PRODERMA 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Proderma 200 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What Proderma 200 mg Hard Capsules is and what it is used for
2. What you need to know before you take Proderma 200 mg Hard Capsules
3. How to take Proderma 200 mg Hard Capsules
4. Possible side effects
5. Storage of Proderma 200 mg Hard Capsules
6. Contents of the pack and other information

1. What Proderma 200 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 indicated primarily in 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 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 (disease transmitted by ticks).

• Fever transmitted by lice and ticks.
• Malaria.
• Severe acne vulgaris.

2. What you need to know before you take Proderma 200 mg Hard Capsules

Do not take Proderma 200 mg Hard Capsules

If you are allergic to doxycycline, tetracyclines, or any of the other components of Proderma 200 mg (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Proderma 200 mg.

Children

Proderma 200 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, 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).
• If you experience diarrhea while receiving treatment with doxycycline, consult your doctor.
• If you take this medication while lying down, or without sufficient water, ulcers may appear in the digestive system, so it is essential to follow the administration instructions (see section 3. How to take Proderma 200 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 checks on renal and hepatic function.
• If you have systemic lupus erythematosus, you should avoid using this medication.
• In case of direct exposure to the sun, skin redness may occur; if this happens, you should consult your doctor.
• If you suffer from myasthenia gravis (a form of muscle weakness), consult your doctor before taking this medication.
• If you are going to have any urine tests, you should inform the healthcare staff that you are being treated with this medication, as doxycycline may interfere with the results.

Using Proderma 200 mg Hard Capsules with other medicines

Tell 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 200 mg can interact with some medicines, such as:

• Aluminum, calcium, and magnesium antacids, as they decrease the absorption of Proderma 200 mg.
• Antibiotics, as they may decrease the effectiveness of Proderma 200 mg.
• Methoxyflurane, along with tetracyclines and Proderma 200 mg, may produce kidney toxicity, which can be severe.
• Anticoagulants (such as warfarin), as Proderma 200 mg may alter the effect of these anticoagulants, so you should consult your doctor.
• Medicines for the treatment of epilepsy, such as carbamazepine and phenytoin.
• Oral contraceptives and barbiturates, as Proderma 200 mg may decrease their effectiveness.
• Chronic alcohol consumption may decrease the effectiveness of Proderma 200 mg.

In case of doubt, consult your doctor or pharmacist.

Taking Proderma 200 mg Hard Capsules with food and drinks:

• During treatment with doxycycline, alcohol consumption should be avoided.
• Proderma 200 mg should be administered with food or water to avoid esophageal irritation (see section 3. How to take Proderma 200 mg Hard Capsules and section 4. Possible side effects).

Pregnancy and lactation

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 medication during breastfeeding.

Driving and using machines

There is no evidence that Proderma 200 mg alters the ability to drive or use machines.

Proderma 200 mg Hard Capsules 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 Proderma 200 mg Hard Capsules

Follow the administration instructions of Proderma 200 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 too strong or too weak.

IMPORTANT:

Your doctor will indicate the duration of treatment with Proderma 200 mg. Do not stop treatment early, 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 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 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 200 mg Hard Capsules than you should

If you have taken more 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 medication and the amount ingested.

If you forget to take Proderma 200 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 200 mg can cause side effects, although not everybody gets them.

The following side effects have been detected after taking Proderma 200 mg:

Blood and lymphatic system disorders:blood disorders after administration of tetracyclines are very rare. However, cases of hemolytic anemia (consequence of high 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 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:it is possible to experience digestive alterations such as esophageal ulcers (see section 3. How to take Proderma 200 mg Hard Capsules), nausea, stomach pain, diarrhea, loss of appetite, tongue inflammation, intestinal inflammation, and anogenital candidiasis (infection by a microscopic fungus).

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 produce 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 skin 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 produce elevated blood urea nitrogen.

General disorders:occasionally, severe hypersensitivity reactions (allergies) may occur, exceptionally urticaria, angioedema (fluid retention in the vessels), hypotension (decrease in 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: 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 think any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

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

5. Storage of Proderma 200 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 carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medication in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and other information

Composition of Proderma 200 mg Hard Capsules

• The active ingredient is doxycycline. Each capsule contains 200 mg of doxycycline (as hyclate).

• The other ingredients (excipients) are: sucrose, cornstarch, crospovidone, polyaminomethacrylate (Eudragit E100), talc, gelatin, carmine indigo (E132), erythrosine (E127), and titanium dioxide (E171).

Appearance of the product and contents of the pack

Proderma 200 mg is presented in packs of 42 capsules.

Other presentations:

Proderma 50 mg Hard Capsules

Proderma 100 mg Hard Capsules

Marketing authorization holder

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Carretera de Cazoña-Adarzo, s/n.

39011, Santander

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

Spain

This 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 Healthcare Products (AEMPS) http://www.aemps.gob.es/