Active ingredients: Minocycline
MINOCIN 50 mg hard capsules
MINOCIN 100 mg hard capsules
Why is Minocin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antibacterial for systemic use
THERAPEUTIC INDICATIONS
MINOCIN is a tetracycline indicated, in adult patients and children aged> 12 years, in the treatment of numerous infections caused by gram-positive and gram-negative microorganisms sensitive to tetracycline.
These infections include:
Respiratory tract infections: pneumonia (lobar or plurilobar), bronchitis, bronchopneumonia, bronchiolitis, lung abscess, laryngotracheitis, tracheobronchitis.
Infections of the genitourinary tract: uncomplicated urinary tract infections, cystitis, prostatitis, gonococcal and non-gonococcal urethritis, pelvic inflammatory disease.
Skin and soft tissue infections: abscesses, acne (including cystic and pustular types), cellulite, infected dermatitis, folliculitis, furunculosis, impetigo, lymphadenitis, suppurative hidradenitis, paronychia, pyoderma, wound infections.
Ear, nose and throat infections: otitis media and externa, bacterial rhinitis, sinusitis, tonsillitis, pharyngitis.
Eye infections: acute conjunctivitis, dacryocystitis, styes.
In addition, microbiological researches have shown the activity of MINOCIN in respect of the following pathologies: diphtheria, erythrasma, mycoplasma pneumonia, meningitis (prophylaxis), salmonellosis (paratyphus), bacillary dysentery, actinomycosis, malignant pustule, puerperal infections, bartonellosis (disease of Carrion), whooping cough, relapsing fever, brucellosis, gas gangrene, granuloma inguinale (donovanosis) acute intestinal amoebiasis, tularemia, listeriosis, plague, petechial typhus, Q fever, Rocky Mountain fever, vesicular rickettiosis, rat-bite fever, syphilis, Vincent's infections, yaws, cholera, venereal lymphogranuloma, psittacosis and trachoma.
Contraindications When Minocin should not be used
Hypersensitivity to the active substance, to other tetracyclines or to any of the excipients.
Severe renal insufficiency.
Minocin must not be used in children under 12 years of age, pregnant and breastfeeding (see sections "Precautions for use" and "Special warnings").
Precautions for use What you need to know before taking Minocin
- Antibiotics are indicated only in infections of bacterial origin.
- Antibiotics, and in general all medicines, should be administered with caution to all those patients who have previously experienced allergy phenomena. Once a therapy has been started with any medicine, and therefore also with MINOCIN, the onset of any allergic-type reaction requires the suspension of the treatment. Hypersensitivity reactions: the use of MINOCIN, like other tetracyclines, has been associated with hypersensitivity reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, hepatitis and systemic lupus erythematosus, particularly in patients taking long-term acne medication. MINOCIN should be discontinued at the first appearance of skin rash, mucosal lesions or any signs of hypersensitivity. Other hypersensitivity reactions may include urticaria, angioedema, pulmonary infiltrates, anaphylaxis, haematological disorders, pericarditis, myocarditis and vasculitis.
- Dental and bone deposition: tetracyclines can be deposited in the teeth and bones during the period of formation and growth, cause hypoplasia and a change in tooth color (yellow-brown pigmentation); therefore MINOCIN should not be administered to children under 12 years of age, pregnant and breastfeeding.
- Antibiotics should be used at full dosage for at least 5 days before they are considered ineffective. Antibiotics should be taken at scheduled times.
- Antibiotic therapy should be prolonged 1-2 days after the disappearance of the symptoms of infection, and then suspended.
- Indiscriminate use of tetracyclines can cause the overgrowth of non-sensitive germs such as Candida (oral candidiasis, vulvovaginitis, anal pruritus) and coliform bacteria such as Psudomonas and Proteus which can cause diarrhea. Serious cases of enterolitis and pseudomembranous colitis have occasionally been reported. .
- Reactions of photosensitivity, which are evidenced by an exaggerated skin reactivity to sunlight and ultraviolet rays, can occur during treatment with tetracyclines in predisposed subjects; it is advisable to keep this possibility in mind and stop treatment as soon as skin erythema appears.
- In the treatment of gonococcal infections, attention must be paid to the risk of masking the manifestations of coexisting syphilis: in these cases, serological checks should be carried out for at least 4 months.
- Skin Pigmentation: The use of minocycline and other tetracyclines is associated with pigmentation of the skin, nails and other tissues. Dark blue spots may appear in inflamed and scarred areas. Gray-blue or hyperpigmented spots may appear in areas of skin Normal Gray-brown spots may arise in areas of skin exposed to the sun Typically, skin pigmentation resolves slowly after stopping the drug.
- Patients with hepatic dysfunction: Cases of hepatotoxicity have been reported following the use of minocycline and other tetracyclines; therefore MINOCIN should be used with caution in patients with hepatic dysfunction and at lower doses. In case of prolonged treatment, periodic monitoring may be useful. liver enzymes. If symptoms suggestive of liver dysfunction occur, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and dark urine, liver enzymes should be checked. If ALT levels are increased by 2 times the upper limit of normal or in case of jaundice, therapy should be suspended.
- Undesirable effects of the central nervous system such as instability, dizziness, dizziness have been reported. These symptoms may eventually disappear during the course of treatment and in any case quickly after discontinuation.
- The use of MINOCIN, particularly in the treatment of acne and for patients with phototype V and VI, has been associated with the onset of DRESS syndrome, a severe drug reaction presenting with fever, rash, lymphadenopathy, eosinophilia, leukocytosis , abnormal liver function tests, hepatitis.
Cases of domed fontanelles in neonates and benign intracranial hypertension in adults have been reported with full dose intake. These effects resolved rapidly upon discontinuation of treatment. Headache and visual disturbances, including blurred vision, scotoma and diplopia, may indicate benign intracranial hypertension ("pseudotumor cerebri") requiring prompt discontinuation of treatment. Tetracyclines can aggravate muscle weakness in patients with myasthenia gravis and cause worsening of systemic lupus erythematosus.
Interactions Which drugs or foods may change the effect of Minocin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
In the event that the patient is suffering from other diseases or is taking other medicines, he or she may ask his / her Doctor for the necessary information.
Oral absorption of tetracyclines is reduced by:
- antacid preparations containing aluminum, calcium and magnesium,
- dairy or milk based foods,
- products containing iron salts, and preparations containing zinc and bismuth orally
It is therefore advisable to avoid simultaneous intakes and to distance the administration of the aforementioned products from that of tetracyclines (at least 2 hours, if possible).
Iron preparations can reduce the absorption of minocline.
Milk and dairy products can also reduce the absorption of tetracyclines and should therefore be taken with an adequate interval. Rare cases of increased plasma concentrations of lithium, methotrexate, digoxin and ergot derivatives have been reported in the literature following concomitant administration of tetracyclines
Penicillins and cephalosporins
The association of tetracyclines, including minocycline, with penicillins and cephalosporins should be avoided due to the possible occurrence of interference between their respective antibacterial activities.
Oral contraceptives
Taking tetracyclines may decrease the effectiveness of oral contraceptive treatments. Some cases of pregnancy or intermenstrual blood loss have been attributed to the concomitant use of tetracyclines with oral contraceptives.
Tetracyclines may increase the effect of coumarin anticoagulants and therefore a reduction in the dose of the latter may be necessary.
Concomitant use not recommended:
Systemic retinoids:
co-administration with tetracyclines increases the risk of developing benign intracranial hypertension (a reversible increase in intracranial pressure).
Methoxyflurane:
co-administration with tetracyclines has resulted in fatal case reports of nephrotoxicity.
Interactions with laboratory investigations
False increases in urinary catecholamine levels may occur due to interference with the fluorescence test.
Warnings It is important to know that:
Long-term treatment cycles require periodic checks of blood count and liver and kidney function.
There have been reports of oesophageal ulcer, particularly after ingestion of capsules with little water at bedtime. Therefore MINOCIN should be taken with at least half a glass of water in a standing or sitting position and at least 1 hour before going to bed.
The administration of minocycline, particularly in patients with phototype V and VI, can lead to the onset of DRESS syndrome; therefore, MINOCIN should be used with caution in patients with these characteristics.
In case of onset of one or more symptoms of DRESS syndrome, it is recommended to immediately discontinue the drug and to inform the doctor or pharmacist.
Rare cases of autoimmune hepatotoxicity (including acute liver failure) have been reported in isolated cases of systemic lupus erythematosus and also exacerbation of pre-existing systemic lupus erythematosus. If the patient develops signs and symptoms of lupus or hepatotoxicity or exacerbation of pre-existing lupus erythematosus occurs, Minocin should be discontinued.
Breathing difficulties: Cases of breathing difficulties including dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia and pneumonia have been reported with the use of minocycline; minocycline
Cross resistance between tetracyclines can result in sensitivity to microorganisms and cross resistance in patients. The use of tetracyclines can cause the overgrowth of non-sensitive germs such as Candida (oral candidiasis, vulvovaginitis, anal pruritus) and coliform bacteria such as Pseudomonas and Proteus which can cause diarrhea. If symptoms of growth of resistant organisms such as enteritis occur, glossitis, stomatitis, vaginitis, pruritus and / or staphylococcal enteritis, Minocin must be discontinued.
Clinical studies have shown that when patients with renal insufficiency are treated with minocycline at the recommended dose, there is no accumulation of the drug in significant amounts; however, in such patients it is advisable to proceed with caution, possibly reducing the amount of doses.
In subjects with renal insufficiency, even normal doses of tetracyclines can give rise to an accumulation in the circulation with possible liver damage; in these cases it is necessary to adapt the posology to the degree of renal function, resorting, if necessary, to checks on blood levels (which should never exceed 15 mcg / ml) and liver function.
It should also be kept in mind that tetracyclines exert an "antianabolic action which can aggravate states of renal insufficiency.
Cases of Clostridium difficile associated diarrhea (CDAD) have been reported with the use of nearly all antibiotics, including doxycycline tetracyclines, ranging in severity from mild diarrhea to fatal colitis. Treatment with antibiotics alters normal. colon flora and leads to an overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of diarrhea. Strains of C. difficile that produce excess toxins cause increased morbidity and mortality rates, as these infections are typically refractory to antibacterial therapy and often require colectomy. The possibility of C. difficile-associated diarrhea should be considered in all patients who present with diarrhea following antibiotic treatment. A careful medical history is also required as cases of C. difficile associated diarrhea have been reported even more than two months after antibiotic administration.
Tetracyclines can aggravate muscle weakness in patients with myasthenia gravis and cause worsening of systemic lupus erythematosus.
There have been reports of oesophageal ulcer, particularly after ingestion of capsules with little water at bedtime. Therefore Minocin should be taken with at least half a glass of water in a standing or sitting position and at least 1 hour before going to bed.
Pregnancy:
Ask your doctor for advice from your pharmacist before taking any medicine.
Minocycline crosses the placental barrier. Like other tetracyclines, minocycline can delay embryo-fetal skeletal development. Therefore, the use of this drug during pregnancy is not recommended.If a patient becomes pregnant while taking MINOCIN, discontinuation of treatment is recommended.
Feeding time:
Minocycline is excreted in breast milk. Treatment with MINOCIN is not recommended for women who are breastfeeding.
Driving and using machines:
Lightheadedness, visual disturbances, dizziness, tinnitus and vertigo have occurred during treatment with minocycline; patients should therefore be warned of the possible risks of driving or operating machines during treatment with Minocin
Dosage and method of use How to use Minocin: Dosage
The usual posology of MINOCIN, minocycline, for adults is 200 mg initially and 100 mg every 12 hours thereafter.
In the treatment of non-gonococcal urethritis, MINOCIN should be administered at the dosage of 1 capsule of 50 mg every 12 hours or 1 capsule of 100 mg in a single administration.
In the treatment of acne vulgaris, MINOCIN should be administered at a dosage of 1 capsule of 50 mg every 12 hours or 1 capsule of 100 mg in a single administration for 6 weeks. In case of persistence of the disease after 6 months of treatment, it is recommended to suspend of the drug.
In the treatment of non-gonococcal genitourinary infections (cervicitis, urethritis), MINOCIN should be administered, between meals, at a dosage of 1 capsule of 50 mg every 12 hours or 1 capsule of 100 mg in a single administration for 7 days.
In the treatment of gonococcal infections, brucellosis, chlamydial ocular and lung infections, rickettsiosis, Q fever, Haemophilus influenzae ENT infections, spirochetosis and cholera, MINOCIN should be administered at a dosage of 100 mg every 12 hours. away from meals.
In the treatment of acute exacerbations of chronic bronchitis, MINOCIN should be administered at a dosage of 100 mg / day, taken between meals
To avoid esophageal irritation, take the product with an "adequate amount of water", in a standing or sitting position and at least 1 hour before going to bed.
All antibiotics should be used at full dosage for at least 5 days, before they are considered ineffective. It is good practice to prolong therapy for 1-2 days after the symptoms have disappeared.
Particular dosage regimens
In subjects with renal insufficiency, since even normal doses of tetracyclines can cause accumulation in the circulation with possible liver damage, the attending physician will adapt the dosage to the degree of renal function, resorting, if necessary, to blood level checks (which should not never exceed 15 mcg / ml) and liver function.
Overdose What to do if you have taken too much Minocin
Following accidental ingestion of excessive doses, it is advisable to contact your doctor.
In case of accidental ingestion / intake of an excessive dose of MINOCIN, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT USING MINOCIN, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Minocin
Like all medicines, MINOCIN can cause side effects, although not everybody gets them.
Suspected adverse reactions are listed by system organ class and by frequency, classified as: very common (> 1/10); common (≥1 / 100,
- Gastrointestinal disorders:
common: Nausea, vomiting, dyspepsia, diarrhea
Uncommon: stomatitis, glossitis, dental discoloration. rare: enterocolitis, esophagitis
Very rare: pancreatitis, pseudo-membranous colitis, dysphagia, oesophageal ulcers, dental enamel hypolasia
- Hepatobiliary disorders:
uncommon: increased liver enzymes rare: hepatitis, jaundice, hepatic cholestasis, hepatic failure, autoimmune hepatotoxicity very rare: hyperbilirubinaemia
not known: autoimmune hepatitis
- Skin and subcutaneous tissue disorders:
uncommon: erythematous and maculo-papular rash, skin and nail hyperpigmentation, photosensitivity
rare: exfoliative dermatitis, erythema multiforme, erythema nodosum, pruritus, fixed drug eruption
Very rare: Stevens Johnson syndrome, toxic epidermal necrolysis, angioedema, alopecia
- Nervous system disorders:
common: dizziness, vertigo, uncommon: headache, visual disturbances
Rare: hypoesthesia, paraesthesia
Very rare: intracranial hypertension, not known rounded fontanelles: convulsions, sedation
- Immune system disorders:
uncommon: angioedema, urticaria rare: anaphylactoid reactions / anaphylaxis, DRESS syndrome, drug reaction with eosinophilia and systemic symptoms (characterized by fever, rash, lymphadenopathy, eosinophilia, leukocytosis, liver function index abnormality, hepatitis).
not known: hypersensitivity, pulmonary infiltrates, anaphylactoid purpura, polyarthritis nodosa
- Infections and infestations:
rare: oral and anogenital candidiasis, vulvovaginitis
- Musculoskeletal and connective tissue disorders:
uncommon: myalgia, altralgia
Rare: systemic lupus erythematosus, polymyositis, lupus-like syndrome
Very rare: arthritis, joint stiffness and joint swelling, exacerbation of systemic lupus erythematosus
- Respiratory, thoracic and mediastinal disorders:
uncommon: dyspnoea, bronchospasm
Rare: cough, pneumonia, exacerbation of asthma, pulmonary eosinophilia
- Disorders of the blood and lymphatic system:
rare: leukopenia, neutropenia, thrombocytopenia, eosinophilia
Very rare: agranulocytosis, haemolytic anemia, aplastic anemia, pancytopenia
not known: decrease in prothrombin activity
- Renal and urinary disorders:
very rare: interstitial nephritis, acute renal failure, increased uricaemia.
- Cardiac disorders:
rare: myocarditis, pericarditis, vasculitis
- Endocrine disorders:
very rare: abnormal thyroid function, including thyroiditis, thyroid nodules, goiter and thyroid cancer. Brown pigmentations of the thyroid gland
- Metabolism and nutrition disorders:
rare: anorexia
- Ear and labyrinth disorders:
rare: tinnitus, hypoacusis, vestibular disorders
- Diseases of the reproductive system and breast
Very rare: balanitis
- General disorders and administration site conditions
Uncommon: fever
Very rare: discolouration of secretions.
- Eye disorders
Not known: visual disturbances, scotoma and double vision. Pigmentation of the cornea, sclera and retina has been reported.
The following syndromes have been reported. In some cases where these syndromes have occurred, the patient's death has been reported. As with other serious adverse reactions, if any of these syndromes is diagnosed, the medicinal product should be discontinued.
Hypersensitivity syndrome consisting of skin reactions (e.g. rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonia, nephritis, myocarditis, pericarditis. Fever and lymphadenopathy may be present.
Lupus-like syndrome consisting of positive antinuclear antibodies, arthralgia, arthritis, joint stiffness or joint swelling, and one or more of the following: fever, myalgia, hepatitis, rash, vasculitis.
Serum sickness-like syndrome with fever, hives or rash and arthralgia, arthritis, joint stiffness and joint swelling. Eosinophilia may be present.
Systemic symptoms and eosinophilia (DRESS) in patients treated for acne. Upon early recognition of DRESS symptoms, a specialist consultation and immediate discontinuation of minocycline therapy is recommended. Post-marketing data showed that fatal cases of eosinophilia and systemic symptoms (DRESS) occurred in acne patients treated with minocycline.
Hyperpigmentation of various areas of the body has been reported, including skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, tear secretions and sweat. This blue / black / gray or brown color can be localized or diffuse. The most frequently reported area is the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases. Generalized brown skin pigmentation may persist, particularly in areas exposed to the sun.
Hepato-biliary system
As with other tetracyclines, increased liver function test values and rarely hepatitis, and acute liver failure have been reported. This may or may not be associated with the presence of autoantibodies. In prolonged therapies (> 6 months) periodic checks of liver function and tests for anti-nuclear factors should be performed.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly through the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package. The expiry date indicated refers to the product in intact packaging, correctly stored. WARNING: do not use the medicine after the expiry date shown on the package. Do not store above 25 ° C Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment. KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
COMPOSITION
- MINOCIN 50 mg hard capsules
One hard capsule contains:
Active ingredient: 54 mg minocycline hydrochloride equivalent to 50 mg minocycline.
Excipients: magnesium stearate, starch, erythrosine (E 127), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
- MINOCIN 100 mg hard capsules
One hard capsule contains:
Active ingredient: 108 mg minocycline hydrochloride equivalent to 100 mg minocycline.
Excipients: magnesium stearate, starch, erythrosine (E 127), indigo carmine (E 132), titanium dioxide (E 171), gelatin.
PHARMACEUTICAL FORM AND CONTENT
- Box of 16 capsules of 50 mg in blister.
- Box of 8 capsules of 100 mg in blister.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MINOCIN HARD CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
MINOCIN 100 mg hard capsules
One capsule contains: Active ingredient: 108 mg minocycline hydrochloride (equivalent to 100 mg minocycline)
MINOCIN 50 mg hard capsules
One capsule contains: Active ingredient: 54 mg minocycline hydrochloride (equivalent to 50 mg minocycline)
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Hard capsules for oral use
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
MINOCIN is a tetracycline indicated, in adult patients and children aged> 12 years, in the treatment of numerous infections caused by gram-positive and gram-negative microorganisms sensitive to tetracycline.
These infections include:
Respiratory infections: pneumonia (lobar or plurilobar), bronchitis, bronchopneumonia, bronchiolitis, lung abscess, laryngotracheitis, tracheobronchitis.
Infections of the genitourinary tract: uncomplicated urinary tract infections, cystitis, prostatitis, gonococcal and non-gonococcal urethritis, pelvic inflammatory disease.
Skin and soft tissue infections: abscesses, acne (including cystic and pustular types), cellulite, infected dermatitis, folliculitis, furunculosis, impetigo, lymphadenitis, suppurative hidradenitis, paronychia, pyoderma, wound infections.
Ear, nose and throat infections: otitis media and externa, bacterial rhinitis, sinusitis, tonsillitis, pharyngitis.
Eye infections: acute conjunctivitis, dacryocystitis, styes.
In addition, microbiological researches have demonstrated the activity of MINOCIN in regard to the following pathologies: diphtheria, erythrasma, mycoplasma pneumonia, meningitis (prophylaxis), salmonellosis (paratyphus), bacillary dysentery, actinomycosis, malignant pustule, puerperal infections, bartonellosis (disease of Carrion), whooping cough, relapsing fever, brucellosis, gas gangrene, granuloma inguinale (donovanosis) acute intestinal amoebiasis, tularemia, listeriosis, plague, petechial typhus, Q fever, Rocky Mountain fever, vesicular rickettsiosis, rat-bite fever, syphilis, Vincent's infections, yaws, cholera, venereal lymphogranuloma, psittacosis and trachoma.
04.2 Posology and method of administration
The usual posology of MINOCIN, minocycline, for adults is 200 mg initially and 100 mg every 12 hours thereafter.
In the treatment of non-gonococcal urethritis, MINOCIN should be administered at the dosage of 1 capsule of 50 mg every 12 hours or 1 capsule of 100 mg in a single administration.
In the treatment of acne vulgaris, MINOCIN should be administered at the dosage of 1 capsule of 50 mg every 12 hours or 1 capsule of 100 mg in a single administration for a minimum of 6 weeks. In case of persistence of the disease after 6 months of treatment, recommends discontinuing the drug.
In the treatment of non-gonococcal genitourinary infections (cervicitis, urethritis), MINOCIN should be administered, between meals, at a dosage of 1 capsule of 50 mg every 12 hours or 1 capsule of 100 mg in a single administration for 7 days.
In the treatment of gonococcal infections, brucellosis, chlamydial ocular and lung infections, rickettsiosis, Q fever, Haemophilus influenzae ENT infections, spirochetosis and cholera, MINOCIN should be administered at a dosage of 100 mg every 12 hours. away from meals.
In the treatment of acute exacerbations of chronic bronchitis the MINOCIN
should be administered at a dosage of 100 mg / day, taken between meals.
To avoid esophageal irritation, take the drug with an "adequate amount of" water, in a standing or sitting position and at least 1 hour before going to bed.
Particular dosage regimens :
Pediatric patients:
in children> 12 years of age, the recommended dose of minocycline is 100 mg total divided into two doses per day.
In subjects with renal insufficiency, since even normal doses of tetracyclines can cause accumulation in the circulation with possible liver damage, the attending physician will adapt the dosage to the degree of renal function, resorting, if necessary, to blood level checks (which should not never exceed 15 mcg / ml) and liver function.
04.3 Contraindications
Hypersensitivity to the active substance, to other tetracyclines or to any of the excipients.
Severe renal insufficiency.
Minocin should not be administered to children under 12 years of age, pregnant and breastfeeding (see sections 4.4 and 4.6).
04.4 Special warnings and appropriate precautions for use
Patients with hepatic dysfunction: Cases of hepatotoxicity have been reported following the use of minocycline and other tetracyclines; therefore Minocin should be used with caution in patients with hepatic dysfunction and at lower doses. In case of prolonged treatment, periodic monitoring may be useful. liver enzymes. If symptoms suggestive of liver dysfunction occur, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and dark urine, liver enzymes should be checked. upper limit of normal or in case of jaundice, therapy should be suspended.
Rare cases of autoimmune hepatotoxicity (including acute liver failure) have been reported in isolated cases of systemic lupus erythematosus and also exacerbation of pre-existing systemic lupus erythematosus. If the patient develops signs and symptoms of lupus or hepatotoxicity or exacerbation of pre-existing lupus erythematosus occurs, Minocin should be discontinued.
Breathing difficulties: Cases of breathing difficulties including dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia and pneumonia (see section 4.8) have been reported with the use of minocycline; if the patient develops difficulty in breathing, they should seek urgent medical attention and discontinue treatment with minocycline.
Cross resistance between tetracyclines can result in sensitivity to microorganisms and cross resistance in patients. The use of tetracyclines can cause the overgrowth of non-sensitive germs such as Candida (oral candidiasis, vulvovaginitis, anal pruritus) and coliform bacteria such as Pseudomonas and Proteus which can cause diarrhea. If symptoms of growth of resistant organisms such as enteritis occur, glossitis, stomatitis, vaginitis, pruritus and / or staphylococcal enteritis, Minocin must be discontinued.
Clinical studies have shown that when patients with renal insufficiency are treated with minocycline at the recommended dose, there is no accumulation of the drug in significant amounts; however, in such patients it is advisable to proceed with caution, possibly reducing the amount of doses.
In subjects with renal insufficiency, even normal doses of tetracyclines can give rise to an accumulation in the circulation with possible liver damage; in these cases it is necessary to adapt the posology to the degree of renal function, resorting, if necessary, to checks on blood levels (which should never exceed 15 mcg / ml) and liver function.
It should also be kept in mind that tetracyclines exert an "antianabolic action which can aggravate states of renal insufficiency.
Skin Pigmentation: The use of Minocycline and other tetracyclines is associated with pigmentation of the skin, nails and other tissues. Dark blue spots may appear in inflamed and scarred areas. Gray-blue or hyperpigmentation spots may appear in areas of skin Normal Gray-brown patches may occur in areas of sun-exposed skin. Generally, skin pigmentation resolves slowly after discontinuation of the drug. Patients should be advised to report any hyperpigmentation without delay and to discontinue treatment with Minocin. Darker-skinned people often show more intense hyperpigmentation than fair-skinned people.
Dental and bone deposition: tetracyclines can be deposited in the teeth and bones during the period of formation and growth, cause hypoplasia and a change in tooth color (yellow-brown pigmentation); therefore Minocin should not be administered to children under 12 years of age, pregnant and lactating (see sections 4.6 and 4.3).
Hypersensitivity reactions: The use of Minocin, like other tetracyclines, has been associated with hypersensitivity reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, Minocin should be discontinued at the first appearance of skin rash, mucosal lesions or any sign of hypersensitivity Other hypersensitivity reactions may include urticaria, angioedema, pulmonary infiltrates, anaphylaxis, haematological disorders, pericarditis, myocarditis and vasculitis.
Patients with dark or black skin (phototype V and VI): cases of DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) have been reported following the use of minocycline in the treatment of acne. The syndrome, which presents with skin rash, fever, swollen lymph nodes and increased eosinophils, has occurred more frequently in patients with phototype V and VI; therefore, MINOCIN should be used with caution in such subpopulations.
Nervous system side effects such as dizziness, lightheadedness, instability, hearing loss and headache have been observed. These symptoms generally tend to disappear during the course of treatment and quickly after discontinuation.
Cases of domed fontanelles in neonates and benign intracranial hypertension in adults have been reported with full dose intake. These effects resolved rapidly upon discontinuation of treatment. Headache and visual disturbances, including blurred vision, scotoma and diplopia, may indicate benign intracranial hypertension ("pseudotumor cerebri") requiring prompt discontinuation of treatment.
Cases of Clostridium difficile associated diarrhea (CDAD) have been reported with the use of nearly all antibiotics, including tetracyclines, and can range in severity from mild diarrhea to fatal colitis. Treatment with antibiotics alters normal flora. colon and leads to an overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of diarrhea. Strains of C. difficile that produce excess toxins cause increased morbidity and mortality rates, as these infections are typically refractory to antibacterial therapy and often require colectomy. The possibility of C. difficile-associated diarrhea should be considered in all patients who present with diarrhea following antibiotic treatment. A careful medical history is also required as cases of C. difficile associated diarrhea have been reported even more than two months after antibiotic administration.
Patients who expose themselves to direct sunlight should be warned that they may have an overreaction to sun exposure (photosensitivity) while using Minocin.
Tetracyclines can aggravate muscle weakness in patients with myasthenia gravis.
There have been reports of oesophageal ulcer, particularly after ingestion of capsules with little water at bedtime. Therefore Minocin should be taken with at least half a glass of water in a standing or sitting position and at least 1 hour before going to bed.
04.5 Interactions with other medicinal products and other forms of interaction
Oral absorption of tetracyclines is reduced by:
• antacid preparations containing aluminum, calcium and magnesium,
• foods based on milk or dairy products,
• products containing iron salts, and preparations containing zinc and bismuth orally
It is therefore advisable to avoid simultaneous intakes and to distance the administration of the aforementioned products from that of tetracyclines (at least 2 hours, if possible).
There have been rare reports in the literature of increased plasma concentrations of lithium, methotrexate, digoxin and ergot derivatives following concomitant administration of tetracyclines.
Penicillins and cephalosporins
The association of tetracyclines, including minocycline, with penicillins and cephalosporins should be avoided, due to the possible occurrence of interferences between the respective
antibacterial activity.
Oral contraceptives
Taking tetracyclines may decrease the effectiveness of oral contraceptive treatments. Some cases of pregnancy or intermenstrual blood loss have been attributed to the concomitant use of tetracyclines with oral contraceptives.
Tetracyclines may increase the effect of coumarin anticoagulants and therefore a reduction in the dose of the latter may be necessary.
Concomitant use not recommended:
Systemic retinoids:
co-administration with tetracyclines increases the risk of developing benign intracranial hypertension (a reversible increase in intracranial pressure).
Methoxyflurane:
co-administration with tetracyclines has resulted in fatal case reports of nephrotoxicity.
Interactions with laboratory investigations
False increases in urinary catecholamine levels may occur due to interference with the fluorescence test.
04.6 Pregnancy and lactation
Minocycline crosses the placental barrier. Like other tetracyclines, minocycline can delay embryo-fetal skeletal development. Therefore, the use of this drug during pregnancy is not recommended.
If a patient becomes pregnant while taking Minocin, discontinuation of treatment is advised.
Minocycline is excreted in breast milk. Treatment with Minocin is not recommended for women who are breastfeeding.
04.7 Effects on ability to drive and use machines
Lightheadedness, visual disturbances, dizziness, tinnitus and vertigo have occurred during treatment with minocycline; patients should therefore be warned of the possible risks of driving or operating machines during treatment with Minocin.
04.8 Undesirable effects
Adverse reactions are listed by system organ class and by frequency. Frequencies are defined as: common (≥1 / 100;
- Gastrointestinal disorders:
common: Nausea, vomiting, dyspepsia, diarrhea
Uncommon: stomatitis, glossitis, dental discoloration. rare: enterocolitis, esophagitis
Very rare: pancreatitis, pseudo-membranous colitis, dysphagia, oesophageal ulcers, dental enamel hypolasia
• Hepatobiliary disorders:
Uncommon: increased liver enzymes
Rare: hepatitis, jaundice, hepatic cholestasis, hepatic failure, autoimmune hepatotoxicity
Very rare: hyperbilirubinaemia
not known: autoimmune hepatitis
- Skin and subcutaneous tissue disorders:
Uncommon: erythematous and maculo-papular rash, skin and nail hyperpigmentation, photosensitivity
Rare: exfoliative dermatitis, erythema multiforme, erythema nodosum, pruritus, fixed drug eruption
Very rare: Stevens Johnson syndrome, toxic epidermal necrolysis, angioedema, alopecia
- Nervous system disorders:
common: dizziness, vertigo,
Uncommon: headache, rare visual disturbances: hypoesthesia, paraesthesia
Very rare: intracranial hypertension, rounded fontanelles
not known: convulsions, sedation
- Disorders of the immune system:
Uncommon: angioedema, urticaria
Rare: anaphylactoid reactions / anaphylaxis, DRESS syndrome, drug reaction with eosinophilia and systemic symptoms (characterized by fever, rash, lymphadenopathy, eosinophilia, leukocytosis, liver function index abnormality, hepatitis).
not known: hypersensitivity, pulmonary infiltrates, anaphylactoid purpura, polyarthritis nodosa
- Infections and infestations:
rare: oral and anogenital candidiasis, vulvovaginitis
- Musculoskeletal and connective tissue disorders:
Uncommon: myalgia, altralgia
Rare: systemic lupus erythematosus, polymyositis, lupus-like syndrome
Very rare: arthritis, joint stiffness and joint swelling, exacerbation of systemic lupus erythematosus
- Respiratory, thoracic and mediastinal disorders:
Uncommon: dyspnoea, bronchospasm
Rare: cough, pneumonia, exacerbation of asthma, pulmonary eosinophilia
- Disorders of the blood and lymphatic system:
rare: leukopenia, neutropenia, thrombocytopenia, eosinophilia
Very rare: agranulocytosis, haemolytic anemia, aplastic anemia, pancytopenia not known: decrease in prothrombin activity
- Renal and urinary disorders:
very rare: interstitial nephritis, acute renal failure, increased uricaemia.
- Cardiac disorders:
rare: myocarditis, pericarditis, vasculitis
- Endocrine pathologies:
very rare: abnormal thyroid function, including thyroiditis, thyroid nodules, goiter and thyroid cancer. Brown pigmentations of the thyroid gland
• Metabolism and nutrition disorders:
rare: anorexia
- Ear and labyrinth disorders:
rare: tinnitus, hypoacusis, vestibular disorders
- Reproductive system and breast disorders
Very rare: balanitis
- General disorders and administration site conditions
Uncommon: fever
Very rare: discolouration of secretions.
- Eye disorders
not known: visual disturbances, scotoma and double vision. Pigmentation of the cornea, sclera and retina has been reported.
The following syndromes have been reported. In some cases where these syndromes have occurred, the patient's death has been reported. As with other serious adverse reactions, if any of these syndromes is diagnosed, the medicinal product should be discontinued.
Hypersensitivity syndrome consisting of skin reactions (e.g. rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonia, nephritis, myocarditis, pericarditis. Fever and lymphadenopathy may be present.
Lupus-like syndrome consisting of positive antinuclear antibodies, arthralgia, arthritis, joint stiffness or joint swelling, and one or more of the following: fever, myalgia, hepatitis, rash, vasculitis.
Serum sickness-like syndrome with fever, hives or rash and arthralgia, arthritis, joint stiffness and joint swelling. Eosinophilia may be present.
Systemic symptoms and eosinophilia (DRESS) in patients treated for acne. Upon early recognition of DRESS symptoms, a specialist consultation and immediate discontinuation of minocycline therapy is recommended. Post-marketing data showed that fatal cases of eosinophilia and systemic symptoms (DRESS) occurred in acne patients treated with minocycline.
Hyperpigmentation of various areas of the body has been reported, including skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, tear secretions and sweat. This blue / black / gray or brown color can be localized or diffuse. The most frequently reported area is the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases. Generalized brown skin pigmentation may persist, particularly in areas exposed to the sun.
Hepato-biliary system As with other tetracyclines, increased liver function test values and rarely hepatitis, and acute liver failure have been reported. This can bebe associated or not with the presence of auto-antibodies. In prolonged therapies (> 6 months) periodic checks of liver function and tests for anti-nuclear factors should be performed.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No signs of acute overdose have been reported. In case of overdose, institute supportive measures and symptomatic treatment.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use. ATC code J01AA08.
Minocycline is a semi-synthetic antibiotic with a spectrum of activity and
mechanism of action similar to that of tetracyclines but is more active on many species including Staphylococcus aureus, streptococci, Neisseria meningitidis, various enterobacteria, Acinetobacter, Bacteroides, Haemophilus, Nocardia, Propionibacterium acnes and some mycobacteria.
Although there is partial cross-resistance, some strains resistant to various tetracyclines remain sensitive to minocycline probably due to better penetration into the bacterial wall.
05.2 Pharmacokinetic properties
Minocycline is rapidly absorbed following oral administration. Absorption is not significantly affected by the presence of food in the stomach. It reaches its peak after approximately 2 hours, with serum rates 2 to 4 times higher than most tetracyclines at all time points. Given the prolonged biological half-life. (approximately 16 hours), minocycline can also be administered as a single daily dose. In patients with hepatic dysfunction the half-life is longer. The majority of studies in patients with renal impairment of varying degrees did not show significant differences in pharmacokinetic parameters when compared to those in healthy patients. Due to the favorable lipid / water partition coefficient, minocycline is widely distributed in the tissues. Elimination occurs mainly via the biliary route and to a small extent via the urinary route in active form. The quantity of active drug recovered in the faeces after oral administration varies between 20% and 34%.
05.3 Preclinical safety data
Toxicology:
The LD50 in mice ranges from 140 mg / kg per i.v. to 3000 mg / kg per os.
High-dose tetracyclines may exhibit some degree of nonspecific toxicity to fetuses.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Minocin 50 mg hard capsules
Magnesium stearate, Starch, Erythrosine (E 127), Yellow iron oxide (E 172), Titanium dioxide (E 171), Gelatin.
Minocin 100 mg hard capsules
Magnesium stearate, pregelatinised starch, Erythrosine (E 127), Indigo carmine (E 132), Titanium dioxide (E 171), Gelatin.
06.2 Incompatibility
The association with antacids based on aluminum, calcium or magnesium which reduce the oral absorption of tetracyclines should be avoided.
The absorption of Minocin is not significantly affected by the ingestion of milk or dairy foods.
06.3 Period of validity
2 years.
The expiry date refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C
06.5 Nature of the immediate packaging and contents of the package
MINOCIN 100 mg hard capsules
8 hard capsules in blister packs
16 hard capsules in blister packs
MINOCIN 50 mg hard capsules
16 hard capsules in blister packs
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
Teofarma S.r.l. Via F.lli Cervi, 8
27010 Salimbene Valley (PV)
08.0 MARKETING AUTHORIZATION NUMBER
MINOCIN 100 mg hard capsules
8 hard capsules 100 mg: A.I.C. No. 022240016
16 hard capsules 100 mg: A.I.C. N. 022240028 (suspended)
MINOCIN 50 mg hard capsules
16 hard capsules 50 mg: A.I.C. No. 022240129
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
MINOCIN 100 mg hard capsules 11.27.1971 / June 2010
MINOCIN 50 mg hard capsules 09.03.1987 / June 2010
