Minocin 100 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Minocin 100 mg hard capsules

minocycline hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects
5. How to store Minocin
6. Contents of the pack and other information

1. What Minocin is and what it is used for

Minocin contains minocycline hydrochloride, an antibiotic belonging to a group of medicines called tetracyclines.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dosage, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

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

• uncomplicated non-gonococcal urethritis;
• respiratory tract infections such as tracheobronchitis;
• ocular infections such as trachoma;
• syphilis, actinomycosis (an infectious disease causing inflammation of lymph nodes in the mouth along with other internal complications), or anthrax (an infectious disease affecting the skin, intestine, or lungs) in patients allergic to penicillin.

2. What you need to know before taking Minocin

Do not take Minocin

• if you are allergic to the active substance, to any other tetracycline, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions include: rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue;
• if you have severe renal impairment;
• if you have severe hepatic impairment;
• if you are pregnant or suspect you may be pregnant;
• if you are breastfeeding.

Minocin must not be used in children under 8 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Minocin.

Before starting treatment with this medicine, 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 woman of childbearing age, it is important to confirm that you are not pregnant before starting treatment with Minocin.

The use of total sunblock creams is recommended, and exposure to sunlight or ultraviolet radiation should be avoided during treatment with Minocin. Skin rashes (reddening) may rarely occur.

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

If you are due to undergo medical tests, inform your doctor that you are taking Minocin, as this medicine may affect the results of certain laboratory 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 develop other infections caused by bacteria or other microorganisms that are insensitive to minocycline;
• if you begin to experience headaches and double vision. This could be due to increased blood pressure in the head;
• if, during treatment, you experience symptoms such as dizziness, involuntary eye movements, hearing loss in one ear, tinnitus, visual disturbances, hallucinations (seeing things that are not there), or dark spots in your visual field;
• if treatment lasts longer than 6 months and you develop symptoms of a specific autoimmune disease (systemic lupus erythematosus, SLE). Typical SLE symptoms include: extreme fatigue, photosensitivity, and inflammation of blood vessels, for example, in the skin;
• if you experience symptoms of liver inflammation. Typical symptoms of hepatitis include: stomach pain, nausea, fatigue, itching, jaundice;
• if you develop severe and persistent diarrhoea while taking minocycline, as this may indicate a type of colitis associated with antibiotic use, which can be serious. In such cases, consult your doctor, who will decide whether minocycline should be discontinued and appropriate treatment initiated.

Children and adolescents

Minocin must not be used in children during tooth development (second half of pregnancy, breastfeeding, and children under 8 years of age), as it may cause permanent tooth discoloration and delay in bone development.

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

Other medicines and Minocin

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

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

• penicillin, as Minocin may interfere with its effect;
• isotretinoin, as taking it together 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 (medicines used to relieve stomach acidity) and other medicines containing aluminium, calcium, or magnesium, and medicines containing iron or bismuth salts, as they may reduce the effect of Minocin;
• antiepileptics and barbiturates (medicines for severe insomnia and seizures), as they may reduce the effect of Minocin;
• methoxyflurane (a medicine used for anaesthesia), as its concomitant use with tetracycline antibiotics such as Minocin may cause severe kidney toxicity.

Taking Minocin with food and drink

• It is important to take Minocin during a meal, with a large glass of water or milk, and to remain upright for at least one hour afterwards, to avoid oesophageal irritation (see section 3).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

It is important to use contraceptive methods during treatment with Minocin to avoid becoming pregnant. Oral contraceptives (hormonal contraceptives) may not be effective, as Minocin reduces their contraceptive effect; therefore, barrier methods are recommended.

Breastfeeding

Minocin must not be used during breastfeeding, as it may cause disturbances in the bone and tooth development of the newborn/infant. Your doctor will decide whether to discontinue breastfeeding or discontinue treatment, after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using machines

This medicine may cause dizziness, vertigo, or affect your vision or hearing. Therefore, you are advised not to drive or operate machinery until you know how this medicine affects you.

Minocin contains Sunset Yellow FCF (E-110)

This medicine contains Sunset Yellow FCF (E-110), which may cause allergic-type reactions.

3. How to take Minocin

Always follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

The usual recommended dose for adults is 200 mg (2 capsules) on the first day of treatment, given 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 for mild infections or 100 mg (1 capsule) every 12 hours for severe infections.

For non-gonococcal urethritis (infection of the urethra), the daily dose is 200 mg administered as 100 mg (1 capsule) every 12 hours for 7 days.

Your doctor will determine the dose and duration of treatment depending on the type of infection you have. In general, treatment should be continued for at least 24 to 48 hours after symptoms have disappeared. Do not stop treatment earlier than instructed by your doctor. Do not exceed the prescribed dose.

Elderly patients:

Your doctor will determine the appropriate dose for you, preferably starting with the lowest possible dose.

Use in children and adolescents

The usual recommended dose for children over 8 years of age is:

• for mild infections: 4 mg/kg body weight on the first day of treatment, followed by a maintenance dose of 2 mg/kg body weight once every 24 hours (given as a single daily dose).

Method of administration

Oral use.

The capsules must be swallowed whole, without chewing.

This medicine should be taken during a meal, with a large glass of water or milk, and you should remain upright for at least one hour after taking it, to help prevent gastrointestinal problems, especially esophageal ulcers.

If you take more Minocin than you should

If you have taken more Minocin than you should, contact your doctor or pharmacist immediately or go to the nearest hospital. If possible, show them the medicine package or this leaflet.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Minocin

If you are sure you have missed a dose, take it as soon as possible and then continue with your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose and take the next capsule at your usual time.

Do not take a double dose to make up for a forgotten dose. If in doubt, consult your doctor or pharmacist.

If you stop Minocin treatment

Your doctor will advise you on how long your treatment with Minocin should last. Do not stop treatment prematurely, as the desired effect may not be achieved.

If you have been taking this medicine for a long period (for example, six months or more), consult your doctor about whether you should continue taking it.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed in patients taking tetracyclines, including minocycline, listed according to their frequency of occurrence:

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

Reduction in platelet count (thrombocytopenia), alteration in white blood cell count: reduction in neutrophils (neutropenia) or increase in eosinophils (eosinophilia), allergic reactions (including swelling of the skin and mucous membranes (angioedema), red, itchy skin lesions (urticaria)).

Uncommon adverse effects (may affect up to 1 in 100 people):

Fever.

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

Excessive destruction of red blood cells (hemolytic anemia), joint pain, severe allergic reactions (anaphylaxis), anaphylactoid purpura, inflammation around the heart (pericarditis) which may cause fever and chest pain, worsening of a condition called systemic lupus erythematosus whose symptoms include: skin rash, hair loss, fever, joint pain or weight loss, pulmonary infiltrates with eosinophils, transient lupus-like syndrome, serum sickness-like reaction and inflammation of blood vessels (vasculitis), bulging of fontanelles (unossified skull areas in young children), increased pressure inside the skull (benign intracranial hypertension) in adults, accompanied by headache (reversible symptoms), tingling, seizures and sedation, anorexia, nausea, vomiting, diarrhea, esophageal inflammation, esophageal ulcers, inflammatory lesions in the anogenital area, anal pruritus, black tongue, stomatitis, changes in laboratory test results (elevated liver enzyme levels), liver damage, inflammation of the liver (hepatitis), alopecia, pruritus, skin rashes (maculopapular and erythematous), widespread skin inflammation with peeling (exfoliative dermatitis), red, raised skin lesions with target-like appearance (erythema multiforme), inflammation of the skin and mucous membranes which may be very severe (Stevens-Johnson syndrome), exaggerated skin reaction to sunlight or ultraviolet radiation, changes in skin, nails and mucous membranes color (usually reversible), bone discoloration, increased blood urea, increased nitrogen-containing compounds such as creatinine and urea in blood (azotemia) in patients with impaired renal function.

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

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

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

Overgrowth of non-susceptible microorganisms, including fungi, reduction in white blood cells (leukopenia, pancytopenia and agranulocytosis), reduced prothrombin activity, drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS syndrome), inflammation of the heart muscle (myocarditis) and pulmonary immunological reactions such as dyspnea, cough, fever, decreased levels of vitamin B, ascorbic acid and folic acid, hallucinations, visual disturbances (scotoma, double vision), corneal, scleral and retinal pigmentation, vestibular disturbances, dizziness, hearing problems or tinnitus, inflammation of blood vessels (polyarteritis nodosa), cough, dyspnea, breathing difficulty or wheezing (bronchospasm), exacerbation of asthma and pulmonary eosinophilia, reduction or absence of bile flow from the liver to the duodenum (hepatic cholestasis), hyperbilirubinemia and jaundice, skin rash, urticaria, erythema nodosum, vasculitis and toxic necrodermatitis, arthritis and joint inflammation and stiffness, tooth discoloration or poor enamel development, which usually occurs during long-term treatment, interstitial nephritis, vaginal discharge, inflammation of the vagina (vaginitis) and penis (balanitis) due to yeast infection (Candida albicans) and discoloration of secretions.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Minocin

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Minocin

• The active substance is minocycline in the form of hydrochloride. Each capsule contains 100 mg of minocycline (as hydrochloride).
• The other components are: pregelatinized corn starch and magnesium stearate. The capsule components are: gelatin, orange yellow 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).

Nature of the product and pack contents

Minocin is presented as hard capsules, orange and navy blue in color.

Minocin is packaged in PVC/aluminum blisters.

Standard pack: 12 capsules.

Hospital pack: 100 capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

Manufacturer

Teofarma S.r.l.

Viale Certosa, 8/A

27100 Pavia, Italy

Date of the most recent revision of this leaflet: March 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)