2, 5 mg and 5 mg tablet 
bendroflumethiazide

Read all of this leaflet carefully before you start taking 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 includes any possible side effects not listed in this leaflet. See section 4.

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

What Bendroflumethiazide Evolan is and what it is used for

This medicine is a diuretic (diuretic) and belongs to the group of thiazide diuretics. It acts on the kidneys and stimulates urine production.

Bendroflumethiazide Evolan can be used to treat edema (swelling) associated with kidney, liver or heart problems and for hypertension (high blood pressure ).

Bendroflumethiazide contained in Bendroflumethiazide Evolan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Bendroflumethiazide Evolan

Do not use Bendroflumethiazide Evolan

– if you are allergic (hypersensitive) to bendroflumethiazide or any of the other ingredients of Bendroflumethiazide Evolan (listed in section 6).

– if you have low levels of potassium in your blood ( hypokalaemia )

– if you have low levels of sodium in your blood ( hyponatremia )

– if you have impaired kidney or liver function

– if you have high levels of uric acid in your blood ( symptomatic hyperuricaemia)

– if you have Addison’s disease (a disease characterized by insufficient production of cortisone in the adrenal glands).

Warnings and cautions

Talk to your doctor or pharmacist before taking Bendroflumethiazide Evolan:

– if you have impaired kidney or liver function.

– if you have lupus erythematosus (a chronic disease that destroys the body’s own cells and causes inflammatory processes in different parts of the body).

– if you get a skin reaction due to exposure to sunlight during treatment; it is recommended that treatment be discontinued, but if treatment with diuretics ( diuretics ) is considered necessary, exposed skin areas should be protected from sunlight and artificial UVA radiation.

– if you are older and are taking or will be taking Bendroflumethiazide Evolan for a long time; you should be examined regularly.

– if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within a few hours to weeks after taking Bendroflumethiazide Evolan. This can 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.

Other medicines and Bendroflumethiazide Evolan

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

There are certain drugs that can alter the effect of Bendroflumethiazide Evolan or that can have their own effect altered by Bendroflumethiazide Evolan.

If you are taking Bendroflumethiazide Evolan with:

Digitalis glycosides: The effect of these medicines may be due to the hypokalaemic effect (decrease in blood potassium levels).

– Lithium: Lithium concentrations may increase with the use of Bendroflumethiazide Evolan or any other thiazide diuretic.

– Non-steroidal anti-inflammatory drugs: These drugs can inhibit the diuretic and antihypertensive effects of Bendroflumethiazide Evolan. A combination of these drugs may increase the risk of nephrotoxicity (impaired renal function).

– Xanthines, beta-agonists, ACTHs, corticosteroids , acetazolamide and carbenoxolone: ​​Taking Bendroflumethiazide Evolan with these medicines may reduce blood potassium levels.

– Tubocurarine (and other non-depolarizing muscle relaxants): Like all other thiazide diuretics, Bendroflumethiazide Evolan may enhance the blocking of nerve signals in the muscles.

– Thiazides , monoamine oxidase inhibitors (MAOIs), baclofen, tizanidine and prazosin (postsynaptic alpha-blockers ): Concomitant use of these drugs with Bendroflumethiazide Evolan may lower blood pressure.

– Barbiturates you or opioid you and tricyclic antidepressants: If these drugs and Bendroflumethiazide Evolan be simultaneously postural hypotension may occur (blood pressure when standing up).

– Carbamazepine and amphotericin: If you take these medicines in combination with Bendroflumethiazide Evolan, there is an increased risk that your blood sodium levels will drop.

– Calcium salts or vitamin D preparations: The risk of hypercalcaemia (abnormally high levels of calcium in the blood) increases if you take these products with Bendroflumethiazine Evolan.

– Cisplatin: There may be an increased risk of nephrotoxicity (renal impairment) and ototoxicity (ear problems) if you take this medicine while taking Bendroflumethiazide Evolan.

– Disopyramide , amiodarone , flecainide and quinidine: Cardiac toxicity due to these drugs increases if hypokalaemia occurs (low levels of potassium in the blood).

– Lidocaine and mexiletine: The effect of these drugs is blocked if the potassium levels in the blood fall.

– Aminoglutethimide: There is an increased risk of hyponatremia (low levels of sodium in the blood).

– Toremifene and reboxetine: May increase the risk of hypercalcaemia (high levels of calcium in the blood).

– Cholestipol and cholestyramine: These medicines may reduce the uptake of thiazide diuretics. They should therefore be given 2 hours before or 2 hours after taking Bendroflumethiazide Evolan.

– Calcium channel blocker and moxisy lyte: May increase the blood pressure lowering effect (drop in blood pressure).

– Estrogen er and birth control pills of combination type: Can counteract the diuretic effect of thiazides like Bendroflumethiazine Evolan.

– Pimozide, thioridazine or terfenadine: In case of hypokalaemia (low potassium levels in the blood) there is an increased risk of irregular heartbeat.

Bendroflumethiazide Evolan with food, drink and alcohol

Do not drink alcohol while you are being treated with Bendroflumethiazide Evolan, as it may cause postural hypotension (drop in blood pressure when you get up).

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

When treating edema (swelling) and hypertension (high blood pressure ) during pregnancy, diuretics should be avoided. These medicines can cause decreased blood flow through the placenta, disturbed salt balance in the fetus and other reactions. Thrombocytopenia in neonates (decreased platelet count in the blood) and jaundice in fetuses and neonates (yellowing of the skin and mucous membranes) have been reported after the mothers used thiazide diuretics.

Bendroflumethiazide is not recommended during the first three months of pregnancy.

Breast-feeding

Because diuretics pass into breast milk and Bendroflumethiazide Evolan may inhibitmilk production, these agents should be avoided in mothers who wish to breast-feed.

Driving and using machines

No studies on the effects of bendroflumethiazide on the ability to drive and use machines have been performed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Bendroflumethiazide Evolan contains lactose

Bendroflumethiazide Evolan contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Bendroflumethiazide Evolan

Always take Bendroflumethiazide Evolan exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Usual dose is:

Adults

In case of edema , the starting dose is 5-10 mg taken in the morning, every day or every other day. The maintenance dose is 2.5–10 mg 1-3 times a week.

In high blood pressure , 2.5 mg is usually taken in the morning. Higher doses are rarely needed.

Children

At the start of treatment, the dosage for a child may be up to 400 micrograms per kg body weight. Thereafter, the dose is reduced one to one maintenance dose of 50–100 micrograms per kg body weight and day.

Older

Dosage one of thiazide diuretics such as Bendroflumethiazide Evolan may need to be reduced in the elderly, especially in people with impaired renal function, due to the risk of affecting the salinity of the blood.

Symptoms of overdose are eg .: loss of appetite, nausea, vomiting, diarrhea, diuresis (very high urine output), dehydration, low blood pressure , dizziness, weakness, muscle cramps, tingling, tetany (involuntary muscle contractions), bleeding in the stomach / intestine, hyponatraemia (low sodium levels in the blood), hypoglycaemia or hyperglycaemia (too low or too high blood sugar), hypokalaemia(low blood potassium levels) and metabolic alkalosis (high levels of bicarbonate in the blood).

If you forget to use Bendroflumethiazide Evolan

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

If you stop using Bendroflumethiazide Evolan

Note that hypotension (drop in blood pressure when you get up) is common for 3-4 days after you have taken the last dose .

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bendroflumethiazide Evolan can cause side effects, although not everybody gets them.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

All thiazide diuretics can cause some degree of imbalance in the body’s salinity, e.g. low levels of potassium .

Thiazide diuretics may increase uric acid levels in the blood, with concomitant worsening of gout in susceptible patients.

Thiazide diuretics can sometimes reduce carbohydrate tolerance and diabetic patients may need to adjust the dosage one of insulin . Caution is required when administering bendroflumethiazide to persons with a known predisposition to diabetes .

Impotence has been reported. This side effect disappears when treatment with bendroflumethiazide is stopped.

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 ) have been reported with the use of thiazide diuretics or thiazide-like diuretics .

The following side effects , listed based on the organ system in the body affected, have been previously associated with bendroflumethiazide:

Specific frequencies for the occurrence of these side effects are not available.

Blood and lymphatic system:

Agranulocytosis (low levels of blood cells in the blood, especially white blood cells , so-called granulocytes ), aplastic anemia (low levels of red blood cells in the blood due to changes in bone marrow ), neutropenia , thrombocytopenia (low levels of platelets in the blood) ( thrombocytopenia has been reported in neonates when the mother received bendroflumethiazide in late pregnancy).

Immune system:

Hypersensitivity reaction .

Metabolism and nutrition disorders:

Gout , hyperglycemia (high blood sugar levels).

Heart / Vessel:

Postural hypotension (drop in blood pressure when getting up).

Respiratory tract:

Pneumonia , fluid in the lungs.

Gastrointestinal tract:

Mild symptoms have been reported, pancreatitis ( inflammation of the pancreas).

Liver and biliary tract:

Intrahepatic cholestasis (impaired or blocked bile flow in the liver).

Skin and subcutaneous tissue disorders:

Rash, photosensitivity (sensitivity to sunlight), severe skin reactions have also been reported.

Reproductive system and mammary glands:

Impotence .

Surveys:

Hypokalaemia (low potassium levels in the blood), hypomagnesaemia (low magnesium levels in the blood), hyponatraemia (low sodium levels in the blood), hypercalcaemia (high calcium levels in the blood), hypochloremia (low chloride levels in the blood), alkalosis (low levels of the body) high levels of uric acid in the blood), altered levels of fat in the blood.

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 Bendroflumethiazide Evolan

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

Store in the original package and at a maximum of 25 ° C.

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

Do not use Bendroflumethiazide Evolan if you notice any signs of damage to the package or tablets.

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 substance is bendroflumethiazide.

The other ingredients are: lactose , pregelatinized corn starch, talc and stearic acid.

What the medicine looks like and the contents of the pack

2.5 mg: white or off-white, circular and curved tablet (5.5 mm).

5 mg: white or almost white, circular tablet with a flat beveled edge and embossed with “5” on one side of the tablet (7 mm).

PVDC / PVC / Alu blister packs containing 14, 28, 56 or 98 tablets and plastic jars of 100 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Manufacturer:

Sofarimex – Chemical and Pharmaceutical Industry, SA

Alto do Colaride

2735-213 Cacém

Portugal

or

Evolan Pharma AB

Box 120

182 12 Danderyd

Muhammad Nadeem

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