Tenaxum

Package Leaflet: Information for the Patient

Tenaxum

1 mg

tablets
Rilmenidine

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have severe depression;
• if you have severe renal impairment (creatinine clearance <15 ml min);< li>
• if you are taking sultopride (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 the medicines you are taking, or have recently taken, and about the medicines you plan to take.
You should not take Tenaxum with the following medicinal product (see also section "When not to take Tenaxum"):

• sultopride.

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

You should make sure your doctor is informed about your taking 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 causing 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 in the treatment of malaria);
• mizolastine (used in the treatment of allergic reactions, such as hay fever);
• moxifloxacin, intravenous erythromycin, intravenous spiramycin (antibiotics used in the treatment of infections);
• pentamidine (used in the treatment of certain types of pneumonia);
• intravenous vincamine (used in the treatment of symptoms of cognitive disorders in elderly patients, including memory disorders);
• bepridil (used in the treatment of angina pectoris - a condition causing chest pain);
• cizapride, difemanil (used in the treatment of gastrointestinal disorders);
• tricyclic antidepressants (used in the treatment of depression);
• antihypertensive medicines other than Tenaxum (used in the treatment of hypertension).

You should make sure your doctor is informed about your taking any of the following medicines, as their combination with Tenaxum may need to be considered:

• alpha-blockers (used in the treatment of hypertension);
• amifostine (used in chemotherapy or radiotherapy);
• corticosteroids (used in the treatment of various diseases, including severe asthma and rheumatoid arthritis), tetracosactide (used in the treatment of Crohn's disease) (oral treatment) (except hydrocortisone used in Addison's disease); other neuroleptics (medicines with a sedative effect, used in the treatment of mental disorders), imipramine-type antidepressants (used in the treatment of mental disorders, such as depression);
• other medicines that have a sedative effect on the central nervous system, which may impair concentration when taken 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 in the treatment of 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 in the treatment of certain cancers), pizotifen and indoramin (used in the treatment of 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 are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Tenaxum contains lactose 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 essentially "sodium-free".

3. How to take Tenaxum

You should always take this medicine exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Tenaxum should be 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 may 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 take more tablets than recommended, 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

You should not stop treatment with Tenaxum 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 slow heart rate (bradycardia), 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 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), swelling, 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): slow heart rate (bradycardia).

Reporting side effects

If you experience any side effects, including those 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 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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 the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after "EXP" (expiry date). The expiry date refers to the last day of the month stated.
The batch number on the packaging is the marketing authorization number of the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. 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.
• The other ingredients are: carboxymethylcellulose sodium, microcrystalline cellulose, 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.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer:

Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
or
ANPHARM Pharmaceutical Company S.A.
Annopol 6B
03-236 Warsaw
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Servier Polska Sp. z o.o.
Phone: (22) 594-90-00

Date of last revision of the leaflet: