Viapres

Italy
Brand name Viapres
Form tablets, film-coated
Active substance / Dosage
LACIDIPINE
Prescription type Prescription only
ATC code
C08CA09
Registration number 027887
Manufacturer S.F. GROUP S.R.L.

Table of Contents

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

VIAPRES 4 mg film-coated tablets, 6 mg film-coated tablets

Lacidipine
Please read this leaflet carefully before taking this medicine.

  • 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.

Contents of this leaflet:

  1. What Viapres is and what it is used for
  2. Before you take/use Viapres
  3. How to take/use Viapres
  4. Possible side effects
  5. How to store Viapres
  6. Further information

1. What Viapres is and what it is used for

Viapres is used to treat high blood pressure (hypertension). It belongs to a class of medicines called "calcium channel blockers". Viapres has the property of widening (dilating) blood vessels, thereby facilitating blood flow and lowering blood pressure.

2. Before taking Viapres

Do not take Viapres:

  • if you are allergic (hypersensitive) to the active substance or to any of the excipients of Viapres;
  • if you have a heart condition called aortic stenosis. This condition is a narrowing of the valve that allows blood to be pumped out of the heart;
  • if you think any of these conditions applies to you, do not take Viapres before speaking with your doctor.

Take special care with Viapres
Before starting treatment with Viapres, your doctor should know:

  • if you have heart problems;
  • if you have liver disease;
  • Viapres contains lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Taking Viapres with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those obtained without a prescription.
Some medicines may alter the activity of Viapres, either reducing or increasing it and causing side effects. Viapres
may also alter the activity of other medicines. These include:

  • other medicines used to treat high blood pressure, such as furosemide, propranolol, or captopril;
  • cimetidine (used to treat stomach ulcers);
  • cyclosporine (used to prevent organ transplant rejection or for certain autoimmune diseases);
  • concomitant use of lacidipine and corticosteroids or tetracosactide may reduce the antihypertensive effect.

Talk to your doctor or pharmacist if you are taking any of these medicines.
Taking Viapres with food and drinks
Do not drink grapefruit juice while taking Viapres.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
There is no information available on the safety of using Viapres during pregnancy. If you are pregnant, think you may be pregnant, or are planning a pregnancy, do not take Viapres without first consulting your doctor. Your doctor will evaluate the risks and benefits of taking Viapres for you and your baby.
The active substance and excipients of Viapres may pass into breast milk. If you are breastfeeding,
consult your doctor before starting treatment with Viapres.
Driving and using machines
Viapres may cause dizziness. Patients should be warned not to drive or operate machinery if they experience dizziness or associated symptoms.
Important information about some excipients in Viapres
Viapres contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Viapres

How much to take
Always take Viapres exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
The usual starting dose of Viapres is 2 mg once daily in the morning.
Your doctor may decide whether to increase the dose to 4 or 6 mg once daily in the morning, after approximately 3–4
weeks of treatment.

How to take it
Swallow the tablet with some water.
It is preferable to take the medicine at the same time each day.
You may take Viapres with or without food.

If you forget to take Viapres
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for
the missed tablet.

If you take more Viapres than you should
If you take too many Viapres tablets, it is very likely that your blood pressure will drop and that your heart rate will change,
which may either increase or decrease.
Contact your doctor or pharmacist for advice.

If you stop taking Viapres
Take Viapres for the length of time recommended by your doctor. Do not stop taking Viapres without
consulting your doctor. If you have any doubts about how to use Viapres, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Viapres can cause side effects, although not everyone experiences them.

Common side effects
May affect up to 1 in 10 people:

  • irregular heartbeat (palpitations);
  • faster heartbeat (tachycardia);
  • fluid retention and swelling;
  • dizziness;
  • frequent urination;
  • headache;
  • skin rash (including redness of the skin and itching);
  • hot flushes;
  • stomach discomfort;
  • nausea;
  • fatigue.

Common side effects that may be observed in blood tests:

  • reversible increase in the level of an enzyme called alkaline phosphatase.

Uncommon side effects
May affect up to 1 in 100 people:

  • worsening of chest pain (worsening of pre-existing angina pectoris);
  • paleness;
  • low blood pressure;
  • bleeding, sore gums;
  • fainting (syncope);
  • hypotension.

Rare side effects
May affect up to 1 in 1,000 people:

  • severe allergic reactions with swelling of the face, tongue or throat, which may cause difficulty in swallowing or breathing;
  • itchy red rash on the skin.

Very rare side effects
May affect up to 1 in 10,000 people:

  • restlessness or tremor of the arms and legs;
  • depression.

If you experience any of these side effects
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

5. How to store Viapres

Keep Viapres out of the reach and sight of children.
Do not use Viapres after the expiry date stated on the packaging.
Store Viapres at a temperature not exceeding 30°C.
Keep it in the original container to protect it from light.
Do not remove the tablet from the blister until it is time to take it.
In case of taking half a 4 mg tablet, the remaining half must be stored back in the blister and
reinserted into the carton to protect it from light, and taken within 48 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Other information

What Viapres contains
The active substance is Lacidipine. Viapres tablets are available in different strengths.
Each tablet contains:
4 mg of lacidipine
6 mg of lacidipine

The other ingredients (excipients) are:
Lactose, povidone, magnesium stearate, hypromellose, titanium dioxide (E 171), polyethylene glycol (PEG) 400, polysorbate 80.

Description of the appearance of Viapres and contents of the pack
Film-coated tablets.
Film-coated, white, round tablets with a break line on one side.
Pack sizes:
14 and 28 film-coated tablets of 4 mg
14, 28 and 35 film-coated tablets of 6 mg

Marketing Authorization Holder
S.F. Group S.r.l., Via Tiburtina 1143 – 00156 Rome, Italy

Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR), Italy

This patient information leaflet was last approved