ALMIDIS 10 mg Tablets

Зміст інструкції

1. ALMIDIS 5 mg tablets, 10 mg tablets
   1. What is ALMIDIS and what is it used for
   2. What you need to know before taking ALMIDIS
   3. How to take ALMIDIS
   4. Possible side effects
   5. How to store ALMIDIS
   6. Contents of the pack and other information

ALMIDIS 5 mg tablets, 10 mg tablets

Amlodipine
Generic medicine

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 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. See section 4.

Contents of this leaflet:

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

1. What is ALMIDIS and what is it used for

Almidis contains the active substance amlodipine which belongs to a group of medicines called
calcium antagonists.
Almidis 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, Almidis improves the blood supply to the heart muscle
which receives more oxygen and thus prevents chest pain. This medicine does not provide an
immediate relief from chest pain due to angina.

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 channel blockers. The reaction may be itching, skin redness or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide the body with sufficient blood).
• If you suffer from heart failure following a heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALMIDIS.
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 dose may need 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Almidis can have effects on other medicines or other medicines can have effects on Almidis, 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 in body temperature)
• simvastatin (medicine used to reduce cholesterol)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to change the way the immune system works)
• cyclosporine (an immunosuppressant).

Almidis may reduce blood pressure even further if you are already taking other
medicines to treat hypertension.

Almidis with food and drink
People taking Almidis should not drink grapefruit juice as grapefruit and grapefruit juice can increase the levels of the active ingredient amlodipine in the blood, and this may
lead to an increase in the hypotensive effect of Almidis.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, 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 believe you are pregnant or are
planning a pregnancy, inform your doctor before taking Almidis.

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

Driving and using machines
Almidis may have an effect on your ability to drive or operate machinery. If the tablets make you feel
unwell, dizzy or tired, or give you a headache, avoid driving or operating 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended initial dose is Almidis 5 mg once a day. The dose may be increased to
Almidis 10 mg once a day.
This medicine can be taken before or after food and beverages. You must take this medicine every
day at the same time with some water. Do not take Almidis with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the recommended initial dose is 2.5 mg per day.
The recommended maximum daily dose is 5 mg per day.
The 2.5 mg dose of amlodipine is not currently available and cannot be obtained with Almidis 5 mg
tablets as these tablets are not manufactured in such a way as to be divided into two equal parts.
It is important to continue taking the tablets for as long as indicated by your doctor. See your
doctor before stopping the tablets.

If you take more ALMIDIS than you should
If you should take an excessive number of tablets, your blood pressure may drop too low and this
may be dangerous. You may experience dizziness, confusion, weakness or fainting. The drop
in blood pressure may be so severe as to cause you 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 taking the medicine.
If you have taken an excessive number of 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 a missed dose.

If you stop taking ALMIDIS
Your doctor will tell you how long to take the medicine. Your condition may recur if you
stop treatment before your doctor tells you to do so.
If you have any further questions on the use of 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 side effects, consult your doctor immediately:

• Sudden onset of 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, urticaria, widespread skin redness, severe itching, blisters, scaling and skin swelling, 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 combined with a feeling of severe malaise

The following very common side effectshave been reported. If any of these effects occur or if they

persistfor more than a week, consult yourdoctor.
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 persist
for more than a week, consult yourdoctor.
Common (may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling your heartbeat), flushing
• Abdominal pain, nausea
• Altered bowel habits, diarrhea, 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, altered taste, fainting
• Sensation of numbness or tingling in the limbs; loss of pain sensation
• Tinnitus (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, 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
• 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 lead to unusual bruising or a tendency to bleed
• High blood sugar levels (hyperglycemia)
• A nervous disorder that can cause muscle weakness, tingling or numbness
• Swelling of the gums (gingival hyperplasia), bleeding gums
• Stomach swelling (gastritis)
• Abnormal liver function, liver inflammation (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 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 ALMIDIS

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 packaging after Expiry. The expiry date
refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater 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 Almidis contains

Almidis 5 mg tablets

• The active ingredient is amlodipine: one tablet contains 5 mg of amlodipine (as besilate).
• The other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate

Almidis 10 mg tablets

• The active ingredient is amlodipine: one tablet contains 10 mg of amlodipine (as besilate).
• The other ingredients 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 is available in packs of 28 tablets in PVC/PVDC/Al blisters.
Almidis 10 mg tablets is available in packs of 14 tablets in PVC/PVDC/Al blisters.

Marketing Authorisation Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (Potenza)

Manufacturer
Doppel Farmaceutici S.r.l -Via Volturno, 48 – 20089 Quinto dé Stampi (Rozzano) - Milano