FISIOTENS 0.2 MG Film-coated tablets

Зміст інструкції

1. What FISIOTENS is and what it is used for
2. What you need to know before you take FISIOTENS
3. How to take FISIOTENS
4. Possible side effects
5. How to store FISIOTENS
6. Contents of the pack and other information

Fisiotens film-coated tablets
0.2 milligrams, 0.3 milligrams, 0.4 milligrams
Moxonidine
Read this leaflet carefully before using the medicine, as it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Fisiotens is and what it is used for
• 2. What you need to know before you take Fisiotens
• 3. How to take Fisiotens
• 4. Possible side effects
• 5. How to store Fisiotens
• 6. Contents of the pack and other information

1. What FISIOTENS is and what it is used for

Fisiotens contains a drug called moxonidine. This drug belongs to a group of drugs called “antihypertensives”.
Fisiotens is used to treat high blood pressure (hypertension) and works by
making blood vessels relaxed and dilated. This helps to lower blood
pressure.

2. What you need to know before you take FISIOTENS

Do not take Fisiotens if:

• you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you have a slow heartbeat due to a heart problem called “sick sinus syndrome” or “second or third degree atrioventricular block”;
• you have heart failure
• bradycardia (resting heart rate <50 beats/min)

Do not take Fisiotens if any of the above conditions apply to you. If you have
doubts, consult your doctor or pharmacist before taking Fisiotens.

Take special care with Fisiotens
Before taking the medicine consult your doctor or pharmacist:

• if you have a heart problem called “first degree atrioventricular block”
• if you have a severe illness of the heart arteries or unstable chest pain (angina)
• if you have kidney problems. Your doctor may need to adjust your dosage

Before taking Fisiotens consult your doctor or pharmacist if any of the
conditions above apply to you (or if you are not sure).

Use with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines, including those without a prescription
and herbal medicines, as Fisiotens may have an effect on the
mechanism of action of other drugs and other drugs may affect the mechanism
of action of Fisiotens.
In particular, tell your doctor or pharmacist if you are already taking any of the
following medicines:

• other medicines to lower blood pressure. Fisiotens may increase the effect of these medicines
• antidepressant medicines (such as tricyclic antidepressants, e.g. imipramine or amitriptyline), co-administration should be avoided tranquilizers, sedatives or hypnotics, as monoxidina may increase their effect
• benzodiazepines
• beta-blockers (see “If you stop taking Fisiotens” in section 3)
• Fisiotens is eliminated through the kidneys through a mechanism called “tubular excretion”. Other drugs eliminated through the kidneys with the same mechanism may have an effect on the action of Fisiotens.

Before taking Fisiotens consult your doctor or pharmacist if any of the
conditions above apply to you (or if you are not sure).

Use with food and drink

• You can take the tablets during or away from meals.
• Do not drink alcohol while taking Fisiotens as the effects of alcohol may be increased by Fisiotens.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a
pregnancy, or if you are breastfeeding with breast milk, ask your doctor or
pharmacist for advice before
taking this medicine

• Tell your doctor if you are pregnant or think you may be soon. The doctor will tell you to stop Fisiotens and take another medicine.
• Tell your doctor if you are breastfeeding or are about to start breastfeeding. Fisiotens is not indicated for breastfeeding women. The doctor will advise you to take another medicine if you want to breastfeed or ask you to stop breastfeeding.

Driving and using machines
You may feel drowsy or dizzy while taking Fisiotens. If this happens,
tell your doctor before driving or using any tools or machinery.

Fisiotens contains
Fisiotens contains lactose (a type of sugar). If your doctor has diagnosed you with
intolerance to certain sugars, contact him before taking this medicine.

3. How to take FISIOTENS

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

Taking the medicine

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

How much to take

• The initial dose is normally 0.2 mg per day.
• Your doctor may increase the dose up to 0.6 mg per day.
• If your doctor has told you to take 0.6 mg per day, the dose must be taken in two separate doses
• The maximum single daily dose is 0.4 mg
• If you have kidney problems, your doctor may advise a lower dose.
• If you are over 65 years of age, your doctor may advise a lower dose.

Children and adolescents
Fisiotens should not be used by children and adolescents under 18 years of age.

If you take more FISIOTENS than you should
If you take more Fisiotens than you should, tell your doctor immediately or go to hospital. Bring the medicine pack with you. Possible side effects may include: headache, feeling sleepy (somnolence, sedation), decreased blood pressure (hypotension), slowed heartbeat (bradycardia), dizziness, vomiting, dry mouth, feeling tired (fatigue), weakness and stomach pain (abdominal pain).
Temporary high blood pressure, tachycardia and hyperglycemia may also occur.

If you forget to take FISIOTENS

• If you forget to take a dose, take it as soon as you remember. However, if it is already almost time to take the next dose, do not take the forgotten dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking FISIOTENS

• Take the tablets until your doctor decides to stop them.
• If you need to stop taking them, your doctor will gradually reduce the dose over a few weeks. If you are taking more than one medicine for high blood pressure (such as beta-blockers), your doctor will tell you which medicine to stop first, to allow your body to slowly adjust to the change.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with this medicine:

Stop taking Fisiotens and consult a doctor immediately if you notice
any of the following serious side effects for which you may need
urgent medical treatment:

• swelling of the face, lips or mouth (angioedema). This effect is uncommon and has been found in less than 1 in 100 people.

Other side effects include:
Very common (affects more than 1 in 10 people)

• dry mouth

Common(affects less than 1 in 10 people)

• back pain
• headache
• weakness (asthenia)
• dizziness, lightheadedness
• rash or itching
• difficulty sleeping (insomnia), drowsiness
• nausea, diarrhea, vomiting, indigestion (dyspepsia)

Uncommon(affects less than 1 in 100 people)

• neck pain
• nervousness
• fainting (syncope)
• swelling (edema)
• sounds or noise in the ears (tinnitus)
• unusually slow heartbeat (bradycardia)
• low blood pressure, including low pressure when standing up

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also
be reported directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store FISIOTENS

• Keep this medicine out of the sight and reach of children.
• Fisiotens 0,2 mg film-coated tablets: do not store at a temperature above 25 °C.
• Fisiotens 0,3 mg and 0.4 mg film-coated tablets: do not store at a temperature above 30°C.
• Do not use Fisiotens after the expiry date which is stated on the package and blister. The expiry date refers to the last day of the month indicated.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fisiotens contains

• The active ingredient is moxonidine. Each tablet contains 0.2 mg, 0.3 mg or 0.4 mg.
• The other ingredients are lactose monohydrate, povidone K 25, crospovidone, magnesium stearate, hypromellose, ethylcellulose, macrogol 6000, talc, red iron oxide (E 172) and titanium dioxide (E 171).

Description of the appearance of Fisiotens and contents of the pack
The 0.2 mg tablets are round, light pink in colour and marked with “0.2”.
The 0.3 mg tablets are round, light red in colour and marked with “0.3”.
The 0.4 mg tablets are round, opaque red in colour and marked with “0.4”.
Fisiotens is supplied in blisters containing 28 tablets in packs of 28 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Fisiotens is:
BGP PRODUCTS S.r.l.- Viale Giorgio Ribotta 11- 00144 Roma
The tablets are manufactured by:
Abbott Healthcare SAS, Route de Belleville, Lieu-dit « Maillard », 01400 Châtillon-sur-
Chalaronne, France