10 mg and 20 mg film-coated tablets
Lercanidipine hydrochloride
What Zanidip is and what it is used for
Zanidip, lercanidipine hydrochloride belongs to a group of drugs called calcium channel blockers (dihydropyridine derivatives) and lowers blood pressure et.
Zanidip is used to treat high blood pressure, also known as hypertension, in adults over 18 (not recommended for children under 18).
Lercanidipine hydrochloride contained in Zanidip may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Zanidip
Do not use Zanidip:
- If you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- If you suffer from certain heart conditions, such as:
- narrowing of blood flow from the heart
- untreated heart failure
- unstable angina (chest pain, i.e. angina that occurs at rest or gradually worsens)
- within one month of a heart attack.
- If you have severe liver problems.
- If you have severe kidney problems or if you are undergoing dialysis.
- If you are using medicines that inhibit liver metabolism, such as:
- antifungal medicine (eg ketoconazole or itraconazole)
- macrolide antibiotics (eg erythromycin, troleandomycin, or clarithromycin)
- medicines against viruses (e.g. ritonavir)
- If you are taking another medicine containing ciclosporin or ciclosporin (used after transplants to prevent organ rejection)
- With grapefruit or grapefruit juice
Warnings and precautions
Talk to your doctor or pharmacist before using Zanidip
- if you have heart problems.
- if you have problems with your liver or kidneys.
You must tell your doctor if you think you are (or may become) pregnant or if you are breastfeeding (see section Pregnancy, breast-feeding and fertility ).
Children and young people
Safety and effectiveness Zanidip for children up to 18 years has not been established.
Other medicines and Zanidip
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines as the effect of Zanidip or the other medicines may change and some side effects may occur more often if Zanidip is taken together with other medicines (see also section 2 “Use not Zanidip”).
You must tell your doctor or pharmacist if you are taking any of the following medicines:
- phenytoin, phenobarbital, or carbamazepine (medicines to treat epilepsy )
- rifampicin (a medicine to treat tuberculosis )
- astemizole or terfenadine (anti-allergy medicine )
- amiodarone , quinidine or sotalol (medicines to treat palpitations)
- midazolam (a medicine to help you sleep)
- digoxin (a medicine to treat heart problems)
- beta-blockers, e.g. metoprolol (medicine for the treatment of high blood pressure, heart failure, and heart rhythm abnormalities)
- cimetidine (more than 800 mg, a medicine to treat stomach ulcers, acid reflux, or heartburn).
- simvastatin (a medicine that lowers cholesterol in your blood)
- other medicines for the treatment of high blood pressure.
Zanidip with food, drink, and alcohol
- A high-fat meal significantly increases blood levels of this medicine (see section 3).
- Alcohol can increase the effect of Zanidip. Do not use alcohol during treatment with Zanidip.
- Zanidip should not be taken with grapefruit or grapefruit juice (they may increase the blood pressure-lowering effect of Zanidip). See section 2 “Do not use Zanidip”.
Pregnancy, breastfeeding, and fertility
Zanidip is not recommended if you are pregnant and should not be used if you are breastfeeding. Data regarding the use of Zanidip in pregnant women and nursing mothers are lacking. Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breastfeeding, if you are not using contraception, think you may be pregnant or plan to become pregnant.
Driving ability and use of machinery
If you experience dizziness, weakness, or sleepiness while using this medicine,
you should not drive or use machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Zanidip contains lactose and sodium
Zanidip contains lactose
Contact your doctor before taking this medicine if your doctor has told you that you have an intolerance to certain sugars.
Zanidip contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to use Zanidip
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Adults: The recommended dose is 10 mg once daily, at the same time each day, preferably in the morning at least 15 minutes before breakfast. If necessary, your doctor may advise you to increase the dose by one to one Zanidip 20 mg daily (see section 2 “Zanidip with food, drink, and alcohol”).
Zanidip 10 mg: the score is only to facilitate dividing to make swallowing the tablet easier, not for dividing into equal doses.
Zanidip 20 mg: the tablet can be divided into two equal doses.
The tablets should preferably be swallowed whole with a little water.
Children and adolescents: This medicine should not be given to children under 18 years of age.
Elderly patients: No adjustment of the daily dose is necessary, but special care should be taken when starting treatment.
Patients with liver or kidney problems: Special care should be taken when starting treatment in these patients and an increase in the daily dose from one to 20 mg should be done cautiously.
If you have used too much Zanidip
Do not exceed the prescribed dose. If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor for an assessment of the risk and advice or go directly to the hospital. Take the medicine package with you.
If you take a larger dose than prescribed, it can lead to blood pressure becoming too low and the heart beating irregularly or faster.
If you forget to take Zanidip
If you forget to take your tablets, skip the dose you forgot and then continue as usual. Do not take a double dose to make up for a missed tablet.
If you stop using Zanidip
If you stop using Zanidip, your blood pressure may increase again. Consult your doctor before stopping treatment.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Some side effects can be serious.
If you experience any of these side effects, contact your doctor immediately.
Rare (may affect up to 1 in 1,000 people): angina pectoris/angina (eg pressure on the chest due to reduced blood flow to your heart), allergic reactions (symptoms include itching, rash, hives ), fainting.
Patients who already have angina pectoris (angina) may experience an increased frequency, duration, and severity of these attacks when using the group of medicines to which Zanidip belongs. Occasional cases of myocardial infarction can be observed.
Other possible side effects:
Common (may affect up to 1 in 10 people): headache, faster heartbeat, palpitations (heart pounding or racing), sudden flushing of the face, neck, or upper chest, and swelling of the ankles.
Uncommon (may affect up to 1 in 100 users): dizziness, drop in blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, increased urine output, and feeling weak or tired.
Rare (may affect up to 1 in 1,000 users): drowsiness, vomiting, diarrhea, hives, increase in the normal number of times you urinate, chest pain.
Have been reported ( cannot be estimated from available data ): enlarged gums, changes in liver function (detected by blood tests), cloudy fluid (when dialyzing through a tube into the abdomen), swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing.
How to store Zanidip
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label, carton, and the blister after EXP. The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is: lercanidipine hydrochloride
One film-coated tablet contains 10 mg lercanidipine hydrochloride (equivalent to 9.4 mg lercanidipine) or 20 mg lercanidipine hydrochloride (equivalent to 18.8 mg lercanidipine). - Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate.
Film coating: hypromellose, talc, titanium dioxide (E171), macrogol 6000, iron oxide (E172).
Appearance and package sizes of the medicine
Zanidip 10 mg: yellow, round, biconvex, film-coated tablet of 6.5 mm, scored on one side.
Zanidip 20 mg: pink, round, biconvex, film-coated tablet of 8.5 mm, scored on one side.
Zanidip 10 mg is supplied in blister packs of 7, 14, 28, 35, 50, 56, 98, and 100 tablets. Not all pack sizes may be marketed.
Zanidip 20 mg is supplied in blister packs of 7, 14, 28, 35, 42, 50, 56, 98, and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Recordati Ireland Limited
Raheen’s East
Ringaskiddy Co. Cork
P43 KD30
Ireland
Manufacturer
RECORDATI Industria Chimica e Farmaceutica SpA
Via Matteo Civitali 1 – 20148 Milan, Italy
Local Representative
Recordati AB, Kista
Phone: +46 8 545 80 230