AMLODIPINE 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Amlodipine Medreg, 5 mg, tablets
3. Amlodipine Medreg, 10 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Amlodipine Medreg and what is it used for
5. Important information before taking Amlodipine Medreg
   1. When not to take Amlodipine Medreg
   2. Warnings and precautions
   3. Children and adolescents
   4. Amlodipine Medreg and other medicines
   5. Amlodipine Medreg with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Amlodipine Medreg contains sodium
6. How to take Amlodipine Medreg
   1. Use in children and adolescents
   2. Taking more than the recommended dose of Amlodipine Medreg
   3. Missing a dose of Amlodipine Medreg
   4. Stopping treatment with Amlodipine Medreg
7. Possible side effects
   1. Reporting side effects
8. How to store Amlodipine Medreg
9. Contents of the pack and other information
   1. What Amlodipine Medreg contains
   2. What Amlodipine Medreg looks like and contents of the pack
   3. Marketing authorization holder and manufacturer/importer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 04/2025

Package Leaflet: Information for the Patient

Amlodipine Medreg, 5 mg, tablets

Amlodipine Medreg, 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Amlodipine Medreg and what is it used for
• 2. Important information before taking Amlodipine Medreg
• 3. How to take Amlodipine Medreg
• 4. Possible side effects
• 5. How to store Amlodipine Medreg
• 6. Contents of the pack and other information

1. What is Amlodipine Medreg and what is it used for

Amlodipine Medreg contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Amlodipine Medreg is indicated for the treatment of high blood pressure (hypertension) or chest pain, known as angina pectoris, which has a rare form called variant angina (Prinzmetal's angina).
In patients with high blood pressure, the medicine widens the blood vessels, making it easier for the blood to flow.
In patients with angina, Amlodipine Medreg makes it easier for blood to reach the heart muscle, increasing the amount of oxygen delivered, which in turn prevents chest pain.
This medicine does not provide immediate relief from angina attacks.
Amlodipine Medreg is intended for adults, adolescents, and children aged 6 years and older.

2. Important information before taking Amlodipine Medreg

When not to take Amlodipine Medreg

Warnings and precautions

Before taking Amlodipine Medreg, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had any of the following conditions:

Children and adolescents

No studies have been conducted on the use of Amlodipine Medreg in children under 6 years of age. Amlodipine Medreg should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).

Amlodipine Medreg and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Amlodipine Medreg may interact with other medicines or other medicines may interact with Amlodipine Medreg:

• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's Wort,
• verapamil, diltiazem (medicines used to treat heart conditions),
• dantrolene (given by infusion in severe body temperature disorders),
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the immune system),
• simvastatin (a medicine that lowers cholesterol levels),
• cyclosporin (an immunosuppressive medicine).

Amlodipine Medreg may lower blood pressure more when you are taking other blood pressure-lowering medicines.

Amlodipine Medreg with food and drink

Patients taking Amlodipine Medreg should not drink grapefruit juice or eat grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which may lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Medreg.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
The safety of amlodipine in pregnant women has not been established.
Amlodipine has been shown to pass into breast milk in small amounts.

Driving and using machines

Amlodipine Medreg may affect your ability to drive or use machines.
If the tablets cause nausea, dizziness, fatigue, or headache, do not drive or use machines; contact your doctor immediately.

Amlodipine Medreg contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Amlodipine Medreg

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended initial dose of Amlodipine Medreg is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.
The medicine can be taken with or without food and drinks. It is recommended to take the medicine at the same time every day, with a glass of water. Do not take Amlodipine Medreg with grapefruit juice.

Use in children and adolescents

In children and adolescents (6-17 years), the recommended initial dose is usually 2.5 mg once daily. Amlodipine Medreg 5 mg tablets can be divided into equal doses. The maximum recommended dose is 5 mg once daily.

Taking more than the recommended dose of Amlodipine Medreg

Taking too many tablets may cause a drop in blood pressure, which can be severe. You may feel dizzy, lightheaded, or faint, or experience palpitations. If the drop in blood pressure is severe, it can lead to shock. Your skin may become cool and clammy, and you may lose consciousness. Even 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema). If you have taken too many Amlodipine Medreg tablets, seek medical help immediately.

Missing a dose of Amlodipine Medreg

If you forget to take a tablet, skip it. Take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Amlodipine Medreg

Your doctor will tell you how long to take the medicine. If you stop taking the medicine before your doctor tells you to, your condition may get worse.
If you have any further questions on the use of this medicine, ask your 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, tell your doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat, causing great difficulty in breathing
• severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and skin swelling, or other allergic reactions
• heart attack, irregular heartbeat
• pancreatitis, which may cause severe abdominal pain, radiating to the back, with very severe illness.

The following very commonside effects have been reported. If the symptoms are troublesome or last more than a week, you should consult your doctor.
Very common(may affect more than 1 in 10 people):

• swelling (fluid retention).

The following commonside effects have been reported. If any of the side effects get serious or last more than a week, you should consult your doctor.
Common(may affect up to 1 in 10 people):

• headache, dizziness, drowsiness (especially at the start of treatment)
• palpitations, flushing (especially of the face)
• abdominal pain, nausea
• changes in bowel movements, diarrhea, constipation, indigestion
• fatigue, weakness
• vision disturbances, double vision
• muscle cramps
• swelling of the ankles.

Other side effects have been reported. If you experience any side effects not listed in this leaflet or if any of the side effects get serious, you should consult your doctor or pharmacist.
Uncommon(may affect up to 1 in 100 people):

• mood changes, anxiety, depression, insomnia
• trembling, taste disturbances, fainting
• numbness or tingling of the limbs, lack of pain sensation
• ringing in the ears
• low blood pressure
• coughing/sneezing due to inflammation of the nasal mucosa (rhinitis)
• cough
• dryness of the mucous membranes 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
• erectile dysfunction, discomfort or enlargement of the breasts in men
• pain, malaise
• joint or muscle pain, back pain
• weight gain or loss.

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

• disorientation.

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

• decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising and bleeding
• increase in blood glucose levels (hyperglycemia)
• nerve disorders, which may cause muscle weakness, numbness, or tingling
• gum swelling
• abdominal bloating (gastritis)
• liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in blood tests
• increased muscle tone
• inflammation of blood vessels, often with skin rash
• sensitivity to light
• disorders including stiffness, trembling, and/or difficulty in movement.

Frequency not known(cannot be estimated from the available data):

• trembling, stiffness of posture, mask-like face, slow movements, and shuffling gait.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Side effects can also be reported to the marketing authorization holder.

5. How to store Amlodipine Medreg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Store in a temperature below 25°C. Store in the original package to protect from light.
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 Amlodipine Medreg contains

• The active substance is amlodipine (as amlodipine besylate). Each tablet contains amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine.
• The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose (type 102), colloidal silica, anhydrous, sodium carboxymethylcellulose (type A), and magnesium stearate.

What Amlodipine Medreg looks like and contents of the pack

Amlodipine Medreg, 5 mg, tablets:
White or almost white, round (8.73 mm to 8.93 mm in size), biconvex, uncoated tablets with "E 21" engraved on one side and a score line on the other side.
The tablet can be divided into equal doses.
Amlodipine Medreg, 10 mg, tablets:
White or almost white, round (10.5 mm to 10.7 mm in size), biconvex, uncoated tablets with "10" engraved on one side.
The tablets are packaged in a non-transparent blister pack (PVC/PVDC/Aluminum) in a cardboard box.
Amlodipine Medreg, 5 mg, tablets:
Pack sizes: 10, 20, 28, 30, 50, 60, 90, 98, and 100 tablets.
Amlodipine Medreg, 10 mg, tablets:
Pack sizes: 10, 14, 20, 28, 30, 50, 60, 90, 98, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

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

Czech Republic:
Amlodipine Medreg
Poland:
Amlodipine Medreg
Romania:
Amlodipină Gemax Pharma 5 mg tablets
Amlodipină Gemax Pharma 10 mg tablets
Slovakia:
Amlodipine Medreg 5 mg
Amlodipine Medreg 10 mg

Date of last revision of the leaflet: 04/2025