Prospect: information for the user

Minocin 100 mg hard capsules

hydrochloride of minocycline

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Minocin is and for what it is used

2.What you need to know before starting to take Minocin

3.How to take Minocin

4.Possible adverse effects

5.Storage of Minocin

6.Contents of the package and additional information

Minocin containsminocycline hydrochloride,a bacteriostatic antibiotic belonging to the group of medications called tetracyclines.

Minocin is indicated for the treatment of the following infections in adults and children over 8 years old:

• non-gonococcal, non-complicated urethritis (urethral inflammation);
• respiratory infections such as tracheobronchitis;
• eye infections such as trachoma;
• syphilis, actinomycosis (an infectious disease causing lymph node inflammation in the mouth, along with other internal complications) or carbuncle (an infectious disease affecting the skin, intestines, or lungs) in patients allergic to penicillin.

Do not take Minocin

• if you are allergic to the active ingredient, any other tetracycline, or any of the other components of this medication (listed in section 6). Allergic reactions include: rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue;
• if you have severe kidney failure;
• if you have severe liver failure;
• if you are pregnant or suspect you may be pregnant;
• if you are breastfeeding.

Minocin should not be used in children under 8 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Minocin.

Before starting to take this medication, inform your doctor if you have any of the following conditions:

• kidney or liver problems;
• Ménière's syndrome (symptoms include dizziness, visual disturbances, and tinnitus);
• history of allergic reactions to tetracyclines. Inform your doctor before starting treatment with minocycline.

If you are a fertile woman, it is essential to check that you are not pregnant before starting treatment with Minocin.

It is recommended to use sunscreen with a high sun protection factor and avoid exposure to the sun or ultraviolet radiation during treatment with Minocin. In rare cases, skin eruptions (red discoloration) may occur.

During long-term treatment, vitamin B deficiency may occur.

If you are undergoing medical tests, inform your doctor that you are taking Minocin, as this medication may affect the results of some analytical tests.

Contact your doctor:

• if you experience severe sunburn reactions after exposure to sunlight or UV rays. Stop using Minocin immediately;
• if, while taking Minocin, you experience other infections caused by bacteria or other microorganisms that are resistant to minocycline;
• if you start experiencing headaches and double vision. This could be due to increased intracranial pressure;
• if, during treatment, you experience symptoms such as dizziness, involuntary eye movements, hearing loss in one ear, tinnitus, visual disturbances, hallucinations, or dark spots in your visual field;
• if treatment lasts more than 6 months and you experience symptoms of a specific autoimmune disease (systemic lupus erythematosus, SLE). Typical SLE symptoms include extreme fatigue, hypersensitivity to light and the sun, and inflammation in blood vessels, for example, in the skin;
• if you experience symptoms of liver inflammation. Typical liver inflammation symptoms include stomach pain, nausea, fatigue, itching, and jaundice;
• if you experience intense and prolonged diarrhea while taking minocycline, you may have antibiotic-associated colitis, which can be severe. In these cases, consult your doctor, who will decide whether to stop administering minocycline and start an appropriate treatment.

Children and adolescents

Minocin should not be used in children during the teething period (second half of pregnancy, lactation, and children under 8 years old) as it may cause permanent tooth discoloration and delayed bone development.

Minocin should only be prescribed to children between 8 and 12 years old after all other treatment options have been exhausted.

Other medications and Minocin

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Certain medications may interact with Minocin. In these cases, it may be necessary to adjust the dosage or discontinue treatment with one of the medications. It is especially important to inform your doctor if you are using any of the following medications:

• penicillin, as Minocin may interfere with its effect;
• isotretinoin, as taken with Minocin may cause benign intracranial hypertension;
• oral contraceptives, as Minocin may reduce their effectiveness;
• anticoagulants (such as warfarin), as Minocin may alter their effect;
• antacids (medications used to calm stomach acidity) and other medications containing aluminum, calcium, magnesium, and medications containing iron or bismuth salts, as they may reduce the effect of Minocin;
• antiepileptic and barbiturate medications (medications for severe insomnia and seizures), as they may reduce the effect of Minocin;
• methoxyflurane (anesthetic medication), as when used together with antibiotics from the tetracycline group, such as Minocin, it may cause severe kidney toxicity.

Minocin with food and beverages

• It is essential to take Minocin during a meal, accompanied by a large glass of water or milk, and to wait at least one hour before lying down or going to bed, to avoid esophageal irritation (see section 3).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Minocin should not be used during pregnancy, as it may harm the development of the fetus's bones and teeth.

It is essential to use contraceptive methods to avoid pregnancy during treatment with Minocin. Oral contraceptives (hormonal) may not be effective, as taking Minocin reduces their effectiveness, and barrier methods are recommended.

Breastfeeding

Minocin should not be used during breastfeeding, as it may cause developmental problems in the baby's bones and teeth. Your doctor will decide whether to stop breastfeeding or discontinue treatment, considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and operating machinery

You may experience dizziness, vertigo, or visual or auditory disturbances with this medication, so it is not recommended that you drive or operate machinery until you have checked that this medication does not affect you.

Minocin contains yellow orange S (E-110)

This medication contains yellow orange S (E-110), which may cause allergic reactions.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

The usual recommended dose in adults is 200 mg (2 capsules) on the first day of treatment, administered as a single daily dose or as 100 mg (1 capsule) every 12 hours, followed by a maintenance dose of 100 mg (1 capsule) every 24 hours in mild infections or 100 mg (1 capsule) every 12 hours in severe infections.

In the case of nongonococcal urethritis (urethral infection), the daily dose is 200 mg administered as 100 mg (1 capsule) every 12 hours for 7 days.

Your doctor will indicate the dose to use and the duration of treatment based on the type of infection you present. In general, treatment should continue for at least 24 to 48 hours after the disappearance of symptoms. Do not discontinue treatment before the indicated time by your doctor. Do not exceed the prescribed dose.

Older patients:

Your doctor will indicate the dose you should use, starting preferably with the lowest possible dose.

Use in children and adolescents

The usual recommended dose in children over 8 years old is:

• in mild infections: 4 mg/kg of body weight on the first day of treatment, continuing treatment with a dose of 2 mg/kg of body weight every 24 hours (administered as a single daily dose).

Administration form

Oral route.

Capsules should be swallowed whole, without crushing them.

This medication should be taken during a meal, accompanied by a large glass of water or milk, and at least one hour before lying down or going to bed, to avoid the appearance of digestive problems, especially esophageal ulcers.

If you take more Minocin than you should

If you have taken more Minocin than you should, consult your doctor or pharmacist immediately or go to the nearest hospital. If possible, show them the packaging of the medication or this leaflet.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Minocin

If you are sure you have forgotten to take a capsule, try to take it as soon as possible and continue with the normal medication. However, if it is almost time to take the next dose, skip the missed dose and take the next capsule at the usual time.

Do not take a double dose to compensate for the missed doses. In case of doubt, consult your doctor or pharmacist.

If you interrupt the treatment with Minocin

Your doctor will indicate the duration of your treatment with Minocin. Do not discontinue treatment before time, as it may not have the desired effect.

If you have taken this medication for a long period of time (such as six months or more), consult your doctor if you should continue taking it.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been observed in patients who have taken tetracyclines, including minocycline, listed in order of their frequency of occurrence:

Frequent side effects(may affect up to 1 in 10 people):

Decreased platelet count (thrombocytopenia), alteration of white blood cell count: decreased neutrophil count (neutropenia) or increased eosinophil count (eosinophilia), allergic reactions (including skin edema and mucosal edema (angioedema), red and itchy skin lesions (urticaria).

Infrequent side effects(may affect up to 1 in 100 people):

Fever.

Rare side effects(may affect up to 1 in 1,000 people):

Severe destruction of red blood cells (hemolytic anemia), joint pain, severe allergic reactions (anaphylaxis), anaphylactoid purpura, pericarditis that may cause fever and chest pain, worsening of systemic lupus erythematosus, whose symptoms include: skin rash, hair loss, fever, joint pain or weight loss, eosinophilic lung infiltrates, transient lupus-like syndrome, serum disease-like reaction, and inflammation of blood vessels (vasculitis), fontanelle bulging (unossified skull space in young children) in children, increased intracranial pressure (benign intracranial hypertension) in adults, accompanied by headache (reversible symptoms), paresthesia, seizures, and sedation, anorexia, nausea, vomiting, diarrhea, esophageal inflammation, esophageal ulcers, anogenital inflammatory lesions, anal pruritus, black tongue, stomatitis, alterations in laboratory results (elevated liver enzyme levels), liver damage, hepatitis, alopecia, pruritus, skin eruptions (maculopapular and erythematous), extensive skin inflammation with desquamation (dermatitis exfoliativa), red and swollen skin lesions in the shape of a target (erythema multiforme), severe inflammation of the skin and mucous membranes (Stevens-Johnson syndrome), exaggerated skin reaction to sunlight or ultraviolet radiation, changes in skin, nail, and mucous membrane color (usually reversible), bone decoloration, elevated blood urea, elevated nitrogen compounds such as creatinine and urea in the blood (azotemia) in patients with renal function impairment.

Very rare side effects(may affect up to 1 in 10,000 people):

Brown-black discoloration of the thyroid gland, changes in thyroid function, including inflammation of thyroid cells (thyroiditis), thyroid nodules, goiter, and thyroid cancer, inflammation of the tongue (glossitis), stomach pain (epigastric pain), dyspepsia, difficulty swallowing (dysphagia), enterocolitis, including staphylococcal enteritis, pancreatitis, alteration in stool volume or fluidity (pseudomembranous colitis), liver damage, occasionally accompanied by pancreatitis, or hepatic or renal dysfunction; prolonged treatment-induced hepatic insufficiency and reversible acute renal dysfunction.

Side effects of unknown frequency(cannot be estimated from available data):

Increased non-susceptible microorganisms, including fungi, decreased white blood cell count (leukopenia, pancytopenia, and agranulocytosis), reduced protrombin activity, drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS syndrome), myocarditis, and immunological pulmonary reactions such as dyspnea, cough, fever, decreased vitamin B values, ascorbic acid, and folic acid, hallucinations, visual disturbances (scotoma, double vision), corneal, scleral, and retinal pigmentation, vestibular alterations, vertigo, hearing problems or tinnitus, inflammation of blood vessels (polyarteritis nodosa), cough, dyspnea, difficulty breathing or wheezing (bronchospasm), exacerbation of asthma, and eosinophilic pneumonia, decreased or absent bile flow from the liver to the duodenum (hepatic cholestasis), hyperbilirubinemia, and jaundice, skin rash, urticaria, erythema nodosum, vasculitis, and toxic necrodermitis, arthritis, and joint inflammation and stiffness, tooth color change or enamel maldevelopment, which usually appears in long-term treatments, interstitial nephritis, vaginal discharge, vaginal inflammation (vaginitis), and penile inflammation (balanitis) due to Candida albicans infection, and decoloration of secretions.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Minocin

• The active ingredient is minocycline in the form of hydrochloride. Each capsule contains 100 mg of minocycline (as hydrochloride).
• The other components are: gelatinized cornstarch and magnesium stearate. The capsule components are: gelatin, yellow-orange S (E-110), erythrosine (E-127), brilliant blue FCF (E-133) and titanium dioxide (E-171). The composition of the printing ink is: shellac (E-904) and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Minocin is presented in the form of hard orange and navy blue capsules.

Minocin is packaged in PVC/Aluminum blisters.

Standard packaging of 12 capsules.

Clinical packaging of 100 capsules.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

Responsible manufacturer

Teofarma S.r.l.

Viale Certosa, 8/A

27100 Pavia, Italy

Last review date of this leaflet:March 2023

Other sources of information

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/