AMLODIPINA 5 mg Coated Tablet

Зміст інструкції

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

Amlodipina Almus 5 mg tablets, 10 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 their symptoms are the same as yours, 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 Almus is and what it is used for
• 2. What you need to know before you take Amlodipina Almus
• 3. How to take Amlodipina Almus
• 4. Possible side effects
• 5. How to store Amlodipina Almus
• 6. Contents of the pack and other information

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

Amlodipina Almus contains the active ingredient amlodipine, which belongs to a group of medicines
called calcium antagonists.
Amlodipina Almus 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 Almus improves the blood supply to the heart muscle
which receives more oxygen and thus prevents chest pain. This medicine does not provide an
immediate relief from chest pain due to angina.

2. What you need to know before taking Amlodipina Almus

Do not take Amlodipina Almus tablets

• If you are allergic (hypersensitive) to amlodipine, or to any of the other ingredients of this medicine listed in section 6, or to any other calcium channel blockers. 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 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 Amlodipina Almus
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 (hepatopathy)
• You are elderly and your dose may need to be increased

Children and adolescents
Amlodipina Almus has not been studied in children under 6 years of age. Amlodipina Almus should
only be used for hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, consult your doctor.

Other medicines and Amlodipina Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Amlodipina Almus can have effects on other medicines or other medicines can have effects on
Amlodipina Almus, such as:

• 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 of body temperature)
• simvastatin (cholesterol-lowering medicine)
• tacrolimus (used to control the immune response, to allow the body to accept the transplanted organ)
• cyclosporine (an immunosuppressant). Amlodipina Almus may lower blood pressure further if you are already taking other medicines to treat high blood pressure.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you believe you are pregnant or are
planning a pregnancy, inform your doctor before taking Amlodipina Almus.
Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or are about to
start breastfeeding, you should inform your doctor before taking Amlodipina Almus.

Driving and using machines
Amlodipina Almus may have an effect on your ability to drive or operate machinery. If the tablets cause
you to feel unwell, dizzy or tired, or if they give you a headache, avoid driving or operating machinery and
contact your doctor immediately.

Amlodipina Almus 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 Almus

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended initial dose is Amlodipina Almus 5 mg once a day. The dose may be
increased to Amlodipina Almus 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 Almus 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.
The recommended maximum daily dose is 5 mg per day. Amlodipina Almus 5 mg can be
divided into two equal parts to obtain a dose of 2.5 mg.
It is important to continue taking the tablets for the entire time indicated by your doctor. See your
doctor before stopping the tablets.

If you take more Amlodipina Almus than you should
If you should take an excessive number of tablets, your blood pressure may drop too low and this
may be dangerous. You may experience dizziness, mental confusion, weakness or fainting. The drop
in blood pressure may be so severe as to cause you shock. Your skin may become cool and
moist 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 Almus tablets, contact your
doctor immediately

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

If you stop taking Amlodipina Almus
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 any doubts about 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 notice any of the following side effects, consult your doctor immediately:

• Sudden onset of shortness of breath, chest pain, wheezing or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat which may cause difficulty in breathing
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, 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 accompanied by a feeling of severe malaise

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

persists for more than a week, see your doctor.
Very common:may affect more than 1 in 10 people

• Swelling of the ankles (edema)

The following common side effectshave been reported. If any of these occur or if persists
for more than a week, see your doctor.
Common:may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling your heartbeat), flushing
• Abdominal pain, nausea
• Altered bowel habits, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Hot flushes Furthermore, the following side effects have been reported.

If any of these side effects gets worse, or if you notice any side effect not listed here

Uncommon:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting
• Feeling 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
• 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, discomfort
• 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 may lead to unusual bruising or a tendency to bleed (damage to red blood cells)
• High blood sugar levels (hyperglycemia)
• A nervous disorder that can cause weakness, tingling or numbness
• Swelling of the gums
• Inflammation of the stomach lining (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in some clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often with a rash
• Sensitivity to light
• Disorders related to stiffness, tremor and/or movement disorders

Not known:frequency cannot be estimated from the available data

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Almus

Keep this medicine out of the sight and reach of children.
Do not use Amlodipina Almus after the expiry date which is stated on the package or the bottle/blister after
Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
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 Almus contains
The active ingredient is amlodipine (as amlodipine besilate).
Amlodipina Almus 5 mg: One tablet contains 5 mg of amlodipine (as amlodipine besilate).
Amlodipina Almus 10 mg: One tablet contains 10 mg of amlodipine (as amlodipine besilate).
The other excipients are: microcrystalline cellulose, dihydrate calcium hydrogen phosphate, magnesium stearate,
sodium carboxymethylcellulose (type A).

Description of the appearance of Amlodipina Almus and contents of the pack
Amlodipina Almus 5 mg tablets: Tablet (8 mm) white, uncoated, round, flat with a
notch on one side and imprinted AB5 on the other side. The tablet can be divided into two equal halves.
Amlodipina Almus 10 mg tablets: Tablet (10 mm) white, uncoated, round, flat with a
notch on one side and imprinted AB10 on the other side. The tablet can be divided into two equal
halves.
Packs:
5 mg tablets:
Blisters: 14, 20, 28, 30, 50, 100 and 300 (30x10) tablets.
Bottles: 14, 20, 28, 50, 100 and 300 (30x10) tablets.
10 mg tablets:
Blisters: 14, 20, 28, 30, 50, 100 and 300 (30x10) tablets.
Bottles: 14, 20, 28, 50, 100 and 300 (30x10) tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Almus S.r.l.
Via Cesarea, 11/10 - 16121 Genova (Italy)

Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovska Shosse Str. - Dupnitsa 2600 (Bulgaria)

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Italy - Amlodipina Almus 5 mg tablets
Italy - Amlodipina Almus 10 mg tablets