Package Insert: Information for the User

Hydroquinidine Serecor 300 mg Extended-Release Hard Capsules

Hydrochloride of Hydroquinidine

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Hidroquinidina Serecor contains the active substance hydroquinidine hydrochloride.

Pharmacotherapeutic group: class Ia antiarrhythmics.

Hidroquinidina Serecor is used to treat and prevent some serious heart rhythm disorders and to prevent symptoms of electrical shock in some patients with an implantable automatic defibrillator (DAI).

Do not take Hidroquinidina Serecor

• if you are allergicto hidroquinidina or quinidina, or to any of the other components of this medication (listed in section 6),
• if you havesome heart rhythm disorders,
• if you have heart failure,
• with medications that can cause torsades de pointes (serious heart rhythm disorders):

• class Ia antiarrhythmics (quinidina, disopiramida), class III antiarrhythmics

(amiodarona, sotalol, dofetilida, ibutilida),

• and other medications such as: arsenic compounds, cisaprida, citalopram,

escitalopram, difemanil, dolasetron IV, dronedarona, eritromicina IV, levofloxacino,

mequitazina, mizolastina, moxifloxacino, prucaloprida, espiramicina IV, toremifeno,

vandetanib, vincamina 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 takeHidroquinidina Serecor.

Due to the possibility of severe allergic reactions, patients must be tested to determine sensitivity before starting treatment with hidroquinidina, in the following way:

• Administer a test capsule.
• Stop treatment and contact your doctor if hypotension, skin rash, fever, asthma attack, or heart disorders appear in the first hours.
• However, if only heart disorders occur after 48 hours (and no other signs described above appear), simply reduce the dose.
• Monitor serum potassium levels and perform ECGs regularly, particularly at the start of treatment.

• Contact your doctor immediately if fever appears.

Generally, do not use hydrochloride of hidroquinidina in the following situations, unless your doctor indicates:

• pregnancy, lactation,
• myasthenia,
• in combination with some antiparasitic medications that can cause torsades de pointes (halofantrina, lumefantrina, pentamidina), some neuroleptics that can cause torsades de pointes (amisulprida, clorpromazina, ciamemazina, domperidona, droperidol, flupentixol, flufenazina, haloperidol, levomepromazina, pimozida, pipamperona, pipotiazina, sulpirida, sultoprida, tiaprida, zuclopentixol), other neuroleptics (tioridazina, trifluoperazina), metadona and fingolimod.

Do not take this medication if you have fructose intolerance, glucose-galactose malabsorption syndrome or saccharase-isomaltase deficiency (rare hereditary diseases).

Stop treatment if certain heart disorders (atrioventricular block, sinoatrial block, bifascicular branch block) appear.

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

Children and adolescents

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

Use of Hidroquinidina Serecor with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

This medication should not be used in combination with medications that can cause torsades de pointes (serious heart rhythm disorders):class Ia antiarrhythmics (quinidina, disopiramida), class III antiarrhythmics (amiodarona, sotalol, dofetilida, ibutilida), and other medications such as: arsenic compounds, cisaprida, citalopram, escitalopram, difemanil, dolasetron IV, dronedarona, eritromicina IV, levofloxacino, mequitazina, mizolastina, moxifloxacino, prucaloprida, espiramicina IV, “toremifeno”, vandetanib, vincamina IV, andin combination with beta-blockers used in heart failure (carvedilol, bisoprolol, metoprolol, nebivolol).

Avoid combining this medication with some antiparasitic medications that can cause torsades de pointes (halofantrina, lumefantrina, pentamidina), some neuroleptics that cancause torsades de pointes (amisulprida, clorpromazina, ciamemazina, domperidona, droperidol, flupentixol, flufenazina, haloperidol, levomepromazina, pimozida, pipamperona, pipotiazina, sulpirida, sultoprida, tiaprida, zuclopentixol), other neuroleptics (tioridazina, trifluoperazina), metadona and fingolimod.

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

Use of Hidroquinidina Serecor with food and drinks

No applies.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

No reliable data are available on the teratogenic effects in animals.

Currently, there is insufficient clinical data to evaluate the possible teratogenic or fetotoxic effects of hidroquinidina when administered to pregnant women.

Therefore, the use of hidroquinidina during pregnancy is not recommended.

Consult your doctor or pharmacist before using any medication.

Lactation

Since this medication passes into breast milk and produces adverse effects, breastfeeding should be avoided while taking hidroquinidina.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No applies.

Hidroquinidina Serecor contains saccharose

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated 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 at night, taken with 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 dose facilitates the regular release of an effective amount of hidroquinidina, without overdose, interruptions, or significant adverse effects.

You must therefore strictly follow the prescription and should not change the dose or interrupt the intake of this medication without consulting your doctor.

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

If you take more Hidroquinidina Serecor than you should

If you take more Hidroquinidina Serecor than you should, consult your doctor or pharmacist immediately.

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Inform your doctor if you experience any of these adverse effects; they will indicate whether you should continue or discontinue treatment with Hidroquinidina Serecor.

Adverse effectsvery frequent(may affect more than 1 in 10 people):

• Diarrhea.

Adverse effectsfrequent(may affect up to 1 in 10 people):

Nausea, dizziness.

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

Unknown frequency(cannot be estimated from available data):

• Small red spots or "cardinals" 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.
• Allergies (hypersensitivity).
• For the most part, 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 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 prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not take this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Hidroquinidina Serecor

• The active ingredient is hydrochloride of hidroquinidina. Each prolonged-release hard capsule contains 300 mg of hydrochloride of hidroquinidina.
• The other components are: saccharose, cornstarch, povidone, copolymers of methacrylic acid - methyl methacrylate (1:1), talc for each prolonged-release hard capsule.
• Capsule: gelatin, titanium dioxide (E171), erythrosine (E127), indigotin (E132), yellow iron oxide (E172).

Appearance of the product and content of the container

Hidroquinidina Serecor prolonged-release hard capsule is a hard capsule of green opaque and pink transparent color that contains white to cream-colored micropellets.

Hidroquinidina Serecor is available in containers of 20 and 60 prolonged-release hard capsules in blisters.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Responsible for manufacturing

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 authorized in the member states of the European Economic Area with the following names:

France : SERECOR 300mg, prolonged-release gel capsule

Spain : HIDROQUINIDINA SERECOR 300 mg prolonged-release hard capsules

Last review date of this leaflet: January 2020

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/