Normatens

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Normatens

5 mg + 0.5 mg + 0.1 mg, sugar-coated tablets

Clopamidum + Dihydroergocristinum + Reserpinum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Normatens and what is it used for
• 2. Important information before using Normatens
• 3. How to use Normatens
• 4. Possible side effects
• 5. How to store Normatens
• 6. Contents of the package 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, reduces the risk of side effects, and makes dosing easier.
Reserpine lowers blood pressure by affecting the conduction 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 the tension of blood vessels, thus reducing blood pressure.
Thanks to the fact that Normatens causes a long-lasting reduction in blood pressure, it is used in all forms of hypertension, in which the use of a single active substance does not allow for sufficient blood pressure reduction.

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 potassium levels in the blood,
• if the patient is pregnant or breastfeeding.

Warnings and precautions

Before starting to use Normatens, you should discuss it with your doctor or pharmacist:

• if the patient has diabetes or reduced glucose tolerance, as the medicine may increase blood glucose levels (blood glucose levels should be periodically monitored and the dose of the antidiabetic medicine may need to be adjusted),
• if the patient has gout (the medicine should be avoided, as it may increase uric acid levels in the blood),
• if the patient has kidney failure (the medicine may damage the kidneys, and its effectiveness may decrease; in patients with severe liver and kidney failure, Normatens is not recommended),
• if the patient experiences 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 blood potassium levels; patients taking this medicine should follow a potassium-rich diet (fruits, vegetables, fish) and regularly monitor their blood potassium levels.
It should be remembered 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

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may change the effectiveness 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 effectiveness 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 used 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 using any new medicine (including over-the-counter medicines), you should consult your doctor.

Normatens with food, drinks, 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 effect of alcohol on the brain (so it should not be consumed during treatment with Normatens).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using 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 ingredients 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 people taking the medicine should not drive vehicles 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 the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to use Normatens

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The dosage is determined individually for each patient by their 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 dose of Normatens 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 per day is sufficient, and in some cases even 1 sugar-coated tablet every other day. However, in some cases, 2 sugar-coated tablets per day in divided doses, and in exceptional cases 3 sugar-coated tablets per day in divided doses, may be necessary (higher doses should not be used).
Sugar-coated tablets should be taken during or immediately after a meal.
Dosage for the elderly:
There is no need to change the dose, but due to the greater susceptibility of this group of patients to blood pressure fluctuations and the occurrence of water and electrolyte disorders,
particular caution is recommended during treatment with the medicine.
Dosage for patients with kidney and liver failure:
Normatens is not recommended for patients with severe liver and kidney failure.

Use in children and adolescents

Normatens should not be used in children and adolescents.

Using a higher than recommended dose of Normatens

In case of overdose, 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 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).
A person who has overdosed on the medicine should immediately consult a doctor.

Missing a dose of Normatens

In case of missing a dose, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. A double dose should not be taken 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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Normatens can cause side effects, although not everybody gets them.
The following side effects have been observed during treatment with Normatens:
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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the 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 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 specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the package and other information

What Normatens contains

• The active substances of Normatens are: clopamide, dihydroergocristine (in the form of dihydroergocristine mesylate), reserpine.
• The other ingredients are: core: lactose monohydrate, potato starch, povidone, talc, magnesium stearate; coating: sucrose, talc, arabic gum, white wax, carnauba wax.

What Normatens looks like and what the package contains

PVC/Al foil blisters in a cardboard box.
20 sugar-coated tablets (1 blister of 20).
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

SIA Meda Pharma
Mūkusalas 101
Riga LV-1004
Latvia

Manufacturer:

ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
Poland

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
Drawska 14/1
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Latvia, the country of export: 96-0576
Parallel import authorization number: 426/19
Date of leaflet approval: 11.01.2023
[Information about the trademark]