TENAXUM 1 mg. 30 tablets

What is TENAXUM and what it is used
This medicine recommended for the treatment of hypertension.
2. What you need to know before taking TENAXUM
Do not take TENAXUM:
if you are allergic to rilmenidine or any of the other ingredients of this medicine (listed in section. 6);
if you have severe depression;
if you suffer from severe renal failure;
if you take sultopride (see. section "Other medicines and TENAXUM").
Warnings and Precautions
Talk to your doctor or pharmacist before taking TENAXUM
If you are elderly, please note the increased risk of falling due to the possibility of low blood pressure in the upright position.
Pay special attention to:
If you have recently had heart problems or have had a stroke;
if you are taking both beta-blockers (medicines to treat irregular heartbeats);
if you are taking MAO inhibitors (medicine for the treatment of depressive disorders);
if you want to stop treatment TENAXUM: talk to your doctor before stopping treatment with TENAXUM! The dose should be decreased gradually, not suddenly stop treatment.
Children and adolescents
TENAXUM is not intended for use in children.
Other medicines and TENAXUM
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.
TENAXUM not take the following medicines (see. Also "Do not take TENAXUM" in section 2):
Sultopride (used to treat psychiatric disorders such as schizophrenia).
Talk to your doctor if you are taking any of these medicines as their combination with TENAKSUM not recommended:
Beta-blockers (bisoprolol, carvedilol, metoprolol) used for the treatment of heart failure;
MAO inhibitors (used to treat depression).
Talk to your doctor if you are taking any of these medicines as may be required special attention:
baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis);
beta-blockers (used to treat high blood pressure, angina pectoris, a condition causing chest pain);
drugs used to treat heart rhythm problems (quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, sotalol);
some neuroleptics (ie. "soothing nerves substances" used to treat psychiatric disorders: chlorpromazine, levomepromazine, thioridazine, amisulpride, sulpiride, tiapride, droperidol, haloperidol, pimozide;
halofantrine (antiparasitic drug used to treat certain types of malaria);
mizolastine (used to treat allergic reactions such as hay fever);
moxifloxacin, erythromycin IV, spiramycin IV (antibiotics used to treat infections);
pentamidine (used to treat certain types of pneumonia);
vincamine IV (used to treat symptomatic cognitive disorders in elderly including memory loss);
bepridil (used to treat angina condition causing chest pain);
cisapride, diphemanil (used for the treatment of gastrointestinal problems);
tricyclic antidepressants (used to treat depression);
other antihypertensives except TENAXUM (used to treat high blood pressure).
Talk to your doctor if you are taking any of these medicines as their combination with TENAXUM should be considered:
alpha-blockers (used to treat high blood pressure);
amifostine (used in chemo- and radiotherapy);
corticosteroids (used to treat various conditions including acute asthma and rheumatoid arthritis), tetracosactide (for the treatment of Crohn's disease) (oral treatment) (except hydrocortisone used in Addison's disease);
other neuroleptics (ie. "soothing nerves substances" used to treat psychiatric disorders), Imipramine antidepressants (used to treat psychiatric disorders such as depression);
other drugs acting on the central nervous system that can impair your alertness when used in combination with TENAXUM: derivatives of morphine (analgesics, cough medicines and replacement therapies), medication for anxiety; sleep problems (benzodiazepines, anxiolytics other than benzodiazepines, hypnotics, neuroleptics), H1 sedating histamine antagonists (used for the treatment of allergy or allergic reactions), drugs to treat depression (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine ), other centrally acting antihypertensive agents, baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis), thalidomide (used to treat certain types of cancer), pizotifen and indoramin (used for the treatment of migraine).
TENAXUM with food, drinks and alcohol
Avoid alcohol during treatment with TENAXUM
Take TENAKSUM as prescribed by your doctor at the beginning of meals.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
pregnancy
This medicine is not recommended during pregnancy.
breastfeeding
You should not take TENAXUM if you are breastfeeding. Tell your doctor immediately if you are breast feeding, or think to start breast-feeding.
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Fertility
Studies to date have shown no effect on fertility.
Driving and using machines
TENAXUM can affect your ability to drive or operate machinery due to the risk of drowsiness.
TENAKSUM contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.
3. How to take TENAXUM
Method and routes of administration
Oral use.
Dosage and frequency of administration
Always take TENAKSUM just as you have been told by your doctor. Talk to him or your pharmacist if you are unsure about something. The usual dose is 1 tablet per day. It is recommended to take the drug as a single dose in the morning.
In the event of an unsatisfactory result after one month of treatment, the dose may be increased to 2 tablets per day. It is recommended to be taken in two doses (one tablet in the morning and evening) before meals.
In renal failure, if creatinine clearance is greater than 15 ml / min, the dose is generally remains the same.
If you take more than the amount TENAXUM
In case you take too many tablets, your blood pressure can greatly change your vigilance and not be disturbed. Please immediately contact your pharmacist
If you forget to take TENAXUM
Do not take a double dose to make up for a forgotten tablet.
If you stop taking TENAXUM
Never stop treatment suddenly, your doctor will gradually reduce your dose.
If you have further questions about using this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like any drug, this drug can cause side effects, although not everybody gets them.
The following adverse reactions have been reported:
Common (may affect up to 1 in 10 people):
anxiety, depression, insomnia, drowsiness, headache, dizziness, palpitations (awareness of heartbeats), abdominal pain, dry mouth, diarrhea, constipation, skin rash, itching, muscle cramps, cold extremities (hands and / or feet) edema, weakness, fatigue, sexual dysfunction.
Uncommon (may affect up to 1 in 100 people):
nausea, hot flashes, decrease in blood pressure in the upright position.

5. How to store TENAXUM
Keep at temperatures below 25 ° C.
Keep out of reach of children.
Do not use TENAXUM after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What TENAXUM
The active substance is rilmenidine, each tablet contains 1 mg of rilmenidine.
Other ingredients are: anhydrous colloidal silica, lactose, magnesium stearate, microcrystalline cellulose, paraffin, sodium starch glycolate, talc, white beeswax.
TENAXUM looks like and contents of the pack
TENAXUM 1 mg tablets are white, convex tablets engraved with "H" on both sides.
The tablets are available in PVC / aluminum packaging (blisters) with 30 tablets.