PRODERMA 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Proderma 50 mg Hard Capsules

Doxycycline

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, 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 only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

1. What Proderma 50 mg Hard Capsules are and what they are used for
2. What you need to know before taking Proderma 50 mg Hard Capsules
3. How to take Proderma 50 mg Hard Capsules
4. Possible side effects
5. Storage of Proderma 50 mg Hard Capsules
6. Package Contents and Additional Information

1. What Proderma 50 mg Hard Capsules are and what they are used for

Doxycycline belongs to a group of medicines called tetracyclines, which are broad-spectrum antibiotics, active against multiple microorganisms.

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

• Atypical pneumonia.
• Psittacosis (disease transmitted to humans by certain birds, characterized by pneumonia, fever, and cough).
• Typhus and other infections caused by microorganisms called rickettsias.
• Sexually transmitted diseases.
• Brucellosis (Malta fever).
• Cholera.
• Early stages of Lyme disease (disease transmitted by ticks).
• Fever transmitted by lice and ticks.
• Malaria.
• Severe acne vulgaris.

2. What you need to know before taking Proderma 50 mg Hard Capsules

Do not take Proderma 50 mg Hard Capsules

If you are allergic to doxycycline, tetracyclines, or any of the other components of Proderma 50 mg (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Proderma 50 mg.

Children

Proderma 50 mg should not be administered during the dentition period (second half of pregnancy, lactation, and children under 8 years), as it may cause permanent tooth discoloration and delay 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) has been reported in both children and adults (see section 4. Possible side effects).
• If you experience diarrhea while receiving treatment with doxycycline, consult your doctor.
• If you take this medicine while lying down or without sufficient water, ulcers may appear in the digestive system; therefore, it is essential to follow the administration instructions (see section 3. How to take Proderma 50 mg Hard Capsules and section 4. Possible side effects).
• If you have liver or kidney disease, consult your doctor.
• In prolonged treatments, the doctor will perform renal and hepatic function tests.
• If you have systemic lupus erythematosus, you should avoid using this medicine.
• In case of direct sun exposure, skin redness may occur; if this happens, consult your doctor.
• 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.

Use of Proderma 50 mg Hard Capsules with other medicines

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

Like all medicines, Proderma 50 mg can interact with some medicines, such as:

• Antacids containing aluminum, calcium, and magnesium, as they decrease the absorption of Proderma 50 mg.
• Antibiotics, as they may decrease the efficacy of Proderma 50 mg.
• Methoxyflurane, as it may cause kidney toxicity when used with tetracyclines and Proderma 50 mg, which can be severe.
• Anticoagulants (such as warfarin), as Proderma 50 mg may alter the effect of these anticoagulants; therefore, consult your doctor.
• Medicines for the treatment of epilepsy, such as carbamazepine and phenytoin.
• Oral contraceptives and barbiturates, as Proderma 50 mg may decrease their efficacy.
• Chronic alcohol consumption may decrease the efficacy of Proderma 50 mg.

In case of doubt, consult your doctor or pharmacist.

Taking Proderma 50 mg Hard Capsules with food and drinks

• During treatment with doxycycline, alcohol consumption should be avoided.
• Proderma 50 mg should be administered with food or water to avoid esophageal irritation (see section 3. How to take Proderma 50 mg Hard Capsules and section 4. Possible side effects).

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.

Breastfeeding

You should avoid taking this medicine during breastfeeding.

Driving and using machines

There is no evidence that Proderma 50 mg alters the ability to drive or use machines.

Proderma 50 mg Hard Capsules containsucrose.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 Proderma 50 mg Hard Capsules

Follow the administration instructions for Proderma 50 mg exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Consult your doctor or pharmacist if you think the effect of doxycycline is not what you expected, either because it is too strong and causes unwanted side effects or because it is too weak and insufficient for the treatment of the infection.

IMPORTANT:

Your doctor will indicate the duration of treatment with Proderma 50 mg. 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, 200 mg/day should be administered throughout the treatment period. In general, treatment should continue until at least 24 to 48 hours after the disappearance of symptoms and fever.

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, administered in a single dose or in two equal doses every 12 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 the symptoms have disappeared.

If you take more Proderma 50 mg Hard Capsules than you should

If you have taken more Proderma 50 mg Hard Capsules than you should, consult your doctor or pharmacist immediately.

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 Proderma 50 mg Hard Capsules

If you forget to take a dose, take the next one when it is due. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, Proderma 50 mg can cause side effects, although not everyone gets them.

The following side effects have been detected after taking Proderma 50 mg:

Blood and lymphatic system disorders:blood disorders after tetracycline administration are very rare. However, cases of hemolytic anemia (consequence of excessive red blood cell destruction), thrombocytopenia (decrease in platelet count), neutropenia (decrease in neutrophil count), and eosinophilia (increase in eosinophil count) have been reported.

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

Gastrointestinal disorders:digestive alterations such as esophageal ulcers (see section 3. How to take Proderma 50 mg Hard Capsules), nausea, stomach pain, diarrhea, loss of appetite, tongue inflammation, intestinal inflammation, and anogenital candidiasis (infection by a microscopic fungus) may occur.

Permanent tooth discoloration may also occur if doxycycline is used during dental development (second half of pregnancy, lactation, and children under 8 years).

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

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

Frequency not known: photoonycholysis (nail pigmentation).

Musculoskeletal and connective tissue disorders:joint pain and muscle pain may occur, as well as delayed growth in children.

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

General disorders:occasionally, severe hypersensitivity reactions (allergies) may occur, exceptionally including urticaria, angioedema (fluid retention in the vessels), hypotension (decreased blood pressure), pericarditis (inflammation of the tissue surrounding the heart), worsening of systemic lupus erythematosus, angioedema, serum sickness (allergic reaction to serum), and very rarely anaphylactic shock (unusual or exaggerated allergic reaction).

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

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Proderma 50 mg Hard Capsules

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Proderma 50 mg Hard Capsules

• The active ingredient is doxycycline. Each capsule contains 50 mg of doxycycline (as hyclate).
• The other ingredients (excipients) are: sucrose, cornstarch, crospovidone, polyaminomethacrylate (Eudragit E100), talc, gelatin, carmine indigo (E132), quinoline yellow (E104), and titanium dioxide (E171).

Appearance of the product and package contents

Proderma 50 mg is available in packs of 30 capsules.

Other presentations:

Proderma 100 mg Hard Capsules

Proderma 200 mg Hard Capsules

Marketing Authorization Holder

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Carretera de Cazoña-Adarzo, s/n.

39011, Santander

Spain

Manufacturer

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

C/ Pirita, 9 28850 Torrejón de Ardoz (Madrid)

Spain

or

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

This package leaflet was approved in June 2022.

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/