numbers of some types of blood cell such as increases in cells called eosinophils, drops in numbers of white blood cells (that help fight infections) and drops in small cells called platelets (that help the blood to clot).

Very rare (in less than one in ten thousand persons)

  • Worsening of asthma.
  • Inflammation of the tongue.
  • Abnormal formation of tooth enamel
  • Swollen, stiff or painful joints.
  • Heartburn or difficulty in swallowing, sometimes due to inflammation of the gullet or ulcers in the gullet.
  • Red patches on the skin, white patches in the mouth or itching around the anus or vulva and vagina which may be accompanied by vaginal discharge.
  • Development of or worsening of symptoms of SLE (systemic lupus erythematosus)
  • Inflammation of the liver that can lead to liver failure.
  • Inflammation of the pancreas.
  • A complete or almost complete lack of white blood cells, with or without a lack of red blood cells (causing severe anaemia) and platelets (see also above).
  • Anaemia due to red blood cells breaking up.
  • Purple spots or blotches in the skin.
  • Inflammation of the area around the tip of the penis.
  • Inflamed or stiff lungs, leading to severe breathing problems with or without wheezing or chest pain
  • Abnormal working of the thyroid gland, which may show up only on abnormal blood test results.
  • Bulging of the heads of babies or very young children due to increased pressure of the fluid surrounding the brain
  • Sleepiness.

If you notice any side effects not mentioned In this leaflet, please Inform your doctor or pharmacist.

Storing Sebact MR [Minocin]

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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.

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