10 mg and 20 mg film-coated tablets
lercanidipine hydrochloride
What Lercanidipine Orion is and what it is used for
Lercanidipine Orion belongs to a group of medicines called calcium channel blockers
(dihydropyridine derivative). Lercanidipine Orion is used to treating mild to moderate high blood pressure, also called hypertension.
Lercanidipine hydrochloride contained in Lercanidipine Orion may also be approved for the treatment of 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 using Lercanidipine Orion
Do not use Lercanidipine Orion
Do not take Lercanidipine Orion:
- if you are allergic (hypersensitive) to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from certain heart diseases:- untreated heart failure- narrowing of blood flow from the heart- unstable angina pectoris (angina pectoris that occurs at rest or that gradually worsens)- within one month after a heart attack
- if you have severe liver problems
- if you have severe kidney problems or if you are undergoing dialysis
- if you are taking medicines that inhibit liver metabolism such as:antifungals (eg ketoconazole or itraconazole)macrolide antibiotics (eg erythromycin or troleandomycin or clarithromycin)- medicines for viruses (eg ritonavir)
- if you are taking another medicine that contains ciclosporin or cyclosporine (used after transplants to prevent organ rejection)
- if you eat grapefruit or grapefruit juice.
Warnings and cautions
Talk to your doctor or pharmacist before taking Lercanidipine Orion if you
- have heart problems
- have liver or kidney problems.
You must tell your doctor if you think you are (or might become) pregnant or breastfeeding (see section Pregnancy, breastfeeding, and fertility ).
Children and young people
The safety and efficacy of Lercanidipine Orion in children up to 18 years of age have not been established.
Other medicines and Lercanidipine Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Lercanidipine Orion may affect or be affected by certain medicines when taken at the same time or it may be more common for certain side effects to occur (see also section 2).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- phenytoin , phenobarbital or carbamazepine (medicines used to treat epilepsy )
- rifampicin (medicine used to treat tuberculosis )
- astemizole or terfenadine (medicines for allergies )
- amiodarone , quinidine or sotalol (medicines used to treat palpitations)
- midazolam (medicine to help you sleep)
- digoxin (drug for the treatment of heart problems)
- beta-blockers , e.g. metoprolol (medicines used to treat high blood pressure , heart failure and cardiac arrhythmias )
- cimetidine (more than 800 mg per day; medicines to treat stomach ulcers ,acid reflux or heartburn)
- simvastatin (a drug that lowers cholesterol in your blood)
- other medicines to treat high blood pressure .
Lercanidipine Orion with food, drink and alcohol
- A high-fat meal significantly increases the blood levels of this medicine (see section 3).
- Alcohol may increase the effect of Lercanidipine Orion. Do not use alcohol during treatment with Lercanidipine Orion.
- Lercanidipine Orion should not be taken with grapefruit or grapefruit juice (they may increase the blood pressure lowering effect of Lercanidipine Orion) (see section 2).
Pregnancy, breastfeeding and fertility
Lercanidipine Orion is not recommended if you are pregnant and should not be used during breastfeeding. There are no data from the use of lercanidipine in pregnant women or nursing mothers. Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breastfeeding, if you are not taking contraceptives, think you may be pregnant or are planning to have a baby.
Driving and using machines
You should not drive or use machines if you experience dizziness, lethargy, or fatigue.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ingredients
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
Lercanidipine Orion contains excipients
Ingredients
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Lercanidipine Orion
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended dose is one 10 mg Lercanidipine Orion tablet 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 one to one Lercanidipine Orion 20 mg tablet or two Lercanidipine Orion 10 mg tablets daily (see section 2).
The tablet should be swallowed whole with a sufficient amount of liquid (eg a glass of water). The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
Use for children
This medicine should not be given to children under 18 years of age.
Older
No adjustment of the daily dose is necessary. However, special care should be taken when starting treatment.
Patients with liver or kidney problems
Particular caution should be exercised when initiating treatment in these patients, and a daily dose increase of one to 20 mg should be used with caution.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 over 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 Lercanidipine Orion belongs. Occasional cases of a heart attack may occur.
Other possible side effects:
Common ( may affect up to 1 in 10 people ):
headache, faster heartbeat, palpitations (heart pounding or rushing), sudden redness of the face, neck, or upper chest, swollen ankles.
Uncommon ( may affect up to 1 in 100 people ):
dizziness, drop in blood pressure, heartburn, nausea, abdominal pain, rash, itching, muscle aches, increased urine output, feeling weak or tired.
Rare ( may affect up to 1 in 1,000 people ):
drowsiness, vomiting, diarrhea, hives, increase in the normal number of times you urinate, chest pain.
Has been reported ( occurs in an unknown number of users ):
enlarged gums, changes in liver function (detected by blood tests), cloudy fluid (by dialysis through a tube into the abdomen), swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.
The Medical Products Agency
Box 26
751 03 Uppsala
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
How to store Lercanidipine Orion
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and each blister.
The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is lercanidipine hydrochloride. Each 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:10 mg film-coated tablets:Tablet core : Maize starch, sodium starch glycolate , anhydrous colloidal silica, microcrystalline cellulose, poloxamer, sodium stearyl fumarate, macrogol.
Film coating : Hypromellose, macrogol, yellow iron oxide (E 172), titanium dioxide (E 171).20 mg film-coated tablets:Tablet core: Microcrystalline cellulose, maize starch, sodium starch glycolate, anhydrous colloidal silica, povidone, sodium stearyl fumarate.Film coating : Hypromellose, macrogol, red iron oxide (E 172), titanium dioxide (E 171).
What the medicine looks like and contents of the pack
Lercanidipine Orion 10 mg tablets are yellow, round, biconvex, and film-coated with a diameter of 6.5 mm and a score line on one side and smooth on the other.
Lercanidipine Orion 20 mg tablets are pink, round, biconvex, and 8.5 mm diameter film-coated with a scoreline on one side and smooth on the other.
Pack sizes:
7, 14, 28, 35, 42, 50, 56, 98, 100, 280 (10×28) film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland