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 Minocycline hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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.
e MINOCIN MR Do not take these capsules if any of the following apply to you unless you have told your doctor or pharmacist:
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.
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.
Like all medicines MINOCIN MR may cause side effects although not everybody gets them. Most people do not get side effects with this medicine. Serious side effects Get medical attention IMMEDIATELY if you experience any of the following;
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.
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: Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom.
Manufacturer: Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary
This leaflet was last revised in 10/2025. For any further information about this medicine, please contact the Marketing Authorisation Holder.
Minocin MR 100 mg Modified Release Capsules comes as capsule containing 100mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Minocin MR 100 mg Modified Release Capsules is minocycline hydrochloride.
Medicines with the same active substance, strength and form include: Acnamino MR 100mg Capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Minocin MR 100 mg Modified Release Capsules, 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.
MINOCIN MR Capsules are indicated for the treatment of acne.
Posology
Adults
One 100mg capsule every 24 hours
Paediatric Population
Children over 12 years: One 100mg capsule every 24 hours
Children under 12 years: Minocycline is not recommended
Elderly
No special dosing requirement
Method of Administration:
To reduce the risk of oesophageal irritation and ulceration, the capsules should be swallowed whole with plenty of fluid, while sitting or standing. Unlike earlier tetracyclines, absorption of minocycline is not significantly impaired by food or moderate amounts of milk.
Treatment of acne should be continued for a minimum of 6 weeks, and where possible limited to a maximum of six months. If, after six months, there is no satisfactory response Minocin MR should be discontinued and other therapies considered.
If Minocin MR is to be continued for longer than six months, patients should be monitored (including laboratory investigations) at least three monthly thereafter for signs and symptoms of hepatitis or systemic lupus erythematosus (SLE) or unusual pigmentation. (see Special Warnings and Precautions)
Use of minocycline is contraindicated in the following:
• Hypersensitivity to the active substance minocycline, other tetracyclines or to any of the excipients.
• Pregnancy and lactation.
• Children under the age of 12 years.
• Complete renal failure.
Rare, anaphylaxis/anaphylactoid reactions including shock and fatalities have been associated with the administration of Minocin MR ( See section 4.8 Undesirable effects).
Minocin MR should be used with caution in patients with hepatic dysfunction and in conjunction with alcohol and other hepatotoxic drugs. It is recommended that alcohol consumption should remain within the Government's recommended limits.
Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) and also exacerbation of pre-existing SLE have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, or suffer exacerbation of pre-existing SLE, minocycline should be discontinued.
Other rare, serious events have occurred with Minocin MR including Stevens-Johnson Syndrome and toxic epidermal necrolysis. (See section 4.8 Undesirable effects). Minocin MR should be discontinued if either of these serious skin reactions is suspected.
Clinical studies have shown that there is no significant drug accumulation in patients with renal impairment when they are treated with Minocin MR in the recommended doses. In cases of severe renal insufficiency, reduction of dosage and monitoring of renal function may be required. The anti-anabolic action of the tetracyclines may cause an increase in serum urea. In patients with significantly impaired renal function, higher serum levels of tetracyclines may lead to uraemia, hyperphosphataemia and acidosis. If renal impairment exists, even usual oral and parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity.
Caution is advised in patients with myasthenia gravis as tetracyclines can cause weak neuromuscular blockade.
Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. Minocin MR should be discontinued if there are signs/symptoms of overgrowth of resistant organisms, e.g. enteritis, glossitis, stomatitis, vaginitis, pruritus ani or Staphylococcal enteritis.
Patients taking oral contraceptives should be warned that if diarrhoea or breakthrough bleeding occur there is a possibility of contraceptive failure.
Minocycline may cause hyperpigmentation at various body sites (see Administration and 4.8 Undesirable Effects). Hyperpigmentation may present regardless of dose or duration of therapy but develops more commonly during long term treatment. Patients should be advised to report any unusual pigmentation without delay and Minocin MR should be discontinued.
If a photosensitivity reaction occurs, patients should be warned to avoid direct exposure to natural or artificial light and to discontinue therapy at the first signs of skin discomfort.
As with other tetracyclines, bulging fontanelleles in infants and benign intracranial hypertension in juveniles and adults have been reported. Presenting features were headache and visual disturbances including blurring of vision, scotoma and diplopia. Permanent vision loss has been reported.
Treatment should cease if evidence of raised intracranial pressure develops.
Elderly:
Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Paediatric population:
The use of tetracyclines during tooth development in children under the age of 12 years may cause permanent discolouration. Enamel hypoplasia has also been reported.
Laboratory monitoring:
Periodic laboratory evaluations of organ system function, including haematopoietic, renal and hepatic should be conducted.
Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary.
Diuretics may aggravate nephrotoxicity by volume depletion.
Bacteriostatic drugs may interfere with the bactericidal action of penicillin. Avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of Minocin MR is impaired by the concomitant administration of antacids, iron, calcium, magnesium, aluminium bismuth and zinc salts (interactions with specific salts, antacids, bismuth containing ulcer – healing drugs, quinapril which contains a magnesium carbonate excipient). It is recommended that any indigestion remedies, vitamins, or other supplements containing these salts are taken at least 3 hours before or after a dose of Minocin MR. Unlike earlier tetracyclines, absorption of Minocin MR is not significantly impaired by food or moderate amounts of milk.
The concomitant use of tetracyclines may reduce the efficacy of oral contraceptives.
Administration of isotretinoin should be avoided shortly before, during and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (benign intracranial hypertension) (see 4.4 Special warnings and precautions).
Interference with laboratory and other diagnostic tests:
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Use in pregnancy:
Minocycline is contraindicated during pregnancy as it can cause fetal harm.
Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Minocin MR therefore, should not be used in pregnancy unless considered essential.
In humans, minocycline like other tetracycline-class antibiotics, crosses the placenta and may cause foetal harm when administered to a pregnant woman. In addition, there have been post marketing reports of congenital abnormalities including limb reduction. If Minocin MR is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to the foetus.
The use of drugs of the tetracycline class during tooth development (last half of pregnancy) may cause permanent discolouration of the teeth (yellow-grey-brown). This adverse reaction is more common during long term use of the drugs but has been observed following repeated short term courses. Enamel hypoplasia has also been reported.
Tetracyclines administered during the last trimester form a stable calcium complex throughout the human skeleton. A decrease in fibula growth rate has been observed in premature human infants given oral tetracyclines in doses up to 25mg/kg every 6 hours. Changes in fibula growth rate were shown to be reversible when the drug was discontinued.
Use in lactation:
Tetracyclines have been found in the milk of lactating women who are taking a drug in this class. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has been reported.
Headache, light-headedness, dizziness, tinnitus and vertigo (more common in women) and, rarely, impaired hearing have occurred with Minocin MR. Patients should be warned about the possible hazards of driving or operating machinery during treatment. These symptoms may disappear during therapy and usually disappear when the drug is discontinued.
The assessment of side effects is based on the following frequency information:
Very common (≥ 1/10)
Common: ((≥1/100 to <1/10)
Uncommon: (≥1/1 000 to <1/100)
Rare: (≥1/10 000 to <1/1 000)
Very Rare: (<1/10 000)
Not known (cannot be determined based on available data).
System Organ Class
Frequency
Adverse Reaction
Infections and Infestations
Very Rare
Oral and anogenital candidiasis, vulvovaginitis.
Blood and Lymphatic System Disorders
Rare
Eosinophilia, leucopoenia, neutropenia, thrombocytopenia
Very Rare
Haemolytic anaemia, pancytopenia.
Not known
Agranulocytosis
Immune System Disorders
Rare
Anaphylaxis/anaphylactoid reaction (including shock and fatalities)
Not Known
Hypersensitivity, pulmonary infiltrates, anaphylactoid purpura, Polyarteritis nodosa.
Endocrine Disorders
Very Rare
Abnormal thyroid function, brown-black discolouration of the thyroid
Metabolism and Nutrition Disorders
Rare
Anorexia
Nervous System Disorders
Common
Dizziness (light-headedness)
Rare
Headache, hypaesthesia, paraesthesia, intracranial hypertension, vertigo
Very Rare
Bulging fontanelle
Not Known
Convulsions, sedation
Ear and Labyrinth Disorders
Rare
Impaired hearing, tinnitus
Cardiac Disorders
Rare
Myocarditis, Pericarditis
Respiratory, Thoracic and Mediastinal Disorders
Rare
Cough, dyspnoea
Very Rare
Bronchospasm, exacerbation of asthma, pulmonary eosinophilia
Not Known
Pneumonitis
Gastrointestinal Disorders
Rare
Diarrhoea, nausea, stomatitis, discolouration of teeth (including adult tooth discolouration), vomiting
Very Rare
Dyspepsia, dysphagia, enamel hypoplasis, enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis There are also reports of: Oral cavity discolouration (including tongue, lip and gum)
Hepatobiliary Disorders
Rare
Increased liver enzymes, hepatitis, autoimmune toxicity
Very Rare
Hepatic cholestatis, hepatic failure (including fatalities), hyperbilirubinaemia, jaundice
Not Known
Autoimmune hepatitis
Skin and Subcutaneous Tissue Disorders
Rare
Alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of skin, photosensitivity, pruritus, rash, urticaria
Very Rare
Angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson Syndrome, toxic epidermal necrolysis, vasculitis.
Musculoskeletal, Connective Tissue and Bone Disorders
Rare
Arthralgia, lupus-like syndrome, myalgia
Very Rare
Arthritis, bone discolouration, cases of or exacerbation of systemic lupus erythematosus (SLE), joint stiffness, joint swelling
Renal and Urinary Disorders
Rare
Increase serum urea, Acute renal failure, interstitial nephritis.
Reproductive System and Breast Disorders
Very Rare
Balanitis
General Disorders and Administration Site Conditions
Uncommon
Fever
Very Rare
Discolouration of secretions
The following syndromes have been reported. In some cases involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognised, the drug should be discontinued immediately:
• Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, pericarditis.
• Fever and lymphadenopathy may be present.
• Lupus-like syndrome consisting of positive antinuclear antibody, arthralgia, arthritis, joint stiffness or joint swelling, and one or more of the following: fever, myalgia, hepatitis, rash, vasculitis.
• Serum sickness-like syndrome consisting fever, urticaria or rash, and arthralgia, arthritis,joint stiffness or joint swelling. Eosinophilia may be present.
• Hyperpigmentation of various body sites including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, lacrimal secretions and perspiration has been reported.
This blue/black/grey or muddy-brown discolouration may be localised or diffuse. The most frequently reported site is in the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases. The generalised muddy-brown skin pigmentation may persist, particularly in areas exposed to the sun.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Dizziness, nausea and vomiting are the adverse effects most commonly seen with overdose. There is no specific antidote. In cases of overdose, discontinue medication, treat symptomatically with appropriate supportive measures. Minocycline is not removed in significant quantities by haemodialysis or peritoneal dialysis.
Ask anything about Minocin MR 100 mg Modified Release Capsules. 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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