Proderma 50 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Proderma 50 mg Hard Capsules

Doxycycline

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet Contents

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. How to store Proderma 50 mg hard capsules
6. Contents of the pack and other information

1. What Proderma 50 mg hard capsules is and what it is used for

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

Doxycycline is primarily indicated in 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, presenting as pneumonia accompanied by fever and cough).
• Typhus and other infections caused by microorganisms called rickettsiae.
• Sexually transmitted diseases.
• Brucellosis (Malta fever).
• Cholera.
• Early stages of Lyme disease (a disease transmitted by ticks).
• Fevers transmitted by lice and ticks.
• Malaria.
• Severe vulgar acne.

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 ingredients 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 tooth development (second half of pregnancy, breastfeeding, and in children under 8 years of age), as it may cause permanent discoloration of the teeth and delayed bone development.

General

• Swelling of the fontanelles (soft spots in the skull) in children and intracranial hypertension (increased pressure of cerebrospinal fluid in the brain) have been reported in both children and adults (see section 4. Possible side effects).
• If you develop diarrhea during treatment with doxycycline, consult your doctor.
• If you take this medicine while lying down or without sufficient water, gastrointestinal ulcers may occur; therefore, it is important 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.
• During prolonged treatment, your doctor will monitor your kidney and liver function.
• If you have systemic lupus erythematosus, you should avoid using this medicine.
• Skin redness may occur following direct exposure to sunlight; if this happens, consult your doctor.
• If you have myasthenia gravis (a form of muscle weakness), consult your doctor before taking this medicine.
• If you are due to have urine tests, inform healthcare personnel that you are being treated with this medicine, as doxycycline may interfere with test results.

Taking Proderma 50 mg hard capsules with other medicines

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

Like all medicines, Proderma 50 mg may interact with certain medicines, such as:

• Aluminum, calcium, and magnesium-containing antacids, which reduce the absorption of Proderma 50 mg.
• Antibiotics, which may reduce the effectiveness of Proderma 50 mg.
• Metoxiflurane together with tetracyclines and Proderma 50 mg may cause kidney toxicity, which can be severe.
• Anticoagulants (such as warfarin), as Proderma 50 mg may alter the effect of these anticoagulants; therefore, consult your doctor.
• Medicines used to treat epilepsy, such as carbamazepine and phenytoin.
• Oral contraceptives and barbiturates, as Proderma 50 mg may reduce their effectiveness.
• Chronic alcohol consumption may reduce the effectiveness of Proderma 50 mg.

If in doubt, consult your doctor or pharmacist.

Taking Proderma 50 mg hard capsules with food and drinks

• Alcohol consumption should be avoided 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 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 affects the ability to drive or operate machinery.

Proderma 50 mg hard capsules contain sucrose. If your doctor has advised you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Proderma 50 mg hard capsules

Follow exactly the administration instructions for Proderma 50 mg provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Consult your doctor or pharmacist if you feel that the effect of doxycycline is not as expected, either because it is too strong and causes unwanted adverse effects, or because it is too weak, making it insufficient for the treatment of the infection.

IMPORTANT:

Your doctor will determine the duration of treatment with Proderma 50 mg. Do not stop the treatment prematurely, even if you have already started to improve.

Adults: The usual dose of doxycycline is 200 mg given in one or two divided 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 entire treatment period. In general, treatment should continue for at least 24 to 48 hours after the disappearance of symptoms and fever.

Children over 8 years of age: For children over 8 years of age weighing 45 kg or less, the usual dose is 4 mg/kg body weight on the first day of treatment, administered either as a single dose or in equal doses every 12 hours. For severe infections: 4 mg/kg 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 more Proderma 50 mg hard capsules than you should

If you have taken more Proderma 50 mg hard capsules than prescribed, contact your doctor or pharmacist immediately.

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

If you forget to take Proderma 50 mg hard capsules

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

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

The following adverse effects have been reported after taking Proderma 50 mg:

Blood and lymphatic system disorders: Blood disorders following tetracycline administration are very rare. However, cases have been reported of: hemolytic anemia (due to excessive destruction of red blood cells), thrombocytopenia (reduced number of platelets), neutropenia (reduced number of neutrophils), and eosinophilia (increased number of eosinophils).

Nervous system disorders: Intracranial hypertension, characterized by headache, nausea, vomiting, dizziness, tinnitus (ringing in the ears), and visual disturbances, may occur infrequently. These symptoms resolve after discontinuation of the drug. Bulging of fontanelles in children has also been reported.

Gastrointestinal disorders: Digestive disturbances may occur, 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 (a fungal microscopic infection).

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

Hepatic disorders: Treatment with high doses may lead to hepatitis and disturbances in liver function.

Skin and subcutaneous tissue disorders: Urticaria, maculopapular rash (skin spots and small elevations), exudative erythema (redness and skin lesions), erythema multiforme (redness and skin swelling), photosensitivity skin reactions, and, exceptionally, exfoliative dermatitis (skin inflammation and peeling), and rarely Stevens-Johnson syndrome.

Frequency not known: photo-onycholysis (nail pigmentation).

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

Renal disorders: Like all tetracyclines, doxycycline may cause increased blood urea nitrogen levels.

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

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.

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

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 Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Proderma 50 mg hard capsules

Keep out of the sight and reach of children.

No special storage conditions are required.

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 containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Proderma 50 mg hard capsules

• The active substance is doxycycline. Each capsule contains 50 mg of doxycycline (as hyclate).
• The other components (excipients) are: sucrose, corn starch, crospovidone, polymethacrylic acid copolymer (Eudragit E100), talc, gelatin, indigo carmine (E132), quinoline yellow (E104), and titanium dioxide (E171).

Appearance of the product and contents of the pack

Proderma 50 mg is available in packs containing 30 capsules.

Other pack sizes:

Proderma 100 mg hard capsules

Proderma 200 mg hard capsules

Marketing Authorization Holder

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Barrio Solía, nº 30,

La Concha de Villaescusa, 39690

Cantabria (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 leaflet was last approved in June 2022.

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