PATIENT GUIDANCE

LEAFLET

Minocin MR*

Minocycline 100mg Modified Release Capsules

WHAT YOU SHOULD KNOW ABOUT MINOCIN MR

This leaflet provides important information about your medicine. Please read it carefully before you start taking MINOCIN MR capsules. If you have any questions, or there is anything you do not understand, ask your doctor or pharmacist (chemist) and they will be able to help you.

WHAT IS IN MINOCIN MR?

MINOCIN MR is available in one strength and a variety of pack sizes and presentations. Each capsule contains 100mg of the active ingredient minocycline hydrochloride. MINOCIN MR is licensed for the following pack sizes:

  1. Blister packs of 2, 49 and 56.
  2. Bottles of 100.

MINOCIN MR is currently available in pack sizes of 2 and 56.

Minocycline is one of a group of antibiotics called the tetracyclines.

MINOCIN MR is a two piece capsule with an orange body and brown cap, containing a mixture of yellow and off-white round pellets. 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 cellulose, croscarmellose sodium, hydroxypropylmethyl cellulose, hydroxypropyl cellulose, phthalate and light mineral oil.

WHO HOLDS THE LICENCE AND MAKES MINOCIN MR?

The licence for MINOCIN MR is held by Cyanamid of Great Britain Ltd, Fareham Road, Gosport, Hampshire, England. MINOCIN MR is manufactured by Lederle Laboratories in Pearl River, New York, USA and Fareham Road, Gosport, Hants.

WHAT CAN MINOCIN MR BE USED TO TREAT?

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.

BEFORE TAKING THIS MEDICINE

If the answer to any of the following questions is "yes" you should talk to your doctor or pharmacist (chemist) before taking these capsules as they may not be suitable for you

MINOCIN MR may cause some people to become dizzy, lightheaded or unsteady. 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.

If you take a contraceptive pill and get diarrhoea or sickness for ANY reason (for example, food poisoning, a 'bug' or as an unwanted effect of a medicine), or you lose blood when you don't expect to, your 'pill' may not work. You should either not have intercourse or use a barrier method of contraception to make sure you don't get pregnant (eg a condom or diaphragm/cap). Please read the leaflet that came with your 'pill', and talk to your doctor or pharmacist if you are not sure what to do or for how long to take these precautions.

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HOW AND WHEN SHOULD I TAKE MINOCIN MR?

WHAT TO DO IF YOU FORGET TO TAKE A CAPSULE

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.

WHAT TO DO IF YOU TAKE TOO MANY CAPSULES

If you have 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 casualty department. Always take the labelled medicine container with you, whether there are any capsules left or not.

AFTER TAKING THIS MEDICINE

Like all medicines MINOCIN MR may cause unwanted effects in some people. Most of these are mild but if you experience any symptoms that worry you or are unusual contact your doctor or pharmacist (chemist) .

MINOCIN MR may cause some people to become dizzy or lightheaded, or have unsteadiness, an upset stomach, sickness, loss of appetite or diarrhoea.

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.

The following effects only occur in a very small number of patients:

Very rarely MINOCIN MR may cause skin problems. These include redness, itchiness, rashes, increased sensitivity of the skin to sunlight, scaling or blistering. Slight blue/black colour staining of the

skin, teeth and the inside of the mouth have occurred very rarely and this staining usually disappears when the capsules are stopped. Skin staining may very rarely persist particularly if there is extensive scarring from acne.

Extremely rarely, MINOCIN MR can cause staining of the eyes, tears or sweat.

MINOCIN MR may cause an increase in pressure inside the head causing headaches. If you have a severe or persistent headache you should contact your doctor.

MINOCIN MR may cause swelling of certain parts of the body, for example, the liver, the pancreas or the outer lining of the heart. With this swelling a fever and 'butterfly' shape rash may rarely appear on the face. Should this rash and fever occur, contact your doctor.

MINOCIN MR may cause hypersensitivity reactions leading to itching, flushing, fever, rashes or difficulty in breathing. If you experience any of these symptoms or pain in your joints you should contact your doctor.

MINOCIN MR may cause problems with the blood such as anaemia.

Remember, if you do experience any symptoms with your medicine that cause you concern, contact your doctor

STORING YOUR MEDICINE

Keep your capsules in a dry place at room temperature (below 25°C). Do not remove a capsule until you

are due to take it. The container protects the capsules from moisture which may spoil them: keeping the capsules out of the container means that they are more likely to be affected by moisture.

Keep all medicines in a safe place away from children.

If your doctor decides to stop your treatment you should return any capsules that are left to your pharmacist (chemist) for disposal. Medicines should not be put down the sink or toilet or in the bin.

Do not use after the expiry date. This date is printed on your pack.

Date of preparation or last review: May 1995

Remember: this medicine is for you . Only a doctor can prescribe it for you. Do not give it to anyone else, even if they have the same symptoms as you as it may harm them. This leaflet does not contain the complete information about your medicine. If you have any questions or you are not sure about anything, ask your doctor or pharmacist (chemist) who can give you more information. The information in this leaflet applies only to MINOCIN MR capsules. You should keep this leaflet in case you want to look at it again.

The Product Licence Number for MINOCIN MR is PL 0095/0240.

Lederle Laboratories, Cyanamid House, Fareham Road, Gosport, Hampshire, England.

*Registered Trademark.