Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Erythromycin, Tretinoin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Aknemycin Plus is a treatment for acne which is applied to the skin. Aknemycin Plus is a solution and contains Erythromycin and Tretinoin as active ingredients. Erythromycin is an antibiotic which kills the germs found in acne and reduces the inflammation of your skin. Tretinoin encourages the layer of dead and hardened skin cells that form on the skin surface to peel off. At the same time, it clears the blackheads which block your skin pores and cause spots to form. Once the pore is unblocked, sebum can escape so that germ activity is limited. Aknemycin Plus also helps dissolve away the excess oil in your skin.
e Aknemycin Plus
Do not use Aknemycin Plus
Aknemycin Plus Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Proof:
Artwork Information Panel
1
Description: PIL Aknemycin Plus Solution GB Mock up
Printing Colours
Regulatory text: PIL Aknemycin Plus Solution GB 80015571annotated / uk-pl-aknemycinplus-QRD-Sep2018_annotated (1-2) Item Number: 00000000
Material size: 148 x 297 mm
Designer:
Date: 30.03.2020
Fonts: Graphik Regular / Regular Italic / Semibold "8pt in Graphic Font equal to 9pt on Times New Roman"
Manufacturer's Technical check Manufacturer confirms the printability and technical compliance of this packaging material for correct use during packaging process.
Minimum Font Size: 8 pt Prefixes (eg.Lot/Exp) Font Size: Leading: 3 mm
Date and Signature
P Black
Non Printing Colours Die Cut
Colour reference in PMS Bridge Equate with CMYK
Inline control code PHES Code
Normally you should apply Aknemycin Plus once or twice daily as advised by your doctor. After use the applicator will close again automatically.
Activating the applicator
Applying the solution
Duration of treatment Carry on using Aknemycin Plus for as long as your doctor tells you.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. For example, when you first use Aknemycin Plus your skin problem may seem to get worse. This is a sign that the medicine is beginning to act. However this should soon pass and you will then see an improvement. Contact your doctor immediately if you experience a serious skin reaction: a red scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this side effect is not known (cannot be estimated from the available data). Rarely, the skin can be irritated by Aknemycin Plus and you may have a sore, dry or burnt feeling or see peeling. In very rare cases these symptoms may also be an expression of an allergic reaction. If this happens, see your doctor. Rarely, the skin may become darker or lighter in colour. People with dark skin may see a lightening of their skin where Aknemycin Plus has been used. This is temporary. Your skin will go back to its usual colour when you stop using Aknemycin Plus. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Aknemycin Plus Keep this medicine out of the sight and reach of children. Aknemycin Plus should be kept in the outer carton to protect from direct sunlight. Store below 30°C. Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Aknemycin Plus contains
00000000 / GB / 0320
Proof:
Artwork Information Panel
1
Description: PIL Aknemycin Plus Solution GB Mock up
Printing Colours
Regulatory text: PIL Aknemycin Plus Solution GB 80015571annotated / uk-pl-aknemycinplus-QRD-Sep2018_annotated (2-2) Item Number: 00000000
Material size: 148 x 297 mm
Designer:
Date: 30.03.2020
Fonts: Graphik Regular / Regular Italic / Semibold "8pt in Graphic Font equal to 9pt on Times New Roman"
Manufacturer's Technical check Manufacturer confirms the printability and technical compliance of this packaging material for correct use during packaging process.
Minimum Font Size: 8 pt Prefixes (eg.Lot/Exp) Font Size: Leading: 3 mm
Date and Signature
P Black
Non Printing Colours Die Cut
Colour reference in PMS Bridge Equate with CMYK
Inline control code PHES Code
The active substance in Aknemycin Plus is erythromycin, tretinoin.
This leaflet reproduces the patient information leaflet approved for Aknemycin Plus, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Aknemycin Plus is indicated for the treatment of all forms of acne, both non-inflammatory forms with comedones and inflammatory forms with papules and pustules particularly those associated with a very oily skin.
Posology
To be applied to the affected areas once or twice daily. Treatment should continue for 9-12 weeks according to the condition of the skin. It should be noted that therapeutic improvement may not be observed for several weeks after starting treatment.
Consistent application makes a significant contribution to the success of the therapy.
Excess application of Aknemycin Plus should be avoided since it may result in marked erythema, drying and discomfort of the treated areas.
The dosage is the same for all ages.
Method of administration
For application to the skin.
The applicator allows direct administration to the skin. The patient should press the top of the screw cap on the foam pad before each use and should feel a 'click' which indicates that the applicator will close again automatically.
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
• A family history of cutaneous epithelioma.
• In acute eczemas, rosacea and acute inflammatory conditions of the skin, especially around the mouth.
• When underlying sunburn is present
• Concomitant use with other skin medications particularly those containing keratolytic agents (see section 4.5).
• Pregnancy (see section 4.6)
• Women planning a pregnancy.
Photosensitivity may occur during treatment with Aknemycin Plus. Exposure to sunlight should be minimised and use of sun lamps or sun beds avoided during treatment. Patients with sunburn should not use this product until recovered because of the increased susceptibility to sunlight whilst using tretinoin. Wind and rain may be unusually irritating to patients under treatment.
Accumulation of the product in skin folds or in the angles of the nose should be avoided.
The product should not be allowed to come into contact with the eyes or eyelids - if this occurs, thorough rinsing with water is recommended.
As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
This medicine contains 752 mg of alcohol (ethanol) in each ml. It may cause burning sensation on damaged skin.
Do not light a cigarette or expose yourself to flame until the medicine has dried completely.
Skin irritation may be enhanced by UV rays (natural sunlight, sun lamps, sun beds), X-rays or by bathing in chlorinated or salt water.
Any sunburn should be allowed to heal before the start of treatment with Aknemycin Plus.
Aknemycin Plus should not be used concomitantly with other skin medications particularly those containing keratolytic agents (see section 4.3), as this may exacerbate any skin irritation that is present.
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Pregnancy
Aknemycin Plus is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy.
If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Breast-feeding
It is known that orally administered retinoids and their metabolites are secreted in breast milk. As a precaution therefore, Aknemycin Plus should be avoided in women who are breast feeding.
Aknemycin Plus has no or negligible influence on the ability to drive and use machines.
The following frequency categories are used for the evaluation of undesirable effects:
Very common
Common
Uncommon
Rare
Very rare
Not known
(≥1/10)
(≥1/100 to <1/10)
(≥1/1,000 to <1/100)
(≥1/10,000 to <1/1,000)
(<1/10,000)
(frequency cannot be estimated from the available data)
Skin and subcutaneous tissue disorders:
There may be rare cases of skin irritation in the form of erythema, burning, drying or peeling of the skin may be observed. In very rare cases the above symptoms may also be an expression of a hypersensitivity reaction (allergic contact eczema).There may be an apparent deterioration in acne with an increase in inflammatory symptoms at the commencement of treatment; this is a sign that the medicine is beginning to act and is usually transitory. If the above occurs, treatment should not be interrupted but the frequency of application reduced.
Rarely, a temporary hypopigmentation or hyperpigmentation has been reported in individuals treated with tretinoin. Temporary depigmentation in non-caucasians is possible.
Not known: acute generalised exanthematous pustulosis (AGEP).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Aknemycin Plus is for topical use only. Overdosage will not occur since the amount of erythromycin and tretinoin applied is too small to induce systemic toxicity. If the product is accidentally taken orally, unless the amount is small, gastric lavage should be performed as soon as possible.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Erythromycin, Tretinoin. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Aknemycin Plus. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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