Normodipine

Package Leaflet: Information for the Patient

Normodipine, 5 mg, tablets

Normodipine, 10 mg, tablets

Amlodipine

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

• Keep this 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Normodipine and what is it used for

Normodipine contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Normodipine is used to treat high blood pressure (hypertension) or chest pain (angina pectoris) and its rare form called Prinzmetal's angina.
In patients with high blood pressure, the medicine widens the blood vessels so that blood can flow more easily.
In patients with coronary heart disease, Normodipine improves blood supply to the heart muscle, increasing the amount of oxygen delivered, which in turn prevents chest pain. The medicine does not provide immediate relief from chest pain caused by coronary heart disease.

2. Important information before taking Normodipine

When not to take Normodipine:

• if you are allergic to amlodipine or any other ingredient of this medicine (listed in section 6), or to any other calcium antagonist. Symptoms may include itching, skin rash, or breathing problems,
• if you have severe low blood pressure,
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart cannot deliver enough blood to the body),
• if you have heart failure after a heart attack.

Warnings and precautions

Before taking Normodipine, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had:

• Recently had a heart attack,
• Heart failure,
• Sudden increase in blood pressure (hypertensive crisis),
• Liver disease,
• Necessity to increase the dose in elderly patients.

Children and adolescents

No studies have been conducted on the use of Normodipine in children under 6 years of age. Normodipine should be used in hypertension in children and adolescents from 6 to 17 years old (see section 3).
To get more information, consult your doctor.

Normodipine and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Normodipine may interact with other medicines or other medicines may interact with Normodipine:

• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV),
• rifampicin, erythromycin, clarithromycin (antibiotics used to treat bacterial infections),
• St. John's Wort,
• verapamil, diltiazem (medicines used to treat heart conditions),
• dantrolene (infusion used to treat severe body temperature disorders),
• simvastatin (a medicine that lowers cholesterol levels),
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the patient's immune system),
• cyclosporin (a medicine that suppresses the immune system).

Normodipine may increase the lowering of blood pressure to a greater extent if you are taking other antihypertensive medicines.

Taking Normodipine with food and drink

Patients taking Normodipine should not consume grapefruit juice or grapefruit, as they may cause an increase in the levels of active amlodipine ingredients in the blood, which may result in an unexpected increase in the blood pressure-lowering effect of Normodipine.

Pregnancy, breastfeeding, and fertility

No data are available on the safety of amlodipine during pregnancy. It has been shown that small amounts of amlodipine pass into human milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Normodipine may affect your ability to drive and use machines. If the tablets cause nausea, dizziness, fatigue, or headache, do not drive or operate machinery; contact your doctor immediately.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Normodipine

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended initial dose of Normodipine is 5 mg once daily. The dose may be increased to 10 mg once daily.
The medicine can be taken with or without food and drinks. It is recommended to take the medicine at the same time every day, with a glass of water. Do not take Normodipine with grapefruit juice.

Use in children and adolescents

In children and adolescents (aged 6 to 17 years), the recommended initial dose is usually 2.5 mg once daily. The maximum recommended dose is 5 mg once daily.
Amlodipine at a dose of 2.5 mg is not currently available, and doses of 2.5 mg cannot be obtained from Normodipine 5 mg tablets, as these tablets are manufactured in a way that prevents them from being broken in half.
It is important to take the tablets continuously. Do not wait until you have used up all the tablets before visiting your doctor.

Taking more Normodipine than prescribed

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. Dizziness, lightheadedness, fainting, or weakness may occur. If the blood pressure drop is too severe, shock may occur. The skin may become cool and moist, and fainting may also occur. If you have taken too many Normodipine tablets, seek medical help immediately.
Even up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Normodipine

Stay calm. If you forget to take a tablet, skip it. Take the next dose at the right time. Do not take a double dose to make up for the missed dose.

Stopping Normodipine treatment

Your doctor will tell you how long to take Normodipine. If you stop taking the medicine before your doctor tells you to, your condition may get worse.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Normodipine can cause side effects, although not everybody gets them.
If you experience any of the following side effects after taking this medicine, contact your doctor immediately.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing,
• Swelling of the eyelids, face, and lips,
• Swelling of the tongue and throat, causing severe difficulty breathing,
• Severe skin reactions, including strong rash, hives, redness of the skin, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membrane (Stevens-Johnson syndrome, toxic epidermal necrolysis) and other allergic reactions,
• Heart attack, arrhythmias,
• Pancreatitis, which can cause severe abdominal and back pain with very poor general condition. The following side effects have been reported. If any side effect bothers you or lasts more than a week, contact your doctor.

Very common side effect:may affect up to 1 in 10 people

• Swelling.

Common side effects:may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment),
• Visual disturbances, double vision,
• Palpitations (awareness of heartbeat), sudden flushing (especially of the face),
• Abdominal pain, nausea, indigestion, changes in bowel movements (including diarrhea and constipation),
• Swelling of the ankles, muscle cramps,
• Fatigue, weakness.

Uncommon side effects:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia,
• Tremors, taste disturbances, fainting,
• Numbness or tingling of limbs, decreased pain sensation,
• Ringing in the ears,
• Arrhythmias (including slowed or accelerated heart rate, atrial fibrillation),
• Low blood pressure,
• Cough,
• Sneezing and (or) runny nose due to inflammation of the nasal mucosa (rhinitis),
• Dryness of the mucous membrane of the mouth, vomiting,
• Hair loss, increased sweating, itching, red spots on the skin (erythema), skin discoloration, rash, hives,
• Urination disorders, increased need to urinate at night, increased frequency of urination,
• Impotence, discomfort or enlargement of the breasts in men,
• Chest pain, pain, poor general condition,
• Joint pain, muscle pain, back pain,
• Weight gain or loss.

Rare side effects:may affect up to 1 in 1,000 people

• Disorientation.

Very rare side effects:may affect up to 1 in 10,000 people

• Decreased white blood cell count, decreased platelet count, which can lead to unusual bruising and easier bleeding,
• High blood sugar levels (hyperglycemia),
• Increased muscle tension, nerve disorders, which can cause weakness, numbness, or tingling,
• Heart attack,
• Gingival swelling,
• Gastritis,
• Pancreatitis,
• Hepatitis, jaundice, increased liver enzyme activity, as shown in blood test results,
• Vasculitis, often with skin rash,
• Severe skin reactions (angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome) and other allergic reactions,
• Photosensitivity,
• A disorder involving stiffness, tremors, and (or) difficulty moving.

Frequency not known(frequency cannot be estimated from available data)

• Tremors, stiffness, mask-like face, slow movements, unsteady gait with dragging of the feet,
• Severe skin reactions (toxic epidermal necrolysis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Normodipine

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after (EXP). The expiry date refers to the last day of the month.
Store below 30°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Normodipine contains

• The active substance is amlodipine in the form of amlodipine besylate.
• Normodipine, 5 mg tablets: each tablet contains 5 mg of amlodipine in the form of amlodipine besylate.
• Normodipine, 10 mg tablets: each tablet contains 10 mg of amlodipine in the form of amlodipine besylate.
• Other excipients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethylcellulose, magnesium stearate.

What Normodipine looks like and contents of the pack

5 mg tablets: White or almost white, elongated, biconvex tablets with a length of 8.7 mm and a width of 6.2 mm, with the inscription "5" on one side of the tablet.
10 mg tablets: White or almost white, elongated, biconvex tablets with a length of 11.5 mm and a width of 8.3 mm, with the inscription "10" on one side and a dividing line on the other side of the tablet.
30 tablets are packaged in aluminum/PVC blisters and a cardboard box.

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
POLAND

Manufacturer:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
POLAND
Gedeon Richter Plc.,
Gyömrői út 19-21,
1103 Budapest
HUNGARY
To get more detailed information, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet: