Amlopin 10 mg

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Amlopin 10 mg (Amlodipin HEXAL 10 mg Tabletten)
10 mg, tablets
Amlodipinum
Amlopin 10 mg and Amlodipin HEXAL 10 mg Tabletten are different trade names for the same
medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult 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 identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Amlopin 10 mg is and what it is used for
2. What you need to know before taking Amlopin 10 mg
3. How to take Amlopin 10 mg
4. Possible side effects
5. How to store Amlopin 10 mg
6. Contents of the pack and other information

1. What Amlopin 10 mg is and what it is used for

Amlopin 10 mg belongs to a group of medicines called calcium channel blockers.
It is used to treat:

• high blood pressure (hypertension),
• a certain type of chest pain known as angina pectoris, including its rare form, Prinzmetal's angina (variant angina).

In patients with high blood pressure, the medicine reduces vascular resistance, thereby improving blood flow.
In patients with angina pectoris, Amlopin 10 mg improves blood supply to the heart muscle and, via blood, oxygen delivery, thus preventing episodes of chest pain.
Amlopin 10 mg does not provide immediate relief of angina pain.

2. Important information before taking Amlopin 10 mg

When not to use Amlopin 10 mg

• if the patient is allergic to amlodipine, to any other calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include: itching, skin redness, or difficulty breathing.
• if the patient has very low blood pressure (hypotension).
• if the patient has aortic valve stenosis or cardiogenic shock (a condition in which the heart cannot deliver sufficient blood to the body).
• if the patient has heart failure following a recent myocardial infarction.

Warnings and precautions
Before starting treatment, discuss with a doctor or pharmacist if the patient has currently or has had in the past:

• a recent myocardial infarction,
• heart failure,
• severe high blood pressure (hypertensive crisis),
• liver disease,
• need for dose adjustment (in elderly patients).

Children and adolescents
The use of Amlopin 10 mg has not been studied in children under 6 years of age. The medicine should be used to treat hypertension only in children and adolescents aged 6 to 17 years (see section 3). For further information, consult a doctor.
Amlopin 10 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Amlopin 10 mg and other medicines may affect each other's actions. These include:

• ketoconazole and itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV infection);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St John's wort (Hypericum perforatum);
• verapamil, diltiazem (medicines used for heart conditions);
• dantrolene (a medicine used intravenously in severe disturbances of body temperature);
• simvastatin (a medicine used to lower elevated blood cholesterol levels);
• tacrolimus, sirolimus, everolimus, and cyclosporine (medicines used to prevent rejection of transplanted organs and in cancer treatment);
• temsirolimus (a medicine used in cancer treatment).

Amlopin 10 mg may lower blood pressure more strongly if the patient is already taking other antihypertensive medicines.
Amlopin 10 mg with food and drink
If the patient is taking Amlopin 10 mg, they should not eat grapefruit or drink grapefruit juice.
These may increase the blood concentration of the active substance (amlodipine) and, consequently, unpredictably intensify the blood pressure-lowering effect.
Pregnancy and breastfeeding
Pregnancy
The safety of Amlopin 10 mg in pregnant women has not been established. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk. If the patient is breastfeeding or planning to breastfeed, she should inform her doctor before starting treatment with Amlopin 10 mg.
Driving and operating machinery
Amlopin 10 mg may affect the ability to drive or operate machinery.
If the patient experiences nausea, dizziness, fatigue, or headache, they should not drive or operate machinery. Inform the doctor immediately.
Amlopin 10 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Amlopin 10 mg

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The following products are available on the market: Amlopin 5 mg and Amlopin 10 mg.
The usual initial dose of Amlopin is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.
This medicine can be taken regardless of meals and drinks. It should be taken at the same time each day, with water. Do not take Amlopin 10 mg with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the recommended starting dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day.
It is important to take the tablets continuously. Do not wait until all prescribed tablets are used up before visiting your doctor.
Tablets may be divided into equal doses.
Taking more Amlopin 10 mg than prescribed
Taking too many tablets may cause a significant drop in blood pressure, even to dangerously low levels.
Dizziness, lightheadedness, fainting, or weakness may occur. A marked decrease in blood pressure may lead to shock. The patient's skin may become cold and clammy, and loss of consciousness is possible. If a patient has taken too many Amlopin 10 mg tablets, seek immediate medical help.
Breathing difficulties due to fluid accumulation in the lungs (pulmonary edema) may occur even 24 to 48 hours after taking the medicine.
Missing a dose of Amlopin 10 mg
Stay calm. If the patient forgets to take a tablet, they should skip that dose and take the next dose at the usual time. Never take a double dose to make up for a missed dose.
Stopping Amlopin 10 mg treatment
Your doctor will determine how long you should take this medicine. Stopping treatment earlier than advised may cause the condition to return.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur in the patient after taking the medicine,
seek immediate medical advice:

• sudden wheezing, chest tightness, shortness of breath or difficulty breathing;
• swelling of the eyelids, face or lips;
• swelling of the tongue and throat, significantly impairing breathing;
• severe skin reactions, including intense rash, urticaria, redness of the entire skin surface, severe itching, flu-like symptoms associated with blister formation, peeling and swelling of the skin, lips, eyes and genital areas (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• myocardial infarction, irregular heartbeat;
• pancreatitis, which may cause severe abdominal and back pain accompanied by a general feeling of being unwell;
• hepatitis, which may cause yellowing of the skin and whites of the eyes (jaundice), fever, chills, fatigue, loss of appetite, abdominal pain, malaise, and dark urine.

The following very common adverse reaction has been reported. If it is troublesome for the patient or
persists for more than one week , consult a doctor .
Very common : may affect more than 1 in 10 people

• swelling (fluid retention)

The following common adverse reactions have been reported. If any of them are troublesome for
the patient or persist for more than one week , consult a doctor.
Common : may affect up to 1 in 10 people

• headache, dizziness, drowsiness (especially at the beginning of treatment)
• palpitations (awareness of heartbeat), skin flushing (especially of the face)
• difficulty breathing
• abdominal pain, nausea
• changes in bowel habits, diarrhoea, constipation, dyspepsia
• ankle swelling
• feeling of 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 : may affect up to 1 in 100 people

• mood swings, anxiety, depression, insomnia
• tremor, taste disturbances, fainting
• numbness or tingling of limbs, loss of pain sensation
• tinnitus
• low blood pressure
• sneezing/rhinorrhea due to inflammation of the nasal mucosa (rhinitis)
• cough
• dry mouth, vomiting
• hair loss, excessive sweating, skin itching, rash, presence of red spots on the skin, skin discoloration
• disturbances in urination, increased need to urinate at night, increased frequency of urination
• impotence, discomfort or enlargement of breasts in men
• chest pain
• pain, general malaise
• joint or muscle pain, back pain
• weight gain or weight loss

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

• confusion

Very rare : may affect up to 1 in 10,000 people

• decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising or easy bleeding
• increased blood sugar levels (hyperglycaemia)
• nerve disorders, which may cause weakness, tingling or numbness
• gum swelling
• abdominal bloating (gastritis)
• liver function abnormalities, skin yellowing (jaundice), increased liver enzyme activity, which may affect results of certain diagnostic tests
• increased muscle tension
• vasculitis, often with skin rash
• increased sensitivity to light

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

• tremor, rigid posture, mask-like face, slowed movements and shuffling gait, unsteady gait.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Amlopin 10 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see imprint.
Do not store above 30°C. Store in the original packaging to protect from light.
Medicines must 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 Amlopin 10 mg contains

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

What Amlopin 10 mg looks like and contents of the pack
White or almost white, elongated tablets with bevelled edges, marked with a score line on one side and the number "10" on the other side.
The tablets are packed in Al/PVC or Al/OPA/Al/PVC blisters and placed in a cardboard carton.
Pack sizes: 30 or 60 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
Hexal AG, Industriestraße 25, 83607 Holzkirchen, Germany
Manufacturers:
LEK S.A., ul. Podlipie 16, 95-010 Stryków, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
LEK S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland
ROWA Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork, Ireland
Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania
Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Germany, the country of export: 66345.00.00
Parallel Import Authorisation Number: 63/23
This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:
Austria Amlodipin Hexal 10 mg – Tabletten
Denmark Amlohexal
Germany Amlodipin HEXAL 10 mg Tabletten
Hungary Amlodipin Sandoz 10 mg tabletta
Ireland Amlode 10 mg tablets
Italy AMLODIPINA HEXAL AG
Poland Amlopin 10 mg