Leaflet: information for the patient

Ivabradina Stada 7.5 mg film-coated tablets

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Ivabradina Stada and what it is used for

2. What you need to know before starting to take Ivabradina Stada

3. How to take Ivabradina Stada

4. Possible side effects

5. Storage of Ivabradina Stada

6. Contents of the pack and additional information

Ivabradina is a heart medication that is used to treat:

• Stable angina pectoris (chest pain) in adult patients with a heart rate of 70 beats per minute or higher. It is used in adult patients who cannot tolerate or take beta-blocker medications. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker.
• Chronic heart failure in adult patients with a heart rate of 75 beats per minute or higher. It is used in combination with standard treatment, including beta-blocker treatment, or when beta-blockers are contraindicated or not tolerated.

About stable angina (also known as "angina")

Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually appears in people between the ages of 40 and 50. The most common symptom of angina is chest pain or discomfort. Angina is more likely to occur when the heart beats faster in situations such as exercise, emotion, exposure to cold, or after eating. This increased heart rate can cause chest pain in people with angina.

About chronic heart failure:

Chronic heart failure is a heart disease that occurs when your heart cannot pump enough blood to the rest of your body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How does Ivabradina work?

Ivabradina primarily works by reducing the heart rate by a few beats per minute. This reduces the heart's need for oxygen, especially in situations where angina attacks are more likely to occur. In this way, Ivabradina tablets help control and reduce the number of angina attacks.

Additionally, as a high heart rate negatively affects heart function and vital prognosis in patients with chronic heart failure, the specific action of reducing heart rate by Ivabradina helps improve heart function and vital prognosis in these patients.

Do not take Ivabradina tablets

• if you areallergic to ivabradina or any of the other components of this medication(listed in section 6);
• if yourresting heart rate before treatment is too slow(below 70 beats per minute);
• if you havecardiogenic shock(a heart problem treated in the hospital);
• if you havearrhythmia;
• if you are having aheart attack;
• if you havevery low blood pressure;
• if you haveunstable angina(a severe type of angina in which chest pain appears very frequently with or without exercise);
• if you haveheart failurethat has worsened recently;
• if yourheart rate is exclusively determined by your pacemaker;
• if you havesevere liver problems;
• if you are taking medications for the treatment of fungal infections (such asketoconazole,itraconazole), macrolide antibiotics (such asjosamycin,clarithromycin,telithromycinorerythromycingiven orally), medications to treat HIV infections (such asnelfinavir,ritonavir) ornefazodone(a medication to treat depression) ordiltiazem,verapamil(used to treat high blood pressure or angina pectoris);
• if you are apregnant woman and do not use reliable contraceptive methods;
• if you arepregnant or trying to become pregnant;
• if you are in thelactation period.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ivabradina tablets:

• if you havearrhythmias(such as irregular heartbeat, palpitations, increased chest pain) orsustained atrial fibrillation(a type of irregular heartbeat), or anelectrocardiogram (ECG) anomalycalled “prolonged QT syndrome”,
• if you have symptoms such asfatigue,dizzinessordifficulty breathing(this may mean that your heart is beating too slowly),
• if you have symptoms ofatrial fibrillation(unusual resting pulse above 110 beats per minute or irregular, without apparent reason, that makes it difficult to measure).
• if you have had arecent stroke(cerebral attack),
• if you havelow blood pressureof mild to moderate severity,
• if you haveuncontrolled high blood pressure, especially after a change in your antihypertensive treatment,
• if you havesevere heart failureorheart failure with ECG anomalycalled “Bundle Branch Block”,
• if you havechronic retinal disease of the eye,
• if you havemoderate liver problems,
• if you havesevere kidney problems.

If you have any of these conditions, consult your doctor immediately before or during treatment with Ivabradina tablets.

Children

Ivabradina tablets are not intended for use in children and adolescents under 18 years of age.

Use of Ivabradina tablets with other medications

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

Make sure to inform your doctor if you are taking any of the following medications, as it may be necessary to adjust the dose of Ivabradina tablets or monitor:

• fluconazole(an antifungal medication)
• rifampicin(an antibiotic)
• barbiturates(for sleep problems or epilepsy)
• phenytoin(for epilepsy)
• Hypericum perforatumor St. John's Wort(a medicinal plant for the treatment of depression).
• Medications that prolong the QT interval to treat arrhythmias or other alterations:
• • quinidine,disopyramide,ibutilide,sotalol,amiodarone(to treat arrhythmias)
  • bepridil(to treat angina pectoris)
  • Certain types of medications to treat anxiety, schizophrenia or other psychoses (such aspimozide,ziprasidone,sertindole)
  • Antimalarial medications (such asmefloquineorhalofantrine)
  • intravenous erythromycin(an antibiotic)
  • pentamidine(an antiparasitic medication)
  • cisapride(for gastroesophageal reflux).
• Some types of diuretics that may cause a reduction in blood potassium levels, such asfurosemide,hydrochlorothiazide,indapamide(used to treat edema, high blood pressure).

Taking Ivabradina tablets with food and drinks

Avoid grapefruit juice during treatment with Ivabradina tablets.

Pregnancy and lactation

Do not take Ivabradina tablets if you are pregnant or intend to become pregnant (see “Do not take Ivabradina tablets”).

If you are pregnant and have taken Ivabradina tablets, consult your doctor.

Do not take Ivabradina tablets if you are fertile and do not use reliable contraceptive methods (see “Do not take Ivabradina tablets”).

Do not take Ivabradina tablets if you are in the lactation period (see “Do not take Ivabradina tablets”). Talk to your doctor if you are in the lactation period or intend to start lactation, as lactation should be interrupted if you are taking Ivabradina tablets.

If you are pregnant or in the lactation period, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Ivabradina tablets may cause transient visual phenomena (a brief luminosity in the field of vision, see “Possible side effects”). If this happens, be careful when driving or operating machinery in situations where sudden changes in light intensity may occur, especially at night.

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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

Ivabradina tablets should be taken with breakfast and dinner.

If you are being treated for stable angina

The starting dose should not exceed one Ivabradina 5 mg tablet twice a day. If you still have angina symptoms and have tolerated the 5 mg twice a day dose well, the dose can be increased. The maintenance dose should not exceed 7.5 mg twice a day. Your doctor will prescribe the correct dose for you. The usual dose is one tablet in the morning and one tablet at night. In some cases (e.g. if you are an elderly patient), your doctor may prescribe half the dose, that is, half a 5 mg Ivabradina tablet (corresponding to 2.5 mg of Ivabradina) in the morning and half a 5 mg tablet at night.

If you are being treated for chronic heart failure

The recommended initial normal dose is one 5 mg Ivabradina tablet twice a day, increasing if necessary to one 7.5 mg Ivabradina tablet twice a day. Your doctor will decide on the suitable dose for you. The usual dose is one tablet in the morning and one tablet at night. In some cases (for example, if you are an elderly person), your doctor may prescribe half the dose, that is, half a 5 mg Ivabradina tablet (corresponding to 2.5 mg of Ivabradina) in the morning and half a 5 mg tablet at night.

If you take more Ivabradina tablets than you should

A high dose of Ivabradina tablets may make you feel tired or have difficulty breathing due to your heart beating too slowly.If this happens, contact your doctor immediately.

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

If you forgot to take Ivabradina tablets

If you forgot to take a dose of Ivabradina tablets, take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ivabradina tablets

Generally, treatment for angina or chronic heart failure is lifelong, so you should consult your doctor before stopping this medication.

If you think the action of Ivabradina tablets is too strong or too weak, inform your doctor or pharmacist.

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

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

The most common side effects with this medicine are dose-dependent and related to its mechanism of action:

Side effectsvery common (can affect more than 1 in 10 people)

Phenomena of visual light (brief moments of increased brightness, caused almost always by sudden changes in light intensity). They can also be described as a halo, flashes of color, image decomposition, or multiple images. These usually appear during the first two months of treatment, after which they may occur repeatedly and resolve during or after treatment.

Side effectscommon (can affect up to 1 in 10 people)

Modification of heart function (symptoms are a slowing of heart rate). This occurs especially in the first 2 to 3 months after starting treatment.

Other side effects have also been reported:

Side effectscommon (can affect up to 1 in 10 people)

• Irregular rapid heart contractions
• Abnormal heart palpitations
• Uncontrolled high blood pressure
• Headache
• Dizziness and blurred vision (hazy vision).

Side effectsuncommon (can affect up to 1 in 100 people)

• Palpitations and additional heartbeats
• Dizziness (nausea)
• Constipation
• Diarrhea
• Abdominal pain
• Sensation of spinning (dizziness)
• Difficulty breathing (dyspnea)
• Muscle cramps
• Changes in laboratory tests: elevated blood levels of uric acid, eosinophilia (an excess of a type of white blood cell), and elevated blood levels of creatinine (a muscle breakdown product)
• Skin rash
• Angioedema (inflammation of the face, tongue, or throat, difficulty breathing or swallowing)
• Low blood pressure
• Fainting
• Feeling tired
• Feeling weak
• Abnormal electrocardiogram
• Dual vision
• Visual disturbance.

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

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through the drains or in the trash. Deposit the packaging and medicines that you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Composition of Ivabradina Stada

• The active ingredient is ivabradina (as a chlorhydrate).

Ivabradina Stada 7.5 mg: a film-coated tablet contains 7.5 mg of ivabradina (equivalent to 8.085 mg of ivabradina as a chlorhydrate).

• The other components are: Betadex, microcrystalline cellulose, sodium croscarmellose, magnesium stearate (core); hypromellose (HPMC 2910), lactose monohydrate, titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172) (coating).

Appearance of the product and content of the packaging

Ivabradina Stada 7.5 mg: film-coated tablets, round, pink, approximately 9.5 mm, marked with “I9VB” on one face and with “7.5” on the other face.

The tablets are presented in PVC/PE/PVDC/Aluminum or Aluminum/Aluminum blister packs of 14, 28, 28 (sample), 56, 98, 100, or 112 film-coated tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing:

Synthon Hispania S.L.

C/Castelló nº1, Pol. Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22 Nijmegen

6545 CM

Netherlands

or

Synthon s.r.o.

Brnenská 32/cp. 597

678 01 Blansko

Czech Republic

or

STADA Arzneimittel AG

Stadastrasse 2 - 18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E
4814 NE Breda
Netherlands

This medicine is authorized in the Member States of the European Economic Area with the following names:

ATIvabradin Stada 7.5 mg Filmtabletten

DEIvabradin AL 7.5 mg Filmtabletten

ESIvabradina Stada 7.5 mg comprimidos recubiertos con película EFG

FRIVABRADINE EG 7.5 mg, comprimé pelliculé

ITIVABRADINA EG

NLIvabradine CF 7.5 mg, filmomhulde tabletten

PTIvabradina Ciclum

SIIvabradin Stada 7.5 mg filmsko obložene tablete

SKIvabradín Stada 7.5 mg filmom obalené tablety

Revision date of this leaflet:December 2021

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