Concor®

Bisoprolol fumarate
Selective beta blocking agents

1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Concor 1.25 mg Each film-coated tablet contains 1.25 mg Bisoprolol fumarate.
Concor 2.5 mg Each film-coated tablet contains 2.5 mg Bisoprolol fumarate.
Concor 5 mg Each film-coated tablet contains 5 mg Bisoprolol fumarate.
Concor 10 mg Each film-coated tablet contains 10 mg Bisoprolol fumarate.

2. PHARMACEUTICAL FORM
Film-coated tablet.

3. CLINICAL PARTICULARS
3.1 Indications
Concor 1.25 mg, Concor 2.5 mg, Concor 5 mg, and Concor 10 mg
Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE
inhibitors, and diuretics, and optionally cardiac glycosides.

Concor 5 mg and Concor 10 mg

- Treatment of hypertension
- Treatment of coronary heart disease (angina pectoris)

3.2 Posology and Method of Administration

Posology
Treatment of hypertension or angina pectoris
Adults: For both indications the dosage is 5 mg Bisoprolol fumarate once daily. If necessary, the dose may
be increased to 10 mg Bisoprolol fumarate once daily.

The maximum recommended dose is 20 mg once daily.

In all cases the dosage is adjusted individually, in particular according to the pulse rate and therapeutic
success.

Treatment of stable chronic heart failure

The patients should have stable chronic heart failure without acute failure during the past six weeks and a
mainly unchanged basic therapy during the past two weeks. They should be treated at optimal dose with
an optimal dose with an ACE inhibitor (or other vasodilator in case of intolerance to ACE inhibitors) and a
diuretic, and optionally cardiac glycosides, prior to the administration of Bisoprolol.

Titration phase
The treatment of stable chronic heart failure with bisoprolol is initiated according to the following titration
scheme, individual adaptation may be necessary depending on how well the patient tolerates each dose,
i.e. the dose is to be increased only, if the previous dose is well tolerated.

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• 1.25 mg Bisoprolol fumarate once daily for 1week; if well tolerated increase to
• 2.5 mg Bisoprolol fumarate once daily for a further week; if well tolerated increase to
• 3.75 mg Bisoprolol fumarate once daily for a further week; if well tolerated increase to
• 5 mg Bisoprolol fumarate once daily for the 4 following weeks; if well tolerated increase to
• 7.5 mg Bisoprolol fumarate once daily for the 4 following weeks; if well tolerated increase to
• 10 mg Bisoprolol fumarate once daily for the maintenance therapy.

Close monitoring of vital signs (blood pressure, heart rate) and symptoms of worsening heart failure is
recommended during the titration phase. Symptoms may already occur within the first day after initiating
the therapy.

The maximum recommended dose is 10 mg Bisoprolol fumarate once daily.

Treatment modification
If the maximum recommended dose is not well tolerated gradual dose reduction may be considered.

In case of transient worsening of heart failure, hypotension, or bradycardia reconsideration of the dosage
of the concomitant medication is recommended. It may also be necessary to temporarily lower the dose of
bisoprolol or to consider discontinuation.

The reintroduction and/or uptitration of bisoprolol should always be considered when the patient becomes
stable again.

If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead
to acute deterioration of the patients condition.

Treatment with bisoprolol is generally a long-term therapy.

Renal or liver impairment

Treatment of hypertension or angina pectoris: In patients with liver or kidney function disorders of mild to
moderate severity, no dosage adjustment is normally required. In patients with severe renal impairment
(creatinine clearance <20 mL/min) and in patients with severe liver function disorders it is recommended
that a daily dose of 10 mg Bisoprolol fumarate is not exceeded.

Treatment of stable chronic heart failure: There is no information regarding pharmacokinetics of Bisoprolol
in patients with chronic heart failure and with impaired liver or renal function. Uptitration of the dose in these
populations should therefore be made with additional caution.

Elderly
No dosage adjustment is required.

Children
There is no experience with bisoprolol in children, therefore its use cannot be recommended for children.

Administration
Tablets are taken in the morning with or without food. They are swallowed with some liquid and not to be
chewed.

3.3 Contraindications
Bisoprolol is contraindicated in patients with:
• acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy
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• cardiogenic shock
• second or third degree AV block
• sick sinus syndrome
• sinoatrial block
• symptomatic bradycardia
• symptomatic hypotension
• severe bronchial asthma
• severe forms of peripheral arterial occlusive disease or Raynaud's syndrome
• untreated phaeochromocytoma (see section 3.4 Special Warnings and Special Precautions for Use)
• metabolic acidosis
• hypersensitivity to Bisoprolol or to any of the excipients (see section 5.1 List of Excipients)

3.4 Special Warnings and Special Precautions for Use

The treatment of stable chronic heart failure with Bisoprolol has to be initiated with a special titration phase.

Especially in patients with ischaemic heart disease the cessation of therapy with Bisoprolol must not be
done abruptly unless clearly indicated, because this may lead to transitional worsening of heart condition.

The initiation and cessation of treatment with bisoprolol necessitates regular monitoring.

Bisoprolol must be used with caution in patients with hypertension or angina pectoris and accompanying
heart failure.

There is no therapeutic experience of bisoprolol treatment of heart failure in patients with the following
diseases and conditions:
• insulin dependent diabetes mellitus (type I)
• severely impaired renal function,
• severely impaired liver function,
• restrictive cardiomyopathy,
• congenital heart diseases
• haemodynamically significant organic valvular disease.
• myocardial infarction within 3 months.

Bisoprolol must be used with caution in:

• bronchospasm (bronchial asthma, obstructive airways diseases)
• diabetes mellitus with large fluctuations in blood glucose values; symptoms of hypoglycaemia can be
masked
• strict fasting,
• ongoing desensitisation therapy. As with other beta-blockers, Bisoprolol may increase both the
sensitivity towards allergens and the severity of anaphylactic reactions. Epinephrine treatment may not
always yield the expected therapeutic effect,
• first degree AV block
• Prinzmetal’s angina angina; Cases of coronary vasospasm have been observed. Despite its high beta1-
selectivity, angina attacks cannot be completely excluded when Bisoprolol is administered to patients
with Prinzmetal's angina.
• peripheral arterial occlusive disease. Aggravation of symptoms may occur especially when starting
therapy,
• general anaesthesia
In patients undergoing general anaesthesia beta-blockade reduces the incidence of arrhytmias and
myocardial ischemia during induction and intubation, and the post –operative period. It is currently
recommended that maintenance beta-blockade be continued peri-operatively. The anaesthetist must be
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 aware of beta-blockade because of the potential for interactions with other drugs, resulting in
bradyarrhytmias, attenuation of the reflex tachycardia and the decreased reflex ability to compensate
for blood loss. If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be
done gradually and completed about 48 hours before anaesthesia.

Combination of Bisoprolol with calcium antagonist of the Verapamil or Diltiazem type, with Class I
antiarrhytmic drugs and with centrally acting antihypertensive drugs is generally not recommended, for
details please refer to section 3.5 Interaction with other medicinal products and other forms of interaction.

Although cardioselective (beta1) beta-blockers may have less effect on lung function than non-selective
beta-blockers, as with all beta-blockers, these should be avoided in patients with obstructive airways
diseases, unless there are compelling clinical reasons for their use. Where such reasons exist, Bisoprolol
may be used with caution. In patients with obstructive airways diseases the treatment with Bisoprolol should
be started at the lowest possible dose and patients should be carefully monitored for new symptoms (e.g.
dyspnea, exercise intolerance, cough). In bronchial asthma or other chronic obstructive lung diseases,
which may cause symptoms, bronchodilating therapy should be given concomitantly. Occasionally an
increase of the airway resistance may occur in patients with asthma, therefore the dose of beta2-stimulants
may have to be increased.

Patients with psoriasis or with a history of psoriasis should only be given beta-blockers (e.g Bisoprolol) after
carefully balancing the benefits against the risks.

In patients with phaeochromocytoma Bisoprolol must not be administered until after alpha-receptor
blockade.

Under treatment with Bisoprolol the symptoms of a thyreotoxicosis may be masked.

3.5 Interaction with Other Medicinal Products and Other Forms of Interaction
Combinations not recommended
Treatment of stable chronic heart failure
Class-I antiarrhythmic drugs (e.g. Quinidine, Disopyramide; Lidocaine, Phenytoin; Flecainide,
Propafenone): Effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect
increased.

All indications
Calcium antagonists of the Verapamil type and to a lesser extent of the Diltiazem type: Negative influence
on contractility, atrio-ventricular conduction and blood pressure. Intravenous administration of Verapamil in
patients on beta-blocker treatment may lead to profound hypotension and atrioventricular block.

Centrally acting blood pressure-lowering medicines (such as Clonidine, Methyldopa, Moxonodine,

Rilmenidine): Concomitant use of centrally acting antihypertensive drug may worsen heart failure by a
decrease in the central sympathetic tonus (reduction of heart rate and cardic output, vasodilation). Abrupt
withdrawal, particularly if prior to beta-blocker discontinuation, may increase risk of rebound hypertension.

Combinations to be used with caution

Treatment of hypertension or coronary heart disease (angina pectoris)
Class-I antiarrhythmic drugs (e.g. Quinidine, Disopyramide; Lidocaine, Phenytoin; Flecainide,
Propafenone): Effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect
increased.

All indications
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Calcium antagonists of the dihydropyridine type (e.g. Nifedipine, Felodipine, Amlodipine): Concomitant use
may increase the risk of hypotension, and an increased risk of a further deterioration of the ventricular pump
function in patients with heart failure cannot be excluded.

Class-III antiarrhythmic medicines (e.g. Amiodarone): Effect on atrio-ventricular conduction time may be
potentiated.

Topical beta-blockers (e.g. eye drops for glaucoma treatment) may add to the systemic effects of Concor.

Parasympathomimetic drugs: Concomitant use may increase atrio-ventricular conduction time and the risk
of bradycardia.

Insulin and oral antidiabetic drugs: Intensification of blood sugar lowering effect. Blockade of beta-
adrenoreceptors may mask symptoms of hypoglycaemia.

Anaesthetic agents: Attenuation of the reflex tachycardia and increase of the risk of hypotension.

Digitalis glycosides: Reduction of heart rate, increase of atrio-ventricular conduction time.

Non-steroidal anti-inflammatory drugs (NSAIDs): may reduce the hypotensive effect of bisoprolol.

Beta-Sympathomimetics (e.g. Isoprenaline, Dobutamine): combination with bisoprolol may reduce the
effect of both agents.

Sympathomimetics that active both beta-and alpha-adrenoceptors (e.g. Noradrenaline, Adrenaline):

Combination with Bisoprolol may unmask the alpha-adrenoceptor-mediated vasoconstrictor effect of these
agents leading to blood pressure increase and exacerbated intermittent claudiation. Such interactions are
considered to be more likely with nonselective beta-blockers

Concomitant use with antihypertensive agents as well as with other drugs with blood pressure lowering
potential (e.g. tricyclic antidepressants, barbiturates, phenothiazines) may increase the risk of hypotension.

Combinations to be considered
Mefloquine: increased risk of bradycardia.

Monoamineoxidase inhibitors (except MAO-B inhibitors): Enhanced hypotensive effect of beta-blockers but
also risk of hypertensive crisis.

3.6 Pregnancy and Lactation

Pregnancy
Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the
fetus/newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been
associated with growth retardation, intrauterine death, abortion or early labour. Adverse effects (e.g.
hypoglycaemia and bradycardia) may occur in the fetus and newborn infant. If treatment with beta-
adrenoceptor blockers is necessary beta1-selective adrenoceptor blockers are preferable.

Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with Bisoprolol is
considered necessary, the uteroplacental blood flow and the fetal growth should be monitored. In case of
harmful effects on pregnancy or the fetus alternative treatment should be considered. The newborn infant
must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected
within the first 3 days.
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Breast-feeding
It is not known whether this drug is excreted in human milk. Therefore, breastfeeding is not recommended
during administration of Bisoprolol.

3.7 Effects on Ability to Drive and Use Machines

In a study with coronary heart disease patients Bisoprolol did not impair driving performance.

However, due to individual variations in reactions to the drug, the ability to drive a vehicle or to operate
machinery may be impaired. This should be considered particularly at start of treatment and upon change
of medication as well as in conjunction with alcohol.

3.8 Undesirable Effects

The following definitions apply to the frequency terminology used hereafter:
Very common (> 1/10)
Common (> 1/100 to < 1/10)
Uncommon (>1/1,000 to <1/100)
Rare (> 1/10,000 to < 1/ 1,000)
Very rare (< 1/10,000)

Cardiac disorders
Very common: bradycardia (in patients with chronic heart failure)
Common: worsening of heart failure (in patients with chronic heart failure)
Uncommon: AV-conduction disturbances; worsening of pre-existing heart failure (in patients with
hypertension or angina pectoris); bradycardia (in patients with hypertension or angina
pectoris)

Investigations
Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT)

Nervous system disorders

Common: dizziness*, headache*
Rare: syncope

Eye disorders
Rare: reduced tear flow (to be considered if the patient uses contact lenses)
Very rare: conjunctivitis

Ear and labyrinth disorders

Rare: hearing disorders

Respiratory, thoracic and mediastinal disorders

Uncommon: bronchospasm in patients with bronchial asthma or a history of obstructive airways disease
Rare: allergic rhinitis

Gastrointestinal disorders
Common: gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation

Skin and subcutaneous tissue disorders

Rare: hypersensitivity reactions such as pruritus, flush, rash
Very rare: alopecia. Beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash.
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Musculoskeletal and connective tissue disorders
Uncommon: muscle weakness, muscle cramps

Vascular disorders
Common: feeling of coldness or numbness in the extremities, hypotension, especially in patients with
hearth failure

General disorders
Common: asthenia (in patients with chronic heart failure), fatigue*
Uncommon: asthenia (in patients with hypertention of angina pectoris)

Hepatobilary disorders
Rare: hepatitis

Reproductive system and breast disorders

Rare: erectile dysfunction

Psychiatric disorders
Uncommon: depression, sleep disorder
Rare: nightmare, hallucination

* applies only to Hypertension or angina pectoris:

These symptoms especially occur at the beginning of the therapy. They are generally mild and usually
disappear within 1-2 weeks.

3.9 Overdose
Symptoms
With overdose (e.g. daily dose of 15 mg instead of 7.5 mg) third degree AV-block, bradycardia, and
dizziness have been reported. In general the most common signs expected with overdosage of a beta-
blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. To
date a few cases of overdose (maximum: 2000 mg) with bisoprolol have been reported in patients suffering
from hypertension and/or coronary heart disease showing bradycardia and/or hypotension; all patients
recovered. There is a wide interindividual variation in sensitivity to one single high dose of bisoprolol and
patients with heart failure are probably very sensitive. Therefore it is mandatory to initiate the treatment of
these patients with a gradual uptitration according to the scheme given in section 3.2 Posology and Method
of Administration.

Management
If overdose occurs, bisoprolol treatment should be stopped and supportive and symptomatic treatment
should be provided. Limited data suggest that bisoprolol is hardly dialysable. Based on the expected
pharmacologic actions and recommendations for other beta-bockers, the following general measures
should be considered when clinically warranted.

Bradycardia: Administer intravenous atropine. If response is inadequate, isoprenaline or another agent with
positive chronotropic properties may be given cautiously. Under some circumstances, transvenous
pacemaker insertion may be necessary.

Hypotension: Intravenous fluids and vasopressors should be administered. Intravenous glucagon may be
useful.
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AV block (second or third degree): Patients should be carefully monitored and treated with Isoprenaline
infusion or transvenous cardiac pacemaker insertion.

Acute worsening of heart failure: Administer i.v. diuretics, inotropic agents, vasodilating agents.

Bronchospasm: Administer bronchodilator therapy such as isoprenaline, beta2-sympathomimetic drugs

and/or Aminophylline.

Hypoglycaemia: administer i.v. glucose.

4. PHARMACOLOGICAL PROPERTIES
4.1 Pharmacodynamic Properties
Pharmacotherapeutic group : Beta blocking agents, selective. ATC Code : C07AB07

Mechanism of action
Bisoprolol is a highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and relevant
membrane stabilising activity. It only shows low affinity to the beta2-receptor of the smooth muscles of
bronchi and vessels as well as to the beta2-receptors concerned with metabolic regulation. Therefore,
Bisoprolol is generally not to be expected to influence the airway resistance and beta2- mediated metabolic
effects. Its beta1-selectivity extends beyond the therapeutic dose range.

In acute administration in patients with coronary heart disease without chronic heart failure Bisoprolol
reduces the heart rate and stroke volume and thus the cardiac output and oxygen consumption. In chronic
administration the initially elevated peripheral resistance decreases.

Clinical efficacy and safety

In total 2647 patients with chronic heart failure were included in the CIBIS II trial. 83% (n = 2202) were in
NYHA class III and 17% (n = 445) were in NYHA class IV. They had stable symptomatic systolic heart
failure (ejection fraction <35%, based on echocardiography). Total mortality was reduced from 17.3% to
11.8% (relative reduction 34%). A decrease in sudden death (3.6% vs 6.3%, relative reduction 44%) and a
reduced number of heart failure episodes requiring hospital admission (12% vs 17.6%, relative reduction
36%) was observed. Finally, a significant improvement of the functional status according to NYHA
classification has been shown. During the initiation and titration of Bisoprolol hospital admission due to
bradycardia (0.53%), hypotension (0.23%), and acute decompensation (4.97%) were observed, but they
were not more frequent than in the placebo-group (0%, 0.3% and 6.74%). The numbers of fatal and
disabling strokes during the total study period were 20 in the Bisoprolol group and 15 in the placebo group.

The CIBIS III trial investigated 1010 patients aged ≥65 years with mild to moderate chronic heart failure
(CHF; NYHA class II or III) and left ventricular ejection fraction ≤35%, who had not been treated previously
with ACE inhibitors, beta-blockers, or angiotensin receptor blockers. Patients were treated with a
combination of bisoprolol and enalapril for 6 to 24 months after an initial 6 months treatment with either
Bisoprolol or Enalapril.

There was a trend toward higher frequency of chronic heart failure worsening when Bisoprolol was used as
the initial 6 months treatment. Non inferiority of Bisoprolol-first versus enalapril-first treatment was not
proven in the per-protocol analysis, although the two strategies for initiation of CHF treatment showed a
similar rate of the primary combined endpoint death and hospitalization at study end (32.4% in the
Bisoprolol-first group vs. 33.1 % in the Enalapril-first group, per-protocol population). The study shows that
Bisoprolol can also be used in elderly chronic heart failure patients with mild to moderate disease.

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Bisoprolol is also used for the treatment of hypertension and angina.

4.2 Pharmacokinetic Properties

Absorption
Bisoprolol is absorbed and has a biological availability of about 90% after oral administration.

Distribution
The plasma protein binding of bisoprolol is about 30%. The distribution volume is 3.5 L/kg. Total clearance
is approximately 15 L/h. The half-life in plasma of 10-12 hours gives a 24 hour effect after dosing once
daily.

Metabolism and elimination

Bisoprolol is excreted from the body by two routes. 50% is metabolised by the liver to inactive metabolites
which are then excreted by the kidneys. The remaining 50% is excreted by the kidneys in an unmetabolised
form. Since the elimination takes place in the kidneys and the liver to the same extent a dosage adjustment
is not required for patients with impaired liver function or renal insufficiency. The pharmacokinetics in
patients with stable chronic heart failure and with impaired liver or renal function has not been studied.

Linearity
The kinetics of Bisoprolol are linear and independent of age.

Special population
Since the elimination takes place in the kidneys and the liver to the same extent a dosage adjustment is
not required for patients with mild to moderate impaired liver function or renal insufficiency. The
pharmacokinetics in patients with stable chronic heart failure and with impaired liver or renal function has
not been studied. In patients with chronic heart failure (NYHA stage III) the plasma levels of Bisoprolol are
higher and half-life is prolonged compared to healthy volunteers. Maximum plasma concentration at steady
state is 64±21 ng/mL at a daily dose of 10 mg and the half-life is 17±5 hours.

4.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated
dose toxicity, genotoxicity/mutagenicity or carcinogenicity. Like other beta-blockers, Bisoprolol caused
maternal (decreased food intake and decreased body weight) and embryo/fetal toxicity (increased
incidence of resorptions, reduced birth weight of the offspring, retarded physical development) at high doses
but was not teratogenic.

5. PHARMACEUTICAL PARTICULARS
5.1 List of Excipients
Concor 1.25 mg: Calcium hydrogen phosphate anhydrous, Corn starch, Pregelatinized maize starch,
Colloidal silicon dioxide, Microcrystalline cellulose pH 101, Crosspovidone, Magnesium stearate,
Hydroxypropyl methyl cellulose 2910, Polyethylene Glycol 400, Dimeticon 100, Titanium Dioxide, Talc fine
powder, Purified water.

Concor 2.5 mg: Calcium hydrogen phosphate anhydrous, Corn starch, Colloidal silicon dioxide,
Microcrystalline cellulose pH 101, Crospovidone, Magnesium stearate, Hydroxypropyl methyl cellulose 615,
Polyethylene Glycol 400, Titanium dioxide, Dimeticon 100, Purified water.

Concor 5 mg: Calcium hydrogen phosphate anhydrous, Corn starch, Colloidal silicon dioxide,
Microcrystalline cellulose pH 101, Crospovidone, Magnesium stearate, Hydroxyproyl methyl cellulose 615,
Polyethylene Glycol 400, Titanium dioxide, Dimeticon 100, Iron Oxide Yellow (Cl No. 77492), Purified water.

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Concor 10 mg: Calcium hydrogen phosphate anhydrous, Corn starch, Colloidal silicon dioxide,
Microcrystalline cellulose pH 101, Crospovidone, Magnesium stearate, Hypermelose 2910, Macrogol 400,
Dimeticon 100, Iron oxide yellow, Iron oxide red, Titanium dioxide, Purified water.

5.2 Shelf-life
The expiry date is indicated on the packaging.

5.3 Storage Condition

Store below 30°C.

5.4 Package Quantities and Registration Number

Concor 1.25 mg Box, 5 blisters @ 10 film-coated tablets Reg. No. DKL1015803817C1
Concor 2.5 mg Box, 10 blisters @ 10 film-coated tablets Reg. No. DKL0215803817B1
Concor 5 mg Box, 10 blisters @ 10 film-coated tablets Reg. No. DKL9115803817A1
Concor 10 mg Box, 3 blisters @ 10 film-coated tablets Reg. No. DKL9115803817B1

HARUS DENGAN RESEP DOKTER

Manufactured by
PT Merck Tbk,
Jakarta, Indonesia

Under licence from

Merck Healthcare KGaA,
Darmstadt, Germany

PI based on CCDS ver 11.0

IP/dw/16 Apr 2020

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