Package Insert: Information for the User

Proderma 50 mg Hard Capsules

Doxycycline

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

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

2. What you need to know before starting to take 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. Contents of the pack and additional information

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

Doxycycline is indicated primarily for skin and soft tissue infections, respiratory tract infections, and urinary tract infections, such as:

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

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 period of teething (2 to 1/2 of pregnancy, lactation, and children under 8 years), as it may cause permanent tooth discoloration, as well as delay in bone development.

General

• There have been reports of fontanelle bulging (unossified space of the skull) in children and intracranial hypertension (increase in cerebrospinal fluid pressure in the brain) 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 ingest this medication while lying down, or without sufficient water, ulcers in the digestive system may appear, so 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 controls.
• If you have systemic lupus erythematosus, avoid using this medication.
• In case of direct exposure to the sun, skin reddening may occur; if this happens, consult your doctor.
• If you have myasthenia gravis (a form of muscle weakness), consult your doctor before taking this medication.
• If you are undergoing urine analysis, inform the healthcare staff that you are taking this medication, as doxycycline may interfere with the results.

Use of Proderma 50 mg hard capsules with other medications

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

Like all medications, Proderma 50 mg may interact with some medications such as:

• Anti-acids containing aluminum, calcium, and magnesium, which decrease the absorption of Proderma 50 mg.
• Antibiotics, which may decrease the effectiveness of Proderma 50 mg.
• Methoxyflurane, along with tetracyclines and Proderma 50 mg, may produce renal toxicity, which can be severe.
• Anticoagulants (such as warfarin), as Proderma 50 mg may alter the effect of these anticoagulants, so consult your doctor.
• Medications for epilepsy treatment, such as carbamazepine and phenytoin.
• Oral contraceptives and barbiturates, as Proderma 50 mg may decrease the effectiveness of these medications.
• Chronic alcohol consumption may decrease the effectiveness of Proderma 50 mg.

In case of doubt, consult your doctor or pharmacist.

Taking Proderma 50 mg hard capsules with food and drinks

• Avoid consuming alcohol during treatment with doxycycline.
• Proderma 50 mg should be taken with food or water to avoid esophageal irritation (see section 3. How to take Proderma 50 mg hard capsules).

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Lactation

Avoid taking this medication during lactation.

Driving and operating machinery

There is no evidence that Proderma 50 mg affects the ability to drive or operate machinery.

Proderma 50 mg hard capsules contain saccharose.If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Remember to take your medication.

Consult your doctor or pharmacist if you consider that the effect of doxycycline is not as expected, either because it is too strong and produces unwanted side effects, or because it is too weak, resulting in insufficient treatment for the infection.

IMPORTANT:

Your doctor will indicate the duration of treatment with Proderma 50 mg. Do not discontinue treatment before time, 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, administer 200 mg/day throughout the treatment period. In general, treatment should continue for at least24 to48 hours after the disappearance of symptoms and fever.

Children over 8 years:Children over 8 years weighing45 kgor less, the usual dose is 4 mg/kg of body weight, on the first day of treatment, administered in a single dose or in 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 for24 to48 hours after symptoms have disappeared.

If you take more Proderma 50 mg hard capsules than you should

If you have taken more hard capsules of Proderma 50 mg 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 Toxicological Information Service. Phone:(91) 562 04 20, indicating the medication and the amount ingested.'

If you forgot to take Proderma 50 mg hard capsules

If you forgot to take a dose, take the next one when it is due. Do not take a double dose to compensate for the missed dose.

Like all medicines, Proderma 50 mg may cause side effects, although not everyone will experience them.

After taking Proderma 50 mg, the following side effects have been detected:

Blood and lymphatic system disorders:blood disorders following tetracycline administration are very rare. However, cases of:hemolytic anemia (consequence of high 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. Abdominal distension 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 (microscopic fungal infection) may occur.

Permanent tooth discoloration may also occur if doxycycline is used during dental development (2nd half of pregnancy, lactation, and children under 8 years old).

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

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

Unknown frequency: photoonycholysis (nail pigmentation).

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

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

General disorders: occasional hypersensitivity reactions (allergies) may occur, including:urticaria, angioedema (fluid retention in vessels), hypotension (blood pressure drop), pericarditis (inflammation of the heart tissue), systemic lupus erythematosus exacerbation, angioneuritic edema, serum disease (serum allergy reaction), and very rarely anaphylactic shock (unusual or excessive allergic reaction).

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

If you consider any of the side effects you experience to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this leaflet. You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human UseWebsite:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date indicated on the box after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and medicines that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Proderma 50 mg hard capsules

• The active ingredient is doxycycline. Each capsule contains 50 mg of doxycycline (as hyclate).
• The other components (excipients) are: sucrose, cornstarch, crospovidone, polyaminometacrylate (Eudragit E 100), talc, gelatin, indigo carmine (E 132), yellow quinoline (E 104), and titanium dioxide (E 171).

Appearance of the product and content of the packaging

Proderma 50 mg is presented in packs of 30 capsules.

Other presentations:

Proderma 100 mg hard capsules

Proderma 200 mg hard capsules

Holder of the marketing authorization

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Carretera de Cazoña-Adarzo, s/n.

39011, Santander

Spain

Responsible for manufacturing

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 leaflet has been approved in June 2022.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/