FINAMLOX 5 mg Tablets

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. Finamlox, 5 mg, tablets
3. Finamlox, 10 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Finamlox and what is it used for
5. Important information before taking Finamlox
   1. When not to take Finamlox:
   2. Warnings and precautions
   3. Children and adolescents
   4. Finamlox and other medicines
   5. Finamlox with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Finamlox
   1. Use in children and adolescents
   2. Taking a higher dose of Finamlox than recommended
   3. Missing a dose of Finamlox
   4. Stopping treatment with Finamlox
7. Possible side effects
   1. Reporting side effects
8. How to store Finamlox
9. Contents of the pack and other information
   1. What Finamlox contains
   2. What Finamlox looks like and contents of the pack
   3. Marketing Authorization Holder:
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Patient Information Leaflet: User Information

Finamlox, 5 mg, tablets

Finamlox, 10 mg, tablets

Amlodipine besylate

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

1. What is Finamlox and what is it used for

Finamlox contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Finamlox 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, Finamlox improves blood flow to the heart muscle, increasing the supply of oxygen, which prevents chest pain. This medicine does not provide immediate relief from chest pain caused by coronary heart disease.

2. Important information before taking Finamlox

When not to take Finamlox:

• if you are allergic (hypersensitive) 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 you have severe low blood pressure.
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body).
• if you have heart failure after a heart attack.

Warnings and precautions

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

• recently had a heart attack
• heart failure
• severe 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 Finamlox in children under 6 years of age.
Finamlox should be used in hypertension in children and adolescents from 6 to 17 years of age (see section 3).
For further information, consult your doctor.

Finamlox and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Finamlox may affect other medicines or other medicines may affect Finamlox:

• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's Wort,
• verapamil, diltiazem (medicines used to treat heart conditions),
• dantrolene (infusion used to treat 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).

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

Finamlox with food and drink

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

Pregnancy and breastfeeding

Pregnancy
There is no data on the safety of amlodipine in pregnancy. If you are pregnant or plan to become pregnant, tell your doctor before taking Finamlox.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, tell your doctor before taking Finamlox.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

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

3. How to take Finamlox

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended initial dose of Finamlox is 5 mg once daily. The dose of Finamlox may be increased to 10 mg once daily.
This medicine can be taken with or without food and drink. It is recommended to take this medicine at the same time every day, with a glass of water. Do not take Finamlox with grapefruit juice.

Use in children and adolescents

In children and adolescents (6-17 years), the usual recommended initial dose is 2.5 mg once daily.
The maximum recommended dose is 5 mg once daily.
Finamlox 2.5 mg is not currently available, and 2.5 mg doses cannot be obtained from Finamlox 5 mg tablets, as these tablets are designed in a way that prevents them from being split in half.
It is essential to take the tablets continuously. Do not wait until you have used all the tablets before visiting your doctor.

Taking a higher dose of Finamlox than recommended

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. You may experience dizziness, lightheadedness, fainting, or weakness. If the blood pressure drop is too severe, it may lead to shock. The skin may become cool and moist, and fainting may occur. If you have taken too many Finamlox tablets, seek medical help immediately.

Missing a dose of Finamlox

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 treatment with Finamlox

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 get worse.
If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• sudden wheezing, chest pain, shortness of breath, or breathing difficulties
• swelling of the eyelids, face, and lips
• swelling of the tongue and throat, causing severe breathing difficulties
• severe skin reactions, including intense rash, hives, redness of the skin, itching, blisters, 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 and back pain, with a feeling of being unwell

The following have been reported as very common side effects. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Very common side effects (may affect more than 1 in 10 people):

• swelling (fluid retention)

The following have been reported as common side effects. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people):

• headache, dizziness, drowsiness (especially at the start of treatment)
• palpitations (awareness of heartbeat), flushing
• 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 the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
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, lack of pain sensation
• ringing in the ears
• low blood pressure
• coughing/sneezing due to inflammation of the nasal mucosa (rhinitis)
• cough
• dry 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 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):

• 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 weakness, numbness, or tingling
• gum swelling
• abdominal bloating (gastritis)
• abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect some laboratory tests
• increased muscle tension
• inflammation of blood vessels, often with skin rash
• sensitivity to light
• disorders including stiffness, tremors, and (or) movement problems

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

• tremors, stiff posture, mask-like face, slow movement, and (or) shuffling gait, unsteady gait

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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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 Finamlox

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP:". The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
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 Finamlox contains

• The active substance is 5 mg amlodipine (as besylate). The active substance is 10 mg amlodipine (as besylate).
• The other ingredients are microcrystalline cellulose and magnesium stearate.

What Finamlox looks like and contents of the pack

Finamlox, 5 mg: white or almost white, oval, flat, uncoated tablets with beveled edges, with "AMB" engraved on one side and "5" on the other side.
Finamlox, 10 mg: white or almost white, oval, flat, uncoated tablets with beveled edges, with "AMB" engraved on one side and "10" on the other side.
Finamlox, 5 mg is available in packs of 30, 50, and 100 tablets.
Finamlox, 10 mg is available in packs of 30, 50, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer:

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
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]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland:
Finamlox / Finamlox
United Kingdom:
Amlodipine 5 mg Tablets / Amlodipine 10 mg Tablets
Date of last revision of the leaflet:06.11.2020