Hydroquinidine Serecor 300 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Hidroquinidina Serecor 300 mg prolonged-release hard capsules

Hydroquinidine hydrochloride

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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Hidroquinidina Serecor is and what it is used for
2. What you need to know before taking Hidroquinidina Serecor
3. How to take Hidroquinidina Serecor
4. Possible side effects
5. How to store Hidroquinidina Serecor
6. Contents of the pack and other information

1. What Hidroquinidina Serecor is and what it is used for

Hidroquinidina Serecor contains the active substance quinidine hydrochloride.

Pharmacotherapeutic group: Class Ia antiarrhythmics.

Hidroquinidina Serecor is used to treat and prevent certain serious heart rhythm disorders and to prevent electric shock symptoms in some patients with an implanted automatic defibrillator (ICD).

2. What you need to know before taking Hidroquinidina Serecor

Do not take Hidroquinidina Serecor

• if you are allergic to hydroquinidine or quinidine, or to any of the other ingredients of this medicine (listed in section 6),

• if you have certain heart rhythm disorders,

• if you have heart failure,

• with medicines that may cause torsades de pointes (serious heart rhythm disorders):

• class Ia antiarrhythmics (quinidine, disopyramide), class III antiarrhythmics
  (amiodarone, sotalol, dofetilide, ibutilide),

• and other medicines such as: arsenic compounds, cisapride, citalopram,
  escitalopram, dihydroquinidine, dolasetron IV, dronedarone, erythromycin IV, levofloxacin,
  mequitazine, mizolastine, moxifloxacin, prucalopride, spiramycin IV, toremifene,
  vandetanib, vincamine IV,

• in combination with beta-blockers used in heart failure (carvedilol, bisoprolol, metoprolol, nebivolol).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidroquinidina Serecor.

Due to the possibility of severe allergic reactions, patients must be tested to determine sensitivity before starting treatment with hydroquinidine, as follows:

• A test capsule is administered.

• Stop treatment and contact your doctor immediately if hypotension, skin rash, fever, asthma attack, or cardiac disturbances occur within the first hours.

• However, if only cardiac disturbances occur after 48 hours (and no other symptoms described above appear), the dose should simply be reduced.

• Serum potassium levels (amount of potassium in the blood) should be monitored and ECGs performed regularly, especially at the beginning of treatment.

• Contact your doctor immediately if fever occurs.

Hydroquinidine hydrochloride should generally not be used in the following situations unless directed by your doctor:

• pregnancy, breastfeeding,
• myasthenia,
• in combination with certain antiparasitic medicines that may cause torsades de pointes (halofantrine, lumefantrine, pentamidine), certain neuroleptics that may cause torsades de pointes (amisulpride, chlorpromazine, ciamemazine, domperidone, droperidol, flupentixol, flufenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sulpiride, sultopride, tiapride, zuclopentixol), other neuroleptics (thioridazine, trifluoperazine), methadone and fingolimod.

Do not take this medicine if you have fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (rare inherited disorders).

Treatment must be discontinued if certain cardiac disorders occur (atrioventricular block, sinoventricular block, bifascicular block).

Inform your doctor if you have renal impairment or if you have a pacemaker.

Children and adolescents

This medicine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Hidroquinidina Serecor

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This medicine must not be used in combination with medicines that may cause torsades de pointes (serious heart rhythm disorders): class Ia antiarrhythmics (quinidine, disopyramide), class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide), and other medicines such as: arsenic compounds, cisapride, citalopram, escitalopram, dihydroquinidine, dolasetron IV, dronedarone, erythromycin IV, levofloxacin, mequitazine, mizolastine, moxifloxacin, prucalopride, spiramycin IV, toremifene, vandetanib, vincamine IV, and in combination with beta-blockers used in heart failure (carvedilol, bisoprolol, metoprolol, nebivolol).

The combination of this medicine with certain antiparasitic medicines that may cause torsades de pointes (halofantrine, lumefantrine, pentamidine), certain neuroleptics that may cause torsades de pointes (amisulpride, chlorpromazine, ciamemazine, domperidone, droperidol, flupentixol, flufenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sulpiride, sultopride, tiapride, zuclopentixol), other neuroleptics (thioridazine, trifluoperazine), methadone and fingolimod should be avoided.

To prevent any interaction between different medicines, you must always inform your doctor about any other treatment you are taking.

Taking Hidroquinidina Serecor with food and drink

Not applicable.

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.

Pregnancy

There are no data on the safety of hydroquinidine during pregnancy; therefore, the use of hydroquinidine during pregnancy is not recommended.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Since this medicine passes into breast milk and may cause adverse effects, breastfeeding should be avoided while taking hydroquinidine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Not applicable.

Hidroquinidina Serecor contains sucrose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Hydroquinidine Serecor

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

The recommended dose is normally 1 hard capsule in the morning and 1 hard capsule at night, taken at an interval of 12 hours. If the arrhythmia is not adequately controlled, 2 hard capsules in the morning and 2 hard capsules at night. This dosing regimen ensures regular release of an effective amount of hydroquinidine, without overdose, interruptions, or significant adverse effects.

Therefore, you must strictly follow the prescription and must not change the dose or stop taking this medicine without consulting your doctor.

The hard capsules must be swallowed whole (do not open or chew) with a large glass of water.

If you take more Hydroquinidine Serecor than you should

If you take more Hydroquinidine Serecor than you should, 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 medicine and the amount ingested.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Inform your doctor if you experience any of these adverse effects; he/she will advise you whether you should continue or stop treatment with Hidroquinidina Serecor.

Very common adverse effects (may affect more than 1 in 10 people):

• Diarrhea.

Frequent adverse effects (may affect up to 1 in 10 people):

? Nausea, dizziness.

• Like all antiarrhythmics (especially class I antiarrhythmics), hydroquinidine may cause ventricular rhythm disturbances in the heart and severe syncope (sudden loss of consciousness).
• Risk of liver damage, most often accompanied by fever.

Frequency not known (cannot be estimated from the available data):

• Small red spots or "bruises" may appear on the skin, anemia (insufficient levels of red blood cells).
• Cardiac arrest, certain heart disorders (atrioventricular block, most frequently intraventricular block, extrasystoles).
• Vomiting.
• Increased sensitivity of the skin to sunlight.
• Allergic reactions (hypersensitivity).
• To a large extent, in cases of overdose: dizziness, double vision, excessive sensitivity to light, noises/ringing in the ears, hearing loss. At normal doses, these signs may be mild and occur separately.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Hydroquinidine Serecor

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please 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 Hydroquinidine Serecor

• The active substance is hydroquinidine hydrochloride. Each prolonged-release hard capsule contains 300 mg of hydroquinidine hydrochloride.
• The other components are: sucrose, corn starch, povidone, methacrylic acid-methyl methacrylate copolymers (1:1), talc for each prolonged-release hard capsule.
• Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132), yellow iron oxide (E172).

Appearance of the product and pack contents

Hydroquinidine Serecor prolonged-release hard capsule is an opaque green and transparent pink hard capsule containing white to cream-colored micropellets.

Hydroquinidine Serecor is available in packs of 20 and 60 prolonged-release hard capsules in blister packs.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

Delpharm Dijon
6 Boulevard de l'Europe
21800 Quetigny
France

or

Esifar, S.L.
Ctra. Antigua Ajalvir, Km. 2.200
28806 Alcalá de Henares – Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

France: SERECOR 300 mg, prolonged-release capsule
Spain: HIDROQUINIDINA SERECOR 300 mg prolonged-release hard capsules

Date of the most recent review of this leaflet: March 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/