Minocin: detailed information

MINOCIN 50 mg, hard capsules
MINOCIN 100 mg, hard capsules
Minocycline hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet
1. What MINOCIN is and what it is used for
2. What you need to know before taking MINOCIN
3. How to take MINOCIN
4. Possible side effects
5. How to store MINOCIN
6. Contents of the pack and other information

1. What MINOCIN hard capsules are and what they are used for

Minocin contains the active substance minocycline. Minocycline is an antibiotic belonging to the tetracycline family (antibacterials) which acts against infections that can affect various parts of the body.
Minocin is used to treat:

Respiratory tract infections: pneumonias (lobar or multilobar), bronchitis, bronchopneumonia, bronchiolitis, lung abscesses, laryngotracheitis, tracheobronchitis.
Genitourinary tract infections: 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), cellulitis, 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.
Furthermore, recent research has demonstrated the activity of MINOCIN against the following conditions: diphtheria, erythrasma, mycoplasma pneumonia, meningitis (prophylaxis), salmonellosis (paratyphoid), bacillary dysentery, actinomycosis, anthrax, puerperal infections, bartonellosis (Carrion's disease), pertussis, relapsing fever, brucellosis, gas gangrene, granuloma inguinale (donovanosis), acute intestinal amoebiasis, tularemia, listeriosis, plague, typhus fever, Q fever, Rocky Mountain spotted fever, vesicular rickettsiosis, rat-bite fever, syphilis, Vincent's infections, framboesia, cholera, lymphogranuloma venereum, psittacosis and trachoma.

2. What you should know before taking MINOCIN

Do not take MINOCIN:

if you are allergic to minocycline hydrochloride, to any other tetracycline, or to any of the other ingredients of this medicine (listed in section 6)
if you have severe renal impairment (severe kidney disease)
if you are breastfeeding or pregnant (see section “Pregnancy and breastfeeding”)
if the patient is a child under 12 years of age (see “Warnings and precautions”)

Warnings and precautions
Talk to your doctor or pharmacist before taking MINOCIN.

If in the past you experienced an allergic reaction to minocycline, to a tetracycline, or to any antibiotic after taking an antibiotic, inform your doctor before taking MINOCIN. In case of an allergic reaction, stop treatment with MINOCIN immediately and go to the nearest hospital.

Hypersensitivity reactions: the use of MINOCIN, like other tetracyclines, has been associated with hypersensitivity reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, hepatitis, and drug-induced systemic lupus erythematosus (see section “Undesirable effects”), particularly in patients receiving long-term treatment for acne. MINOCIN should be discontinued at the first sign of skin rash, mucosal lesions, or any sign of hypersensitivity. Other hypersensitivity reactions may include urticaria, angioedema, pulmonary infiltrates, anaphylaxis, hematological disorders, pericarditis, myocarditis, and vasculitis (see section “Undesirable effects”).

Indiscriminate use of tetracyclines may lead to overgrowth of non-susceptible organisms such as Candida (oral candidiasis, vulvovaginitis, anal itching) and certain bacteria such as Pseudomonas and Proteus, which may cause diarrhea.
A photosensitization reaction, manifesting as an exaggerated skin reaction to sunlight and ultraviolet rays, may occur during treatment with a tetracycline in sensitive individuals; if exposure to direct sunlight or UV rays is necessary, treatment with minocycline should be suspended as soon as a skin rash appears.
When treating infections caused by gonococcus (bacteria), care should be taken to avoid masking symptoms of coexisting syphilis: in such cases, blood tests should be performed for at least 4 months.
Skin pigmentation (change in skin color): the use of minocycline and other tetracyclines has been associated with increased pigmentation of the skin, nails, and other tissues (see section “Undesirable effects”).
Bluish-black spots may appear in inflamed or scarred areas.
Grey-blue spots or hyperpigmentation may appear in areas of otherwise normal skin.
Grey-brown spots may develop in areas of skin exposed to sunlight. Generally, skin pigmentation resolves slowly after discontinuation of the drug.
Hepatic impairment (liver problems): the use of minocycline and other tetracyclines may cause serious liver disorders. If you experience symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia (weight loss), or dark urine, consult your doctor.
During treatment with minocycline, symptoms such as instability (loss of balance), dizziness, and vertigo may occur. These symptoms resolve rapidly after discontinuation of the drug.
If you experience symptoms such as headache or visual disturbances, stop treatment immediately and consult your doctor.
If you have myasthenia gravis (a neuromuscular disease), the use of minocycline may worsen muscle weakness.
If you have systemic lupus erythematosus (a chronic inflammatory disease), the use of minocycline may exacerbate the condition.
The use of minocycline, particularly in acne treatment and in patients with skin phototypes V and VI, has been associated with the occurrence of DRESS syndrome, a severe drug reaction characterized by fever, rash, lymphadenopathy, eosinophilia, leukocytosis, abnormal liver function tests, and hepatitis. If one or more symptoms of DRESS syndrome occur, immediate discontinuation of the drug is recommended, and your doctor or pharmacist should be informed.
Cases of bulging fontanelles in newborns and benign intracranial hypertension in adults have been reported with full-dose therapy. These effects resolved rapidly upon discontinuation of treatment. The onset of headache and visual disturbances, including blurred vision, scotoma, and diplopia, may indicate benign intracranial hypertension (“pseudotumor cerebri”), which requires prompt discontinuation of treatment (refer to section 4, “Possible side effects”).
Respiratory difficulties: cases of respiratory difficulties including dyspnea, bronchospasm, asthma exacerbation, pulmonary eosinophilia, and pneumonia (see section 4) have been reported with minocycline use; if the patient develops breathing difficulties, medical attention should be sought urgently and treatment with minocycline should be discontinued.

Children
Dental and bone deposition: tetracyclines may deposit in teeth and bones during periods of formation and growth, causing dental hypoplasia and discoloration (yellow-brown pigmentation); therefore, MINOCIN must not be administered to children under 12 years of age, during pregnancy, or while breastfeeding.

Other medicines and MINOCIN, hard capsules
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Talk to your doctor if you are taking any of the following medicines:

Antacid preparations containing aluminium, calcium, or magnesium (used for certain digestive disorders); since these reduce the absorption and therefore the effectiveness of MINOCIN, therefore you must separate the administration of these medicines from MINOCIN by at least 2 hours, if possible.
Oral treatments containing iron, zinc, or bismuth;
Oral contraceptives (because reduced contraceptive effectiveness may occur, leading to unintended pregnancies or intermenstrual bleeding);
A vitamin K antagonist anticoagulant (coumarin derivative). MINOCIN may enhance the effect of these anticoagulants, so a dose reduction may be necessary.

Concomitant use not recommended with MINOCIN and:

Systemic retinoids; co-administration increases the risk of benign intracranial hypertension (a reversible increase in pressure inside the skull).
Methoxyflurane; co-administration has led to fatal cases due to nephrotoxic effects.

MINOCIN may affect laboratory tests
False increases in urinary catecholamine levels may occur due to interference with fluorescence testing.

Rare interactions between MINOCIN and the following have been reported:

Lithium (used for mental disorders)
Methotrexate (used for immune disorders or cancer therapy)
Digoxin (used for heart conditions)
Ergotamine derivatives (used for acute migraine and other disorders)

Concomitant administration of MINOCIN with Penicillins or Cephalosporins (antibiotic drugs for the treatment of infections) should be avoided.

MINOCIN with food and drink
Milk and dairy products may reduce the absorption of MINOCIN, and therefore should be consumed at least two hours apart from the medicine.
Cases of esophageal ulceration have been reported, particularly after swallowing capsules with little water just before lying down. Therefore, MINOCIN should be taken with at least half a glass of water, while sitting or standing upright, and at least one hour before going to bed.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

The use of MINOCIN is not recommended during pregnancy. This medicine, like other tetracyclines, crosses the placenta and may impair skeletal development in the unborn child. 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.

Driving and using machines
MINOCIN may cause visual disturbances, dizziness, tinnitus, and vertigo. Therefore, before driving or operating machinery, make sure you are aware of how this medicine affects you.

3. How to take MINOCIN, hard capsules

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

The usual initial dose in adults is 200 mg, followed by 100 mg every 12 hours.

Treatment of acne: MINOCIN should be administered at a dosage of one 50 mg capsule every 12 hours or one 100 mg capsule once daily (treatment should continue for at least 6 weeks).

Treatment of non-gonococcal genitourinary infections (cervicitis, urethritis): MINOCIN should be administered on an empty stomach at a dosage of one 50 mg capsule every 12 hours or one 100 mg capsule once daily for 7 days.

Treatment of gonococcal infections, brucellosis, ocular and pulmonary chlamydial infections, rickettsial diseases, Q fever, otolaryngological infections due to Haemophilus influenzae, spirochetoses, and cholera: MINOCIN should be administered at a dosage of 100 mg every 12 hours, taken on an empty stomach.

Treatment of acute exacerbations of chronic bronchitis: MINOCIN should be administered at a dosage of 100 mg daily, taken on an empty stomach.

Patients with renal impairment: Since even normal doses of tetracyclines may lead to accumulation in the bloodstream with possible liver damage, your treating physician will adjust the dosage according to the severity of renal impairment and may, if necessary, monitor blood levels (which should never exceed 15 mcg/ml) and liver function.

Use in children (over 12 years of age)
The recommended dose of Minocin is 100 mg total, divided into two daily doses, according to the instructions provided by the doctor.

Method of administration
To avoid irritation of the oesophagus (the tube connecting the throat to the stomach), take the capsule with at least half a glass of water, while standing or sitting upright, and at least 1 hour before going to bed.

Duration of treatment
All antibiotics should be used at full dosage for at least 5 days before being considered ineffective. Your doctor will advise you on how long to continue treatment (therapy is normally continued for 1–2 days after symptoms have disappeared).

If you take more MINOCIN, hard capsules than you should
In case of accidental ingestion/overdose of MINOCIN, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following the instructions contained in this leaflet reduces the risk of side effects.

Common side effects (≥1/100, <1/10)

Nausea, vomiting, dyspepsia (stomach digestive disorders), diarrhoea
Dizziness, vertigo

Uncommon side effects (≥1/1,000, <1/100)

Stomatitis (inflammation of the oral mucosa), glossitis (inflammation of the tongue), tooth discoloration
Increased liver enzymes
Maculopapular erythematous rash (skin rash with red patches), hyperpigmentation (excessive increase in coloration) of the skin, nails, teeth, oral mucosa, bones, thyroid, and eyes (including sclera and conjunctiva), photosensitivity (abnormal skin reaction to sunlight)
Headache, visual disturbances*
Fever, urticaria (skin rash with hives and itching)
Myalgia (muscle pain), arthralgia (joint pain)
Dyspnoea (difficulty breathing), bronchospasm (narrowing of the bronchi)

Rare side effects (≥1/10,000, <1/1,000)

Enterocolitis (inflammation of the intestinal mucosa), oesophagitis (inflammation of the oesophagus)
Hepatitis (liver inflammation), jaundice (yellowing of the skin and whites of the eyes due to elevated bilirubin levels in the blood), hepatic cholestasis (interruption of bile flow), liver failure, autoimmune hepatitis
Anorexia (weight loss)
Tinnitus (ringing in the ears), hypoacusis (reduced hearing), vestibular disorders
Exfoliative dermatitis (skin inflammation with peeling), erythema multiforme, erythema nodosum, pruritus (itching), drug-induced fixed eruption
Anaphylactoid/anaphylactic reactions (severe allergic reactions)
Oral and ano-genital candidiasis (localized fungal infection), vaginitis (inflammation of the vagina)
Systemic lupus erythematosus, polymyositis (inflammatory muscle disease), lupus-like syndrome
Pneumonia (lung infection), cough, worsening of asthma, pulmonary eosinophilia
Leucopenia (reduction in certain white blood cells), neutropenia (decrease in certain blood cells), thrombocytopenia (reduction in certain blood cells), eosinophilia (increase in certain white blood cells)
Myocarditis (heart inflammation), pericarditis (inflammation of the membrane surrounding the heart), vasculitis (inflammation of blood vessels)
Hypoesthesia, paraesthesia (partial or complete reduction in tactile, thermal, or pain sensitivity)
DRESS syndrome, drug reaction with eosinophilia and systemic symptoms (characterized by fever, rash, lymphadenopathy, eosinophilia, leucocytosis, abnormal liver function tests, hepatitis)

Very rare side effects (<1/10,000), including isolated cases

Pancreatitis (inflammation of the pancreas), pseudomembranous colitis (severe inflammation of the colon)
Stevens-Johnson syndrome (serious hypersensitivity reaction affecting the skin and mucous membranes), toxic epidermal necrolysis, angioedema, alopecia (hair loss)
Benign intracranial hypertension* (increased pressure inside the skull), bulging fontanelles, hearing loss
Agranulocytosis (marked reduction in certain white blood cells, potentially leading to their complete absence), haemolytic anaemia (destruction of red blood cells), aplastic anaemia (inadequate production of blood cells), pancytopenia (reduction in all blood cells)
Interstitial nephritis (kidney inflammation), acute renal failure, increased uricemia (elevated uric acid levels in the blood)
Arthritis, joint stiffness and joint swelling, exacerbation of systemic lupus erythematosus (chronic autoimmune disease that can affect various organs and tissues)

Side effects not known

* With tetracyclines, including Minocycline, benign intracranial hypertension has been reported, with possible symptoms including headache, vomiting, and visual disturbances such as blurred vision, scotoma, diplopia, or permanent vision loss. The onset of clinical symptoms, including headache or visual disturbances, should raise suspicion of benign intracranial hypertension. If increased intracranial pressure is suspected during treatment with tetracyclines, administration must be discontinued.

Reporting of side effects
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. How to store MINOCIN, hard capsules

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the product in its original packaging, properly stored.
Store at room temperature below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What MINOCIN hard capsules contain
MINOCIN 50 mg, hard capsules
The active substance is: minocycline hydrochloride...54 mg
(equivalent to 50 mg of minocycline)
per capsule.
The other components are: magnesium stearate, starch, erythrosine (E127), yellow iron oxide
(E172), titanium dioxide (E171), gelatin.
MINOCIN 100 mg, hard capsules
The active substance is: minocycline hydrochloride...108 mg (equivalent to 100 mg of minocycline)
per capsule.
The other components are: magnesium stearate, starch, erythrosine (E127), indigo carmine (E132),
titanium dioxide (E171), gelatin.

Description of the appearance of MINOCIN hard capsules and contents of the pack
Box containing 16 hard capsules of 50 mg in blister packs
Box containing 8 hard capsules of 100 mg in blister packs

Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Fax 0382.525845
e-mail: [email protected]

Manufacturer:
TEOFARMA S.r.l.
Viale Certosa, 8/A - 27100 Pavia

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA): www.agenziafarmaco.gov.it