Amlodipine medreg

Package leaflet: Information for the patient

Amlodipine Medreg, 5 mg, tablets
Amlodipine Medreg, 10 mg, tablets
Amlodipinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Amlodipine Medreg is and what it is used for
2. What you need to know 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 Amlodipine Medreg is and what it is used for

Amlodipine Medreg contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Amlodipine Medreg is indicated for the treatment of high blood pressure (hypertension) or chest pain known as angina, including a less common form called vasospastic angina (Prinzmetal's angina).
In patients with high blood pressure, the medicine relaxes blood vessels, making it easier for blood to flow. In patients with angina, Amlodipine Medreg improves blood flow to the heart muscle, increasing oxygen supply and thereby preventing chest pain.
This medicine does not provide immediate relief from angina pain.
Amlodipine Medreg is intended for use in adults, adolescents, and children aged 6 years and older.

2. Important information before using Amlodipine Medreg

When not to use Amlodipine Medreg

• if the patient has hypersensitivity (allergy) to amlodipine or to any of the other ingredients of the medicine (listed in section 6), or to any other calcium antagonist. Symptoms may include itching, skin redness or difficulty breathing.
• if the patient has significant 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 previous heart attack.

Warnings and precautions
Before starting treatment with Amlodipine Medreg, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has had any of the following conditions:

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

Children and adolescents
Studies on the use of Amlodipine Medreg in children under 6 years of age have not been conducted. Amlodipine Medreg should only be used for the treatment of hypertension in children and adolescents aged 6 to 17 years (see section 3).
Amlodipine Medreg 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.
Amlodipine Medreg may affect the action of other medicines or other medicines may affect the action of Amlodipine Medreg:

• ketoconazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV infection),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's wort,
• verapamil, diltiazem (medicines used for heart diseases),
• dantrolene (administered intravenously in severe disturbances of body temperature),
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the immune system),
• simvastatin (a medicine that lowers cholesterol levels),
• cyclosporine (an immunosuppressive medicine).

Amlodipine Medreg may lower blood pressure to a greater extent if the patient is taking other antihypertensive medicines.
Amlodipine Medreg with food and drink
Patients taking Amlodipine Medreg should not consume grapefruit juice or grapefruits, as they may increase the blood concentration of the active substance amlodipine, which could lead to an unexpected intensification of the blood pressure-lowering effect of Amlodipine Medreg.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before taking this medicine.
The safety of amlodipine use during pregnancy has not been established.
It has been shown that amlodipine passes into breast milk in small amounts.
Driving and operating machinery
Amlodipine Medreg may affect the ability to drive or operate machinery.
If the tablets cause nausea, dizziness, fatigue or headache, the patient should not drive or operate machinery and should contact the doctor immediately.
Amlodipine Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to use Amlodipine Medreg

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult 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.
This medicine may be taken independently of meals and drinks. It is recommended to take this medicine
at the same time every day, with water. Do not take Amlodipine Medreg with grapefruit juice.
Use in children and adolescents
In children and adolescents (6–17 years of age), the usual recommended starting dose is 2.5 mg per day.
Amlodipine Medreg 5 mg tablets may be divided into equal doses. The maximum recommended dose is 5
mg per day.
Taking more Amlodipine Medreg than recommended
Taking too many tablets may cause a decrease, or even a dangerously low drop, in blood pressure.
Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur.
If the drop in blood pressure is very severe, shock may develop. The patient's skin then becomes
cold and clammy, and the patient may lose consciousness. Within 24–48 hours after taking the medicine,
breathlessness may occur due to fluid accumulation in the lungs (pulmonary oedema). If too many
tablets of Amlodipine Medreg have been taken, seek immediate medical attention.
If you miss a dose of Amlodipine Medreg
If the patient forgets to take a tablet, the missed dose should be skipped. Take the next dose at the
usual time. Do not take a double dose to make up for a missed dose.
Stopping Amlodipine Medreg
Your doctor will inform you about the duration of treatment. If the patient stops taking this medicine
before the doctor advises, the condition may recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• sudden wheezing, chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue and throat causing severe breathing difficulties
• severe skin reactions, including intense rash, hives, redness of the entire skin surface, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack, cardiac arrhythmias
• pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition.

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

• swelling (fluid retention).

The following common adverse reactions have been observed. If any of these adverse reactions are
bothersome to the patient or if they last longer than one week , you should consult your doctor .
Common (may affect less than 1 in 10 people):

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

Other reported adverse reactions are listed below. If any of the adverse effects worsen or if any adverse
effects not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon (may affect less than 1 in 100 people):

• mood changes, anxiety, depression, insomnia
• tremor, taste disturbances, fainting
• sensation of numbness or tingling in limbs, loss of pain sensation
• tinnitus
• low blood pressure
• sneezing/runny nose 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 disorders, increased need to urinate at night, increased frequency of urination
• erectile dysfunction, discomfort or enlargement of breasts in men
• pain, malaise
• joint or muscle pain, back pain
• weight gain or weight loss.

Rare (may affect less than 1 in 1,000 people):

• disorientation.

Very rare (may affect less than 1 in 10,000 people):

• decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising and easier bleeding
• increased blood glucose concentration (hyperglycaemia)
• nerve disorders which may cause muscle weakness, tingling or numbness
• gum swelling
• abdominal bloating (dyspepsia)
• liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in blood tests
• increased muscle tone
• vasculitis, often with skin rash
• photosensitivity
• movement disorders involving stiffness, tremor and (or) difficulty moving.

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

• tremor, postural rigidity, mask-like facial expression, slowed movements and shuffling gait, unsteady gait.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur,
inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reactions, including any 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Amlodipine Medreg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging in order 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. These measures will help protect the environment.

6. Contents of the package and other information

What Amlodipine Medreg contains

• The active substance is amlodipine (as amlodipine besilate). Each tablet contains amlodipine besilate equivalent to 5 mg or 10 mg of amlodipine.
• The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose (type 102), colloidal anhydrous silica, sodium carboxymethyl starch (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 (measuring 8.73 mm to 8.93 mm), biconvex, uncoated tablets,
with the imprint “E 21” on one side and a break line on the other side.
The tablet can be divided into equal doses.
Amlodipine Medreg, 10 mg, tablets:
White or almost white, round (measuring 10.5 mm to 10.7 mm), biconvex, uncoated tablets,
with the imprint “10” on one side.
The tablets are packed in opaque blisters made of PVC/PVDC/Aluminum, contained 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 Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Amlodipine Medreg
Poland: Amlodipine Medreg
Romania: Amlodipină Gemax Pharma 5 mg comprimate
Amlodipină Gemax Pharma 10 mg comprimate
Slovakia: Amlodipine Medreg 5 mg
Amlodipine Medreg 10 mg