Physiotens 0.2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Physiotens 0.2
0.2 mg, coated tablets
Moxonidinum
Please read this leaflet carefully before taking this 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. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Table of contents

1. What Physiotens 0.2 is and what it is used for
2. Important information before taking Physiotens 0.2
3. How to take Physiotens 0.2
4. Possible side effects
5. How to store Physiotens 0.2
6. Contents of the pack and other information

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

Physiotens 0.2 contains the active substance moxonidine. This medicine belongs to a group of medicines called antihypertensives.
Physiotens 0.2 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 0.2

When not to take Physiotens 0.2:

• if the patient is allergic (hypersensitive) to moxonidine or 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 to take Physiotens 0.2, consult a doctor or pharmacist if:

• the patient has a heart condition called "first-degree atrioventricular block"
• the patient has severe coronary insufficiency or unstable angina pectoris
• the patient has renal impairment. Dose adjustment by a doctor may be necessary

If any of the above apply or if there are any doubts, speak to a doctor or pharmacist before taking Physiotens 0.2.

Physiotens 0.2 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 0.2 may affect the action of other medicines, and other medicines may affect the action of Physiotens 0.2.
In particular, inform your doctor or pharmacist if you are taking any of 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 by 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, speak to a doctor or pharmacist before taking 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 stopping treatment with Physiotens 0.2 and will prescribe another medicine instead.
• Inform your doctor if you are breastfeeding or intend to breastfeed. Physiotens 0.2 is not recommended for breastfeeding women. Your doctor may recommend taking another medicine or advise discontinuing breastfeeding.
• Before taking any medicine during pregnancy or breastfeeding, consult your doctor or pharmacist.

Driving and operating machinery
During treatment with Physiotens 0.2, drowsiness or dizziness may occur.
If these symptoms occur, consult your doctor before driving or operating machinery.
Physiotens 0.2 contains monohydrate lactose (a type of sugar). If you have an intolerance or are unable to digest certain sugars, consult your doctor before taking Physiotens 0.2.

3. How to take Physiotens 0.2

Physiotens 0.2 must always be taken as prescribed by the doctor. In case of doubt,
consult your doctor or pharmacist again.
Administration instructions

• Swallow the tablets whole with a full glass of water.
• The tablets should be taken 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 to 0.6 mg per day.
• If your doctor has prescribed 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 you should
If you take more Physiotens 0.2 than prescribed, inform your doctor immediately or go to the nearest hospital. Take the medicine package with you. The following symptoms may occur: headache, drowsiness (sedation), low blood pressure (hypotension), slow heart rate (bradycardia), dizziness, dry mouth, nausea (vomiting), feeling tired, weakness, and abdominal pain.
If you forget to take 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 forgotten dose.

Stopping Physiotens 0.2

• Continue taking the tablets until your doctor decides to stop treatment.
• 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 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, Physiotens 0.2 may cause adverse reactions, although not everyone will experience them. The following undesirable effects may occur after taking this medicine:
Immediately discontinue use of Physiotens 0.2 if any of the following serious 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 (occur in more than 1 in 10 people)

• dryness of the oral mucosa

Common (occur in 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 (occur in less than 1 in 100 people)

• neck pain
• nervousness
• fainting
• oedema (swelling)
• 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Physiotens 0,2

• Keep the medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine after the expiry date stated on the carton and blister. 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 pack and other information

What Physiotens 0.2 contains

• The active substance is moxonidine. Each tablet contains 0.2 mg of moxonidine.
• Other ingredients are:
  Core: monohydrate lactose, povidone, crospovidone, magnesium stearate.
  Coating: hypromellose, ethylcellulose, macrogol 6000, talc, iron oxide red (E 172), titanium dioxide (E 171).

What Physiotens 0.2 looks like and contents of the pack
Tablets with a strength of 0.2 mg are round, light pink, with an embossed "0.2".
The pack contains 28 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Lithuania, country of export: LT/1/97/1627/001
Parallel import authorisation number: 268/19