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LEO Pharma

Cashel Road, Dublin 12,
Telephone: +353 1 490 8924
WWW: http://www.leo-pharma.ie
Medical Information Direct Line: +353 1 4908924
Medical Information e-mail: medical-info.ie@leo-pharma.com
Medical Information Facsimile: +353 1 708 2089


Summary of Product Characteristics last updated on medicines.ie: 02/08/2013
SPC Low Centyl K



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1. NAME OF THE MEDICINAL PRODUCT

Low Centyl® K 1.25 mg/573 mg modified-release tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 1.25 mg of bendroflumethiazide and 573 mg of potassium chloride.

For a full list of excipients see section 6.1.


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3. PHARMACEUTICAL FORM

Modified release tablet.

Light yellow film-coated oval shaped modified release coated tablet.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Indications for use:

In the management of hypertension alone or in combination with other antihypertensives.


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4.2 Posology and method of administration

For oral administration.

Adults: Hypertension: 1 tablet daily.


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4.3 Contraindications

• Known hypersensitivity to the active substance or any of the excipients.

• Severe electrolyte imbalance including hypercalcaemia, hyperchloraemia, hyponatraemia, hypokalaemia, hyperkalaemia or any situation which might lead to hyperkalaemia.

• Severe renal impairment.

• Severe hepatic impairment.

• Addison's disease.

• Established gout

• Ulcer or obstruction of the gastrointestinal tract.

• As with other diuretics, Low Centyl® K should not be administered concurrently to patients taking lithium.


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4.4 Special warnings and precautions for use

Thiazide diuretics should be used with caution in patients with renal or hepatic impairment and in patients with potential obstruction of the urinary tract.

Consideration should be given to fluid and electrolyte status to avoid inadequate potassium supplementation or excessive loss of fluid, especially in elderly patients.

Potassium chloride may induce ulceration in the gastrointestinal tract in particular the small bowel. Potassium chloride should be administered with caution to patients in whom passage through the gastro-intestinal tract may be delayed. Treatment should be discontinued if severe nausea, vomiting, or abdominal distress develops.

Potassium chloride should be administered with considerable care to patients with cardiac disease or conditions predisposing to hyperkalaemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns. Serum potassium should be monitored in patients with cardiac or renal impairment. The tablets must be taken with at least ½ glass of fluid.

Thiazides may provoke hyperglycaemia and glycosuria in diabetic and other susceptible patients. In case of reduced glucose tolerance, adjustment of anti-diabetic medicines may be necessary.

Thiazides may cause hyperuricaemia and precipitate or aggravate attacks of gout.

Bendroflumethiazide may cause exacerbation or activating of systemic lupus erythematous.

Bendroflumethiazide found in urine by doping test is cause for disqualification of athletes.


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4.5 Interaction with other medicinal products and other forms of interaction

Due to the content of potassium chloride, concomitant treatment with potassium-sparing diuretics or Angiotensin Converting Enzyme (ACE) inhibitors increases the risk of hyperkalaemia.

Bendroflumethiazide may potentiate the effect of antihypertensive agents and drugs inducing postural hypotension e.g. tricyclic antidepressants.

Bendroflumethiazide may impair control by hypoglycaemic agents in cases of diabetes mellitus (see section 4.4).

Non-steroidal anti-inflammatory drugs (NSAID) inhibit the effect of bendroflumethiazide.

Bendroflumethiazide reduces lithium clearance resulting in high serum levels of lithium, therefore concomitant therapy should be avoided and if used requires close monitoring of serum lithium levels

Probenecid inhibits the renal tubular secretion of bendroflumethiazide leading to a diminished natriuresis.

Cholestyramine and similar drugs reduces the absorption of thiazides.

Co-administration of bendroflumethiazide and other drugs known to cause photosensitivity reactions may increase the severity of these reactions.

Hypokalaemia (which may be induced by bendroflumethiazide) increases the sensitivity to digitalis glycosides and non-depolarising neuromuscular blocking agents.

The urinary excretion of calcium is reduced.


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4.6 Pregnancy and lactation

There are no adequate data from the use of bendroflumethiazide with potassium chloride in pregnant women.

Animal studies are insufficient with respect to effects on pregnancy. The potential risk for humans is unknown. Bendroflumethiazide should not be used during pregnancy unless clearly necessary.

Diuretics are excreted in breast milk and should not be used during lactation.


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4.7 Effects on ability to drive and use machines

Bendroflumethiazide with potassium chloride has no or negligible influence on the ability to drive and use machines.


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4.8 Undesirable effects

Very common >1/10

Common >1/100 and <1/10

Uncommon >1/1,000 and <1/100

Rare >1/10,000 and <1/1,000

Very rare <1/10,000

The most frequently reported undesirable effects are headache, dizziness, fatigue, gastrointestinal symptoms including nausea, and postural hypotension/orthostatic reactions. Electrolyte disturbances can occur especially during long term treatment.

Thiazide diuretics may cause a number of metabolic disturbances including reduced glucose tolerance and hyperuricaemia. Muscle cramps, various skin reactions and erectile dysfunction are less frequent.

Based on clinical trial data for Centyl® K, 16% of the patients can be expected to experience an undesirable effect, mainly non-serious and dose-dependent.

Based on post-marketing data for both Centyl® and Centyl® K, the total 'reporting rate' of undesirable effects is very rare being approximately 2:100,000 treatment months.

Renal failure and abnormal hepatic function have been reported in post-marketing safety surveillance.

The undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

Blood and the lymphatic system disorders

Frequency unknown*:

Thrombocytopenia

Granulocytopenia

Endocrine disorders

Uncommon:

Hyperparathyroidism

Metabolism and nutrition disorders**

Very common:

Hypomagnesaemia

Hypokalaemia

Uncommon:

Hyperuricaemia

Gout

Increased creatinine

Rare:

Glucose metabolism disorders

Frequency unknown:

Hyponatraemia

Dehydration

Hyperkalaemia

Metabolic alkalosis

Hypochloraemia

Hypocalcaemia

Psychiatric disorders

Uncommon:

Depression

Sleep disturbance

Nervous system disorders

Common:

Headache

Dizziness

Uncommon:

Vertigo

Rare:

Syncope

Dysgeusia

Ataxia

Disorientation

Eye disorders

Uncommon:

Eye irritation

Rare:

Blurred vision

Cardiac disorders

Uncommon:

Palpitations

Cardiovascular disturbance

Vascular disorders

Common:

Orthostatic reactions

Hypotension or postural hypotension

Uncommon:

Flushing

Cold extremities

Rare:

Vasodilation

Frequency unknown:

Vasculitis

Respiratory, thoracic and mediastinal disorders

Uncommon:

Respiratory disorder

Cough

Dyspnoea

Gastrointestinal disorders

Common:

Nausea

Gastrointestinal disturbance

Dry mouth

Constipation

Uncommon:

Diarrhoea

Abdominal pain

Flatulence

Vomiting

Frequency unknown:

Gastric irritation

Skin and subcutaneous tissue disorders

Uncommon:

Skin disorders

Rash

Pruritus

Sweating

Urticaria

Rare:

Face oedema

Frequency unknown:

Photosensitivity reactions

Musculoskeletal, connective tissue and bone disorders

Uncommon:

Arthralgia

Muscle cramp

Pain in the extremities

Not known:

Myalgia

Renal and urinary disorders

Uncommon:

Polyuria

Rare:

Bladder tension

Reproductive system and breast disorders

Common:

Erectile dysfunction

General disorders and administration site conditions

Common:

Fatigue/asthenia

Uncommon:

Pain

Flu-like symptoms

Oedema

Weakness

Thirst

Rare:

Paraesthesia

Investigations

Uncommon:

Sputum increased

* Not known: cannot be estimated from the available data

** The table includes data on bendroflumethiazide products both with and without potassium. The frequency of hypokalaemia can be expected to be lower in patients receiving Centyl K® .

Centyl® and Centyl K® have been extensively used in the elderly and no safety information was specifically observed for the elderly.


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4.9 Overdose

In high doses thiazide diuretics may cause electrolyte imbalance, dehydration and polyuria.

Symptoms of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, gastrointestinal disturbances, restlessness, muscle pain and cramps, and seizures.

Treatment is adjustment of the fluid and electrolyte imbalance.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

ATC code: C03A B01

Low Centyl® K is a combination of a thiazide diuretic with a potassium supplement. Bendroflumethiazide acts on both determinants of hypertension i.e. cardiac output and peripheral resistance.

Cardiac output is reduced due to a decrease in blood volume resulting from the diuretic effect. Peripheral resistance is reduced by a vasodilating effect, the mechanism of which is not completely understood. In oedematous conditions, the diuretic action reduces extravascular fluid volume.

Some degree of potassium depletion may be associated with prolonged thiazide therapy. A potassium supplement is therefore included in Low Centyl® K to help counteract this. Because of the reported dangers of localised high concentrations of potassium salts in the small bowel, the potassium chloride in Low Centyl® K is formulated in an inert wax core from which it is gradually released over several hours. The bendroflumethiazide is contained in a coat which surrounds the central core.


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5.2 Pharmacokinetic properties

Bendroflumethiazide is well absorbed from the gastrointestinal tract after oral administration and the absorption is not affected by food. Plasma protein binding, as with most thiazides, is high. The plasma half-life averaged 3.9 hours after a 5 mg dose. There is evidence that bendroflumethiazide is fairly extensively metabolised; about 30% is excreted unchanged in the urine.


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5.3 Preclinical safety data

No additional data.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Core:

ethyl cellulose

glycerol

stearyl alcohol

magnesium stearate

Film Coating:

glycerol

hypromellose 15 cps

hypromellose 3 cps

citric acid monohydrate

saccharin sodium

talc

titanium dioxide (E171)

polysorbate 20

quinoline yellow lake (E104)


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 Years.


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6.4 Special precautions for storage

Do not store above 30°C.

Keep the bottle tightly closed as the product is sensitive to moisture.


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6.5 Nature and contents of container

Amber glass bottles with polypropylene screw cap and a desiccant (silica) containing 25, 30, 100 or 250 modified-release tablets.

Or

High-density polypropylene (HDPE) bottle with a polypropylene (PP) tamper-evident closure with an integrated silica gel desiccant. Pack sizes of 25, 30, 100 or 250 modified-release tablets.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measure will help to protect the environment.


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7. MARKETING AUTHORISATION HOLDER

LEO Laboratories Limited, Cashel Road, Dublin 12.


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8. MARKETING AUTHORISATION NUMBER(S)

PA 46/19/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14 November 1997

Date of last renewal: 14 November 2007


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10. DATE OF REVISION OF THE TEXT

July 2013


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LEGAL CATEGORY

Product subject to prescription which may be renewed.



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Active Ingredients

 
   Potassium Chloride
   Bendroflumethiazide