Document: leaflet MAH BRAND_PL 33016-0005 change

• leaflet MAH BRAND_PL 33016-0005
• leaflet MAH BRAND_PL 33016-0006

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aknemin 50 capsules

Minocycline base 50 mg (as the hydrochloride Ph Eur) per capsule

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.

•    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.

In this leaflet:

1.    What Aknemin 50 is and what it is used for

2.    Before you take Aknemin 50

3.    How to take Aknemin 50

4.    Possible side effects

5.    How to store Aknemin 50

6.    Further information

1.    WHAT AKNEMIN 50 IS AND WHAT IT IS USED FOR

Aknemin 50 is one of a group of antibiotics called tetracyclines. These are used in the treatment of acne, and for other bacterial infections.

Acne is a common condition caused by an over production of the skin's sebum. It blocks pores causing blackheads. These become infected with bacteria. Then the surrounding skin gets inflamed causing acne spots. Aknemin 50 reduces the inflammation and allows spots to heal.

2.    BEFORE YOU TAKE AKNEMIN 50

Do not take Aknemin 50

•    if you are allergic (hypersensitive) to minocycline hydrochloride, any other antibiotic from a group called tetracyclines or any of the other ingredients of Aknemin 50 (see section 6).

•    if you have been told that you have a condition called Systemic Lupus Erythematosus (SLE).

•    if you have problems with your kidneys.

•    if you are pregnant or there is a possibility that you may be pregnant or if you are breast-feeding.

Aknemin 50 should not be given to children under 12 years of age.

Take special care with Aknemin 50

•    if you have problems with your liver, eg if you have a condition called acute porphyria.

•    if you have been told that you have a muscle disease called Myasthenia Gravis. Taking other medicines

Talk to your doctor or pharmacist if you are taking

•    a medicine to reduce clotting of blood (an anticoagulant such as warfarin).

•    a penicillin antibiotic.

•    indigestion products such as antacids.

•    any medicines which contain iron, calcium, aluminium, magnesium, bismuth or zinc salts.

•    diuretics (sometimes described as “water tablets”).

If you are taking the contraceptive pill and experience diarrhoea or bleeding in between your periods, there is a possibility that the contraceptive may not be working.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Aknemin 50 with food and drink

Avoid drinking alcohol while you are taking Aknemin 50. Your doctor can advise you on the importance of this to you.

Pregnancy and breast-feeding

Do not take Aknemin 50 if you are pregnant or thinking of becoming pregnant or if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or operate machines if you get headaches, light-headedness, dizziness or vertigo whilst taking Aknemin 50.

3. HOW TO TAKE AKNEMIN 50

Take Aknemin 50 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    The usual dose for the treatment of acne is one capsule taken twice a day.

•    If you are being treated for a problem other than acne your doctor may prescribe a different dose.

•    Children above 12 years: the normal dose is one capsule every 12 hours.

•    The Elderly: Aknemin 50 may be used at the normal recommended dosage but caution is advised in patients with kidney problems.

Swallow the capsule whole with a glass of water. It doesn’t matter whether you take it with food or on an empty stomach. The blister pack is printed with days of the week to help you remember to take your Aknemin 50. Choose times when you are likely to best remember such as breakfast time or tea time. As with all capsules the patient should be in an upright position when taking Aknemin 50 capsules.

Duration of treatment

Your doctor will tell you how long to take Aknemin 50.

•    If you are treated for acne this will usually be for at least 6 weeks.

•    It may take several weeks before you see an improvement in your acne. The full benefits may take much longer so it is important to finish taking all the capsules that the doctor has prescribed and return to see the doctor if that is what he/she told you to do.

•    If your acne has not improved after 6 months, your doctor may tell you to stop taking Aknemin 50.

•    If your treatment with Aknemin 50 continues for more than 6 months, your doctor will need to see you regulary to check on your progress and to ensure you do not develop any side effects.

If you take more Aknemin 50 than you should

Contact a doctor as soon as possible if you accidently exceed the prescribed dose as an overdose may be serious. The doctor will decide which measures should be taken.

If you forget to take Aknemin 50

If you forget to take a capsule at the usual time take it as soon as you remember that day.

Do not take a double dose to make up for a forgotten capsule.

If you have any further questions on the use of this product, ask your doctor or p harmacist.

FM-H8071527

4. POSSIBLE SIDE EFFECTS

Like all medicines, Aknemin 50 can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects stop taking Aknemin straight away and contact your doctor:

•    Allergic reactions, which may include collapse, breathlessness and difficulties in swallowing.

•    Increased pressure in the brain resulting in lasting headache, feeling sick, being sick and changes in your eyesight including blurred vision.

•    Persistant or worsening of diarrhoea, which can be a sign of a serious inflammation of the bowel.

•    Difficulty in swallowing or pain when swallowing, which can be signs of inflammation and ulceration of the throat.

•    Inflammatory reactions including fever.

•    Serious illness with blistering of the skin, mouth, eyes and genitals.

Other side effects, that have been reported are listed below:

Effects on the heart

•    Rarely, inflammation of the heart which can cause fever and chest pain.

Effects on lungs

•    Pneumonia with increase in eosinophils (a type of white blood cells). The symptoms you may experience are cough, fever, increasing breathlessness, and night sweats.

Effects on blood

•    Anaemia.

•    Reduction in blood platelets, which increases risk of bleeding or bruising.

•    Reduction in white blood cells which makes infections more likely.

Effects on the nervous system

•    Headaches, light-headedness, dizziness, difficulty in controlling movements or vertigo.

•    Rarely numbness or tingling feelings may occur.

Effects on the eyes

•    In isolated cases, changes in the colour of the eye and of tears.

Effects on the ears

•    Rarely, impaired hearing or ringing in the ears.

Effects on the chest

•    Rarely, inflammation of the lung.

Effects on the digestive system

•    Loss of appetite, feeling or being sick, diarrhoea, indigestion, or inflammation of the bowel.

•    There have been isolated cases of inflammation of the pancreas.

Effects on the kidneys

•    Rarely, damage to the kidneys was reported.

Effects on the skin

•    Rarely skin reactions including rashes, inflammation of the skin and an increased sensitivity to the effects of the sun or sun lamps have been reported.

•    Rarely, hair loss occurred.

•    Occasionally discolouration of the skin may occur. Rash. Also a condition known as DRESS syndrome which includes skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

Allergic reactions

•    These can include redness of skin and rashes, fever, joint pain and swelling.

•    A condition known as polyartheritis nodosa which includes symptoms of fever, abdominal pain and muscle and joint aches.

If you have any allergic reaction, stop taking Aknemin 50 and contact your doctor.

Effects on the liver

•    Abnormal liver function tests and rarely, an inflammation of the liver has been reported.

•    Occasional occurence of liver failure or injury with raised blood bilirubin causing yellowing of the skin and whites of the eyes.

If you experience yellowing of the whites of your eyes or tummy pain, stop taking Aknemin 50 and see your doctor.

Other effects

•    Occasionally, a discolouration of teeth, gums, tongue, mucous membranes or body fluids (eg perspiration) may occur.

Reporting of side-effects

If you get any side effects, talk to your doctor or pharmacist. 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.

5.    HOW TO STORE AKNEMIN 50

Keep out of the reach and sight of children.

Do not use Aknemin 50 after the expiry date which is stated on the carton and blister pack after EXP.

The expiry date refers to the last day of that month.

You should store Aknemin 50 at room temperature (below 25°C) in its original pack.

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 Aknemin 50 contains

•    The active substance is minocycline hydrochloride.

•    The other ingredients are polyethylene glycol, erythrosine (E127), red iron oxide (172), yellow iron oxide (E172), titanium dioxide (E171) and gelatin.

What Aknemin 50 looks like and contents of the pack

Aknemin 50 capsules are orange/caramel hard gelatin capsules, filled with spherical yellow to yellow-green pellets.

Marketing Authorisation Holder and Manufacturer

Almirall Hermal GmbH

ScholtzstraBe 3, 21465 Reinbek, Germany

This leaflet was last approved in 06/2015

80009562 / GB / 0615    FM-H8071527    4

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