Leaflet: information for the patient

Ivabradina Pensa 5 mg film-coated tablets EFG

Read this 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, consult 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 Ivabradina Pensa is and what it is used for

2. What you need to know before you start taking Ivabradina Pensa

3. How to take Ivabradina Pensa

4. Possible side effects

5. Storage of Ivabradina Pensa

6. Contents of the pack and additional information

Ivabradina is a heart medication that serves to treat:

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

About stable angina (usually known as “angina”)

Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually appears in ages between 40 and 50 years. The most frequent symptom of angina is chest pain or discomfort. Angina is more likely to appear when the heart beats faster in situations such as exercise, emotion, exposure to cold, or after eating. This increase in 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 the body. The most frequent symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does Ivabradina work?

Ivabradina primarily acts by reducing the heart rate by a few beats per minute. In this way, the need for oxygen by the heart is reduced, especially in situations where an angina attack is more likely to appear. In this way, Ivabradina tablets help to control and reduce the number of angina attacks.

Additionally, as a high heart rate negatively affects the functioning of the

heart and the vital prognosis in patients with chronic heart failure, the specific action of heart rate reduction by Ivabradina helps to improve the functioning of the heart and the vital prognosis in these patients.

Do not take Ivabradina tablets

• if you are allergic to ivabradina or any of the other ingredients of this medicine (listed in section 6);
• if your resting heart rate before treatment is too slow (below 70 beats per minute);
• if you are experiencing cardiogenic shock (a heart problem treated in the hospital);
• if you have a heart rhythm disorder;
• if you are having a heart attack;
• if you have very low blood pressure;
• if you have unstable angina (a severe type of angina where chest pain appears frequently with or without exercise);
• if you have recently worsened heart failure;
• if your heart rate is exclusively determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medications for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV infection medications (such as nelfinavir, ritonavir), or nefazodone (a medication for depression) or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a fertile woman and do not use reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions

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

• if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an electrocardiogram (ECG) anomaly called "prolonged QT syndrome",
• if you have symptoms such as fatigue, dizziness, or difficulty breathing (this may mean your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (an unusual resting pulse above 110 beats per minute or irregular, without apparent reason, that makes it difficult to measure),
• if you have had a recent stroke (cerebral attack),
• if you have mild to moderate low blood pressure,
• if you have uncontrolled high blood pressure, especially after a change in your antihypertensive treatment,
• if you have severe heart failure or heart failure with an ECG anomaly called "branch block",
• if you have chronic retinal disease of the eye,
• if you have moderate liver problems,
• if you have severe kidney problems.

If you meet 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 old.

Use of Ivabradina tablets with other medicines

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

Make sure to inform your doctor if you are taking any of the following medicines, 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 perforatum or St. John's Wort (a medicinal plant for treating depression).
• Medicines that prolong the QT interval to treat heart rhythm disorders or other alterations:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders)
  • bepridil (for treating angina)
  • certain types of medications for treating anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole)
  • antimalarial medications (such as mefloquine or halofantrine)
  • 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 as furosemide, 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 breastfeeding

Do not take Ivabradina tablets if you are pregnant or trying 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 breastfeeding (see "Do not take Ivabradina tablets"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as you should stop breastfeeding if you are taking Ivabradina tablets.

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.

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 there may be sudden changes in light intensity, especially when driving at night.

This medicine contains lactose

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

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 initial dose should not exceed one Ivabradina 5 mg tablet twice a day. If you still have angina symptoms and have tolerated the 5 mg dose twice a day, 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, i.e., 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 (e.g., if you are an elderly person), your doctor may prescribe half the dose, i.e., 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.

The printed calendar on the blister containing the tablets will help you remember when you last took an Ivabradina tablet.

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 weak, inform your doctor or pharmacist.

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

pharmacist.

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteveryonewillexperiencethem.

Thefrequencyofpossiblesideeffectslistedbelowisdefinedusingthefollowingscheme:

Veryfrequent:canaffectmorethan1in10people.

Frequent:canaffectupto1in10people.

Rare:canaffectupto1in100people.Veryrare:canaffectupto1in1,000people.

Veryrare:canaffectupto1in10,000people.

Unknownfrequency:thefrequencycannotbeestimatedfromavailabledata.

Themostfrequentadversereactionswiththismedicinearedose-dependentandarerelatedtoitsmechanismofaction:

Frequent:

Visualphenomena(briefmomentsofincreasedluminosity,causednearlyalwaysbybrusquechangesinlightintensity).Theycanalsobedescribedasahalo,flashesofcolors,imagedecomposition,ormultipleimages.Thesegenerallyappearwithinthefirsttwomonthsoftreatmentafterwhichtheymayoccurrepeatedlyandresolveduringoraftertreatment.

Frequent:

Cardiacfunctionalteration(symptomsareaslowingofheartrate).Thishappensespeciallyinthefirst2to3monthsafterthestartoftreatment.

Otheradverseeffectshavebeenreported:

Frequent:

Irregularrapidheartbeats,abnormalheartbeatsensation,uncontrolledbloodpressure,headache,dizziness,andblurredvision(cloudyvision).

Rare:

Palpitationsandadditionalheartbeats,nausea,constipation,diarrhea,abdominalpain,sensationofspinning(dizziness),difficultybreathing(dyspnea),musclecramps,changesinanalyticaltests:highbloodlevelsofuricacid,eosinophilia(atypeofwhitebloodcell),andhighbloodlevelsofcreatinine(aproductofmuscledegradation),skineruption,angioedema(inflammationoftheface,lips,orthroat,difficultybreathingorswallowing),lowbloodpressure,syncope,sensationoffatigue,sensationofweakness,abnormalelectrocardiogram,doublevision,visualdisturbance.

Rare::

Urticaria,pruritus,skinredness,indisposition.

Veryrare:

Irregularheartbeats.

Reportingofadversereactions

Ifyouexperienceanytypeofadversereaction,consultyourdoctororpharmacist,evenifitisapossibleadversereactionthatdoesnotappearinthisleaflet.YoucanalsoreportthemdirectlythroughtheSpanishSystemofPharmacovigilanceforHumanUse:https://www.notificaram.es.Byreportingadversereactions,youcancontributetoprovidingmoreinformationonthesafetyofthismedicine.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Ivabradina Pensa

• The active ingredient is ivabradina (as hydrochloride).

A coated tablet contains 5 mg of ivabradina (equivalent to 5,390 mg of ivabradina as hydrochloride).

• The other components in the tablet core are: cornstarch, maltodextrin, anhydrous colloidal silica, lactose monohydrate, magnesium stearate, and in the tablet coating: lactose monohydrate, titanium dioxide (E-171), hypromellose, macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and content of the packaging:

Ivabradina Pensa 5 mg tablets are coated, are light salmon in color, have a capsule shape, are biconvex, and have a notch on one side.

The tablet can be divided into equal doses.

The tablets are presented in calendar packaging (Aluminum/Aluminum blisters) of 56 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

NOUCOR HEALTH, S.A.

Avda. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Last review date of this leaflet: June 2017

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