AMLODIPINA 5 mg Coated Tablet

Зміст інструкції

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

Amlodipina Medreg 5 mg tablets, 10 mg tablets

amlodipina

Generic medicine

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Amlodipina Medreg contains the active substance amlodipine, which belongs to a group of medicines
called calcium antagonists.
Amlodipina Medreg is used for the treatment of high blood pressure (hypertension) or a type of
chest pain called angina, including a rare form called Prinzmetal's angina or variant angina.
In patients with hypertension, this medicine works by relaxing the blood vessels, so that blood
can flow more easily. In patients with angina, Amlodipina Medreg improves the supply
of blood to the heart muscle, which receives more oxygen and thus prevents chest pain.
This medicine does not provide immediate relief from chest pain due to angina.
Amlodipina Medreg is indicated for adults, adolescents and children starting from 6 years of age.

2. What you need to know before taking Amlodipina Medreg

Do not take Amlodipina Medreg

• If you are allergic to amlodipine, or to any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonists. The reaction may be itching, skin redness or difficulty breathing.
• If you have severely low blood pressure (hypotension).
• If you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide the body with enough blood).
• If you suffer from heart failure following a heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipina Medreg .
Tell your doctor if you have or have suffered from the following conditions:

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are elderly and your dose may need to be increased

Children and adolescents
Amlodipina Medreg has not been studied in children under the age of 6 years. Amlodipina Medreg
should only be used for hypertension in children and adolescents aged 6 to 17 years (see
section 3).

Other medicines and Amlodipina Medreg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Amlodipina Medreg can affect or be affected by other medicines, such as for example:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used for the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St John's wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe alterations in body temperature)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to change the way the immune system works)
• simvastatin (cholesterol-lowering medicine)
• cyclosporine (an immunosuppressant)

Amlodipina Medreg may reduce blood pressure even more if you are already taking
other medicines to treat hypertension at the same time.

Amlodipina Medreg with food and drink
People taking Amlodipina Medreg should not consume grapefruit and grapefruit juice.
Because grapefruit and grapefruit juice can induce an increase in the levels of the active substance
amlodipine in the blood, and this may lead to an increase in the hypotensive effect of Amlodipina
Medreg.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, if you are
breastfeeding, 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
Amlodipina Medreg may have an effect on your ability to drive or operate machinery. If the
tablets make you feel unwell, dizzy or tired, or give you a headache, avoid driving or
operating machinery and contact your doctor immediately.

Amlodipina Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Amlodipina Medreg

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended initial dose is Amlodipina Medreg 5 mg once a day. The dose may be
increased to Amlodipina Medreg 10 mg once a day.
This medicine can be taken before or after food and drinks. You must take this medicine
every day at the same time with a little water. Do not take Amlodipina Medreg with grapefruit
juice.

Use in children and adolescents
For children and adolescents (from 6 to 17 years of age), the recommended initial dose is 2.5 mg per
day. Amlodipina Medreg 5 mg can be divided into two equal parts. The maximum
daily recommended dose is 5 mg per day.

If you take more Amlodipina Medreg than you should
If you should take an excessive number of tablets, your blood pressure may drop
too low and this could be dangerous. You may experience dizziness, mental confusion, weakness or
fainting. The drop in blood pressure could be so severe as to cause you shock. Your skin may
become cool and clammy and you may lose consciousness. Excess fluid may accumulate
in the lungs (pulmonary edema) causing shortness of breath which may develop up to 24-48 hours
after taking the medicine. If you have taken an excessive number of Amlodipina Medreg tablets,
contact your doctor immediately.

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

If you stop taking Amlodipina Medreg
Your doctor will tell you how long to take the medicine. Your condition may return if you
stop treatment before your doctor tells you to do so.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, it can cause side effects, although not everyone experiences them.
Consult your doctor immediatelyif you experience any of the following side effects after
taking this medicine:

• Sudden onset of dyspnea, chest pain, shortness of breath or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat which can cause difficulty breathing
• Severe skin reactions including intense rash, urticaria, widespread skin redness, severe itching, blisters, scaling and skin swelling, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflammation of the pancreas which can cause severe abdominal and back pain combined with a feeling of severe malaise.

The following very common side effectshave been reported. If any of these effects occur or
persist for more than one week, consult your doctor.

Very common(may affect more than 1 in 10 people)

• edema (fluid retention).

The following common side effectshave been reported. If any of these effects occur or if

persist for more than one week, consult your doctor.

Common(may affect up to 1 in 10 people):

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of your heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Altered bowel habits, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

In addition, the following side effects have been reported. If any of these
side effects worsen, or if you notice any side effect not listed in this

Uncommon(may affect up to 1 in 100 people):

• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting
• Sensation of numbness or tingling in the limbs; loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (malaise)
• Hair loss, increased sweating, itchy skin, red patches on the skin, skin discoloration
• Urinary disorders, need to urinate at night, frequent urination
• Inability to achieve an erection; 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):

• Confusion

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

• Low levels of white blood cells and platelets in the blood, which can lead to unusual bruising or a tendency to bleed
• High blood sugar levels (hyperglycemia)
• A nervous disorder that can cause muscle weakness, tingling or numbness
• Swelling of the gums
• Stomach swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
• increased liver enzymes which can lead to changes in some clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often with a rash
• Sensitivity to light
• Disorders related to rigidity, tremor and/or movement disorders

Not known (the frequency cannot be estimated based on available data):

• Tremor, rigid posture, mask-like face, slow movements and an unbalanced, shuffling gait

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Amlodipina Medreg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after ‘EXP’. The expiry
date refers to the last day of that month.
Store at a temperature below 25°C. Store in the original packaging to protect the
medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amlodipina Medreg contains

• The active ingredient 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), anhydrous colloidal silica, sodium glycolate starch (type A) and magnesium stearate.

Description of the appearance of Amlodina Medreg and contents of the pack

Amlodipina Medreg 5 mg tablets:
Tablets of colour from white to off-white, circular (from 8.73 mm to 8.93 mm), biconvex, not
coated, with imprinted “E 21” on one side and incised on the other side. The tablet can be divided into equal doses.

Amlodipina Medreg 10 mg tablets:
Tablets of colour from white to off-white, round (from 10.5 mm to 10.7 mm), biconvex, not
coated with imprinted “10” on one side.
The tablets are available in opaque PVC/PVDC/Al blisters in cardboard packaging.

Amlodipina Medreg 5 mg tablets:
Pack size: 10, 20, 28, 30, 50, 60, 90, 98 and 100 tablets.

Amlodipina Medreg 10 mg tablets:
Pack size: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturers
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 medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Republic: Amlodipine Medreg
Poland: Amlodipine Medreg
Slovakia: Amlodipine Medreg 5 mg
Amlodipine Medreg 10 mg
Italy: Amlodipina Medreg 5 mg
Amlodipina Medreg 10 mg
Romania: Amlodipinӑ Gemax Pharma 5 mg tablets
Amlodipinӑ Gemax Pharma 10 mg tablets