Brand name Proderma 200 mg hard capsules

Form capsules, hard

Active substance / Dosage

DOXYCYCLINE HYCLATE · 230,8 mg

Prescription type Prescription Only Medicine

ATC code

J01A J01AA J01AA02

Registration number 61227

Manufacturer Industrial Farmaceutica Cantabria S.A.

Proderma 200 mg hard capsules capsules, hard

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Proderma 200 mg hard capsules is and what it is used for
2. What you need to know before taking Proderma 200 mg hard capsules
3. How to take Proderma 200 mg hard capsules
4. Possible adverse effects
5. Storage of Proderma 200 mg hard capsules
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Proderma 200 mg hard capsules

Doxycycline

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents

What Proderma 200 mg hard capsules is and what it is used for
What you need to know before taking Proderma 200 mg hard capsules
How to take Proderma 200 mg hard capsules
Possible adverse effects
How to store Proderma 200 mg hard capsules
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.

Spanish text on white background explaining the Doxycycline is primarily indicated 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, 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 200 mg hard capsules

Do not take Proderma 200 mg hard capsules

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Proderma 200 mg.

Children

Proderma 200 mg must not be given during the period of tooth development (second half of pregnancy, breastfeeding, and children under 8 years of age), as it may cause permanent discoloration of teeth and delayed bone development.

General

Bulging of fontanelles (soft spots in the skull) in children and intracranial hypertension (increased pressure of the cerebrospinal fluid in the brain) have been reported in both children and adults (see section 4. Possible side effects).
If you develop diarrhea while being treated with doxycycline, consult your doctor.
If you take this medicine while lying down or without taking enough water, ulcers in the digestive tract may occur. Therefore, it is important 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.
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 sun exposure; 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 professionals that you are being treated with this medicine, as doxycycline may interfere with test results.

Taking 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 may interact with certain medicines, such as:

Aluminum, calcium, and magnesium-containing antacids, as they reduce the absorption of Proderma 200 mg.
Antibiotics, as they may reduce the effectiveness of Proderma 200 mg.
Methoxyflurane together with tetracyclines and Proderma 200 mg may cause kidney toxicity, which can be severe.
Anticoagulants (such as warfarin), as Proderma 200 mg may alter their effect; therefore, consult your doctor.
Medicines used to treat epilepsy, such as carbamazepine and phenytoin.
Oral contraceptives and barbiturates, as Proderma 200 mg may reduce their effectiveness.
Chronic alcohol consumption may reduce the effectiveness of Proderma 200 mg.

If in 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 taken with food or water to avoid esophageal irritation (see section 3. How to take Proderma 200 mg hard capsules).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 200 mg affects the ability to drive or operate machinery.

Proderma 200 mg hard capsules contain sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Proderma 200 mg hard capsules

Follow exactly the administration instructions for Proderma 200 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 think 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, resulting in insufficient treatment of the infection.

IMPORTANT:

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

It is important to remain upright for at least one hour after taking the medicine, before lying down or going to bed.

These recommendations aim to prevent gastrointestinal problems, especially stomach ulcers.

Your doctor will determine the duration of treatment with Proderma 200 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, given as 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 Proderma 200 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. Telephone (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 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 200 mg can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported after taking Proderma 200 mg:

Blood and lymphatic system disorders: Blood disorders after administration of tetracyclines 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: Gastrointestinal disturbances may occur, such as esophageal ulcers (see section 3. How to take Proderma 200 mg hard capsules), nausea, stomach pain, diarrhea, loss of appetite, inflammation of the tongue, intestinal inflammation, and anogenital candidiasis (fungal infection).

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

Hepatic disorders: Treatment with high doses may cause 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 elevations in blood urea nitrogen.

General disorders: Hypersensitivity reactions (allergies), sometimes severe, may occasionally occur, including urticaria, angioedema (fluid retention in vessels), hypotension (low blood pressure), pericarditis (inflammation of the tissue surrounding the heart), worsening of systemic lupus erythematosus, angioneurotic edema, 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. This reaction may occur 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 can 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 200 mg hard capsules

Keep out of sight and reach of children.

No special storage conditions required.

Do not use this medicine after the expiry date stated on the pack 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 medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Proderma 200 mg hard capsules

The active substance is doxycycline. Each capsule contains 200 mg of doxycycline (as hyclate).
The other components (excipients) are: sucrose, corn starch, crospovidone, polymethacrylic acid copolymer (Eudragit E100), talc, gelatin, indigo carmine (E132), erythrosine (E127) and titanium dioxide (E171).

Appearance of the product and contents of the pack

Proderma 200 mg is available in packs containing 42 capsules.