Lerblok ™ Film-Coated Tablets

LERBLOK, lercanidipine hydrochloride, belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives). Lercanidipine lowers blood pressure by relaxing your blood vessels. LERBLOK is used to treat mild to moderate high blood pressure (hypertension) in adults.

Do not take LERBLOK:

• If you are hypersensitive (allergic) to lercanidipine hydrochloride or to any other ingredients of LERBLOK (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
• If you have severe liver problems
• If you have severe kidney problems
• If you are taking the following medicines:
• antifungal medicines (such as ketoconazole, itraconazole)
• fluoxetine (an antidepressant)
• antibiotics (such as erythromycin)
• ciclosporin (a medicine used for preventing the rejection of organ transplants)
• antiviral medicines (such as ritonavir).
• If you are pregnant, or breastfeeding (see Pregnancy, breastfeeding and fertility).
• If you are a woman of childbearing potential, unless you are using effective contraception.

Do not take LERBLOK with grapefruit or grapefruit juice.

Do not share medicines prescribed for you with any other person. Always take LERBLOK exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual starting dose is one 10 mg tablet per day. Swallow the tablet whole with a glass of water, at least 15 minutes before a meal. The score line is only to facilitate breaking if required for ease of swallowing, and not to divide the tablet into equal doses.

Your doctor will tell you what dose is suitable for you and may want to gradually increase your dosage. If you are elderly, no adjustment of the daily dose is required. Your doctor will check your response on the treatment. If you have liver or kidney problems, your doctor may have special dosing instructions for you. Your doctor will tell you how long your treatment with LERBLOK will last. Do not stop treatment early, because your blood pressure may increase again.

If you have the impression that LERBLOK is too strong or too weak, you should talk to your doctor or pharmacist.

If you take more LERBLOK than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken. Signs of overdosage differ; you may feel dizzy from blood pressure dropping too low and have a fast heartbeat.

If you forget to take LERBLOK

Try to take LERBLOK at the same time each day. If you forget to take a tablet, take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking LERBLOK

If you stop taking LERBLOK your blood pressure may increase again. Please consult your doctor before stopping the treatment.

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

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

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash, red itchy skin, hives. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LERBLOK. 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 the following:

• Heart attack (chest pain or discomfort that does not go away can be a sign of a heart attack).
• Angina (chest pain, shortness of breath, nausea, pain in the back, shoulders and jaw).
• Changes in the way your heart beats, for example, if you notice it beating faster. These are all serious side effects. You may need urgent medical attention.

Other possible side effects:

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Headache
• Dizziness
• Quick heartbeat
• Palpitations (fast-beating, fluttering or pounding heart)
• Flushing, swelling in your lower legs or hands
• Weakness and lack of energy (asthenia)
• Less frequent side effects:
• Sleepiness
• Depression
• Fatigue
• Fainting
• Low blood pressure (you may feel dizzy or lightheaded)
• Indigestion, discomfort or pain in abdomen
• Nausea
• Diarrhoea
• Abdominal pain
• Vomiting
• Muscle pain
• Large volumes of urine or frequent, abnormal urination.
• Fatigue
• Frequency unknown
• Eye pain.
• Swollen gums
• Laboratory tests may reveal increased liver enzymes.

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LERBLOK.

Store all medicines out of reach of children. Store at or below 25 °C, in the original packaging. Keep blisters in the carton to protect from light, until required for use. Do not store in a bathroom. Do not use after the expiry date printed on the carton and on the blister. Return all unused or expired medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).