PHYSIOTENS 0.4

Package leaflet: Information for the patient

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 the following information 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 share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately.

Table of contents

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

Physiotens 0.4 contains moxonidine. This medicine belongs to a group of antihypertensive drugs.
Physiotens 0.4 is used in the treatment of high blood pressure (hypertension).
It works by relaxing and widening blood vessels. This helps 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 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 conditions apply. If in doubt, consult a doctor or pharmacist before taking Physiotens 0.4.

Warnings and precautions
Before starting treatment with Physiotens 0.4, 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 conditions apply or if in doubt, consult a doctor or pharmacist before taking Physiotens 0.4.

Physiotens 0.4 and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, including those obtained without a prescription, as well as herbal remedies. Physiotens 0.4 may affect the action of other medicines, and other medicines may affect the action of Physiotens 0.4. Specifically, inform your doctor or pharmacist if you are taking the following medicines:

• other antihypertensive medicines. Physiotens 0.4 may enhance their effect;
• medicines used in depression such as imipramine or amitriptyline;
• sedatives or sleeping medicines such as benzodiazepines;
• β-blockers (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 in the same way may influence the effect of Physiotens 0.4. If any of the above apply or if in doubt, 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 discontinuing treatment with Physiotens 0.4 and will prescribe an alternative medicine.
• Inform your doctor if you are breastfeeding or intend to breastfeed. Physiotens 0.4 is not recommended for breastfeeding women. Your doctor may prescribe an alternative 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 0.4, drowsiness or dizziness may occur. If these symptoms occur, consult your doctor before driving or operating machinery.

Physiotens 0.4 contains monohydrate lactose (a type of sugar). If you have an intolerance or impaired ability 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 directed by your doctor. If you have any doubts,
you should contact your doctor or pharmacist again.
Instructions for administration

• 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 up to 0.6 mg per day.
• If your doctor has prescribed 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 you should
If you take more Physiotens 0.4 than prescribed, you must immediately inform your doctor 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 forget to take 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 forgotten dose.

Stopping Physiotens 0.4

• You should continue taking the tablets until your doctor decides to stop treatment.
• If you need 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 blood pressure (such as a β-blocker), your doctor will decide which medicine should be stopped 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 reactions

Like all medicines, Physiotens 0.4 may cause adverse reactions, although not everybody gets them. The following undesirable effects may occur after taking this medicine:
Immediately discontinue use of Physiotens 0.4 if any of the following serious adverse reactions occur – urgent medical treatment may be required:

• 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 disturbances (insomnia), drowsiness (somnolence)
• nausea, diarrhoea, vomiting, digestive disorders (dyspepsia).

Uncommon (occur in 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 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 packaging. The expiry date refers to the last day of the specified month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Physiotens 0.4 contains

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

What Physiotens 0.4 looks like and contents of the pack
Tablets of 0.4 mg are round, dark red, with an embossed "0.4".
Pack contains 28 film-coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Lithuania, country of export:
Viatris SIA
Mūkusalas 101
Riga, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Lithuania, country of export: LT/1/97/1627/003
Parallel Import Authorisation Number: 136/20