NATAM 5 мг Таблетка

Содержание инструкции

1. Natam 5 mg and 10 mg tablets
   1. WHAT NATAM IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING NATAM
2. Natam has not been studied in children under the age of 6 years. Natam must be
3. Natam may have an effect on the ability to drive or operate machinery. If the
   1. HOW TO TAKE NATAM
   2. POSSIBLE SIDE EFFECTS
   3. HOW TO STORE NATAM
   4. CONTENTS OF THE PACK AND OTHER INFORMATION

Natam 5 mg and 10 mg tablets

Amlodipine

Read this leaflet carefully before you start taking this medicine.

• 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.

Contents of this leaflet:

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

1. WHAT NATAM IS AND WHAT IT IS USED FOR

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

Do not take Natam

• 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, skin redness or difficulty breathing.
• If you suffer from severe 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 the body with enough blood).
• If you suffer from heart failure following a heart attack

Warning and precautions
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 dosage may need to be increased

Children and adolescents

Natam has not been studied in children under the age of 6 years. Natam must be

used only 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 NATAM
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including those without a prescription.
Natam may have effects on other medicines or other medicines may have effects on
Natam, 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)

Natam may reduce blood pressure even further if you are already taking
other medicines to treat hypertension at the same time.

Natam with food and drink
People taking Natam should not drink grapefruit juice as grapefruit and its juice can induce an increase in the levels of the active substance
amlodipine in the blood, and this may determine an increase in the hypotensive effect of
Natam.

Pregnancy and Breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you believe you
are pregnant or if you are planning a pregnancy, inform your doctor before
taking Natam.

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 Natam.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Natam may have an effect on the 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.

Natam contains lactose
The product contains lactose. It should not be taken by patients with hereditary
lactose intolerance or glucose/galactose malabsorption.

3. HOW TO TAKE NATAM

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

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the usual starting dose is 2.5
mg per day. The recommended maximum daily dose is 5 mg per day. Natam 5
mg can be divided into two equal parts to obtain a dose of 2.5 mg.
Continue taking the tablets for as long as your doctor has told you. See your
doctor before stopping the tablets.

If you take more Natam than you should
If you should take an excessive number of tablets, your blood pressure may
drop too low and this could be dangerous. You may feel dizzy,
lightheaded, weak or faint. 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 Natam tablets, contact
your doctor immediately .
If you forget to take Natam
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 missed dose.

If you stop taking Natam
You must continue to take the medicine for as long as your doctor tells you.
Stopping treatment may cause your condition to worsen.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Natam can cause side effects, although not everybody gets them.
If you notice any of the following very rare and serious side effects, consult

immediatelyyour doctor:

• 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 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 persistfor more than one week, see yourdoctor.
Common:may affect up to 1 in 10 people:

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Flushing
• Abdominal pain, nausea
• Swelling of the ankles (edema), fatigue

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

Uncommon:may affect up to 1 in 1,000 people:

• Palpitations (feeling your heartbeat)
• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting, weakness
• Sensation of numbness or tingling in the limbs; loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Altered bowel habits, diarrhea, constipation, indigestion, 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
• Weakness, pain, malaise
• Joint or muscle pain, muscle cramps, back pain
• Weight gain or loss

Rare:may affect up to 1 in 10,000 people:

• Confusion

Very rare:may affect less than 1 in 10,000 people:

• 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
• Cough, swelling of the 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 a skin rash
• Sensitivity to light
• Disorders related to stiffness, tremor and/or movement disorders

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

Keep the medicine out of 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.
Tablets
Store at a temperature not exceeding 25°C.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Natam contains
The active substance of Natam 5 mg tablets is amlodipine (as besilate).
The active substance of Natam 10 mg tablets is amlodipine (as besilate).
The excipients are:
Microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate.

Description of the appearance of Natam and contents of the pack
5 mg tablets: white, round, flat tablets with a score line
on one side.
10 mg tablets: white, round, flat tablets with a score line
on one side.
Natam 5 mg tablets is available in blisters containing 28 divisible tablets
Natam 10 mg tablets is available in blisters containing 14 divisible tablets.

Marketing Authorisation Holder and Manufacturer
LANOVA FARMACEUTICI S.r.l. – Via Conca D’Oro, 212 – 00141 Roma

Manufacturer
Special Product's Line S.P.A -
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) Italia
Batches marked only by numbers are produced at:

• West Pharma Producoeos de Especialitades Farmaceuticas SA - Rua Joao de Deus, 11 - Venda Nova, Amadora (Portugal)

Batches marked by letters and numbers are produced at:

• Atlantic Pharma Produções Farmacêuticas, S.A. - Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra (Portugal)