TENAXUM

Package leaflet: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Tenaxum
1 mg, tablets
Rilmenidinum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Tenaxum is and what it is 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 Tenaxum is and what it is used for

Tenaxum contains rilmenidine as the active substance, which lowers arterial 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 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 been diagnosed with 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.

• Never stop treatment abruptly; your doctor will gradually reduce the dose for you.
• 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 medicine (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 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 problems);
• bepridil (used to treat angina pectoris – a condition causing chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• tricyclic antidepressants (used to treat depression);
• antihypertensive medicines other than Tenaxum (used to treat high blood pressure).

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 that depress the central nervous system, which may impair concentration when used together 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), sedating H₁ histamine 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 indoramine (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 you are breastfeeding. Inform your doctor immediately if you are breastfeeding or intend to breastfeed.
  If you are pregnant or breastfeeding, think you may be pregnant, or if you are planning to have a baby, consult your doctor or pharmacist before using this medicine.
  Driving and operating machinery
  Tenaxum may impair the ability to drive or operate machinery due to the risk of drowsiness associated with this medicine.
  Tenaxum contains monohydrate lactose 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, i.e. the medicine is considered "sodium-free".

3. How to use the medicine Tenaxum

This medicine should always be used as directed by the physician. In case of doubt,
consult a 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
Use of Tenaxum is not recommended 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.
Contact a doctor or pharmacist immediately.
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
Treatment with Tenaxum should not be stopped abruptly. 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 experiences them.
If the patient experiences symptoms of slowed heartbeat (bradycardia), including feeling faint, fainting, or fatigue, they should contact their doctor.
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), swelling, weakness, fatigue;
• Uncommon (may occur in up to 1 in 100 patients): nausea, hot flushes, drop in blood pressure upon standing;
• Unknown frequency (cannot be estimated from available data): slowed heart rate (bradycardia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tenaxum

Keep this medicine 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 stated month.
Medicines should 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 pack and other information

What Tenaxum contains

• The active substance is rilmenidine. One tablet contains 1 mg of rilmenidine, equivalent to 1.544 mg of rilmenidine dihydrogen phosphate.
• The other ingredients are: sodium carboxymethyl starch, microcrystalline cellulose, monohydrate lactose, 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, please contact the responsible party or the parallel importer.
Marketing Authorisation 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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Lithuania, country of export: LT/1/99/0094/002
Parallel Import Authorisation Number: 201/23