Tenaxum

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

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

Tenaxum

1 mg, tablets

Rilmenidine

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 you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Tenaxum and what is it used for

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

2. Important information before taking Tenaxum

When not to take Tenaxum:

• if the patient is allergic to the active substance or 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);< li>
• if the patient is taking sultopride concomitantly (see section "Tenaxum and other medicines").

Warnings and precautions

Before starting to take Tenaxum, the patient should discuss it with their doctor or pharmacist.

• The treatment should never be stopped abruptly; the doctor will gradually reduce the dose of the medicine for the patient.
• The patient should tell their doctor if they have severe renal impairment or have recently had heart disease.
• If the patient is elderly, they should be careful about the increased risk of falls due to 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 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The patient should not take Tenaxum with the following medicinal product (see also section "When not to take Tenaxum"):

• sultopride.

The patient should ensure that their doctor is informed about the use of 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;
• monoamine oxidase inhibitors (MAOIs) (used in the treatment of depression).

The patient should ensure that their doctor is informed about the use of any of the following medicines, as special caution may be required:

• baclofen (a medicine used to treat muscle stiffness in diseases such as multiple sclerosis);
• beta-blockers (used in the treatment of hypertension, angina pectoris - a condition that causes chest pain);
• medicines used to treat heart rhythm disorders: quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, sotalol;
• certain neuroleptics (medicines with a sedative effect, used in the treatment of mental 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 vincamine (used to treat symptoms of cognitive disorders in elderly patients, including memory disorders);
• bepridil (used to treat angina pectoris - a condition that causes chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• tricyclic antidepressants (used to treat depression);
• antihypertensive medicines other than Tenaxum (used to treat hypertension).

The patient should ensure that their doctor is informed about the use of any of the following medicines, as their combination with Tenaxum may need to be considered:

• alpha-blockers (used to treat hypertension);
• amifostine (used in chemotherapy or radiotherapy);
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis), tetracosactide (used to treat Crohn's disease) (oral treatment) (except for hydrocortisone used in Addison's disease);
• other neuroleptics (medicines with a sedative effect, used to treat mental disorders), imipramine-type antidepressants (used to treat mental disorders, such as depression);
• other medicines that have a sedative effect on the central nervous system, which may disrupt concentration when used concomitantly with Tenaxum: morphine derivatives (painkillers, antitussives, and medicines used in opioid substitution therapy, such as buprenorphine, methadone), medicines used to treat anxiety, sleep disorders (benzodiazepine derivatives, anxiolytics other than benzodiazepine derivatives, sleeping pills, neuroleptics), histamine H receptor antagonists with a sedative effect (used to treat allergies or allergic reactions), medicines used to treat depression (amitriptyline, doxepin,

mianserin, mirtazapine, trimipramine), other centrally acting antihypertensive medicines, baclofen (a medicine used to treat muscle stiffness in diseases such as multiple sclerosis), thalidomide (used to treat certain cancers), pizotifen and indoramin (used to treat migraine attacks).

Tenaxum with food, drink, and alcohol

The patient should not drink alcohol while taking Tenaxum.

Pregnancy and breastfeeding

This medicine is not recommended during pregnancy.
The patient should not take Tenaxum if they are breastfeeding. They should immediately inform their doctor if they are breastfeeding or plan to breastfeed.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Tenaxum may affect the patient's ability to drive or operate machinery due to the risk of drowsiness caused by the medicine.

Tenaxum contains lactose monohydrate and sodium

If the patient has previously been diagnosed with an intolerance to some sugars, they should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Tenaxum

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Tenaxum is taken orally.
The recommended dose is 1 tablet (1 mg) per day, taken in the morning at the start of a meal.
If after one month of treatment, the blood pressure values have not normalized, the doctor will increase the dose to 2 tablets (2 mg) per day (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 a higher dose of Tenaxum than recommended

If the patient takes too many tablets, they may experience very low blood pressure and attention disorders.
The patient should immediately contact their doctor or pharmacist.

Missing a dose of Tenaxum

The patient should not take a double dose to make up for a missed dose, but should take the next dose as usual.

Stopping treatment with Tenaxum

Treatment with Tenaxum should not be stopped abruptly. If it is necessary to discontinue the medicine, the dose should be gradually reduced under the doctor's supervision.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Tenaxum can cause side effects, although not everybody gets them.
If the patient experiences symptoms of bradycardia (slow heart rate), including dizziness, fainting, or fatigue, they should contact their doctor.
The following side effects have been reported:

• common (may affect up to 1 in 10 people): palpitations (feeling of heartbeat), insomnia, drowsiness, anxiety, depression, headache, dizziness, sexual disorders, stomach pain, dry mouth, diarrhea, constipation, rash, itching, muscle cramps, feeling of cold in the limbs (hands and/or feet), edema, weakness, fatigue.
• uncommon (may affect up to 1 in 100 people): nausea; hot flashes, decrease in blood pressure when standing up.
• frequency not known (cannot be estimated from the available data): bradycardia (slow heart rate).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Tenaxum

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tenaxum contains

• The active substance of Tenaxum is rilmenidine. One tablet contains 1 mg of rilmenidine (as rilmenidine dihydrogen phosphate).
• The other ingredients of the medicine are: carboxymethylcellulose sodium, microcrystalline cellulose, lactose monohydrate, paraffin 54/56, colloidal silica anhydrous, magnesium stearate, talc, white wax.

What Tenaxum looks like and contents of the pack

Tenaxum is available in a pack (cardboard box) containing 2 blisters of polyamide/Al/PVC with 15 tablets each.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the 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 by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Lithuania, the country of export:
LT/1/99/0094/001
LT/1/99/0094/002
LT/1/99/0094/003
Parallel import authorization number: 29/24

Date of leaflet approval: 22.01.2024

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