Package leaflet: Information for the user

Jospiten, 10 mg, film-coated tablets
Jospiten, 20 mg, film-coated tablets
Lercanidipini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Jospiten is and what it is used for
Important information before taking Jospiten
How to take Jospiten
Possible side effects
How to store Jospiten
Contents of the pack and other information

1. What Jospiten film-coated tablets are and what they are used for
Jospiten contains the active substance lercanidipine hydrochloride, which belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives) that lower blood pressure.
Jospiten is used in adults aged over 18 years for the treatment of high blood pressure, also known as arterial hypertension (it is not recommended for children under 18 years of age).

2. Important information before taking Jospiten

When not to take Jospiten:

if you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
if you have certain heart conditions:
- impaired outflow of blood from the heart
- untreated heart failure
- unstable angina (chest pain at rest or with increasing severity)
- within one month after a heart attack
if you have severe liver disease
if you have severe kidney impairment or are on dialysis
if you are taking medicines that are inhibitors of hepatic metabolism, such as:
- antifungal medicines (such as ketoconazole or itraconazole)
- macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
- antiviral medicines (such as ritonavir)
if you are taking a medicine called cyclosporine (used after organ transplantation to prevent rejection)
with grapefruit or grapefruit juice.

Warnings and precautions
Before starting treatment with Jospiten, discuss with your doctor or pharmacist:

if you have been diagnosed with heart disease
if you have been diagnosed with liver or kidney disorders

Tell your doctor if you think you are pregnant, could become pregnant, or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
Children and adolescents
The safety and efficacy of Jospiten in children and adolescents under 18 years of age have not been established.
Jospiten and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking Jospiten with certain other medicines may alter the effect of these medicines or of Jospiten, and some adverse effects may occur more frequently (see also section 2. “When not to take Jospiten”).
In particular, tell your doctor and pharmacist if you are taking any of the following medicines:

phenytoin, phenobarbital or carbamazepine (medicines used to treat epilepsy)
rifampicin (a medicine used to treat tuberculosis)
astemizole or terfenadine (antihistamines)
amiodarone, quinidine or sotalol (medicines used to treat rapid heartbeat)
midazolam (a medicine to aid sleep)
digoxin (a medicine used to treat heart conditions)
beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and heart rhythm disorders)
cimetidine at doses exceeding 800 mg (a medicine used for peptic ulcer, indigestion or heartburn)
simvastatin (a medicine to lower blood cholesterol)
other medicines used to treat high blood pressure.

Taking Jospiten with food, drink and alcohol

A high-fat meal significantly increases the concentration of the medicine in the blood (see section 3); therefore, take the medicine in the morning, preferably at least 15 minutes before breakfast.
Alcohol may enhance the effect of Jospiten. Do not drink alcohol during treatment with Jospiten.
Do not take Jospiten with grapefruit or grapefruit juice (they may enhance the hypotensive effect). See section 2 “When not to take Jospiten”.

Pregnancy, breastfeeding and fertility
Jospiten is not recommended if you are pregnant and should not be used during breastfeeding. There are no data on the use of lercanidipine hydrochloride in pregnant women or in breastfeeding mothers. If you are pregnant or breastfeeding, if you are not using any contraceptive method, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you experience dizziness, weakness or drowsiness while taking this medicine, do not drive or operate machinery.
Jospiten film-coated tablets contain sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Jospiten

This medicine should always be taken as directed by the physician. In case of doubts, consult a doctor or pharmacist.

Adults
The recommended dose is 10 mg once daily, taken at the same time each day, preferably in the morning, at least 15 minutes before breakfast (see section 2, "Taking Jospiten with food, drink and alcohol"). If necessary, the physician may recommend increasing the dose to 20 mg per day (two tablets of Jospiten 10 mg or one tablet of Jospiten 20 mg).
Tablets should preferably be swallowed whole, with an adequate amount of liquid (e.g. one glass of water).

Elderly patients
There is no need to adjust the daily dose. However, particular caution should be exercised when initiating treatment.

Patients with hepatic or renal impairment
Particular caution is required when starting treatment in these patients, as well as when increasing the daily dose to 20 mg.

Use in children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.

The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing.

Taking more Jospiten than prescribed
Do not take more than the prescribed dose. If an overdose has occurred, contact a doctor immediately or go to the nearest hospital emergency department. Bring the medicine packaging with you. Taking too high a dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat.

Missing a dose of Jospiten
If a patient forgets to take a tablet, the missed dose should be skipped and the next dose taken at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Jospiten
If treatment with Jospiten is discontinued, blood pressure may rise again. Consult a doctor before stopping treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur with the use of this medicine:
Some adverse reactions may be serious. If any of the following symptoms occur,
contact your doctor immediately:
Rare adverse reactions (may occur in up to 1 in 1000 patients):
angina (e.g. chest tightness due to insufficient blood flow to the heart),
allergic reactions (with symptoms such as itching, rash, urticaria), fainting.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
facial, lip, tongue or throat swelling, which may cause difficulty in breathing or swallowing.
In patients with pre-existing angina, increased frequency, prolonged duration or worsening of angina attacks may occur in those taking medicines from the group to which Jospiten belongs. Single cases of myocardial infarction may be observed.
Other possible adverse reactions
Common (may occur in up to 1 in 10 people):
headache, fast heartbeat, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck or upper chest (hot flush), swelling of the ankle area.
Uncommon (may occur in up to 1 in 100 people):
dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, passing large amounts of urine, feeling weak or tired.
Rare (may occur in up to 1 in 1000 patients):
drowsiness, vomiting, diarrhoea, urticaria, passing urine more frequently than usual, chest pain.
Frequency unknown (frequency cannot be estimated from available data):
gingival swelling, liver function abnormalities (detected in blood tests), clouding of fluid (during dialysis using a catheter placed in the abdominal cavity).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Jospiten

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package after: EXP. The expiry date refers to the last day of the stated month.
Jospiten, 10 mg, film-coated tablets
Store in the original packaging to protect from light.
Jospiten, 20 mg, film-coated tablets
Store below 30°C.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What the medicine Jospiten contains

The active substance is lerkanidipine hydrochloride. Jospiten 10 mg, film-coated tablets: Each film-coated tablet contains 10 mg of lerkanidipine hydrochloride, equivalent to 9.4 mg of lerkanidipine. Jospiten 20 mg, film-coated tablets: Each film-coated tablet contains 20 mg of lerkanidipine hydrochloride, equivalent to 18.8 mg of lerkanidipine.
The other ingredients are: Jospiten 10 mg, film-coated tablets: Core: Maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, microcrystalline cellulose (PH113), poloxamer 188, sodium stearyl fumarate, polyethylene glycol 6000. Coating: Hypromellose 2910 6mPa*s, polyethylene glycol 6000, iron oxide yellow (E172), titanium dioxide (E171). Jospiten 20 mg, film-coated tablets: Core: Microcrystalline cellulose, maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, povidone K 30, sodium stearyl fumarate. Coating: Hypromellose 2910 6mPa*s, polyethylene glycol 6000, iron oxide red (E172), titanium dioxide (E171).

What Jospiten looks like and contents of the pack
Jospiten 10 mg, film-coated tablets are yellow, round (6.5 mm in diameter), biconvex film-coated tablets with a break line on one side and smooth on the other side. The break line on the tablet is intended only to facilitate breaking for easier swallowing, not for dividing into equal doses.
Jospiten 20 mg, film-coated tablets are pink, round (8.5 mm in diameter), biconvex film-coated tablets with a break line on one side and smooth on the other side. The break line on the tablet is intended only to facilitate breaking for easier swallowing, not for dividing into equal doses.
Blister packs made of PVC/PVDC/Aluminium in cardboard cartons.
Pack sizes: 7, 14, 28, 30, 35, 42, 50, 56, 60, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Egis Pharmaceuticals PLC
1106 Budapest
Kereszturi út 30-38
Hungary
Importer:
Torrent Pharma (Malta) Ltd.
Central Business Centre, Level 2, Triq Hal Tarxien,
Il-Gudja, GDJ 1907
Malta
For further information about this medicine, please contact the local representative of the marketing authorisation holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00
This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic Jospiten
Poland Jospiten