АНТАКАЛ 5 мг Таблетка

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1. Antacal 5 mg tablets, 10 mg tablets
   1. What Antacal is and what it is used for
   2. What you need to know before taking Antacal
2. Antacal may reduce blood pressure even further if you are already taking
   1. How to take Antacal
3. Antacal has not been studied in children under 6 years of age (see section 2
   1. Possible side effects
   2. How to store Antacal
   3. Contents of the pack and other information

Antacal 5 mg tablets, 10 mg tablets

Amlodipine

Read this leaflet carefully before you start 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. 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, 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 you take 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 ingredient amlodipine, which belongs to a group of medicines
called calcium antagonists.
Antacal 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 who suffer from high blood pressure, this medicine works by relaxing the
blood vessels so that blood can flow more easily. In patients with
angina, Antacal improves the blood supply to the heart, which receives more oxygen and thus prevents chest pain. The medicine does not provide immediate relief from
chest pain due to angina.

2. What you need to 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 of the calcium channel blockers. The reaction may be itching, redness of the skin or difficulty breathing
• If you suffer from severe low blood pressure (arterial hypotension)
• If you suffer from heart problems, for example if you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body)
• If you have had a heart attack and as a result your heart is functioning less than normal (heart failure).

Warnings and precautions
Talk to your doctor or pharmacist before taking Antacal.
Tell your doctor if you have or have suffered from the following conditions:

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

Children and adolescents
Antacal has not been studied in children under 6 years of age. Antacal should be
used only 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
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including those available without a prescription.
Antacal can have effects on other medicines or other medicines can have effects on
Antacal, such as:

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

Antacal may reduce blood pressure even further if you are already taking

other medicines to treat high blood pressure (hypertension) at the same time.

Antacal with food and drink
Do not drink grapefruit juice during treatment with this medicine as grapefruit and its juice can cause an increase in the levels of this medicine
in the blood, and this may lead to a marked reduction in blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are
breastfeeding, 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 think you
may be pregnant or are planning a pregnancy, tell your doctor before
taking Antacal.
Breastfeeding
It has been demonstrated that amlodipine passes into breast milk in small amounts. If you are
breastfeeding or will start breastfeeding, tell your doctor before taking Antacal.

Driving and using machines
Antacal may have an effect on the ability to drive or use machines. If you experience
illness, dizziness or fatigue, or headache during treatment with this medicine, avoid driving
or using machines 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 following the instructions of your doctor exactly. If you have
any doubts, consult your doctor or pharmacist.
The usual starting dose is 1 tablet of 5 mg once a day. The dose may be
increased to 1 tablet of 10 mg once a day.
You can take this medicine before or after food and drinks. You must take the
medicine every day at the same time with some 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 per day. The recommended maximum daily dose is 5 mg. Antacal 5 mg can
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 told you. See your
doctor before stopping the tablets.

If you take more Antacal than you should
If you take an excessive number of tablets, your blood pressure may drop
too low, which could be dangerous. You may experience dizziness, lightheadedness, weakness
or fainting. The drop in blood pressure could be so severe as to cause you to go into 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 up to 24-48 hours after taking the medication.

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 a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you notice any of the following very rare and serious side effects, consult

immediatelyyour doctor:

• Sudden onset of difficulty breathing (dyspnea), chest pain, shortness of breath 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 rash, hives, widespread skin redness, severe itching, blisters, 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 effects occur or if they persist for more than a week, consult your doctor.
Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

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

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling of noticing heartbeats), hot flashes
• Abdominal pain and nausea
• Altered bowel habits, diarrhea, 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 the side effects worsen, or if you notice the appearance of any other, contact your
pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting
• Sensation of numbness or tingling in the limbs; loss of pain sensitivity
• 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 urination
• Inability to achieve an erection (impotence); breast discomfort or enlargement of the breasts in men
• Pain, malaise
• 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 can determine 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, 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, often with skin rash
• Sensitivity to light
• Disorders related to rigidity, tremor and/or movement disorders

Not known: frequency cannot be estimated based on available data

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

Reporting of side effects
If you experience any side effects, including 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 Antacal

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 that 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 dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Antacal contains
The active ingredient of Antacal 5 mg tablets is amlodipine (as besilate).
The active ingredient of Antacal 10 mg tablets is amlodipine (as besilate).
The other ingredients are: microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium glycolate starch and magnesium stearate.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano
Manufacturer
R-Pharm Germany GmbH
Heinrick-Mack-Str. 35
89257 Illertissen
Germany
Pfizer Manufacturing Deutschland GmbH
Freiburg Site
Mooswaldallee 1
79090 Freiburg,
Germany