Amlopin 10 mg

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Amlopin 10 mg (Amlodipine - 1A Pharma 10 mg Tablets N)

10 mg, tablets

Amlodipine
Amlopin 10 mg and Amlodipine - 1A Pharma 10 mg Tablets N 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. Do not pass it on 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, pharmacist, or nurse. 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, you should discuss it with your doctor or pharmacist if you 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, you should consult a doctor.

Amlopin 10 mg and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those that are 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 infusion to treat 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 to treat cancer)
temsirolimus (a medicine used to treat cancer).
Amlopin 10 mg may reduce blood pressure more strongly if you are already taking other anti-hypertensive medicines.

Amlopin 10 mg with food and drink

If you are taking Amlopin 10 mg, you should not eat grapefruits or drink grapefruit juice. They may cause an increase in the level 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 you are pregnant, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk. If you are breastfeeding or plan to breastfeed, you should tell your doctor before starting to take Amlopin 10 mg.

Driving and using machines

Amlopin 10 mg may affect your ability to drive or use machines.
If you feel nauseous, dizzy, tired, or have a headache, you should not drive or use machines. You should immediately tell your doctor.

Amlopin 10 mg contains sodium

This 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 Amlopin 10 mg

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult a doctor or pharmacist.
Amlopin 5 mg and Amlopin 10 mg are available on the market.
The usual initial dose of Amlopin 10 mg is 5 mg once a day. Your doctor may increase the dose to 10 mg once a day.
The medicine can be taken regardless of meals and drinks. You should take it at the same time every day, with a glass of water. You 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 important to take the tablets continuously. You should not wait for a visit to the doctor until all prescribed tablets have been used up.
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 decrease in blood pressure, even to dangerously low values. You may feel dizzy, faint, or weak. A significant decrease in blood pressure may cause shock. Your skin may be cool and moist, and you may lose consciousness. If you have taken too many Amlopin 10 mg tablets, you 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

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

Stopping treatment with Amlopin 10 mg

Your doctor will decide how long you should take this medicine. Stopping treatment earlier than recommended may cause the disease to recur.
If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

• sudden wheezing, chest tightness, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, which can make breathing difficult;
• 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;
• liver inflammation, 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 you or lasts for more than a week, you should contact your 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 you or last for more than a week, you should contact your doctor.
Common: may affect up to 1 in 10 people
headache, dizziness, drowsiness (especially at the start of treatment)
palpitations (feeling of heartbeat), flushing of the skin (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 side effects that have been reported are listed below. If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people
mood changes, anxiety, depression, insomnia
tremor, taste disturbances, fainting
numbness or tingling of limbs, lack of pain sensation
ringing in the ears
low blood pressure
rhinitis (runny nose)
cough
dry mouth, vomiting
hair loss, increased sweating, itching of the skin, rash, red spots on the skin, skin discoloration
urinary disturbances, 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 increase or decrease
Rare: may affect up to 1 in 1,000 people
confusion
Very rare: may affect up to 1 in 10,000 people
reduced number of white blood cells, reduced number of platelets, which can cause unusual bruising or bleeding
high blood sugar levels (hyperglycemia)
nerve disorders, which can cause weakness, numbness, or tingling
gum swelling
abdominal bloating (gastritis)
liver function disorders, jaundice, increased liver enzyme activity, which can affect the results of some diagnostic tests
increased muscle tension
inflammation of blood vessels, often with skin rash
increased sensitivity to light
Side effects with unknown frequency:frequency cannot be estimated from the available data
tremor, stiff posture, mask-like face, slow movements, and shuffling gait,
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlopin 10 mg

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: see imprint – Batch number/expiry date: see imprinting
Do not store above 30°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 contents of the packaging

Amlopin 10 mg
White or almost white, oblong tablet with a score line on one side and the marking "10" on the other side.
The tablets are packaged in blisters of aluminum/PVC or aluminum/OPA/aluminum/PVC, placed in a carton.
Pack sizes:
Blisters of 30 and 60 tablets.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany

Manufacturer:

Lek S.A.
16, ul. Podlipie
95-010
Stryków
Poland
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia
ROWA Pharmaceuticals Ltd.
Bantry, Co. Cork
Ireland
Sandoz S.R.L.
Str. Livezeni nr 4
540472 Targu-Mures
Romania

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Germany, the country of export:

• 66351.00.00 Marketing authorization number for parallel import: 87/23

This medicine is authorized 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 tablet

Ireland Amlode 10 mg tablets
Italy AMLODIPINA HEXAL AG
Poland Amlopin 10 mg
Date of leaflet approval: 19.05.2023
[Information about the trademark]