Sequacor

Patient Information Leaflet

Sequacor 1.25 mg film-coated tablets, 2.5 mg film-coated tablets, 3.75 mg film-coated tablets, 5 mg film-coated tablets, 7.5 mg film-coated tablets, 10 mg film-coated tablets

bisoprolol fumarate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Sequacor is and what it is used for

The active substance in Sequacor is bisoprolol. Bisoprolol belongs to a group of medicines known as beta-blockers. These medicines work by affecting the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and allows the heart to pump blood more easily throughout the body.
Heart failure occurs when the heart muscle becomes weakened and is no longer able to pump enough blood to meet the body's needs. Sequacor is indicated for the treatment of stable chronic heart failure.
It is usually used in combination with other medicines indicated for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you should know before taking Sequacor

Do not use Sequacor
Do not take Sequacor if any of the following apply to you:

• Allergy (hypersensitivity) to bisoprolol or to any of the ingredients (see section 6 “What Sequacor contains”);
• Severe asthma;
• Severe circulatory problems in the extremities (such as Raynaud's syndrome), causing tingling in the fingers and toes, which may become pale or turn blue;
• Untreated phaeochromocytoma, which is a rare tumour of the adrenal gland;
• Metabolic acidosis, i.e. a condition in which there is an increase in acid levels in the blood.

Do not take Sequacor if you have any of the following heart conditions:

• Acute heart failure;
• Worsening heart failure requiring intravenous administration of medicines that increase the heart's pumping strength;
• Slow heart rate;
• Low blood pressure;
• Certain heart conditions causing slowed heart rate or irregular heartbeat;
• Cardiogenic shock, i.e. a severe acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions
If you have any of the following conditions, inform your doctor before taking Sequacor; your doctor may need to take special precautions (for example, prescribe additional treatment or perform more frequent checks):

• Diabetes;
• Prolonged fasting;
• Certain heart conditions such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina);
• Kidney or liver problems;
• Mild circulatory problems in the extremities;
• Chronic lung disease or mild asthma;
• History of skin peeling (psoriasis);
• Tumour of the adrenal gland (phaeochromocytoma);
• Thyroid disorders.

Also inform your doctor if you are about to undergo:

• Desensitisation therapy (e.g. to prevent hay fever), as Sequacor may increase the likelihood of an allergic reaction, or make such a reaction more severe;
• Anaesthesia (e.g. for surgery), as Sequacor may affect your body's response in this situation.

Inform your doctor immediately if you have chronic lung disease or mild asthma and develop new breathing difficulties, cough, wheezing after physical exertion, etc., while taking Sequacor.

Children and adolescents
The use of Sequacor is not recommended in children and adolescents.

For those engaged in sports: using this medicine without a medical need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Sequacor
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take the following medicines together with Sequacor unless specifically instructed by your doctor:

• Certain medicines used to treat abnormal or irregular heartbeat (Class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• Certain medicines used to treat high blood pressure, angina pectoris, or irregular heartbeat (calcium antagonists such as verapamil and diltiazem);
• Certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonidine, rilmenidine. Do not stop taking these medicines without first consulting your doctor.

Consult your doctor before taking any of the following medicines together with Sequacor; your doctor may need to monitor your condition more frequently:

• Certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine calcium antagonists such as felodipine and amlodipine);
• Certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic drugs such as amiodarone);
• Topically used beta-blockers (e.g. timolol eye drops used to treat glaucoma);
• Certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline or dobutamine);
• Antidiabetic medicines, including insulin;
• Anaesthetics (e.g. during surgery);
• Digitalis, used to treat heart failure;
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (e.g. ibuprofen or diclofenac);
• Any medicine that can lower blood pressure, whether intended or not, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or used during anaesthesia (barbiturates such as phenobarbital), or certain medicines used to treat psychotic disorders characterised by loss of contact with reality (phenothiazines such as levomepromazine);
• Mefloquine, used for prevention or treatment of malaria;
• Antidepressants known as monoamine oxidase inhibitors (excluding MAO-B inhibitors), such as moclobemide.

Pregnancy and breastfeeding
Pregnancy
Taking Sequacor during pregnancy may harm the unborn child. Inform your doctor if you are pregnant or planning to become pregnant. Your doctor will decide whether you can take Sequacor during pregnancy.

Breastfeeding
It is not known whether bisoprolol passes into breast milk. Breastfeeding is therefore not recommended during treatment with Sequacor.

Driving and operating machinery
Your ability to drive or operate machinery may be impaired depending on your individual response to the medicine. Exercise particular caution at the beginning of treatment, when the dose is increased, when switching to another medicine, and also if you consume alcohol while taking this medicine.

3. How to take Sequacor

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Treatment with Sequacor should be carried out under regular medical supervision, particularly at the beginning of treatment, during dose escalation, and at the end of treatment.
Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet.
Tablets with a score line may be divided into two equal doses.
Treatment with Sequacor is usually long-term.

Adults, including elderly patients:
Treatment with bisoprolol should be initiated at a low dose, which is then gradually increased.
Your doctor will decide how to increase the dose. Normally, this will proceed as follows:

• 1.25 mg bisoprolol once daily for one week;
• 2.5 mg bisoprolol once daily for one week;
• 3.75 mg bisoprolol once daily for one week;
• 5 mg bisoprolol once daily for four weeks;
• 7.5 mg bisoprolol once daily for four weeks;
• 10 mg bisoprolol once daily as the maintenance (long-term) dose.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on your tolerance to the medicine, your doctor may decide to extend the intervals between dose increases. If your condition worsens or you are no longer able to tolerate the medicine, it may become necessary to reduce the dose or discontinue treatment. In some patients, a maintenance dose of bisoprolol lower than 10 mg may be sufficient.
Your doctor will advise you accordingly.
If you need to stop treatment permanently, your doctor will usually recommend gradually reducing the dose. Otherwise, your condition could worsen.

If you take more Sequacor than you should
If you have taken more Sequacor tablets than prescribed, inform your doctor immediately. Your doctor will determine what measures to take.
Symptoms of overdose may include: slowed heart rate, severe breathing difficulties, dizziness, or tremor (due to low blood sugar).

If you forget to take Sequacor
Do not take a double dose to make up for the missed dose. Take your usual dose the following morning.

If you stop taking Sequacor
Do not stop taking Sequacor unless your doctor tells you to. Otherwise, your condition may worsen seriously.

If you have any questions about 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 everyone gets them.
To prevent serious reactions, contact your doctor immediately if you experience a side effect that is severe, sudden in onset, or rapidly worsening.
The most serious side effects involve heart function:

• Slowing of the heart rate (may affect more than 1 in 10 people)
• Worsening of heart failure (may affect up to 1 in 10 people)
• Slow or irregular heartbeat (may affect up to 1 in 100 people)

If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.
Other side effects are listed below, according to their frequency:

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

• Tiredness, weakness, dizziness, headache;
• Feeling cold or numbness in hands or feet;
• Low blood pressure;
• Stomach or intestinal problems such as nausea, vomiting, diarrhoea or constipation.

Uncommon (may affect up to 1 in 100 people):

• Sleep disorders;
• Depression;
• Dizziness upon standing;
• Breathing problems in patients with asthma or chronic lung disease;
• Muscle weakness, muscle cramps.

Rare (may affect up to 1 in 1,000 people):

• Hearing problems;
• Allergic rhinitis;
• Reduced tear production;
• Inflammatory liver disorder which may cause yellowing of the skin or whites of the eyes (jaundice);
• Abnormal results in certain blood tests for liver function or abnormal levels of fats in the blood;
• Allergy-like reactions such as itching, flushing, skin rash. You should contact your doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth or throat, or difficulty breathing;
• Erectile dysfunction;
• Nightmares, hallucinations;
• Fainting (syncope).

Very rare (may affect up to 1 in 10,000 people):

• Eye irritation and redness (conjunctivitis);
• Hair loss;
• Onset or worsening of skin peeling (psoriasis); psoriasis in the form of a skin rash.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sequacor

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

• Do not use this medicine after the expiry date stated on the blister and carton after the word EXP. The expiry date refers to the last day of that month.

Sequacor 1.25 mg film-coated tablets:
Sequacor 2.5 mg film-coated tablets:
Sequacor 3.75 mg film-coated tablets:

• Store below 25°C.

Sequacor 5 mg film-coated tablets:
Sequacor 7.5 mg film-coated tablets:
Sequacor 10 mg film-coated tablets:

• Store below 30°C.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sequacor contains
Sequacor 1.25 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg.
• The other components are:
  Tablet core: anhydrous colloidal silica; magnesium stearate; crospovidone; pregelatinized corn starch; corn starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).
  Coating: dimethicone; talc; macrogol 400; titanium dioxide (E171); hypromellose.

Sequacor 2.5 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg.
• The other components are:
  Tablet core: anhydrous colloidal silica; magnesium stearate; crospovidone; corn starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).
  Coating: dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.

Sequacor 3.75 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 3.75 mg.
• The other components are:
  Tablet core: anhydrous colloidal silica; magnesium stearate; crospovidone; corn starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).
  Coating: yellow iron oxide (E172); dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.

Sequacor 5 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 5 mg.
• The other components are:
  Tablet core: anhydrous colloidal silica; magnesium stearate; crospovidone; corn starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).
  Coating: yellow iron oxide (E172); dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.

Sequacor 7.5 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 7.5 mg.
• The other components are:
  Tablet core: anhydrous colloidal silica; magnesium stearate; crospovidone; corn starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).
  Coating: yellow iron oxide (E172); dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.

Sequacor 10 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 10 mg.
• The other components are:
  Tablet core: anhydrous colloidal silica; magnesium stearate; crospovidone; corn starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).
  Coating: red iron oxide (E172); yellow iron oxide (E172); dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.

Description of the appearance of Sequacor and the contents of the pack
Sequacor 1.25 mg film-coated tablets are round and white.
Sequacor 2.5 mg film-coated tablets are heart-shaped, white tablets with a score line on both sides.
Sequacor 3.75 mg film-coated tablets are heart-shaped, cream-colored tablets with a score line on both sides.
Sequacor 5 mg film-coated tablets are heart-shaped, yellowish-white tablets with a score line on both sides.
Sequacor 7.5 mg film-coated tablets are heart-shaped, light yellow tablets with a score line on both sides.
Sequacor 10 mg film-coated tablets are heart-shaped, pale orange to light orange tablets with a score line on both sides.
Each pack contains 20, 28, 30, 50, 56, 60, 90, or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milan, Italy

Manufacturing, quality control, and batch release
(all packs):
Merck KGaA - Frankfurter Strasse 250, 64293 Darmstadt, Germany

Primary and secondary packaging
(all packs):
Merck KGaA - Frankfurter Strasse 250, 64293 Darmstadt, Germany
Merck KGaA & Co Werk Spittal, Hӧsslgasse 20 – 9800 Spittal – Austria
Merck S.L. Poligono Merck 08100 Mollet del Vallés (Barcelona), Spain

Primary and secondary packaging
(all packs except the 1.25 mg pack):
Haupt Pharma Berlin GmbH, Werk Brackenheim, Klingenberger Strasse 7, 74336 Brackenheim – Germany
Catalent Germany Schorndorf GmbH, Steinbeisstrasse 2, 73614 Schorndorf – Germany

Alternatively, for batch release only
(all packs):
Merck KGaA - Frankfurter Strasse 250, 64293 Darmstadt, Germany
Merck KGaA & Co Werk Spittal, Hӧsslgasse 20 – 9800 Spittal – Austria
Merck S.L. Poligono Merck 08100 Mollet del Vallés (Barcelona), Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Concor COR
Belgium: Emconcor HF *
Finland: Emconcor CHF
France: Cardensiel
Germany: Concor COR
Ireland: Cardicor
Italy: Sequacor
Luxembourg: Concor COR
Netherlands: Emcor Deco
Portugal: Concor IC
Spain: Emconcor COR
Sweden: Emconcor CHF
United Kingdom: Cardicor
Film-coated tablets of *2.5 mg: Emconcor Minor