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 taking 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, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. 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 "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 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 medicine (see also "When not to take Tenaxum"):

• sultopride.

The patient should make sure 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 to treat heart failure;
• MAO inhibitors (used to treat depression).

The patient should make sure 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 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).

The patient should make sure their doctor is informed about the use of any of the following medicines, as their combination with Tenaxum may 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 central nervous system depressant effect, which may impair concentration when taken 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 baby, they should consult their doctor or pharmacist before taking this medicine.

  Driving and using machines

  Tenaxum may impair the ability to drive or operate machines due to the risk of drowsiness after taking this medicine.

  Tenaxum contains lactose monohydrate

  If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking this medicine.

  3. How to take Tenaxum

  This medicine should always be taken exactly as prescribed 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 do not normalize, 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 impaired attention.
  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 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 medical 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 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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, more information can be gathered on the safety of the medicine.

  • Country of registration
    Poland
  • Active substance
    rilmenidine
  • Prescription required
    Yes
  • Marketing authorisation holder (MAH)
    Les Laboratoires Servier
  • This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.

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  5. How to store Tenaxum
  The medicine should be stored out of sight and reach of children.
  Store in a temperature below 30°C.
  Do not use the medicine after the expiry date stated on the packaging.
  The expiry date stated is the last day of the given month.
  Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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, which corresponds to 1.544 mg of rilmenidine dihydrogen phosphate.
  Other ingredients of the medicine are: carboxymethylcellulose sodium, microcrystalline cellulose, lactose monohydrate, paraffin, colloidal silica anhydrous, magnesium stearate, talc, white wax.
  The appearance of Tenaxum and the contents of the pack
  are not specified in this translation.
  Tenaxum is available in packs containing 30 tablets. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer. Marketing authorization holder in the Czech Republic, 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: 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 the Czech Republic, the country of export:58/477/97-C Parallel import authorization number:136/13 Date of leaflet approval: 23.02.2023 [Information about the trademark is not translated].