HYDROQUINIDINE SERECOR 300 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Hydroquinidine Serecor 300 mg prolonged-release hard capsules

Hydroquinidine hydrochloride

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. See section 4.

Contents of the package leaflet:

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

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

Hydroquinidine Serecor contains the active substance hydroquinidine hydrochloride.

Pharmaco-therapeutic group: class Ia anti-arrhythmics.

Hydroquinidine Serecor is used to treat and prevent certain severe heart rhythm disorders and to prevent symptoms of electric shock in some patients with an implanted automatic defibrillator (DAI).

2. What you need to know before you take Hydroquinidine Serecor

Do not take Hydroquinidine 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 can cause torsades de pointes (severe heart rhythm disorders):

• class Ia anti-arrhythmics (quinidine, disopyramide), class III anti-arrhythmics

(amiodarone, sotalol, dofetilide, ibutilide),

• and other medicines such as: arsenic compounds, cisapride, citalopram,

escitalopram, difemanil, 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 Hydroquinidine Serecor.

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

• A test capsule is administered.
• Stop treatment and contact your doctor if hypotension, skin rash, fever, asthma attack, or heart disorders appear in the first few hours.
• However, if only heart disorders occur after 48 hours (and if none of the above signs occur), the dose should simply be reduced.
• Potassium serum levels (amount of potassium in the blood) should be monitored and ECGs should be performed regularly, particularly at the start of treatment.

• Contact your doctor immediately if fever appears.

Hydroquinidine hydrochloride should not normally be used in the following situations, unless your doctor indicates otherwise:

• pregnancy, breastfeeding,
• myasthenia,
• in combination with certain antiparasitic medicines that can cause torsades de pointes (halofantrine, lumefantrine, pentamidine), certain neuroleptics that can cause torsades de pointes (amisulpride, chlorpromazine, ciamemazine, domperidone, droperidol, flupentixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sulpiride, sultopride, tiapride, zuclopenthixol), 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 hereditary diseases).

Treatment should be discontinued if certain heart disorders occur (atrioventricular block, sinoventricular block, bifascicular block).

Tell your doctor if you have kidney failure or if you have a pacemaker.

Children and adolescents

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

Other medicines and Hydroquinidine Serecor

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

This medicine should not be used in combination with medicines that can cause torsades de pointes (severe heart rhythm disorders): class Ia anti-arrhythmics (quinidine, disopyramide), class III anti-arrhythmics (amiodarone, sotalol, dofetilide, ibutilide), and other medicines such as: arsenic compounds, cisapride, citalopram, escitalopram, difemanil, 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).

Avoid combining this medicine with certain antiparasitic medicines that can cause torsades de pointes (halofantrine, lumefantrine, pentamidine), certain neuroleptics that can cause torsades de pointes (amisulpride, chlorpromazine, ciamemazine, domperidone, droperidol, flupentixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sulpiride, sultopride, tiapride, zuclopenthixol), other neuroleptics (thioridazine, trifluoperazine), methadone and fingolimod.

To avoid any interaction between different medicines, you should always inform your doctor of any other treatment you are taking.

Taking Hydroquinidine Serecor with food and drinks

Not applicable.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding

Since this medicine passes into breast milk and the adverse effects it produces, breastfeeding should be avoided while taking hydroquinidine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Not applicable.

Hydroquinidine Serecor contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take Hydroquinidine Serecor

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is usually 1 hard capsule in the morning and 1 hard capsule in the evening, taken with a 12-hour interval. If the arrhythmia is not adequately controlled, 2 hard capsules in the morning and 2 hard capsules in the evening. This dose allows for the regular release of an effective amount of hydroquinidine, without overdose, interruptions or significant side effects.

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

Swallow the hard capsules 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, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you experience any of these side effects, he/she will indicate whether you should continue or stop treatment with Hydroquinidine Serecor.

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

• Diarrhea.

Common side effects(may affect up to 1 in 10 people):

Nausea, dizziness.

• Like all anti-arrhythmics (especially class I anti-arrhythmics), hydroquinidine can cause ventricular rhythm disorders 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 "petechiae" may appear on the skin, anemia (insufficient levels of red blood cells).
• Cardiac arrest, certain heart disorders (atrioventricular block, more frequently intraventricular block, extrasystoles).
• Vomiting.
• Increased skin sensitivity to the sun.
• Allergic reactions (hypersensitivity).
• To a large extent, in the case of an overdose: dizziness, double vision, excessive sensitivity to light, ringing/noise in the ears, hearing loss. At normal doses, these signs may be mild and occur separately.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, 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 take this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and further information

Composition of Hydroquinidine Serecor

• The active substance is hydroquinidine hydrochloride. Each prolonged-release hard capsule contains 300 mg of hydroquinidine hydrochloride.
• The other ingredients are: sucrose, corn starch, povidone, methacrylic acid - methyl methacrylate copolymer (1:1), talc for each prolonged-release hard capsule.
• Capsule: 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 a hard capsule of opaque green and transparent pink color containing white to cream-colored micropellets.

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

Not all pack sizes may be marketed.

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

France: SERECOR 300 mg, prolonged-release capsule

Spain: HIDROQUINIDINA SERECOR 300 mg prolonged-release hard capsules

Date of last revision of this leaflet:March 2025

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