Package leaflet: Information for the patient

Amlodipine Medreg 5 mg tablets, 10 mg tablets

amlodipine
Equivalent medicine
Please read all of 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 other people, even if their symptoms are similar to yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Amlodipine Medreg is and what it is used for
What you need to know before taking Amlodipine Medreg
How to take Amlodipine Medreg
Possible side effects
How to store Amlodipine Medreg
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 used to treat high blood pressure (hypertension) or a type of chest pain known as angina, including a rare form called Prinzmetal's angina or variant angina.
In patients with hypertension, this medicine works by relaxing blood vessels, allowing blood to flow more easily. In patients with angina, Amlodipine Medreg improves blood supply to the heart muscle, thereby increasing oxygen delivery and preventing chest pain.
This medicine does not provide immediate relief of angina-related chest pain.
Amlodipine Medreg is indicated for adults, adolescents, and children from the age of 6 years.

2. What you should know before taking Amlodipine Medreg

Do not take Amlodipine Medreg

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine Medreg.
Inform your doctor if you have or have previously had any of the following conditions:

Recent heart attack
Heart failure
Severe high blood pressure (hypertensive crisis)
Liver disease
You are elderly and your dose needs to be increased

Children and adolescents
Amlodipine Medreg has not been studied in children under 6 years of age. Amlodipine Medreg
should only be used for hypertension in children and adolescents aged 6 to 17 years (see
section 3).
Other medicines and Amlodipine Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Amlodipine Medreg may affect or be affected by other medicines, such as:

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

Amlodipine Medreg may further reduce blood pressure if you are already taking other medicines for the treatment of hypertension.
Amlodipine Medreg with food and drinks
People taking Amlodipine Medreg should not consume grapefruit or grapefruit juice.
Grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could enhance the hypotensive effect of Amlodipine Medreg.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The safety of amlodipine in pregnant women has not been established.
It has been shown that amlodipine passes into breast milk in small amounts.
Driving and using machines
Amlodipine Medreg may affect your ability to drive or use machinery. If the tablets cause you discomfort, dizziness or fatigue, or give you headaches, avoid driving or using machinery and contact your doctor immediately.
Amlodipine 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 Amlodipine Medreg

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is Amlodipine Medreg 5 mg once daily. The dose may be
increased to Amlodipine Medreg 10 mg once daily.
This medicine can be taken before or after food and drink. Take this medicine
every day at the same time with a glass of water. Do not take Amlodipine Medreg with
grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the recommended starting dose is 2.5 mg daily.
Amlodipine Medreg 5 mg may be divided into two equal parts. The maximum recommended
daily dose is 5 mg daily.
If you take more Amlodipine Medreg than you should
If you take too many tablets, your blood pressure could drop too low, which could be dangerous. You may experience dizziness, mental confusion, weakness, or fainting. The drop in blood pressure could be so severe as to cause shock. Your skin may become cold and clammy, and you may lose consciousness. Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion. If you have taken too many Amlodipine Medreg tablets, contact your doctor immediately.
If you forget to take Amlodipine Medreg
If you forget to take a tablet, skip the missed dose completely. 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 Amlodipine 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Sudden onset of shortness of breath, chest pain, breathlessness or difficulty breathing
Swelling of the eyelids, face or lips
Swelling of the tongue and throat which may cause difficulty breathing
Severe skin reactions including intense rash, hives, redness of the skin all over the body, intense itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
Heart attack, irregular heartbeat
Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of general malaise

The following very common side effects have been reported. If you experience any of these, or if they last longer than one week, consult your doctor.
Very common (may affect more than 1 in 10 people):

Edema (fluid retention)

The following common side effects have been reported. If you experience any of these, or if they last longer 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)
Changes in bowel habits, diarrhoea, constipation, indigestion
Tiredness, 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 effects not listed in this leaflet, inform your doctor or pharmacist.
Uncommon (may affect up to 1 in 100 people):

Mood changes, anxiety, depression, insomnia
Tremor, altered taste, fainting
Numbness or tingling sensation in 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 (feeling unwell)
Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
Urinary disorders, need to urinate at night, frequent need to urinate
Inability to achieve an erection; discomfort or breast enlargement in men
Pain, feeling unwell
Joint or muscle pain, back pain
Weight gain or weight 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 may lead to unusual bruising or tendency to bleed
High blood sugar levels (hyperglycaemia)
A nerve disorder which may cause muscle weakness, tingling or numbness
Swelling of the gums
Abdominal swelling (gastritis)
Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
Increased liver enzymes which may lead to abnormalities in certain clinical tests
Increased muscle tension
Inflammation of blood vessels, often associated with skin rash
Light sensitivity
Disorders related to rigidity, tremor and/or movement disorders

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

Tremor, rigid posture, mask-like facial expression, slow movements and a shuffling, unbalanced gait

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: 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 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 after 'EXP'. The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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), anhydrous colloidal silicon dioxide, sodium starch glycolate (type A) and magnesium stearate.

Description of the appearance of Amlodipine Medreg and pack sizes
Amlodipine Medreg 5 mg tablets:
White to off-white, circular tablets (8.73 mm to 8.93 mm in diameter), biconvex, uncoated, with "E 21" engraved on one side and a breakline on the other side. The tablet may be divided into equal doses.
Amlodipine Medreg 10 mg tablets:
White to off-white, round tablets (10.5 mm to 10.7 mm in diameter), biconvex, uncoated, with "10" engraved on one side.
The tablets are available in opaque PVC/PVDC/Al blisters packed in cardboard cartons.
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

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
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 comprimate
Amlodipinӑ Gemax Pharma 10 mg comprimate