Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Normatens
5 mg + 0.5 mg + 0.1 mg, coated tablets
Clopamidum + Dihydroergocristinum + Reserpinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Normatens is and what it is used for
Important information before taking Normatens
How to take Normatens
Possible side effects
How to store Normatens
Contents of the pack and other information

1. What Normatens is and what it is used for

Normatens is a medicine containing three active substances that reduce arterial blood pressure:
reserpine, clopamide, and dihydroergocristine (in the form of dihydroergocristine mesylate). The combination
of these three substances in a single tablet allows for lower doses of each individual component,
reduces the risk of adverse effects, and facilitates dosing.
Reserpine lowers arterial blood pressure by affecting the transmission of certain stimuli
in the nervous system. It causes dilation of blood vessels (resulting in reduced blood pressure)
and slows down heart function.
Clopamide is a diuretic agent. It increases the excretion of water and sodium from the body,
thereby reducing arterial blood pressure.
Dihydroergocristine acts on the central nervous system, reducing the tone of smooth muscles in blood vessels,
thus lowering arterial blood pressure.
Because Normatens provides a prolonged reduction in arterial blood pressure, it is used in all forms of
hypertension where treatment with a single active substance does not achieve adequate blood pressure control.

2. Important information before using Normatens

When not to use Normatens:

if the patient is allergic to clopamide, reserpine, dihydroergocristine, sulfonamides, ergot alkaloids, or any of the other ingredients of this medicine (listed in section 6),
if the patient has low serum potassium levels,
if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Normatens, discuss this with your doctor, pharmacist, or nurse:

if the patient has diabetes or impaired glucose tolerance, as the medicine may increase serum glucose levels (serum glucose levels should be monitored periodically and, if necessary, the dose of antidiabetic medication adjusted),
if the patient has gout (the medicine should be avoided in such cases, as it may increase serum uric acid levels),
if the patient has renal impairment (the medicine may damage the kidneys and its effect may be reduced; Normatens is not recommended in patients with severe hepatic and renal impairment),
if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive accumulation of fluid between choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Normatens. If left untreated, they may lead to permanent vision loss. Patients who previously experienced allergy to penicillin or sulfonamides may be at increased risk of developing these symptoms.

Normatens may reduce potassium levels in the blood. Patients taking this medicine should follow a diet rich in potassium (fruits, vegetables, fish) and have their blood potassium levels monitored regularly.
It should be noted that the full effect of Normatens, as with many other antihypertensive medicines, may take several days, or even 2 to 4 weeks, to become apparent. Therefore, at the beginning of treatment, the medicine may seem ineffective.
Children and adolescents
Normatens must not be used in children and adolescents.
Normatens with other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to take.
Some medicines may alter 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. cold medicines available without prescription).

Conversely, Normatens may alter the effect of other medicines, including:

lithium-containing preparations (e.g. Lithium carbonicum),
oral anticoagulants (e.g. acenocoumarol, ticlopidine, acetylsalicylic acid),
medicines with central nervous system depressant effects (e.g. phenobarbital, diazepam, nitrazepam),
medicines belonging to the so-called MAO inhibitors (e.g. moclobemide); if Normatens is to be used after discontinuation of such a medicine, the first dose may be taken no earlier than 2 weeks after the last dose of an MAO inhibitor,
levodopa (a medicine used in Parkinson's disease).

Therefore, before taking any new medicine (including those available without prescription), 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.
It should be remembered that Normatens increases the harmful effects of alcohol on the brain (therefore, alcohol should not be consumed during treatment with Normatens).
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
This product is contraindicated in pregnant women, as animal studies and observations in humans indicate a significant risk to the fetus, which clearly outweighs any potential benefit to the mother.
Breastfeeding
Do not use during breastfeeding, as reserpine and dihydroergocristine, components of Normatens, pass into breast milk and may adversely affect breastfed infants.
Driving and operating machinery
During the initial phase of treatment, fatigue and orthostatic hypotension (dizziness and weakness upon changing position from lying to standing) may occur. Therefore, patients should not drive or operate machinery during this period.
Normatens contains monohydrate lactose and sucrose
Normatens contains 44.9 mg of monohydrate lactose.
Normatens contains 44.975 mg of sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. How to use Normatens

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The dosage is determined individually by the physician for each patient.
Recommended dosage:
Dosage in adults:
Treatment usually starts with 1 coated tablet per day. Depending on the effect and tolerance,
this dose may be increased up to a maximum of 3 coated tablets per day, administered in divided doses.
WARNING: The dosage may be increased only on a physician's instruction.
After achieving a satisfactory effect, maintenance of therapeutic efficacy is usually achieved with
1 coated tablet once daily, or in some cases even 1 coated tablet every other day. However, in some instances,
administration of 2 coated tablets per day in divided doses may be necessary, and exceptionally,
3 coated tablets per day in divided doses (higher doses should not be used).
Coated tablets should be taken during or immediately after a meal.
Dosage in elderly patients:
Dosage adjustment is not required; however, due to the increased susceptibility of this patient group
to fluctuations in blood pressure and the occurrence of water-electrolyte imbalances,
particular caution is advised during treatment.
Dosage in patients with renal or hepatic impairment:
The use of this medicine is not recommended in patients with severe hepatic or renal impairment.
Use in children and adolescents
Normatens should not be used in children and adolescents.
Use of a higher than recommended dose of Normatens
In case of overdose, life-threatening symptoms may occur,
such as sudden drop in blood pressure, loss of consciousness, breathing difficulties.
Other symptoms that may occur after overdose include: nausea, vomiting,
diarrhea, headache, feeling of warmth and thirst, decreased blood potassium concentration,
muscle weakness, slowed heart rate, cardiac arrhythmias, depression, coma.
A person who has overdosed on this medicine should seek immediate medical attention.
Missed dose of Normatens
If a dose is missed, it should be taken as soon as possible. However, if the time for the next dose
is approaching, the missed dose should be skipped. A double dose should not be taken to make up
for the missed dose.
Discontinuation of Normatens
Premature discontinuation of treatment with Normatens may lead to increased blood pressure.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse effects have been observed during treatment with Normatens.
Frequency unknown – cannot be estimated from available data:

nausea and vomiting
hypokalaemia (reduced potassium levels in the blood)
orthostatic hypotension (reduced blood pressure upon changing body position from lying to standing)
myasthenia (muscle weakness)
catarrh
increased blood glucose and uric acid levels
feeling of excessive fatigue
thrombocytopenia (reduced number of blood platelets)
depression
visual disturbances or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid buildup between choroid and sclera – or acute angle-closure glaucoma).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Normatens

Store below 25°C.
Store in the original packaging to protect from light and moisture.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Normatens contains

The active substances are: clopamide - 5 mg, dihydroergocristine - 0.5 mg (as dihydroergocristine mesilate - 0.58 mg), reserpine - 0.1 mg.
Other ingredients: monohydrate lactose - 44.9 mg, potato starch, povidone, talc, magnesium stearate; coating: sucrose - 44.975 mg, talc, gum arabic, white wax and Carnauba wax.

What Normatens looks like and contents of the pack
Al/PVC blisters containing white or almost white, round coated tablets, packed in a cardboard box.
Pack size: 20 or 40 coated tablets (1 or 2 blisters with 20 tablets each).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN, Ireland
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów, Poland
Parallel importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Latvia, country of export: 96-0576
Parallel Import Licence Number: 50/16