Normodipine

Package leaflet: Information for the user

Normodipine, 5 mg, tablets
Normodipine, 10 mg, tablets
Amlodipine
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Normodipine is and what it is 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 Normodipine is and what it is used for

Normodipine contains the active substance amlodipine, which belongs to a group of medicines called
calcium channel blockers.
Normodipine is indicated for the treatment of high blood pressure (hypertension) or chest pain known as
angina pectoris, including its rare form known as Prinzmetal's angina.
In patients with high blood pressure, the medicine dilates blood vessels, allowing blood to flow more easily. In
patients with ischemic heart disease, Normodipine improves blood flow to the heart muscle by increasing the
oxygen supply, thereby preventing chest pain. Normodipine does not provide immediate relief of chest pain
caused by ischemic heart disease.

2. Information before using Normodipine

When not to use Normodipine:

• if the patient is allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist. Symptoms may include itching, redness of the skin or breathing difficulties,
• if the patient has severe hypotension,
• if the patient has left ventricular outflow tract obstruction (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot deliver sufficient blood to the body),
• if the patient has heart failure following a previous heart attack.

Warnings and precautions
Before starting treatment with Normodipine, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has previously had:

• recent myocardial infarction,
• heart failure,
• acute increase in blood pressure (hypertensive crisis),
• liver disease,
• need for dose adjustment in elderly patients.

Children and adolescents
Studies on the use of Normodipine in children under 6 years of age have not been conducted. Normodipine should be used for arterial hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.

Normodipine and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Normodipine may affect the action of other medicines or other medicines may affect the action of Normodipine:

• ketoconazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV),
• rifampicin, erythromycin, clarithromycin (antibiotics used to treat bacterial infections),
• St John's wort,
• verapamil, diltiazem (medicines used in heart diseases),
• dantrolene (infusion used in severe disturbances of body temperature),
• simvastatin (a medicine that reduces cholesterol levels),
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the patient's immune system),
• cyclosporine (an immunosuppressive medicine).

Normodipine may cause a greater reduction in blood pressure if the patient is taking other antihypertensive medicines.

Taking Normodipine with food and drink
Patients taking Normodipine should not consume grapefruit juice or grapefruits, as they may increase the blood concentration of amlodipine, which could result in an unexpected intensification of the blood pressure-lowering effect of Normodipine.

Pregnancy, breastfeeding and fertility
There are no data available on the safety of amlodipine use during pregnancy. It has been shown that small amounts of amlodipine pass into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
Normodipine may affect the ability to drive and operate machinery. If the tablets cause nausea, dizziness, fatigue or headache, the patient should not drive or operate machinery and should contact their doctor immediately.

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which essentially means it is "sodium-free".

3. How to use Normodipine

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult 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.
Normodipine may be taken regardless of meals and beverages. It is recommended to take the medicine at
the same time each day, with water. Normodipine must not be taken with grapefruit juice.
Use in children and adolescents
In children and adolescents (aged 6 to 17 years), the usual recommended starting dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day.
Amlodipine 2.5 mg is currently not available, and a 2.5 mg dose cannot be obtained from Normodipine 5 mg
tablets, as these tablets are manufactured in a way that prevents splitting in half.
It is important to take the tablets continuously. Do not wait until all tablets are used up before visiting the
doctor.
Taking more Normodipine than recommended
Taking too many tablets may cause a reduction, or even a dangerous drop, in blood pressure. Symptoms
may include dizziness, a feeling of emptiness in the head, fainting, or weakness. If the drop in blood
pressure is too severe, shock may occur. The skin may become cold and clammy, and fainting may also
occur. If too many Normodipine tablets have been taken, seek immediate medical help.
Even 24 to 48 hours after taking the medicine, shortness of breath may occur due to excess fluid
accumulating in the lungs (pulmonary edema).
Missing a dose of Normodipine
Stay calm. If a dose is missed, skip it. Take the next dose at the usual time. Do not take a double dose to
make up for a missed dose.
Stopping Normodipine treatment
The doctor will inform the patient about the duration of Normodipine therapy. If the patient stops taking
the medicine before the doctor recommends, the condition may recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur after using this medicine, you should
seek immediate medical advice.

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing,
• Swelling of the eyelids, face and lips,
• Swelling of the tongue and throat causing significant breathing difficulties,
• Severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions,
• Myocardial infarction, heart rhythm disorders,
• Pancreatitis, which may cause sudden severe abdominal and back pain accompanied by a general feeling of severe illness.

The following adverse reactions have been reported. If any of these adverse reactions are troublesome to the patient or if they last longer than one week, you should contact your doctor.

Very common adverse reactions: may affect at least 1 in 10 people

• Swelling (oedema).

Common adverse reactions: may affect less than 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, dyspepsia, changes in bowel habits (including diarrhoea and constipation),
• Swelling around the ankles, muscle cramps,
• Fatigue, weakness.

Uncommon adverse reactions: may affect less than 1 in 100 people

• Mood changes, anxiety, depression, insomnia,
• Tremor, taste disturbances, fainting,
• Numbness or tingling of limbs, reduced pain sensation,
• Tinnitus,
• Heart rhythm disorders (including slowing or speeding of the heartbeat, atrial fibrillation),
• Low blood pressure,
• Cough,
• Sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis),
• Dryness of the oral mucosa, vomiting,
• Hair loss, increased sweating, skin itching, red spots on the skin (purpura), skin discoloration, rash, urticaria,
• Urinary disorders, increased need to urinate at night, increased frequency of urination,
• Erectile dysfunction, discomfort or breast enlargement in men,
• Chest pain, pain, malaise,
• Joint pain, muscle pain, back pain,
• Increased or decreased body weight.

Rare adverse reactions: may affect less than 1 in 1,000 people

• Disorientation.

Very rare adverse reactions: may affect less than 1 in 10,000 people

• Decreased white blood cell count, decreased platelet count, which may lead to unusual bruising and easier bleeding,
• Increased blood glucose (hyperglycaemia),
• Increased muscle tension, nerve function disorders which may cause weakness, tingling or numbness,
• Myocardial infarction,
• Gum swelling,
• Gastritis,
• Pancreatitis,
• Hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in blood tests,
• Vasculitis, often with skin rash,
• Severe skin reactions (angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome) and other allergic reactions,
• Photosensitivity,
• Movement disorder involving stiffness, tremor and/or difficulty moving.

Frequency unknown (frequency cannot be estimated from available data)

• Tremor, postural rigidity, facial masking, slowed movements, unsteady gait with shuffling steps,
• Severe skin reactions (toxic epidermal necrolysis).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Normodipine

Keep this 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 specified month.
Store below 30°C. Keep 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 no longer required. This will help protect the environment.

6. Contents of the packaging 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 as amlodipine besylate.
• Normodipine 10 mg tablets: each tablet contains 10 mg of amlodipine as amlodipine besylate.
• Other excipients: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethyl starch, magnesium stearate.

What Normodipine looks like and contents of the pack
5 mg tablets: White or almost white, elongated, biconvex tablets with a major diameter of 8.7 mm and minor diameter of 6.2 mm, engraved with the number '5' on one side of the tablet.
10 mg tablets: White or almost white, elongated, biconvex tablets with a major diameter of 11.5 mm and minor diameter of 8.3 mm, engraved with the number '10' on one side and a division line on the other side of the tablet.
Packaged in blisters of aluminium/PVC foil containing 30 tablets, with a cardboard carton.

Marketing Authorisation 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

For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]