DOXIPIL 100 mg HARD CAPSULES

Introduction

PROSPECTUS: INFORMATION FOR THE USER

DOXIPIL 100 mg hard capsules

Doxycycline

Read the entire prospectus carefully before starting to take the medicine.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Contents of the prospectus:

1. What DOXIPIL 100 mg capsules are and what they are used for
2. Before taking DOXIPIL 100 mg capsules
3. How to take DOXIPIL 100 mg capsules
4. Possible side effects
5. Storage of DOXIPIL 100 mg capsules
6. Additional information

1. What DOXIPIL 100 mg capsules are and what they are used for

DOXIPIL 100 mg is a medicine that contains doxycycline as the active ingredient. Doxycycline belongs to a group of medicines called tetracyclines and works by preventing the development of bacteria.

Doxycycline is indicated primarily for infections of the skin and soft tissues, respiratory tract infections, and genitourinary infections, such as:

• Atypical pneumonia.
• Psittacosis (a disease transmitted to humans by certain birds that occurs as pneumonia accompanied by fever and cough).
• Typhus and other infections caused by microorganisms called rickettsias.
• Sexually transmitted diseases.
• Brucellosis (Malta fever).
• Cholera
• Early stages of Lyme disease (a disease transmitted by ticks).
• Fever transmitted by lice and ticks.
• Malaria
• Moderate to severe acne vulgaris and papulopustular rosacea.

2. Before taking DOXIPIL 100 mg capsules

Do not take DOXIPIL 100 mg:

If you are allergic (hypersensitive) to doxycycline, tetracyclines, or any of the other components of this medicine.

Be careful withDOXIPIL 100 mg

Use in children:

Doxycycline should not be used during the teething period, the second half of pregnancy, lactation, and in children under 8 years of age, as it may cause permanent tooth discoloration, as well as delayed bone development.

General:

Bulging of the fontanelles (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"). These effects disappear after treatment is discontinued.

If you experience diarrhea while being treated with doxycycline, consult your doctor.

If the patient takes this medicine while lying down or without accompanying it with a sufficient amount of water, ulcers may appear in the digestive system. Therefore, it is essential to follow the administration instructions (see section 3. "HOW TO TAKE DOXIPIL 100 mg capsules" and section 4. "POSSIBLE SIDE EFFECTS").

If you need to take DOXIPIL 100 mg for an extended period, your doctor will perform periodic blood tests and checks on kidney and liver function.

If you have liver or kidney disease, consult your doctor.

If you have systemic lupus erythematosus, you should avoid using this medicine.

In case of direct exposure to the sun, skin redness may occur; if this happens, treatment should be discontinued, and a doctor consulted.

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

If you are going to have a urine test, inform the healthcare staff that you are being treated with this medicine, as doxycycline may interfere with the results.

Taking other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those purchased without a prescription.

Some medicines, when taken at the same time as DOXIPIL 100 mg, may affect their mechanism of action:

Antacids containing aluminum, calcium, or magnesium, as well as antidiarrheal drugs, decrease the absorption of doxycycline. It is recommended to space the use of tetracyclines and these compounds 2 or 3 hours apart.

Do not administer simultaneously with bactericidal antibiotics (such as penicillin), as this reduces the effect of the latter.

In simultaneous treatment with anticoagulants (such as warfarin), the dose of these should be reduced, as DOXIPIL 100 mg influences the effect of these anticoagulants. Consult your doctor; they will indicate the appropriate dose.

DOXIPIL 100 mg may reduce the effectiveness of oral contraceptives.

Alcohol, barbiturates, carbamazepine, and phenytoin may decrease the effect of DOXIPIL 100 mg when taken together.

Chronic alcohol consumption may decrease the effectiveness of DOXIPIL 100 mg. In case of doubt, consult your doctor or pharmacist.

Note that these instructions may also apply to medicines taken before or after.

Taking DOXIPIL 100 mg with food and drinks

Avoid using doxycycline and alcohol together.

It is recommended to take DOXIPIL 100 mg with food and a large glass of water to avoid irritating the esophagus (see section 3. "HOW TO TAKE DOXIPIL 100 mg capsules").

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Consult your doctor or pharmacist before using DOXIPIL 100 mg if you are pregnant or think you may be pregnant.

Breastfeeding

Consult your doctor or pharmacist before using any medicine while breastfeeding.

You should avoid taking DOXIPIL 100 mg during breastfeeding.

Driving and using machines

No effects on the ability to drive vehicles and use machines have been described.

Important information about some of the components ofDOXIPIL 100 mg capsules

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

3. How to take DOXIPIL 100 mg capsules

Follow the administration instructions for DOXIPIL 100 mg exactly as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

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

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

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

Do not stop treatment prematurely, even if you have started to improve.

Adults

The usual dose of doxycycline is 200 mg in one or two doses on the first day of treatment, followed by a maintenance dose of 100 mg/day. For the treatment of more severe infections, treatment should be continued for at least 24 to 48 hours after the disappearance of symptoms and fever.

For the treatment of acne vulgaris, the usual initial dose is 100 mg per day for 6 to 12 weeks, followed by a maintenance dose of 50 mg per day for 4 to 6 months.

For the treatment of rosacea, the usual dose is 50 to 100 mg once a day for 6 to 12 weeks.

Children over 8 years old:

Children over 8 years old who weigh 45 kg or less, the usual dose is 4 mg/kg of body weight on the first day of treatment, 4 mg/kg of body weight (administered in a single dose or in two equal doses every 12 hours). After the first day, continue treatment with a dose of 2 mg/kg of body weight every 24 hours.

In severe infections: 4 mg/kg of body weight every 24 hours, maintaining the same dose throughout treatment.

Treatment should continue for 24 to 48 hours after symptoms have disappeared.

If you take moreDOXIPIL 100 mg than you should

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

If you forget to takeDOXIPIL 100 mg

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. If you forget to take a capsule, take the next one when it is due.

If you interrupt treatment withDOXIPIL 100 mg

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

4. Possible side effects

Like all medicines, DOXIPIL 100 mg can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, talk to your doctor as soon as possible:

After taking DOXIPIL 100 mg, the following side effects have been detected:

Blood and lymphatic system disorders: these disorders are extremely rare. However, cases of hemolytic anemia (consequence of increased destruction of red blood cells), thrombocytopenia (decrease in the number of platelets), neutropenia (decrease in the number of neutrophils), and eosinophilia (increase in the number of eosinophils) have been reported.

Nervous system disorders: infrequently, intracranial hypertension occurs in both children and adults. This syndrome is characterized by headache, nausea, and vomiting, dizziness, tinnitus, and visual disturbances. These symptoms resolve after the drug is discontinued. Bulging of the fontanelles has also been reported in children.

Gastrointestinal disorders: pancreatitis (inflammation of the pancreas), possible appearance of digestive alterations such as esophageal ulcers (see section 3. "HOW TO TAKE DOXIPIL 100 mg capsules"), 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 used during dental development (second half of pregnancy, lactation, and children under 8 years of age).

Liver disorders: treatment with high doses of tetracyclines may cause liver function disorders and hepatitis.

Skin and subcutaneous tissue disorders: urticaria, maculopapular rash (spots and small elevations of the skin), exudative erythema (redness and swelling of the skin), multiform eruptions (redness and swelling of the skin), cutaneous photosensitivity reactions, exceptionally exfoliative dermatitis (inflammation and peeling of the skin), and rarely Stevens-Johnson syndrome. Unknown frequency: photoonycholysis (nail pigmentation).

Musculoskeletal and connective tissue disorders: joint pain, muscle pain, as well as growth retardation in children, which ceases when treatment is discontinued.

Kidney disorders: like all tetracyclines, doxycycline may cause elevated blood urea nitrogen.

General disorders: occasionally, exceptionally severe reactions may appear, angioedema (fluid retention in the vessels), bronchial obstruction, pericarditis (inflammation of the tissue surrounding the heart), hypotension (decreased 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.

If you consider that any of the side effects you suffer from is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of DOXIPIL 100 mg capsules

Keep DOXIPIL 100 mg out of the reach and sight of children.

Do not store above 30°C.

This medicine should not be used after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition ofDOXIPIL 100 mg capsules

• The active ingredient is doxycycline hyclate. Each capsule contains 100 mg of doxycycline (in the form of doxycycline hyclate).
• The other components (excipients) are: sucrose, cornstarch (gluten-free), povidone, hydroxypropyl methylcellulose phthalate, diacetylated monoglycerides, talc, and gelatin.

Appearance of the product and packaging content

Hard gelatin capsules, size 2.

DOXIPIL 100 mg capsules are presented in packages containing blisters of 21 and 42 capsules.

Marketing authorization holder and manufacturer

LABORATORIO REIG JOFRÉ, S.A.

Avda. Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Date of the last revision of this prospectus: March 2024