Amlopin 10 mg

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Amlopin 10 mg(Amlodipine HEXAL 10 mg Tablets)
10 mg,tablets
Amlodipine
Amlopin 10 mg and Amlodipine HEXAL 10 mg Tablets are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Amlopin 10 mg and what is it used for
• 2. Important information 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 packaging and other information

1. What is Amlopin 10 mg and what is it 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 called angina pectoris and its rare form, Prinzmetal's angina (variant angina).

In patients with high blood pressure, the medicine reduces the tension of blood vessels, making it easier for blood to flow.
In patients with angina pectoris, Amlopin 10 mg improves the supply of blood to the heart muscle and, through it, oxygen, thus preventing the occurrence of chest pain.
Amlopin 10 mg does not provide immediate relief from angina pain.

2. Important information before taking Amlopin 10 mg

When not to take Amlopin 10 mg

• if the patient is allergic to amlodipine, to any other calcium channel blocker, 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 a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body).
• if the patient has heart failure after a heart attack.

Warnings and precautions

Before starting treatment, the patient should discuss it with their doctor or pharmacist if they currently have or have had:

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

Children and adolescents

The use of Amlopin 10 mg in children under 6 years of age has not been studied. The medicine should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).
To obtain further information, the patient should consult their doctor.

Amlopin 10 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Amlopin 10 mg and other medicines may interact with each other. These medicines include:

• ketokonazole and itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV infection);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St. John's Wort (Hypericum perforatum);
• verapamil, diltiazem (medicines used to treat heart conditions);
• dantrolene (a medicine used in severe body temperature disorders);
• simvastatin (a medicine used to lower high cholesterol levels in the blood);
• tacrolimus, sirolimus, everolimus, and cyclosporine (medicines used to prevent organ rejection and treat cancer);
• temsirolimus (a medicine used to treat cancer).

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 grapefruits or drink grapefruit juice.
They may cause an increase in the concentration of the active substance of the medicine (amlodipine) in the blood and, as a result, an unpredictable increase in the blood pressure-lowering effect.

Pregnancy and breastfeeding

Pregnancy
The safety of using Amlopin 10 mg in pregnant women has not been established. If the patient is pregnant, 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 breast milk. If the patient is breastfeeding or plans to breastfeed, they should tell their doctor before starting to take Amlopin 10 mg.

Driving and operating machinery

Amlopin 10 mg may affect the ability to drive or operate machinery.
If the patient feels nausea, dizziness, fatigue, or headache, they should not drive or operate machinery. They should immediately tell their doctor.

Amlopin 10 mg contains sodium

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

3. How to take Amlopin 10 mg

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Amlopin 5 mg and Amlopin 10 mg are available on the market.
The usual initial dose of Amlopin is 5 mg once a day. The doctor may increase the dose to 10 mg once a day.
The medicine can be taken regardless of meals and drinks. It should be taken at the same time every day, with a glass of water. The patient should not take Amlopin 10 mg with grapefruit juice.

Use in children and adolescents

For children and adolescents (from 6 to 17 years old), the recommended initial dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day.
It is essential to take the tablets continuously. The patient should not wait for a doctor's visit until all prescribed tablets have been taken.
The tablets can be divided into equal doses.

Taking a higher dose of Amlopin 10 mg than recommended

Taking too many tablets may cause a significant drop in blood pressure, even to dangerously low values. The patient may experience dizziness, fainting, or weakness. A significant drop in blood pressure may cause shock. The patient's skin may be cool and moist, and they may lose consciousness. If the patient has taken too many Amlopin 10 mg tablets, they should seek medical help immediately.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Amlopin 10 mg

The patient should stay calm. If they forget to take a tablet, they should skip it and take the next dose at the right time. They should never take a double dose to make up for a missed dose.

Stopping the use of Amlopin 10 mg

The doctor will determine how long the patient should take this medicine. Stopping the treatment earlier than recommended may cause the disease to recur.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 immediately contact their doctor:

• sudden wheezing, chest tightness, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, significantly hindering breathing;
• severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, flu-like symptoms accompanied by the formation of blisters, peeling, and swelling of the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, irregular heartbeat;
• pancreatitis, which can cause severe abdominal and back pain with very poor general condition;
• hepatitis, which can cause yellowing of the skin and whites of the eyes (jaundice), fever, chills, fatigue, loss of appetite, abdominal pain, poor general condition, dark urine.

The following very common side effecthas been reported. If it is troublesome for the patient or persists for more than a week, they should contact their doctor.
Very common: may affect more than 1 in 10 people

• swelling (fluid retention)

The following common side effectshave been reported. If any of them are troublesome for the patient or persist 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 (feeling of heartbeat), skin redness (especially of the face)
• breathing difficulties
• abdominal pain, nausea
• changes in bowel movements, diarrhea, constipation, indigestion
• swelling of the ankles
• feeling of tiredness, weakness
• vision disturbances, double vision
• muscle cramps

Other reported side effects are listed below. If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people

• mood swings, 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, rash, red spots on the skin, skin discoloration
• urination disorders, increased need to urinate at night, increased frequency of urination
• impotence, feeling of discomfort or breast enlargement in men
• chest pain
• pain, poor general condition
• joint or muscle pain, back pain
• weight gain or 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 cause unusual bruising or easy bleeding
• high blood sugar levels (hyperglycemia)
• nerve disorders, which can cause weakness, numbness, or tingling
• gum swelling
• abdominal bloating (gastritis)
• liver function disorders, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect the results of some diagnostic tests
• increased muscle tension
• vasculitis, often with skin rash
• increased sensitivity to light

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

• tremors, stiff posture, mask-like face, slow movements, and shuffling gait, unsteady gait.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Amlopin 10 mg

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung– batch number/expiry date: see embossing.
The medicine should not be stored at temperatures above 30°C. It should be stored in the original packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amlopin 10 mg contains

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

What Amlopin 10 mg looks like and what the packaging contains

White or almost white, oblong tablets with broken edges, with a score line on one side and the marking "10" on the other side.
The tablets are packaged in Al/PVC or Al/OPA/Al/PVC blisters and placed in a cardboard box.
Pack sizes: 30 or 60 tablets.
To obtain more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Hexal AG, Industriestraße 25, 83607 Holzkirchen, Germany

Manufacturer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Germany, the country of export:66345.00.00

Parallel import authorization number: 63/23

This medicine is authorized for marketing in the Member States of the European Economic Area under the following names:

Austria
Amlodipin Hexal 10 mg – Tablets
Denmark
Amlohexal
Germany
Amlodipin HEXAL 10 mg Tablets
Hungary
Amlodipin Sandoz 10 mg tabletta
Ireland
Amlode 10 mg tablets
Italy
AMLODIPINA HEXAL AG
Poland
Amlopin 10 mg
Date of leaflet approval: 04.04.2023
[Information about the trademark]