Package leaflet: Information for the user

ALMIDIS 5 mg tablets, 10 mg tablets

Amlodipine
Equivalent medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ALMIDIS is and what it is used for

Almidis contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Almidis is used to treat high blood pressure (hypertension) or a type of chest pain known as angina, including a rare form called Prinzmetal's or variant angina.
In patients with high blood pressure, this medicine works by relaxing the blood vessels, allowing blood to flow more easily. In patients with angina, Almidis improves 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 need to know before taking ALMIDIS

Do not take ALMIDIS

If you are allergic to amlodipine, or to any of the other ingredients of this medicine listed in section 6, or to any other 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
Talk to your doctor or pharmacist before taking ALMIDIS.
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 dose needs to be increased

Children and adolescents
Amlodipine has not been studied in children under 6 years of age. ALMIDIS 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 ALMIDIS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
ALMIDIS may affect other medicines or other medicines may affect ALMIDIS, such as:

ketoconazole, itraconazole (antifungal medicines)
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV)
rifampicin, erythromycin, clarithromycin (antibiotics)
Hypericum perforatum (St. John's wort)
verapamil, diltiazem (heart medicines)
dantrolene (infusion for severe body temperature disorders)
simvastatin (a medicine used to lower cholesterol)
tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the way the immune system works)
cyclosporine (an immunosuppressant).

ALMIDIS may lower your blood pressure even more if you are already taking other
medicines for the treatment of hypertension at the same time.
ALMIDIS with food and drink
People taking ALMIDIS should not drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, which could lead to an enhanced hypotensive effect of ALMIDIS.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or 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 are pregnant or are planning a pregnancy, inform your doctor before taking ALMIDIS.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you must inform your doctor before taking ALMIDIS.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
ALMIDIS may affect your ability to drive or use machinery. If the tablets cause you discomfort, dizziness or tiredness, or give you headaches, avoid driving or using machinery and contact your doctor immediately.
ALMIDIS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take ALMIDIS

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended starting dose is Almidis 5 mg once daily. The dose may be increased to
Almidis 10 mg once daily.
This medicine can be taken before or after food and drink. Take this medicine every
day at the same time with a glass of water. Do not take Almidis 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 maximum recommended daily dose is 5 mg daily.
The 2.5 mg amlodipine dose is currently unavailable and cannot be obtained with Almidis 5 mg
tablets, as these tablets are not manufactured to be split into equal halves.
It is important to continue taking the tablets for the entire duration indicated by your doctor. Contact
your doctor before stopping the tablets.
If you take more Almidis than you should
If you take too many tablets, your blood pressure may drop too low, which could be dangerous. You may experience dizziness, mental confusion, 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.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.
If you have taken too many Almidis tablets, contact your doctor immediately.
If you forget to take Almidis
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 Almidis
Your doctor will tell you how long to take the medicine. Your condition may return if you
stop treatment before your doctor tells you to do so.
If you have any questions about using 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 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 rash, hives, redness of the skin all over the body, intense itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
Heart attack, irregular heartbeat
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 persist 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 been reported. If any of these occur or persist 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), flushing
Abdominal pain, nausea
Changes in bowel habits, diarrhoea, constipation, indigestion
Swollen ankles
Fatigue, weakness
Visual disturbances, double vision
Muscle cramps

In addition, the following side effects have been reported.
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 sensitivity
Ringing in the ears
Low blood pressure
Sneezing/runny nose due to inflammation of 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; 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
High blood sugar levels (hyperglycaemia)
A nerve disorder which may cause muscle weakness, tingling, or numbness
Swollen gums (gingival hyperplasia), bleeding gums
Abdominal swelling (gastritis)
Liver dysfunction, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to abnormalities 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 disturbances

Not known (frequency cannot be estimated from 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 ALMIDIS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp." The expiry date refers to the last day of that month.
Do not store above 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 Almidis contains
Almidis 5 mg tablets

The active substance is amlodipine: one tablet contains 5 mg of amlodipine (as besylate).
Other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.

Almidis 10 mg tablets

The active substance is amlodipine: one tablet contains 10 mg of amlodipine (as besylate).
Other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.

Description of the appearance of Almidis and contents of the pack
White octagonal tablets with a score line.
Almidis 5 mg tablets are available in packs of 28 tablets in PVC/PVDC/Al blisters.
Almidis 10 mg tablets are available in packs of 14 tablets in PVC/PVDC/Al blisters.

Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (Potenza)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 – 20089 Quinto de Stampi (Rozzano) - Milano