Amlodipine Almus Pharma

PACKAGE LEAFLET

Package leaflet: information for the patient

Amlodipine Almus Pharma 5 mg tablets, 10 mg tablets

Equivalent medicine
Please read this leaflet carefully before 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, consult 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 those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

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

2. What you need to know before taking Amlodipine Almus Pharma

Do not take Amlodipine Almus Pharma

• 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 a 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
Talk to your doctor or pharmacist before taking Amlodipine Almus Pharma.
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
• You are elderly and your dose needs to be increased

Children and adolescents
Amlodipine Almus Pharma has not been studied in children under 6 years of age. Amlodipine Almus Pharma 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 Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Amlodipine Almus Pharma may affect other medicines, or other medicines may affect Amlodipine Almus Pharma, 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 disturbances in body temperature)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the way the immune system works)
• simvastatin (a medicine to lower cholesterol)
• ciclosporin (an immunosuppressant).

Amlodipine Almus Pharma may lower blood pressure even more if you are already taking other medicines for high blood pressure.
Amlodipine Almus Pharma with food and drinks
People taking Amlodipine Almus Pharma should not drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Almus Pharma.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, you must inform your doctor before taking Amlodipine Almus Pharma.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or are planning to breastfeed, you must inform your doctor before taking Amlodipine Almus Pharma.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine Almus Pharma may affect your ability to drive or use machinery. If the tablets make you feel unwell, dizzy or tired, or cause you to have headaches, do not drive or use machinery and contact your doctor immediately.
Amlodipine Almus Pharma 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 Pharma

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 of Amlodipine Almus Pharma is 5 mg once daily. The dose of Amlodipine Almus Pharma may be increased to 10 mg once daily.
This medicine can be taken before or after food and drink. You should take this medicine every day at the same time with a glass of water. Do not take Amlodipine Almus Pharma with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the usual recommended starting dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily.
Amlodipine Almus Pharma 5 mg tablets may be divided into two equal parts to obtain a dose of 2.5 mg.

It is important to continue taking the tablets for the length of time prescribed by your doctor. Contact your doctor before stopping the tablets.

If you take more Amlodipine Almus Pharma than you should
If you take too many tablets, your blood pressure could drop too much, which could be dangerous. You may feel dizzy, lightheaded, weak, or you may faint. 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 Amlodipine Almus Pharma tablets, contact your doctor immediately.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathlessness, which may develop up to 24–48 hours after ingestion.

If you forget to take Amlodipine Almus Pharma
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 Pharma
Your doctor will tell you how long to take this medicine. Your condition may return if you stop treatment before your doctor advises you to do so.

If you have any questions about how to use this medicine, ask 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 after taking this medicine, consult your doctor immediately:

• Sudden onset of wheezing, chest pain, breathlessness, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat which may cause severe breathing difficulties
• Severe skin reactions including intense rash, hives, widespread skin redness, 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 accompanied by a strong feeling of malaise.

The following very common side effect has been reported. If this side effect causes you problems or persists 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 side effects cause you problems 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
• 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 the limbs; loss of pain sensation
• Ringing in the ears (tinnitus)
• 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 colour changes
• Urinary disorders, increased need to urinate at night, frequent need to urinate
• Inability to achieve an erection; breast discomfort or 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 result in unusual bruising or tendency to bleed
• High blood sugar levels (hyperglycaemia)
• A nerve disorder which may cause muscle weakness, tingling, or numbness
• Swollen gums, 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 laboratory tests
• Increased muscle tension
• Inflammation of blood vessels, often associated 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 unbalanced, shuffling gait

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. 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 Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect the medicine from light.
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. Pack contents and other information

What Amlodipine Almus Pharma contains

• The active substance is amlodipine. Each tablet contains amlodipine besilate equivalent to 5 mg or 10 mg of amlodipine.
• The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium glycolate starch type A and magnesium stearate.

Description of the appearance of Amlodipine Almus Pharma and pack contents
Amlodipine Almus Pharma 5 mg tablets are round tablets (approximately 7.50 mm in diameter), white to off-white in colour, marked with "TV" on one side and "5" and a score line on the other side.
Amlodipine Almus Pharma 10 mg tablets are round tablets (approximately 9.50 mm in diameter), white to off-white in colour, marked with "TV" on one side and "10" and a score line on the other side.
Amlodipine Almus Pharma 5 mg tablets are available in blisters containing 28 tablets.
Amlodipine Almus Pharma 10 mg tablets are available in blisters containing 14 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea, 11/10
16121 Genoa
Italy
[email protected]

Manufacturer
Teva Gyógyszergyár Zrt.
Pallagi út 13
4042 Debrecen
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Amlodipine Almus Pharma 5 mg tablets
Amlodipine Almus Pharma 10 mg tablets
Netherlands: Berturamer 5 mg, tabletten
Berturamer 10 mg, tabletten