Amlodipine Almus

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine Almus 5 mg tablets, 10 mg tablets

Equivalent 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Amlodipine Almus is and what it is used for

Amlodipine Almus contains the active substance amlodipine, which belongs to a group of medicines
called calcium antagonists.
Amlodipine Almus is used to treat high blood pressure (hypertension) or a type of chest pain called angina, including a rare form known as Prinzmetal's 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, Amlodipine Almus improves blood supply to the heart muscle, delivering 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 Amlodipine Almus

Do not take Amlodipine Almus tablets

• If you are allergic (hypersensitive) 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 sufficient blood to the body).
• If you have heart failure following a heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine Almus.
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 Almus has not been studied in children under 6 years of age. Amlodipine Almus 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 Amlodipine Almus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Amlodipine Almus may affect other medicines, or other medicines may affect Amlodipine Almus, 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 disturbances in body temperature)
• simvastatin (a cholesterol-lowering medicine)
• tacrolimus (used to control the immune response, to allow the body to accept a transplanted organ)
• ciclosporin (an immunosuppressant). Amlodipine Almus may lower blood pressure even further if you are already taking other medicines for the treatment of hypertension.

Amlodipine Almus with food and drink
People taking Amlodipine Almus should not drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, which could lead to an increased hypotensive effect of Amlodipine Almus.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are 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 Amlodipine Almus.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or are about to start breastfeeding, you must inform your doctor before taking Amlodipine Almus.
Driving and using machines
Amlodipine Almus may affect your ability to drive or use machinery. If the tablets cause you discomfort, dizziness, fatigue, or headache, avoid driving or using machinery and contact your doctor immediately.
Amlodipine Almus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Amlodipine Almus

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended starting dose of Amlodipine Almus is 5 mg once daily. The dose may be
increased to Amlodipine Almus 10 mg once daily.
This medicine can be taken before or after food and drinks. You should take this medicine every
day at the same time, with a glass of water. Do not take Amlodipine Almus with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the recommended starting dose is 2.5 mg daily.
The maximum recommended daily dose is 5 mg. Amlodipine Almus 5 mg tablets may be
split into two equal parts to achieve a dose of 2.5 mg.
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 Amlodipine Almus than you should
If you take too many tablets, your blood pressure could 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 breathlessness, which may
develop 24–48 hours after ingestion.
If you have taken too many Amlodipine Almus tablets, contact your doctor immediately.
If you forget to take Amlodipine Almus
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 Amlodipine Almus
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 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 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, irregular heartbeat
• Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of malaise

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

• Swelling of the ankles (oedema)

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 your heartbeat), flushing
• Abdominal pain, nausea
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Tiredness, weakness
• Visual disturbances, double vision
• Muscle cramps
• Hot flushes

In addition, the following side effects have also been reported.

If any of the side effects worsen, or if you notice any side effect 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 pain sensation
• 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, skin itching, red patches on the skin, skin discolouration
• Urinary problems, need to urinate at night, frequent need to urinate
• Inability to achieve an erection; breast discomfort or 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 levels of white blood cells and platelets in the blood which may result in unusual bruising or tendency to bleed (damage to red blood cells)
• High blood sugar levels (hyperglycaemia)
• A nerve disorder which may cause weakness, tingling or numbness
• Swollen gums
• Inflammation of the stomach lining (gastritis)
• Liver function abnormalities, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain laboratory 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 the available data

• Tremor, rigid posture, mask-like facial expression, slow movements and 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 Amlodipine Almus

Keep this medicine out of the sight and reach of children.
Do not use Amlodipine Almus after the expiry date which is stated on the carton or bottle/blister after
Exp. The expiry date refers to the last day of the 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. Contents of the pack and other information

What Amlodipine Almus contains
The active substance is amlodipine (as amlodipine besilate).
Amlodipine Almus 5 mg: One tablet contains 5 mg of amlodipine (as amlodipine besilate).
Amlodipine Almus 10 mg: One tablet contains 10 mg of amlodipine (as amlodipine besilate).
The other excipients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, magnesium stearate,
sodium carboxymethylstarch (type A).

Description of the appearance of Amlodipine Almus and contents of the pack
Amlodipine Almus 5 mg tablets: White, uncoated, round, flat tablet (8 mm) with a score line on one side and AB5 engraved on the other side. The tablet can be divided into two equal parts.
Amlodipine Almus 10 mg tablets: White, uncoated, round, flat tablet (10 mm) with a score line on one side and AB10 engraved on the other side. The tablet can be divided into two equal parts.

Pack sizes:
5 mg tablets:
Blister packs: 14, 20, 28, 30, 50, 100 and 300 (30x10) tablets.
Bottles: 14, 20, 28, 50, 100 and 300 (30x10) tablets.

10 mg tablets:
Blister packs: 14, 20, 28, 30, 50, 100 and 300 (30x10) tablets.
Bottles: 14, 20, 28, 50, 100 and 300 (30x10) tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Almus S.r.l.
Via Cesarea, 11/10 - 16121 Genoa (Italy)

Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovska Shosse Str. - Dupnitsa 2600 (Bulgaria)

This medicinal product is authorized in the European Economic Area member states under the following names:
Italy - Amlodipine Almus 5 mg tablets
Italy - Amlodipine Almus 10 mg tablets