ADIPINE 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Adipine, 5 mg, tablets
3. Adipine, 10 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
4. What Adipine is and what it is used for
5. Important information before taking Adipine
   1. When not to take Adipine
   2. Warnings and precautions
   3. Children and adolescents
   4. Adipine and other medicines
   5. Adipine with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Adipine contains sodium
6. How to take Adipine
   1. Use in children and adolescents
   2. Taking a higher dose of Adipine than recommended
   3. Missing a dose of Adipine
   4. Stopping treatment with Adipine
7. Possible side effects
   1. Very common side effects (may affect more than 1 in 10 people)
   2. Reporting side effects
8. How to store Adipine
9. Contents of the pack and other information
   1. What Adipine contains
   2. What Adipine 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:

Package Leaflet: Information for the Patient

Adipine, 5 mg, tablets

Adipine, 10 mg, tablets

Amlodipine

Read the package 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
• 1. What Adipine is and what it is used for
• 2. Important information before taking Adipine
• 3. How to take Adipine
• 4. Possible side effects
• 5. How to store Adipine
• 6. Contents of the pack and other information

1. What Adipine is and what it is used for

Adipine contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Adipine 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, Adipine widens the blood vessels and makes it easier for the blood to flow.
In patients with coronary heart disease, Adipine improves blood flow to the heart muscle, increasing the amount of oxygen delivered, which in turn prevents chest pain.
Adipine does not immediately relieve chest pain caused by angina pectoris.

2. Important information before taking Adipine

When not to take Adipine

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6), or to other calcium antagonists (this may be itching, redness of the skin, shortness of breath);
• if you have very low blood pressure;
• if you have narrowing of the outflow tract from the left ventricle (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot distribute enough blood to parts of the body);
• if you have heart failure after a heart attack.

Warnings and precautions

Before starting to take Adipine, discuss it with your doctor.
Inform your doctor if you have or have had any of the following conditions:

• recently had a heart attack,
• heart failure,
• sudden increase in blood pressure (hypertensive crisis),
• liver disease,
• need to increase the dose in elderly patients.

Children and adolescents

Adipine has not been studied in children under 6 years of age. Adipine should be used in hypertension in children and adolescents from 6 to 17 years of age (see section 3). For more information, consult your doctor.

Adipine and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
Adipine may interact with other medicines or other medicines may interact with Adipine:

• 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 (used in severe body temperature disorders),
• tacrolimus (a medicine used to control the immune response, allowing the body to accept a transplanted organ),
• simvastatin (a medicine that lowers cholesterol levels),
• cyclosporin (an immunosuppressive medicine). Adipine may enhance the blood pressure-lowering effect of other antihypertensive medicines.

Adipine with food and drink

Patients taking Adipine should not consume grapefruit juice or grapefruit, as they may increase the amount of amlodipine in the blood, which may lead to an unexpected increase in the blood pressure-lowering effect of Adipine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
There are no data on the safety of amlodipine in pregnancy.
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 Adipine.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Adipine may affect your ability to drive and use machines. If you experience nausea, dizziness, fatigue, or headache after taking the tablets, do not drive or operate machinery; consult your doctor immediately.

Adipine contains sodium

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

3. How to take Adipine

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

Use in children and adolescents

In children and adolescents (from 6 to 17 years of age), the usual recommended initial dose is 2.5 mg once a day. The maximum recommended dose is 5 mg once a day.
Amlodipine 2.5 mg is not currently available, and this dose cannot be obtained with Adipine 5 mg, as these tablets are not designed to be divided into equal parts.
It is important to take the tablets continuously. Do not wait until you have used up all the tablets before visiting your doctor.
Dividing 10 mg tablets: holding the tablet with your fingers on both hands and not touching the break line with your thumbs, gently break the tablet into two parts.

Taking a higher dose of Adipine than recommended

Taking too many tablets may cause a significant decrease in blood pressure, leading to dizziness, feeling of emptiness in the head, fainting, or weakness.
If the blood pressure drop is severe, it may lead to shock. The skin may be cool and moist, and there may be loss of consciousness.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.
If you have taken too many Adipine tablets, seek medical attention immediately.

Missing a dose of Adipine

This does not matter. If you forget to take a tablet, skip that dose and take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Adipine

Your doctor will decide how long you should take Adipine. If you stop taking the medicine before your doctor advises you to, your condition may worsen.
If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• sudden wheezing, chest pain, shortness of breath, difficulty breathing;
• swelling of the eyelids, face, and lips;
• swelling of the tongue and throat, causing difficulty breathing;
• severe skin reactions including increased 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) or other allergic reactions;

• heart attack, arrhythmias;
• pancreatitis, which can cause severe abdominal and back pain with very poor general condition. The following very common side effectshave been reported. If any side effect bothers you, or if it lasts for more than a week, you should consult your doctor.

Very common side effects (may affect more than 1 in 10 people)

• Swelling of the ankles (edema). The following common side effectshave been reported. If any side effect bothers you or lasts for more than a week, you should consult your doctor. Common side effects(may affect up to 1 in 10 people):
• headache, dizziness, drowsiness (especially at the beginning of treatment),
• palpitations (perceived heart rhythm), hot flushes,
• abdominal pain, nausea,
• change in bowel movements, diarrhea, constipation, indigestion,
• fatigue, weakness,
• vision disturbances, double vision,
• muscle cramps. Other reported side effects are listed below. If any side effect worsens or if you experience any side effects not listed in this leaflet, inform 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,
• sneezing/runny nose caused by inflammation of the nasal mucosa (rhinitis),
• cough,
• dryness of the mucous membrane of the mouth, vomiting,
• hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration,
• urination disorders, increased need to urinate at night, increased frequency of urination,
• impotence, discomfort or enlargement of the breasts in men,
• pain, poor general condition,
• 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 can cause excessive bruising and bleeding (red blood cell damage),
• increase in blood sugar levels (hyperglycemia),
• nerve damage, which can cause weakness, numbness, or tingling,
• gum swelling,
• abdominal bloating (gastritis),
• liver dysfunction, 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,
• sensitivity to light.

Side effects with unknown frequency(frequency cannot be estimated from available data):

• tremors, stiff posture, mask-like face, slow movements and dragging of the feet, unsteady gait.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist, or nurse. 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, tel.: 22 49-21-301, fax: 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 Adipine

• 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.
• 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 Adipine contains

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

What Adipine looks like and contents of the pack

Adipine, 5 mg, tablets
White, round tablets with a diameter of about 8 mm.
Pack sizes: 30, 50, 100, 300, 500 tablets
Adipine, 10 mg, tablets
White, round tablets with a diameter of about 10.5 mm, with a break line on one side.
The tablet can be divided into two equal parts.
Pack sizes: 30, 50, 100, 500 tablets

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Poland
or
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Poland

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

DK: Adipine, 5 & 10 mg, tablets
PL: Adipine, 5 & 10 mg, tablets
HU: AMLOBESYL 5 & 10 mg tablet
Date of last revision of the leaflet: July 2022