Balarm

Italy
Brand name Balarm
Form tablets
Active substance / Dosage
AMLODIPINE BESYLATE
Prescription type Prescription only
ATC code
C08CA01
Registration number 038055
Manufacturer S.F. GROUP S.R.L.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

BALARM 5 mg tablets, 10 mg tablets

Amlodipine
Equivalent medicine
Please 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. Never give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

  1. What BALARM is and what it is used for

  2. What you need to know before taking BALARM

  3. How to take BALARM

  4. Possible side effects

  5. How to store BALARM

  6. Contents of the pack and other information

  7. WHAT BALARM IS AND WHAT IT IS USED FOR

BALARM contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
BALARM is used to treat high blood pressure (hypertension) or a type of chest pain known as angina, including a rare form called Prinzmetal's or variant angina.
In patients with hypertension, this medicine works by relaxing blood vessels so that blood can flow more easily.
In patients with angina, BALARM improves blood supply to the heart muscle, providing more oxygen and thereby preventing chest pain. This medicine does not provide immediate relief from angina-related chest pain.

  1. WHAT YOU NEED TO KNOW BEFORE TAKING BALARM

Do not take BALARM

  • If you are allergic (hypersensitive) to amlodipine, to any of the excipients (see section 6), or to any 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 aortic heart 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 BALARM.
Inform your doctor if you have or have had any of the following conditions:

  • Recent heart attack
  • Heart failure
  • Severe high blood pressure (hypertensive crisis)
  • Liver disease (hepatopathy)
  • You are elderly and your dosage needs 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 aged 6 to 17 years (see section 3).
For further information, consult your doctor.
Other medicines and BALARM
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
BALARM may affect other medicines, or other medicines may affect BALARM, 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 (heart medicines)
  • 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)
  • cyclosporine (an immunosuppressant)

BALARM may lower your blood pressure even more if you are already taking other medicines for hypertension.
BALARM with food and drinks
People taking BALARM should not drink grapefruit juice, as grapefruit and its juice can increase blood levels of the active substance amlodipine, which may enhance 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, inform your doctor before taking BALARM.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or intend to breastfeed, inform 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 cause you discomfort, dizziness, fatigue, headache, or nausea, avoid driving or operating 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 diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

  1. HOW TO TAKE BALARM

Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
The recommended starting dose is BALARM 5 mg once daily. The dose may be increased to BALARM 10 mg once daily.
This medicine can be taken before or after food and drink. Take the medicine at the same time each day with a glass of water. Do not take BALARM 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. The maximum recommended daily dose is 5 mg. BALARM 2.5 mg is not currently available, and the 2.5 mg dose cannot be obtained from BALARM 5 mg tablets, as these tablets are not designed to be split into equal halves.
Continue taking the tablets for as long as your doctor has instructed. See your doctor before stopping treatment.
If you take more BALARM than you should
If you take too many tablets, your blood pressure may drop too much, which could be dangerous. You may experience dizziness, vertigo, 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 breathlessness, which may develop up to 24–48 hours after ingestion.
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 forgotten tablet.
If you stop taking BALARM
You must continue taking the medicine for as long as your doctor has instructed. Stopping treatment may worsen your condition.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, BALARM (amlodipine) can have adverse reactions, although not everyone experiences them.
If you notice any of the following very rare and serious adverse reactions, consult your doctor immediately:

  • 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 over the entire body, severe itching, blisters, skin peeling, and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.
  • Myocardial infarction, arrhythmia.
  • Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of malaise.

The following common adverse reactions have been reported. If any of these occur, or if they persist for more than one week, consult your doctor.
Very common: may affect up to 1 in 10 people

  • Edema (fluid retention)

The following common adverse reactions have also been reported. If any of these occur, or if they persist for more than one week, consult your doctor.
Common: may affect up to 1 in 10 people

  • Headache, dizziness, somnolence (especially at the beginning of treatment).
  • Palpitations (awareness of your heartbeat)
  • Abdominal pain, nausea.
  • Changes in bowel habits, diarrhea, constipation, indigestion.
  • Fatigue, weakness
  • Muscle cramps.
  • Swelling of the ankles
  • Hot flushes

In addition, the following adverse reactions have been reported.
If any of these adverse reactions worsen, or if you notice any adverse reaction 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, taste disturbances, fainting.
  • Sensation of numbness or tingling in limbs; loss of sensitivity to pain.
  • 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, 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, discomfort.
  • Chest pain
  • Joint or muscle pain, back pain.
  • Weight gain or weight loss.
  • Visual disturbances, including double vision (diplopia)
  • Arrhythmia, bradycardia, tachycardia

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 (damage to red blood cells).
  • High blood sugar levels (hyperglycemia).
  • A nerve disorder which may cause weakness, tingling, or numbness.
  • Inflammation of the pancreas (pancreatitis)
  • Myocardial infarction
  • Swelling of the gums, bleeding 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 (vasculitis), often with skin rash.
  • Skin eruptions characterized by redness, skin spots, swelling, skin peeling, and itching

Not known: frequency cannot be estimated from the available data

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

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 stated on the carton after 'EXP'.
The expiry date refers to the last day of the month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

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

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

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

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

April 2023