Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Tenaxum
1 mg, tablets
Rilmenidinum
Please read the following information carefully before using the 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, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Tenaxum is and what it is used for

Tenaxum contains rilmenidine as the active substance, which lowers blood pressure.
The effect of the medicine lasts for 24 hours.
Tenaxum is indicated for the treatment of essential (primary) hypertension.

2. Important information before using Tenaxum

When not to use Tenaxum:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if the patient has severe depression;
if the patient has severe renal impairment (creatinine clearance < 15 ml/min);
if the patient is concurrently taking sultopride (see section "Tenaxum with other medicines").

Warnings and precautions
Before starting treatment with Tenaxum, discuss this with your doctor or pharmacist.

Do not stop treatment suddenly; your doctor will gradually reduce the dose.
Inform your doctor if the patient has severe renal impairment or has recently suffered from heart disease.
If the patient is elderly, caution is advised due to an increased risk of falls caused by low blood pressure, which may occur, for example, when standing up.

Children and adolescents
Tenaxum is not recommended for use in children and adolescents.
Tenaxum with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Tenaxum with the following medicinal product (see also section "When not to use Tenaxum"):

sultopride.

Ensure that your doctor is informed if the patient is taking any of the following medicines, as their combination with Tenaxum is not recommended:

beta-blockers (bisoprolol, carvedilol, metoprolol) used in the treatment of heart failure;
MAO inhibitors (used in the treatment of depression).

Ensure that your doctor is informed if the patient is taking any of the following medicines, as special caution may be required:

baclofen (a medicine used to treat muscle stiffness occurring in diseases such as multiple sclerosis);
beta-blockers (used in the treatment of hypertension, angina pectoris – a condition causing chest pain);
medicines used to treat cardiac arrhythmias: quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, sotalol;
certain neuroleptics (medicines with a calming effect, used in the treatment of psychiatric disorders): chlorpromazine, levomepromazine, thioridazine, amisulpride, sulpiride, tiapride, droperidol, haloperidol, pimozide;
halofantrine (an antiparasitic medicine used to treat malaria);
mizolastine (used to treat allergic reactions such as hay fever);
moxifloxacin, intravenous erythromycin, intravenous spiramycin (antibiotics used to treat infections);
pentamidine (used to treat certain types of pneumonia);
intravenous vinpocetine (used to treat symptoms of cognitive disorders in elderly patients, including memory impairment);
bepridil (used to treat angina pectoris – a condition causing chest pain);
cisapride, difemethil (used to treat gastrointestinal disorders);
tricyclic antidepressants (used to treat depression);
antihypertensive medicines other than Tenaxum (used to treat hypertension).

Ensure that your doctor is informed if the patient is taking any of the following medicines, as combination with Tenaxum should be considered:

alpha-blockers (used to treat hypertension);
amifostine (used in chemotherapy or radiotherapy);
corticosteroids (used to treat various medical conditions, including severe asthma and rheumatoid arthritis), tetracosactide (used to treat Crohn's disease) (oral treatment) (except hydrocortisone used in Addison's disease);
other neuroleptics (medicines with a calming effect, used in the treatment of psychiatric disorders), imipramine-type antidepressants (used to treat psychiatric disorders such as depression);
other medicines acting centrally on the nervous system, which may impair concentration when used concomitantly with Tenaxum: morphine derivatives (analgesics, antitussives, and medicines used in opioid substitution therapy such as buprenorphine, methadone), medicines used to treat anxiety, sleep disorders (benzodiazepine derivatives, non-benzodiazepine anxiolytics, hypnotics, neuroleptics), sedative H\1-receptor antagonists (used to treat allergies or allergic reactions), antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), other centrally acting antihypertensives, baclofen (a medicine used to treat muscle stiffness occurring in diseases such as multiple sclerosis), thalidomide (used to treat certain neoplastic diseases), pizotifen and indoramin (used to treat migraine attacks).

Tenaxum with food, drink and alcohol
Do not drink alcohol while taking Tenaxum.
Pregnancy and breastfeeding
This medicine is not recommended during pregnancy.
Do not take Tenaxum if the patient is breastfeeding. Inform your doctor immediately if the patient is breastfeeding or planning to breastfeed.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and using machines
Tenaxum may impair the ability to drive or operate machinery due to the risk of drowsiness associated with this medicine.
Tenaxum contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use the medicine Tenaxum

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Tenaxum should be taken orally.
The recommended dose is 1 tablet (1 mg) daily, taken in the morning at the start of a meal.
If blood pressure values have not normalized after one month of treatment, the doctor may
increase the dose to 2 tablets (2 mg) daily (one tablet in the morning and one in the evening).
Use in children and adolescents
Tenaxum is not recommended for use in children and adolescents.
Taking more Tenaxum than recommended
If too many tablets are taken, the patient may experience very low blood pressure and
attention disturbances.
Seek immediate medical advice from a doctor or pharmacist.
Missing a dose of Tenaxum
Do not take a double dose to make up for a missed dose; take the next dose as usual.
Stopping Tenaxum
Do not stop treatment with Tenaxum suddenly. If discontinuation of the medicine is necessary,
the dose should be gradually reduced under medical supervision.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone gets them.
If the patient experiences symptoms of slowed heart rate (bradycardia), including dizziness, fainting or fatigue, medical advice should be sought.

The following adverse reactions have been reported:

Common (may occur in up to 1 in 10 patients): palpitations (awareness of heartbeat), insomnia, drowsiness, anxiety, depression, headache, dizziness, sexual dysfunction, stomach pain, dryness of the oral mucosa, diarrhoea, constipation, rash, itching, muscle cramps, sensation of cold in the extremities (in hands and/or feet), oedema, weakness, fatigue.
Uncommon (may occur in up to 1 in 100 patients): nausea; hot flushes, drop in blood pressure upon standing.
Frequency not known (cannot be estimated from the available data): slowed heart rate (bradycardia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 Tenaxum

Keep the medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tenaxum contains

The active substance is rilmenidine. One tablet contains 1 mg of rilmenidine in the form of 1.544 mg rilmenidine dihydrogen phosphate.
The other ingredients are: sodium carboxymethyl starch, microcrystalline cellulose, white wax, monohydrate lactose, solid paraffin, colloidal anhydrous silica, magnesium stearate, talc.

What Tenaxum looks like and contents of the pack
Tenaxum is available in packs containing 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France
Manufacturer:
Les Laboratoires Servier Industrie
905, Route de Saran
45520 Gidy
France
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Marketing authorisation number in the Czech Republic, country of export: 58/477/97-C
Parallel import authorisation number: 245/18