Package Insert: Information for the Patient

Doxiciclina Normon 100 mg Coated Tablets

Doxiciclina (Hiclato)

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

Doxiciclina Normon is an antibiotic belonging to the tetracyclines group. It is a broad-spectrum antibiotic with bacteriostatic action.

Doxiciclina Normon is indicated, among others, for skin and soft tissue infections (including vulgaris acne), otolaryngological infections and genitourinary infections.

Do not take Doxiciclina Normon 100 mgcoated tablets

If you are allergic to doxycycline, tetracyclines or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxiciclina Normon 100 mg coated tablets

Children

Do not use Doxiciclina Normon 100 mg coated tablets during the period of teething (second half of pregnancy, lactation and children under 8 years), as it may cause permanent discoloration of the teeth, as well as delay in bone development.

General

• There have been reports of bulging fontanelles (space without ossification in the skull) in children and intracranial hypertension (increase in cerebrospinal fluid pressure in the brain) in both children and adults. (See section 4. Possible side effects).
• If you experience diarrhea while receiving treatment with doxycycline, consult your doctor.
• If the patient ingests this medicine while lying down or without sufficient water, ulcers in the digestive system may appear, so it is essential to follow the administration instructions. (See section 3. How to take Doxiciclina Normon 100 mg coated tablets and section 4. Possible side effects).
• If you have liver or kidney disease, consult your doctor.
• In prolonged treatments, the doctor will perform periodic checks of renal and hepatic functions.
• If you have systemic lupus erythematosus, avoid using this medicine.
• In case of direct exposure to the sun, skin reddening may occur; if this happens, interrupt treatment and consult your doctor.
• If you have myasthenia gravis (a form of muscle weakness), consult your doctor before taking this medicine.
• If you are undergoing urine analysis, inform the healthcare staff that you are taking this medicine, as doxycycline may interfere with the results.

Other medicines and Doxiciclina Normon 100 mg coated tablets

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Some medicines, when taken at the same time as Doxiciclina Normon 100 mg coated tablets, may affect its mechanism of action:

• Antacids containing aluminum, calcium or magnesium reduce the absorption of doxycycline.
• Penicillin: should not be administered concurrently with bactericidal antibiotics, as their effect is reduced.
• Diuretics, methoxyflurane and other nephrotoxic medicines may increase the nephrotoxic effect of tetracyclines.
• Retinoids used with doxycycline may cause an increase in benign intracranial hypertension.
• Doxycycline may increase plasma concentrations of lithium, digoxin and theophylline.
• Anticoagulants (such as warfarin): the dose of these should be reduced, as Doxiciclina Normon 100 mg coated tablets affect their effect. Consult your doctor; they will indicate the appropriate dose.
• Ergotamine alkaloids and methotrexate: their toxic effect may occasionally be increased by tetracyclines.
• Ocular preparations containing thimerosal: may cause eye inflammation.
• Oral contraceptives: tetracyclines may reduce their effectiveness.
• Chronic alcohol use, antiepileptics and rifampicin may activate doxycycline metabolism.
• In case of doubt, consult your doctor or pharmacist.

Use of Doxiciclina Normon 100 mg coated tablets with food, drinks and alcohol

Avoid the concurrent use of doxycycline and alcohol.

It is recommended to take Doxiciclina Normon 100 mg coated tablets with food and a large glass of water to avoid esophageal irritation. (See section 3. How to take Doxiciclina Normon 100 mg coated tablets).

Pregnancy and lactation

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

Avoid taking Doxiciclina Normon 100 mg coated tablets during lactation.

Driving and operating machinery

The influence of Doxiciclina Normon 100 mg coated tablets on the ability to drive and operate machinery is negligible or insignificant.

Doxiciclina Normon 100 mg coated tablets contain lactose and saccharose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

Remember to take your medication. If you estimate that the action of doxycycline is too strong or weak, inform your doctor or pharmacist.

IMPORTANT:

Your doctor will indicate the duration of treatment with Doxycycline Normon 100 mg coated tablets. Do not discontinue treatment before completing the schedule recommended by your doctor, as it is detrimental to a rapid recovery of your disease due to the risk of relapse, and may generate resistance of microorganisms to this antibiotic, which would lead to a prolongation of your disease.

Adults

The recommended dose is2 coated tablets (200 mg) on the first day of treatment administered in a single dose or 1 coated tablet (100 mg) every 12 hours, continuing treatment with a dose of 1 coated tablet (100 mg) every 24 hours. In severe infections: 1 coated tablet (100 mg) every 12 hours, maintaining this dose throughout treatment.

Children over 8 years old

Children over 8 years old weighing 45 kg or less, the recommended dose is: 4 mg/kg of body weight on the first day of treatment (administered in a single dose or in two equal doses every 12 hours) continuing with a dose of 2 mg/kg of body weight every 24 hours. In severe infections: 4 mg/kg of body weight every 24 hours, maintaining the same dose throughout treatment.

Treatment should continue for 24 to 48 hours after symptoms have disappeared.

Infections due to group A beta-hemolytic streptococcus should be treated for at least 10 days.

If you take more Doxycycline Normon 100 mgcoated tablets than you should

If you take more Doxycycline Normon 100 mgcoated tablets than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (Tel. 91 562 04 20) indicating the product and the amount administered. Bring this leaflet with you.

Information for the doctor:Dialysis does not alter the plasma half-life of doxycycline and would not be beneficial in the treatment of overdose.

If you forgot to take Doxycycline Normon 100 mgcoated tablets

Do not take a double dose to compensate for the missed doses. It is essential to take the medication regularly at the same time of day. If you forget to take a dose, take the next one when it is due.

If you interrupt the treatment with Doxycycline Normon 100 mgcoated tablets

You should not interrupt treatment and follow the schedule indicated by your doctor. If you interrupt it without completing it, you may cause the infection to recur.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Blood alterations:blood disorders following tetracycline administration are extremely rare. However, cases of: hemolytic anemia (consequence of high red blood cell destruction), thrombocytopenia (decrease in platelet count), neutropenia (decrease in neutrophil count), and eosinophilia (increase in eosinophil count) have been reported.

Nervous system alterations:infrequently, intracranial hypertension occurs in children and adults, characterized by headache, nausea, vomiting, dizziness, tinnitus, and visual disturbances. These symptoms resolve after the medication is discontinued. Also, fontanelle bulging has been reported in children.

Digestive system alterations:possible appearance of digestive alterations: esophageal ulcers (See section 3. How to take Doxiciclina Normon 100 mg coated tablets), nausea, stomach pain, diarrhea, loss of appetite, tongue inflammation, intestinal inflammation, anogenital candidiasis (infection by a microscopic fungus). Also, permanent tooth discoloration occurs if doxiciclina is used during dental development (2nd half of pregnancy, lactation, and children under 8 years old).

Liver alterations:treatment with high doses may produce hepatitis and liver function disorders.

Skin alterations:urticaria, maculopapular rash (skin patches and small elevations), exudative erythema (skin redness and patches), multiform eruptions (skin redness and swelling), photosensitivity skin reactions, exceptionally exfoliative dermatitis (skin inflammation and peeling), rarely Stevens-Johnson syndrome, and, with unknown frequency, photoonycholysis (nail pigmentation).

Muscle and bone alterations:it may produce joint pain, muscle pain, as well as delayed growth in children that ceases upon discontinuing treatment.

Urinary alterations:like all tetracyclines, doxiciclina may produce elevated urea nitrogen in the blood.

General alterations:occasionally, severe allergic reactions may occur, including urticaria, angioedema (fluid retention in vessels), bronchial obstruction, pericarditis (inflammation of the heart tissue), hypotension (blood pressure drop), systemic lupus erythematosus exacerbation, serum disease (allergic reaction to serum), and, very rarely, anaphylactic shock (unusual or excessive allergic reaction).

Jarisch-Herxheimer reaction:characterized by fever, chills, headache, muscle pain, and skin eruption, and usually resolves spontaneously. It occurs shortly after starting doxiciclina treatment for spirochetal infections, such as Lyme disease.

Reporting adverse effects

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

Store below 25°C. Store in the original packaging to protect it from humidity.

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.

Medicines should not be thrown down the drains or into the trash. Dispose of the packaging and the medication that you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Doxiciclina Normon 100 mg coated tablets

• The active ingredient is doxiciclina (hydrochloride). Each coated tablet contains 100 mg of doxiciclina.
• The other components are povidone, cornstarch, magnesium stearate, lactose monohydrate, sucrose, talc, gum arabic, copolymer dispersion of metacrylate of ammonium, titanium dioxide, green sepisperse color, white wax, carnauba wax.

Appearance of the product and content of the packaging

Doxiciclina Normon 100 mg coated tablets are presented in packaging that contains 14, 21 and 42 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos – Madrid (SPAIN)

This leaflet has been reviewed in September 2020.

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)websiteoftheSpanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/