Phisiotens 0,4

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Physiotens 0.4, 0.4 mg, coated tablets
Moxonidine

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 or pharmacist.
• This medicine has been prescribed specifically for you. 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 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 widening the blood vessels. This helps to lower blood pressure.

2. Important information before taking Physiotens 0.4

When not to take Physiotens 0.4:

• if the patient is allergic (hypersensitive) to moxonidine or any of the other ingredients of Physiotens 0.4 (listed in section 6);
• if the patient has a slow heart rate caused by a disease called "sick sinus syndrome" or "second- or third-degree atrioventricular block";
• if the patient has 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 obtained 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-adrenergic 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 tubular excretion". Other medicines that are excreted 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 plan 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 these symptoms occur, consult your doctor before driving or operating machinery.
Physiotens 0.4 contains lactose monohydrate(a type of sugar). If you have an intolerance or are unable to digest some sugars, consult your doctor before taking Physiotens 0.4.

3. How to take Physiotens 0.4

Physiotens 0.4 should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Administration

• Swallow the tablets whole with a glass of water.
• Take the tablets at the same time every 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, the dose should be taken 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.

Taking a higher dose of Physiotens 0.4 than prescribed

If you have taken a higher dose of Physiotens 0.4 than prescribed, tell your doctor or go to the nearest hospital immediately. Take the packaging 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 Physiotens 0.4, your doctor will gradually reduce the dose over a period of several weeks. If you are taking more than one medicine to lower blood pressure, your doctor will decide which medicine 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 if you experience any of the following serious side effects - you may need urgent medical attention:

• -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)

• dryness of the 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
• edema
• 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
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 packaging. The expiry date refers to the last day of the month stated.
• 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 coated tablets.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Viatris SIA
Mūkusalas 101
Ryga, LV 1004
Latvia

Manufacturer:

Mylan Laboratories SAS
Route de Belleville
Lieu-dit “Maillard”
01400 Chatillon sur Chalaronne
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 Lithuania, the country of export:LT/1/97/1627/003
Parallel import authorization number:136/20

Date of approval of the leaflet: 21.03.2025

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