Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Physiotens 0.4
0.4 mg, coated tablets
Moxonidinum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
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. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Physiotens 0.4 is and what it is used for
What you need to know before taking Physiotens 0.4
How to take Physiotens 0.4
Possible side effects
How to store Physiotens 0.4
Contents of the pack and other information

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

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

2. Information before taking Physiotens 0.4

When not to take Physiotens 0.4:

if the patient is allergic (hypersensitive) to moxonidine or to any of the other ingredients of Physiotens 0.4 (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 0.4 if any of the above apply. If in doubt, consult a doctor or pharmacist before taking Physiotens 0.4.

Warnings and precautions
Before starting to take Physiotens 0.4, consult a doctor or pharmacist if:

there is a heart condition called "first-degree atrioventricular block";
there is severe coronary insufficiency or unstable angina pectoris;
there is renal impairment. The doctor may need to adjust the dose. If any of the above apply or if there is any uncertainty, consult a doctor or pharmacist before taking Physiotens 0.4.

Physiotens 0.4 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, including those obtained without a prescription, as well as herbal medicines. Physiotens 0.4 may affect the action of other medicines, and other medicines may 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 enhance the effect of these medicines;
medicines used for depression, such as imipramine or amitriptyline;
sedatives or sleeping medicines, such as benzodiazepines;
β-adrenolytics (see "Discontinuation of Physiotens 0.4" in section 3);
Physiotens 0.4 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 0.4. If any of the above apply or if there is any uncertainty, consult a doctor or pharmacist before taking Physiotens 0.4.

Taking Physiotens 0.4 with food and drink

Tablets may be taken with or without food.
Do not drink alcohol while taking Physiotens 0.4. Physiotens 0.4 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 stopping treatment with Physiotens 0.4 and will prescribe an alternative medicine.
Inform your doctor if you are breastfeeding or planning to breastfeed. Physiotens 0.4 is not recommended for breastfeeding women. Your doctor may prescribe an alternative medicine or advise stopping breastfeeding.
Always consult a doctor or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and operating machinery
Drowsiness or dizziness may occur while taking Physiotens 0.4. If these symptoms occur, contact your doctor before driving or operating machinery.

Physiotens 0.4 contains lactose monohydrate
Physiotens 0.4 contains lactose monohydrate (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

Physiotens 0.4 should always be taken as prescribed by your doctor. If you have any doubts,
you should contact your doctor or pharmacist again.
The following products are available on the market: Physiotens 0.2 (0.2 mg), Physiotens 0.4 (0.4 mg).
Administration instructions

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 separate 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 must not be given to children and adolescents under 18 years of age.
If you take more Physiotens 0.4 than prescribed
If you take more Physiotens 0.4 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 0.4

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

Stopping Physiotens 0.4

Continue taking the tablets until your doctor decides to discontinue treatment.
If it becomes necessary to stop taking 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 intended to allow your body to adjust to the change. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, the medicine Physiotens 0.4 may cause adverse reactions, although not everyone experiences them. The following undesirable symptoms may occur after taking this medicine:
Immediately discontinue use of Physiotens 0.4 if any of the following severe adverse reactions occur – urgent medical treatment may be necessary:

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

Other adverse reactions include:
Very common (affecting more than 1 in 10 people)

dryness of the oral mucosa.

Common (affecting less than 1 in 10 people)

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

Uncommon (affecting 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Physiotens 0,4

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines must 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.
Other ingredients are: lactose monohydrate, povidone, crospovidone, magnesium stearate.
Coating composition: hypromellose, ethylcellulose, polyethylene glycol 6000, talc, iron oxide red (E 172), titanium dioxide (E 171).

What Physiotens 0.4 looks like and contents of the pack
Round, dark red coated tablets, embossed with "0.4".
Pack contains 28 or 98 coated tablets.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Lithuania, country of export:
Viatris SIA
Mūkusalas 101, Riga, LV 1004, Latvia
Manufacturer:
Mylan Laboratories SAS
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 authorization number in Lithuania, country of export: LT/1/97/1627/003
LT/1/97/1627/004
Parallel import authorization number: 273/20