Sparkal and Sparkal Mite – Amiloride hydrochloride and hydrochlorothiazide uses, dose and side effects


5 mg/50 mg and 2.5 mg/25 mg tablets
amiloride hydrochloride and hydrochlorothiazide

What Sparkal/Sparkal Mite is and what it is used for

Sparkal/Sparkal Mite is used for the treatment of high blood pressure, edema (fluid accumulation in the tissues ) due to heart failure, and cirrhosis with fluid in the abdominal cavity.

The two active substances in Sparkal/Sparkal Mite are diuretic and blood pressure lowering. Amiloride hydrochloride is also potassium- and magnesium-sparing and counteracts the losses of potassium and magnesium that can be caused by diuretics.

Amiloride hydrochloride and hydrochlorothiazide found in Sparkal/Sparkal Mite may also be approved to treat 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 using Sparkal/Sparkal Mite

Do not use Sparkal/Sparkal Mite:

  • If you are allergic to amiloride hydrochloride and hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
  • if you are hypersensitive to ingredients or chemically related agents, e.g. certain other diuretics or sulfa drugs.
  • If you have severely impaired kidney or liver function.
  • If you have high levels of potassium in your blood.
  • If you use other potassium-sparing agents or potassium supplements.
  • If you have decreased or stopped passing urine.
  • If you have gout.

Warnings and precautions

Talk to your doctor or pharmacist before using Sparkal/Sparkal Mite:

  • if you have reduced kidney or liver function.
  • if you are older, you may then be extra sensitive to disturbances in the salt balance in the blood
  • if you have diabetes, this may be worsened by the treatment, and an adjustment of the dose of one of your diabetes medicines may be needed.
  • if you have high levels of uric acid, cholesterol, or triglycerides (a type of cholesterol ) in your blood.
  • if you have systemic lupus erythematosus (an autoimmune disease), this may be worsened by the treatment.
  • if you have had skin cancer or if you get an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while using Sparkal/Sparkal Mite.
  • if you have previously had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or severe breathing problems after taking Sparkal/Sparkal Mite, seek medical attention immediately.

If you experience impaired vision or eye pain, contact a doctor. These may be symptoms of fluid accumulation in the eye (between the choroid and sclera) or an increase in pressure in the eye and may occur within hours to weeks of taking Sparkal/Sparkal Mite. This can lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at a higher risk of developing this. 

Other medicines and Sparkal/Sparkal Mite

Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.

The doctor needs to know if you are being treated with:

  • Potassium-sparing agents or potassium supplements.
  • Digitalis and sotalol (heart medicine).
  • Cholestyramine and colestipol, are used against high cholesterol levels (hyperlipidemia).
  • Lithium (anti-mania/depression) or certain sedative medications.
  • ACE inhibitors (blood pressure lowering).
  • Non-steroidal anti-inflammatory drugs ( NSAIDs ) (certain pain/inflammation agents).
  • Barbiturates, are used for sleep problems or anxiety.
  • Insulin and diabetes drugs.
  • Steroids, are used to treat many different conditions, such as rheumatism, arthritis, allergies , skin problems, asthma, and a certain type of blood disorder.
  • ACTH, is used to test the function of the adrenal glands.
  • Medicines are injected for allergic reactions, for example, adrenaline (also called epinephrine ).

Sparkal/Sparkal Mite with food, drink, and alcohol

Your doctor may have asked you to change your diet slightly and not to eat certain foods that contain a lot of potassium. Your doctor can tell you what you should not eat. If you are unsure about which foods you should avoid, consult your doctor before taking Sparkal/Sparkal Mite.

Your doctor may have asked you to minimize your alcohol intake while taking Sparkal/Sparkal Mite. Alcohol can increase the effect of Sparkal/Sparkal Mite, which may make you feel dizzy when you stand up quickly.

Pregnancy, breastfeeding, and fertility

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


Usually, your doctor will suggest that you take another medicine instead of Sparkal/Sparkal Mite because Sparkal/Sparkal Mite is not recommended during pregnancy. This is because Sparkal/Sparkal Mite passes to the fetus and can cause harm to the fetus and the newborn if used during the last 6 months of pregnancy.


Tell your doctor if you are breastfeeding or intend to start breastfeeding. Sparkal/Sparkal Mite is not recommended during breastfeeding.

Driving ability and use of machinery

If you experience side effects such as dizziness, fatigue, and weakness, do not drive or use machinery.

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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

Sparkal/Sparkal Mite contains lactose and wheat starch

If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.

This medicine contains only very low levels of gluten (from wheat starch). It is very unlikely to cause problems if you have gluten intolerance ( celiac disease ).

One Sparkal tablet contains no more than 8.3 micrograms of gluten and one Sparkal Mite tablet contains no more than 4.2 micrograms of gluten.

If you are allergic to wheat (a disease other than gluten intolerance) you should not use this medicine.

How to use Sparkal/Sparkal Mite

Sparkal/Sparkal Mite

Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

High blood pressure: Usual dose is 1 tablet of Sparkal Mite daily.

Edema in heart failure: Usual starting dose is 1 tablet of Sparkal daily (equivalent to 2 tablets of Sparkal Mite ). The dose for long-term treatment depends on how you respond to the treatment and is determined by the doctor.

Edema in cirrhosis of the liver: Usual starting dose is 1 tablet of Sparkal (equivalent to 2 tablets of Sparkal Mite ) daily. The dose for long-term treatment depends on how you respond to the treatment and is determined by the doctor.

If you have used too much Sparkal/Sparkal Mite

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, or hospital for an assessment of the risk and advice.

If you forget to use Sparkal/Sparkal Mite

Do not take a double dose to make up for a missed tablet. Return to a regular schedule as soon as possible.

If you stop using Sparkal/Sparkal Mite

Do not stop taking Sparkal/Sparkal Mite without talking to your doctor.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible side effects

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

Serious side effects, contact the doctor immediately if you experience any of the following symptoms:

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

  • Hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure
  • Sparkal/Sparkal Mite 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 a greatly worsened general condition or fever with local symptoms of infection such as sore throat/pharynx/mouth or vomiting, you should see a doctor as soon as possible so that a lack of white blood cells ( agranulocytosis ) can be ruled out via a blood test. It is important that you then information about your medication.

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

  • Acute respiratory distress syndrome (signs of this are severe shortness of breath, fever, weakness, and confusion).

Other side effects:

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

Weakness, fatigue, loss of appetite, dizziness, headache, effect on heart rhythm, nausea, diarrhea, abdominal pain, skin rash (exanthema), itching, shortness of breath, increased blood sugar levels, increased amount of uric acid in the blood, pain in legs and arms.

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

Joint pain, chest and back pain, impotence, dizziness due to a drop in blood pressure when standing up quickly, palpitations, chest pain, “and crawling”, gastrointestinal disturbances such as bad taste in the mouth, vomiting, feeling full, constipation and flatulence, hiccups, thirst, stomach ache, nasal congestion, gout. Nausea, malaise, muscle weakness, and confusion due to low sodium levels in the blood. General weakness, dizziness, and fainting due to lack of fluids, and dehydration ( dehydration ). Muscle cramps, sleep disturbances, nervousness, depression, mental confusion, urination problems, and visual disturbances.

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

Fainting, anemia and other blood changes, reduced level of alertness, gastrointestinal bleeding, redness, hypersensitivity to sunlight, vessel wall inflammation, jaundice (cholestasis), cough, and impaired kidney function. Muscle weakness, confusion, and difficulty speaking due to high potassium levels in the blood.

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

Skin and lip cancer (Non- melanoma skin cancer). Decreased vision or pain in the eyes due to high pressure (possible sign of fluid accumulation in the eye (between the choroid and sclera) or acute narrow-angle glaucoma ).

How to store Sparkal/Sparkal Mite

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

Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substances areSparkal: 5 mg (amiloride hydrochloride) + 50 mg ( hydrochlorothiazide )Sparkal Mite: 2.5 mg (amiloride hydrochloride) + 25 mg ( hydrochlorothiazide ).
  • Other ingredients/excipient(s) are lactose monohydrate, magnesium stearate, gelatin, talc, and wheat starch.

Appearance and package sizes of the medicine

  • Sparkal: A pale yellow, round, flat scored tablet, coded EV 7 on one side and GEA on the other. Diameter: 8.5 mm.
  • Sparkal Mite: A pale yellow, round, flat scored tablet, coded EZ 3 on one side and GEA on the other. Diameter: 7 mm.

Polyethylene tablet container

Cans of 30, 100, and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Hexal A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

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