Patient Information Leaflet

Caution! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Physiotens 0.2 (Physiotens 0.2 mg)
0.2 mg, film-coated tablets
Moxonidinum
Physiotens 0.2 and Physiotens 0.2 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are similar.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Table of Contents

What Physiotens 0.2 is and what it is used for
Important information before taking Physiotens 0.2
How to take Physiotens 0.2
Possible side effects
How to store Physiotens 0.2
Contents of the pack and other information

1. What Physiotens 0.2 is and what it is used for

Physiotens 0.2 contains moxonidine. This medicine belongs to a group of medicines known as antihypertensives.
Physiotens 0.2 is used in the treatment of high blood pressure (hypertension).
It works by relaxing and widening blood vessels, which helps lower blood pressure.

2. Important information before taking Physiotens 0.2

When not to take Physiotens 0.2:

if the patient is allergic (hypersensitive) to moxonidine or to any of the other ingredients of Physiotens 0.2 (listed in section 6);
if the patient has a slow heart rate caused by a condition called "sick sinus syndrome" or "second- or third-degree atrioventricular block";
if the patient has heart failure. Do not take Physiotens 0.2 if any of the above apply. If in doubt, consult a doctor or pharmacist before taking Physiotens 0.2.

Warnings and precautions
Before starting treatment with Physiotens 0.2, consult a doctor or
pharmacist if:

there is a heart condition known as "first-degree atrioventricular block";
there is severe coronary insufficiency or unstable angina pectoris;
there is renal impairment. Dose adjustment by a doctor may be necessary. If any of the above apply or if there are any doubts, speak with a doctor or pharmacist before using Physiotens 0.2.

Physiotens 0.2 and other medicines
Inform your doctor or pharmacist about all medicines currently taken, including those
obtained without a prescription, as well as herbal medicines. Physiotens 0.2 may affect the
action of other medicines. Likewise, other medicines may affect the action of Physiotens 0.2.
In particular, inform your doctor or pharmacist if you are taking the following medicines:

other antihypertensive medicines. Physiotens 0.2 may enhance the effect of these medicines;
medicines used for depression such as imipramine or amitriptyline;
sedatives or sleeping medicines such as benzodiazepines;
β-blockers (see "Discontinuation of Physiotens 0.2" in section 3);
Physiotens 0.2 is eliminated from the body via the kidneys through a process called "tubular secretion". Other medicines eliminated by the kidneys in the same way may influence the action of Physiotens 0.2. If any of the above apply or if there are any doubts, consult a doctor or pharmacist before using Physiotens 0.2.

Taking Physiotens 0.2 with food and drink

Tablets may be taken with or without food.
Do not drink alcohol while taking Physiotens 0.2. Physiotens 0.2 may intensify the effects of alcohol.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or suspect you may be pregnant. Your doctor will usually advise discontinuation of treatment with Physiotens 0.2 and prescribe an alternative medicine.
Inform your doctor if you are breastfeeding or intend to breastfeed. Physiotens 0.2 is not recommended for breastfeeding women. Your doctor may prescribe an alternative medicine or advise you to stop breastfeeding.
Before taking any medicine during pregnancy or breastfeeding, consult your doctor or pharmacist.

Driving and operating machinery
Drowsiness or dizziness may occur while taking Physiotens 0.2. If these symptoms occur, contact your doctor before driving or operating machinery.
Physiotens 0.2 contains monohydrate lactose (a type of sugar). If you have intolerance or impaired ability to digest certain sugars, consult your doctor before taking Physiotens 0.2.

3. How to take Physiotens 0.2

Physiotens 0.2 should always be taken exactly as prescribed by your doctor. If you are unsure,
please consult your doctor or pharmacist again.
Instructions for administration

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

Dosage

The usual starting dose is 0.2 mg once daily.
Your doctor may increase the dose up to 0.6 mg per day.
If your doctor prescribes 0.6 mg per day, this dose should be divided into two 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 0.2 must not be given to children and adolescents under 18 years of age.
If you take more Physiotens 0.2 than prescribed
If you take more Physiotens 0.2 than prescribed, inform your doctor immediately or go to the nearest hospital.
Take the medicine pack with you. The following symptoms may occur: headache, drowsiness (sedation),
low blood pressure (hypotension), slow heart rate (bradycardia), dizziness, dry mouth, nausea (vomiting),
feeling of fatigue, weakness, and abdominal pain.
If you miss a dose of Physiotens 0.2

If you miss a dose of Physiotens 0.2, 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 0.2

Continue taking the tablets until your doctor decides that treatment should be stopped.
If it becomes necessary to discontinue the medicine, your doctor will gradually reduce the dose over a period of several weeks. If you are taking more than one medicine to lower your blood pressure (such as a β-blocker), your doctor will decide which medicine to stop first. This is to help your body adjust to the change. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Physiotens 0.2 may cause adverse effects, although not everyone experiences them. The following undesirable effects may occur after taking this medicine:
Stop taking Physiotens 0.2 immediately if any of the following serious adverse effects occur – urgent treatment may be required:

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

Other adverse effects include:
Very common (affects more than 1 in 10 people)

dryness of the oral mucosa.

Common (affects less than 1 in 10 people)

back pain,
headache,
fatigue,
dizziness,
rash or itching,
sleep disturbances (insomnia), drowsiness,
nausea, diarrhoea, vomiting, digestive disturbances (dyspepsia).

Uncommon (affects less than 1 in 100 people)

neck pain,
nervousness,
fainting,
oedema,
ringing or noise in the ears (tinnitus),
abnormally slow heart rate (bradycardia),
low blood pressure, including low blood pressure upon standing (orthostatic hypotension).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Physiotens 0.2

Keep this medicine out of the sight and reach of children.
Store below 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Physiotens 0.2 contains

The active substance is moxonidine. Each tablet contains 0.2 mg of moxonidine.
Other ingredients: monohydrate lactose, povidone K 25, crospovidone, magnesium stearate. Coating composition: hypromellose 6 mPa·s, ethylcellulose, polyethylene glycol 6000, talc, iron oxide red (E 172), titanium dioxide.

What Physiotens 0.2 looks like and contents of the pack
The 0.2 mg tablets are round, light pink, with the imprint "0.2".
Pack contains 28 coated tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Croatia, the country of export:
Viatris Hrvatska d.o.o., Koranska 2, 10000 Zagreb, Croatia
Manufacturer:
Mylan Laboratories S.A.S., Route de Belleville, Lieu-dit "Maillard", 01400 Châtillon-sur-Chalaronne,
France
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Croatia, the country of export: HR-H-790867387-01
Parallel Import Authorisation number: 240/23
Translation of weekday abbreviations printed on the blister:
Ponedjeljak - Monday
Utorak - Tuesday
Srijeda - Wednesday
Četvrtak - Thursday
Petak - Friday
Subota - Saturday
Nedjelja - Sunday