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MINOCIN MR CAPSULES 100MG

Active substance(s): MINOCYCLINE HYDROCHLORIDE

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Bemerkung/remark

1. WHAT MINOCIN MR IS AND WHAT IT IS USED FOR
Minocycline, the active ingredient in MINOCIN MR, is a tetracycline antibiotic used in the treatment of acne. Acne results from
clogging of skin pores. In its mildest form this causes whiteheads and blackheads. If these become infected, spots appear.
MINOCIN MR reduces the infection and allows the spots to heal.

Korrektur notwendig/
correction required

MINOCIN MR®100mg Modified Release Capsules (Minocycline)
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 further questions, please ask your doctor or 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist
In this leaflet:
1. What MINOCIN MR is and what it is used for
2. Before you take MINOCIN MR
3. How to take MINOCIN MR
4. Possible side effects
5. How to store MINOCIN MR
6. Further information

Datum /date: Unterschrift/signature:

®

Freigabe/release

PATIENT INFORMATION LEAFLET

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contract manufacturer:
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Typopharma # 109464

MEDA Pharma GmbH & Co.KG
Code
––
Fontsize 8 / 8,3 pt / 80%
technical 6 pt
Used Font Helvetica Neue
Colours
black
Meda
Order File

Sec. Edge Marks

Minocin MR 100 mg
56UK1842110-02
N/A
UK
13728 und 13729
148 x 280 mm
Weimer Pharma
Product
Material No.
Replaced No.
Country
Code No.
Dimension
Drawing No.

3. HOW TO TAKE MINOCIN MR
Always take your capsules exactly as your doctor tells you to. This information will also be on the pharmacist’s label. If you are
not
sure how to take your capsules your pharmacist will be able to help you.
The usual dose is one capsule every day.
For elderly patients, your doctor will advise if any dosage reduction is required.
MINOCIN MR should be taken at the same time(s) each day.
MINOCIN MR should be swallowed whole with a drink of water. The capsules should be taken while you are sitting or standing.
They should not be sucked or chewed. It does not matter whether you take MINOCIN MR on an empty stomach or after food.
Do not remove a capsule from the pack until you are due to take it. The container protects the capsules from moisture, which
may spoil them.
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 before you see any improvement in your acne and even
longer before the full benefits are seen. For this reason it is important to finish taking all of the capsules prescribed for you by
your doctor and return to see him/her when you have been asked to do so. 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.
If your doctor decides to continue your treatment with MINOCIN MR for longer than 6 months, your doctor should ask to see
you on a regular basis, usually once every 3 months, to examine you for any possible side effects related to the liver or unusual
pigmentation or a condition called Systemic Lupus Erythematosus (SLE) which can include pain or stiffness of joints, rash or
fever.
Your doctor will also monitor your blood and renal function during therapy.
If You Take More MINOCIN MR Than You Should
If you have accidentally taken an overdose of MINOCIN MR, that is 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 MINOCIN MR capsules left or not.
If You Forget To Take MINOCIN MR
If you do miss a dose you should take it as soon as possible. This will help to keep a constant amount of medicine in the
blood.
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.
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2. BEFORE YOU TAKE MINOCIN MR
Do not take these capsules if any of the following apply to you unless you have told your doctor or pharmacist:
• you have had an allergic reaction to any tetracycline antibiotic in the past (e.g. oxytetracycline, tetracycline, doxycycline
or minocycline), or any of the components of MINOCIN MR;
• you are pregnant, breastfeeding or trying for a baby;
• the person that the medicine has been prescribed for is under the age of 12;
• you have kidney disease;
Tell your doctor or pharmacist if:
• you are taking any of the following:
anticoagulants e.g. warfarin; penicillin antibiotics e.g. amoxicillin; isotretinoin (or other retinoids or retinol); quinapril,
ergotamine, methysergide, indigestion remedies, vitamins or any preparations containing iron, calcium, aluminium,
magnesium, bismuth or zinc salts; diuretics (to regulate body water content);
• you are taking any other medicines including those that you have bought without a prescription;
• you are taking preparations containing iron, calcium, aluminium, magnesium, bismuth or zinc salts which can prevent
MINOCIN MR from working effectively when taken at the same time. It is recommended that any indigestion remedies,
vitamins or other supplements containing these are taken at least 3 hours before or after your dose of MINOCIN MR;
• you have a condition called systemic lupus erythematosus (SLE) or myasthenia gravis;
• you have liver disease.
MINOCIN MR may affect some medical tests. If you visit a hospital or clinic for any medicinal tests you should tell your doctor
concerned you are taking MINOCIN MR.
Taking other medicines
If you take a contraceptive pill and get diarrhoea or sickness or bleed when you don’t expect to, your pill may not work (please
see “4. Possible Side Effects”).
Taking MINOCIN MR with food and drink
It is recommended that whilst taking MINOCIN MR alcohol consumption should remain within the Government’s recommended
limits.

84236
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Bemerkung/remark

Korrektur notwendig/
correction required

Datum /date: Unterschrift/signature:
Freigabe/release

additional NON PRINTING
Cutting

1. proof 13.11.2013 mz
2. proof 15.11.2013 mz
3. proof
4. proof
5. proof
6. proof

Sec. Edge Marks

Minocin MR 100 mg
56UK1842110-02
N/A
UK
13728 und 13729
148 x 280 mm
Weimer Pharma
Product
Material No.
Replaced No.
Country
Code No.
Dimension
Drawing No.

For any further information about this medicine, please contact the Marketing Authorisation Holder.
Leaflet approved: 11/2013

Meda
Order File

6. FURTHER INFORMATION
What MINOCIN MR Contains
Each capsule contains 100mg of the active ingredient minocycline hydrochloride. Minocycline is one of a group of antibiotics
called the tetracyclines.
The capsule body contains titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and gelatin. The capsule cap
ingredients are iron oxide black (E172) and those listed for the capsule body. Other ingredients which are added so that
MINOCIN MR can be swallowed easily include microcrystalline cellulose, croscarmellose sodium, hypromellose phthalate 50,
hypromellose (E464) and light liquid paraffin.
What MINOCIN MR Looks Like and Contents of the Pack
MINOCIN MR is a modified release capsule and is available in one strength and a variety of pack sizes and
presentations.MINOCIN MR is licensed for the following pack sizes:
(i) Blister packs of 2, 49 and 56.
(ii) Bottles of 100.
MINOCIN MR is currently supplied in pack sizes of 56.
MINOCIN MR is a two piece, hard shell, size 2 capsules with an orange opaque body and a brown opaque cap containing a
mixture of off-white and coloured(yellow, green, brown/black) spherical pellets.
Marketing Authorisation Holder and Manufacturer
The Product Licence is held by:
The Manufacturers are:
Meda Pharmaceuticals Ltd.
MEDA Pharma GmbH & Co. KG
Skyway House, Parsonage Road
Benzstrasse 1
Takeley, Bishop’s Stortford
61352 Bad Homburg
CM22 6PU, United Kingdom
Germany

contract manufacturer:
Weimer Pharma
84236
Page 2 of 2
Typopharma # 109464

5. HOW TO STORE MINOCIN MR
Keep out of the reach and sight of children
Do not use MINOCIN MR after the expiry date. This date is printed on the pack.
Do not store above 25°C
Blisters:
Store in the original container
Keep the container in the outer carton
Bottles:
Keep the container tightly closed. Store in the original container.
If your doctor decides to stop your treatment you should return any capsules that are left to your pharmacist for disposal.
Medicines should not be put down the sink or toilet or in the bin.

MEDA Pharma GmbH & Co.KG
Code
––
Fontsize 8 / 8,3 pt / 80%
technical 6 pt
Used Font Helvetica Neue
Colours
black

4. POSSIBLE SIDE EFFECTS
Like all medicines MINOCIN MR may cause side effects although not everybody gets them. Most people do not get side
effects with this medicine. The following effects that can occur are usually mild but if you experience any symptoms which are
severe, persist or worry you, contact your doctor or pharmacist:
• Stomach upsets, diarrhoea, sickness, loss of appetite or sore mouth. If you take a contraceptive pill and get diarrhoea or
sickness or bleed when you don’t expect to, 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. Read the leaflet that came with your “pill”;
• Headache, dizziness, hearing problems such as ringing in the ears, light-headedness, or unsteadiness. Make sure you
know how you react to this medicine before you drive, use machines or do anything else that could be dangerous if you
are dizzy or not alert;
• Skin problems such as rashes most commonly due to increased sensitivity of the skin to sunlight, itching, redness,
scaling or blistering. You should avoid direct exposure to sunlight or artificial light. If you experience skin discomfort then
stop taking your tablets and seek advice from your doctor;
• Cough;
• Loss of hair.
The following effects are rare or very rare, but you should contact your doctor immediately if any of them happen to you:
• Anaphylaxis/anaphylactoid reactions (including a sudden, generalised allergic reactions that may lead to life-threatening
shock [symptoms include difficulty in breathing, wheezing, rash, swelling, drop of blood pressure, fast pulse]);
• Severe skin rashes, as they may be life threatening;
• Headache, with blurred or double vision or loss of vision;
• Swollen, stiff or painful joints or muscle pain. Tender, bruise like swellings of the shins;
• Pain in the abdomen, pale stools or difficulty passing urine;
• Yellowing of the skin or whites of the eyes;
• Sudden unexplained fever or sore throat, extreme tiredness, convulsions, unexplained bruising or bleeding;
• Pain in the upper abdomen or back;
• Swelling and redness of the tongue, inside of the mouth, or around the eyes;
• Heartburn or difficulty in swallowing, lower abdominal pain or blood and mucous in stools;
• Difficulty breathing or chest pain;
• Inflammation of the blood vessels;
• Redness or swelling of the penis;
• Red patches on the skin, white patches in the mouth or itching around the anus or vagina which may be accompanied by
vaginal discharge. Vaginal inflammation which may be accompanied by pain on urinating;
• A worsening or development of symptoms of SLE (systemic lupus erythematosus) or a worsening of the symptoms of
myasthenia gravis;
• Numbness, tingling feelings (like pins and needles) in the hands and feet.
Contact your doctor if you notice any staining of your skin, teeth (including adult teeth), tongue, lips, gums or nails so that your
treatment can be reviewed. Slight blue/black/grey colour staining of the skin, teeth, nails, inside of the mouth, eyes, tears,
breast milk or sweat has been reported. Staining may appear at any time during MINOCIN MR therapy but is more common
during long-term treatment. Any blue/black/grey staining of the skin or mouth usually disappears a few months after MINOCIN
MR is stopped.
Staining in the other parts of the body, although less common, may persist. A persistent muddy-brown skin stain, particularly in
sunexposed 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.
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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