Doxiclat 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

DOXICLAT 100 mg film-coated tablets

Doxycycline

Read the entire package leaflet carefully before you start taking this medicine, as 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 should not give it to others, 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 they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Doxiclat is and what it is used for
2. What you need to know before taking Doxiclat
3. How to take Doxiclat
4. Possible adverse effects
5. How to store Doxiclat
6. Contents of the pack and other information

1. What Doxiclat is and what it is used for

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

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 dose, dosing interval, and duration of treatment as prescribed by your doctor. Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Doxiclat is indicated in adults and adolescents for the treatment of certain infections caused by susceptible microorganisms, of varying origin and localization, such as:

• Atypical pneumonia.

• Psittacosis, a disease transmitted to humans by certain birds, characterized by fever and cough.

• Sexually transmitted diseases, such as: urethritis (inflammation of the urethra), cervicitis (inflammation of the cervix), proctitis (inflammation of the rectum), pelvic inflammatory disease, uncomplicated non-gonococcal infections, lymphogranuloma venereum (a disease initially characterized by genital ulcers followed by lymph node swelling), granuloma inguinale (genital ulceration), acute orchiepididymitis (inflammation of the testicles), 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 known as rickettsias, including Rocky Mountain spotted fever, Mediterranean fever, endemic typhus, scrub typhus, and Q fever.

• Brucellosis (Malta fever).

• Cholera (an infectious disease characterized by severe diarrhea, dehydration, and vomiting).

• Early stages (stages 1 and 2) of Lyme disease (a tick-borne infection).

• Relapsing fevers transmitted by lice and ticks.

• Malaria in areas with chloroquine resistance (an infectious disease characterized by chills and sweating, transmitted by the bite of an infected mosquito that introduces the malaria parasite into the bloodstream).

In addition, doxycycline may be considered as an alternative treatment for other infections such as anthrax, tularemia (a rodent-borne disease similar to plague), listeriosis (an infectious disease that may affect the fetus during pregnancy, newborns, and adults), bartonellosis (an infectious disease presenting with severe anemia and fever), and actinomycosis (an infectious disease causing inflammation of lymph nodes in the mouth along with other internal complications).

Doxiclat is also indicated for the prevention of malaria in areas with resistance to antimalarials and for the prevention of anthrax.

Finally, Doxiclat is indicated for the treatment of severe acne vulgaris in combination with other medicines, and for the treatment of rosacea (a chronic inflammatory skin condition most commonly affecting the face).

2. What you need to know before taking Doxiclat

Do not take Doxiclat

• if you are allergic to doxycycline, other tetracyclines, or any of the other ingredients of this medicine (listed in section 6);
• in combination with oral retinoids (medications used for acne) (see Other medicines and Doxiclat);
• if you are pregnant or think you may be pregnant;
• during breastfeeding.

Doxiclat must not be used in children during tooth development (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 proper tooth development.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxiclat.

This medicine should be used as directed by your doctor:

• During treatment with Doxiclat, direct exposure to sunlight or UV radiation should be avoided. Stop taking this medicine if you experience skin redness (photosensitization) (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 issues), avoid using this medicine (see section 4 Possible side effects).

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

• If you have liver or kidney disease, consult your doctor, who will perform periodic blood tests and monitor kidney and liver function.

  • Due to the presence of lactose, if your doctor has diagnosed you with intolerance to certain sugars, consult with them before taking this medicine (see section Doxiclat contains).

• If you experience severe skin reactions such as blisters on the skin and mucous membranes (mouth, nose, eyes, and genitals) and/or widespread skin peeling after starting treatment with doxycycline, stop taking this medicine and inform your doctor immediately. These may be symptoms of a condition known as Stevens-Johnson syndrome or exfoliative dermatitis, which can be serious and potentially life-threatening (see section 4 Possible side effects).

• If you develop fever, chills, muscle pain, or worsening of a skin rash, these could be signs of a reaction called Jarisch-Herxheimer, which may occur after starting doxycycline treatment for a specific bacterial infection (spirochetal infections, e.g., Lyme disease). Stop taking this medicine and inform your doctor immediately.

• If you experience severe skin reactions, such as the appearance of round/oval, well-defined erythematous patches on the skin and/or mucous membranes associated with itching and burning sensations after starting doxycycline treatment, stop taking this medicine and inform your doctor immediately. These may be symptoms of a condition known as drug-induced fixed eruption (see section 4 Possible side effects).

• If you develop fever, swollen lymph nodes, or a skin rash after starting doxycycline treatment, stop taking this medicine and inform your doctor immediately. These may be symptoms of a condition known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms), which can be serious and potentially fatal (see section 4 Possible side effects).

  • If you have severe and persistent diarrhea, it may be due to a special type of colitis called pseudomembranous colitis, which can be serious. In such cases, your doctor will decide whether to discontinue doxycycline and initiate appropriate treatment.

• If you experience headache, nausea and vomiting, dizziness, tinnitus, or visual disturbances after starting doxycycline treatment, stop taking this medicine and inform your doctor immediately. If visual disturbances occur during treatment, an ophthalmological evaluation should be performed, as these may be symptoms of benign intracranial hypertension (a condition affecting the brain due to increased pressure within the skull). In young children, bulging of the fontanelles (soft spots on the skull in infants) may occur. These symptoms usually resolve upon discontinuation of treatment (see section 4 Possible side effects).

  • Due to the risk of esophageal damage, it is important to follow the recommendations regarding how to take the medicine (see section Method of administration and section 4 Possible side effects).
  • The use of antibiotics may increase the risk of infections caused by microorganisms 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 must not be used in children during tooth development (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 proper tooth development.

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

The use of doxycycline for the treatment of acute infections in children aged 8 to 12 years should be carefully justified in situations where other drugs are unavailable, likely to be ineffective, or contraindicated.

Other medicines and Doxiclat

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

• Oral retinoids should be avoided, as they may increase the risk of benign intracranial hypertension (increased pressure of cerebrospinal fluid in the brain).

• Diuretics, methoxyflurane, and other nephrotoxic drugs, as they may increase the risk of kidney toxicity. Therefore, the use of tetracyclines in preoperative treatments is not recommended.

• Lithium, because Doxiclat may reduce renal elimination of lithium.

• Oral contraceptives, because Doxiclat may reduce their effectiveness.

• Anticonvulsants and rifampicin, as they may reduce the efficacy of Doxiclat.

• Iron and zinc salts, bismuth, and topical gastrointestinal agents, as they may reduce the absorption of Doxiclat. Administration of these medicines should be separated from Doxiclat by at least 2 hours.

• Strontium, due to reduced absorption of strontium; administration of this medicine should be separated from Doxiclat by at least 2 hours.

• Oral anticoagulants, as they may increase the risk of bleeding.

• Digoxin, theophylline, vinca alkaloids, and methotrexate, because tetracycline may increase the potential toxic effects of these products.

Use of Doxiclat with food and drinks

The effect of doxycycline may be reduced if alcoholic beverages are consumed during treatment.

Therefore, alcohol consumption should be avoided 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 development or tooth discoloration in children) (see “Do not use Doxiclat”).

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

Driving and using machines

Doxiclat does not affect the ability to drive or operate machinery.

Doxiclat contains

Each film-coated tablet contains 60.2 mg of lactose (as monohydrate). If your doctor has diagnosed you with intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., essentially “sodium-free”.

3. How to take Doxiclat

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the dose and duration of treatment most suitable for you, depending on your condition and your response to treatment. Do not stop treatment prematurely, as even if you feel better, your illness could worsen or recur.

If your medical condition requires a dose and/or duration different from the recommended dose, your doctor will indicate the dose and/or duration of treatment to follow in your case. As a general rule, the recommended dose of the medicine and the frequency of administration is as follows:

Adults and adolescents (from 12 to under 18 years of age):

The recommended dose of doxycycline is 200 mg on the first day of treatment (one tablet in the morning and one tablet at night, taken approximately 12 hours apart), and from the second day onwards, 100 mg (one tablet) daily. For the treatment of more severe infections, 200 mg daily should be administered throughout the treatment period. The duration of treatment 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.

Malaria prophylaxis: 100 mg daily.

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

Use in children and adolescents

Children from birth up to 8 years of age:

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

In certain circumstances (e.g., severe or potentially life-threatening conditions), your doctor may decide that the benefits outweigh this risk in children under 8 years of age, and Doxiclat may be prescribed.

Children from 8 to under 12 years of age:

Doxiclat should be used in children from 8 to under 12 years of age only when carefully justified in situations where other medicines are unavailable, contraindicated, ineffective, 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 kg of body weight (as a single dose or divided into two doses), and then from the second day onwards, 2.2 mg per kg of body weight (as a single dose or divided into two doses). The duration of treatment depends on the type of infection being treated.

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

• In children weighing over 45 kg:

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

The 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.

Malaria prophylaxis:

2.2 mg/kg administered as a single daily dose, without exceeding the adult dose (100 mg daily).

Prophylaxis should begin 1–2 days before traveling to endemic areas, continued daily throughout the stay in the endemic area, and maintained for 4 weeks after leaving the endemic area.

Elderly patients:

Dose adjustment is not necessary.

Patients with reduced kidney function:

Unlike other tetracyclines, doxycycline does not require dose adjustment in patients with impaired renal function.

Patients with impaired liver function:

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

Method of administration

Oral use

IMPORTANT:

This medicine must be taken during a meal, accompanied by a large glass of water.

It is important that, after taking the medicine, you remain upright for at least one hour before lying down or going to bed.

The above recommendations aim to prevent the occurrence of gastrointestinal problems, especially esophageal ulceration.

If you take more Doxiclat than you should

Stop treatment immediately and consult your doctor or pharmacist.

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

If you forget to take Doxiclat

Do not take a double dose to make up for missed doses. If you forget to take a dose, take the next one at the scheduled time.

If you stop treatment with Doxiclat

Do not interrupt treatment; continue following the regimen prescribed by your doctor. Interrupting treatment before completion may cause the infection to reappear.

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.

Stop taking this medicine and inform your doctor immediately if you experience any of the following serious adverse effects after taking this medicine.

Adverse effects with frequency not known (cannot be estimated from available data):

• Sudden wheezing, difficulty breathing, chest pain, fever, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body), or red spots on the skin associated with arthritis and abdominal pain. These may be symptoms of severe generalized allergic reactions (angioedema, anaphylactic reaction, serum sickness or Henoch-Schönlein purpura).
• Stomach discomfort, loss of appetite, severe, persistent or bloody diarrhoea (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 could be a sign of severe intestinal inflammation.
• Fever, swollen lymph nodes or skin rash. These may be symptoms of a condition known as DRESS (drug reaction with eosinophilia and systemic symptoms), which can be serious and life-threatening.
• Severe illness with widespread severe blistering of the skin, mouth, eyes and genitals. These may be symptoms of a condition known as Stevens-Johnson syndrome.
• Severe illness with widespread skin rash and skin peeling (exfoliative dermatitis).
• Appearance of well-defined erythematous macules, round/oval in shape, on the skin and/or mucous membranes, associated with itching and burning sensation (drug-induced fixed eruption).
• In case of headache, nausea, vomiting, dizziness, tinnitus or visual disturbances, sometimes severe, due to risk of benign intracranial hypertension (increased pressure within the skull) in adults and children.

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

Adverse effect with frequency not known (cannot be estimated from available data):

• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain and skin rash, which usually resolves spontaneously. This occurs shortly after starting doxycycline treatment for spirochetal infections such as Lyme disease.
• Inflammation and/or ulcers of the throat/esophagus, with increased risk if the patient lies down soon after taking this medicine or when taken without sufficient water. (see section 3).
• Possible changes in blood counts: excessive breakdown of red blood cells (haemolytic anaemia), decreased platelets and white blood cells, increased eosinophil count.
• Photosensitization (a skin reaction following exposure to sunlight or ultraviolet rays).
• Skin allergic reactions: urticaria, skin rashes, itching.
• Exacerbation of pre-existing systemic lupus erythematosus.
• Photo-onycholysis (separation of the nail plate from the nail bed and discoloration of the nails induced by ultraviolet light).
• Hyperpigmentation 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).
• Gastrointestinal disturbances may occur: difficulty swallowing, oesophageal pain, nausea, upper stomach pain, diarrhoea, loss of appetite, inflammation of the tongue, intestinal inflammation (enterocolitis), anal or genital thrush (fungal infection caused by Candida) (candidiasis).
• Liver function disorders and hepatitis (inflammation of the liver).
• Increased blood urea nitrogen.
• Arthralgia, myalgia and increased muscle weakness in patients with myasthenia gravis.
• Bronchial obstruction.
• Discoloration of thyroid tissue when administered for prolonged periods. The medicine does not alter thyroid function.
• Discoloration and/or impaired growth of teeth.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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 Doxiclat

Keep this medicine out of sight and reach of children.

Store below 30 °C.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxiclat

• The active substance 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).

Appearance of the medicinal product and contents of the pack

Film-coated, round, white, scored tablet.

Doxiclat is available in packs of 14 and 42 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona (Spain).

Manufacturer

PIERRE FABRE MEDICAMENT PRODUCTION,

Site Progipharm,

Rue du Lycée

45500 Gien, France

Date of the most recent revision of this summary: April 2025

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es”