Antacal

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antacal 5 mg tablets, 10 mg tablets

Amlodipine
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Antacal is and what it is used for

Antacal contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Antacal 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 high blood pressure, this medicine works by relaxing the blood vessels so that blood can flow more easily. In patients with angina, Antacal improves blood supply to the heart, thereby increasing oxygen delivery and preventing chest pain. The medicine does not provide immediate relief from angina-related chest pain.

2. What you should know before taking Antacal

Do not take Antacal

• If you are allergic (hypersensitive) to amlodipine, or to any of the other ingredients of this medicine (listed in section 6), or to any calcium antagonist medicines. The reaction may include itching, skin redness, or difficulty breathing
• If you suffer from severe low blood pressure (arterial hypotension)
• If you have heart problems, for example, 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 have had a heart attack and as a result your heart functions less than normal (heart failure).

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

• Recent heart attack
• Reduced heart function (heart failure)
• Severe high blood pressure (hypertensive crisis)
• Liver disease (hepatopathy)
• You are elderly and your dose needs to be increased (see section 3).

Children and adolescents
Antacal has not been studied in children under 6 years of age. Antacal should only be used for the treatment of high blood pressure (hypertension) in children and adolescents aged 6 to 17 years (see section 3).
For further information, consult your doctor.
Other medicines and Antacal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Antacal may affect other medicines, or other medicines may affect Antacal, such as:

• ketoconazole, itraconazole, medicines used to treat fungal infections (antifungal drugs)
• ritonavir, indinavir, nelfinavir, so-called protease inhibitors used in the treatment of HIV
• rifampicin, erythromycin, clarithromycin, antibiotic medicines used to treat bacterial infections
• Hypericum perforatum, also known as St. John's wort, used to treat certain forms of depression
• verapamil, diltiazem, heart medicines
• dantrolene, used to treat severe disturbances in body temperature when administered intravenously (infusion)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the way the immune system works)
• simvastatin, a medicine used to treat high levels of fats in the blood (a cholesterol-lowering medicine)
• ciclosporin (an immunosuppressant).

Antacal may lower your blood pressure even more if you are already taking other medicines for high blood pressure (hypertension).
Antacal with food and drink
Do not drink grapefruit juice during treatment with this medicine, as grapefruit and grapefruit juice may increase the levels of this medicine in the blood, which could lead to a marked reduction in blood pressure.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
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 Antacal.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or plan to breastfeed, inform your doctor before taking Antacal.
Driving and using machines
Antacal may affect your ability to drive or operate machinery. If during treatment with this medicine you experience discomfort, dizziness, fatigue, or headache (cephalalgia), avoid driving or operating machinery and contact your doctor immediately.
Antacal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially 'sodium-free'.

3. How to take Antacal

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The usual starting dose is 1 tablet of 5 mg once daily. The dose may be increased to 1 tablet of 10 mg once daily.
You may take this medicine before or after food and drinks. Take the medicine at the same time each day with a glass of water. Do not take Antacal 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 daily. The recommended maximum daily dose is 5 mg. Antacal 5 mg may be divided into two equal parts to obtain a dose of 2.5 mg.
Antacal has not been studied in children under 6 years of age (see section 2 “Children and adolescents”).

Continue taking the tablets for as long as your doctor has instructed. Contact your doctor before stopping the tablets.

If you take more Antacal than you should
If you take too many tablets, your blood pressure may drop too low, 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. If you have taken an excessive number of Antacal tablets, contact your doctor immediately.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take Antacal
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 the forgotten dose.

If you stop taking Antacal
You must continue taking this medicine for the entire duration prescribed by your doctor. Stopping treatment may cause your condition to worsen.

If you have any doubts about how to use this medicine, consult 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 very rare and serious side effects, consult your doctor immediately:

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

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

• Oedema (fluid retention)

The following common side effects have been reported. If any of these occur or if they last 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 heartbeat), hot flushes
• Abdominal pain and nausea
• Changes in bowel habits, diarrhoea, 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 leaflet, inform your doctor or pharmacist.
Uncommon : may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, 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
• 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 (impotence); breast discomfort or breast enlargement in men
• Pain, malaise
• 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 (damage to red blood cells)
• High blood sugar levels (hyperglycaemia)
• A nerve disorder which may cause weakness, tingling or numbness
• Swollen 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 changes in certain clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Light sensitivity
• Disorders related to stiffness, 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 unbalanced, shuffling 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
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 Antacal

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.
Do not dispose of any medicine 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 Antacal contains
The active substance in Antacal 5 mg tablets is amlodipine (as besylate).
The active substance in Antacal 10 mg tablets is amlodipine (as besylate).
The other components are: microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium glycolate starch, and magnesium stearate.

Description of the appearance of Antacal and the contents of the pack
5 mg tablets: white to off-white, octagonal tablets, marked with "AML 5" and a score line on one side.
10 mg tablets: white to off-white, octagonal tablets, marked with "AML-10" on one side.
Antacal 5 mg tablets are available in blisters containing 28 tablets.
Antacal 10 mg tablets are available in blisters containing 14 tablets.

Marketing authorization holder and manufacturer
Marketing authorization holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano, Italy

Manufacturers
R-Pharm Germany GmbH
Heinrick-Mack-Str. 35
89257 Illertissen, Germany
Pfizer Manufacturing Deutschland GmbH
Site Freiburg
Mooswaldallee 1
79090 Freiburg, Germany