2.5 mg / 573 mg film-coated tablets 
Bendroflumethiazide/potassium chloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Centyl K is and what it is used for 
2. What you need to know before you use Centyl K 
3. How to use Centyl K 
4. Possible side effects 
5. How to store Centyl K 
6. Contents of the packaging and other information 

1. What Centyl K is and what it is used for

Centyl K contains two different types of drugs. One drug is called bendroflumethiazide. It is a diuretic (diuretic). The other drug is called potassium chloride. It is a potassium supplement. The two drugs are active at the same time but in different ways.

Bendroflumethiazide works by removing excess fluid from the body. This means that you will need to urinate more often, which means that you will also lose some of your body’s potassium. Potassium chloride reduces the risk of potassium deficiency.

Centyl K is used:

– To treat edema. Edema means that there is too much fluid in the body. Edema can cause symptoms such as swollen ankles or difficulty breathing.

– To treat high blood pressure ( hypertension ).

– To prevent the formation of kidney stones.

2. What you need to know before using Centyl K

Do not use Centyl K

– if you are allergic to bendroflumethiazide, potassium chloride, or any of the other ingredients of this medicine (listed in section 6)

– if you have severe liver or kidney disease

– if you have gout

– if you have Addison’s disease (a disease affecting the adrenal cortex )

– if you have problems emptying your bladder or if you do not produce urine.

– if you are dehydrated and have a disturbance in the body’s fluid and salt balance (electrolyte imbalance)

– if you have acute gastric ulcer or narrowing of the gastrointestinal tract

Warnings and cautions

Talk to your doctor or pharmacist before using Centyl K

If you have diabetes, treatment with Centyl K may increase your blood glucose levels, so it may be necessary to adjust your diabetes medicine.

If the treatment lasts for a long time, the doctor may need to take blood samples to check the potassium content in the blood, especially in the elderly. If the level is low, any supplements may be needed.

If you are going to have a test for parathyroid function (parathyroid function), tell your doctor that you are using Centyl K.

If you have kidney or liver disease or narrowing of the urinary tract, Centyl K should be used with caution.

If you have low blood pressure, use Centyl K with caution

Centyl K can increase the level of uric acid in the blood and aggravate or accelerate attacks of gout. Centyl K may also accelerate or trigger systemic lupus erythematosus.

If you are being treated with lithium, you should not use Centyl K without careful monitoring of your lithium levels as Centyl K may cause them to increase

If you have impaired heart or kidney function, you should have your doctor check your blood potassium level.

If you experience impaired vision or eye pain, consult a doctor immediately. This may be a symptom of fluid accumulation in the eye (between the choroid and the retina) or an increase in pressure in the eye and may occur within a few hours or weeks after taking Centyl K which may lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at higher risk of developing this.

Treatment should be discontinued if severe nausea, vomiting, or abdominal discomfort occurs, it may be due to ulcers in the gastrointestinal tract.

The tablets should be taken with or after meals and with at least 1 glass of water or other liquid as potassium chloride may cause ulceration of the esophagus, stomach, and intestines.

Other drugs and Centyl K

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

Centyl K can affect or be affected by certain medicines if taken at the same time, eg:

• Some antidepressants. Concomitant treatment with lithium increases the risk of lithium poisoning (weakness, tremors, increased thirst, confusion). Selective serotonin reuptake inhibitors ( SSRIs ) increase the risk of too low sodium levels and tricyclic antidepressants (TCAs) may have an enhanced effect.

• Non-steroidal anti-inflammatory / anti-rheumatic drugs ( NSAIDs ) for pain, inflammation, and fever, may counteract the effects of Centyl K and increase the effects of NSAIDs on the kidneys.

• Medicines for heart problems such as digitalis glycosides and antiarrhythmics. Concomitant use can cause digitalis poisoning (nausea, vomiting, and irregular heartbeat) or cause disturbance of the body’s salt balance (electrolyte imbalance) and thus the heart.

• Muscle relaxants, the effect of which may increase with concomitant use

• Asthma medicines (Beta-2-adrenergic agonists ) may increase the risk of too low potassium levels

• The effect of antihypertensive agents can be enhanced

• Medicines that increase potassium levels (potassium-sparing diuretics, ACE inhibitors, and angiotensin II antagonists ) increase the risk of excessive potassium levels.

• Medicine for diabetes. The effects of antidiabetics can be detrimental.

• Calcium and drugs that increase the levels of calcium. Concomitant use may lead to elevated calcium levels in the blood

• Medicines that can make your skin sensitive to light

Cholesterol-lowering agent (cholestyramine). These can reduce the uptake of Centyl K and the medicines should be taken several hours apart

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is a risk that the fetus is affected. Centyl K should not be used during pregnancy unless clearly necessary and never without a doctor’s prescription.

Breast-feeding

If you are breast-feeding, you should not use Centyl K. Bendroflumethiazide passes into breast milk and may also inhibit milk production.

Driving and using machines

Temporary dizziness may occur during blood pressure treatment and this should be taken into account when driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Centyl K

Always use this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor who adapts it specifically for you.

The tablets should be swallowed whole with at least 1 full glass of water at mealtime.

The tablets contain a core that is excreted in the feces.

If you forget to take Centyl K

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

Centyl K can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

The following side effects have also been reported:

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

  • Too low potassium in the blood. Elevated uric acid levels may cause gout problems.
  • Headache, dizziness, fatigue.
  • Skin rash (rash, hives, and eczema ).
  • Disorders of the gastrointestinal tract. Nausea, dry mouth, and thirst.
  • Joint pain, muscle pain.
  • Flu-like symptoms (including cough and runny nose).

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

  • Dehydration, disturbances in the acid-base balance. Decreased levels of chlorine, sodium, calcium, and magnesium in the blood. Overproduction of parathyroid hormone, diabetes
  • Fainting, difficulty coordinating movements, numbness, inability to feel the taste, depression, confusion, sleep disturbances. Visual disturbance and blurred vision.
  • Hypersensitivity to sunlight, itching, increased sweating.
  • Taste, weight gain, diarrhea, vomiting, constipation, abdominal pain, and discomfort.
  • Muscle spasms and twitches
  • Impaired renal function, increased urine output, and need to urinate at night, increased creatinine in the urine, swelling.
  • Palpitations, low blood pressure , hemorrhage, peripheral cold, and impotence.
  • Shortness of breath, shortness of breath, and wheezing.

Has been reported (occurs in an unknown number of users):

  • Elevated levels of calcium in the blood.
  • Decreased vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Centyl K

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

Do not store above 30 ° C. Close the jar tightly. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

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

6. Contents of the packaging and other information

Content declaration

– The active substances are bendroflumethiazide and potassium chloride. One tablet contains 2.5 mg bendroflumethiazide and 573 mg of potassium chloride.

The other ingredients are ethylcellulose, stearyl alcohol, magnesium stearate, glycerol, talc, hypromellose, polysorbate 20, citric acid monohydrate, saccharin sodium, titanium dioxide (dye E 171), quinoline yellow (dye E 104), patent blue (dye E 131).

What the medicine looks like and the contents of the pack

Green, oval, film-coated tablet.

Pack sizes of 30, 100, and 250 film-coated tablets in a jar whose lid has a built-in desiccant.

Not all pack sizes may be marketed.

medinfo@karopharma.com

Manufacturer

Paramedical A / S

Vassingerødvej 3-7

3540 Lynge

Denmark

Muhammad Nadeem

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