Adipine

Patient Information Leaflet

Adipine, 5 mg, tablets
Adipine, 10 mg, tablets
Amlodipine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4. Contents of the leaflet:
  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 channel blockers.
Adipine is indicated for the treatment of high blood pressure (hypertension) or chest pain known as
angina pectoris, including its rare form called Prinzmetal's angina.
In patients with high blood pressure, Adipine dilates blood vessels and improves blood flow.
In patients with ischemic heart disease, Adipine improves blood flow to the heart muscle, increasing
the supply of oxygen, thereby preventing chest pain.
Adipine does not provide immediate relief of chest pain caused by angina pectoris.

2. Important information before using Adipine

When not to use Adipine

• if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6), or to other medicines in the calcium antagonist class (this may cause itching, redness of the skin, shortness of breath);
• if the patient has very low blood pressure;
• if the patient has left ventricular outflow tract obstruction (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot pump sufficient blood to body tissues);
• if the patient has heart failure following a recent heart attack.

Warnings and precautions

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

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

Children and adolescents

Adipine has not been studied in children under 6 years of age. Adipine may be used for the treatment of hypertension in children and adolescents aged 6 to 17 years (see section 3). For additional information, consult your doctor.

Adipine and other medicines

Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription. Adipine may affect the action of other medicines, or other medicines may affect the action of Adipine:

• ketoconazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used in HIV treatment),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's wort (herbal remedy),
• verapamil, diltiazem (medicines used for heart conditions),
• dantrolene (used intravenously in severe disturbances of body temperature),
• tacrolimus (a medicine used to control immune response, allowing acceptance of transplanted organs),
• simvastatin (a cholesterol-lowering medicine),
• cyclosporine (an immunosuppressive medicine).

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

Adipine with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Pregnancy
There is insufficient data on the safety of amlodipine during pregnancy.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before using Adipine.

Before using any medicine, consult your doctor or pharmacist.

Driving and operating machinery

Adipine may affect the ability to drive or operate machinery. If nausea, dizziness, fatigue, or headache occur after taking the tablets, the patient should not drive or operate machinery and should contact the doctor immediately.

Adipine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Adipine

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual starting dose of Adipine is 5 mg once daily. The dose may be increased to 10 mg once daily.
Adipine can be taken regardless of meals and drinks. It is recommended to take the medicine at the same time each day, with water. Do not take Adipine 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 this dose cannot be obtained from Adipine 5 mg tablets, because these tablets are not manufactured in a way that allows them to be divided into equal parts.
It is important to take the tablets continuously. Do not wait until all tablets have been used before visiting your doctor.
Dividing 10 mg tablets: hold the tablet between the fingers of both hands and, without touching the score line with your thumbs, gently break the tablet into two parts.
Taking more Adipine than prescribed
Taking too many tablets may cause blood pressure to drop to dangerously low levels. Dizziness, a feeling of emptiness in the head, fainting, or weakness may occur.
If the drop in blood pressure is severe, shock may develop. The skin may become cold and clammy, and loss of consciousness may occur.
Breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur even 24 to 48 hours after taking the medicine.
If too many Adipine tablets have been taken, seek medical help immediately.
Missing a dose of Adipine
This is not harmful. If a dose is missed, skip that dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Adipine treatment
Your doctor will determine how long you should take Adipine. If you stop taking the medicine before your doctor advises, your condition may return.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur after taking the medicine, you should seek immediate medical advice:

• 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 intense rash, hives, redness of the entire body surface, severe itching, blisters, skin peeling and swelling, mucosal inflammation

(Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;

• heart attack, heart rhythm disorders;
• pancreatitis, which may cause severe abdominal and back pain accompanied by a very poor general condition.

The following very common adverse reactions have been reported. If any of these adverse reactions are troublesome for the patient or last longer than one week , you should contact a doctor .
Very common adverse reactions (may affect more than 1 in 10 patients):

• Swelling in the ankle area (edema).

The following common adverse reactions have been reported. If any of these adverse reactions are troublesome for the patient or last longer than one week , you should contact a doctor .
Common adverse reactions (may affect up to 1 in 10 patients):

• headache, dizziness, drowsiness (especially at the beginning of treatment),
• palpitations (awareness of heartbeat), hot flushes,
• abdominal pain, nausea,
• changes in bowel rhythm, diarrhoea, constipation, indigestion,
• fatigue, weakness,
• visual disturbances, double vision,
• muscle cramps.

Other reported adverse reactions are listed below. If any of the adverse symptoms worsen or if any adverse reactions not mentioned in this leaflet occur, inform your doctor or pharmacist.
Uncommon adverse reactions (may affect up to 1 in 100 patients):

• mood changes, anxiety, depression, insomnia,
• tremor, taste disturbances, fainting,
• numbness or tingling of limbs, loss of pain sensation,
• tinnitus,
• low blood pressure,
• sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis),
• cough,
• dryness of the oral mucosa, vomiting,
• hair loss, increased sweating, skin itching, red skin spots, skin discoloration,
• urinary disturbances, increased need to urinate at night, increased frequency of urination,
• inability to achieve erection, discomfort or enlargement of breasts in men,
• pain, malaise,
• joint or muscle pain, back pain,
• increase or decrease in body weight.

Rare adverse reactions (may affect up to 1 in 1000 patients):

• disorientation.

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

• decreased number of white blood cells, decreased number of platelets, which may lead to excessive bruising and increased bleeding tendency (damage to red blood cells),
• increased blood glucose levels (hyperglycaemia),
• nerve damage which may cause weakness, tingling or numbness,
• gum swelling,
• abdominal bloating (gastritis),
• liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity which may affect certain laboratory test results,
• increased muscle tone,
• vasculitis, often with skin rash,
• photosensitivity.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• tremors, rigid posture, mask-like face, slow movements and shuffling gait, unbalanced gait.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
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 Adipine

• Keep the medicine out of 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 the stated month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Adipine contains

• The active substance 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 carboxymethyl starch (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 approximately 8 mm.
Pack sizes: 30, 50, 100, 300, 500 tablets.
Adipine 10 mg tablets: White, round tablets with a diameter of approximately 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 Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
DK: Adipine, 5 & 10 mg, tabletter
PL: Adipine, 5 & 10 mg, tabletki
HU: AMLOBESYL 5 & 10 mg tabletta