DOXICICLINA NORMON 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Doxiciclina Normon 100 mg Coated Tablets

Doxiciclina (Hyclate)

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Doxiciclina Normon 100 mg Coated Tablets are and what they are used for
2. What you need to know before taking Doxiciclina Normon 100 mg Coated Tablets
3. How to take Doxiciclina Normon 100 mg Coated Tablets
4. Possible side effects
5. Storage of Doxiciclina Normon 100 mg Coated Tablets
6. Package contents and additional information

1. What Doxiciclina Normon 100 mg Coated Tablets are and what they are used for

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

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

2. What you need to know before taking Doxiciclina Normon 100 mg Coated Tablets

Do not take Doxiciclina Normon 100 mg Coated Tablets

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxiciclina Normon 100 mg Coated Tablets

Children

Doxiciclina Normon 100 mg Coated Tablets should not be used during the teething period (second half of pregnancy, lactation, and children under 8 years), as it may cause permanent tooth discoloration and delay bone development.

General

• Fontanelle bulging (unossified space in the skull) has been reported in children, and intracranial hypertension (increased pressure of the cerebrospinal fluid 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 takes this medication while lying down or without sufficient water, ulcers may appear in the digestive system. Therefore, 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 function.
• If you have systemic lupus erythematosus, you should avoid using this medication.
• In case of direct sun exposure, skin redness may occur; if this happens, treatment should be discontinued, and the doctor consulted.
• If you have myasthenia gravis (a form of muscle weakness), consult your doctor before taking this medication.
• If you need to undergo any urine analysis, inform the healthcare staff that you are being treated with this medication, as doxycycline may interfere with the results.

Other medications and Doxiciclina Normon 100 mg Coated Tablets

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

Some medications, when taken at the same time as Doxiciclina Normon 100 mg Coated Tablets, may affect their mechanism of action:

• Antacids containing aluminum, calcium, or magnesium decrease the absorption of doxycycline.
• Penicillin: should not be administered concurrently with bactericidal antibiotics, as it reduces the effect of the latter.
• Diuretics, methoxyflurane, and other nephrotoxic medications may increase the nephrotoxic effect of tetracyclines.
• Retinoids used with doxycycline may produce 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 influence the effect of these anticoagulants. Consult your doctor; they will indicate the appropriate dose.
• Ergotamine alkaloids and methotrexate: their toxic effect may occasionally be increased by tetracyclines.
• Ophthalmic preparations containing thimerosal: eye inflammation may occur.
• Oral contraceptives: tetracyclines may decrease their effectiveness.
• Chronic alcohol use, antiepileptics, and rifampicin may activate the metabolism of doxycycline.
• In case of doubt, consult your doctor or pharmacist.

Using Doxiciclina Normon 100 mg Coated Tablets with food, drinks, and alcohol

Avoid using doxycycline and alcohol together.

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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should avoid taking Doxiciclina Normon 100 mg Coated Tablets during breastfeeding.

Driving and using machines

The influence of Doxiciclina Normon 100 mg Coated Tablets on the ability to drive and use machines is nil or insignificant.

Doxiciclina Normon 100 mg Coated Tablets contain lactose and sucrose.If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

3. How to take Doxiciclina Normon 100 mg Coated Tablets

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

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

IMPORTANT:

Your doctor will indicate the duration of treatment with Doxiciclina Normon 100 mg Coated Tablets. Do not stop treatment before completing the prescribed treatment, as it may be harmful to your rapid recovery from the disease due to the risk of relapse, and may generate resistance of microorganisms to this antibiotic, which would prolong your disease.

Adults

The recommended dose is 2 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

Children over 8 years who weigh 45 kg or less, the recommended dose is: 4 mg/kg 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 body weight every 24 hours. In severe infections: 4 mg/kg 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 Doxiciclina Normon 100 mg Coated Tablets than you should

If you take more Doxiciclina Normon 100 mg Coated Tablets than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (Tel. 91 562 04 20) indicating the product and the amount administered. Bring this package 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 forget to take Doxiciclina Normon 100 mg Coated Tablets

Do not take a double dose to make up for forgotten 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 treatment with Doxiciclina Normon 100 mg Coated Tablets

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Blood disorders:blood disorders after administration of tetracyclines 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 disorders:infrequently, intracranial hypertension occurs in children and adults, characterized by headache, nausea, vomiting, dizziness, tinnitus, and visual disturbances. These symptoms resolve after withdrawal of the medication. Fontanelle bulging has also been reported in children.

Gastrointestinal disorders:possible appearance of gastrointestinal disorders: 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). Permanent tooth discoloration may also occur if doxycycline is used during dental development (second half of pregnancy, lactation, and children under 8 years).

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

Skin disorders:urticaria, maculopapular rash (spots and small elevations of the skin), exudative erythema (redness and spots on the skin), multiform eruptions (redness and swellings on the skin), cutaneous photosensitivity reactions, exceptionally exfoliative dermatitis (inflammation and scaling of the skin), rarely Stevens-Johnson syndrome, and with unknown frequency photoonycholysis (nail pigmentation).

Musculoskeletal and bone disorders:joint pain, muscle pain, and growth delay in children may occur, which ceases when treatment is discontinued.

Urinary disorders:like all tetracyclines, doxycycline may produce elevated blood urea nitrogen levels.

General disorders:occasionally, severe allergic reactions may occur, exceptionally urticaria, angioedema (fluid retention in blood vessels), bronchial obstruction, pericarditis (inflammation of the tissue surrounding the heart), hypotension (decrease in blood pressure), worsening of systemic lupus erythematosus, serum sickness (allergic reaction to serum), and very rarely anaphylactic shock (unusual or exaggerated allergic reaction).

Jarisch-Herxheimer reaction:which occurs with fever, chills, headache, muscle pain, and skin rash, and usually resolves spontaneously. It occurs shortly after starting treatment with doxycycline for spirochetal infections, such as Lyme disease.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Doxiciclina Normon 100 mg Coated Tablets

Store below 25°C. Keep in the original packaging to protect from moisture.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Doxiciclina Normon 100 mg Coated Tablets

• The active principle is doxycycline (hyclate). Each coated tablet contains 100 mg of doxycycline.
• The other components are povidone, cornstarch, magnesium stearate, lactose monohydrate, sucrose, talc, gum arabic, ammonio methacrylate copolymer dispersion, titanium dioxide, green sepisperse color, white wax, carnauba wax.

Appearance of the product and package contents

Doxiciclina Normon 100 mg Coated Tablets are available in packages containing 14, 21, and 42 coated tablets

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

This package leaflet was revised in September 2020.

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