BALARM 5 mg Tablet

Зміст інструкції

1. BALARM 5 mg tablets, 10 mg tablets
   1. POSSIBLE SIDE EFFECTS
   2. HOW TO STORE BALARM
   3. PACKAGE CONTENTS AND OTHER INFORMATION

BALARM 5 mg tablets, 10 mg tablets

Amlodipine
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 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 is BALARM and what it is used for
• 2. What you need to know before you take BALARM
• 3. How to take BALARM
• 4. Possible side effects
• 5. How to store BALARM
• 6. Contents of the pack and other information
• 1. WHAT IS BALARM AND WHAT IT IS USED FOR

BALARM contains the active ingredient amlodipine, which belongs to a group of medicines called
calcium antagonists.
BALARM 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, BALARM improves blood supply 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.

• 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BALARM

Do not take BALARM

• If you are allergic (hypersensitive) to amlodipine, or to any of the excipients (see section 6), or to any of the calcium antagonists. The reaction may be itching, redness of the skin 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 enough 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 BALARM.
Tell your doctor if you have or have suffered from the following conditions:

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

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

Other medicines and BALARM
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
those available without a prescription.
BALARM can affect other medicines or other medicines can affect BALARM
such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat 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 (a medicine that lowers cholesterol)
• cyclosporine (an immunosuppressant)

BALARM may lower blood pressure even further if you are already taking other medicines for the treatment
of hypertension.

BALARM with food and drink
People taking BALARM should not drink grapefruit juice as grapefruit and grapefruit juice can
increase the levels of the active ingredient amlodipine in the blood, which may increase the hypotensive
effect of BALARM.

Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you may be pregnant
or are planning a pregnancy, tell your doctor before taking BALARM.
Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or are
planning to start breastfeeding, tell your doctor before taking BALARM.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
BALARM may affect your ability to drive or operate machinery. If the tablets make you feel unwell,
dizzy, tired, or cause headache or nausea, do not drive or operate machinery and contact your doctor
immediately.

BALARM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

BALARM contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

• 3. HOW TO TAKE BALARM

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or
pharmacist.
The recommended starting dose is BALARM 5 mg once a day. The dose may be increased to BALARM 10 mg
once a day.
This medicine can be taken before or after food and drink. You should take the medicine every day at
the same time with a little water. Do not take BALARM with grapefruit juice.

Use in children and adolescents
For children and adolescents (from 6 to 17 years of age), the recommended starting dose is 2.5 mg per
day. The maximum recommended daily dose is 5 mg per day. BALARM 2.5 mg is not currently available
and a 2.5 mg dose cannot be obtained with BALARM 5 mg tablets as these tablets are not designed to be
divided into two equal parts.
Continue taking the tablets for as long as your doctor tells you. See your doctor before stopping the
tablets.

If you take more BALARM than you should
If you take too many tablets, your blood pressure may drop too low, which could be dangerous. You may
feel dizzy, lightheaded, weak or faint. The drop in blood pressure may 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 up to 24-48 hours after
administration.
If you have taken too many BALARM tablets, contact your doctor immediately .
If you forget to take BALARM
Do not worry. If you forget to take a tablet, skip the missed dose. Take the next tablet at your usual time.
Do not take a double dose to make up for a missed dose.

If you stop taking BALARM
You should continue to take the medicine for as long as your doctor tells you. Stopping treatment may
worsen your condition.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, BALARM (amlodipine) can cause side effects, although not everybody gets them.
If you notice any of the following very rare and serious 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 can cause difficulty breathing.
• Severe skin reactions including intense skin rash, hives, skin redness all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, arrhythmia.
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe discomfort.

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

they persist for more than a week, see your doctor.

Very common:may affect up to 1 in 10 people

• Edema (fluid retention)

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

they persist 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)
• Abdominal pain, nausea.
• Altered bowel habits, diarrhea, constipation, indigestion.
• Fatigue, weakness
• Muscle cramps.
• Swelling of the ankles
• Hot flushes

In addition, the following side effects have been reported.
If any of these side effects worsen, or if you notice any effect

Uncommon:may affect up to 1 in 100:

• 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.
• 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.
• Chest pain
• Joint or muscle pain, back pain.
• Weight gain or loss.
• Visual disturbances, including double vision (diplopia)
• Arrhythmia, bradycardia, tachycardia

Rare:may affect up to 1 in 1,000:

• Confusion

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

• Low levels of white blood cells and platelets in the blood which can 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.
• Inflammation of the pancreas (pancreatitis)
• Myocardial infarction
• Swelling of the gums, bleeding gums.
• Abdominal bloating (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 (vasculitis), often with skin rash.
• Skin rashes characterized by redness, spots on the skin, swelling, skin peeling and itching

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 BALARM

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 the month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What BALARM contains
The active ingredient of BALARM 5 mg tablets is amlodipine (as besilate).
The active ingredient of BALARM 10 mg tablets is amlodipine (as besilate).
The excipients are: Microcrystalline cellulose, Lactose monohydrate, Sodium glycolate starch, Magne-
sium stearate

Description of the appearance of BALARM and contents of the pack
5 mg tablets: blister containing 28 white, round tablets.
10 mg tablets: blister containing 14 white, round tablets.

MARKETING AUTHORISATION HOLDER
S.F. GROUP srl
Via Tiburtina, n° 1143 - 00156 Rome

MANUFACTURER
SPECIAL PRODUCT'S LINE S.p.A
Via Fratta Rotonda Vado Largo, n° 1 - 03012 Anagni (FR)