Fisiotens

Package leaflet: Information for the user

Fisiotens film-coated tablets

0.2 milligrams, 0.3 milligrams, 0.4 milligrams
Moxonidine
Please read this leaflet carefully before using this medicine, because 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 for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 medicine called moxonidine. This medicine belongs to a group of medicines called "antihypertensives".
FISIOTENS is used to treat high blood pressure (hypertension) and works by relaxing and widening the blood vessels. This helps to lower blood pressure.

2. What you need to know before taking FISIOTENS

Do not take Fisiotens if:

• you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you have a slow heartbeat due to a heart condition called "sinoatrial disease" or "second- or third-degree atrioventricular block";
• you have heart failure;
• you have bradycardia (resting heart rate <50 beats/min).

Do not take Fisiotens if any of the conditions listed above 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 condition called "first-degree atrioventricular block";
• if you have severe coronary artery disease 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 listed above apply to you (or if you are unsure).
Use with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines, including those without a prescription and
herbal medicines, as Fisiotens may affect the way other drugs work, and other drugs may influence the action of Fisiotens.
In particular, inform your doctor or pharmacist if you are already taking any of
the following medicines:

• other medicines to lower blood pressure. Fisiotens may enhance the effect of these medicines;
• antidepressants (such as tricyclic antidepressants, e.g. imipramine or amitriptyline); co-administration should be avoided, as well as tranquilizers, sedatives or hypnotics, since monoxidine may increase their effects;
• benzodiazepines;
• beta-blockers (see "If you stop taking Fisiotens" in section 3);
• Fisiotens is eliminated through the kidneys via a mechanism called "tubular excretion". Other drugs eliminated through the kidneys by the same mechanism may affect the action of Fisiotens.

Before taking Fisiotens, consult your doctor or pharmacist if any of the
conditions listed above apply to you (or if you are unsure).
Use of Fisiotens with food and drink

• You may take the tablets during or between 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, planning a pregnancy, or breastfeeding,
seek advice from your doctor or pharmacist before taking this medicine.

• Inform your doctor if you are pregnant or think you might become pregnant soon. Your doctor will tell you to stop taking Fisiotens and switch to another medicine.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Fisiotens is not recommended for women who are breastfeeding. Your doctor will advise you to take another medicine if you wish to breastfeed or will ask you to stop breastfeeding.

Driving and using machines
You may experience drowsiness or dizziness while taking Fisiotens. If this occurs,
inform your doctor before driving or operating any tools or machinery.
Fisiotens contains
Fisiotens contains lactose (a type of sugar). If your doctor has diagnosed you with an
intolerance to certain sugars, contact them before taking this medicine.

3. How to take FISIOTENS

Take this medicine exactly as prescribed by your doctor. If you
have any doubts, consult your doctor or pharmacist.
How to take the medicine

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

Dosage

• The usual starting dose is 0.2 mg daily.
• Your doctor may increase your dose up to 0.6 mg daily.
• If your doctor has instructed you to take 0.6 mg daily, this dose should be taken in two separate doses.
• The maximum single daily dose is 0.4 mg.
• If you have kidney problems, your doctor may prescribe you a lower dose.
• If you are over 65 years old, your doctor may prescribe you a lower dose.

Children and adolescents
FISIOTENS must not be used in children and adolescents under 18 years of age.
If you take more FISIOTENS than you should
If you take more FISIOTENS than prescribed, contact your doctor immediately or go
to hospital. Take the medicine pack with you. The following symptoms may occur:
headache, drowsiness (sedation), decreased blood pressure (hypotension), slow heart
rate (bradycardia), dizziness, vomiting, dry mouth, feeling of fatigue (tiredness),
weakness, and stomach pain (abdominal pain).
Temporary hypertension, tachycardia, and hyperglycaemia 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 almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking FISIOTENS

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

If you have any questions about how to use this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone experiences 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 which may require
urgent medical treatment:

• swelling of the face, lips or mouth (angioedema). This effect is not common and has been observed in fewer 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 falling asleep (insomnia), drowsiness
• nausea, diarrhoea, vomiting, indigestion (dyspepsia)

Uncommon (affects less than 1 in 100 people)

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

Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, talk to your doctor or pharmacist. Side effects can also
be reported directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects
helps 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 above 25°C.
• Fisiotens 0.3 mg and 0.4 mg film-coated tablets: do not store above 30°C.
• Do not use Fisiotens after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month indicated.
• Medicines must 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. Package contents and other information

What Fisiotens contains

• The active substance 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, iron oxide red (E 172) and titanium dioxide (E 171).

Description of the appearance of Fisiotens and package contents
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 Rome, Italy
The tablets are manufactured by:
Abbott Healthcare SAS, Route de Belleville, Lieu-dit « Maillard », 01400 Châtillon-sur-Chalaronne, France