DOSIL 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Dosil 100 mg Hard Capsules

Doxycycline

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Dosil and what is it used for

Dosil contains doxycycline, an antibiotic that belongs to a group called tetracyclines.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is essential that you follow the dosage instructions, administration intervals, and treatment duration indicated by your doctor.

Do not store or use this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Dosil is indicated for:

• treatment of the following infections:

• Atypical pneumonia.
• Psittacosis (disease transmitted by certain birds that presents as pneumonia accompanied by fever and cough).
• Urethritis (inflammation of the urethra), cervicitis (inflammation of the cervix), proctitis (inflammation of the rectum), lymphogranuloma venereum (infection characterized by ulcers in the genitals followed by inflammation of the lymph nodes), granuloma inguinale (purulent ulceration of the genitals), pelvic inflammatory disease, syphilis in patients allergic to penicillin, acute epididymo-orchitis (inflammation of the testicles, purulent and mainly affecting newborns).
• Ocular infections such as: trachoma, inclusion conjunctivitis.
• Typhus and other infections caused by microorganisms called rickettsias.
• Brucellosis (Malta fever).
• Cholera (infectious disease that presents with severe diarrhea, dehydration, and vomiting).
• Early stages of Lyme disease (transmitted by ticks).
• Recurrent fevers transmitted by lice and ticks.
• Malaria (infectious disease with fever, chills, and sweating, produced by microorganisms that parasitize red blood cells).
• Severe acne vulgaris.

• alternative treatment of: anthrax (infectious disease that affects the skin, intestine, or lungs), tularemia (disease of rodents similar to plague), listeriosis (severe infectious disease that can affect the fetus during pregnancy, the newborn, and the adult), bartonellosis (infectious disease that presents with severe anemia and fever) and actinomycosis (infectious disease that causes inflammation of the lymph nodes in the mouth along with other internal complications).

• prevention of malaria (transmitted through mosquito bites) and prevention of anthrax after exposure to bacteria that cause this disease.

2. What you need to know before you take Dosil

Do not take Dosil

• If you are allergic to doxycycline, any other tetracycline, or any of the other components of this medicine (listed in section 6).
• If you are using methoxyflurane (a medicine used for anesthesia), as severe kidney toxicity with fatal outcome may occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dosil:

• it is recommended to use total sunblock creams and avoid sun exposure or ultraviolet radiation, as skin redness may occur. If this happens, you should consult your doctor,
• the use of antibiotics can increase the risk of developing infections with microorganisms that are not sensitive to treatment, including fungi, so your doctor will monitor the appearance of any possible signs of infection.

Children

• Dosil should not be used in children during the teething period (last half of pregnancy, infants, and children under 8 years) because it may cause permanent tooth discoloration, as well as delayed bone development.

Use in children and adolescents

• In children under 8 years, the use of Dosil is not recommended.
• In children over 8 years and up to 45 kg in weight, there is another presentation more suitable for dose adjustment.

• In children over 8 years and over 45 kg in weight, the same dose as in adults is recommended, see section 3.

Taking Dosil with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines may interact with Dosil. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are using any of the following medicines:

• Penicillin, as Dosil may interfere with its effect.
• Oral contraceptives, as Dosil may reduce their effectiveness.
• Anticoagulants (such as warfarin), as Dosil may alter their effect.
• Antacids (medicines used to calm stomach acidity) and other medicines that contain aluminum, calcium, or magnesium, and medicines that contain iron or bismuth salts, as they may reduce the effect of Dosil.
• Antiepileptics and barbiturates (medicines for severe insomnia and seizures), as they may reduce the effect of Dosil.
• Methoxyflurane (a medicine used for anesthesia), as when used in combination with tetracycline antibiotics, such as Dosil, severe kidney toxicity may occur.

Taking Dosil with food, drinks, and alcohol

• You should avoid consuming alcohol during treatment with Dosil, as alcohol reduces the effect of doxycycline.
• It is essential to take Dosil during a meal, accompanied by a large glass of water or milk, to avoid esophageal irritation (see section 3).

Pregnancy and breastfeeding

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.

Pregnancy

The use of Dosil is not recommended during pregnancy, as it may cause disorders in the development of the child's bones and teeth. Your doctor will decide on the convenience of using Dosil in these cases.

It is essential that during treatment with Dosil, you use contraceptive methods to avoid becoming pregnant. Oral contraceptives (hormonal) may not be effective, as taking Dosil reduces the contraceptive effect, and therefore, barrier methods are recommended.

Breastfeeding

The use of Dosil should be avoided during breastfeeding, as it may cause disorders in the development of the child's bones and teeth.

Driving and using machines

There is no evidence that Dosil alters the ability to drive or use machines.

This medicine contains lactose and wheat starch

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains wheat starch, which is equivalent to 100 ppm of gluten, which should be taken into account by celiac patients.

Patients with a wheat allergy (distinct from celiac disease) should not take this medicine.

3. How to take Dosil

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

Remember to take your medicine. It is essential to take the capsules regularly at the same time of day.

Your doctor will indicate the duration of treatment with this medicine. Do not discontinue treatment until your doctor indicates it, even if you have started to improve.

The dose will be established by the doctor based on individual characteristics and the type of infection. As a general rule, the usual dose and administration frequency are as follows:

Adults:

• The usual dose is 200 mg of doxycycline (2 capsules of 100 mg) on the first day of treatment, administered in a single dose or divided into two doses, and then 100 mg of doxycycline (1 capsule) to complete the treatment, administered in a single dose or divided into two doses.
• For the treatment of more severe infections (particularly chronic urinary tract infections), 200 mg should be administered daily throughout the treatment period. In general, treatment should continue until at least 24 to 48 hours after the disappearance of symptoms and fever.

Specific dosage guidelines for adults:

(1) Due to the potential severity of the infection, a rapid-acting antimalarial such as quinine should always be administered in combination with doxycycline. Quinine dosage recommendations vary in different geographic areas.

There are different doses available for different dosing regimens.

Patients with hepatic impairment

Doxycycline should be administered with caution in patients with hepatic impairment.

Patients with renal impairment

Doxycycline does not require dose adjustment in patients with renal impairment.

Elderly patients

No dose adjustment is necessary.

Use in children and adolescents

In children under 8 years, the use of Dosil is not recommended.

In children over 8 years and up to 45 kg in weight, there is another presentation more suitable for dose adjustment.

In children over 8 years and over 45 kg in weight, the same dose as in adults is recommended.

Method of administration

Oral route.

This medicine should be taken during a meal, accompanied by a large glass of water or milk.

It is essential that, after taking the medicine, you wait at least one hour before lying down or going to bed.

The above recommendations aim to prevent the appearance of digestive problems, especially esophageal ulcers.

If you take more Dosil than you should

Information for the healthcare professional: In case of overdose, administration should be discontinued, and symptomatic treatment and support measures should be initiated.

Peritoneal dialysis does not alter the plasma elimination half-life and therefore would not be beneficial in the treatment of overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dosil

If you forget to take a dose, take the next one at the usual time. Do not take a double dose to make up for forgotten doses. It is essential to take the medicine regularly at the same time of day.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects have been observed in patients who have taken tetracyclines, including doxycycline, ordered according to their frequency of appearance:

Frequent Adverse Effects (may affect up to 1 in 10 people):

Allergic reactions (including skin and mucous membrane edema (angioedema), exacerbation of lupus erythematosus, inflammation of the tissue surrounding the heart (pericarditis), hypersensitivity, serum sickness, Henoch-Schonlein purpura, decrease in blood pressure (hypotension), difficulty breathing (dyspnea), rapid heart rate (tachycardia), fluid retention in the extremities (peripheral edema), and red, raised, and itchy skin lesions (urticaria), headache, nausea, vomiting, exaggerated skin reaction to sunlight or ultraviolet radiation, skin rash (including erythematous and maculopapular types).

Uncommon Adverse Effects (may affect up to 1 in 100 people):

Digestive disorders (heartburn/gastritis).

Rare Adverse Effects (may affect up to 1 in 1,000 people):

Increased destruction of red blood cells (hemolytic anemia), decrease in platelet count (thrombocytopenia), alteration in the number of white blood cells: decrease in the number of neutrophils (neutropenia) or increase in the number of eosinophils (eosinophilia), drug rash with eosinophilia or systemic symptoms, brown-black microscopic discoloration of the thyroid gland, decreased appetite, increased pressure inside the skull (benign intracranial hypertension) in adults, bulging of the fontanelles (unossified space in the skull of young children) in children, ringing in the ears (tinnitus), reddening of the face (flushing), alteration in the volume or fluidity of the stools (diarrhea, pseudomembranous colitis), esophageal ulcers, esophagitis, intestinal inflammation, inflammatory lesions in the anogenital area, difficulty swallowing (dysphagia), abdominal pain, inflammation of the tongue (glossitis), alteration in liver function, liver inflammation (hepatitis) and liver damage, skin inflammation with blisters (toxic epidermal necrolysis), skin and mucous membrane inflammation that can be severe (Stevens-Johnson syndrome), red, raised, and target-shaped skin lesions (erythema multiforme), widespread skin inflammation with peeling (exfoliative dermatitis), nail loss (photo-onycholysis), joint pain (arthralgia) and muscle pain (myalgia), elevated blood urea levels.

Adverse Effects of Unknown Frequency (cannot be estimated from available data):

Jarisch-Herxheimer reaction, which is characterized by 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.

As with all tetracyclines, doxycycline may cause permanent tooth discoloration (from grayish-brown to yellowish) and alteration in bone growth.

Reporting Adverse Effects

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

5. Storage of Dosil

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

Store in the original packaging to protect it from moisture. Do not store at a temperature above 30°C.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dosil

• The active ingredient is doxycycline. Each capsule contains 100 mg of doxycycline (as hyclate).
• The other components are:

Capsule content:calcium hydrogen phosphate, magnesium trisilicate, wheat starch, lactose monohydrate, and magnesium stearate.

Appearance of the Product and Package Contents

Dosil is presented in the form of hard green capsules.

Aluminum and PVC blister pack.

Each package contains 14 or 500 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Llorens, S.L.

Ciudad de Balaguer, 7-11

08022 Barcelona

Manufacturer

Laboratorios Llorens S.L.

C/ Llacuna, 19-21

08005 Barcelona

Date of the Last Revision of this Prospectus: 04/2024

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