Phisiotens 0,2

Package Leaflet: Information for the Patient

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

Physiotens 0.2

0.2 mg, coated tablets
Moxonidine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Table of Contents of the Leaflet

• 1. What is Physiotens 0.2 and what is it 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. Package contents and other information

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

Physiotens 0.2 contains moxonidine. This medicine belongs to a group of antihypertensive medicines.
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. Important information before taking Physiotens 0.2

When not to take Physiotens 0.2:

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

Warnings and precautions

Before starting to take Physiotens 0.2, 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 doubts, consult your doctor or pharmacist before taking Physiotens 0.2.

Physiotens 0.2 and other medicines

Tell your doctor or pharmacist about all the medicines you have taken recently, including those that are available without a prescription and herbal medicines. Physiotens 0.2 may affect the action of other medicines. Other medicines may also affect the action of Physiotens 0.2.
In particular, inform your doctor or pharmacist if you are taking:

• other medicines that lower blood pressure. Physiotens 0.2 may increase the effect of these medicines;
• medicines used in depression, such as imipramine or amitriptyline;
• sedatives or sleeping pills, such as benzodiazepines;
• β-adrenoreceptor blockers (see "Stopping 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 affect the action of Physiotens 0.2. If any of the above applies to you or if you have doubts, consult your doctor or pharmacist before taking Physiotens 0.2.

Taking Physiotens 0.2 with food and drink

• You can take the tablets with or without food.
• Do not drink alcohol while taking Physiotens 0.2. Physiotens 0.2 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 0.2. Your doctor will prescribe another medicine instead of Physiotens 0.2.
• Tell your doctor if you are breastfeeding or planning to breastfeed. Physiotens 0.2 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 0.2, you may feel drowsy or dizzy. If you experience these symptoms, consult your doctor before driving or operating machinery.
Physiotens 0.2 contains lactose monohydrate(a type of sugar). If you have intolerance or inability to digest some sugars, consult your doctor before taking Physiotens 0.2.

3. How to take Physiotens 0.2

Always take Physiotens 0.2 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Administration rules

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

Doses used

• 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, take the dose 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

Do not give Physiotens 0.2 to children and adolescents under 18 years of age.

Taking a higher dose of Physiotens 0.2 than recommended

If you have taken more Physiotens 0.2 than recommended, tell your doctor or go to the nearest hospital immediately. Take the package leaflet with you. You may experience the following symptoms: headache, drowsiness, low blood pressure, slow heart rate, dizziness, dry mouth, nausea, vomiting, fatigue, weakness, and stomach pain.

Missing 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 the missed dose.

Stopping Physiotens 0.2

• Take the tablets until your doctor decides to stop the treatment.
• If you need to stop taking Physiotens 0.2, your doctor will gradually reduce the dose over a few weeks. If you are taking more than one medicine to lower blood pressure, your doctor will decide which one to stop first. This is to help your body adjust to the change. If you have doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Physiotens 0.2 can cause side effects, although not everybody gets them. After taking this medicine, you may experience the following side effects:

Stop taking Physiotens 0.2 immediately and seek urgent medical attention if you experience any of the following severe side effects:

• 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)

• dry mouth.

Common (occurring in less than 1 in 10 people)

• back pain,
• headache,
• weakness,
• dizziness,
• rash or itching,
• sleep disorders (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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
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 0.2

• 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 packaging. The expiry date refers to the last day of the month stated.
• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Physiotens 0.2 contains

• The active substance is moxonidine. Each tablet contains 0.2 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 0.2 looks like and contents of the pack

The 0.2 mg tablets are round, pale pink, with "0.2" engraved.
The package contains 28 or 98 coated tablets.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Mylan Healthcare SIA
Mūkusalas 101
Riga, LV 1004
Latvia

Manufacturer:

Mylan Laboratories SAS
Route de Belleville
Lieu-dit “Maillard”
01400 Chatillon sur Chalaronne
France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Lithuanian, country of export marketing authorization number: LT/1/97/1627/001
LT/1/97/1627/002

Parallel import authorization number: 116/18 Date of approval of the leaflet: 30.03.2023

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