Lisitens

Package leaflet: Information for the user

LISITENS 10 mg, 20 mg film-coated tablets

Active substance: lercanidipine hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start taking 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Lisitens is and what it is used for

Lisitens is a selective calcium channel blocker belonging to a group of medicines called
dihydropyridines. Selective calcium channel blockers reduce high blood pressure. They act
on the blood vessels by relaxing them, thereby causing them to dilate.
Lisitens is used for:

• treating mild to moderate high blood pressure (essential hypertension).

2. What you should know before taking Lisitens

DO NOT take Lisitens

• if you are allergic to lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have allergic reactions to medicines closely related to Lisitens (such as amlodipine, nicardipine, felodipina, isradipine, nifedipine, or lacidipine);
• if you are pregnant, breastfeeding, or if pregnancy is possible (see section
  2. Pregnancy and breastfeeding);
• if you suffer from certain heart conditions:
  • uncontrolled heart failure,
  • obstruction of blood flow from the heart,
  • unstable angina (angina at rest or worsening progressively),
  • heart attack within the last month;
• if you have severe liver or kidney problems;
• if you are taking medicines/foods that may affect the effect and/or side effects of Lisitens, such as:
  • antifungal medicines (such as ketoconazole or itraconazole),
• macrolide antibiotics (such as erythromycin or troleandomycin),
• antiviral medicines (such as ritonavir, a medicine used to treat AIDS),
• cyclosporine (a medicine used to prevent organ transplant rejection),
• grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lisitens, especially if you have or have ever had any of the following conditions or diseases:

• sick sinus syndrome (a heart condition affecting heart rate by making it too fast or too slow), if a pacemaker has not been implanted;
• left ventricular dysfunction (a heart condition in which one of the heart chambers fails to fill or pump blood normally);
• ischemic heart disease (in which blood supply to the heart is insufficient);
• pre-existing angina (chest pain);
• mild to moderate kidney or liver problems.

Other medicines and Lisitens
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
DO NOT take Lisitens together with medicines that inhibit metabolism and may therefore affect the effect and/or side effects of lercanidipine. Your doctor will know which these are. They include, for example:

• cyclosporine (a medicine used to prevent transplant rejection);
• ketoconazole or itraconazole (medicines used to treat fungal infections);
• ritonavir (a medicine used to treat AIDS);
• erythromycin or troleandomycin (antibiotics).

Some other medicines that are metabolized (activated or altered) by the CYP3A4 enzyme or that induce this enzyme may affect lercanidipine blood levels. Therefore, you must consult your doctor if you are taking other medicines.
The effect of lercanidipine is increased by:

• midazolam (a sedative);
• terfenadine, astemizole (antihistamines used to treat hay fever and other allergies);
• amiodarone, quinidine (used to treat irregular heartbeat);
• cimetidine (used to treat stomach ulcers), administered at high doses (> 800 mg per day).

The effect of lercanidipine is reduced by:

• phenytoin, carbamazepine (anticonvulsant medicines used to treat epilepsy);
• rifampicin (an antibiotic);
• beta-blockers (medicines used to treat high blood pressure and heart conditions, e.g. metoprolol).

Lercanidipine enhances the effect of:

• digoxin (used to treat heart conditions);
• simvastatin (a medicine that lowers cholesterol).

Lisitens with food, drinks and alcohol
Always take Lisitens tablets at least 15 minutes before a meal (preferably breakfast).
Alcohol may increase the effects and side effects of lercanidipine. Therefore, alcoholic beverages should not be consumed during treatment.
Grapefruit juice may increase lercanidipine blood levels. Do not eat grapefruit or drink grapefruit juice while taking Lisitens.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Lisitens if you are pregnant. If you suspect or plan to become pregnant, consult your doctor. A change in treatment may be necessary.
Breastfeeding
Women who are breastfeeding should not take Lisitens. Lercanidipine may pass to the baby through breast milk. If treatment with Lisitens must continue, breastfeeding should be discontinued.

Driving and using machines
Lercanidipine may cause dizziness, weakness, fatigue, and drowsiness. If these symptoms occur, do not drive or operate machinery.

Lisitens contains lactose (milk sugar) and sodium
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Lisitens

Take Lisitens exactly as directed by your doctor. If you have any doubts, consult your doctor.
Lisitens tablets or half tablets must be swallowed whole with a glass of water, preferably in the morning, at least 15 minutes before breakfast.
Lisitens 20 mg film-coated tablets
The tablets may be divided into equal doses.
Store the remaining half tablet protected from light, for example by placing it back into the blister pack, covering it with the blister foil, and then returning the blister pack to the outer carton. Take this remaining half with your next dose.
Dosage
Adults
The recommended dose is 10 mg once daily. If necessary, your doctor may increase the dose to 20 mg daily.
Elderly patients
In general, no dose adjustment is required for elderly patients.
Patients with impaired liver or kidney function
In cases of mild to moderate liver or kidney impairment, the usual starting dose is 10 mg once daily. Your doctor will increase the dose cautiously. Lisitens must not be taken in cases of severe liver or kidney impairment.
Use in children and adolescents
There is insufficient information on the efficacy and safety of Lisitens in children and adolescents under 18 years of age, and therefore its use is not recommended in this age group.
If you take more Lisitens than you should
If you take too many tablets, inform your doctor or go immediately to the nearest hospital. An overdose may cause excessive lowering of blood pressure (hypotension), slowing or speeding of the heartbeat, loss of consciousness, and other serious effects. Other symptoms are listed in section 4. Possible adverse effects may be more pronounced in case of overdose.
If you forget to take Lisitens
Do not take a double dose to make up for the forgotten tablet. Take the next dose as usual.
If you stop taking Lisitens
Do not stop treatment with Lisitens without first consulting your doctor.
If you have any questions about 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 experiences them.
The following side effects have been associated with Lisitens:

Uncommon: (may affect up to 1 in 100 people)

• increased heart rate (tachycardia);
• palpitations (awareness of heartbeat);
• peripheral edema (fluid accumulation in the extremities, especially the legs);
• headache;
• dizziness;
• hot flushes (skin redness, especially in the face).

Rare: (may affect up to 1 in 1,000 people)

• angina pectoris (chest pain);
• some medicines similar to Lisitens may cause precordial pain (pain in the front part of the chest);
• drowsiness;
• feeling unwell (nausea);
• indigestion;
• diarrhoea;
• abdominal pain;
• vomiting;
• polyuria (passing large amounts of urine);
• rash;
• muscle pain;
• weakness;
• feeling of fatigue.

Very rare: (may affect up to 1 in 10,000 people)

• in cases of pre-existing angina pectoris, symptoms may occur more frequently, last longer, or be more severe;
• isolated cases of heart attack (myocardial infarction) may occur;
• loss of consciousness (syncope);
• increased levels of liver enzymes (usually reversible when treatment is discontinued);
• gum enlargement (gingival hyperplasia);
• urinary frequency (passing urine more often than usual);
• hypotension (low blood pressure);
• chest pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lisitens

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Store the tablets in the original packaging to protect them from light.
Half tablets must be protected from light.
Do not dispose of 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 Lisitens contains:
The active substance is lercanidipine.
Lisitens 10 mg film-coated tablets
Each tablet contains 10 mg of lercanidipine hydrochloride as lercanidipine hydrochloride hemihydrate.
Lisitens 20 mg film-coated tablets
Each tablet contains 20 mg of lercanidipine hydrochloride as lercanidipine hydrochloride hemihydrate.

The other components are:
Tablet core:

• Monohydrate lactose
• Pregelatinized corn starch
• Sodium croscarmellose
• Hypromellose
• Anhydrous colloidal silicon dioxide
• Magnesium stearate
  Coating:
• Hypromellose
• Macrogol 8000
• Titanium dioxide (E 171)
• Talc

Lisitens 10 mg film-coated tablets also contain yellow iron oxide (E 172).
Lisitens 20 mg film-coated tablets also contain red iron oxide (E 172).

Description of the appearance of Lisitens and packaging contents
Lisitens 10 mg film-coated tablets are yellow, round, biconvex, 6.5 mm in diameter, with a score line.
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole and is not intended for dividing the tablet into equal doses.

Lisitens 20 mg film-coated tablets are pink, round, biconvex, 8.1 mm in diameter, with a score line. The tablets may be divided into equal doses.

Lisitens is available in packs of 14, 28, 50 or 100 tablets contained in white, opaque Aluminum/PVC/PVdC blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Marketing rights licensee: S.F. Group S.r.l., Via Tiburtina 1143 - 00156 Rome, Italy

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel (Germany)
Eurogenerics N.V., Heizel Esplanade B22, B-1020 Brussels (Belgium)
STADA Production Ireland Ltd., Waterford Road, IRL-Clonmel, Co Tipperary (Ireland)
LAMP SAN PROSPERO S.p.A., Via della Pace 25/A, 41030 San Prospero – Modena (Italy)
STADA M&D SRL, Str. Trascăului, nr 10, RO-401135, Turda (Romania)