Amlodipine Orion

PATIENT INFORMATION LEAFLET: USER INFORMATION

Amlodipine Orion, 5 mg, tablets

Amlodipine Orion, 10 mg, tablets

Amlodipine

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

• 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Amlodipine Orion and what is it used for

Amlodipine Orion contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Amlodipine Orion 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, making it easier for the blood to pass through them. In patients with angina, Amlodipine Orion improves blood supply to the heart muscle, increasing the amount of oxygen supplied, which in turn prevents chest pain. This medicine does not immediately relieve chest pain caused by angina.

2. Important information before taking Amlodipine Orion

When not to take Amlodipine Orion

• 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, redness of the skin, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart cannot supply enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Before taking Amlodipine Orion, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had any of the following conditions:

• recent heart attack,
• heart failure,
• significant increase in blood pressure (hypertensive crisis),
• liver disease,
• need to increase the dose in elderly patients.

Children and adolescents

No studies have been conducted on the use of amlodipine in children under 6 years of age. Amlodipine Orion can be used in children and adolescents from 6 to 17 years of age only for the treatment of high blood pressure (see section 3).
Doses of 2.5 mg cannot be obtained with Amlodipine Orion 5 mg tablets, as these tablets are produced in a way that prevents them from being broken in half. To obtain a dose of 2.5 mg, other amlodipine-containing medicines should be used.
It is essential to take the tablets continuously. Do not wait until all the tablets have been used before visiting your doctor.

Amlodipine Orion 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.
Amlodipine Orion may interact with other medicines or other medicines may interact with Amlodipine Orion. These include:

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

Amlodipine Orion may lower blood pressure more when you are taking other blood pressure-lowering medicines.

Amlodipine Orion with food and drink

While taking Amlodipine Orion, do not drink grapefruit juice or eat grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which may cause unpredictable enhancement of the blood pressure-lowering effect of Amlodipine Orion.

Pregnancy and breastfeeding Pregnancy

There is no data on the safety of amlodipine during pregnancy. 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.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Amlodipine Orion.

Driving and using machines

Amlodipine Orion may affect your ability to drive or use machines.
If the tablets cause nausea, dizziness, fatigue, or headache, do not drive or use machines and contact your doctor immediately.

Excipients

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

3. How to take Amlodipine Orion

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended initial dose is 5 mg of amlodipine once a day. Your doctor may increase the dose to 10 mg once a day.
This medicine can be taken before or after meals and drinks. Take the medicine every day at the same time, with a glass of water.

Use in children and adolescents

In children and adolescents (6-17 years old) the recommended initial dose is 2.5 mg once a day. The maximum recommended dose is 5 mg once a day. Doses of 2.5 mg cannot be obtained with Amlodipine Orion 5 mg tablets, as these tablets are produced in a way that prevents them from being broken in half. To obtain a dose of 2.5 mg, other amlodipine-containing medicines should be used.
It is essential to take the tablets continuously. Do not wait until all the tablets have been used before visiting your doctor.

Taking too much Amlodipine Orion

Taking too many tablets may cause a significant drop in blood pressure. You may feel dizzy, lightheaded, or faint, or experience palpitations. If the drop in blood pressure is severe, it may lead to shock.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.
In such a case, the skin becomes cool and moist, and the patient may lose consciousness. If you have taken too many Amlodipine Orion tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Amlodipine Orion

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

Stopping treatment with Amlodipine Orion

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

4. Possible side effects

Like all medicines, Amlodipine Orion can cause side effects, although not everybody gets them.
If you experience any of the following side effects, contact your doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing,
• swelling of the eyelids, face, or lips,
• swelling of the tongue and throat, causing severe difficulty in breathing,
• severe skin reactions, including increased rash, hives, redness of the skin, severe itching, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions,
• heart attack, arrhythmias,
• pancreatitis, which may cause severe abdominal pain radiating to the back, with very poor general condition.

The following side effects have been reported. If any of these side effects bother you or last more than a week, contact your doctor.

Very common: may affect more than 1 in 10 people

• edema (fluid retention)

The following side effects have been reported. If any of these side effects bother you or last more than a week, contact your doctor.

Common: may affect up to 1 in 10 people

• headache, dizziness, somnolence (especially at the beginning of treatment)
• palpitations (awareness of heartbeat), sudden redness, especially of the face and neck
• abdominal pain, nausea
• changes in bowel movements, diarrhea, constipation, indigestion
• fatigue, weakness
• visual disturbances, double vision
• muscle cramps
• swelling of the ankles

Other side effects have been reported, which are listed below. If any of these side effects worsen or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• mood changes, anxiety, depression, insomnia
• tremors, taste disturbances, fainting
• numbness or tingling of the limbs, loss of pain sensation
• tinnitus
• low blood pressure
• rhinitis (runny nose)
• cough
• dry mouth, vomiting
• hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• urinary disturbances, increased need to urinate at night, increased frequency of urination
• erectile dysfunction, discomfort or enlargement of the breasts in men
• pain, poor general condition
• joint or muscle pain, back pain
• weight gain or loss

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

• disorientation

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

• decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising and bleeding
• high blood sugar levels (hyperglycemia)
• nerve disorders, which may cause muscle weakness, tingling, or numbness
• gum swelling
• abdominal distension (gastritis)
• abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect some test results
• increased muscle tone
• vasculitis, often with skin rash
• photosensitivity
• disorders including stiffness, tremors, and (or) difficulty in moving

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the
Department of Drug Safety Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C, 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 Amlodipine Orion

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage of the medicinal product.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP:" / "EXP:". The expiry date refers to the last day of the month.
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 pack and other information

What Amlodipine Orion contains

• The active substance is amlodipine. 5 mg:Each tablet contains 5 mg of amlodipine (as amlodipine besylate). 10 mg:Each tablet contains 10 mg of amlodipine (as amlodipine besylate).
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethylcellulose (Type A), magnesium stearate.

What Amlodipine Orion looks like and contents of the pack

5 mg: White or almost white, flat, uncoated tablets with a biconvex shape, with beveled edges, with the inscription "C" on one side and "58" on the other. The tablet dimensions are 7.9 mm x 5.6 mm.
10 mg: White or almost white, flat, round, uncoated tablets with beveled edges, with the inscription "C" on one side and "59" on the other. The tablet diameter is 9.5 mm.
PVC/PVDC/Aluminum blister pack in a cardboard box.
Pack sizes: 30 tablets

Marketing authorization holder:

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer/Importer:

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the leaflet:21.06.2022