Leaflet: information for the user

DOXICLAT 100 mg film-coated tablets

Doxiciclina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

1. What is Doxilat and what it is used for

2. What you need to know before you start taking Doxilat

3. How to take Doxilat

4. Possible side effects

5. Storage of Doxilat

6. Contents of the pack and additional information

Doxycycline belongs to a group of medicines called tetracyclines, which are broad-spectrum antibiotics. It is active against a wide variety of bacteria causing numerous infections.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or common cold. It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor. Do not store or reuse this medication. If you have leftover antibiotics after completing treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or trash..

Doxycycline is indicated for adults and adolescents in the treatment of certain infections caused by sensitive microorganisms and of varied origin and location, such as:

• Atypical pneumonia.
• Psittacosis, which is a disease transmitted to humans by certain birds that presents with fever and cough.
• Sexually transmitted diseases, such as: urethritis (urethral inflammation), cervicitis (cervical inflammation), proctitis (rectal inflammation), pelvic inflammatory disease, non-gonococcal uncomplicated infections, lymphogranuloma venereum (a disease initially characterized by genital ulcers followed by lymph node inflammation), granuloma inguinale (genital ulceration), acute epididymo-orchitis (testicular inflammation), primary and secondary stages of syphilis, as well as late and latent syphilis in patients allergic to penicillin.

• Infections caused by a group of microorganisms called rickettsias, which include infections such as Rocky Mountain spotted fever, Mediterranean fever, endemic typhus, scrub typhus, and Q fever.
• Brucellosis (Malta fever).
• Cholera (a highly infectious disease that presents with severe diarrhea, dehydration, and vomiting).
• Initial stages (stages 1 and 2) of Lyme disease (a tick-borne infection).
• Recurring fevers transmitted by lice and ticks.
• Malaria in areas with chloroquine resistance (a highly infectious disease that presents with chills and sweating, transmitted by the bite of an infected mosquito that introduces the malaria parasite into the blood).

In addition, doxycycline could be considered as an alternative treatment for other infections such as carbuncle, tularemia (a rodent-borne disease similar to the plague), listeriosis (an infectious disease that can affect the fetus during pregnancy, the newborn, and the adult), bartonellosis (an infectious disease that presents with severe anemia and fever), and actinomycosis (an infectious disease that causes lymph node inflammation of the mouth along with other internal complications).

Doxycycline is also indicated for the prevention of malaria in areas with resistance to antimalarial medications and for the prevention of carbuncle.

Lastly, Doxycycline is indicated for the treatment of severe acne vulgaris along with other medications and rosacea (a chronic inflammatory skin condition that most frequently affects the face).

Do not take Doxiclat

-if you are allergic to doxycycline, other tetracyclines, orany of the other componentsof this medication (listed in section 6);

-in combination with oral retinoids (medication used for acne) (see other medications and Doxiclat);

-if you are pregnant or think you may be pregnant.

-during breastfeeding.

Doxiclat should not be used in children during teething (pregnancy, infants, and children under 8 years of age) because it may cause permanent discoloration of the teeth(from grayish-brown to yellowish) or affect theproper development of the teeth.

There may be circumstances (e.g., life-threatening situations), in which your doctor may decide that the benefits outweigh the risks in children under 8 years and Doxiclat should be used.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxiclat.

This medication should be used according to your doctor's instructions:

• During treatment with Doxiclat, avoid direct exposure to the sun or UV radiation. Stop taking this medication if you experience skin redness (photosensitivity) (see section 4 possible side effects).
• If you have systemic lupus erythematosus (a chronic connective tissue disorder that may involve skin rash, arthritis, kidney problems, and anemia, among other problems), avoid using this medication(see section 4 possible side effects).

-If you have myasthenia gravis (a form of muscle weakness), consult your doctor before taking this medication.

-If you have liver or kidney disease, consult your doctor, who will perform regular blood tests and liver and kidney function tests.

• Due to the presence of lactose, if your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication (see Doxiclat contains).

• If you experience severe skin reactions, such as blisters on the skin and mucous membranes (mouth, nose, eyes, and genitals) and/or generalized skin peeling, once treatment with doxycycline has begun, stop taking this medicatione inform your doctor immediately. These may be symptoms of a condition known as Stevens-Johnson syndrome or exfoliative dermatitis and can be severe and potentially life-threatening(see section 4 possible side effects).
• If you experience fever, chills, muscle pain, or worsening of a skin rash. These may be signs of a reaction called Jarisch-Herxheimer that can occur after starting treatment with doxycycline for a specific bacterial infection (e.g., Lyme disease). Stop taking this medication and inform your doctor immediately.

-If you experience severe skin reactions, such as the development of rounded/oval-shaped macules, well-defined erythematous lesions on the skin and/or mucous membranes associated with itching and burning, once treatment with doxycycline has begun, stop taking this medication and inform your doctor immediately. These may be symptoms of a condition known as fixed drug eruption(see section 4 possible side effects).

-If you experience fever, lymph node inflammation, or skin rash, once treatment with doxycycline has begun, stop taking this medication and inform your doctor immediately. These may be symptoms of a condition known as DRESS (drug reaction with eosinophilia and systemic symptoms) and can be severe and potentially life-threatening(see section 4 possible side effects).

• If you experience intense and prolonged diarrhea, it may be due to a special type of colitis called pseudomembranous colitis, which can be severe. In these cases, your doctor will decide whether to discontinue doxycycline administration and initiate appropriate treatment.

-If you experience headache, nausea, vomiting, dizziness, tinnitus, and visual disturbances, once treatment with doxycycline has begun, stop taking this medication and inform your doctor immediately. If visual disturbances occur during treatment, you should undergo an ophthalmological evaluation,as they may be symptoms of benign intracranial hypertension (a process affecting the brain due to an increase in intracranial pressure). In young children, it may cause fontanelle bulging (unossified space of the skull in young children). These alterations disappear when treatment is interrupted(see section 4 possible side effects).

• Due to the risk of esophageal damage, it is essential to respect the recommendations on how to administer the medication (see section method of administration and section 4 possible side effects).
• The use of antibiotics may increase the risk of developing infections caused by microorganisms that are not sensitive to treatment, including fungi, so your doctor will monitor for any possible signs of infection.

Children and adolescents

(see section 3 How to take Doxiclat)

Doxiclat should not be used in children during teething (pregnancy, infants, and children under 8 years of age) because it may cause permanent discoloration of the teeth(from grayish-brown to yellowish) or affect theproper development of the teeth.

There may be circumstances (e.g., life-threatening situations), in which your doctor may decide that the benefits outweigh the risks in children under 8 years and Doxiclat should be used.

The use of doxycycline for the treatment of acute infections in children aged 8 to 12 years should be justified carefully in situations where other medications are not available, are unlikely to be effective, or are contraindicated.

Other medications and Doxiclat

Inform your doctor or pharmacist if you are using or have used recentlyor may need to use any other medication.

• Penicillin should be avoided due to a possible interference of Doxiclat with the action of penicillin.

• Retinoids should be avoided, as it may increase the risk of benign intracranial hypertension (increase in intracranial pressure).
• Diuretics, methoxiflurane, and other nephrotoxic medications, as it may increase the risk of nephrotoxicity. Therefore, tetracyclines are not recommended for preoperative treatments.
• Lithium, as Doxiclat may decrease lithium elimination by the kidneys.
• Oral contraceptives, as Doxiclat may decrease the effectiveness of these.
• Anticonvulsants and rifampicin, as they may reduce the effectiveness of Doxiclat.
• Iron and zinc salts, bismuth, and topical gastrointestinal medications, as they may decrease the absorption of Doxiclat. You should separate the administration of these medications and Doxiclat by at least 2 hours.
• Strontium, as it may decrease the absorption of strontium,you should separate the administration of this medication and Doxiclat by at least 2 hours.
• Oral anticoagulants, as it may increase the risk of bleeding.
• Digoxin, theophylline, vinca alkaloids, and methotrexate, as tetracycline may increase the potential toxic effects of these products.

Use ofDoxiclat with food and beverages

The effect of doxycycline may be reduced if you consume alcoholic beverages during treatment.

Therefore, you should avoid consuming alcohol during treatment with doxycycline.

Doxiclat should be taken with food or water to avoid esophageal irritation (see section 3, How to take Doxiclat).

Pregnancy and breastfeeding

Do not use Doxiclat during pregnancy and breastfeeding (risk of abnormal tooth growth or tooth discoloration in children) (see “do not use Doxiclat”).

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

Driving and operating machinery

Doxiclat does not affect your ability to drive vehicles or operate machinery.

Doxiclat contains

Each coated tablet contains 60.2 mg of lactose (as monohydrate). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

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

Your doctor will indicate the most suitable dose and treatment duration for you, according to your condition and response to treatment. Do not stop treatment prematurely, as your condition may worsen or reappear, even if you feel better.

If your condition requires a different dose and/or treatment duration than the recommended dose, your doctor will indicate the dose and/or treatment duration to follow in your case.

As a general rule, the recommended dose of medication and administration frequency is as follows:

Adults and adolescents (12 years to under 18 years):

The recommended dose of doxicycline is 200 mg on the first day of treatment (one tablet in the morning and one tablet at night, taken with an approximate 12-hour interval) and 100 mg (one tablet) per day from the second day onwards. For the treatment of more severe infections, 200 mg per day should be administered throughout the treatment period. The treatment duration depends on the type of infection being treated.

Specific cases:

• Severe acne vulgaris: 100 mg every 24 hours for 12 weeks.

• Rosacea: 100 mg every 24 hours for 12 weeks.

Prophylaxis of malaria: 100 mg per day.

Prophylaxis should begin 1 or 2 days before traveling to endemic areas, continue daily throughout the trip to the endemic area, and continue for 4 weeks after leaving the endemic area.

Use in children and adolescents

Children from birth to 8 years:

Doxiclat should not be used in children under 8 years due to the risk of tooth discoloration or enamel hypoplasia.

In some circumstances (e.g., severe or potentially fatal conditions), your doctor may decide that the benefits outweigh this risk in children under 8 years and prescribe Doxiclat.

Children 8 years to under 12 years:

Doxiclat should only be used in children 8 years to under 12 years when carefully justified in situations where other medications are not available, contraindicated, not effective, or should not be used. In these circumstances, the recommended dose is:

• In children weighing 45 kg or less:

First day: 4.4 mg per kilogram of body weight (in a single dose or divided into two doses) and from the second day onwards, 2.2 mg per kilogram of body weight (in a single dose or divided into two doses). The treatment duration depends on the type of infection being treated.

In more severe infections, up to 4.4 mg per kilogram of body weight should be administered during treatment.

• In children weighing more than 45 kg:

The recommended adult dose will be used; 200 mg on the first day, then 100 mg per day from the second day onwards. For the treatment of more severe infections, 200 mg per day should be administered throughout the treatment period. The treatment duration depends on the type of infection being treated.

Tablets are not recommended for children weighing less than 45 kg because they do not allow for precise dosing. For administration in children weighing less than 45 kg and in patients who cannot swallow tablets, other more suitable pharmaceutical forms may be used.

Prophylaxis of malaria:

2.2 mg/kg administered as a single daily dose, not exceeding the adult dose (100 mg per day).

Prophylaxis should begin 1-2 days before traveling to endemic areas, continue daily throughout the trip to the endemic area, and continue for 4 weeks after leaving the endemic area.

Older patients:

No dose adjustment is necessary.

Patients with reduced renal function:

Unlike other tetracyclines, doxicycline does not require dose adjustment in patients with renal function impairment.

Patients with liver function impairment:

Doxicycline should be administered with caution in patients with impaired liver function.

Method of administration

Oral route

IMPORTANT:

If you take more Doxiclat than you should:

Stop treatment immediately and consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service. Tel. 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Doxiclat:

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, take the next one when it is due.

If you interrupt treatment with Doxiclat:

Do not interrupt treatment and follow the schedule indicated by your doctor. If you interrupt treatment without completing it, the infection may reappear.

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

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

Stop taking this medicine and tell your doctor immediatelyif you experience any of the following severe side effects after taking this medicine.

Unknown frequency side effects (cannot be estimated from available data):

• Sudden wheezing, difficulty breathing, chest pain, fever, swelling of eyelids, face, or lips, rash or itching (especially affecting the entire body) or red patches on the skin associated with arthritis and abdominal pain. These may be symptoms of severe generalized allergic reactions (angioedema, anaphylactic reaction, serum disease, or Henoch-Schonlein purpura).
• Stomach discomfort, loss of appetite, intense, persistent, or bloody diarrhea (this may occur up to two or three months after the last dose and may be associated with stomach pain or fever). This may occur after antibiotic treatment and may be a sign of severe intestinal inflammation.
• Fever, swollen lymph nodes, or skin rash. These may be symptoms of a known condition called DRESS (drug reaction with eosinophilia and systemic symptoms) and may be severe and life-threatening.
• Severe disease with severe blistering of the skin, mouth, eyes, and genitals. These may be symptoms of a known condition called Stevens-Johnson syndrome.
• Severe disease with generalized rash and skin peeling (exfoliative dermatitis).
• Appearance of well-defined, red, rounded/oval macules on the skin and/or mucous membranes associated with a sensation of itching and burning (fixed drug eruption).

• In case of headache, nausea, vomiting, dizziness,tinnitusor sometimes severe visual disturbances, because there is a risk of benign intracranial hypertension (increased pressure within the skull) in adults and children.

If any of the following side effects occur, inform your doctor as soon as possible:

Unknown frequency side effects (cannot be estimated from available data):

• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain, and skin rash that usuallyremits spontaneously. This occurs shortly after initiating doxycycline treatment for spirochetal infections such as Lyme disease.
• Inflammation and/or ulcers of the throat/esophagus with a higher risk if the patient lies down shortly after taking this medicine or when taken without sufficient water intake. (see section 3).
• Possible changes in blood count: excessive breakdown of red blood cells (hemolytic anemia), decreased platelets and white blood cells, increased eosinophil count.
• Photosensitivity (a skin reaction after exposure to the sun or ultraviolet rays).
• Allergic skin reactions: urticaria, skin rashes, itching.
• Exacerbation of pre-existing lupus erythematosus.
• Photoonycholysis (separation of the nail plate from the nail bed and discoloration of the nails induced by ultraviolet light).
• Pigmentation of the skin (dark spots on the skin).
• Cardiac disorder: inflammation of the membrane surrounding the heart (pericarditis), low blood pressure (hypotension).
• Pancreatitis (inflammation of the pancreas).
• May cause gastrointestinal disturbances: difficulty swallowing, esophageal pain, nausea, upper stomach pain, diarrhea, loss of appetite, tongue inflammation, intestinal inflammation (enterocolitis), anal or genital ulcers (candidiasis caused by Candida) (candidiasis).
• Liver function disorders and hepatitis (inflammation of the liver).
• Increased urea nitrogen in the blood.
• Arthralgia, myalgia, and increased muscle weakness in patients with myasthenia gravis.
• Bronchial obstruction.
• Decoloration of the thyroid tissue when administered for prolonged periods. The medicine does not affect thyroid function.
• Decoloration and/or lack of growth of teeth.

Reporting of side effects:

If you experienceany type of side effect, consult your doctor or pharmacist even if it is apossibleside effect not listed in this leaflet.You can also report them directly tothrough 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.

Store below 30 °C.

Do not useDoxiclatafter the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Doxycycline Composition

- The active principle is doxycycline (as monohydrate).Each tablet contains doxycycline monohydrate in an amount equivalent to 100 mg of anhydrous doxycycline.

• The other components are:

Tablet core: sodium croscarmellose, povidone, talc, magnesium stearate, lactose monohydrate.

Tablet coating: Sepifilm LP 010 (hypromellose, microcrystalline cellulose, stearic acid), titanium dioxide (E171), sodium lauryl sulfate, glycerol (E422).

Product appearance and packaging contents

Coated tablet, round, white, and scored.

Doxiclat is presented in packaging of 14 and 42 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona (Spain).

Responsible manufacturer

PIERRE FABRE MEDICAMENT PRODUCTION,

Site Progipharm,

Rue du Lycée

45500 Gien, France

Last review date of this leaflet: April 2025

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es”