Physiotens (Moxonidine) 28 Tablets

PHYSIOTENS film coated tablet is taken orally.

Excipients

Tablet core: Lactose monohydrate, povidone K25, crospovidone, magnesium stearate. Tablet coating: Hypromellose, ethylcellulose, macrogol 6000, talc, red iron oxide (E172), titanium dioxide (E171).

2. What is PHYSIOTENS and what is it used for?

PHYSIOTENS is presented in blister packaging containing 28 film coated tablets.

Tablets are printed on a face of "0.4", matte red in color, convex and round. Blister pack contains 28 film coated tablets.

Each film tablet contains 0.4 mg of moxonidine.

PHYSIOTENS is a group of drugs called antihypertensives. Drugs in this group reduce high blood pressure.

3. How to use PHYSIOTENS?

Instructions for proper use and dose / frequency of administration

Patients with high blood pressure often do not pay attention to the symptoms of this problem. Many people may feel normal in this situation. Even if you feel good, it makes it more important for you to take your medication and to do what your doctor and pharmacist say. To get the best result and reduce the risk of side effects, it is very important that you take this medicine exactly as your doctor says.

Do not exceed the recommended dose.

Your doctor will decide how much and how often to use PHYSIOTENS.
For the treatment of high blood pressure, the standard starting dose is a 0.2 mg tablet once a day. In some cases, your doctor may prescribe a higher dose, 0.4 mg. Do not take more than 0.4 mg dose at a time. The highest daily dose that can be taken is 0.6 mg divided into 2 equal doses.

Application route and method

PHYSIOTENS are used only by mouth.

PHYSIOTENS may be taken on an empty stomach or in combination with food. Swallow the tablet with a glass of water.

Different age groups

Use inuse

children Due to insufficient safety and efficacy data, thief PHYSIOTENS in children or adolescents under 18 years of age is not recommended.

use in elderly

A special dose for persons aged 65 or over is not a suggestion.

Specific conditions of use

Kidney failure If you have

moderate or severe kidney disease (kidney failure) or if hemodialysis (mechanical cleansing of blood) is applied, you as your starting dose

will be given 0.2 mg per day. Your doctor can increase the daily dose to 0.4 mg if necessary and tolerated.

Unless your doctor recommends otherwise follow these instructions. Your doctor will tell you how long your treatment with PHYSIOTENS will take. Do not interrupt treatment early, because stopping PHYSIOTENS may cause your illness to deteriorate.

If you PHYSIOTENS is have an impression that the effect of too strong or too weak, talk to your doctor or pharmacist.

UsingNizar

PHYSIOTENS If you use more than you should

talk to your doctor or pharmacist if you use more than you need to use the physıotens'.

If you have forgotten to use PHYSIOTENS

, it is recommended that you take your medicine every day at the same time, preferably in the morning. When you forget to take a dose of the drug, take a tablet immediately.

If the next dose is close to the time of taking the medication, do not skip this dose and then continue normal use.

Do not take double doses to compensate for forgotten doses.

The effects that may occur when treatment with PHYSIOTENS is stopped Interrupting PHYSIOTENS may cause your

illness to deteriorate.

Do not discontinue the treatment unless indicated by your doctor.

4. What are the possible side effects?

As with all medicines, PHYSIOTENS may have side effects in people who are sensitive to substances found in their contents.

(During the placebo-controlled studies (patients moxonidine n = 886) observed undesirable effects)

if one of the following, please stop using the physıotens and tell your doctor immediately, or you contact the emergency department of the nearest hospital:

rash, allergic skin reactions such as itching

head, face and Angioedema characterized by sudden swelling seen in the neck area

Extensive swelling of the body (edema) in the arms and legs

Faintness (syncope)

These are all very serious side effects.

If you have one of these, you have a serious allergy to PHYSIOTENS. You may need urgent medical attention or hospitalization. All of these very serious side effects are very rare.

If you notice any of the following, report it to your doctor immediately or contact the nearest hospital emergency department:

Slow heart rate (bradycardia)

Blood pressure drop (including blood pressure drop while standing)

These are all serious side effects. Emergency medical intervention may be required.

Serious side effects are very rare.

If you notice any of the following, tell your doctor:

Headache

Dizziness / vertigo

Mouth dryness, nausea

General fatigue, halzis

Drowsiness

rash Itching, rash

Tinnitus

Diarrhea, vomiting, indigestion

Low back pain / neck pain

Insomnia, irritability

These are PHYSIOTENS slight side effects.

2. Things to consider before using

PHYSIOTENS DO NOT use PHYSIOTENSmoxonidine

if: You

• are hypersensitive to any of the excipients in the above-mentioned composition ofor the drug (consult your doctor for advice if you think you may be allergic).

• Sick sinus syndrome (heart arrhythmia due to sinus nodule)

• Severe bradycardia, ie when your heart rate at rest is below 50 strokes / minute.

• 2nd or 3rd degree AV block (a heart rhythm disorder where the heart rate slows down and the heart's contractile power decreases)

• Heart failure (heart muscle weakness)

• Tell your doctor if any of the above conditions fit you.

• USE PHYSIOTENS CAREFULLY

• • If you have kidney failure

• Physiotens active substance (moxonidine) is excreted from your body mainly with your kidneys, your doctor will be careful about the drug dose if you have kidney disease. In general, the dose will be increased starting with a daily dose of 0.2 mg of moxonidine, and only when necessary and well tolerated (max. 0.4 mg per day).

• If you are diagnosed with a 1st degree AV block (decrease in heart rate), your doctor will monitor you closely and / or take special precautions when using Physiotens to prevent excessive heart rate (bradycardia).

• If you have severe cardiovascular disease (coronary artery disease) or long-lasting chest pain (unstable angina pectoris), your physician will be cautious in recommending Physiotens as experience in using Physiotens is limited in people with this condition. In these circumstances, you will only receive this medicine when it is very necessary.

• If a drug is added to your treatment, the beta blocker should be discontinued gradually in the event of withdrawal of both drugs.
  Before the beta blocker and after a few days the Physiotens will be cut off.

• Although there is no evidence that the immediate discontinuation of Physiotens therapy has a secondary effect on blood pressure, abrupt discontinuation of your medication is not recommended. Therefore during treatment cessation you will be told to cut down by a period of two weeks.

• Please consult your doctor if these warnings are valid for you, even at any time in the past. Using

• PHYSIOTENS with food and drink You can take

• PHYSIOTENS with food or on an empty stomach.

• Pregnancy

• Consult your doctor or pharmacist before using the medicine.

• If you are pregnant, plan to become pregnant, or suspect that you are pregnant, tell your doctor immediately.

• Pregnant women have not been studied; therefore, no data were collected for these individuals.

• The potential risk for humans is unknown, but if you are pregnant you should not use Physiotens unless your doctor decides it is absolutely necessary.

• If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

• Breastfeeding

• Consult your doctor or pharmacist before using the medicine.

• Tell your doctor if you are breastfeeding.

• Moxonidine passes into breast milk and therefore do not use PHYSIOTENS during the breastfeeding period. If your doctor determines that Physiotens treatment is absolutely necessary, you should stop breastfeeding your baby.

• Use of and machines

• tool No studies have been carried out on whether PHYSIOTENS has an effect on the use of vehicles or machinery.

• However, since drowsiness and dizziness are reported as possible side effects, you should be aware of how this medicine affects you before using the tool and machine.

• Important information about some of the ingredients in the

• content of PHYSIOTENS If you do not have an extreme sensitivity to the excipients contained in PHYSIOTENS content, no adverse effect due to these substances is expected.

• This drug contains lactose. If you have hereditary disorders such as galactose intolerance (lap-lactase deficiency or glucose-galactose malabsorption), you should not use this medicine.

• In combination with other drugs

• Other blood pressure medications, antidepressants, sedatives, tranklizanlar and alcohol can interact with moxonidine. If you are using any of these drugs, please inform your doctor. Do not drink alcohol while using Physiotens.

• • When moxonidin is used in combination with other drugs that lower blood pressure (other antihypertensive drugs), the drugs do not interfere with the blood pressure lowering effect of each (more additive effect).

• Tricyclic antidepressants (eg Amitriptyline) used in the treatment of depression may reduce the effectiveness of PHYSIOTENS (and other centrally acting antihypertensives). Combination of these drugs is not recommended.

• Moxonidine may increase the effect of tricyclic antidepressants, tranklizans, alcohol, sedatives and hypnotics. These drugs should not be given with moxonidine.

• Please inform your doctor if you are using certain medicines that are used to treat anxiety, anxiety and classified as benzodiazepine.

• Moxonidine Impaired performance (eg cognitive functions in lorazepam users
  moderately deteriorated, concentration, memory function) in. Moxonidine may increase the sedative effect of benzodiazepines (eg Valium) when used together.

• Moxonidine is excreted by tubular excretion (via the kidneys). Therefore, it is possible for Moxonidine to interact with drugs thrown in the same way.

Storage of

PHYSIOTENS PHYSIOTENS Keep out of the reach of children and in its packaging.

Store at room temperature below 30 ° C. Use in accordance with the expiry date.

Do not use PHYSIOTENS after the expiration date in the packaging.