Phisiotens 0,4

Package Leaflet: Information for the Patient

Physiotens 0.4

0.4 mg, coated tablets
Moxonidine

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Table of Contents of the Leaflet

• 1. What is Physiotens 0.4 and what is it used for
• 2. Important information before taking Physiotens 0.4
• 3. How to take Physiotens 0.4
• 4. Possible side effects
• 5. How to store Physiotens 0.4
• 6. Contents of the pack and other information

1. What is Physiotens 0.4 and what is it used for

Physiotens 0.4 contains moxonidine. This medicine belongs to a group of antihypertensive medicines.
Physiotens 0.4 is used to treat high blood pressure (hypertension). It works
by relaxing and dilating blood vessels. This helps to lower blood pressure.

When not to take Physiotens 0.4:

• if you are allergic (hypersensitive) to moxonidine or any of the other ingredients of Physiotens 0.4 (listed in section 6)
• if you have a slow heart rate caused by a disease called "sick sinus syndrome" or "second- or third-degree atrioventricular block"
• if you have heart failure. Do not take Physiotens 0.4 if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking Physiotens 0.4.

Warnings and Precautions

Before starting to take Physiotens 0.4, consult your doctor
or pharmacist if:

• you have a heart disease called "first-degree atrioventricular block"
• you have severe coronary insufficiency and unstable angina pectoris
• you have kidney failure. Your doctor may need to adjust the dose. If any of the above applies to you or if you have any doubts, consult your doctor or pharmacist before taking Physiotens 0.4.

Physiotens 0.4 and other medicines

Tell your doctor or pharmacist about all the medicines you have taken recently, including
those that are available without a prescription, as well as herbal medicines. Physiotens 0.4 may affect
the action of other medicines. Other medicines may also affect the action of Physiotens 0.4.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medicines that lower blood pressure. Physiotens 0.4 may increase the effect of these medicines
• medicines used to treat depression, such as imipramine or amitriptyline
• sedatives or sleeping pills, such as benzodiazepines
• β-blockers (see "Stopping Physiotens 0.4" in section 3)
• Physiotens 0.4 is eliminated from the body by the kidneys through a process called "renal excretion". Other medicines that are eliminated by the kidneys in the same way may affect the action of Physiotens 0.4. If any of the above applies to you or if you have any doubts, consult your doctor or pharmacist before taking Physiotens 0.4.

Taking Physiotens 0.4 with food and drink

• The tablets can be taken with or without food.
• Do not drink alcohol while taking Physiotens 0.4. Physiotens 0.4 may increase the effect of alcohol.

Pregnancy and breastfeeding

• Tell your doctor if you are pregnant or think you may be pregnant. Your doctor will usually advise you to stop taking Physiotens 0.4. Your doctor will prescribe another medicine instead of Physiotens 0.4.
• Tell your doctor if you are breastfeeding or planning to breastfeed. Physiotens 0.4 is not recommended for breastfeeding women. Your doctor may advise you to take another medicine or stop breastfeeding.
• Before taking any medicine during pregnancy or breastfeeding, consult your doctor or pharmacist.

Driving and using machines

While taking Physiotens 0.4, you may experience drowsiness or dizziness.
If you experience these symptoms, consult your doctor before driving or operating
machines.
Physiotens 0.4 contains lactose(a type of sugar). If you have an intolerance or are unable to digest certain sugars, consult your doctor before taking Physiotens 0.4.

3. How to take Physiotens 0.4

Always take Physiotens 0.4 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Administration

• Swallow the tablets whole with a glass of water.
• Take the tablets at the same time each day. This will help you remember to take them.

Dosage

• The usual starting dose is 0.2 mg per day.
• Your doctor may increase the dose to 0.6 mg per day.
• If your doctor has prescribed 0.6 mg per day, take it in two divided doses.
• The maximum single dose is 0.4 mg.
• Your doctor may prescribe a lower dose if you have kidney disease.

Use in children and adolescents

Physiotens 0.4 should not be given to children and adolescents under 18 years of age.

Overdose of Physiotens 0.4

If you have taken more Physiotens 0.4 than prescribed, tell your doctor or go to the nearest hospital. Take the package leaflet with you. The following symptoms may occur: headache, drowsiness, low blood pressure, slow heart rate, dizziness, dry mouth, nausea, vomiting, fatigue, weakness, and abdominal pain.

Missing a dose of Physiotens 0.4

• If you miss a dose of Physiotens 0.4, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

Stopping Physiotens 0.4

• Take the tablets until your doctor decides to stop the treatment.
• If you need to stop taking the medicine, your doctor will gradually reduce the dose over a few weeks. If you are taking more than one medicine to lower blood pressure, your doctor will decide which one to stop first. This is to allow your body to adjust to the change. If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Physiotens 0.4 can cause side effects, although not everybody gets them. After taking this medicine, the following side effects may occur:

Stop taking Physiotens 0.4 immediately and seek medical attention if you experience any of the following serious side effects:

• swelling of the face, tongue, or lips (angioedema). This is an uncommon side effect, occurring in less than 1 in 100 people.

Other side effects include:

Very common (occurring in more than 1 in 10 people)

• dry mouth.

Common (occurring in less than 1 in 10 people)

• back pain
• headache
• weakness
• dizziness
• rash or itching
• sleep disturbances (insomnia), drowsiness
• nausea, diarrhea, vomiting, digestive disorders (dyspepsia).

Uncommon (occurring in less than 1 in 100 people)

• neck pain
• nervousness
• fainting
• swelling
• ringing or noise in the ears (tinnitus)
• abnormally slow heart rate (bradycardia)
• low blood pressure, including low blood pressure when standing up.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Pharmacovigilance 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
You can also report side effects 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 Physiotens 0.4

• Keep the medicine out of the sight and reach of children.
• Do not store above 30°C.
• Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
• Medicines should not be disposed of via wastewater or household waste. 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 Physiotens 0.4 contains

• The active substance is moxonidine. Each tablet contains 0.4 mg of moxonidine.
• The other ingredients are: lactose monohydrate, povidone, crospovidone, magnesium stearate. The coating contains: hypromellose, ethylcellulose, macrogol 6000, talc, red iron oxide (E 172), titanium dioxide (E 171).

What Physiotens 0.4 looks like and contents of the pack

The 0.4 mg tablets are round, dark red, with "0.4" engraved.
The pack contains 28 or 98 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer

Mylan Laboratories SAS
Route de Belleville, Lieu-dit Maillard
01400 Châtillon sur Chalaronne
France

For more information, contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
phone: 22 546 64 00
Date of last revision of the leaflet:02/2024