Package leaflet: information for the patient

AMLODIPINA DOC Generici 5 mg tablets, 10 mg tablets

Generic 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What AMLODIPINA DOC Generici tablets are and what they are used for
What you need to know before taking AMLODIPINA DOC Generici tablets
How to take AMLODIPINA DOC Generici tablets
Possible side effects
How to store AMLODIPINA DOC Generici tablets
Contents of the pack and other information

1. What AMLODIPINA DOC Generici tablets are and what they are used for

AMLODIPINA DOC Generici tablets contain the active substance amlodipine, which belongs to a group of
medicines called calcium antagonists.
AMLODIPINA DOC Generici tablets are 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 hypertension, this medicine works by relaxing the blood vessels, allowing blood to flow more
easily. In patients with angina, AMLODIPINA DOC Generici tablets improve 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.

2. What you should know before taking AMLODIPINA DOC Generici tablets

Do not take AMLODIPINA DOC Generici tablets:

If you are allergic to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to any of the 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 heart's aortic 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
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
AMLODIPINA DOC Generici tablets have not been studied in children under 6 years of age.
AMLODIPINA DOC Generici tablets 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 AMLODIPINA DOC Generici tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
AMLODIPINA DOC Generici tablets may affect other medicines, or other medicines may affect AMLODIPINA DOC Generici tablets, 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 disturbances in body temperature)
tacrolimus (a medicine used to modify the way the immune system works, allowing your body to accept a transplanted organ)
clarithromycin (for infections caused by bacteria)
simvastatin (a medicine used to lower cholesterol in the blood)
ciclosporina (a ciclosporin, an immunosuppressant)

AMLODIPINA DOC Generici tablets may lower blood pressure even more if you are already taking other medicines for the treatment of hypertension.
AMLODIPINA DOC Generici tablets with food and drink
People taking AMLODIPINA DOC Generici tablets should not drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, which could lead to an increased hypotensive effect of AMLODIPINA DOC Generici tablets.
Pregnancy and breastfeeding
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 AMLODIPINA DOC Generici tablets.
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 AMLODIPINA DOC Generici tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
AMLODIPINA DOC Generici tablets may affect your ability to drive or operate machinery. If the tablets cause you discomfort, dizziness or fatigue, or give you headaches, avoid driving or operating machinery and contact your doctor immediately.
AMLODIPINA DOC Generici tablets contain lactose monohydrate
These tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take AMLODIPINA DOC Generici tablets

Take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or
pharmacist.
The recommended starting dose is AMLODIPINA DOC Generici 5 mg once daily. The dose may
be increased to AMLODIPINA DOC Generici 10 mg once daily.
This medicine can be taken before or after food and drinks. Take the tablet every day at the same
time with a glass of water. Do not take AMLODIPINA DOC Generici tablets 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. Amlodipine 2.5 mg is not currently available, and a 2.5 mg dose cannot be obtained using AMLODIPINA DOC Generici 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. Contact your doctor before stopping the treatment.
If you take more AMLODIPINA DOC Generici tablets 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 too many AMLODIPINA DOC Generici tablets, contact your doctor immediately.
If you forget to take AMLODIPINA DOC Generici tablets
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 AMLODIPINA DOC Generici tablets
You must continue taking this medicine for as long as your doctor has prescribed. 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 everyone gets them.
If you notice any of the following very rare and serious side effects, consult your doctor immediately:

Sudden onset of breathlessness, chest pain, shortness of breath 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, hives, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
Heart attack, arrhythmia
Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of malaise

The following very common side effect has been reported. If this causes you problems or if it lasts for more than one week, consult your doctor.
Very common: may affect more than 1 in 10 people

Edema (fluid retention)

The following common side effects have also been reported. If any of these cause you problems 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 your heartbeat), flushing
Abdominal pain, feeling unwell (nausea)
Changes in bowel habits, diarrhoea, constipation, indigestion
Tiredness, 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 effects 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 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 (feeling unwell)
Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
Urinary problems, increased need to urinate at night, frequent need to urinate
Inability to achieve an erection; discomfort or breast enlargement in men
Pain, discomfort
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 white blood cell counts, reduced number of platelets in the blood which may lead to unusual bruising or tendency to bleed
High blood sugar levels (hyperglycaemia)
A nerve disorder which may cause weakness, tingling or numbness
Swelling of the gums
Abdominal swelling (gastritis)
Liver function abnormalities, 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 face, 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AMLODIPINA DOC Generici tablets

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
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.
Do not dispose of medicines 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 AMLODIPINA DOC Generici tablets contain
The active substance is amlodipine.
AMLODIPINA DOC Generici 5 mg tablets contain amlodipine besylate equivalent to 5 mg of amlodipine per tablet.
AMLODIPINA DOC Generici 10 mg tablets contain amlodipine besylate equivalent to 10 mg of amlodipine per tablet.
The other components are:
Microcrystalline cellulose, lactose monohydrate, maize starch and magnesium stearate (E470B).

Description of the appearance of AMLODIPINA DOC Generici tablets and package contents
AMLODIPINA DOC Generici tablets are tablets.
AMLODIPINA DOC Generici 5 mg tablets are round, almost white to white. The tablets are engraved with "APO" and "AML" on one side and "5" on the other side.
AMLODIPINA DOC Generici 10 mg tablets are round, almost white to white. The tablets are engraved with "APO" on one side and "AML" and "10" on the other side.
AMLODIPINA DOC Generici 5 mg tablets are available in aluminum/PVC/PVDC blisters containing 28 and 30 tablets.
AMLODIPINA DOC Generici 10 mg tablets are available in aluminum/PVC/PVDC blisters containing 14 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturer
Lamp S. Prospero S.p.A.
Via della Pace, 25/A, San Prospero (MO),
Italy
S.I.I.T. S.r.l.
Via L. Ariosto, 50/60, Trezzano Sul Naviglio (MI),
Italy
Apotex Nederland BV
Archimedesweg 2
2333 CN Leiden
The Netherlands
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Follereau, 25
24027 Nembro (Bergamo)
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands:
Amlodipine Apotex 5 mg, Tabletten
Amlodipine Apotex 10 mg, Tabletten
Italy:
AMLODIPINA DOC Generici 5 mg tablets
AMLODIPINA DOC Generici 10 mg tablets