Tenaxum

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging 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.
• If you have 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 tell 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 packaging 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, you should discuss it with your doctor or
pharmacist.

• You should never suddenly stop treatment; your doctor will gradually reduce the dose of the medicine for you.
• You should tell your doctor if you have severe renal impairment or have recently had heart disease.
• If you are elderly, you 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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
You should not take Tenaxum with the following medicine (see also section "When not to take Tenaxum"):

• sultopride.

You should make sure your doctor is informed about your use of any of the following medicines, as their combination with Tenaxum is not recommended:

• beta-blockers (bisoprolol, carvedilol, metoprolol) used to treat heart failure;
• MAO inhibitors (used to treat depression).

You should make sure your doctor is informed about your 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 to treat 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 to treat 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).

You should make sure your doctor is informed about your 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 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 impair concentration when used concomitantly with Tenaxum: morphine derivatives (painkillers, antitussives, and medicines used in substitution therapy for opioid dependence, 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

You should not drink alcohol while taking Tenaxum.

Pregnancy and breastfeeding

This medicine is not recommended during pregnancy.
You should not take Tenaxum if you are breastfeeding. You should immediately inform your doctor if you are breastfeeding or plan to breastfeed.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Tenaxum may impair your ability to drive or operate machines due to the risk of drowsiness caused by this medicine.

Tenaxum contains lactose monohydrate and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Tenaxum

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your 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, blood pressure values have not normalized, your 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 more than the recommended dose of Tenaxum

If you have taken too many tablets, you may experience very low blood pressure and attention disorders.
You should immediately contact your doctor or pharmacist.

Missing a dose of Tenaxum

You should not take a double dose to make up for a missed dose, just take the next dose as usual.

Stopping treatment with Tenaxum

Treatment with Tenaxum should not be stopped suddenly. If it is necessary to discontinue the medicine, the dose should be gradually reduced under medical supervision.
If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• common (may affect up to 1 in 10 people): palpitations (feeling of heart beating), 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this 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 the 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tenaxum contains

• The active substance of Tenaxum is rilmenidine. One tablet contains 1 mg of rilmenidine, which corresponds to 1.544 mg of rilmenidine dihydrogen phosphate.
• The other ingredients of the medicine are: sodium carboxymethylcellulose, microcrystalline cellulose, lactose monohydrate, paraffin 54/56, colloidal anhydrous silica, magnesium stearate, talc, white wax.

What Tenaxum looks like and contents of the pack

Tenaxum is available in packs containing 30 tablets.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Lithuania, country of export:LT/1/99/0094/002

Parallel import authorization number: 201/23

Date of leaflet approval: 18.09.2023

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