5 mg / 50 mg 2.5 mg / 25 mg tablets
amiloride hydrochloride / hydrochlorothiazide
What Normorix and Normorix mite are and what they are used for
Normorix and Normorix mite are diuretics and antihypertensives. The two active substances complement each other in such a way that hydrochlorothiazide is diuretic and lowers blood pressure, while amiloride hydrochloride is potassium-sparing and counteracts the potassium losses that can be caused by diuretics. Amiloride hydrochloride also has a mild diuretic and antihypertensive effect, thus enhancing the effect of hydrochlorothiazide.
The increased urine excretion begins within 1-2 hours after ingestion is greatest after about 4 hours, and lasts about 12 hours.
Normorix and Normorix mite are used to treat high blood pressure or fluid retention in the tissues ( edema ) due to heart failure, cirrhosis of the liver with fluid retention in the abdominal cavity.
Amiloride hydrochloride and hydrochlorothiazide contained in Normorix and Normorix mite may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Normorix and Normorix mite
Do not use Normorix and Normorix mite
- if you are allergic to hydrochlorothiazide or amiloride hydrochloride or any of the other ingredients of this medicine (listed in section 6). This also applies if you are allergic to substances that are closely related to the active substances, such as so-called thiazides ( diuretics ) or sulfonamides (eg certain oral diabetes medicines).
- if you have severe renal impairment, have high levels of potassium in your blood or if you use other potassium-sparing agents (eg spironolactone ) or potassium supplements.
- if you have no urine excretion
- if you have affected consciousness as a result of cirrhosis.
- if you have gout .
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Normorix or Normorix 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 taking Normorix or Normorix mite .
- have a high age
- has impaired renal function
- have diabetes
- has elevated potassium levels in the blood
- has lupus erythematosus ( SLE )
- have heart-lung disease
- have liver problems
- have obstruction of the urinary tract
- should do a glucose tolerance test
- should take a sample to check the level of parathyroid hormone in the blood, as you may need to stop treatment before taking the sample.
- 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 Normorix or Normorix mite , seek medical attention immediately.
Talk to your doctor or nurse 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 Normorix or Normorix mite. This can lead to permanent visual impairment if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at a higher risk of developing this.
Normorix / Normorix 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 severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
Before surgery with anesthesia (also applies to the dentist), the doctor/dentist should know that you are being treated with Normorix or Normorix mite, as there is a risk that the blood pressure may drop suddenly.
Treatment with thiazides can increase the levels of certain blood fats ( cholesterol and triglycerides ).
Other medicines and Normorix and Normorix mite
The effect of the treatment can be affected if Normorix or Normorix mite is taken at the same time as certain other medicines. Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This applies above all to:
- other potassium-sparing agents or potassium supplements
- other antihypertensive agents ( ACE inhibitors )
- insulin and antidiabetic agents
- certain lipid-lowering agents (cholestyramine, colestipol)
- cardiac medicine ( digitalis , sotalol, epinephrine )
- cortisone
- certain painkillers (eg acetylsalicylic acid and ibuprofen )
- certain antidepressants (lithium)
- certain drugs that lower the immune system (cyclosporine and tacrolimus)
- certain agents against disturbed calcium metabolism (calcitriol)
- certain antiepileptic drugs (carbamazepine, topiramate)
- certain anti-cancer drugs (cyclophosphamide)
- calcium-containing agents, such as calcium supplements and certain anti-acidic agents (so-called antacids)
Some sedatives may increase the blood pressure-lowering effect of Normorix and Normorix mite.
Intake of Normorix and Normorix mite with food and drink
You should avoid consuming large amounts of dairy products or other calcium-containing foods.
Alcohol may increase the blood pressure-lowering effect of Normorix and Normorix mite.
Pregnancy and breastfeeding
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 taking this medicine.
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 Normorix / Normorix mite as Normorix / Normorix mite is not recommended during pregnancy. This is because Normorix / Normorix mite passes to 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 breastfeeding or planning to start breastfeeding. Normorix / Normorix mite is not recommended for breastfeeding.
Driving and using machines
Side effects such as dizziness and fatigue may occur. Under these conditions, the ability to react and the ability to judge can decrease and this should be observed, for example, when driving a car and precision work. 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.
Normorix and Normorix 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.
How to use Normorix and Normorix mite
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dose one is determined by the doctor, who adjusts it individually for you.
The usual dose is 1 tablet daily. Do not change the dosage without consulting your doctor.
Normorix
The tablet can be divided into two equal doses.
If you use too much Normorix or Normorix mite
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to use Normorix or Normorix mite
Do not take a double dose to make up for a forgotten tablet. Return to the regular schedule the next day.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- Fatigue, weakness
- Headache and dizziness
- Nausea, diarrhea and indigestion
- Skin rash, itching
- Pain in legs and arms
- Shortness of breath, cough
- Irregular heartbeat
- Loss of appetite. Elevated blood sugar levels, elevated or decreased (with long-term use) potassium levels in the blood. Decreased magnesium levels in the blood. Increased amount of uric acid in the blood.
Uncommon (may affect up to 1 in 100 people):
- Vomiting, constipation, flatulence, hiccups, dry mouth
- Thirst
- Insomnia, nervousness, depression and confusion
- Dizziness due to drop in blood pressure when getting up quickly, dizziness, fast pulse
- Angina pectoris
- Ant crawls, numbness, decreased alertness
- Muscle cramps, joint pain, chest and back pain
- Urinary incontinence and incontinence
- Impotence
- Visual disturbances
Rare (may affect up to 1 in 1,000 people):
- Hypersensitivity reaction with fever, rash, swelling and sometimes a drop in blood pressure. Vascular wall inflammation
- Skin reaction in connection with sun exposure
- Fainting
- Impaired renal function
- Gastrointestinal bleeding, inflammation of the pancreas
- Jaundice
- Decreased sodium levels in the blood
- Anemia and other changes in the blood picture, eg lack of white blood cells , so-called agranulocytosis , see also Warnings and caution
Very rare (may affect up to 1 in 10,000 people):
- Fluid in the lungs
- Acute shortness of breath syndrome (signs of this are severe shortness of breath, fever, weakness and confusion).
- Abdominal pain
- Skin and mucosal changes (sometimes severe)
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 )
- Gout , dehydration
- Nasal congestion
- Impaired bile flow
- Nocturnal urination
How to store Normorix and Normorix mite
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the label 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.
Contents of the pack and other information
Content declaration
- The active substances are amiloride chloride and hydrochlorothiazide .
- Normorix 5 mg / 50 mg contains 5 mg of amiloride hydrochloride in the form of amiloride hydrochloride dihydrate and 50 mg of hydrochlorothiazide .
- Normorix mite 2.5 mg / 25 mg contains 2.5 mg amiloride hydrochloride in the form of amiloride hydrochloride dihydrate and 25 mg hydrochlorothiazide .
- The other ingredients are lactose monohydrate 60 mg (Normorix) and 30 mg (Normorix mite ), magnesium stearate, povidone, microcrystalline cellulose, talc and rice starch.
What the medicine looks like and contents of the pack
Normorix 5 mg / 50 mg is a white to yellowish, round tablet with a diameter of 8 mm. The tablet has a breaking notch and is embossed with AB 71.
Normorix mite 2.5 mg / 25 mg is a white to yellowish, round tablet with a diameter of 6 mm. The tablet is slightly concave and is embossed with AB 73.
Pack sizes:
30 and 100 tablets in a plastic jar, respectively.
98 x 1 tablets (single dose) in the blister pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orifarm Healthcare A / S
Energizer 15
5260 Odense S
Denmark
info@orifarm.com
Local representative
Orifarm Healthcare
Box 56048
102 17 Stockholm
Manufacturer
Orifarm Manufacturing Poland Sp. z oo
Ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland