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

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 can harm them, even if they show signs of illness 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 you will find information about: 
1. What Amiloferm / Amiloferm mite is and what it is used for 
2. What you need to know before using Amiloferm / Amiloferm mite 
3. How to use Amiloferm / Amiloferm mite 
4. Possible side effects 
5. How Amiloferm / Amiloferm mite to be stored 
6. Contents of the pack and other information

1. What Amiloferm / Amiloferm mite is and what it is used for

Amiloferm / Amiloferm mite is a diuretic and antihypertensive agent.

The active ingredients are amiloride hydrochloride and hydrochlorothiazide. The two active substances complement each other in that hydrochlorothiazide is diuretic and antihypertensive, while amiloride hydrochloride is potassium and magnesium saving and counteracts the losses of potassium and magnesium caused by diuretics. Amiloride hydrochloride also has a mild diuretic and antihypertensive effect, which enhances these effects of hydrochlorothiazide.

Amiloferm / Amiloferm mite is used to treat high blood pressure or edema (fluid retention) due to heart failure or cirrhosis ( liver cirrhosis ) with fluid retention in the abdominal cavity.

Amiloferm mite tablets are half as strong as Amiloferm tablets.

The diuretic effect begins within 1-2 hours, is greatest after about 4 hours, and lasts about 12 hours.

2. What you need to know before using Amiloferm / Amiloferm mite

Do not use Amiloferm / Amiloferm mite

  • if you are allergic to amiloride hydrochloride, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6), or to certain other diuretics( thiazides ) and certain antibacterial agents ( sulfonamides ),
  • if you use other potassium-sparing agents or potassium supplements,
  • if you have severe kidney or liver function,
  • if you have high levels of potassium in your blood,
  • if you have gout.

Warnings and cautions

Talk to your doctor or pharmacist before using Amiloferm / Amiloferm mite:

  • if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with 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 Amiloferm / Amiloferm mite,
  • if you have impaired kidney or liver function
  • if you have diabetes 
  • if you have lupus erythematosus ( SLE ),
  • 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 hours to weeks after taking Amiloferm / Amiloferm 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 greater risk of developing this.

Amiloferm / Amiloferm mite can in rare cases affect the white blood cells so that the defense of 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.

Before surgery and anesthesia (also applies to the dentist), the doctor/dentist should know that you are being treated with Amiloferm / Amiloferm mite as there is a risk that your blood pressure may drop suddenly.

Alcohol may increase the blood pressure-lowering effect of Amiloferm / Amiloferm mite.

Other medicines and Amiloferm / Amiloferm mite

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important for your doctor to know if you are being treated with so-called ACE inhibitors (antihypertensives), other potassium-sparing agents, or potassium supplements. It is also important for your doctor to know if you are being treated with other antihypertensive or diuretic drugs, insulin and diabetes drugs, certain lipid-lowering drugs (so-called resins), digitalis (heart medicine), cortisone, certain painkillers / anti-inflammatory drugs, lithium (anti-mania drugs) / depression) or certain sedatives.

Pregnancy and breastfeeding

Pregnancy

Contact your doctor if you are pregnant or think you may be pregnant. Your doctor will usually suggest that you take another medicine instead of Amiloferm / Amiloferm mite as Amiloferm / Amiloferm mite is not recommended during pregnancy. This is because Amiloferm / Amiloferm mite passes into the fetus and can cause harm to the fetus and the newborn baby if used during the last 6 months of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Amiloferm / Amiloferm mite is not recommended during breast-feeding.

Driving and using machines

If you experience dizziness or fatigue during treatment with Amiloferm / Amiloferm mite, you should refrain from driving or using machines.

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

Amiloferm / Amiloferm mite contains lactose

Amiloferm and Amiloferm mite contain lactose. 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 Amiloferm / Amiloferm mite

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

High blood pressure: The usual dose is 1 tablet of Amiloferm mite daily.

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

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

The tablets are taken with a little liquid, such as a glass of water.

Do not change the dosage without consulting a doctor.

If you forget to take Amiloferm / Amiloferm mite

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are often due to the diuretic effect of the drug.

Common (affects more than 1 user in 100): Headache, dizziness, weakness, tiredness, loss of appetite. Irregular heartbeat. Nausea, diarrhea, and abdominal pain. Skin rash, itching. Respiratory distress. Elevated blood sugar levels in diabetics, elevated uric acid levels which can cause gout problems. Pain in arms and legs.

Uncommon (affects more than 1 user in 1,000 but less than 1 in 100 users): Impotence. Dizziness when getting up quickly, fast pulse, angina. Ant crawls. Gastrointestinal disorders such as bad taste in the mouth, vomiting, satiety, constipation, flatulence, hiccups, thirst (due to decreased fluid in the body), acid regurgitation. Nasal congestion. Gout, disorders of the salt balance ( sodium, potassium ). Muscle cramps, joint pain, chest, and back pain. Sleep disturbances, nervousness, depression, confusion. Urination problems. Visual disturbances.

Rare (affects less than 1 user in 1,000): Cough. Sweating, fainting, hypersensitivity reactions of varying degrees of difficulty. Bruising (abnormally mild), anemia, and other blood changes (eg agranulocytosis, see also Take special care with Amiloferm / Amiloferm mite ). Reduced alertness. Gastrointestinal bleeding. Skin redness, hypersensitivity to sunlight, vascular wall inflammation. Jaundice. Impaired renal function.

Has been reported (occurs 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 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 Amiloferm / Amiloferm mite

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton after “Ed. date .: ”. 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 amiloride hydrochloride and hydrochlorothiazide.
  • Amiloferm: 
    Each tablet contains 5 mg of amiloride hydrochloride and 50 mg of hydrochlorothiazide . 
    The other ingredients are lactose monohydrate (92.4 mg), maize starch, microcrystalline cellulose, sodium starch glycolate, talc, colloidal anhydrous silica, magnesium stearate, yellow iron oxide (dye E 172), and red iron oxide (dye E 172).
  • Amiloferm mite: 
    Each tablet contains 2.5 mg amiloride hydrochloride and 25 mg hydrochlorothiazide . 
    The other ingredients are lactose monohydrate (46.2 mg), maize starch, microcrystalline cellulose, sodium starch glycolate, talc, colloidal anhydrous silica, magnesium stearate, yellow iron oxide (dye E 172), and red iron oxide (dye E 172).

What the medicine looks like and the contents of the pack

Amiloferm and Amiloferm mite tablets are light orange, mottled, round, cupped with a notch on one side. Diameter: Amiloferm 9 mm, Amiloferm mite 7 mm.

Amiloferm and Amiloferm mite are available in blister packs, 100 x 1 tablets (single dose).

Marketing Authorisation Holder

Nordic Drugs AB

Box 300 35

200 61 Limhamn

Manufacturer

Merckle GmbH, Blaubeuren, Germany

Muhammad Nadeem

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