Iospiten

Package Leaflet: Information for the User

Jospiten, 10 mg, coated tablets

Jospiten, 20 mg, coated tablets

Lercanidipine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the package leaflet

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

1. What Jospiten 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), which lower blood pressure.
Jospiten is used in adults over 18 years of age to treat high blood pressure, also known as 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 diseases:
• obstructed blood flow from the heart,
• untreated heart failure,
• unstable angina pectoris (chest pain at rest or with increasing severity)
• within a month after a heart attack
• if you have severe liver disease
• if you have severe kidney problems or are on dialysis
• if you are taking medicines that are inhibitors of liver 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 cyclosporin (used after organ transplantation to prevent rejection)
• with grapefruit or grapefruit juice.

Warnings and precautions

Before starting to take Jospiten, discuss it with your doctor or pharmacist:

• if you have heart disease
• if you have liver or kidney problems

Tell your doctor if you think you are pregnant or might become pregnant or are breast-feeding (see section "Pregnancy, breast-feeding 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 the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Taking Jospiten with some other medicines may change their effects or the effect of Jospiten, and some side 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 (medicines for allergies)
• amiodarone, quinidine or sotalol (medicines used to treat rapid heartbeat)
• midazolam (a medicine that helps you fall asleep)
• digoxin (a medicine used to treat heart disease)
• beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and irregular heartbeat)
• cimetidine in a dose greater than 800 mg (a medicine used to treat stomach ulcers, indigestion or heartburn)
• simvastatin (a medicine that lowers blood cholesterol levels)
• 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), so the medicine should be taken in the morning, at least 15 minutes before breakfast.
• Alcohol may enhance the effect of Jospiten. Do not drink alcohol during treatment with Jospiten.
• Jospiten should not be taken with grapefruits or grapefruit juice (they may enhance the hypotensive effect). See section 2 "When not to take Jospiten".

Pregnancy, breast-feeding and fertility

Jospiten should not be taken if you are pregnant and should not be used during breast-feeding. There are no data on the use of lercanidipine hydrochloride in pregnant or breast-feeding women. If you are pregnant or breast-feeding, if you do not use any contraceptive method, think you may be pregnant or plan to have a baby, ask your doctor or pharmacist for advice 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 contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Jospiten

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist.

Adults

The recommended dose is 10 mg once a day, taken every day at the same time, preferably in the morning, at least 15 minutes before breakfast (see section 2 "Taking Jospiten with food, drink and alcohol"). If necessary, your doctor may increase the dose to 20 mg once a day (two 10 mg Jospiten tablets or one 20 mg Jospiten tablet).
Tablets should be swallowed whole with a sufficient amount of liquid (e.g. one glass of water).

Elderly patients

No dose adjustment is necessary. However, caution should be exercised when starting treatment.

Patients with liver or kidney problems

Caution should be exercised when starting treatment in these patients and 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 to facilitate breaking the tablet to make it easier to swallow.

Taking more Jospiten than prescribed

Do not take more than the prescribed dose. If you have taken more than the prescribed dose of Jospiten, contact your doctor or go to the emergency department of your nearest hospital immediately. Take the medicine package with you. Taking too much of this medicine may cause excessive lowering of blood pressure and irregular or rapid heartbeat.

Missing a dose of Jospiten

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

Stopping treatment with Jospiten

If you stop taking Jospiten, your blood pressure may rise again. Before stopping treatment, consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Jospiten can cause side effects, although not everybody gets them.
The following side effects may occur with the use of this medicine:

Some side effects may be serious. If you experience any of the following symptoms, contact your doctor immediately:

Rare side effects(may affect up to 1 in 1000 people):
angina pectoris (e.g. chest pain due to insufficient blood flow to the heart),
allergic reactions (with symptoms such as itching, rash, hives), fainting.
Side effects of unknown frequency (frequency cannot be estimated from available data): swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing.
In patients with pre-existing angina pectoris, an increased frequency, duration or severity of these episodes may occur when taking medicines from the same group as Jospiten. Single cases of heart attack may be observed.

Other possible side effects

Common(may affect up to 1 in 10 people):
headache, rapid heartbeat, feeling of rapid or irregular heartbeat (palpitations),
sudden reddening of the face, neck or upper chest (flush), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people):
dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching,
muscle pain, frequent urination, feeling of weakness or fatigue.
Rare (may affect up to 1 in 1000 people):
drowsiness, vomiting, diarrhea, hives, frequent urination, chest pain.
Frequency not known(frequency cannot be estimated from available data):
gum swelling, liver problems (detected in blood tests), clouding of the fluid (during dialysis with a catheter in the abdominal cavity).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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 carton after: EXP. The expiry date refers to the last day of the month.
Jospiten, 10 mg, coated tablets
Store in the original package to protect from light.
Jospiten, 20 mg, coated tablets
Store below 30°C.
Store in the original package to protect from light.
Medicines should 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. Contents of the pack and other information

What Jospiten contains

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

What Jospiten looks like and contents of the pack

Jospiten, 10 mg, coated tablets are yellow, round (6.5 mm in diameter), biconvex coated tablets with a score line on one side and a smooth surface on the other. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Jospiten, 20 mg, coated tablets are pink, round (8.5 mm in diameter), biconvex coated tablets with a score line on one side and a smooth surface on the other. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
PVC/PVDC/Aluminium blisters in cartons.
Package sizes: 7, 14, 28, 30, 35, 42, 50, 56, 60, 90, 98 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Jospiten
Poland
Jospiten

Date of last revision of the package leaflet: