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AKNEMIN 50

Active substance(s): MINOCYCLINE HYDROCHLORIDE

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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.

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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 pharmacist.

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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.

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• 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
Scholtzstraße 3, 21465 Reinbek, Germany
This leaflet was last approved in 06/2015

80009562 / GB / 0615

FM-H8071527

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Name Description:

PROOF:

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PIL Aknemin 50mg Capsules GB 80009562
Regulatory text number:

uk-leaflet-aknemin-50-annotated
Name:

Item number:

80009562
Date:

Version number:

05/06/2015

Printing Colours

In Line Control Code

PHES Code

P Reflex Blue

480
Non Printing Colours

01

DIE CUT

Material size:

150 x 210 mm

Fonts: Helvetica LT Std Roman, Helvetica LT Std Bold.

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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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