Normatens

Package Leaflet: Information for the User

Normatens

5 mg + 0.5 mg + 0.1 mg, sugar-coated tablets
Clopamidum + Dihydroergocristinum + Reserpinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Normatens and what is it used for
• 2. Important information before taking Normatens
• 3. How to take Normatens
• 4. Possible side effects
• 5. How to store Normatens
• 6. Contents of the pack and other information.

1. What is Normatens and what is it used for

Normatens is a medicine that contains three active substances that lower blood pressure: reserpine, clopamide, and dihydroergocristine (in the form of dihydroergocristine mesylate). Their combination in one medicine allows for the use of smaller doses of individual substances, reducing the risk of side effects and making dosing easier.
Reserpine lowers blood pressure by affecting the transmission of certain stimuli in the nervous system. It causes blood vessels to dilate (which reduces blood pressure) and slows down heart activity.
Clopamide is a diuretic. It increases the amount of water and sodium excreted by the body, thereby reducing blood pressure.
Dihydroergocristine, acting on the central nervous system, reduces muscle tension in blood vessels, thus reducing blood pressure.
Thanks to the fact that Normatens causes long-term blood pressure reduction, it is used in all forms of hypertension where the use of a single active substance does not allow for sufficient blood pressure reduction.

2. Important information before taking Normatens

When not to take Normatens

• if you are allergic to clopamide, reserpine, dihydroergocristine, sulfonamides, ergot alkaloids, or any of the other ingredients of this medicine (listed in section 6),
• if you have low potassium levels in your blood,
• if you are pregnant or breastfeeding.

Warnings and precautions

Before starting treatment with Normatens, discuss it with your doctor, pharmacist, or nurse:

• if you have diabetes or reduced glucose tolerance, as the medicine may increase blood glucose levels (you should periodically check your blood glucose levels and, if necessary, adjust the dosage of your antidiabetic medicine),

your blood glucose levels and, if necessary, adjust the dosage of your antidiabetic medicine),

• if you have gout (you should avoid taking the medicine, as it may increase uric acid levels in your blood),
• if you have kidney failure (the medicine may harm your kidneys, and its effect may be reduced; it is not recommended to take Normatens if you have severe liver and kidney failure),
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - they may occur within a few hours to weeks after taking Normatens. If left untreated, they may lead to permanent vision loss. Patients who have previously been allergic to penicillin or sulfonamides may be at increased risk of these symptoms.

Normatens may cause a decrease in potassium levels in the blood; patients taking this medicine should follow a potassium-rich diet (fruits, vegetables, fish) and regularly check their potassium levels.
Remember that the full effect of Normatens, like many other blood pressure-lowering medicines, appears after several days or even 2 to 4 weeks after starting treatment, so at the beginning of treatment, it may seem that the medicine is not working strongly enough.

Children and adolescents

Normatens should not be used in children and adolescents.

Normatens and other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Some medicines may change the effect of Normatens. These include:

• all medicines that lower blood pressure (medicines used to treat hypertension),
• corticosteroids (e.g., hydrocortisone, methylprednisolone, dexamethasone) and non-steroidal anti-inflammatory drugs (e.g., over-the-counter cold medicines). In turn, Normatens may change the effect of other medicines, including:
• products containing lithium (e.g., Lithium carbonicum),
• oral anticoagulants (e.g., acenocoumarol, ticlopidine, acetylsalicylic acid),
• medicines that act on the central nervous system (e.g., phenobarbital, diazepam, nitrazepam),
• monoamine oxidase inhibitors (e.g., moclobemide); if Normatens is to be taken after stopping such a medicine, the first dose can be taken at the earliest 2 weeks after the last dose of the monoamine oxidase inhibitor,
• levodopa (a medicine used in Parkinson's disease). Therefore, before taking any new medicine (including over-the-counter medicines), consult your doctor.

Normatens with food, drink, and alcohol

Normatens should be taken during or immediately after a meal.
Patients taking Normatens should not consume alcoholic beverages.
Remember that Normatens increases the harmful effect of alcohol on the brain (so it should not be consumed during treatment with Normatens).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The product is contraindicated in pregnant women, as both animal studies and human observations indicate a significant risk to the fetus, which far outweighs the potential benefits to the mother.
Breastfeeding
Do not use during breastfeeding, as reserpine and dihydroergocristine, which are components of Normatens, pass into breast milk and may have an adverse effect on breastfed children.

Driving and using machines

In the initial phase of treatment, weakness and orthostatic hypotension (dizziness and weakness when changing body position from lying to standing) may occur, so patients taking the medicine should not drive or operate machinery during this period.

Normatens contains lactose and sucrose

1 sugar-coated tablet of Normatens contains 44.8 mg of sucrose and 44.9 mg of lactose monohydrate.
If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Normatens

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The dosage is determined individually by your doctor.
The recommended dose is:
Dosage for adults:
Treatment usually starts with 1 sugar-coated tablet per day. Depending on the effect and tolerance, the dose can be increased to a maximum of 3 sugar-coated tablets per day, taken in divided doses.
NOTE: The dosage of the medicine can only be increased on the advice of a doctor.
After achieving the desired effect, to maintain the effectiveness of the treatment, usually 1 sugar-coated tablet taken once a day is sufficient, and in some cases even 1 sugar-coated tablet every other day. However, sometimes it is necessary to take 2 sugar-coated tablets per day in divided doses, and in exceptional cases 3 sugar-coated tablets per day in divided doses (higher doses should not be taken).
Sugar-coated tablets should be taken during or immediately after a meal.
Dosage for the elderly:
There is no need to change the dosage, but due to the greater susceptibility of this group of patients to blood pressure fluctuations and electrolyte disturbances, it is recommended to exercise particular caution when taking the medicine.
Dosage for patients with kidney and liver failure:
It is not recommended to take the medicine in patients with severe liver and kidney failure.

Use in children and adolescents

Normatens should not be used in children and adolescents.

Overdose of Normatens

In case of taking too much Normatens, life-threatening symptoms may occur, such as a sudden decrease in blood pressure, loss of consciousness, and respiratory disorders. Other symptoms that may occur after an overdose include: nausea, vomiting, diarrhea, headaches, feeling of heat and thirst, decreased potassium levels in the blood, muscle weakness, slowed heart rate, arrhythmias, depression, coma.
A person who has overdosed on the medicine should immediately consult a doctor.

Missed dose of Normatens

In case of missing a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Normatens

In case of premature termination of treatment with Normatens, an increase in blood pressure may occur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Normatens can cause side effects, although not everybody gets them.
During treatment with Normatens, the following side effects have been observed:
Frequency not known - cannot be estimated from the available data:

• nausea and vomiting
• hypokalemia (decreased potassium levels in the blood)
• orthostatic hypotension (decreased blood pressure when changing body position from lying to standing)
• myasthenia (muscle weakness)
• rhinitis
• increased glucose and uric acid levels in the blood
• feeling of excessive weakness
• thrombocytopenia (decreased platelet count)
• depression
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Normatens

Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
Store out of the sight and reach of children.
Do not use Normatens after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Normatens contains

• The active substances are: clopamide - 5 mg, dihydroergocristine - 0.5 mg (in the form of dihydroergocristine mesylate - 0.58 mg), reserpine - 0.1 mg.
• The other ingredients are: core: lactose monohydrate - 44.9 mg, potato starch, povidone, talc, magnesium stearate; coating: sucrose - 44.8 mg, talc, gum arabic, a mixture of beeswax and carnauba wax.

What Normatens looks like and contents of the pack

PVC/Al blisters in a cardboard box.
20 or 40 sugar-coated tablets (1 or 2 blisters of 20 each).

Marketing authorization holder and manufacturer

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów, Poland

Date of revision of the leaflet: April 2025