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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 blood to flow through them. In patients with angina, Amlodipine Orion makes it easier for blood to reach 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 the patient is 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 the patient has very low blood pressure (hypotension).
• If the patient has narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart cannot supply enough blood to the body).
• If the patient has heart failure after a heart attack.

Warnings and precautions

Before taking Amlodipine Orion, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor if they have or have had any of the following conditions:

• recently had a 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 manufactured 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 the doctor.

Amlodipine Orion and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking or have recently taken, as well as any medicines they 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 if the patient is taking other antihypertensive medicines.

Amlodipine Orion with food and drink

While taking Amlodipine Orion, the patient should 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or plans to breastfeed, they should consult their doctor before taking Amlodipine Orion.

Driving and using machines

Amlodipine Orion may affect the patient's ability to drive or use machines.
If the tablets cause nausea, dizziness, fatigue, or headache, the patient should not drive or use machines and should contact their 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

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should ask their doctor or pharmacist.
The recommended initial dose is 5 mg of amlodipine once a day. The doctor may increase the dose to 10 mg once a day.
This medicine can be taken before or after meals and drinks. The patient should 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), 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 manufactured 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 the doctor.

Overdose of Amlodipine Orion

Taking too many tablets may cause a significant drop in blood pressure. The patient may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. If the drop in blood pressure is severe, it may lead to shock.
Even 24-48 hours after taking the medicine, the patient may experience shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema).
The skin may become cool and moist, and the patient may lose consciousness. If the patient has taken too many Amlodipine Orion tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately.

Missed dose of Amlodipine Orion

If the patient forgets to take a tablet, they should skip it. They should 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

The doctor will tell the patient how long to take the medicine. If the patient stops taking the medicine before the doctor advises, their condition may worsen.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine Orion can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects after taking the medicine, they should immediatelycontact their doctor:

• 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 breathing,
• severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blistering, peeling, and swelling 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 are troublesome for the patient or last for more than a week, they should contact their doctor.

Very common: may affect up to 1 in 10 people

• edema (fluid retention)

The following side effects have been reported. If any of these side effects are troublesome for the patient or last for more than a week, they should contact their doctor.

Common: may affect up to 1 in 10 people

• headache, dizziness, drowsiness (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
• vision disturbances, double vision
• muscle cramps
• swelling of the ankles

Other side effects that have been reported are listed below. If any of these side effects worsen or if the patient experiences any side effects not listed in this leaflet, they should tell their 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
• coughing/sneezing due to inflammation of the nasal mucosa (rhinitis)
• cough
• dryness of the mucous membranes of the mouth, vomiting
• hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• urination disorders, increased need to urinate at night, increased frequency of urination
• erectile dysfunction, discomfort or enlargement of the breasts in men
• pain, malaise
• 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 up to 1 in 10,000 people

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

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the
Department for Monitoring of Adverse Reactions to Medicinal Products
National Institute of Medicines
Al. Jerozolimskie 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Amlodipine Orion

The medicine should be stored out of 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:" or "EXP:". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amlodipine Orion contains

• The active substance of the medicine 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 about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl
Date of last revision of the leaflet:21.06.2022