Dosil 100 mg hard capsules

Package leaflet: Information for the user

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 questions, ask 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 as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Dosil is and what it is 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 important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not keep or use this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Dosil is indicated for:

• the treatment of the following infections:

• Atypical pneumonia.

• Psittacosis (a disease transmitted by certain birds, presenting as pneumonia accompanied by fever and cough).

• Urethritis (inflammation of the urethra), cervicitis (inflammation of the cervix), proctitis (inflammation of the rectum), lymphogranuloma venereum (an infection initially characterized by genital ulcers followed by lymph node swelling), granuloma inguinale (purulent ulceration of the genitals), pelvic inflammatory disease, syphilis in penicillin-allergic patients, acute purulent orchiepididymitis (inflammation of the testicles, mainly affecting newborns).

• Ocular infections such as: trachoma, inclusion conjunctivitis.

• Typhus and other infections caused by microorganisms called rickettsiae.

• Brucellosis (Malta fever).

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

• Early stages of Lyme disease (transmitted by ticks).

• Relapsing fevers transmitted by lice and ticks.

• Malaria (a febrile infectious disease with chills and sweating, caused by microorganisms that parasitize red blood cells).

• Severe acne vulgaris.

• as an alternative treatment for: anthrax (an infectious disease affecting the skin, intestine, or lungs), tularemia (a rodent-borne disease similar to plague), listeriosis (a serious 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).

• prevention of malaria (transmitted through mosquito bites) and prevention of anthrax following exposure to the causative bacteria.

2. What you need to know before taking Dosil

Do not take Dosil

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Dosil:

• if during treatment with Dosil you experience unusual headaches accompanied by dizziness, blurred vision, ringing in the ears, nausea, or vomiting, consult your doctor, as these may be symptoms of benign intracranial hypertension (a condition affecting the brain due to increased pressure inside the skull). In young children, bulging of the fontanelles (soft spots on the skull in infants) may occur. These effects resolve when treatment is discontinued.
• if you are taking a medicine called isotretinoin, as taking it together with Dosil may cause benign intracranial hypertension.
  • if you develop severe and persistent diarrhea while on doxycycline treatment, you may have a type of antibiotic-associated colitis called pseudomembranous colitis, which can be serious. In such cases, you should consult your doctor, who will decide whether to discontinue doxycycline and initiate appropriate treatment.
  • if you take this medicine while lying down or without sufficient water or milk, inflammation and ulcers in the esophagus may occur; therefore, it is important to follow the administration instructions exactly (see section 3).
  • if you have liver disease, consult your doctor. During prolonged treatment, your doctor may need to perform periodic blood tests.
  • the use of total sunblock creams and avoidance of sun exposure or ultraviolet radiation is recommended, as skin redness may occur. If this happens, you should consult your doctor.
  • the use of antibiotics may increase the risk of infections caused by microorganisms not sensitive to the treatment, including fungi, so your doctor will monitor for any possible signs of infection.
  • if you need to undergo a urine test, inform healthcare personnel that you are being treated with Dosil, as it may interfere with test results.

Children

• Dosil must not be used in children during tooth development (second half of pregnancy, infants, and children under 8 years of age), as it may cause permanent tooth discoloration and delayed bone development.

Use in children and adolescents

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

  • In children over 8 years of age and weighing up to 45 kg, another formulation more suitable for dose adjustment is available.

• In children over 8 years of age and weighing more than 45 kg, 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 need to take any other medicines.

Certain medicines may interact with Dosil. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are taking 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 relieve stomach acidity) and other medicines containing aluminum, calcium, or magnesium, and medicines containing iron salts 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 concomitant use with tetracycline antibiotics such as Dosil may cause severe kidney toxicity.

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 important 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 during pregnancy is not recommended, as it may cause disturbances in the child's bone and tooth development. Your doctor will decide whether it is appropriate to use Dosil in such cases.

It is important to use contraceptive methods during treatment with Dosil to avoid pregnancy. Oral contraceptives (hormonal) may not be effective, as Dosil reduces contraceptive efficacy; therefore, barrier methods are recommended.

Breastfeeding

The use of Dosil should be avoided during breastfeeding, as it may cause disturbances in the infant's bone and tooth development.

Driving and using machines

There is no evidence that Dosil affects the ability to drive or operate machinery.

This medicine contains lactose and wheat starch

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains wheat starch, equivalent to 100 ppm of gluten, which should be considered by patients with celiac disease.

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

3. How to take Dosil

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

Remember to take your medicine. It is important to take the capsules regularly at the same time each day.

Your doctor will indicate how long you should take this medicine. Do not stop treatment until your doctor tells you to do so, even if you are already feeling better.

The dose will be determined by your doctor according to your individual characteristics and the type of infection. As a general rule, the usual dose and frequency of administration is as follows:

Adults:

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

Specific dosing regimens in adults:

(1) Due to the potentially severe nature of the infection, a rapidly acting antimalarial such as quinine should always be administered in combination with doxycycline. Quinine dosing recommendations vary across different geographical regions.

Various dosage regimens with different dose strengths are available.

Patients with impaired hepatic function

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

Patients with renal insufficiency

Doxycycline does not require dose adjustment in patients with impaired renal function.

Elderly patients

No dose adjustment is necessary.

Use in children and adolescents

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

In children over 8 years of age and weighing up to 45 kg, there is another more appropriate formulation available for dose adjustment.

In children over 8 years of age and weighing more than 45 kg, the same dose as in adults is recommended.

Method of administration

Oral use.

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

It is important to remain upright for at least one hour after taking the medicine before lying down.

These recommendations aim to prevent the occurrence of gastrointestinal problems, particularly esophageal ulcers.

If you take more Dosil than you should

Information for healthcare professionals: In case of overdose, administration should be discontinued and symptomatic treatment and supportive measures should be initiated.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dosil

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for missed doses. It is important to take the medicine regularly at the same time each day.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed in patients taking tetracyclines, including doxycycline, listed according to their frequency of occurrence:

Common adverse effects (may affect up to 1 in 10 people):

Allergic reactions (including skin and mucosal swelling (angioedema), lupus erythematosus exacerbation, inflammation of the tissue surrounding the heart (pericarditis), hypersensitivity, serum sickness, Henoch-Schönlein purpura, low blood pressure (hypotension), difficulty breathing (dyspnea), rapid heartbeat (tachycardia), fluid retention in the limbs (peripheral edema), and red, raised, 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 disturbances (heartburn/gastritis).

Rare adverse effects (may affect up to 1 in 1,000 people):

Excessive destruction of red blood cells (hemolytic anemia), reduced platelet count (thrombocytopenia), changes in white blood cell count: reduced neutrophil count (neutropenia) or increased eosinophil count (eosinophilia), drug-induced rash with eosinophilia or systemic symptoms, microscopic brown-black pigmentation of the thyroid gland, loss of appetite, increased pressure within the skull (benign intracranial hypertension) in adults, bulging of fontanelles (unossified skull areas in young children) in children, ringing in the ears (tinnitus), facial redness (rubefaction), changes in volume or consistency of stools (diarrhea, pseudomembranous colitis), esophageal ulcers, inflammation of the esophagus, intestinal inflammation, inflammatory lesions in the anogenital area, difficulty swallowing (dysphagia), abdominal pain, inflammation of the tongue (glossitis), impaired liver function, liver inflammation (hepatitis) and liver damage, skin inflammation with blistering (toxic epidermal necrolysis), skin and mucosal inflammation which may be severe (Stevens-Johnson syndrome), raised red skin lesions with target-like appearance (erythema multiforme), widespread skin inflammation with peeling (exfoliative dermatitis), nail loss (photo-onycholysis), joint pain (arthralgia) and muscle pain (myalgia), increased blood urea levels.

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

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

As with all tetracyclines, doxycycline may cause permanent tooth discoloration (ranging from grayish to yellowish) and impaired bone growth.

Reporting of 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 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 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 above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dosil

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

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

Appearance of the product and contents of the pack

Dosil is presented as green hard capsules.

Aluminum and PVC blister pack.

Each pack 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 most recent revision of this leaflet: 04/2024

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