PACKAGE LEAFLET: INFORMATION FOR THE USER

Natam 5 mg and 10 mg tablets

Amlodipine
Please read this leaflet carefully before 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. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Natam is and what it is used for
What you need to know before taking Natam
How to take Natam
Possible side effects
How to store Natam
Contents of the pack and other information

1. WHAT NATAM IS AND WHAT IT IS USED FOR

Natam contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Natam 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 blood vessels so that blood can flow more easily. In patients with angina, Natam improves blood supply to the heart muscle, providing more oxygen, thereby preventing chest pain. The medicine does not provide immediate relief from angina-related chest pain.

2. WHAT YOU SHOULD 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 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 enough blood to the body)
If you suffer from heart failure following a heart attack

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

ketoconazole, itraconazole (antifungal medicines)
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV)
rifampicin, erythromycin, clarithromycin (antibiotics)
Hypericum perforatum (St. John's wort)
verapamil, diltiazem (heart medicines)
dantrolene (infusion for severe body temperature disorders)
simvastatin (cholesterol-lowering medicine)

Natam may lower your blood pressure even more if you are already taking other medicines for the treatment of hypertension.
Natam with food and drinks
People taking Natam should not drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, which could enhance the hypotensive effect of Natam.
Pregnancy and Breast-feeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you are pregnant or are planning a pregnancy, inform your doctor before taking Natam.
Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breast-feeding or planning to breast-feed, you must inform your doctor before taking Natam.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Natam may affect your ability to drive or operate machinery. If the tablets cause you discomfort, dizziness, fatigue, or headache, avoid driving or operating machinery and contact your doctor immediately.
Natam contains lactose
This product contains lactose. It must not be taken by patients with hereditary lactose intolerance or glucose/galactose malabsorption.

3. HOW TO TAKE NATAM

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual starting dose is Natam 5 mg once daily. The dose may be increased to Natam 10 mg once daily.
This medicine may be taken before or after food and drinks. You should take the medicine every day at the same time with some 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 daily. The maximum recommended daily dose is 5 mg. Natam 5 mg tablets may be divided into two equal parts to achieve a 2.5 mg dose.
Continue taking the tablets for as long as your doctor has instructed. Contact your doctor before stopping the tablets.
If you take more Natam 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 amount 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 your usual time. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Natam
You must continue taking the medicine for as long as your doctor has told you. 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 ADVERSE REACTIONS

Like all medicines, Natam may cause 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 skin rash, urticaria, widespread skin redness, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
Myocardial infarction, arrhythmia
Pancreatic inflammation which may cause severe abdominal and back pain accompanied by a strong feeling of malaise

The following common adverse reactions have been reported. If any of these occur or persist for more than one week, consult your doctor.
Common: may occur in 1 to 10 patients out of 100:

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

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 occur in 1 to 10 patients out of 1,000:

Palpitations (awareness of heartbeat)
Mood changes, anxiety, depression, insomnia
Tremor, altered taste, fainting, weakness
Numbness or tingling sensation in limbs; loss of pain sensitivity
Visual disturbances, double vision, tinnitus
Low blood pressure
Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
Changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting
Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
Urinary disorders, nocturia, frequent need to urinate
Inability to achieve an erection; discomfort or breast enlargement in men
Weakness, pain, malaise
Joint or muscle pain, muscle cramps, back pain
Weight gain or weight loss

Rare: may occur in 1 to 10 patients out of 10,000:

Confusion

Very rare: may occur in fewer than 1 patient out of 10,000:

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
Cough, swollen gums
Abdominal swelling (gastritis)
Abnormal liver function, liver inflammation (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 associated with skin rash
Light sensitivity
Disorders related to stiffness, tremor, and/or movement disturbances

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
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 NATAM

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.
Tablets
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

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

Description of the appearance of Natam and pack contents
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 are available in blisters containing 28 divisible tablets.
Natam 10 mg tablets are available in blisters containing 14 divisible tablets.

Marketing Authorization Holder and Manufacturer
LANOVA FARMACEUTICI S.r.l. – Via Conca D’Oro, 212 – 00141 Rome, Italy

Manufacturer
Special Product's Line S.P.A. -
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy

Batches identified by numbers only are manufactured at:

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

Batches identified by letters and numbers are manufactured at:

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