Lendidip 10 mg Film-Coated Tablets

The active substance is lercanidipine hydrochloride. Lercanidipine belongs to a group of medicines called calcium channel blockers (of the dihydropyridine group) which are used to treat high blood pressure. LENDIDIP is used to treat high blood pressure, also known as hypertension.

Do not take LENDIDIP:

• If you are hypersensitive (allergic) to lercanidipine hydrochloride or any of the other ingredients of LENDIDIP (listed in section 6).
• If you are suffering from certain heart diseases:
• obstruction to flow of blood from the heart.
• untreated heart failure.
• unstable angina (chest discomfort occurring at rest or progressively increasing)
• within one month of heart attack
• With grapefruit or grapefruit juice.
• If you have severe liver or kidney problems - you are undergoing dialysis.
• If you are taking medicines that are inhibitors of the hepatic metabolism, such as:
• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
• antivirals (such as ritonavir).
• antidepressants (such as fluoxetine)
• If you are taking another medicine called ciclosporin or cyclosporin (used after transplants to prevent organ rejection).

Warnings and precautions

Take special care with LENDIDIP

• Certain other heart conditions, or if you have a pacemaker.
• Problems with your liver or kidney, or you are dialysis.

You must tell your doctor if you think you are (or might become) pregnant or breast - feeding (see pregnancy, breast - feeding and fertility section).

Children and adolescents

The safety and efficacy of Lercanidipine HCl in children aged up to 18 years have not been established.

Other medicines and LENDIDIP

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines). Tell your doctor or pharmacist if:

• You are taking medicines that are inhibitors of CYP3A4 isoenzyme (medicines that will increase the absorption of lercanidipine):
• Antifungal medicines (such as ketoconazole or itraconazole).
• Macrolide antibiotics (such as erythromycin or troleandomycin).
• Antivirals (such as ritonavir).
• Antidepressants (such as fluoxetine)
• You are taking beta - blockers, diuretics or ACE - inhibitors (medicines to treat high blood pressure), although these may be safely taken with LENDIDIP
• You are taking digoxin (a medicine to treat a heart problem).
• You are taking cimetidine (a medicine for ulcers, indigestion, or heartburn).
• You are taking midazolam (a medicine that helps you sleep).
• You are taking rifampicin (a medicine to treat tuberculosis).
• You are taking astemizole or terfenadine (medicines for allergies).
• You are taking amiodarone, quinidine or sotalol (medicines to treat a fast heart beat).
• You are taking phenytoin, phenobarbital or carbamazepine (medicines for epilepsy).
• You are taking medicines which lower the body’s resistance to disease (such as cyclosporin).
• You are taking grapefruit or grapefruit juice.
• Simvastatin (a medicine to lower cholesterol in your blood)

Do not share medicines prescribed for you with any other person. Always take LENDIDIP exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one LENDIDIP 10 mg film - coated tablet daily at the same time each day, preferably in the morning at least 15 minutes before breakfast. Your doctor may advise you to increase the dose to one LENDIDIP 20 mg film - coated tablet daily, if needed. The tablets should preferably be swallowed whole with some water.

If you have the impression that the effect of LENDIDIP is too strong or too weak, talk to your doctor or pharmacist.

If you take more LENDIDIP than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Exceeding the correct dosage may cause blood pressure to become too low, and the heart to beat irregularly or faster. It may also lead to unconsciousness.

If you forget to take LENDIDIP

Do not take a double dose to make up for forgotten individual doses.

LENDIDIP can have side effects. Not all side effects reported for LENDIDIP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LENDIDIP, please consult your health care provider for advice.

If any of the of the following happens, stop taking LENDIDIP and tell your doctor immediately or go to the casualty department at your nearest hospital:

• ‘swelling of the ankles or legs, face, lip, tongue, or throat, difficulty in swallowing or breathing’
• ‘rash or itching’
• ‘fainting’

These are all very serious side effects. If you have them, you may have had a serious reaction to LENDIDIP. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• chest pain,
• angina
• changes in the way your heart beats, for example, if you notice it beating faster.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache,
• fast heart rate
• feeling of fast or uneven heartbeat (palpitations)

Less frequent side effects:

• dizziness
• low blood pressure
• heartburn
• feeling sick
• stomach pain
• muscle pain
• passing large amounts of urine
• feeling weak or feeling tired
• sleepiness
• vomiting
• diarrhoea
• hives
• increase in the usual number of times one urinates
• changes in liver function
• cloudy fluid

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website or to the Holder of certificate of registration through the mail: [email protected]. By reporting side effects, you can help provide more information on the safety of LENDIDIP.

Store all medicines out of reach of children.

Store at or below 25 °C

Store in the original package.

Protect from light/ moisture.

Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).